Back Bay Life Science Report

In this episode, Dr. Peter Bak is joined by Trent Gordon and Dr. Mavra Nasir as they discuss their Bioprocess Online article published earlier this year, “The Transactional Landscape of ADCs: A Payday for Payloads.” This conversation explores the dynamics and data within the emerging ADC field, including:

Background information on the class of therapeutics known as ADCs, which have been on the market since 2000
The number of headlines around ADCs lately, especially the standing ovation the data from Enhertu received at ASCO in 2022, making waves in breast cancer treatment
Deal structures and the BD side of ADCs, and their extended revenue generation potential
Where the field is headed, in terms of clinical, BD and commercial standpoints

Read and connect with our authors: The Transactional Landscape Of ADCs: A Payday for Payloads

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For biopharma and medtech companies, the decision to go public is predicated on many business decisions—what kind of capital can be raised? Is our investor base strong and interested? Is now the right time? The Nordic Markets offer some distinct advantages at the earlier stage, and also offer new possibilities for US companies to list abroad. And although the specific logistical and mechanical aspects are exceedingly important, at the end of the day, the decision to do something like this is predicated on an amalgam of strategic decisions.

In this episode Back Bay Life Science Advisors and Nasdaq outline best practices for companies considering a public listing, including:

Steps in best practice strategy in an increasingly complex market
Advantages of listing with a smaller listing threshold market
Similarities and differences between Nasdaq US and Nasdaq Nordic markets
The strategic change and new dual listing option for US companies
The unique way retail participation makes up a large portion of the Nasdaq Nordic market (>25% of trades come in from retail)
Differences in support for emerging companies, Nordic v. US markets

Jonathan Gertler is CEO of Back Bay Life Science Advisors and Managing Partner at Bioventures Medtech Funds. Maria Groschopp Dellwik is Nasdaq’s Head of Strategy and Business Development for Global Listing Services in the Nordics, where she manages new offerings and key strategic change initiatives to improve listing offerings and the Swedish capital market.

Download “Preparing for a Public Listing: Best Practices for Biopharma, Medtech and
Healthtech Companies” from Back Bay Life Science Advisors and Nasdaq
https://bblsa.com/investment-banking-1

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with Back Bay Life Science Advisors’ Dr. Peter Bak and Dr. Mavra Nasir

Dr. Mavra Nasir recently published a thought piece in Biopharma Dealmakers outlining the current state of play in the promising field of protein degradation. In this episode, Dr. Nasir sits down with Peter Bak to discuss the recent surge of venture funding and partnerships surrounding TPDs.

Read Dr. Nasir's article "From drug target inhibition to degradation: a TACtical strategy" here.

Topics in this podcast include:

An intro into targeted protein degradation (TPDs) and proteolysis-targeting chimeras (PROTACs)
Industry advantages of TPDs vs. traditional antibodies
Biopharma and VC's growing interest in molecular glues
Commercial hurdles ahead in this space
How TPD companies can differentiate, from a pipeline and breadth of opportunities to select an indication, communicate to investors and drive value

If you have a question about life sciences development, submit it here. We may feature it on an upcoming episode.

Thanks for joining us!

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Mavra Nasir, PhD is a senior consultant at Back Bay Life Science Advisors where she supports strategic engagements across a range of therapeutic areas including rare diseases, hematology/oncology and metabolic diseases for biopharma and MedTech. Dr. Nasir joined Back Bay after receiving her PhD in Quantitative Biomedical Sciences from Dartmouth College.

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This is the first episode in our podcast series of Q&As on biopharma and medtech development—directly from active developers. Our podcast listeners, including Back Bay clients, have submitted timely and relevant questions about life science development and the daily challenges they face.

Christian Thieniel and Brendan Wang, two senior members of the Back Bay Life Science Advisors team with a tremendous amount of experience in the life sciences, especially as it relates to scientific, clinical and commercial issues, offer guidance on issues related to pricing and early market access.

Topics include:

For early-stage clients, when is the right time to think about pricing and access, and why it is important to identify market access hurdles early
For later stage clients, how to get more granular on pricing and market access insights (narrowing the price range, broadening the payer sample, etc.)
Which real-life and project examples lend clarity here, including an example from Back Bay’s past work in the anti-infectives space. How can upfront P&MA research lead to more confidence and varied project positioning in partnering discussions?

Would you like us to include your life sciences development question in an upcoming episode? Please submit it here.

Make sure to subscribe to our podcast on your favorite podcast platforms and follow Back Bay Life Science Advisors on LinkedIn.
Thank you for joining us.

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In this episode of Back Bay’s industry podcast, The Life Science Report, Dr. Peter Bak is joined by Mike Bogetofte Barnkob, a doctor with the Department of Clinical Immunology at Odense University Hospital in Denmark and a research fellow at the University of Southern Denmark, to discuss current perspectives—clinical, scientific and manufacturing—on the cell therapy space.

Dr. Barnkob’s expertise spans basic and clinical immunology, with a particular interest in advanced cellular modalities, such as chimeric antigen or CAR T-cells. He studied at the Massachusetts Institute of Technology, in Back Bay’s hometown, and completed his PhD at Oxford University.

Topics in this podcast include:

The current clinical and academic uses of CAR T-cells and where they are headed in the near-term
How cellular therapies factor into a robust and thriving public healthcare-based system
Ongoing questions of pricing and reimbursement
Challenges and approval processes in getting these "living medicines" to people
Hurdles and considerations when building a Good Manufacturing Practice (GMP) cellular facility

Do you have a question about development in the cell therapy space? Drop Back Bay a line.

Make sure to subscribe to our podcast and follow Back Bay Life Science Advisors on LinkedIn.

Thank you for joining us.

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Biopharma companies looking to establish a footprint in Europe face country-specific decision-making processes. The health technology assessments (HTAs) in France and Germany, for example, look very different.

Does this regional level of thinking make it easier or potentially more difficult to get medicines to market and into the hands of patients who need them?

In this episode of Back Bay’s Life Science podcast, Pete Bak is joined by Alexander Natz, Secretary-General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Europe’s principal trade body for companies working in the field of pharma, biotech, and medtech. Based in Brussels, EUCOPE provides expertise across a number of strategic issues such as regulatory paths and pricing and market access.

Topics in this podcast include:

A brief overview of EU HTAs as they pertain to novel technologies, including cell and gene therapies
The differences and nuances between cell and gene therapies and best practices for companies during early clinical development
Where medication approval could be denied in the absence of specific data
The right time to start talking to EU payors
How the regulatory framework will continue to evolve
Impact on drug indication choice and strategy and examples of where the regulatory process has gone well or faltered

For questions on regulatory and market access, reach out to Back Bay Life Science Advisors and check-in with EUCOPE at www.eucope.org.

Follow EUCOPE on LinkedIn www.linkedin.com/company/eucope and on Twitter: @EUCOPE.

Make sure to subscribe to The Life Science Report podcast, follow Back Bay Life Science Advisors on LinkedIn and sign up for our industry newsletter.

Thank you for joining us.

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Fifteen years ago, scientists discovered optogenetics, a technique of using light to stimulate light-sensitive receptors in order to turn brain cells “on” and “off" at the flip of a switch. Advances in optogenetics have allowed this technology to move from the laboratory to humans, and more recently biopharma companies have been quick to incorporate optogenetic therapies into their ophthalmology portfolios.

In this episode of Back Bay’s Life Science Report, Peter Bak is joined by Kevin Norman to discuss the promise and commercial considerations of optogenetics.

Topics include:

The basic principles of optogenetics and the diseases it may be a treatment for
How Big Pharma, biotech and VC view the promise of optogenetics for the future
Current issues, technical challenges and functional endpoints for active therapy trials like those with Nanoscope Therapeutics, GenSight Biologics, Allergan, etc.
The state of play for how optogenetics may be useful as a technology beyond the realm of ophthalmology, including cancer

Read Back Bay Life Science Advisors' latest industry article on optogenetics in Cell & Gene here.

Make sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn and Twitter. Thank you for joining us.

If there's a question or subject you'd like us to cover, submit it here. It may be the topic of one of our upcoming podcasts.

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Antibiotics act as a safety net for all of healthcare. They make medical procedures such as surgeries, childbirth and cancer treatments possible, but what happens when bacteria or other microorganisms become resistant to the drugs we use against them?

Back Bay Life Science Advisors’ Managing Director Peter Bak sits down with Marc Lemonnier, a molecular and cellular microbiologist and CEO of Antabio, a clinical stage company located in France developing novel antibiotic therapies, for a conversation on the current clinical landscape of novel agents to address antimicrobial resistance and the regional and global initiatives to tackle the issue.

Topics include:

The growing rates of antimicrobial resistance (AMR)
Which global organizations are at work on this issue and their list of priority pathogens a/k/a the world’s “most wanted deadly super bugs”?
How COVID 19 and the pandemic exacerbated the issue of AMR
Push and pull incentives and subscription models for innovative antimicrobials and how they work in various countries around the world
Why global access is a real issue and how to solve the problem

For more, read Back Bay Life Science Advisors' recent take on the role of investments in antimicrobials in STAT here.

Learn more about Antabio, a private biopharmaceutical company developing novel antibacterials targeting drug-resistant pathogens that are deemed a critical priority by the WHO. www.antabio.com

Make sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn and Twitter. Thank you for joining us.

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Despite the heavy influx of capital over the past years, medtech or biopharma sell-side assignments can still be ripe with challenges. In this episode of Back Bay’s industry podcast, Back Bay Life Science Advisors’ investment banking team discuss best practices for successful sell-side licensing, partnering, and M&A, including:

Best practices for readying vital aspects of deal preparation
Identifying deal issues, red flags ahead of time
Articulation of the path forward, including indication and proof of concept and telling the story through to market
The importance of choosing the right partner and alignment for stakeholders, management, board, investors, internal champions and others
The most significant mistakes made in competitive intelligence, technology, position, IP regulatory strategies
Networking, contacts and how to know who’s going to be responsible for what and when

Make sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn. Thank you for joining us.

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Cell and gene therapies are currently among the hottest investments in the biotech space, both in the public and private markets. In this episode, Back Bay’s Managing Director and host Pete Bak, PhD is joined by Kyle O’Neil and Brendan Wang, who are returning to the podcast after attending the 2021 Cell and Gene Meeting on the Mesa. Tune in to hear their discussion on emerging investment themes and which ones were key topics of discussion at this year’s conference.

Topics include:

The next generation of gene-editing technology
- CRISPR 2.0
- Off-target effects
- Novel nucleases
- PAM sequences
Autologous and Allogeneic CAR-T cell therapy
- Ex vivo vs. in vivo approaches
The business model on gene therapies
- Figuring out manufacturing capabilities first
- How to tap into larger markets
- Building businesses around small monogenic diseases

Learn more, read Bay Life Science Advisors' latest white paper on gene therapy innovation here.

Make sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn.

Thank you for joining us.

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“I have a deep belief that medtech and healthtech are going to carry us forward to markedly improve delivery and quality of healthcare.” - Jonathan P. Gertler, MD

For years, biotech has been the dominant theme in life sciences development, offering a great deal in treatment advances and in terms of investing versatility and returns potential. But with promising system solutions serving broader swaths of patients, medtech is resurging.

Medtech investment has grown dramatically over time, with scale and diversification capable of weathering economic storms and fueling expansion in the markets.

Medtech is a significant driver of our healthcare economy, contributing to more meaningful patient care solutions and technology that continue to move care further from the hospital and more toward the home.

In this episode of The Life Science Report, Back Bay Life Science Advisors’ industry podcast, Dr. Jonathan Gertler speaks with Paul LaViolette Managing Partner & COO, SV Health Investors about the varying elements of medtech investments, including structured deals and strategies, the regulatory changes that are driving medtech forward and how more cost-effective care will be a turning point for granting access to more and more patients.

Topics in this podcast include:

The role of investment in medtech and how to match capital to the asset or company
Why “incremental" is a four-letter word in the world of venture
How medtech is a systems solution provider, which differs from biotech as a disease modifier based on increasing patient segmentation
How structured deals, traditionally the territory of biotech, have found their way deeply into medtech M&A and how the public markets are offering alternatives in a more robust way than recent history has shown
The regulatory changes for medtech in Europe and the profound impact this has on how investors and buyers make decisions

Subscribe to our industry podcast, The Life Science Report, and follow Back Bay Life Science Advisors on LinkedIn. Thank you for joining us.

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One of the unexpected outcomes of the COVID-19 pandemic has been the rapid and widespread uptake of remote patient monitoring. Just ahead of the pandemic, investment in patient monitoring was booming; priming the system for quick uptake and innovation. As with vaccines, much groundwork had been done to prepare for dramatic innovation and widespread, rapid patient use, seemingly “overnight.”

In this episode of Back Bay Life Science Advisors' industry podcast, Drs. Jonathan Gertler and Corinne Nawn discuss the clinical considerations of remote patient monitoring, including advances in sensing platforms, wearables, and the current investment landscape driving the innovations allowing patients and physicians to interact meaningfully and safely from different locations.

Topics in this podcast include:

Investment in digital healthcare companies
- The spectrum of financings, acquisitions, IPOs, and SPACs in this space
New ways of patient monitoring through wearable tech
Understanding the details of sensing and capturing
Coordinating care based on analytics
Company partnerships and/or acquisitions

Read about MedTech's ascendance from Jonathan Gertler here.

Make sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn and Twitter. Thank you for joining us.

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In this episode of our life science industry podcast, Dr. Peter Bak sits down with Brendan Wang and Christian Thienel of Back Bay Life Science Advisors to discuss how pharmaceutical companies price their drugs. They cover the ins and outs of health economics, how payers make sense of a high price, and ways this varies around the globe.

With a focus on Biogen’s recent Aduhelm approval, the discussion includes how Biogen likely went about price setting and how this aligns with ICER’s initial evaluation and analysis.

Topics in this podcast include:

Relevant pricing analogs
Net level pricing decisions
Demand and utilization of products affecting pricing
Patient population levels
ICER’s role in drug pricing
The price point of a drug, given its controversial approval

Read Back Bay’s perspective on early-stage market access and price setting in STAT News, here.

Make sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn and Twitter. Thank you for joining us.

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In this episode Jonathan Gertler, Back Bay’s CEO and Managing Partner, sits down with Dr. Peter Bak, Managing Director at Back Bay, to discuss Dr. Bak’s latest article in STAT News and to talk about the world of anti-infectives.

Dr. Bak has more than ten years of expertise in infection and treatment. He began his research at Dartmouth Medical School and later continued at MIT, where he was an American Cancer Society Postdoctoral Fellow at the Koch Institute of Integrative Cancer Research.

Topics include:

-The landscape of antiinfectives, antimicrobials & antifungals -How commercial dynamics drive clinical unmet need -The role the pandemic played on development & investments -The deployment of cell therapies for viral diseases -Foundation support for anti-infectives -“Push incentives” to usher therapies into commercial stages

Link to Dr. Peter Bak's published article in STAT News, “Investment in antimicrobials was up in 2020, but much work remains," https://www.statnews.com/2021/04/28/investment-antimicrobials-uptick-2020-much-work-remains/

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Welcome to Episode #2 of The Life Science Report. In this week’s episode Jonathan Gertler, Back Bay’s CEO and Managing Partner, is joined by Gregory Benning and Vasilios Kofitsas of Back Bay’s investment banking team to talk about the market of Special Purpose Acquisition Companies (SPACs).

The feeling surrounding healthcare SPACs right now is almost...giddy. With enormous capital flowing into the biotech sector, SPACs have emerged as one of the hottest financing options. Last year, the market saw $80B in SPAC issuance, which 2021 will far exceed.

We’re still in the beginning of this market shift, but is the SPAC vehicle the right vehicle to fund the strategy of science?

Topics include:

Traditional IPO markets vs. the hot market of SPACs
How COVID affected the SPAC landscape
The delicate balance of near-term data, valuations & due diligence
Cautions, concerns & the importance of use of proceeds
Regulators & litigation risks in biotech
The potential of U.S. SPAC markets for European companies

Register for the June 17th Endpoints News and Back Bay Life Science Advisors webinar, “Life Science SPACs” here.

Thank you for joining us. To learn more about Back Bay Life Science Advisors, visit our website at www.bblsa.com or follow us on LinkedIn and Twitter.

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Welcome to Episode 1 of The Life Science Report. In this episode our host, Dr. Peter Bak, sits down with Brendan Wang and Kyle O’Neil of Back Bay Life Science Advisors to discuss the field of gene therapies and insights from their recently authored piece in Cell & Gene, “The Next Decade In Gene Therapy Innovation — 6 Critical Questions (And Answers),” and their newly released white paper on BBLSA.com.

Gene therapy has been talked about for many years, and it’s only in the past few years that we’ve begun to see some initial products make it to market. When many people think about gene therapies, they think they will be a curative treatment, but commercial positioning, pricing and the business model of gene therapies are still in flux.

Topics in this podcast include:

The scientific and commercial challenges of gene therapies
How the space is evolving from a commercial standpoint -The complicated issue of delivery
The investment of gene therapy & the outcome-based gene therapy business models
Risk-sharing agreements, payment methodologies & pricing models
The unfolding future of gene therapies

Cell & Gene guest column

Brendan Wang and Kyle O’Neil’s white paper on the Back Bay Life Science Advisors website.

Make sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn and Twitter. Thank you for joining us.

Back Bay Life Science Report: Recent Episodes

Jonathan P. Gertler