Making Medicine: Recent Episodes
Incubate Coalition
There's a scientific breakthrough in your medicine cabinet. But how did it get there? At a time when medicines are helping us all live longer and healthier lives, this podcast will explore where these taken-for-granted miracles come from, how many of them almost never happened, where the life science ecosystem is taking us next, and most importantly, what it means for patients. From chance meetings that led to new ideas, to risky investments that never pay off, hear from the people behind today's and tomorrow's treatments, vaccines, technologies, devices, and yes, cures. In this golden age of health discovery and innovation fueled by record breaking investment in the life sciences, we'll bring guests who really understand what it means to be Making Medicine.
🇺🇸 Every breakthrough medicine begins with a scientific discovery. But turning that discovery into a treatment that reaches patients*requires navigating one of the most challenging journeys in medicine.
Before a new therapy can change lives, promising science must attract funding, become a startup company, navigate years of development, survive the "Valley of Death," scale manufacturing, and ultimately secure the support of larger pharmaceutical companies capable of bringing lifesaving treatments to patients around the world.
In Episode 3 of How America Makes Medicine, John Stanford sits down with Sheila Mikhail, serial biotech entrepreneur and co-founder of AskBio, Bamboo Therapeutics, Chatham Therapeutics, and M34, to explore what it really takes to build a biotech company from groundbreaking science. Drawing from decades of experience gene therapy, Sheila shares how perseverance, early-stage investment, scientific innovation, and smart partnerships help move promising discoveries from university laboratories to patients.
We explore:
🔹 The real journey from scientific discovery to approved medicine
🔹 Why the "Valley of Death" threatens breakthrough innovations
🔹 How SBIR funding helps launch biotech startups
🔹 Why early-stage companies eventually partner with Big Pharma
🔹 The future of gene therapy and Alzheimer's research
🔹 Manufacturing innovation and lowering the cost of advanced medicines
🔹 America's biotechnology ecosystem and global competition
🔹 How AI could transform drug development
One of the conversation's strongest themes is that great science alone is never enough. Every successful medicine requires scientists, entrepreneurs, investors, regulators, and pharmaceutical companies working together to move discoveries from the laboratory to patients.
This episode is part of How America Makes Medicine, a special editorial series from the Making Medicine Podcast exploring the people, policies, discoveries, and innovations shaping the future of American medicine.
Watch the full episode and let us know your thoughts below ⬇️
Why do you think so many promising medical discoveries never become medicines?
Should America invest more in early-stage biotechnology?
What breakthrough technology will define the next generation of medicine?
Drop your thoughts in the comments below 👇
👍 Subscribe to the Making Medicine Podcast so you don't miss the next chapter of How America Makes Medicine, our seven-part documentary series celebrating 250 years of American pharmaceutical innovation.
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Timestamps
00:00 Patients Don't Care Where Medicine Comes From
00:35 Why Every Medical Breakthrough Needs an Entrepreneur
01:54 The Bayh-Dole Act and the Birth of Modern Biotech
04:40 How AskBio Was Founded
07:05 Betting on Gene Therapy Before Anyone Else
11:10 Building Biotech Companies Without Venture Capital
16:30 Why SBIR Funding Saves Medical Innovation
19:10 Is China Winning the Biotech Race?
24:20 Lower Drug Costs Through Better Innovation
26:10 AI, Gene Therapy & the Future of Drug Development
34:00 Making Gene Therapies Affordable Worldwide
39:10 When Should a Startup Partner With Big Pharma?
43:40 Lessons From Selling AskBio to Bayer
50:15 AI, Innovation & The Next Generation of Medicine
DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
HowAmericaMakesMedicine #biotech #genetherapy #drugdiscovery #medicalinnovation #healthcarepolicy #sbir #biotechnology #pharmaceuticalinnovation #innovation
🇺🇸 Every breakthrough medicine starts somewhere. Discover how research universities, NIH funding, and American innovation change lives.
Every new medicine’s journey begins long before it reaches a patient. In Episode 2 of our How America Makes Medicine series, John Stanford sits down with Kate Hudson of the Association of American Universities (AAU) to explain why research universities are one of America's greatest strategic advantages.
From federally funded NIH research to technology transfer, startups, biotechnology companies, and ultimately life-saving medicines, this conversation reveals the innovation pipeline that has powered American pharmaceutical leadership for generations.
The discussion explores why curiosity-driven research matters, how the Bayh-Dole Act transformed commercialization and why America faces increasing competition from China in scientific research and biotechnology.
Whether you're interested in biotech, healthcare policy, drug discovery, academic research, or the future of American competitiveness, this episode explains why basic research remains one of the country's most important long-term investments.
Topics include:
🔹 NIH and NSF research funding
🔹 Research universities and scientific discovery
🔹 Technology transfer and commercialization
🔹 Drug discovery and pharmaceutical innovation
🔹 Bayh-Dole Act
🔹 mRNA vaccines
🔹 Basic research versus applied research
🔹 America's biotechnology ecosystem
🔹 Competition with China
🔹 The future of scientific innovation
This episode is part of How America Makes Medicine, a seven-part series celebrating 250 years of American pharmaceutical innovation.
If you're passionate about biotechnology, pharmaceutical innovation, healthcare policy, scientific discovery, or the history of medicine, subscribe to the Making Medicine Podcast and follow How America Makes Medicine as we continue telling the story behind the medicines that have shaped our world.
Watch the full episode and let us know your thoughts below ⬇️
Why should taxpayers invest in basic scientific research?
Is America doing enough to maintain leadership in biotechnology?
What breakthrough medicine do you think will define the next 25 years?
Drop your thoughts in the comments below 👇
👍 Subscribe to the Making Medicine Podcast so you don't miss the next chapter of How America Makes Medicine, our seven-part documentary series celebrating 250 years of American pharmaceutical innovation.
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:
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Timestamps:
00:00 Why Research Universities Matter to American Pharmaceutical Innovation
01:28 Meet Kate Hudson of the Association of American Universities
04:20 The History of America's Research Universities
08:32 Why Universities Drive Scientific Discovery
10:42 NIH Funding, NSF Grants & Basic Research Explained
14:09 Why the Free Market Alone Won't Create Medical Breakthroughs
16:05 mRNA Vaccines Took Decades of Research
18:55 The True Return on Investment in Scientific Research
21:18 Why Scientific Talent Matters More Than Ever
24:10 OMB Proposal, NIH Grants & Research Stability
29:20 Why Uncertainty Slows Drug Discovery
33:12 Technology Transfer & How Universities Create Biotech Startups
35:40 Crossing the Valley of Death in Drug Development
38:10 Bayh-Dole, China & America's Innovation Advantage
41:58 Episode Wrap Up & Next Episode Preview
DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
HowAmericaMakesMedicine #biotech #drugdiscovery #ResearchUniversities #innovation #healthcarepolicy #science #pharmaceuticalinnovation #technologytransfer
🇺🇸 How America Makes Medicine begins with the remarkable story of 250 years of American pharmaceutical innovation.
Welcome to How America Makes Medicine, a new seven-part series from the Making Medicine Podcast celebrating 250 years of American pharmaceutical innovation.
As the United States celebrates its *250th anniversary, this inaugural episode of the series traces the extraordinary journey from the medicine chest of 1776 to today's breakthrough therapies. Throughout How America Makes Medicine, we'll explore the discoveries, scientists, entrepreneurs, manufacturers, regulators, and patients who transformed medicine from simple remedies into one of humanity's greatest achievements.
Part I of How America Makes Medicine follows some of the most significant milestones in pharmaceutical history, from the commercialization of insulin and the biotechnology revolution to monoclonal antibodies, HIV therapies, precision medicine, the Human Genome Project, gene therapy, and mRNA vaccines. Along the way, we examine why manufacturing, scientific collaboration, and decades of research are just as important as the discoveries themselves in bringing new medicines to patients.
This episode covers
🔹 How insulin changed diabetes from a fatal diagnosis into a manageable disease
🔹 The biotechnology revolution and recombinant DNA
🔹 The birth of modern biotech
🔹 Monoclonal antibodies and targeted medicine
🔹 HIV therapies and one of medicine's greatest public health successes
🔹 The Human Genome Project and precision medicine
🔹 Gene therapy and cell therapy
🔹 The decades of research behind mRNA vaccines
🔹 Why manufacturing, regulation, and scientific collaboration remain essential to the next generation of medical breakthroughs
Throughout How America Makes Medicine, we explore not only breakthrough discoveries but also the people, companies, manufacturers, researchers, regulators, and patients who made those discoveries possible. This seven-part documentary series celebrates 250 years of American pharmaceutical innovation and highlights how curiosity, entrepreneurship, manufacturing excellence, and scientific persistence continue to improve lives around the world.
If you're passionate about biotechnology, pharmaceutical innovation, healthcare policy, scientific discovery, or the history of medicine, subscribe to the Making Medicine Podcast and follow How America Makes Medicine as we continue telling the story behind the medicines that have shaped our world.
Catch the full episode and Join the Conversation ⬇️
Which medical breakthrough do you think has had the greatest impact on humanity?
What innovation do you believe will define the next generation of medicine?
Which chapter of pharmaceutical history would you like us to explore in a future episode?
Drop your thoughts in the comments below 👇
👍 Subscribe to the Making Medicine Podcast so you don't miss the next chapter of How America Makes Medicine, our seven-part documentary series celebrating 250 years of American pharmaceutical innovation.
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:
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Timestamps:
0:00 250 Years of American Pharmaceutical Innovation | Introduction
0:52 Benjamin Rush & Colonial Medicine | America's First Medical Innovator
2:32 American Apothecaries to Modern Drug Manufacturing
4:05 The U.S. Patent System & Pharmaceutical Innovation
5:06 FDA History | Frances Kelsey, Drug Safety & Public Trust
6:23 Eli Lilly, Insulin & the Birth of Modern Pharmaceutical Manufacturing
8:53 The Biotechnology Revolution | Recombinant DNA & Genentech
11:32 Monoclonal Antibodies, HIV Therapies & Modern Biopharmaceuticals
13:15 The Human Genome Project, Precision Medicine & Gene Therapy
14:45 mRNA Vaccines | Why Medical Breakthroughs Take Decades
16:08 The Five Pillars of American Pharmaceutical Innovation
17:35 Clinical Trials, Patients & The Next 250 Years of Medicine
19:40 How America Makes Medicine | Episode 2 Preview & Subscribe
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
HowAmericaMakesMedicine #pharmaceuticalinnovation #biotechnology #healthcareinnovation #humangenomeproject
🇺🇸 FDA leadership, China's growing role in clinical trials, NIH research, and biotechnology innovation are shaping the future of American medicine.
This week on the Making Medicine Podcast, John Stanford breaks down the latest developments in the search for the next FDA Commissioner, including the three reported finalists: Dr. Heidi Overton, White House health policy adviser; Dr. Jeffrey Vacirca, oncologist and CEO of New York Cancer & Blood Specialists; and Dr. Stephen Ferrara, Deputy Assistant Secretary of Defense for Health Affairs and former CIA Chief Medical Officer. John explores what the next FDA leader could mean for regulatory modernization, drug development, and the future of American biotechnology.
This episode covers:
🔹 The latest FDA Commissioner search and what the three finalists could mean for the agency
🔹 Congressional hearings on FDA modernization and biomedical innovation
🔹 China's rapid expansion in global clinical trials and growing biotech competitiveness
🔹 Patent eligibility reform, intellectual property protections, and the future of biotech investment
🔹 NIH research funding, research security, and protecting American scientific leadership
🔹 FDA Approvals Corner featuring new therapies from Rigel Pharmaceuticals, BeOne Medicines, AstraZeneca, Gilead Sciences, AbbVie, Haisco Pharmaceutical Group, Shionogi, Wockhardt, Bayer, GSK, and Viridian Therapeutics
From FDA leadership and congressional hearings to intellectual property, research security, and global competition with China, this episode examines the policy decisions shaping the future of biomedical innovation. John also highlights why protecting NIH-funded research, modernizing the FDA, and strengthening America's innovation ecosystem remain essential to delivering the next generation of medicines and improving patient access.
The episode concludes with another edition of FDA Approvals Corner, celebrating newly approved therapies across oncology, infectious disease, cardiovascular medicine, rare diseases, anesthesia, and diagnostic imaging, highlighting the continued progress being made for patients around the world.
Watch the full episode and Join the Conversation ⬇️
Who should lead the FDA?
How should America compete with China's growing biotech industry?
What role should NIH-funded research play in future drug development?
Drop your thoughts in the comments below 👇
👍 Like and subscribe for more conversations on biotechnology, healthcare policy, FDA news, clinical trials, pharmaceutical innovation, and life sciences.
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Timestamps:
00:00 Why American Biotech Matters
01:35 FDA Leadership Search
03:14 FDA & China Hearings
05:13 Clinical Trial Competition
06:25 Patent Reform Explained
07:52 NIH Research Security
08:58 Why NIH Funding Matters
09:19 FDA Approvals Corner
11:32 July FDA Outlook
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
fda #biotech #healthcarepolicy #clinicaltrials #NIH
Japan's biotech industry is at a crossroads. Drug pricing reform, clinical trials, venture capital investment, and life sciences policy are all in flux as the country tries to figure out its path forward.
This week on the Making Medicine Podcast, guest host John Guy, Incubate's Policy Director, is joined by John Gutierrez of Ascenta Capital and Josh Lipscomb, Incubate’s International Programs Manager, to recap their recent biotechnology delegation to Japan. After meeting with government officials, investors, startup founders, and policymakers across Tokyo, they discuss the challenges Japan faces in strengthening its biotech ecosystem and the open question of whether pharmaceuticals can become a bigger driver of economic growth.
This episode covers
🔹 Japan's biotech growth strategy — and its limitations
🔹 Drug pricing reform and the slow pace of pharmaceutical innovation
🔹 Drug lag and ongoing barriers to patient access
🔹 International clinical trials and the difficulty of attracting startup investment
🔹 Venture capital gaps in Japan's life sciences ecosystem
🔹 Takeaways from the BIO International Convention
One of the takeaways is that Japan has moved past simply acknowledging its biotech challenges and has started attempting policy reforms. The discussion explores whether changes to drug pricing, international clinical trial access, startup support, and venture capital could meaningfully accelerate innovation, or whether structural hurdles will continue to slow patient access to new medicines.
The conversation also touches on Japan's presence at the BIO International Convention, where government leaders, investors, and entrepreneurs made the case for the country as a destination for biotech investment — even as it continues to compete with more established markets. As global competition for innovation intensifies, it remains to be seen how much ground Japan can gain in the future of drug development.
Watch the full episode and Join the Conversation ⬇️
Can Japan become one of the world's leading biotech ecosystems?
Is drug pricing reform the key to attracting more biotech investment?
What lessons can other countries learn from Japan's approach to life sciences innovation?
Drop your thoughts in the comments below 👇
👍 Like and subscribe for more conversations on biotechnology, healthcare policy, drug pricing, venture capital, clinical trials, pharmaceutical innovation, and global life sciences.
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Tmestamps
00:00 Japan Drug Lag Explained
01:45 Japan's Biotech Growth Strategy
06:10 Drug Pricing Reform
08:24 Why Japan Misses New Medicines
11:42 Japan's Innovation Advantage
13:35 Building Japan's Startup Ecosystem
14:42 BIO International Convention
16:28 Japan's Global Investment Strategy
19:00 What's Next for Japan Biotech
22:44 Outro
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
biotech #Japan #DrugDevelopment #ClinicalTrials #HealthcarePolicy #Making Medicine
Georgia's life sciences industry is growing fast. Biotech manufacturing, clinical trials, workforce development, and healthcare policy are reshaping America's innovation economy.
This week on the Making Medicine Podcast, John Stanford sits down with Maria Thacker Goethe, President and CEO of Georgia Life Sciences, to discuss why Georgia has become one of the fastest-growing biotechnology hubs in the United States and what it will take to keep America globally competitive.
Fresh off the BIO International Convention, Maria shares how policy conversations have evolved from niche discussions to a central focus for biotech leaders. From clinical trial modernization and manufacturing investments to workforce shortages, drug pricing, and China's expanding biotechnology capabilities, she explains why policy decisions now directly influence innovation, investment, and patient access.
This episode covers:
🔹 Georgia's rise as a national life sciences and biomanufacturing hub
🔹 Why workforce development has become biotech's biggest challenge
🔹How universities, industry, and government are building the next generation of talent 🔹China's growing influence in biotechnology and global drug development
🔹Drug pricing, innovation, and protecting investment in breakthrough medicines
🔹 Operation Trial Blazer and the future of faster clinical trials
🔹Why collaboration remains America's greatest competitive advantage
One of the biggest takeaways is that biotechnology is no longer just about scientific discovery. It's about building an ecosystem where policy, workforce, capital, manufacturing, and research all work together. Maria explains why states like Georgia are proving that biotech leadership isn't limited to Boston or San Diego, and why strategic investments in people and infrastructure will determine America's future competitiveness.
Whether discussing clinical trial reform, rare disease innovation, or the balance between national security and global scientific collaboration, this conversation highlights how today's policy decisions will shape tomorrow's medical breakthroughs.
Watch the full episode and Join the Conversation ⬇️
Can Georgia become one of America's top biotech hubs?
What is the biggest challenge facing US biotech today: workforce, capital, or policy?
Should America focus more on innovation than restrictions to stay globally competitive?
Drop your thoughts in the comments below 👇
👍 Like and subscribe for more conversations on biotechnology, healthcare policy, FDA modernization, clinical trials, workforce development, drug pricing, life sciences investment, and healthcare innovation.
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true
Timestamps
00:00 Operation Trial Blazer & US Clinical Trials
05:01 BIO 2026 and US Biotech Competitiveness
08:46 Georgia's Life Sciences Growth
12:07 Building the Next Biotech Hub
18:15 Drug Pricing and Biotech Innovation
21:29 Operation Trial Blazer Reforms
22:11 China and US Biotech Competition
26:18 Biotech Workforce Development
30:06 Why Biotech Needs Skilled Trades
33:21 Georgia Life Sciences Summit
35:42 Closing Thoughts
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
biotech #lifesciences #healthcarepolicy #clinicaltrials #drugdevelopment
FDA instability is reshaping biotech investment decisions in real time. Investors are recalibrating risk, pulling back, and even shifting capital abroad.
In case you missed it: We are bringing one of our most critical recent conversations to unpack how regulatory uncertainty is shifting the future of medicine. FDA instability is reshaping biotech investment decisions in real time. Across the board, investors are recalibrating risk, pulling back on funding, and even shifting capital abroad.
In this episode of the Making Medicine Podcast, John Stanford is joined by Rachel Sher of Manatt Health to unpack new, original research conducted with investors across the biotech ecosystem. The goal was simple: move beyond speculation and understand whether recent leadership changes, staffing cuts, and policy uncertainty at the FDA are actually dictating investor behavior.
The signal is clear. Across venture capital, public equity, private equity, and industry investors, the vast majority agree that recent changes at the FDA have fundamentally altered how they allocate capital and view the attractiveness of U.S.-based drug development.
This Episode Covers Four Major Themes:
🔹 Regulatory Instability: Growing investor concern over shifting FDA standards.
🔹 Shifting Portfolios: A reduced appetite for funding complex product categories like gene therapy and vaccines.
🔹 Global Competition: Increasing attention and capital flowing toward China and other international markets.
🔹 The Innovation Pipeline: Broader fears that instability across agencies like the NIH and FDA will weaken long-term medical breakthroughs.
At the center of it all is one core issue: regulatory predictability. When investors lose confidence in policy clarity and institutional knowledge, the consequences extend far beyond individual companies—they dictate where innovation happens next.
Even with these concerns, investors still want to back innovation in the United States. The question is whether policymakers and regulators can restore the stability and trust that made the U.S. the global leader in biotech in the first place.
Watch for a grounded conversation on what investors are really saying, what it means for the biotech ecosystem, and why FDA predictability matters more than ever.
Check out the full report https://www.incubatecoalition.org/post/one-pager-complete-report-regulatory-instability-at-fda-is-reshaping-biotech-investment
Join the Conversation ⬇️
Do you think FDA instability is already changing the future of biotech investment?
Are investors right to look abroad when U.S. regulatory signals become less predictable?
What matters more right now: speed, stability, or scientific consistency?
Drop your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:
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👍 Like and subscribe for more biotech and healthcare policy coverage.
Time Stamps
00:00 Intro & Disclaimer
00:16 Investors Say FDA Changes Are Impacting Decisions
03:22 How We Surveyed Investors (Research Design)
07:27 Theme 1: FDA Instability & Investor Uncertainty
10:22 Investors Repricing Risk in Biotech
12:05 “Chaos Is the Only Thing” – Investor Quote
13:00 Theme 2: Pullback from Gene Therapy, Vaccines, Oncology
14:28 Theme 3: Capital Shifting Abroad (China & Competition)
17:02 Theme 4: NIH Cuts & Long-Term Innovation Risk
25:24 Key Takeaway: Regulatory Predictability Drives Investment
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
Biotech #FDA #BiotechInvesting #HealthcarePolicy #DrugDevelopment #makingmedicine
China's biotech innovation is accelerating. Clinical trials, NIH funding, and global competition are reshaping healthcare. Biocom’s President & CEO Tim Scott explains why America should focus on "playing to win" rather than "playing not to lose."
China’s biotech industry is moving faster than many policymakers realize. From investigator-initiated clinical trials and massive patient registries to government-backed investment strategies, China is rapidly becoming a major force in global drug development. This week on the Making Medicine Podcast, John Stanford sits down with Tim, fresh off a biotech delegation trip to Shanghai. He shares firsthand observations from China's rapidly growing life sciences ecosystem, what surprised him most, and what American biotech leaders should learn from the experience.
This Episode Covers
🔹 Why major pharmaceutical companies are increasingly sourcing innovation from China
🔹 How China’s investigator-initiated trial system accelerates drug development
🔹 The role of patient registries and trial-ready cohorts
🔹 Why China is becoming a global biotech powerhouse
🔹 The debate over biosecurity, protectionism, and global scientific collaboration
🔹 NIH funding, workforce development, and America’s innovation advantage
🔹 How the United States can remain the world leader in biotechnology
One of the most thought-provoking moments comes when Tim compares the biotech race to the New York Knicks' championship run, arguing that America must focus on "playing to win" through investment, innovation, NIH funding, and scientific leadership rather than simply "playing not to lose" by slowing competitors down. The analogy becomes a powerful framework for understanding the choices facing US policymakers as China continues to expand its role in global drug development.
The conversation ultimately challenges listeners to think beyond today's headlines and consider how the United States can maintain its leadership in biotechnology while continuing to deliver breakthrough medicines for patients around the world.
The question is no longer whether China matters in biotech. The question is how America responds.
Will the US continue playing to win through investment and innovation, or will it focus primarily on slowing competitors down?
Watch the full episode and Join the Conversation⬇️
Do you believe China is now a permanent biotech superpower?
Can the United States maintain its leadership in biomedical innovation?
Should scientific collaboration continue despite growing geopolitical tensions?
Let us know your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:
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👍 Like and subscribe for more biotech and healthcare policy coverage.
Timestamps
00:00 China Biotech Competition
01:00 California Life Sciences Leadership
07:45 Pharma Licensing Deals in China
13:10 China Clinical Trials Explained
20:00 Drug Pricing and Biotech Innovation
23:18 Shanghai Biotech Ecosystem
25:28 China's Biotechnology Growth Strategy
35:28 Biosecurity and US-China Biotech Policy
40:20 Playing to Win in Biotech
42:10 Knicks Analogy and Innovation Leadership
43:20 NIH Funding and American Innovation
47:35 AI, China and the Future of Biotechnology
49:58 Outro
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
Biotech #China #DrugDevelopment #ClinicalTrials #HealthcarePolicy
Rare diseases. Patient advocacy. Drug development. FDA partnerships. Clinical trials.
Patient organizations have evolved into powerful engines of drug development, building registries, funding research, shaping clinical trial design, and partnering with regulators to accelerate new treatments.
This week on the Making Medicine Podcast, John Stanford sits down with Lisa Bonebrake, Executive Director of the Alport Syndrome Foundation, and Janis Naeve, world-class VC and Co-Founder & Partner of Bright Frontier, to discuss the evolving, high-impact role of patient organizations in modern drug development.
Patient advocacy groups are building the critical data and clinical infrastructure required to advance medical research. Lisa shares how the Alport Syndrome Foundation is directly de-risking clinical trials, building global patient registries, and driving the ASCENT Initiative, a historic public-private partnership with the FDA to establish surrogate endpoints for kidney disease.
The discussion also explores the venture capital perspective with Janis Naeve, highlighting why investors view patient-led data infrastructure as a "highway" for innovation, how pharmaceutical companies can successfully integrate patient feedback into trial design, and why establishing clear regulatory pathways is vital to accelerating rare disease treatments.
This Episode Covers
🔹 Why patient advocacy groups are the new infrastructure of drug discovery
🔹 The real impact of Alport syndrome and the importance of early genetic testing
🔹 The ASCENT Initiative and establishing surrogate endpoints with the FDA
🔹 The impact of Alport syndrome and the importance of early genetic testing
🔹 Why pharmaceutical companies must include patient voices in clinical trial design
🔹 The venture capital perspective on funding rare disease innovation
🔹 Regulatory clarity and de-risking biotech investment
🔹 How public-private partnerships accelerate the timeline for lifesaving treatments
Patient advocates are no longer passive charities, they are the essential infrastructure of modern drug discovery. This conversation serves as a blueprint for the future of healthcare policy, exploring how rare disease organizations are partnering with the FDA, saving pharma millions by rescuing flawed clinical trials, and driving venture capital investment to accelerate lifesaving treatments.
Join the Conversation
⬇️ Should patient organizations have a larger role in shaping FDA regulatory pathways? What's the biggest obstacle preventing more rare disease drug development? How can policymakers better support patient-led research infrastructure?
Let us know your thoughts in the comments below 👇
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👍 Like and subscribe for more biotech and healthcare policy coverage.
Timestamps
0:00 - The Real ROI of Patient Advocacy
0:26 - Welcome to the Making Medicine Podcast
1:52 - Breaking News in Alport Syndrome Research
4:03 - What is Alport Syndrome? 5:58 - Redefining the Role of Patient Organizations
9:09 - A VC Investor’s Perspective on Rare Disease
11:38 - The ASCENT Initiative & FDA Public-Private Partnership
18:03 - Understanding Surrogate Endpoints in Clinical Trials
25:19 - How to Build a Fearless Patient Advocacy Group
30:26 - Why Pharma Needs to Listen Directly to Patients
35:31 - Educating the Biotech Industry on Patient Integration
39:35 - Key Takeaways for Policymakers and Investors
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
rarediseases #drugdevelopment #clinicaltrials #fda #biotech #patientadvocacy #makingmedicine #podcast
Healthcare costs. PBM reform. Drug price controls. FDA stability. American manufacturing.
This week on the Making Medicine Podcast, John Stanford sits down with Charles Crain, Vice President of Domestic Policy at the National Association of Manufacturers, to discuss a new report examining the rising cost of healthcare and its impact on American manufacturers.
Manufacturers provide health coverage to millions of workers, making healthcare affordability a major business concern. But according to NAM, the solution isn't limiting pharmaceutical innovation. Instead, the conversation focuses on PBM reform, 340B program transparency, regulatory certainty, preventative care, and policies that lower costs without undermining America's leadership in medical innovation.
The discussion also explores why FDA stability matters beyond the biotech sector, how regulatory uncertainty affects long-term investment, and what policymakers should prioritize to strengthen American competitiveness in the face of growing global competition.
This Episode Covers:
🔹 Why healthcare costs are manufacturers' top business concern
🔹Why NAM opposes pharmaceutical price controls
🔹The real drivers of rising healthcare costs
🔹PBM reform and prescription drug transparency
🔹The 340B program and hospital incentives
🔹Why FDA stability matters for innovation
🔹Regulatory certainty and biotech investment
🔹Manufacturing, R&D, and American competitiveness
🔹Lessons from COVID supply chain vulnerabilities
🔹How to compete with China through innovation
At the center of this conversation is a simple question: How do we lower healthcare costs without weakening the innovation ecosystem that develops new medicines? Charles Crain argues that affordability and innovation are not competing goals, and that policymakers should focus on the structural drivers of healthcare spending rather than policies that could reduce future medical breakthroughs.
Check out the NAM report: "Prescription for a Healthy Workforce: Manufacturers' Roadmap to Lower Healthcare Costs"
https://nam.org/issues/health-care/
Join the Conversation ⬇️
Are policymakers focusing on the right drivers of healthcare costs?
Should PBM reform be a higher priority than drug price controls?
What matters most for U.S. competitiveness: tax policy, regulatory certainty, or innovation incentives? Let us know your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're here!
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👍 Like and subscribe for more conversations on FDA policy, biotech investing, healthcare innovation, drug development, gene therapy, AI in medicine, and the future of biotechnology.
Timestamps
00:00 Intro & Disclaimer
00:37 Meet Charles Crain & NAM
01:03 Why Manufacturers Care About Healthcare Costs
03:24 Why Healthcare Costs Keep Rising
05:57 What NAM Would Do to Lower Costs
08:03 Why Manufacturers Oppose Drug Price Controls
09:20 The Innovation Tradeoff Explained
10:54 Understanding the 340B Program
13:16 PBMs & Healthcare Middlemen
15:09 How Powerful Are PBMs?
17:13 Why FDA Stability Matters
18:16 Regulatory Costs & Uncertainty
19:30 Why Biotech Needs Predictable Rules
20:43 Building Bipartisan Policy Solutions
23:18 Competing With China Through Innovation
25:12 Final Thoughts
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
healthcarepolicy #pbm #biotech #drugpricing #fda #manufacturing #makingmedicine
China and biotech competition. Drug pricing reform. The FDA. PBMs. America’s innovation economy.
This week on the Making Medicine Podcast, John Stanford sits down with Rep. Scott Peters to discuss the future of American biotech innovation, the importance of ending the “pill penalty,” and why China’s rapid rise in biotechnology is becoming a major strategic concern for the United States.
Representing one of the country’s leading biotech hubs in San Diego, Congressman Peters explains why policies tied to the Inflation Reduction Act and investment incentives directly impact whether innovative medicines get funded, developed, and brought to patients.
The conversation also explores the future of PBM reform, rare disease investment, FDA modernization, the workforce and scientific talent, supply chain security, and what policymakers must do to keep America competitive in biotech and life sciences innovation.
This episode covers:
🔹 Why San Diego became a biotech powerhouse
🔹 The “pill penalty” and the EPIC Act
🔹 How the IRA changed biotech investment incentives
🔹 Why rare disease investment rebounded after the ORPHAN Cures Act
🔹 China’s growing role in global biotech innovation
🔹 FDA modernization and regulatory competitiveness
🔹 Immigration, talent, and scientific leadership
🔹 PBM reform and healthcare affordability
🔹 Why diagnostics and genomics may transform healthcare
🔹 The importance of bipartisan problem-solving in healthcare policy
At the center of the discussion is one core issue: competitiveness. Congressman Peters argues that America’s advantage in biotech depends on stable investment incentives, strong scientific institutions, private-sector innovation, and policies that continue attracting talent and capital into the United States.
Check out more from Incubate Coalition:
https://www.incubatecoalition.org/
Join the Conversation ⬇️
Do you think the United States is doing enough to stay competitive with China in biotech innovation? Should Congress further reform the IRA to encourage more biotech investment and drug development?
What matters most for the future of American healthcare innovation: FDA modernization, PBM reform, or stronger investment incentives?
Let us know your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:
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👍 Like and subscribe for more conversations on FDA policy, biotech investing, healthcare innovation, drug development, gene therapy, AI in medicine, and the future of biotechnology.
Timestamps
00:00 Intro & Disclaimer
00:17 Why China Is Catching Up in Biotech
00:31 Meet Congressman Scott Peters
01:28 Why San Diego Became a Biotech Hub
03:24 The Role of NIH & Research Institutions
05:02 Venture Capital & Biotech Growth
07:06 The “Pill Penalty” Explained
08:05 The IRA & Medicare Drug Negotiation
09:25 Why Investment Incentives Matter
11:11 How Small Molecule Investment Was Affected
12:20 Political Risks of Supporting Biotech
15:17 Why Independence Still Matters in Congress
21:26 Rare Disease Investment & Orphan Cures Act
24:00 China’s Rise in Biotech Innovation
25:27 FDA Challenges & Global Competition
27:19 Immigration, Talent & Scientific Leadership
30:25 PBM Reform & Healthcare Costs 33:19 Diagnostics, Genomics & Preventive Medicine
34:19 Why Congress Needs Better Biotech Education
36:35 Closing Thoughts
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
fda #biotech #drugpricing #china #pbm #healthcarepolicy #innovation
What does the FDA actually look like on the inside — and why does its structure matter for drug approvals, rare disease therapies, and biotech investment?
This week on the Making Medicine Podcast, host John Stanford is joined by Jef Akst, senior editor at BioSpace, to break down the FDA's key divisions, what each one is responsible for, and how they shape the drug development landscape.
Jef walks through the roles of CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research) — what each center oversees, how they differ, and why their review processes matter to biotech companies navigating approval timelines. The episode also explains how FDA advisory committees work, what authority they hold, and how their recommendations influence regulatory outcomes.
The conversation then expands to the broader policy environment shaping biotech today — including CMS marketplace rule changes that affect patient cost exposure, Section 232 pharmaceutical tariff procedures, Most Favored Nation pricing, and the Orphan Cures Act.
The episode closes with data from the INCUBATE Coalition's biotech investment tracker, examining how IRA policy and regulatory uncertainty are influencing capital allocation across the life sciences sector.
Check out the full report from Manatt Health
https://www.incubatecoalition.org/post/one-pager-complete-report-regulatory-instability-at-fda-is-reshaping-biotech-investment
Check out INCUBATE'S biotech investment tracker
https://lifesciencetracker.com/
Join the Conversation ⬇️
Do you think FDA leadership turnover is creating too much uncertainty for biotech companies and investors?
Should the FDA rely more heavily on advisory committees and outside scientific experts during periods of instability?
How should policymakers balance lower healthcare premiums with the risk of higher out-of-pocket costs for patients?
Let us know your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:
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👍 Like, follow, and subscribe for more conversations on FDA policy, biotech innovation, healthcare regulation, drug pricing, rare disease development, and life sciences investment.
Time Stamps
00:00 Intro & Disclaimer
00:17 FDA Instability & Biotech Uncertainty
00:39 Meet BioSpace’s Jef Akst
01:51 FDA, HHS & RFK Jr. Influence
04:13 What CDER Does
05:55 Drug Delays & FDA Inconsistency
07:23 What CBER Does
10:33 Office of Therapeutic Products Turnover
13:08 FDA Commissioner’s Role Explained
15:17 Advisory Committees & Expert Panels
18:00 CMS ACA Rule Changes
19:24 Pharma Tariffs & MFN Pricing
21:06 Senator Bill Cassidy’s Primary Loss
22:50 New Biotech Investment Tracker Data
24:41 Rare Disease Investment Trends
25:17 Closing Thoughts
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
FDA #Biotech #HealthcarePolicy #DrugDevelopment #RareDisease #CMS #Pharma #LifeSciences #MFN #MakingMedicine
FDA instability. AI in clinical trials. China overtaking the United States in biotech development.
Following news that Marty Makary has stepped down as FDA commissioner, questions around regulatory stability, scientific leadership, and the future of biotech innovation are back in focus.
This week on the Making Medicine Podcast, John Stanford examines what the FDA needs most during periods of leadership transition: scientific credibility, regulatory expertise, and a stable, predictable process for developing new medicines.
Recorded before the latest leadership announcement, this episode focuses less on personalities and more on the broader institutional questions shaping the future of drug development, clinical trials, AI-enabled regulation, rare disease research, and America’s global competitiveness in biotech.
This episode covers:
This episode covers:
🔹 What Marty Makary’s departure could mean for the FDA
🔹 Why FDA stability matters for biotech investment
🔹 The qualities that define effective FDA leadership
🔹 AI, clinical trials, and the future of drug development
🔹 FDA modernization and new approach methodologies
🔹 Rare disease development and regulatory predictability
🔹 Why global biotech competition is accelerating
🔹 How FDA credibility impacts patients, investors, and innovation
At the center of the conversation is one core issue: confidence. Confidence that the FDA remains a science-driven institution capable of supporting innovation while ensuring drugs are safe and effective for American patients. Because uncertainty at the agency doesn’t just affect markets — it affects clinical timelines, capital allocation, and ultimately whether treatments reach patients.
Join the Conversation ⬇️
Do you think the FDA is becoming less predictable?
Should AI play a larger role in clinical trials?
Can America maintain its leadership in biotech innovation?
Let us know your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're
here! Follow us for more:
https://x.com/MakingMedPod
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https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true
https://www.tiktok.com/@makingmedicinepodcast?lang=en
👍 Like and subscribe for more conversations on FDA policy, biotech investing, healthcare innovation, drug development, gene therapy, AI in medicine, and the future of biotechnology.
Timestamps
00:00 Intro & Disclaimer
00:33 Why FDA Leadership Matters
01:00 FDA Leadership Shakeup Explained
01:50 Why FDA Stability Impacts Biotech
02:14 The Cost Of Regulatory Uncertainty
02:59 The Three Qualities Of A Strong FDA Commissioner
03:51 Why Regulatory Experience Matters
04:40 AI & The Future Of Clinical Trials
05:47 America’s Healthcare Data Problem
06:17 Why The FDA Must Lead On AI
06:41 The Limits Of FDA Authority
07:07 Why Investors Need Predictability
07:33 FDA Modernization & Innovation
07:55 Why This Matters For Patients
08:21 Rare Disease Patients & FDA Stability
08:41 Passage Bio’s FDA Setback
09:27 China Surpasses The U.S. In Drug Trials
10:09 What The Industry Wants From The FDA
10:32 Why Stable Regulation Matters
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
FDA #Biotech #AI #ClinicalTrials #HealthcarePolicy #RareDisease #GeneTherapy #DrugDevelopment #China #MakingMedicine
Gene therapy breakthroughs. The first oral GLP-1 pill. A troubling signal for scientific talent. And a German pricing move that could quietly reshape global drug development.
This week on the Making Medicine podcast, John Stanford breaks down four stories shaping the future of life sciences and biotech investment. From the FDA's landmark approval of Regeneron's gene therapy for genetic hearing loss to new survey data showing immigration policy is already influencing where top researchers choose to build their careers — the pressure on the innovation ecosystem is building from multiple directions at once.
This episode covers:
🔹 FDA Approvals Corner: Eli Lilly's Foundayo (first oral small-molecule GLP-1 for weight management), Regeneron's Otarmeni (gene therapy for genetic hearing loss), and Merck's Idvynso (once-daily HIV treatment).
🔹 Immigration policy and what a new STAT News survey says about the research pipeline.
🔹 Germany's drug discount proposal and why it complicates the U.S. Most Favored Nation pricing strategy.
At the center of all these conversations is one critical question: can the United States maintain the confidence, in its regulators, its talent pipeline, and its pricing environment, that keeps the biomedical innovation engine running?
Check out the full STAT News Report
https://www.statnews.com/2026/05/04/trump-immigration-policy-stat-survey-measures-science-impact/
Join the Conversation ⬇️
Do you think the FDA is becoming less predictable?
Should the US rethink its MFN drug pricing strategy?
Can America maintain its leadership in biotech innovation?
Let us know your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true
👍 Like and subscribe for more conversations on FDA policy, biotech investment, drug pricing, healthcare innovation, China competition, and national security.
Time Stamps
00:00 Intro & Disclaimer
00:17 Innovation Ecosystem Runs on Confidence
00:33 FDA, Germany & Biotech Headlines Preview
01:18 FDA Drug Approvals Roundup
01:41 Eli Lilly’s Oral GLP-1 Approval
02:16 Regeneron Gene Therapy Breakthrough
03:18 Immigration Policy & Scientific Talent Concerns
04:56 Germany Challenges MFN Drug Pricing
05:57 Why Global Drug Pricing Could Reshape Launch Strategy
06:49 Rare Disease Investment Risks
07:12 Germany vs Trump MFN Policy
08:08 Why Biotech Innovation Depends on Confidence
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
fda #biotech #drugpricing #glp1 #healthcarepolicy #mfn #germany #regeneron #EliLilly #MakingMedicine
Biotech is no longer just about medicine. It is now a frontline issue in national security, global competition, and economic independence.
In this episode of the Making Medicine Podcast, Senator Todd Young joins us to break down the growing risks of relying on China for critical biotech inputs, why FDA speed and regulatory clarity matter more than ever, and how the US can stay competitive in a rapidly shifting global landscape.
From supply chain vulnerabilities to AI-driven drug development, this conversation explores the intersection of policy, innovation, and national defense. Senator Young also shares insights on drug pricing, biotech investment, and why strengthening the full ecosystem from startups to large manufacturers is critical for long-term US leadership.
If the US fails to act, the consequences go far beyond healthcare. They shape who leads the next century of innovation.
At stake is not just faster cures, but whether America remains the global leader in biotech or falls behind.
Join the Conversation ⬇️
Should the US decouple biotech supply chains from China?
Can the FDA move faster without sacrificing safety?
What policy change would most strengthen US biotech leadership?
Drop your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're here!
Follow us for more:
https://x.com/MakingMedPod
https://www.instagram.com/makingmedicinepod/
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Time Stamps
00:00 Intro and disclaimer
00:17 Senator Young on China dependency risk
00:33 Meet Senator Todd Young
01:53 Why biotech is national security
03:23 Biotech’s role in defense, materials, and Department of War
04:17 Supply chain resiliency and China risk
05:16 Biotech threats, food security, and countermeasures
06:41 China, biotech standards, and global competition
08:04 Why innovators go abroad for speed and cost
08:46 FDA optimization, AI, and faster drug development
12:16 Indiana’s biotech ecosystem and Eli Lilly
16:32 Why small biotech and big pharma need each other
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
biotech #FDA #China #nationalsecurity #pharma #healthpolicy #innovation #senatortoddyoung
FDA instability is reshaping biotech investment decisions in real time. Investors are recalibrating risk, pulling back, and even shifting capital abroad.
In this episode of the Making Medicine Podcast, John Stanford is joined by Rachel Sher of Manatt Health to unpack new original research conducted with investors across the biotech ecosystem. The goal was simple: move beyond speculation and understand whether recent leadership changes, staffing cuts, and policy uncertainty at FDA are actually shaping investor behavior.
What emerged is a clear signal. Across venture capital, public equity, private equity, and industry investors, the vast majority said recent changes at FDA have altered how they think about risk, capital allocation, and the attractiveness of U.S.-based drug development.
This conversation walks through the four major themes that surfaced in the research: growing concern about regulatory instability, reduced appetite for certain product categories like gene therapy and vaccines, increasing attention to China and other international markets, and broader concern that instability across agencies like NIH and FDA could weaken the long-term innovation pipeline.
At the center of it all is one core issue: regulatory predictability. When investors lose confidence in consistency, policy clarity, and institutional knowledge, the consequences extend far beyond individual companies. They affect portfolios, research priorities, and where innovation happens next.
This episode also highlights something important. Even with all these concerns, investors still want to back innovation in the United States. The question is whether policymakers and regulators can restore the stability and trust that made the U.S. the global leader in biotech in the first place.
Watch for a grounded conversation on what investors are really saying, what it means for the biotech ecosystem, and why FDA predictability matters more than ever.
Check out the full report
https://www.incubatecoalition.org/post/one-pager-complete-report-regulatory-instability-at-fda-is-reshaping-biotech-investment
Join the Conversation ⬇️
Do you think FDA instability is already changing the future of biotech investment?
Are investors right to look abroad when U.S. regulatory signals become less predictable?
What matters more right now: speed, stability, or scientific consistency?
Drop your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
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Time Stamps
00:00 Intro & Disclaimer
00:16 Investors Say FDA Changes Are Impacting Decisions
03:22 How We Surveyed Investors (Research Design)
07:27 Theme 1: FDA Instability & Investor Uncertainty
10:22 Investors Repricing Risk in Biotech
12:05 “Chaos Is the Only Thing” – Investor Quote
13:00 Theme 2: Pullback from Gene Therapy, Vaccines, Oncology
14:28 Theme 3: Capital Shifting Abroad (China & Competition)
17:02 Theme 4: NIH Cuts & Long-Term Innovation Risk
25:24 Key Takeaway: Regulatory Predictability Drives Investment
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
#Biotech #FDA #BiotechInvesting #HealthcarePolicy #DrugDevelopment
FDA signals are starting to break down, and biotech is feeling it. One company is collapsing while another is breaking through.
As lawmakers return to Washington for a packed schedule of healthcare hearings, the conversation will be shaped by what’s happening inside the biotech ecosystem right now, both the breakthroughs and the breakdowns.
In this episode of Making Medicine, we connect the dots between what’s unfolding on Capitol Hill and what companies are experiencing on the ground.
We start with the policy backdrop: multiple hearings across the House and Senate, including appearances by HHS Secretary RFK Jr. and a renewed focus on drug pricing, FDA oversight, and the future of biomedical innovation.
Then we turn to two stories that highlight what’s at stake.
On one side is Replimune, a biotech facing layoffs and a collapsing market response after repeated FDA rejections and what leadership described as inconsistent communication and a slow-moving regulatory process.
On the other is Revolution Medicines, whose pancreatic cancer drug is delivering unprecedented clinical results and offering real hope to patients, a powerful example of what the innovation ecosystem looks like when it works.
Together, these stories raise a critical question: Can companies and investors still rely on FDA signals?
Because when those signals become unpredictable, capital pulls back, risk tolerance shrinks, and fewer breakthrough therapies get funded.
We also explore how early-stage investors rely on regulatory clarity, how large pharma acquisitions are helping fuel the biotech ecosystem, and why Congress plays a critical role in shaping what comes next.
The takeaway is simple: Biotech doesn’t succeed or fail in isolation. Policy, regulation, and capital all move together.
Join the Conversation ⬇️
Are we creating a system that rewards safe, incremental drugs over true breakthroughs? If FDA decisions feel unpredictable, does capital move elsewhere, or does innovation slow down entirely?
Drop your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
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Time Stamps
00:00 Intro + Why Biotech Policy Matters Right Now
00:38 Congress Returns: RFK Jr., Drug Pricing, and Key Hearings
03:29 When FDA Delays Kill Companies (Kezar Case)
04:01 Replimune Collapse: From Breakthrough to Rejection
05:46 The Real Risk: Can Investors Trust FDA Signals?
06:51 Revolution Medicines: A Cancer Breakthrough
07:49 Historic Results: First Survival Gains in Pancreatic Cancer
08:22 How Biotech Actually Works (Startups → Pharma)
09:56 Why Big Pharma Deals Matter for Patients
10:06 Collapse vs Breakthrough: Which Future Are We Heading Toward?
10:22 What Congress and FDA Need to Fix
10:50 Faster Drug Development? New FDA Pathway Explained
12:25 Final Take: The Stakes for U.S. Biotech Leadership
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
Biotech #FDA #DrugDevelopment #HealthcarePolicy #BiotechInvesting
Tariffs, MFN pricing, and FDA delays are colliding, and small biotech is paying the price. One company already collapsed. More could follow.
In this episode, we break down how Section 232 pharmaceutical tariffs, the push to codify Most Favored Nation (MFN) pricing, and new proposals in the FDA budget are reshaping biotech in real time.
The stakes are high. These policies don’t just exist on paper, they directly impact where drugs are developed, how capital flows, and whether small biotech companies survive.
We explore how tariffs could strain supply chains and smaller companies, how MFN could change global pricing and investment behavior, and how a proposed expedited IND pathway could help keep early-stage drug development in the United States.
But the biggest signal comes from a real-world example: Kezar Life Sciences, a biotech that shut down after FDA delays disrupted its timeline and investor support.
This episode makes one thing clear: policy is now one of the biggest drivers of innovation or failure in biotech.
When the system works, it accelerates breakthroughs. When it doesn’t, it pushes capital, companies, and science elsewhere.
Join the Conversation ⬇️
Are U.S. biotech policies slowing down the industry more than global competitors like China?
If a company shuts down because of regulatory delays, is that a policy failure or just the cost of doing business?
Would you accept higher risk in early drug development if it meant faster innovation and more breakthroughs?
Drop your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
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Time Stamps
0:00 Episode Introduction
1:36 Section 232 Pharma Tariffs Explained
2:47 Onshoring, MFN Deals, & Exemptions
4:57 The Impact on Small Biotechs & VC
8:17 Why Codifying MFN is Dangerous
9:56 Promising FDA Budget Proposals
11:32 Expedited INDs to Keep Trials in the US
15:49 The Fatal Cost of FDA Delays
17:52 Proposed NIH Budget Cuts & Grant Changes
20:45 The Big Disconnect in Biotech Policy
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
biotechpolicy #fda #drugdevelopment #healthcarepolicy #china #BiotechInnovation
Last week, seven leading life sciences investors went to Washington. They met with the National Security Commission on Emerging Biotechnology, walked the halls of Congress, and shared which roadblocks are preventing them from being a part of the next breakthrough.
John Gutierrez was one of those investors — and the throughline of nearly every room he walked into was China.
Not as a future threat to get ahead of. But as a current competitor that is already having a real impact on how capital decisions are made and exposing just how much American biotech policy is working against itself.
On this episode, John breaks down what policymakers are missing and what investors are actually seeing: drug pricing proposals that undermine early-stage innovation, an FDA uncertainty gap that large companies can absorb and small companies can't, and a China that is building a cheaper, faster, better-funded competitor while Washington debates the wrong questions.
The U.S. still has the best life sciences ecosystem in the world. Whether that stays true depends on decisions being made right now, and whether the people making them understand what's actually at stake.
This is that conversation.
Join the Conversation ⬇️
What do you think is the biggest risk to U.S. biotech leadership right now?
Is policy helping or hurting innovation in this moment?
Drop your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
https://www.instagram.com/makingmedicinepod/
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Timestamps
00:00 Disclaimer and opening context
00:37 Capitol Hill biotech roundtable with NSCEB
01:25 Meet investor John Gutierrez and Ascend to Capital
02:15 How biotech investors build and scale companies
03:13 The rise of new biotech hubs like Florida
04:58 Why investors are stepping into policy debates
06:29 Biotech as a national security priority
08:31 Is the U.S. losing biotech leadership to China?
10:30 Competing with China vs trying to contain it
11:06 Why innovation is becoming incremental not transformational
13:43 “Tell me the incentive” how policy drives investor behavior
15:01 The pill penalty and shift away from small molecule drugs
17:04 Policy silos vs the real global biotech competition
18:42 Inside Capitol Hill conversations and policy blind spots
21:26 How global pharma deals fund biotech innovation
23:56 Closing thoughts on U.S. biotech leadership
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
biotech #biotechpolicy #nationalsecurity #biotechinnovation #chinabiotech
In this special re-air of the Making Medicine Podcast, we revisit a timely conversation with Dr. Michelle Rozo of the National Security Commission on Emerging Biotechnology NSCEB, originally recorded live at JPM 2026.
We are re-airing this episode in recognition of a recent roundtable hosted on Capitol Hill by the Incubate Coalition and NSCEB, where these same themes took center stage. As policymakers, investors, and industry leaders increasingly focus on the intersection of biotechnology and national security, this discussion offers critical context on how global competition and U.S. policy choices are shaping the future of innovation.
Filmed live at JPM, host John Stanford sits down with leaders operating at the ground level, what one panelist calls the “frogs in the mud”, to unpack how capital flows, regulatory signals, and long-term strategy are evolving in real time.
Rather than framing innovation as a zero-sum global rivalry, the conversation highlights a more complex reality. The U.S. remains deeply connected to global science, but risks falling behind if domestic policies create friction for innovation.
The takeaway is clear. Maintaining U.S. leadership in biotech is not guaranteed. It requires a policy environment that supports discovery, development, and scale while recognizing the growing national security implications of the life sciences.
Join the Conversation ⬇️
Do you think the U.S. is treating biotech as a national security priority yet?
Drop your thoughts in the comments below 👇
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
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Time Stamps
0:00 Intro: Is the U.S. losing the biotech arms race?
1:10 "Frogs in the Mud": Why D.C. policy misses the mark
3:45 The 20-year Chinese strategic plan for biotech
6:15 How IRA price controls stifle American innovation
9:30 Strategic prioritization: Can the U.S. catch up?
12:50 The $350B patent cliff and global market impacts
16:20 Navigating the "Valley of Death" for startups
20:05 Clinical trial speed: Why China is outperforming the U.S.
24:30 SBIR breakthrough: New hope for early-stage funding
28:10 The "Playbook for Congress" and the road to 2030
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
Biotech #NationalSecurity #NSCEB #LifeSciences #HealthcareInnovation #BiotechPolicy #Innovation #JPM2026
With Japanese Prime Minister Sanae Takaichi meeting President Trump this week, we are re-airing our special episode from Tokyo. We explore why the U.S. delegation must prioritize a fair pricing agreement that ensures Japan pays its fair share while giving patients access to life-saving cures.
As the US and Japan put renewed focus on their partnership in science and the life sciences, we are revisiting a special episode of the Making Medicine podcast recorded on the ground in Tokyo late last year to mark this critical geopolitical moment.
This week's summit presents a rare win-win opportunity if the U.S. delegation focuses on securing a fair commercial pricing agreement. For years, arcane and arbitrary pricing schemes have limited the value Japan is willing to pay for medical breakthroughs. By pushing Japan to pay its "fair share" for innovation, U.S. leaders can help solve the severe drug lag that leaves 70 percent of new American medicines unavailable to Japanese patients. A modernized pricing agreement wouldn't just protect early-stage biopharma investments; it would give Japan's aging population access to the breakthroughs they desperately need.
During this international panel, John Stanford sat down with a premier group of global investors to discuss the path forward. He was joined by Shaan Gandhi of Pfizer, Patrick Jordan of NovaQuest Capital Management, Heather Berger of Forge Life Sciences, and Johannes Freuhauf of Biolabs.
The group explored how the Japanese government is systematically addressing structural challenges through unified agency alignment from the MHLW and METI. A major highlight of the conversation was a remarkably forward-looking program that offers a two-to-one non-dilutive matching grant for accredited international venture capital investments. The panel also discussed the rapid expansion of vital infrastructure, celebrating the announcement of a second Biolabs incubator facility opening in Tokyo in mid-2026.
However, the investors agreed that early-stage funding must be paired with a predictable commercial pricing environment. To ensure sustainable global investment, Prime Minister Takaichi's administration must commit to valuing innovation across the entire value chain, allowing for the successful exits and capital recycling that fuel the next generation of medicines.
Join the Conversation ⬇️
What policy changes would most effectively help Japan reduce its drug lag?
Do you believe government matching grants are the most effective way to accelerate early-stage biotech ecosystems?
Can Japan build a globally competitive biotech sector without a modernized pricing agreement?
Drop your thoughts in the comments below 👇
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Time Stamps
00:00 Episode disclaimer
00:23 Japan episode introduction
01:17 Why the US Japan meeting matters
01:53 Japan’s drug lag problem
02:47 Why Japan missed the COVID vaccine moment
03:19 Live discussion from Tokyo
06:36 Why BioLabs doubled down in Japan
08:00 Japan’s science to startup opportunity
14:00 Government alignment on biotech innovation
20:23 Japan’s matching grant model
25:46 Drug lag, pricing, and patient access
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
japanbiotech #healthcarepolicy #drugdevelopment #lifesciences #medicalinnovation
The FDA is being asked to keep pace with today's rapid scientific advancements amid ongoing resource constraints. In this episode, we unpack why regulatory predictability and stability matters more than ever for the future of America's medical innovation ecosystem.
Regulatory uncertainty is reshaping where biotech capital flows. In this episode of the Making Medicine podcast, John Stanford sits down with Cartier Esham of Esham Strategies and Executive Director of the Alliance for a Stronger FDA to examine how budget pressures and workforce challenges at the FDA are affecting investors, innovators, and the companies betting on U.S. regulatory predictability.
As scientific complexity accelerates, questions are mounting about whether the agency has the capacity needed to meet its growing responsibilities. For biotech investors, uncertainty around review timelines and approval pathways can quickly influence where capital is deployed – and whether the U.S. remains the preferred marketing for early- stage innovation.
Meanwhile, the FDA, industry, and other stakeholders are looking towards the next reauthorization of the Prescription Drug User Fee Act (PDUFA) program. These five- year user fee agreements are more than just a funding mechanism; they are a key pillar of the predictable, science-based regulatory framework that underpins biotech investment. When that framework is in doubt, review timelines stretch, approval certainty erodes, and risk calculations for early-stage investment changes.
The global context raises the states. While the U.S. continues to lead in clinical trial activity, other countries like China are investing aggressively to narrow the gap. A strong, well-functioning FDA is not just a domestic priority: it is a signal to global capital that the U.S. remains committed to regulatory excellence and innovation leadership.
Join the Conversation ⬇️
Is FDA instability already showing up in your investment decisions or deal timelines?
As China scales its clinical trial infrastructure, how long can the U.S. afford regulatory uncertainty?
Drop your thoughts in the comments below 👇
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Time Stamps
0:00 Legal Disclaimer and Making Medicine Introduction
1:42 Cartier Esham’s Journey to Health Policy
4:08 The Mission of the Alliance for a Stronger FDA
6:44 Understanding FDA Funding: User Fees vs. Appropriations
7:48 Managing Operating Reserves During Government Shutdowns
10:10 Navigating the 4% FDA Budget Cut and Staffing Levels
15:55 Evidence-Based Assessment: 2025 CDER Drug Approvals
18:01 Inside the PDUFA VIII Negotiations
21:27 Establishing Financial Stability for the FDA's Future
27:00 Keeping Pace with China's Biotech and Clinical Trial Growth
31:05 Tracking Global Clinical Trial Starts as a Barometer for Success
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
BiotechPolicy #FDAResources #PDUFA #MakingMedicine #ChinaCompetition #HealthcareInnovation
China has now overtaken the United States in new drug clinical trials. At the same time regulatory uncertainty and funding lapses are raising new questions about the future of the American biotech leadership.
In this episode of the Making Medicine Podcast, host John Stanford examines three developments shaping the future of the biotechnology ecosystem.
First, the Senate passed a bipartisan agreement to reauthorize the Small Business Innovation Research and Small Business Technology Transfer programs. These programs have long served as a launchpad for biotech startups and early-stage medical innovation across the United States.
The reauthorization comes after the first lapse in the program’s 44-year history, which paused billions in potential research funding for months. Restarting SBIR is a major development for small biotech companies developing new therapies.
Recent regulatory decisions and declining approval numbers are raising new questions among investors and researchers about the stability of the regulatory environment.
Finally, new global data shows China has now overtaken the United States in new drug clinical trials. Faster recruitment, national biotechnology policy incentives, and streamlined regulatory review are helping China accelerate its clinical research ecosystem.
The United States has been the global leader in biomedical innovation for decades. Maintaining that leadership will require strong research funding, regulatory clarity, and policies that continue to support innovation and investment.
BiotechInnovation #HealthcarePolicy #ClinicalTrials #DrugDevelopment #MedicalInnovation
Join the Conversation ⬇️
Do you think the United States can maintain its leadership in biomedical innovation? What policies are most important for supporting biotech startups and early-stage research? How should regulators balance speed and safety when approving new medicines? Drop your thoughts in the comments below 👇
Link to WSJ Report
https://www.wsj.com/tech/biotech/maha-is-bringing-chaos-to-biotech-investment-beyond-just-vaccines-fbb82c6b?gaa_at=eafs&gaa_n=AWEtsqek_Ljd3Z49rusYI-f_MECgRKwStXEjR6_pP7SqdkNhBeyB-fywedtgZKvdRLg%3D&gaa_ts=69a8660d&gaa_sig=FMTHTFVHKAw_gdNro4NTyS35w2SRxhfgz7
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Time Stamps
0:00 Biotech policy and innovation overview
1:05 SBIR reauthorization passes the Senate
2:45 Why SBIR matters for biotech startups
4:40 The five month SBIR funding lapse
5:23 FDA accelerated approval pathway explained
6:10 Accelerated approvals drop in 2025
7:30 Regulatory uncertainty and biotech investment
8:26 Rare disease treatment gap
9:02 China overtakes the U.S. in clinical trials
9:30 Why China recruits trial patients faster
10:11 China biotech policy advantage
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
About 90–95% of rare diseases still lack an FDA-approved treatment, underscoring the urgency for continued innovation on behalf of the estimated 30 million Americans — and families — affected by these conditions
During Rare Disease Week, this special episode of the Making Medicine podcast focuses on the patients, caregivers, and policy choices shaping the future of rare disease research. Host John Stanford is joined by Lisa Schlager (FORCE), Elaine Towle (Prader-Willi Syndrome Association), and Josh Trent (Save Rare Treatments Task Force) for a thoughtful discussion on the scientific, financial, and regulatory realities of developing therapies for small patient populations.
The conversation explores how federal incentives, reimbursement frameworks, and regulatory clarity can influence whether promising treatments move forward, as well as the broader ripple effects rare diseases have on families and support networks. The panel also reflects on ongoing policy discussions, including proposals such as Most Favored Nation (MFN) drug pricing, and how stakeholders are evaluating their potential impact on future innovation.
Progress in rare diseases depends on sustained collaboration among patients, advocates, researchers, investors, and policymakers. This episode highlights both the scale of unmet need and the growing momentum to deliver new treatments and hope to millions of Americans.
Do you believe the Orphan Cures Act went far enough to protect rare disease research?
Should the Pediatric Priority Review Voucher program be made permanent?
What rare disease policy reform should Congress address next?
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Timestamps:
0:00 Rare Disease Week and disclaimer
0:43 Rare disease innovation, 30 million Americans
2:46 Hereditary cancer and rare genetic subtypes
7:36 Prader-Willi syndrome, hyperphagia and hypothalamus
11:14 First Prader-Willi FDA approval and Phase 3 pipeline
12:54 FDA patient focused drug development meetings
14:39 Save Rare Treatments Task Force and advocacy strategy
17:20 95% lack FDA treatments and pediatric rare disease stakes
21:05 Orphan Cures Act, IRA negotiation, second indications
26:17 PARP inhibitors, ovarian cancer and pancreatic cancer
33:01 Rare disease investment rebound after Orphan Cures Act
37:36 Pediatric PRV reauthorization and faster FDA review
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
FDA reversals and price controls are handing biotech dominance to China. We expose the national security crisis in drug development.
The FDA is facing a crisis of confidence that threatens the stability of the entire US biopharmaceutical industry. In this episode, John Stanford is joined by Jef Akst, Managing Editor at BioSpace, to expose how recent "regulatory reversals" and inconsistent decision-making are rendering major vaccine and therapeutic programs "uninvestable". We analyze the shocking "Moderna gate" incident, where the FDA issued a "refuse to file" letter for an mRNA flu vaccine only to reverse course days later, a chaotic move that sent stock prices flying and disrupted timelines for the entire vaccine sector.
Beyond the FDA, a new national security threat is emerging in the form of "Most Favored Nation" (MFN) pricing proposals. We unveil data from the Incubate MFN Tracker, which catalogs how these European-style price controls are now being flagged in quarterly SEC filings (10-Ks and 10-Qs) as material risks to business operations. Companies large and small are warning that MFN policies will compress expected returns and force a reprioritization away from riskier, high-impact R&D. This creates a vacuum that allows adversaries like China to further develop their own pipelines and grow a stronger foothold in the global market.
This episode also covers the shifting center of gravity in clinical research. While 58% of industry professionals still choose the US as the best place to start a career, 27% now look to Asia-Pacific, while only 9% choose Europe—a stark warning of what happens when regions adopt restrictive pricing policies. We discuss Senator Bill Cassidy’s new "Patient and Families First" white paper, which proposes solutions like an Australia-style pilot for faster Phase 1 trials and updated pathways for digital health and AI tools.
Finally, we look ahead to the State of the Union, where polling reveals that only 2% of Americans believe Congress should prioritize lowering drug costs, with the vast majority focused on grocery and insurance affordability instead.
Join the Conversation
Does the current FDA instability make you worry about the future of new medicines reaching patients? Do you believe importing foreign price controls is worth the risk of losing American biotech leadership to China?
Should Congress focus on insurance reform instead of drug price caps to help with affordability?
Drop your thoughts in the comments below
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Link to articles
https://endpoints.news/pharma-is-done-negotiating-as-trump-pushes-to-codify-deals/ https://www.biospace.com/business/opinion-2026-could-mark-a-turning-point-for-american-innovation https://endpoints.news/even-europeans-dont-see-a-future-in-euro-biopharma-anymore/
Timestamps
0:00 Making Medicine disclaimer, no medical advice and no investment advice
0:42 Making Medicine Press Pass with BioSpace Managing Editor Jeff Akst
1:16 What BioSpace covers, biotech news, drug development, VC funding, FDA approvals
3:42 Is the FDA functioning properly, transparency and communication problems
4:17 FDA reversals and the Moderna mRNA flu vaccine refuse to file letter
6:19 Ripple effects, Moderna stock, vaccine timelines, and mRNA platform investment risk
8:37 FDA shifting to stricter approvals, risk benefit changes, and trial design uncertainty
10:35 Drug development timelines, regulatory instability, and investor confidence
12:17 Inside FDA culture, leadership turnover, layoffs, and decision making uncertainty
12:50 National priority vouchers, review delays, and why companies hesitate to apply
16:11 Psychedelics for depression and Alzheimer’s drug development with tau targeting
26:13 State of the Union, drug pricing politics, insurance reform, and voter affordability priorities
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
TrumpRx has quickly become part of the broader drug pricing conversation, not as a new insurance program or pharmacy, but as a government website highlighting direct-to-patient cash pricing options for certain brand-name medicines.
In this episode of the Making Medicine Podcast, host John Stanford walks through what TrumpRx is, what it isn’t, and why it’s generating attention right now. Rather than setting prices or replacing insurance, the platform points patients toward manufacturer-listed cash prices for select innovative drugs, bringing another pathway to medicine outside traditional insurance channels.
The episode also steps back to examine the larger shift this represents. Cash markets for prescription drugs have been growing in visibility, from coupon platforms like GoodRx to cost-plus pharmacy models like Mark Cuban Cost Plus Drugs. TrumpRx enters that landscape from a different angle, one tied, at least rhetorically, to “Most Favored Nation” policy discussions and broader debates about international price comparisons.
We discuss early reactions and critiques, including questions about whether some listed products are actually the lowest available option, particularly when lower-cost generics exist. That tension underscores a bigger point: patients often have to shop around, and the system remains opaque enough that even policymakers, manufacturers, and payers frame pricing differently.
More broadly, this moment reflects a structural reality in American healthcare. High deductibles, rebate dynamics, and insurance design can make paying cash cheaper than using coverage, a counterintuitive outcome that continues to fuel debate.
Finally, we touch on how pricing policy conversations intersect with innovation. Short-term affordability tools, cash-market visibility, and long-term price regulation debates are often discussed together, but they have different implications for investment, drug development, and patient access over time.
TrumpRx may or may not be transformative. But it is a visible signal of where the drug pricing conversation is headed: toward transparency, toward cash markets, and toward renewed debate over how the U.S. balances cost, competition, and innovation.
Join the Conversation ⬇️
Is Trump RX a meaningful transparency tool or just a temporary fix for a broken insurance system?
Do you find it cheaper to pay cash for prescriptions rather than using your insurance copay?
Do you believe price controls will help affordability or hurt the development of new cures?
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Timestamps
0:00 Disclaimer: Not Medical, Financial, or Legal Advice
0:42 Introduction: What Is Trump RX?
0:59 How Trump RX Works as a Drug Discount Hub
1:56 Trump RX vs GoodRx vs Mark Cuban’s Cost Plus Drugs
3:03 Early Criticism and Generic Price Comparisons
5:03 Trump RX vs Most Favored Nation (MFN) Pricing
6:12 Free Market Tool or Price Control Policy?
7:29 Why High Deductibles Changed the Drug Market
8:22 Insurance Opacity and the Rise of Cash Markets
9:34 PBMs, Gag Clauses, and Hidden Pricing Structures
11:24 Why Cash Can Be Cheaper Than Insurance
12:13 Final Takeaways: Reform, Transparency, and Innovation
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor
Washington is navigating a period of significant change in health policy, with implications for how new medicines are developed, reviewed, and paid for.
In this episode of Making Medicine, we take a closer look at several recent developments shaping the life sciences landscape. We discuss the FDA’s new priority review voucher pilot and the debate around how the agency can balance speed, scientific rigor, and public trust as it works to accelerate patient access to therapies.
We also break down new reforms aimed at increasing transparency in Medicare Part D and reining in pharmacy benefit manager (PBM) practices, exploring what these changes could mean for patients, payers, and innovators across the system.
Finally, we examine emerging international reference pricing proposals, including the GLOBE and GUARD concepts, and the broader conversation about how the U.S. can maintain its leadership in biomedical innovation while addressing affordability and global competition. If you care about the future of medical innovation, and the policy decisions shaping it, this episode offers context, clarity, and a balanced look at what’s ahead.
Link to article: https://www.washingtonpost.com/opinions/2026/02/03/vaccine-development-moderna-rfk-china-drug-prices/
Join the Conversation ⬇️
Do you believe the government has become the biggest obstacle to the next American cure? Will the U.S. lose its status as the world leader in medical breakthroughs by 2030? Is the FDA's new 'National Priority' pilot a necessary evolution for 21st-century medicine, or is it a dangerous bypass of the scientific checks and balances that protect us all?
Drop your thoughts in the comments below 👇
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Timestamps
0:00 The 1,000-pound predator and the regulatory coup
0:23 Science, policy, and a destabilized ecosystem
1:10 The controversial FDA town hall
2:20 Skipping Congressional approval
3:54 Reforming PBMs in the funding package
5:10 How PBMs siphon half the cost of your medicine
6:55 Why "sunlight" isn't lowering pharmacy prices yet
7:54 GLOBE, GUARD, and foreign price controls
8:32 Why biotech is fleeing to rival markets
9:30 Shifting from price controls to insurance reform
10:12 Addressing out-of-pocket costs
10:45 FDA Approvals Corner
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
The race is being won by someone else. While the headlines focus on the prestige of JPM 2026, a much quieter and more dangerous shift is happening behind the scenes. In this special edition of The Making Medicine Podcast, John Stanford sits down with Terzel Vasquez of STAT Brand Studio to discuss why the American biotech engine is beginning to stall. Stanford argues that capital flows like water, and right now, poorly designed Washington policies are acting like boulders in the stream, forcing vital investment away from life-saving small molecules and rare disease research.
The conversation pulls back the curtain on a massive cognitive dissonance in modern policy. By attacking the end of the value chain, specifically the large manufacturers who bring drugs to the finish line, lawmakers are inadvertently starving the early-stage startups they claim to protect. From the Pill Penalty to the looming shadow of China’s bio-dominance, this episode explores why biotech has officially moved from a healthcare issue to a critical national security prerogative.
Join the Conversation
Is U.S. biotech leadership still a "national security priority," or have we already ceded the lead?
If “unintended consequences" force a choice between a $100,000 injectable biologic and a $200 oral pill that never gets funded, who actually wins?
Is Washington "fixing" the price of medicine, or just distracting us from a broken insurance system?
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Timestamps
0:00 Policy Warning & Headlines
0:23 JPM 2026: Incubate Briefing
0:36 Capital Flight: Policy Barriers
1:24 The IRA "Pill Penalty"
2:22 Rare Disease Funding Gap
2:32 The $1 Billion Fix
3:18 The Innovation Relay Race
4:24 The Movie Studio Paradox
5:28 China’s "Green Light" Strategy
6:58 Biotech: National Security Asset
9:20 The $3 Billion Drug Cost
10:18 Insurance Breakdown & Access
11:36 Fixing the Root Issue
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
Is the U.S. at risk of losing its edge in biotech innovation?
Filmed live at JPM 2026, host John Stanford sits down with industry leaders who are deep in the work,what one panelist calls the “frogs in the mud”, to unpack how long-term global strategies, shifting capital flows, and U.S. policy decisions are reshaping the biotech landscape.
Rather than framing innovation as an all-or-nothing rivalry, the conversation focuses on a harder truth: the U.S. cannot isolate itself from global science, but it can fall behind if domestic policies make innovation harder at home. While Washington often debates from 30,000 feet, this panel dives into the operational realities founders and investors face every day, from the implications of the National Security Commission’s recommendations, to the looming $350B patent cliff, to the “Valley of Death” threatening early-stage companies.
We also examine how pricing uncertainty under the IRA, regulatory friction, and capital constraints intersect, and highlight a recent breakthrough in SBIR funding that offers a glimpse of what pro-innovation policy can look like when it’s done right.
The takeaway is clear: safeguarding U.S. biotech leadership isn’t about cutting science off at the knees or cutting off collaboration, it’s about championing policies that keep America the best place in the world to discover, develop, and scale new medicines.
Watch to understand the real, ground-level forces shaping the future of biotech, and what policymakers need to get right next.
Join the Conversation
Is the U.S. still the global center of gravity for biotech innovation, or are we relying too heavily on past momentum?
What poses the greater long-term risk to patients: short-term cost controls, or policies that reduce where and how new medicines get developed?
In the biotech “Valley of Death,” what matters more for survival: access to capital, or regulatory speed and predictability?
Drop your thoughts in the comments below.
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Timestamps
0:00 Intro: Is the U.S. losing the biotech arms race?
1:10. "Frogs in the Mud": Why D.C. policy misses the mark
3:45 The 20-year Chinese strategic plan for biotech
6:15 How IRA price controls stifle American innovation
9:30 Strategic prioritization: Can the U.S. catch up?
12:50 The $350B patent cliff and global market impacts
16:20 Navigating the "Valley of Death" for startups
20:05 Clinical trial speed: Why China is outperforming the U.S.
24:30 SBIR breakthrough: New hope for early-stage funding
28:10 The "Playbook for Congress" and the road to 2030
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
Filmed live at the JPMorgan Healthcare Conference 2026, this episode of the Making Medicine Podcast examines how global power shifts are reshaping the pharmaceutical industry. This Part 1 conversation features host John Stanford with former Senator Richard Burr and EU Commissioner Phil Hogan as they discuss whether the pharmaceutical industry is losing its long-held “geopolitical immunity.” As thousands of leaders gather in San Francisco for the year’s biggest healthcare event, the discussion offers a roadmap for navigating the shift from business as usual to a new era of geopolitical scrutiny.
What do you think is the biggest "opportunity in the chaos" for biotech in 2026?
Do you believe the FDA will become more or less predictable under the current administration?
How should global pharma companies prepare for the rise of "MAHA" and lifestyle-focused health policy?
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Timestamps
0:00 Welcome to Making Medicine
0:47 Meet the Panel: Senator Richard Burr & Commissioner Phil Hogan
2:21 2026 Outlook: The Disruptive Impact of the Second Trump Admin
3:51 Finding Opportunity in Policy Chaos
6:06 Why Pharma Lost Its "Geopolitical Immunity" in Trade
8:44 Most Favored Nation (MFN) and Global Pricing Realities
10:14 Defining "MAHA" and the Future of Health Policy
11:43 The Power of Direct Engagement: Bringing CEOs to the Hill
15:02 The FDA in 2026: Stability vs. Disruption
17:49 AI and Robotics: The New Subsectors of Medicine
19:08 China, Russia, and the Protection of the Single Market
25:15 2026 Predictions: Cultural Shifts and Economic Roller Coasters
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this episode of the Making Medicine Podcast, John Stanford previews new CMS drug pricing proposals and explains how they could shape biotech investment and innovation. The conversation looks ahead to the JPMorgan Healthcare Conference, where policy, capital formation, and global competition are expected to drive discussion. The episode breaks down the Globe and Guard Medicare models, their potential impact on R&D, and what founders and investors are watching next. It also explores how pricing uncertainty can influence early-stage biotech and global competitiveness. Finally, the listener Q&A highlights where AI is gaining traction across therapeutic areas.
Join us in San Francisco:
https://www.eventbrite.com/e/innovation-at-a-crossroadsbiopharma-policy-in-an-era-of-global-competition-tickets-1965538834565?aff=oddtdtcreator
Click here to be featured in an Incubate short:
https://calendly.com/grace-incubatecoalition/incubate-shorts-jpm-2026?month=2026-01
What should innovators and investors watch most closely as these proposals move forward?
How might policy signals from JPM influence biotech decision-making in 2026?
Where do you see the biggest opportunities for AI in medicine right now?
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Timestamps:
0:00 Welcome and disclaimers
0:17 Episode overview and JPM preview
0:50 Why Incubate produces Making Medicine
1:43 Why policy matters at JPM 2026
3:30 CMS announces new drug pricing proposals
4:26 Globe Part B and Guard Part D explained
5:53 Comment period and policy intent
6:45 Global pricing and international context
8:47 Implications for biotech innovation
10:17 Listener Q&A: AI in drug development
11:56 Closing thoughts and JPM logistics
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this New Year episode of the Making Medicine Podcast, we revisit a full-length conversation with U.S. Senator Thom Tillis of North Carolina, focused on the policies shaping US life sciences. The discussion explores intellectual property, drug pricing dynamics, regulatory balance, and how innovation ecosystems grow at the state and national level. The episode examines approaches to sustaining research and development while maintaining global competitiveness. It also considers the long-term implications of regulatory uncertainty and international competition.
Which policy issue do you think most impacts biotech innovation today?
How should decision-makers balance affordability and long-term R&D investment?
What does the US need to maintain leadership in life sciences?
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true
Timestamps:
0:00 Episode disclaimer
0:17 Welcome to Making Medicine and episode overview
0:30 Why this conversation matters for 2026
1:24 Introducing Senator Thom Tillis
2:16 Building a life sciences ecosystem in North Carolina
3:43 Economic impact of biotech investment
4:27 Tax and regulatory strategy for innovation
7:52 Balancing reform and economic stability
9:58 Why intellectual property matters for life sciences
12:18 Government involvement and innovation risks
13:51 Drug pricing policy and unintended consequences
17:05 R&D investment impacts and innovation trade-offs
20:26 Global competition and China’s growing role
22:55 Changing the narrative around life sciences
26:52 What’s next after public service
28:58 Closing reflections and future outlook
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this special holiday episode, the Making Medicine Podcast looks back at standout conversations since the show’s July relaunch, covering biotech innovation, research funding, and global competitiveness. Highlights include discussions with industry leaders on venture capital, R&D stability, manufacturing, and the importance of a connected life sciences ecosystem. The episode also revisits conversations on international competition, commercialization challenges, and how policy choices shape innovation outcomes. Together, these moments underscore why long-term investment and coordination across the value chain matter for patients and progress.
Which conversation stood out most to you this year?
What policy or innovation topic should we explore more deeply in 2026?
How do you see global competition shaping the future of biotech?
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Timestamps:
0:00 Show disclaimer and welcome
0:23 Holiday greeting and episode overview
1:00 Industry snapshot and biotech competitiveness
3:36 R&D funding, NIH, and innovation stability
5:36 Global competition and maintaining leadership
8:23 Risks and resilience of the innovation economy
8:46 Policy ideas to support US biotech
14:12 Global perspectives on commercialization and pricing
17:20 Integrating early innovators and large pharma
21:27 Policy, pricing, and innovation trade-offs
27:37 IP, R&D incentives, and unintended consequences
28:23 Closing reflections and looking ahead to 2026
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this year-in-review episode, we break down key biotech investment trends from 2025, major policy developments in Congress, and what they mean for innovation and patients. The conversation covers defense-related biotech priorities, healthcare affordability challenges, PBM reform efforts, and capital access for early-stage companies. We also preview new data on venture investment, emerging therapeutic areas, and AI-enabled drug development. The episode closes with a look at recent FDA approvals that highlight real progress reaching patients.
What stood out to you most in the 2025 biotech investment data?
How do you see policy shaping innovation and capital formation in the year ahead?
Which FDA approval gives you the most optimism for patients?
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Timestamps:
0:00 Disclaimers and welcome
0:23 Year in review overview: biotech, policy, and innovation
0:45 Congress wraps up the year and the FY2026 NDAA
1:32 Healthcare legislation and premium pressures
3:19 PBM reform efforts and legislative outlook
5:39 Capital access update and the Invest Act
7:32 2025 biotech investment data preview
8:00 Leading therapeutic areas and rare disease trends
8:41 Geographic investment highlights by state
9:21 Investment by congressional district
10:16 AI-enabled biotech investment trends
10:46 FDA approvals corner
12:31 Closing thoughts and year-end reflections
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
This episode breaks down how Congress is turning biotechnology into a core national security priority. John Stanford explains the biggest shifts in the 2025 defense bill, why China-focused guardrails are expanding, and how new investment rules could reshape biotech funding. We also cover a new bipartisan proposal to create a government-backed investment fund, and a high-stakes battle over ACA subsidies.
What NDAA change do you think will impact biotech most?
Should the U.S. invest directly in emerging biotechnologies?
How should policymakers balance security with scientific innovation?
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Timestamps:
0:00 Disclaimers & Intro
0:23 NDAA Overview and Why It Matters
1:54 Biotech as a Strategic National Security Capability
2:54 Domestic Biomanufacturing & Supply Chain Priorities
3:19 DoD Bioindustrial Base & New Biotech Office
4:34 Data Standardization, AI Readiness & Security
5:07 Guarding the U.S. Biotech Ecosystem from China
7:09 Intelligence Community’s New Biotech Role
8:00 Outbound Investment Regime Explained
10:12 Implications for Investors & Biotech Leaders
12:42 The Independence Investment Fund Act
14:37 Why Congress Wants a Government-Backed Biotech Fund
14:40 Senate Showdown on ACA Subsidies & Healthcare Costs
17:36 Why Access and Innovation Are Interconnected
18:17 Closing Thoughts & Call for Questions
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this episode of Making Medicine, host John Stanford sits down with Senator Thom Tillis, the first sitting U.S. Senator to join the show. Tillis opens up about his relationship with President Trump, the impact of Most Favored Nation (MFN) drug pricing on U.S. innovation, and the forces shaping America’s biotech competitiveness. They discuss why predictable intellectual property and regulatory frameworks are critical for investment and how the U.S. can maintain a leading edge in life sciences. Don’t miss Tillis’s insights on why he chose not to seek reelection and what might come next for his career.
This is a must-listen for anyone interested in biotech policy, life sciences innovation, or U.S. global competitiveness.
What do you think about MFN-style pricing in the U.S.?
How can policymakers best support biotech innovation?
Which part of the life sciences ecosystem do you think needs the most attention right now?
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Timestamps:
0:00 Introduction to Making Medicine and Senator Thom Tillis
1:12 Tillis joins the podcast as the first sitting Senator
2:05 Early career and motivations in public service
4:20 Relationship with President Trump and MFN drug pricing
7:35 Potential impacts of MFN-style controls on U.S. innovation
10:10 America’s global biotech competitiveness and China
13:50 Importance of IP and regulatory predictability for investment
16:25 Reflections on policy successes and challenges
18:40 Decision not to seek reelection 20:30 What’s next for Senator Tillis
22:00 Key takeaways on biotech policy and U.S. innovation
24:15 Closing thoughts and call to action
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this episode of the Making Medicine Podcast, John Stanford sits down with Daphne Zohar, Founder, CEO, and Board Member of Seaport Therapeutics to explore the forces shaping today’s biotech ecosystem. Daphne shares her entrepreneurial path from PureTech to Seaport, offering a rare inside look at building companies, catalyzing innovation, and scaling breakthrough science. The conversation dives into the Massachusetts biotech flywheel, competitiveness with China, U.S. policy risks like the pill penalty and MFN, and how regulatory uncertainty ripples through capital formation and patient impact. Daphne also highlights why she’s bullish heading into 2026 and offers tactical advice for founders gearing up for JPM.
What part of Daphne’s perspective resonated most with you?
Which policy issue do you believe will most affect biotech innovation in 2025?
What should we ask her next time she joins the show?
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Timestamps:
0:00 Welcome & Introduction
1:12 Daphne Zohar’s Path into Biotech
3:05 The Seaport Therapeutics Story
6:10 Biotech Hangout & CEO Sisterhood
8:42 Why Massachusetts Leads in Biotech
10:55 The M&A Flywheel & Metsera Deal
13:40 China’s Biotech Strategy & U.S. Competitiveness
16:20 Pill Penalty, EPIC Act & Drug-Pricing Distortions
18:55 MFN Proposals & Impact on Early-Stage Biotechs
21:30 FDA Uncertainty: Regulation, Capital & Patients
24:00 Positive Signals Heading Into 2026
26:15 JPM Outlook & Advice for Founders
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this special Tokyo edition of the Making Medicine Podcast, John Stanford hosts a powerhouse panel of biotech investors, founders, and industry leaders to break down Japan’s emerging life-sciences boom. Together, they explore Japan’s regulatory shifts, government incentives, and rising startup momentum. This episode unpacks how Japan is positioning itself as a global hub for regenerative medicine, gene therapy, and bioeconomy innovation. Whether you're a policymaker, entrepreneur, or simply curious about global biotech trends, you'll get a front-row seat to Japan’s life sciences ecosystem, and why the rest of the world is watching.
What part of Japan’s biotech ecosystem surprised you the most?
Do you think global biotech companies should be paying more attention to Japan? Why or why not? Where do you see the biggest opportunity for Japan to lead in biotech?
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Time Stamps:
0:00 Introduction: Why We’re Recording in Tokyo
2:45 Japan’s Biotech Vision: From Strategy to Reality
6:10 Role of Government & Public-Private Partnerships
9:20 Innovation Hubs: Shared Labs & Incubators
12:05 Investment Landscape: VCs, Funds & Incentives
15:30 Regenerative Medicine & iPSC Development
18:45 Gene & Cell Therapy Trends in Japan
22:00 Regulatory Reform & Drug Approval Acceleration
24:45 Global Biotech Partnerships: Japan’s Reach Abroad
27:10 Challenges: From Risk-Averse Culture to Commercialization
29:50 The Bioeconomy: Beyond Pharmaceuticals
32:15 What’s Next: Predictions for Japan’s Biotech Future
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
Former Sutro Biopharma CEO Bill Newell joins host John Stanford to discuss the realities of leading a biotech company through economic uncertainty, long development timelines, and a shifting policy landscape. Bill shares lessons from 16 years at the helm, raising over $1.6 billion, navigating clinical trials, and building partnerships with global pharma leaders. The episode dives deep into the challenges of price controls, intellectual property reform, and the importance of FDA consistency for innovation. A must-watch for anyone interested in how science, policy, and investment intersect to bring new medicines to life.
What surprised you most about the biotech development process?
How do you think policymakers should balance access and innovation?
Do you agree with Bill’s stance on price controls and IP reform?
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DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this episode, John Stanford breaks down the surge in U.S. biomanufacturing investments, including Virginia’s new $500B hub, and what it means for the nation’s workforce. He contrasts this expansion with the recent closure of Arena BioWorks, raising questions about the balance between onshoring and sustaining innovation. The discussion also dives into major rumors of a potential Medicare-GLP-1 deal with Eli Lilly and Novo Nordisk and explores the possible implications of new CMS demonstration projects that could impact Part B manufacturers. Finally, John reflects on the growing pressure of tax and pricing policies that could reshape the biotech landscape. Do you think the U.S. is striking the right balance between manufacturing and innovation? How might Medicare coverage of GLP-1 drugs change the healthcare system? What policy signals should Congress send to protect early-stage biotech?
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0:00 Disclaimer and introduction
0:23 Welcome to the Making Medicine Podcast
0:57 FDA leadership shakeup and industry uncertainty
2:06 Arena BioWorks closure and policy contrasts
2:32 FDA predictability and regulatory challenges
3:28 Medicare and GLP-1 coverage discussion
4:08 New FDA guidance on biosimilars and gene editing
5:00 FDA moves to reduce biosimilar development costs
5:49 Gene editing progress and regulatory flexibility
6:53 Impact of pricing and revenue policies on innovation
7:48 Arena BioWorks shutdown and biotech investment climate
10:40 Virginia’s new manufacturing hub and workforce initiative
13:14 White House drug pricing rumors and CMMI demonstration projects
17:39 Closing thoughts and call for engagement
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this episode of Making Medicine, host John Stanford unpacks the Senate HELP Committee hearing on “The Future of Biotech.” From China’s accelerating investment to U.S. policy uncertainty, he explores what’s needed to protect American leadership in life sciences. The episode also covers new White House biosimilar announcements, gene therapy market challenges, and early insights from Incubate Policy Lab’s investment analysis. With over $14 billion invested in early-stage biotech this year, the conversation turns to what’s next for U.S. innovation.
Do you think U.S. biotech can stay ahead of China? What policies would best support innovation?
Should biosimilars have faster, simpler approvals?If you're new to the
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Timestamps:
0:00 – Intro and disclaimer
0:23 – Senate hearing: “The Future of Biotech” overview
1:19 – China’s biotech rise and U.S. competitiveness concerns
2:10 – IP protection, FDA modernization, and investment flight
3:30 – NIH funding stability and bipartisan support
4:00 – PBM reform and patient access challenges
6:00 – John Crowley’s warning: U.S. could lose biotech leadership in 2–3 years
8:00 – Incubate Policy Lab report: “Red lights in the U.S., green lights in China”
10:00 – Policy solutions: pricing predictability and IP certainty
12:00 – White House biosimilars announcement explained
14:00 – Gene and cell therapy market struggles
15:30 – AI-driven biotech investments and top-performing states
17:00 – Incubate at JPM 2026 + FDA during government shutdown
18:12 – Closing thoughts and audience shout-outsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this week’s episode, John breaks down the White House headlines, the FDA’s new wave of priority review vouchers, and September approvals, then celebrates National IP Month with guest Joshua Kresh. We dig into criteria for the new wave of CNPVs, domestic manufacturing pushes (Augmentin XR and ketamine), and why some approvals matter for patients who’ve run out of options. John also unpacks the Orphan Cures Act debate, the latest CBO chatter, and what it all means for long-term innovation. Finally, Joshua explains why IP is the backbone of biotech and flags fixes on eligibility, injunctions, and PTAB. Tell us what you think and we may feature your comment next week.
What’s your take on the FDA’s new voucher selections - smart acceleration or risky subjectivity?
Should Congress protect the Orphan Cures Act or revisit it in light of CBO’s estimates?
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Timestamps:
0:00 Disclaimers
0:23 Welcome & episode setup
0:46 Headlines: White House update & FDA Vouhcer program
1:20 FDA criteria & first recipients (overview)
3:00 Domestic manufacturing: Augmentin XR & ketamine
3:55 Approvals Corner: September FDA approvals
4:54 Orphan Cures Act: fix, CBO score & repeal talk
6:49 Tracking investor sentiment: life science & rare disease
8:05 National IP Month intro
8:47 Guest Joshua Kresh & IPI’s mission
12:36 The big IP issues: eligibility, injunctions (RESTORE), PTAB
24:49 Outro & call to action
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this week’s episode, John Stanford breaks down Day 15 of the federal shutdown’s impact on health agencies, major pullbacks in cell & gene therapy, and the White House’s latest MFN-style deal with AstraZeneca following Pfizer. We’re joined by Incubate’s Policy Director John Guy to explain how “BIOSECURE” found new life inside the Senate’s NDAA and what that means for biopharma. We also cover investment trends, workforce concerns, and the new DoD Biotech Management Office mandate. Stick around to the end for how all this could reshape U.S. innovation and supply chains.
How will MFN-style deals affect launch strategy and U.S. pricing?
Do recent exits by Novo Nordisk and Takeda change your outlook on cell & gene therapy?
What’s your biggest question about BIOSECURE's due-process path and NDAA timing?
DOD 1260H List: https://media.defense.gov/2025/Jan/07/2003625471/-1/-1/1/ENTITIES-IDENTIFIED-AS-CHINESE-MILITARY-COMPANIES-OPERATING-IN-THE-UNITED-STATES.PDF
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Timestamps:
0:00 Disclaimer
0:23 Welcome & agenda
0:47 Shutdown Day 15: CDC RIF confusion
2:29 Court injunction + earlier HHS/FDA/NIH cuts
2:49 Cell therapy pullbacks (Novo, Takeda)
3:58 Investment slump in cell & gene therapy
5:21 Policy clarity, China context & hope
6:00 AstraZeneca White House MFN deal vs Pfizer
8:07 NDAA intro & Biosecure refresher
9:40 Interview: What is Biosecure? (John Guy)
12:19 Biosecure 2.0 details: DOD 1260H list, OMB review & due process
14:43 NDAA path, DoD Biotech Office, workforce & wrap
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this week’s episode, John Stanford reports from Boston - the beating heart of global biotech - with insights from investors, scientists, and executives shaping the future of life sciences. He breaks down what the government shutdown means for FDA operations, unpacks the White House–Pfizer deal, and shares key takeaways from conversations on U.S. competitiveness, biotech investment, and the next generation of talent and technology.
How do you see policy uncertainty affecting biotech innovation?
Are U.S. policies doing enough to keep the next generation of scientists here?
What biotech breakthroughs excite you most right now?
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Timestamps:
0:00 Disclaimer: Not medical or investment advice
0:23 Welcome from Boston - biotech capital of the world
1:11 Government shutdown and FDA operations
2:06 What’s paused at the FDA and why it matters
2:29 Understanding the White House–Pfizer deal
3:19 MFN pricing, TrumpRx, and tariff waivers
4:07 Pfizer’s $70B U.S. investment and industry implications
4:29 Key takeaways from Boston investor meetings
4:58 Policy uncertainty and its impact on biotech investment
5:29 Interest rate cuts and biotech’s comeback potential
6:07 The growing threat to U.S. scientific talent
6:33 The “brain drain” and its implications for America’s biotech future
7:22 Boston’s role in championing life sciences
7:50 Exciting new biotech modalities: gene therapy, RNA, and cell engineering
9:34 Policy clarity, workforce development, and scientific momentum
10:20 Closing thoughts: innovation across America
10:40 Outro and call to action
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
This week, John Stanford breaks down the government shutdown and its impact on FDA, NIH, and biotech innovation. He also covers the surprising lapse of the SBIR program, what it means for early-stage biotech funding, and the fierce political debate around its future. Plus, we analyze President Trump’s deal with Pfizer on “Most Favored Nation” drug pricing and his latest tariff threats.
What does all this mean for the future of U.S. biotech competitiveness?
How should policymakers balance affordability and innovation in drug pricing?
Do you think the SBIR program will be quickly revived, or is this the start of bigger changes?
What impact will tariffs and MFN drug pricing have on biotech investment?
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Timestamps:
0:00 Welcome to Making Medicine
0:21 Government shutdown and biotech impact
1:05 FDA furloughs and regulatory slowdowns
2:00 NIH delays and research funding concerns
2:40 Investor confidence during shutdowns
2:57 SBIR & STTR programs expire
3:22 Political stalemate in the Senate
3:50 Why SBIR matters for biotech innovation
4:05 Trump & Pfizer announce MFN drug pricing deal
5:06 Trump RX website and drug access
6:05 Market reactions and industry uncertainty
6:36 Trump’s 100% pharma tariff threat
7:40 Section 232 investigations on drugs and PPE
7:59 Closing thoughts & audience Q&A
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this week’s episode, John Stanford breaks down the White House autism event, the debate over shifting SEC reports to twice-yearly, and how MFN pressure is reshaping pricing strategy - before welcoming Endpoints News’ Max Bayer for a wide-ranging Press Pass on tariffs, GLP-1s, and China’s biotech surge. We unpack what “success” might look like for the administration’s drug-pricing push, why insurers could make or break any DTC effort, and how policy whiplash is hitting rare disease developers and investors. Max shares on-the-ground reporting about China’s rapidly built “Cambridge-like” ecosystems and the risks of restricting out-licensing. We also discuss the stakes for U.S. competitiveness if Europe becomes the default partner. Stick around to the end for how we’re tracking MFN and IRA signals across company filings.
Should SEC reporting shift to twice a year for biotechs, or does that cut needed transparency?
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Timestamps:
0:05 Welcome to Making Medicine
0:36 Headlines: White House autism event & fallout
1:34 SEC filings: quarterly to semiannual debate
2:13 Press Pass: Max Bayer (Endpoints News) joins
2:39 “Totality” of actions - MFN, tariffs, vaccines, China deals
4:10 Investor lens: regulatory continuity & rare disease shocks
6:01 MFN behavior shifts (e.g., UK pricing moves)
8:39 What counts as success? GLP-1 pricing & insurer role
12:11 China’s biotech surge & the out-licensing boom
15:03 Policy options: restrictions vs. U.S. competitiveness (Europe risk)
17:20 U.S. ecosystem headwinds: jobs, patents, visas, funding
23:51 Outro, subscribe, and where to send tips for Max DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
This week, John Stanford dives into the UK’s pharmaceutical challenges, including ABPI’s warning about declining competitiveness and major companies pausing investment. We also explore the debate over direct-to-consumer drug advertising in the U.S. and how it ties into investment decisions and the pill penalty. Finally, we close with August’s FDA approvals, celebrating breakthroughs for rare diseases and cancer patients.
What do you think?
Can the UK become Europe’s life sciences hub by 2030?
Should the U.S. rethink DTC advertising, or does it play a vital role in innovation?
Which of this month’s FDA approvals excites you most?
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Timestamps:
0:00 Welcome to Making Medicine
0:28 UK pharma outlook and ABPI report
1:37 Weaknesses in UK drug investment
2:24 Companies pausing UK investments
3:08 U.S. vs UK drug access and pricing
4:08 Global pressure for fair drug pricing
4:33 MFN pricing concerns in the U.S.
5:09 Debate over drug advertising
6:09 How DTC ads affect biotech investment
7:26 Connection to the pill penalty
7:48 FDA Approvals Corner – August highlights
8:17 Jazz Pharmaceuticals – Modeyso approval
8:36 Boehringer Ingelheim – Hernexeos approval
9:17 Other rare disease drug approvals
10:23 Closing thoughts & FDA wins
DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
In this week’s episode, John Stanford reflects on Incubate’s own holiday, September 13th (9/13), and the ongoing fight to end the pill penalty through the EPIC Act. He also covers the latest developments on tariffs, HHS hearings, FDA’s new rare disease principles, and the future of the SBIR program. We close with new research on how the IRA is affecting biotech investment.
What are your thoughts on the pill penalty?
Do you think FDA’s new rare disease guidance will accelerate innovation?
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Timestamps:
0:00 Welcome to Making Medicine
0:32 9/13 and the pill penalty explained
1:37 Incubate’s advocacy: EPIC Act and campaigns
2:31 Life Science Investment Tracker: discontinued drugs & programs
3:02 Trump tariffs and pharmaceutical exemptions
4:06 Japan deal and Most Favored Nation strategy
4:22 RFK Jr. Senate hearing on vaccines, IRA, and drug pricing
5:37 The trap of list prices in policy debates
5:39 FDA’s new Rare Disease Evidence Principles (RDEP)
6:34 Why clarity matters for rare disease companies
6:36 SBIR program renewal and uncertainty ahead
7:09 NPC survey on the IRA’s impact on investment
7:51 Closing thoughts & call to action
We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
This week, John Stanford sits down with Kendalle Burlin O’Connell (CEO & President, MassBio) to unpack the 2025 Industry Snapshot - why Massachusetts still attracts 22% of U.S. biotech VC and how advanced modalities keep the state at the cutting edge. We dig into the “flywheel” of the bioeconomy, from NIH and SBIR to FDA uncertainty, tariffs, and MFN. Kendalle lays out a unifying policy roadmap - a comprehensive competitiveness package - to keep the U.S. leading in life sciences. We also talk capital concentration, China’s rapid rise, and what it will take to avoid losing our edge in the next 2-5 years. Stick around for a candid, optimistic close on how the ecosystem rebounds.
What stood out to you most from MassBio’s 2025 Snapshot?
Do you agree the U.S. needs a “comprehensive competitiveness package”- and what should be in it?
How are funding cuts or regulatory uncertainty affecting your team right now?If you're new to the
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https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:
0:00 Intro music & welcome
0:15 Guest intro: Kendalle Burlin O’Connell, MassBio CEO
1:24 2025 MassBio Snapshot: why it matters now
2:12 Key stats: 22% of U.S. VC & advanced modalities lead
3:45 “Massachusetts works”: optimism amid a gloomy market
5:03 The biotech flywheel: how uncertainty stalls the ecosystem
6:59 Funding pipeline: NIH cuts, SBIR reauth, FDA/tariffs/MFN
9:58 Why biotechs need big pharma; price controls’ ripple effects
12:45 Capital crunch: venture down & late-stage concentration
14:51 Why NIH & ARPA-H can’t be replaced by private capital
16:56 The fix: a comprehensive competitiveness package
19:09 China’s rise & the 2-5 year warning
22:23 MA bioeconomy impact, optimism, and outroWe’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.”We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.”
In this week’s episode, John Stanford breaks down the latest headlines across Washington, the FDA, NIH, and industry. We cover the Trump cabinet’s tariff-drug pricing push, BARDA’s funding of vaccine research following recent pivots away from mRNA vaccines, a hopeful return of biotech IPOs, and NIH program cuts. Plus, we debut the FDA Approvals Corner celebrating new medicines reaching patients, and spotlight the looming September deadline for the SBIR and STTR programs.
What do you think about tariffs being tied to drug pricing?
Should Congress extend SBIR funding as-is, or rethink the program? Which FDA approval from July do you think will have the biggest impact?
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Timestamps:
0:05 Welcome to Making Medicine
0:38 Trump cabinet links tariffs & drug pricing
2:24 BARDA shifts vaccine funding away from mRNA
3:36 First biotech IPO in 6 months: LB Pharmaceuticals
4:56 Policy headwinds in SEC filings & MassBio snapshot
5:17 NIH cuts minority biomed research program
5:43 Launch of FDA Approvals Corner
6:25 July FDA approvals roundup
7:45 Policy Spotlight: SBIR & STTR programs
8:46 The Innovate Act and foreign risk concerns
9:42 Extension vs. compromise for SBIR reauthorization
10:27 Closing thoughts & call for comments *We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.”
This week, John Stanford sits down with Dr. Ned Sharpless - former NCI Director, Acting FDA Commissioner, and now venture capitalist at Jupiter Bio Ventures. From the challenges of biotech funding, regulatory uncertainty, and the Inflation Reduction Act to the rise of China in biotech, IP battles, and the hype around AI, Ned offers candid insights you won’t hear anywhere else.
What do you think about the current funding environment in biotech?
How should the U.S. respond to China’s scientific rise?
📱If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true
Timestamps:
0:00 Welcome to Making Medicine
0:12 Guest introduction: Dr. Ned Sharpless
1:03 Launch of Jupiter Bio Ventures
3:31 The tough biotech funding environment
5:27 Regulatory uncertainty, IRA, and FDA challenges
8:02 Leadership turmoil at FDA, NIH, and HHS 10:18 RFK Jr.’s vision and impact on health policy
13:05 Morale, recruitment, and expertise at federal agencies 15:20 How NIH, FDA, and CMS work together
19:00 NIH funding freezes and Congressional outlook 23:36 FDA’s new priority review voucher program
28:02 Public skepticism, politics, and FDA trust
30:02 The “pill penalty,” EPIC Act, and IRA fixes
34:04 Why small molecules still matter for cancer 35:40 IP protections, march-in rights, and investment risks
39:20 The debate over Most Favored Nation drug pricing
43:12 Direct-to-consumer pricing as a potential solution
44:38 AI in biotech-hype vs. reality
46:46 China’s rise in biotech and global competition
50:11 Closing thoughts and optimism for science
In this episode, John Stanford dives into the latest policy and science headlines - from Dr. Vinay Prasad’s dramatic exit and return to the FDA, to HHS’s $500M cut in mRNA research, to looming pharmaceutical tariffs. Then, we debut our new "Industry Perspectives" segment with NovaQuest Capital’s Patrick Jordan, exploring how regulatory uncertainty, populist pricing policies, and global market dynamics impact biotech innovation.
What do you think about HHS’s decision to pull back on mRNA research?
Could foreign reference pricing harm small biotech companies more than big pharma? And how should the FDA navigate leadership instability to keep innovation on track?
📱If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true
This week on the Making Medicine Podcast, John Stanford dives into the “Most Favored Nation” (MFN) pricing concept, championed by President Trump, and what it could mean for drug pricing, innovation, and patients in America. Could aligning U.S. drug prices with those abroad actually save patients money, or would it crush innovation and access? John unpacks the trade-offs of MFN, the global free-riding problem, the role of PBMs, and the rise of direct-to-patient drug models. The episode explores whether America already is the most favored nation in pharmaceuticals and what bold moves are next.
What do you think: Should the U.S. demand lower prices from drug companies or protect innovation at all costs?
Would a direct-to-patient model work better than today's broken system?
If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:
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Timestamps:
0:00 The History of Most Favored Nation
1:06 Trump Brings MFN Back into Focus
1:22 Welcome to Making Medicine
2:19 Why Drug Pricing Became the MFN Battleground
3:04 Trump's Push for MFN & the Pharma Letter
4:02 The Personal Story Driving Trump’s Policy
5:00 The Appeal and Simplicity of MFN
5:19 Industry Pushback & Potential Consequences
6:02 America’s Role in Global Drug Innovation
7:06 Why MFN Could Damage U.S. Biotech
7:25 The Costco Analogy & Why It Fails
8:20 Global Free-Riding and What Other Nations Don’t Pay
9:00 The U.S. Middlemen Problem (PBMs)
10:03 Global Solutions and Missed Opportunities
11:01 Generics: The Hidden Strength of the U.S. System
12:43 What Happens If Generics Vanish?
13:14 Trump's Unclear Path Forward
13:46 Direct-to-Patient Sales: A Better Path?
14:42 Is the U.S. Already the Most Favored Nation?
15:30 Final Thoughts on MFN & What Comes Next
In this week’s special Q&A episode, John Stanford tackles your biggest questions from around the biotech and policy world. From the growing list of drug price controls under the IRA to the newly announced 15% EU tariffs on medicines, there's a lot at stake for patients, companies, and innovation. John also breaks down the temporary NIH funding freeze, what it means for research, and why August recess matters more than you think.
What impact do you think drug price controls will have on innovation?
Should medicines be included in international tariff negotiations?
What policies should Congress prioritize this fall?
📱If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:
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Timestamps:
0:00 Tech setup and behind-the-scenes
3:37 Welcome to the Making Medicine Podcast
4:16 Breaking news: FDA's SBER director steps down
4:58 Are we moving toward more price controls on drugs?
7:47 New EU trade deal and tariffs on pharmaceuticals
10:08 How the IRA continues to impact the investment environment
12:31 Did the White House freeze NIH funding?
15:10 What is August recess and why it matters
16:53 Final thoughts and call for listener questions
In this special Press Pass episode of the Making Medicine Podcast, John Stanford welcomes Nyah Phengsitthy of Bloomberg Law to break down the latest shifts in drug pricing, FDA policy, and the unpredictable pace of the Trump administration. They explore the Medicare drug price negotiation program, new FDA leadership under Dr. Makary, and the industry’s reaction to rapidly changing executive orders. Nyah also shares her approach to filtering meaningful policy changes from political noise. Plus, they dive into how upcoming guidance may reshape the role of physicians in Part B drug distribution and what that means for innovation in medicine. How should industry leaders respond to policy announced via social media posts? Will the new FDA leadership redefine efficiency and access in drug approval? What worries you most (or excites you) about the future of drug pricing policy?
📱If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true
Timestamps:
0:00 There's a lot going on
0:36 Welcome to Making Medicine
1:00 Introducing Nyah Phengsitthy and Press Pass
1:40 Top trends in drug policy under Trump
2:52 Uncertainty and industry response
3:57 How Nyah filters news vs. noise
5:29 A changing FDA and its new direction
6:49 Stakeholder engagement and Makary’s listening tour
7:51 Industry frustration over vague policy
9:00 Medicare drug negotiation: Trump’s first take
10:47 Fixed dose combos and Orphan Cures Act in new guidance
11:50 Part B dynamics and physician involvement
12:56 Listening sessions and future guidance
13:19 Final thoughts and wrap-up
In this week’s episode, John Stanford breaks down the evolving story of President Trump’s aggressive tariff strategy—focusing on a potential 200% tariff on pharmaceuticals. From a historical look at Trump’s decades-long affinity for tariffs to the current Section 232 investigation into pharmaceutical imports, we explore what these actions could mean for national security, drug prices, and innovation. Could this policy lead to onshoring more drug manufacturing—or just higher prices for patients? And what exactly is “Liberation Day”? What are your thoughts on a 200% pharma tariff?
Is this a smart way to strengthen domestic manufacturing—or a policy that could backfire? 📱If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:
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Timestamps:
0:00 Welcome and Overview
0:33 Why Tariffs? A Trump Trade Philosophy
1:32 Trump’s History with Tariffs
2:32 The 2025 Tariff Timeline
3:59 Liberation Day and the Global Tariff Shock
4:53 August 1st Deadline and Market Reaction
5:27 Trump Floats 200% Pharmaceutical Tariff
6:03 Section 232 Investigation Explained
6:56 Incubate’s Response and Global Supply Chain Concerns
7:50 National Security, APIs, and the Commerce Department
8:56 Trump’s Endgame: Manufacturing Medicines at Home
9:44 What the Industry Should Expect
10:26 Why We’re Still in the Dark
10:50 Next Week’s Preview: The Press Pass Segment
John Stanford kicks off the official relaunch of the Making Medicine Podcast with a deep dive into the "one big beautiful bill" that’s shaking up Washington. From major tax cuts to game-changing reforms like the Orphan Cures Act, this episode covers what’s in—and what’s not—in the sweeping legislation. What’s the real impact on biotech innovation, Medicaid, PBMs, and future drug pricing? John breaks it all down while teasing what’s ahead in upcoming episodes, including Trump’s proposed pharma tariffs and the evolving role of the FDA.
Do you think the Orphan Cures Act goes far enough?
How will these tax and policy shifts impact innovation in rare disease and biotech?
📱If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:
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Timestamps:
0:00 Welcome to Making Medicine
0:18 Podcast relaunch and weekly content
1:00 One big beautiful bill becomes law
1:38 Tax cuts, deficit concerns, and social program impacts
2:55 How the bill affects biotech and venture capital
3:26 Orphan Cures Act and rare disease investment
4:20 Inflation Reduction Act reforms not included
4:40 PBM cuts left out of the bill
5:20 Victory on Most Favored Nations policy
6:24 What “pay for” means in DC speak
6:59 Industry spared from being a “pay for”
7:03 What’s coming next: tariffs, NIH cuts, FDA changes
7:45 Subscribe and stay updated
The path to new medicines is complex enough - policy doesn’t need to make it more difficult. But it does.
In this episode, Thomas Kaiser, Co-Founder and Chief Scientific Officer Avicenna Biosciences joins the show to share how the Inflation Reduction Act is unintentionally discouraging investment in small-molecule drugs, creating the pill penalty. He explains why this matters not just to biotech founders, but to millions of patients waiting for treatments for conditions like Parkinson’s, MS, and diabetes.
We also discuss:
* What’s at risk when chronic disease treatments are deprioritized due to poor incentives
* Why policymakers often misunderstand biotech timelines and how that disconnect can block life-saving innovation.
* How North Carolina’s foresight turned it into a biotech innovation hub.
Read Tom’s Op-ed in BioSpace.
In this episode of The Making Medicine podcast, John Stanford sits down with Professor Fred Ledley, Director of the Center for Integration of Science and Industry at Bentley University. Professor Ledley shares his journey from medical school to biotech entrepreneurship and academia, highlighting the critical intersection of science and business. The discussion explores the evolution of gene therapy, personalized medicine, and the role of industry in driving medical innovation.
Key Takeaways:* The integration of science and business is essential for advancing healthcare innovations. * Gene therapy and personalized medicine have evolved significantly, shaping modern treatments. * Collaboration between researchers, entrepreneurs, and policymakers accelerates medical progress.
The U.S. healthcare system is a puzzle for many.
To fix it, we need smarter discussions and a deeper understanding of both the industry and the policies that shape it.
In this episode, host John Stanford talks to healthcare policy expert Brian Reid, Principal at Reid Strategic and author of the Cost Curve newsletter, to discuss the challenges of fixing the incentives that have led to a broken healthcare system.
We also discuss:* How the healthcare debate often overlooks the needs of patients, focusing instead on assigning blame to various system stakeholders. * The potential consequences price controls could have on pharmaceutical innovation (particularly for small molecules and cancer treatments). * Why the current healthcare environment discourages companies from investing in long-term R&D, particularly in drug types that primarily benefit the elderly.
Science should lead our policy decisions—not the other way around.
In this episode, Kirsten Axelson, Senior Policy Lab Advisor at Incubate Coalition, dives deep into the power of small molecule medicines, the promise they hold for the future, and how our current policy landscape may upend their development.
This conversation focuses on Incubate Policy Lab’s most recent white paper, which sheds light on the crucial role these molecules play not only in innovative drug development, but also in ensuring equitable access to life-saving treatments.
Listeners will learn: * The crucial role small molecules play in modern medicine, especially in treating conditions like cancer and neurological diseases. * How current policy decisions, such as those in the Inflation Reduction Act, could negatively affect the development and accessibility of small molecule drugs. * Why small molecule medicines contribute to equitable access to healthcare, especially for underserved populations and in global health contexts.
To learn more about Kirsten’s white paper, please go to incubatecoalition.org
As part of our inaugural CEO series, we're excited to welcome Sherine Chan, the CEO and Co-Founder of Neuroene Therapeutics.
In this episode, Sherine shares her journey from academia to helming a cutting-edge biotech company. She explores the groundbreaking work her company is pioneering in targeting the powerhouses of cells: mitochondria. Sherine also dives into the influence of the Inflation Reduction Act on the development of small-molecule drugs
We also discuss: * Neuroene Therapeutics' ongoing projects. * The critical role of mitochondrial dysfunction in neurological conditions such as epilepsy, Parkinson's, and mitochondrial disorders. * Sherine's insights for aspiring entrepreneurs and scientists.
On World IP Day, Kirsten Axelsen, Senior Advisor of the Incubate Policy Lab, joins host John Stanford to announce the newest whitepaper, delve into the myths and realities surrounding IP in the pharmaceutical industry, explore the dynamics of patent regulations, and touch on the contentious discussions around patent thickets and pharmaceutical pricing under new legislative environments like the Inflation Reduction Act.
Join us as we also discuss:* What to expect out of the Incubate Policy Lab * The role that venture investment plays in advancing promising science and technology. * The latest whitepaper that addresses misconceptions about IP * The implications of IRA policies in weakening the generics industry, potentially disrupting the balance that has historically led to affordable drug pricing post-patent expiration.
Joe Allen, Executive Director of The Bayh-Dole Coalition, was at the forefront of the Bayh-Dole Act back in December 1980, which allowed researchers to own inventions resulting from federally funded research. However, 43 years later, the March-In Rights framework proposed by the Biden administration threatens to weaken America’s innovation. In this episode, Joe delves into the potential implications of this framework on drug pricing, the pipeline, and overall innovation.
Join us as we discuss:* The significance of the Bayh-Dole Act and intellectual property in transforming how America drives innovation. * Why public-private partnerships and collaboration in the medical field are key for funding research projects. * The implications of enacting March-In Rights on the drug development pipeline
How can we create better outcomes for cancer patients?
That’s the big goal Mohit Manrao is aiming for in his work as SVP & Head of US Oncology at AstraZeneca. In this episode, Mohit shares his perspective on the future of oncology and the pursuit of patient-centric care in a post-Inflation Reduction Act world.
Join us as we discuss:
* AstraZeneca's goal of launching 15 new drugs by 2030
* Solving for disparities in care and improving health equity
* Timeline for drug development and its effect on patient outcomes
Can we create a future healthcare system that is accessible and affordable for all patients?
That’s the major question that Mary R. Grealy, CEO of Healthcare Leadership Council, is trying to answer through her work. Mary, a former speech pathologist turned lawyer, shares insights from her unique journey from the healthcare field to advocating for patient-centered, value-based healthcare systems. In this wide-ranging conversation, Mary shares the challenges faced in the industry but also her hope for a future where patients are empowered through collaboration and innovation.
Join us as we discuss:
* Why collaboration between stakeholders is key
* Practical tips for advocates to make a compelling case to Congress
* The potential effects of the new price-setting system
* The impact of proposed legislation on treatments and cures
With recent movement in healthcare including President Biden’s Cancer Moonshot and the Inflation Reduction Act, one thing is clear: American healthcare is at a crossroads.
As we begin to tackle the conversation of healthcare reform, how can we rebuild the system around patients?
In this episode, MacKay Jimeson, Executive Director of The Patient Access & Affordability Project at Patients Rising, joins the show to explain how the system was never designed for patients, the benefits of a patient-centric system, and what the future holds for the industry.
Join us as we discuss:
* Why patient-centricity is notably absent in our healthcare system
* MacKay’s op-ed in response to President Biden’s SOTU
* The impact of The Inflation Reduction Act and Centers for Medicare & Medicaid Services on today’s healthcare landscape
* The true human impact of medicines
MacKay’s Op-Ed: https://www.statnews.com/2023/02/09/state-of-the-union-highlights-americas-awkward-conversation-on-science-medicine-and-financing-the-development-of-new-medicines/
MacKay’s Bio:
https://accessandaffordability.org/person/02-mackay-jimeson/
Even though 80% of the household decisions around health are made by women, only 4% of research and funding goes towards women’s health research.
In today’s episode, Natalie Buford-Young, Chief Executive Officer at Springboard Enterprises, joins us to discuss Springboard’s mission and how they are exploring a designated network to create pathways for emerging female innovators.
We also get to hear about Natalie's experience testifying on the Hill to advocate for reducing the decline of women's entrepreneurship.
Join us as we discuss:
· Innovation in digital health and life sciences;
· The Women's Health Innovation Coalition; and
· Increasing diversity in clinical trials.
Runaway inflation and economic instability is terrible for just about everybody, but are efforts to tackle this problem creating more?
To answer that, Kirsten Axelsen, Senior Policy Advisor at DLA Piper, joins the show to break down all the effects The Inflation Reduction act is having upon medicine,
We discuss:* The potential negative impacts on small-molecule medicine
* How the act affects patents and generic medicine
* Why we may see declines in small-molecule medicine research
John was at the JP Morgan conference and is here to discuss the key takeaways of the Inflation Reduction Act: the small-molecule penalty, the value of small-molecule drugs, the importance of incentivizing post-approval research, intellectual property, and non-coverage decisions at CMS. You’ll also hear John’s take on the demand for a more pro-patient agenda. There was a lot of focus on the role of policy and government, specifically in relation to the inflation reduction act and its impact on the life science and venture capital industries.
Ready to reaffirm its values, Incubate will be focusing its energy on working with the White House and Congress to make necessary amendments to the legislation. They’ll also have a focus on education and awareness to ensure that policymakers understand the critical role they play in the healthcare landscape.
Join us as we discuss:* Why is there excitement for 2023 in the biotech sector, but also some anxiety? * How does the organization, Incubate, plan to address the inflation reduction act? * What Congress can be doing to create a more pro-patient agenda?
How will the Inflation Reduction Act affect life sciences startups, current and future revenues, and drug investment? What will happen to patients amidst the aftermath of unintended consequences? There aren’t too many people who know more about the ins and outs than the fine folks at DLA Piper.
One of the biggest interventions in drug pricing since the Medicare Modernization Act was passed, listen to the inside scoop on what this means for the future of drugs.
Join us as we discuss:
-What drug price negotiations will look like under the act
-How brand competition will play out
-Which drugs and stakeholders will be affected
When you’re working to make good investments in bio and med tech there are three key pillars to consider: science, the management team and finance.
But how does it all come together in the end?
Find out in the latest episode with Christine Brennan, Managing Director, Vertex Venture HC as we talk about Vertex’s investment philosophy, why DEI inclusion is vital for industry, and what investments could look like for the rest of 2022.
Join us as we discuss:
- Christine’s journey to becoming the Managing Director at Vertex
- The investment firm’s philosophy around Bio Tech, therapeutic investments and MedTech
- Why it’s so important for the next generation to have women in tech
As we continue this journey together, we want to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
Everyone wants to make healthy choices. But we don't always have an opportunity to make healthy choices.
In today’s episode, we speak with Dr. Jerome Adams, Executive Director of Health Equity Initiatives at Purdue University and the 20th Surgeon General of the United States, about the need for proactive accessible health care, the economic burden of inaccessible healthcare, and why people need to know you care, before they care about what you know
As we continue this journey together, we want to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
Investors are logical people. They invest in medicines that they expect will give them a return.
Right now, there’s far too little investment in developing new antibiotics. The pipeline of treatment is thin, but the need is greater than ever.
Enter the AMR Action Fund.
Hear our conversation with Dr. Henry Skinner, Chief Executive Officer at AMR Action Fund about:
- The increasing cost of AMR and policy challenges
- How to build the pipeline to reach the new antibiotics we need to save millions
- Leveraging healthcare innovation for AMR before it’s too late
- AMR Action Fund’s first two investments and future outlook
More information about Henry and today’s topics:
- LinkedIn Profile: http://www.linkedin.com/in/henryskinner/
- Company Website: https://www.amractionfund.com/
As we continue this journey together, we want to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
We’ll be the first to say that the healthcare system is broken, especially in patient access complexity.
However, we see three areas where we can execute actionable change for patients in 2022: intellectual property, mergers and acquisitions, and the FDA’s reauthorization.
In this episode, Coalition Manager and podcast host Ashlyn Roberts interviews John Stanford, Executive Director at Incubate Coalition, about opportunities for pro-patient reform.
Join us as we discuss:
- A level set of what’s been happening in Washington lately
- Why drug pricing issues are still evergreen
- 3 areas for improvement: IP, M&A, and PDUFA
- Shifting the narrative about pro-patient reforms
As we continue this journey together, we want to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
Listening on a desktop & can’t see the links? Just search for Making Medicine in your favorite podcast player.
If we want data and clinical trials that meaningfully represent the population of people who take the drug, we’ll need to do more than just issue guides.
In this episode, we interview returning guest Kirsten Axelsen,Senior Advisor for Charles River Associates, about making medicine more accessible to lower income people and creating a more equitable health system with better data.
Join us as we discuss:
- The detrimental effects of price controls on early life stages of drug development
- Why a price control on one is a price control on all
- The deep concerns about health disparity and equity
- How data can address racism, ageism, and poverty in health systems
- 2022 as the year of the non-COVID vaccine
Check out these resources we mentioned:
- Report referenced at 1:16 here and here.
- Build Back Better Act
As we continue this journey together, we want to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
Listening on a desktop & can’t see the links? Just search for Making Medicine in your favorite podcast player.
Drug development is a relay race because you pass the baton to the next runner who will take it to the next level. You are proud to have made it onto the stairs at the end of the race not as an individual but as a huge team of experts of subsequent talents.
In this episode we interview Johannes Fruehauf, Founder and CEO at LabCentral/BioLabs, about how the relay race metaphor shapes our understanding of drug development and why we need knowledgeable capital to forge ahead.
Join us as we discuss:
- Solving challenges that face scaling entrepreneurs
- The stages of the drug development relay race
- Investing in a drug development ecosystem that diversifies talent
- The need for investors who understand pharmaceutical startup proposals
As we continue this journey together, we want to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
Listening on a desktop & can’t see the links? Just search for Making Medicine in your favorite podcast player.
Drug policy debate today is like a wetland. It’s the heart of the ecosystem that has to be preserved at all costs — or else we lose the wetlands, the shore, everything.
In this episode, we interview Jean-Francois Formela, Partner at Atlas Venture, about what brought him to Washington and his views on the government’s role in drug development.
Join us as we discuss:
- Where are we going in drug development
- The role of new modalities
- Investor goals: great science, great company, good return
- A future in which governments enable the biopharmaceutical community to cure disease
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
Listening on a desktop & can’t see the links? Just search for Making Medicine in your favorite podcast player.
Today’s guest describes drug development in the American healthcare market with the analogy of mortgages and rents.
People would rather pay higher mortgages because they are finite than pay rent indefinitely. Market-based pricing means that drugs will cost more until they become generic, whereas price control means paying rent forever.
In this episode, we interview Peter Kolchinsky, Managing Partner at RA Capital Management , LP and author of The Great American Drug Deal, about the state of drug development in the light of current events in policymaking.
In this episode, we discuss:
- The investor’s paradox and expecting drugs to fail
- Why the market, not the government, should steer drug development
- The mortgage vs. rent analogy
- Why insurance is essential to drug development
- How a trust in healthcare allows global society to function
As we continue this journey together, we want to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
Listening on a desktop & can’t see the links? Just search for Making Medicine in your favorite podcast player.
How does an MIT senior year capstone project evolve into an early-stage biotech that creates wearable solutions for Parkinson’s tremors?
Listen to Daniel Carballo speak about the story of Encora Therapeutics in our MIT takeover episode, hosted by guest Lindsay Androski Founder, President, and CEO at Roivant Social Ventures and President, Board Member at Incubate Coalition.
In this episode, we discuss:
- The innovation behind the first wearable prototype
- Daniel’s decision to become an entrepreneur
- His company’s North Star: improving patients’ lives
- The role of venture capital in the commercialization process
As we continue this journey together, we want to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
Listening on a desktop & can’t see the links? Just search for Making Medicine in your favorite podcast player.
As we follow innovation along the R&D value chain, we come across some compelling contributions to the healthcare ecosystem.
Venture capital investors. Causal inference. Real world evidence.
In this episode, we interview three guests about a collaboration story that represents the best of a healthy healthcare ecosystem:
Janis Naeve, Managing Director, Amgen Ventures at Amgen and Incubate Board Treasurer
Brian Bradbury , Vice President of Center for Observational Research at Amgen and Adjunct Professor of Epidemiology at UCLA
Alan Brookhart, Founder and Chief Scientist at NoviSci and Professor of Population Health Sciences at Duke University
In this episode we discuss:
- How Amgen fosters relationships among scientists
- The difference between machine learning and causal inference
- The origin story of NoviSci
- How COVID has affected a fruitful partnership
As we continue this journey together, we want to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
Listening on a desktop & can’t see the links? Just search for Making Medicine in your favorite podcast player.
The price control policies that are being discussed in Congress have the potential to harm innovation in the life science industry. But how, exactly?
In this episode, we interview Kirsten Axelsen, Senior Advisor at Charles Rivers Associates , about what would change in biopharma if price controls were implemented.
In this episode, we discuss:
- The close relationship between economy and drug development
- The U.S.’s role in developing over 40% of the world’s new medicines
- The potential reduction of biopharma global revenues by 19%
- What it means globally when 8-15 fewer medicines are made per decade
- Some flaws in the health technology assessment (HTI) regarding clinical trials
Incubate Policy Lab is the research arm of Incubate Coalition, where we will be releasing reports, whitepapers, and hosting events in partnership with Charles Richards Associates. You can visit our website for more information.
We will be releasing an analysis on the CBO report and how HR 3 will impact life sciences R&D, and another report where we analyze price controls from the venture capital perspective. We also hosted a roundtable, and will be releasing an analysis our findings from experts who attended the event.
As we continue this journey together, we want to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
What goes into a bottle of new medicine is more than the proverbial 15 years and $2 billion. It takes great science, certainly, but it also takes 15 years of relationships.
No one can make medicine alone, not even Big Pharma. Collaboration, innovation, and industry relationships are key to bringing life-saving medicine to market.
In this episode, I interview Imran Nasrullah, Vice President & Head, Open Innovation Center North America - East at Bayer Pharmaceuticals, about strengthening relationships within the biotech ecosystem.
In this episode we discuss:
- The importance of industry relationships in making medicine
- How relationships mitigate the challenge of drug development
- Mentoring options for small, innovative companies
- Relying on partners to actualize different paths to commercialization
As we continue this journey together, we want to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
Listening on a desktop & can’t see the links? Just search for Making Medicine in your favorite podcast player.
High cost out-of-pocket drugs and obstacles to reduce those prices for patients plague the health industry. With patients in mind, organizations are looking to invest and bring drugs directly to market.
Gaurav Gupta and Hugo Beekman, Co-Founders of Ascendant BioCapital, join the show to discuss their organization and how they’re focusing on drugs that truly make a difference for patients.
What we talked about:
- The Founding of Ascendant BioCapital
- The Medical & Investing Backgrounds of the Founders
- Impactful Experiences in the Industry
- Testifying Before Congress & Issues with Out-Of-Pocket Costs
- Importance of Intellectual Property to Biotech
To hear more interviews like this one, subscribe to the Making Medicine Podcast on Apple Podcasts, Spotify, or your preferred podcast platform.
As it turns out, many perceptions about the pharmaceutical industry are based without all of the facts.
That’s why we’re sitting down to understand the data with Ravi Mehrotra, Thought Leader and former Senior Managing Director of Biotechnology Equity Research at Evercore ISI.
What we talked about:
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Defining WBPI while taking a closer look at the industry
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The reality that winners pay for all the losers
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Risk and profitability
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HR3 legislation
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Wall Street’s position on the drug pricing debate
Check out these resources we mentioned during the podcast:
- HR 3 legislation
As we continue this new journey together, we would love to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
Intellectual property (IP) rights have been the driving force behind innovation and entrepreneurship. However, IP has more recently been seen in a negative light.
Through the COVID-19 Pandemic, vaccine IP rights have come into question: should IP rights be waived when concerning an essential technology?
Andrei Iancu, Former Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, joins the podcast to discuss his views and concerns on IP rights:
What we talked about:
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The Benefits of IP
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How Sentiment of IP Has Changed
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Short, Medium, & Long Term Concerns to Waiving IP Rights
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Where Concerns Should Be Focused & How to Improve IP
Check out the resources below for more information:
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Andrei’s LinkedIn
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Our host: John Stanford’s LinkedIn
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www.incubatecoalition.com
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
The fight against Antimicrobial Resistance (AMR) is challenging due to financial, ethical, and legislative issues. Combating infectious disease can prove to be a risky financial investment but much less in comparison to the global impact if solutions are not researched.
Alfonso Chang is the Managing Director of Relativity Healthcare Partners; he shares insight into the challenges and how to overcome them:
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Investor Hesitancy
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Higher clinical and ethical implications
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Preference of existing therapies over new ones
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Unintended consequences from lawmakers due to drafted legislative language
Check out the resources below for more information:
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Alfonso’s LinkedIn
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Our host: John Stanford’s LinkedIn
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
In 1980, the Bayh-Dole Act was enacted by U.S. Congress, which changed how ownership of an invention is pursued. Almost 40 years later, how has this act fared?
On Episode 1 of Making Medicine, John Stanford, Executive Director of Incubate Coalition, introduces Joseph Allen and Associates to cover:
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How Bayh-Dole came to be, starting with Purdue University
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The original intent of ‘march-in’ rights and how it affects Bayh-Dole
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Who was this act for, and how has it played out 40 years later?
As we begin on this new journey together, we would love to hear from you, the listener. Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org what’s top of mind, what story you want to hear, or what you find interesting!
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.
From chance meetings to risky investments, Making Medicine explores the origin stories of life changing medication and how patients, corporations and investment communities benefit from understanding it.
On today’s episode, Kelsey Kohrs, Producer at Sweet Fish Media and John Stanford, Executive Director of Incubate Coalition introduce Making Medicine, a podcast dedicated to sharing life science stories that have led to scientific breakthroughs. These stories will cover:
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What are the different steps of the drug development process?
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How can we sustain future innovation in the life sciences?
-When chance meetings have led to life changing drug innovation
As we begin on this new journey together, we would love to hear from you, the listener. What’s interesting? What do you want to hear more of? Is there a story that you’ve heard of that you’d like our team to dig in to? Email John@incubatecoalition.org or Ashlyn@incubatecoalition.org.
To hear more interviews like this one, subscribe to Making Medicine on Apple Podcasts, Spotify, or your preferred podcast platform.