Drug Solutions: Recent Episodes
Pharm Tech
The Drug Solutions Podcast, presented by Pharmaceutical Technology, features industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join the editors as the experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products. To learn more, visit https://www.pharmtech.com
Sustainability has been a recent focus of both pharmaceutical companies and stakeholders. In this episode of the Drug Solutions podcast, Patrick Lavery, editor for Pharmaceutical Technology®, Pharmaceutical Technology EuropeTM, and BioPharm International®, gathers perspectives from five key opinion leaders across the industry about a variety of applications and equipment, and provides a look into how sustainable practices can be continued and improved upon in the years to come.
Adeno-associated virus (AAV) vectors have become widely used as delivery mechanisms in gene therapy, but there are some complex hurdles to be overcome. In this episode of the Drug Solutions podcast, Patrick Lavery, editor for Pharmaceutical Technology®, Pharmaceutical Technology EuropeTM, and BioPharm International®, surveys two attendees from the recent ASGCT conference about their approaches, the results they have achieved so far, and what further research or investigation might be needed to bring these therapeutic tweaks to a wider cross-section of patients.
In this episode of Drug Solutions, the discussion revolves around current and anticipated new trends in equipment and technologies for optimizing the manufacture of new biotherapeutic modalities, such as cell and gene therapies. Automation technologies and continuous manufacturing emerges as significant drivers for the future biomanufacturing landscape. Innovative and progressive technologies will also play a role in establishing and maintain sustainabililty practices in the industry.
In this episode of the Drug Solutions podcast, Felicity Thomas, Associate Editorial Director, chats with a host of experts about the trends that have impacted the bio/pharma industry in 2024 and those they expect to be impactful in 2025.
In this episode of the Drug Solutions podcast, Felicity Thomas, Associate Editorial Director, chats with a host of experts about artificial intelligence (AI) and the potential impact AI and machine learning may have on the global bio/pharma industry in the near future.
Dosage forms, in particular oral solid dose, continue to evolve as new technologies enter the market, and as customer tastes and demands change. In this episode of the Drug Solutions podcast, Patrick Lavery, editor for Pharmaceutical Technology®, Pharmaceutical Technology EuropeTM, and BioPharm International®, surveys attendees from the recent CPHI Milan gathering about how fast the market is expanding, how it's evolved in recent years and even decades, and what drugs are most conducive to OSD formulations.
The biopharmaceutical industry has long been working on methods to delivery biologic therapeutics in a manner that will enhance ease-of-use and patient compliance. Biologics today are largely administered parenterally, a method that can be painful and undesirable for patients. Furthermore, parenteral formulations of biologics require a strict temperature-controlled environment. Researchers have long been exploring means to formulate biologic-based molecules that can ensure their molecular stability and mitigate some of the stringent manufacturing requirements. In this episode of the Drug Solutions podcast, Feliza Mirasol, science editor of Pharmaceutical Technology®, Pharmaceutical Technology EuropeTM, and BioPharm International® explores the issues challenging biologic formulation and the progress made so far in moving toward alternative routes of biologic drug delivery with Nigel Theobald, CEO of N4 Pharma, a specialist pharmaceutical company developing novel delivery systems for oncology, gene therapy and vaccines.
In this sponsored episode, Jörg Zimmermann from Vetter chats about fill/finish advances.
In this episode of the Drug Solutions podcast, Felicity Thomas, Associate Editorial Director, chats with Hanns-Christian Mahler, CEO and board member of ten23 health, about the growing demand for fill/finish services, technological advances and novel approaches helping to advance fill/finish, sustainable and green practices, the impact of smaller batch sizes, and regulatory guidance updates in the space.SPONSORS: Vetter
In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, chats with Alexander Natz, Secretary-General of EUCOPE, about the European Health Data Space (EHDS), which was formally adopted by the European Parliament in April 2024. The EHDS aims to improve access to and control of health data by individuals and also allow for secondary use of data in research, innovation, policy-making, and regulatory activities.SPONSORS: Solvias
In this episode of the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
In this episode of the Drug Solutions Podcast, industry experts give an overview of the biosimilars market and discuss factors affecting not only their manufacture, but their upstake in the market as well.
In this episode of the Drug Solutions Podcast, industry experts give an overview of the biosimilars market and discuss factors affecting not only their manufacture, but their upstake in the market as well.
In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Tom Fletcher, director of Research and Development at FUJIFILM Irvine Scientific; and Bob Newman, PhD, chief scientific director at FUJIFILM Irvine Scientific, about formulation, specifically with how to prepare culture media for use, single use technologies, and automations to create closed systems in cell/gene therapies.
In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
The trend toward digital transformation in biopharmaceutical manufacturing continues as advanced technologies enter the scene and work their way through to manufacturing operations. With the availability of technologies to take automated biomanufacturing from preclinical to commercial-scale, the industry may start to see a wave of changeovers from manual processes to an automated, digital environment. This episode of the Drug Solutions Podcast will discuss the realities of switching over from manual to digital, and what to expect.
In this episode of the Drug Solutions Podcast, Shawn Liu, the president and CEO of Avirmax, relates his experience in entering the cell and gene therapy manufacturing space and how he began his own startup cell and gene therapy CDMO.SPONSOR: Lonza
Dr. Graziella Piras, senior director of Strategic Marketing at 908 Devices, discusses drug development, specifically about monitoring bioprocess parameters and other important technologies important to moving the process forward, with Pharmaceutical Technology editor Jill Murphy.
Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden, President & CEO at Acuitas Therapeutics.
In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to David Tisi, technical director at Senopsys LLC, and Reenal Gandhi, global business development director for the Prescription Division of Aptar Pharma. In the first segment of the episode, David chats about some of the key challenges impacting oral dosage forms and the approaches and solutions available that are helping developers overcome these hurdles. After, Reenal details the intricacies of intranasal drug dosage forms, such as the convenience and the growth of this route of administration, challenges of development, and the possibilities of repositioning drug products.
SPONSOR: Lonza
In this episode, Sergey Vlasenko from Agilent Diagnostics and Genomics Group chats about bio/pharmaceutical manufacturing trends, with a particular focus on oligonucleotides.
In this episode of the Drug Solutions podcast, Jill Murphy, Editor, talks to Michael Schrader, CEO and co-founder of Vaxess, about the fast pace in production in the pharmaceutical industry, mRNA versus DNA for new vaccines, and the new types of technology used for vaccine administration.
In this episode of the Drug Solutions podcast, Grant Playter, Associate Editor, speaks with Siegfried Schmitt, vice president, Technical at Parexel, discusses the state of biopharma investment in 2023. Topics of discussion include key areas of investment, where investment is occurring and why, and how the industry is adjusting to post-COVID regulatory and supply chain changes.
In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to Hanns-Christian Mahler, CEO and board member, and Andrea Allmendinger, chief scientific officer, both at ten23 health about some of the hurdles facing developers and manufacturers of biological therapies. Hanns-Christian and Andrea take a closer look at some of the solutions being used within industry to overcome these challenges and focus on the issue of sustainability within this sphere. Finally, they touch upon some of the other potentially important future trends that will impact biologic drug development and manufacturing.
Following disruption in the bio/pharmaceutical supply chain as a result of the COVID pandemic, the outsourcing industry has learned to adapt and push forward in a climate that is dyamically different. In this Drug Solutions podcast episode, Pharmaceutical Technology® spoke with Gil Roth, president of the Pharma & Biopharma Outsourcing Association (PBOA), and Tara Dougal, content director, Pharma portfolio, Informa Markets, on the current challenges facing the outsourcing industry today as well how contract service providers are tackling sustainability and other big trends in the industry.SPONSOR:Lonza
In this episode of the Drug Solutions podcast, Jill Murphy, Editor, talks to Lon Johnson, VP of Sales and Marketing at Colbert Packaging Corporation, about drug packaging solutions, sustainable options for companies to move towards, EPR laws, and the challenges of transitioning to more renewable packaging options.Sponsor: Colbert Packaging
In this episode of the Drug Solutions podcast, Jill Murphy, Editor, talks to Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, about point of care, patient manufacturing, and new innovative technologies in the industry.
In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to Rhonda Henry, President of Emmes’ BioPharma Group, and Adam Mendizabal, VP and Director of Emmes’ Cell and Gene Therapy Center, about the role contract research organizations (CROs) play in cell and gene therapy development. Rhonda and Adam will discuss the key factors and solutions driving growth in the CRO market with a particular emphasis on cell and gene therapies entering development pipelines, and will address some of the challenges facing the industry and best practices to ensure these limitations are overcome.SPONSOR: Baxter BioPharma Solutions
In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, catches up with Ana Ladino, Ashland’s Global Director—Regulatory Affairs, about the acceptance of a novel excipient onto CDER’s pilot review program, the next steps involved in progressing an excipient through the review program, and the change in industry’s mindset toward review programs in general.
In this episode of the Drug Solutions podcast, Jill Murphy, Editor, talks to Normand Blais, senior director of Development and Innovation in Biologics at BIOVECTRA, and Jessica Madigan, director of Business Development in Biologics at BIOVECTRA, about multiple topics under the vaccine umbrella. Blais and Madigan discuss the importance of advancements in the pipeline after COVID-19, challenges in the industry, and CDMOs differentiating themselves as vaccine leaders.
Jill Murphy, editor, and Grant Playter, associate editor, discuss the results from Pharmaceutical Technology’s latest employment survey. This survey, which polled approximately 300 members of the pharmaceutical industry, is designed to gather insights on topics like the broader state of pharmaceutical employment, trends going on in the industry, and predictions for its future. In this episode, Jill and Grant take a deep dive into these statistics and discuss what underlying factors might be at the root of it all.
PR agencies perspectives lightening round: buy/hold/sell on mRNA beyond Vaccines, Organ on a chip, Artificial Intelligence (AI) and Machine learning (ML), Viral Vector Yield Improvements, Quality Management Maturity (QMM), Near Patient Manufacturing. The role of a PR agency: are you a coach, a resource, a creative inspiration, a connector, a battering ram, secret sauce, an authoritative stakeholder, experienced guide? How has getting a message out has changed in the last 5 -10 years for pharmaceutical companies. What pharma industry trends do you see as important and want to emphasize, or are simply excited by?SPONSOR: Societal CDMO
How can organizations determine when to outsource vs. insource? What factors can (or should) be considered? The right outsourcing strategy has the potential to limit unnecessary costs, maintain output and turnaround times, and enable continued flexibility. In part two of this outsourcing series, Meg Rivers and Jeff Henderson, key account manager of Vetter, discuss: 1) what the biopharma industry currently tends to outsource, 2) outsourcing strategies the biopharma industry should be utilizing, 3) internal tasks the biopharma industry should consider outsourcing more in development and manufacturing, 4) what the biopharma industry should reconsider outsourcing and instead perform in-house, and 5) what organizations are choosing not to outsource and why.
FDA mentioned QMM in its 2019 report, Drug Shortages: Root Causes and Potential Solutions, which pointed to a lack of manufacturer incentives to improve their quality management beyond the minimum required for current good manufacturing practice (CGMP) compliance. In this podcast learn what QMM is, and how far beyond GMP functions QMM will drill into, and what accountability senior management bears for sustaining a corporate quality management culture, from an interview with executives at Shabbas Solutions LLC, who ran the overseas pilot program.
A look back at challenge and innovation highlights in 2022 for oral solid dosage forms, this podcast episode will review industry experts’ takes on factors driving the evolution of OSD forms as well as innovations in APIs, technology, and methodology. Highlights include commentary from experts at LGM Pharma, Hovione, Syntegon, and Colorcon.
SPONSOR:
Lonza Recipharm
In this episode of the Drug Solutions Podcast, Alivia Leon, assistant editor, speaks with Christian Dunne, director of global corporate business development, Chargepoint Technology, about current and future processing equipment trends. Christian shares his expertise on trends such as automation, cost, and sustainability, and highlights how these aspects can affect processing equipment and the bio/pharma industry.
SPONSOR: Lonza
In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to Ana Ladino, Ashland’s Global Director—Regulatory Affairs, about the role of novel excipients in drug development. Ana highlights the importance of novel excipients in the advancing drug development pipeline, gives an overview of CDER’s pilot review program, discusses potential changes to regulatory approaches in other regions, and provides an overview of best practices for companies to follow when dealing with novel excipients.
SPONSOR: JRS Pharma
Drug delivery has grown in leaps and bounds in recent decades, including growth in administration methods, therapeutic formulation, and delivery systems. David Bunka, chief technical officer, Aptamer Group, joins Meg Rivers, senior editor, for a deep dive into Optimers (optimized aptamers). Bunka discusses some of the key differences between Optimer drug conjugates and antibody-drug conjugates (ADCs), such as their properties, how they are created, and potential immune responses. He also shares how Optimers can target malignant cells without prior knowledge of specific biomarkers, the scalability capabilities of Optimers due to their chemistry/being synthetically manufactured, and what long-term safety could look like.
SPONSOR: JRS Pharma
Cell therapies are a hot topic in the bio/pharma industry today. In this episode, Meg Rivers, senior editor, Andrew Scharenberg, CEO, Umoja Biopharma, and Ryan Crisman, co-founder and chief technical officer, Umoja Biopharma, discuss 1) the greatest advancements in cell therapy to date; 2) where there’s room for improvement; 3) the biggest trends in cell therapy development; 4) the pros and cons of developing cell and gene therapies; 5) the challenges related to retention, 6) scale up vs. scale out; and 7) various challenges and opportunities for autologous and allogeneic therapies.
SPONSORS: Curia, Samsung Biologics
Through research collaborations, consortia, licensing, investments, and acquisitions, the emerging science and innovation team at Pfizer seeks to harness external, cutting-edge preclinical assets and novel technologies in emerging therapies. Increasingly, the focus is on true first-in-class mechanisms, if not only in-class programs, that would allow real breakthroughs for patients.
Chris Spivey, editorial director, interviews Uwe Schoenbeck, senior vice president and chief scientific officer for emerging science and innovation at Pfizer. Some of the areas discussed include repeat expansion disorders, senescence, DNA damage response and nucleic acid sensing, deubiquitinase pathways, and neuroinflammation. Pfizer feels these hold special promise for new innovative therapies.
SPONSORS: Curia and Samsung Biologics
In what instances should organizations outsource vs. insource? Determining the right outsourcing strategy is key to limit unnecessary costs, maintain output and turnaround times, and enable continued flexibility. Meg Rivers, senior editor for Pharmaceutical Technology, and John Koleng, VP of product development and manufacturing for TFF Pharmaceuticals, will discuss: 1) what the biopharma industry currently tends to outsource, 2) outsourcing strategies the biopharma industry should be utilizing, 3) internal tasks the biopharma industry should consider outsourcing more in development and manufacturing, 4) what the biopharma industry should reconsider outsourcing and instead perform in-house, and 5) what organizations are choosing not to outsource and why.
SPONSORS: Curia
In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to Fernando Muzzio, Distinguished Professor, Chemical and Biochemical Engineering, Rutgers University, about a novel approach to improving drug solubility—continuous melt coating. Fernando talks about the technique in some detail, a little about some of the results that have been achieved in research, and provides information about the current patent filing and what companies can do to start working with this new approach.
SPONSORS: Curia
In this episode of the Drug Solutions podcast, Grant Playter, Assistant Editor, talks with Rosalind Beasley, Vice President, Digital Innovation, Dot Compliance, on the current landscape surrounding compliance and validation. Topics of discussion include frequently overlooked factors in the validation process, under-the-radar innovations, the evolving role of the cloud in quality management systems, and much more.
SPONSORS: LabVantage
In this episode of the Drug Solutions podcast, Felicity Thomas, European Editor, talks to a couple of experts on drug packaging advances that have been impactful in recent years and those that may have an impact in the future. Some talking points include sustainable packaging, tailored and patient-centric packaging options, the packaging challenges that arise when dealing with biologics, technological advances making packaging more convenient, and some interesting insights from events. The experts involved in this discussion were Aurelio Arias, who is part of the EMEA thought-leadership group at IQVIA, and Josh Brooks, the marketing and community director for a new event called Connect in Pharma. SPONSORS: LabVantage Solutions
Oral solid dosage forms are a dynamic, ever-changing landscape, driven primarily by more highly potent new chemical entities (NCEs) that require particularly specific formulations. In this Drug Solutions Podcast episode, Deepak Thassu, vice-president R&D and Regulatory Submission, LGM Pharma, and Marco Gil, senior vice-president of Sales & Marketing, Hovione, discuss how, in addition to NCEs, older, more established APIs are finding renewed life because these APIs are continually enhanced to have higher potency at lower doses, changing the way their formulation is handled. Looking toward the future, the bio/pharma industry is also tackling the issue of converting large-molecule (biologic) drugs into orally administered dosage, rather than parenteral administration, for increased patient compliance. SPONSOR: CoreRx
Just how important is training for aseptic processing? Human error is one of the biggest pitfalls for contamination in aseptic processing, and the proper training of staff continues to be of the utmost importance. In this Drug Solutions Podcast episode, Patrick Nieuwenhuizen, director senior consultant, PharmaLex, shares how important training is for aseptic processing along with environmental controls, the differences in aseptic processing for small and large molecules, how single-use technologies impact aseptic processing, how aseptic processing can be better automated, and much more.
SPONSOR: CoreRx
Quality will forever be a topic of discussion for the pharmaceutical industry, and who better to share their insight than FDA? Three representatives from FDA—Michael Kopcha, Sau Lee, and Cindy Buhse—join Chris Spivey, editorial director, for a discussion about 1) emerging technology programs; 2) the framework for regulatory advanced manufacturing evaluation; 3) quality management maturity ratings; 4) quality of pharmaceuticals and its relatability to other variables, such as economics; 5) continuous vs. batch manufacturing; 6) pandemic pressures and improved communication; 7) keeping up with biotech and emerging therapies; and 8) what manufacturers need to know.
SPEAKERS: Michael Kopcha, PhD, R.Ph., director of the FDA’s Office of Pharmaceutical Quality (OPQ); Sau Lee, PhD, deputy director of science, Office of Pharmaceutical Quality, CDER at FDA; Cindy Buhse, PhD, deputy director of operations, Office of Pharmaceutical Quality, CDER at FDA
SPONSOR: Samsung Biologics
In this episode of the Drug Solutions Podcast, Feliza Mirasol, Pharmaceutical Technology’s science editor, discusses technologies enabling biologics and emerging therapies manufacturing and development with Barry Holtz, PhD, chief scientific officer of Phylloceuticals, and Professor Yaakov Nahmias, founder and chief scientific officer, Tissue Dynamics and founder and president, Future Meat Technologies.
In this episode of the Drug Solutions Podcast, Meg Rivers, senior editor, interviews Joy Aho, senior product manager at Be The Match BioTherapies, about sourcing autologous and allogeneic cell therapies.
In this episode of the Drug Solutions podcast, Felicity Thomas, European Editor, talks to a panel of experts on drug dosage forms trends that have been impactful in recent years and those that may have an impact in the future. Some talking points include recent overarching dosage form developments, the value and importance of patient-centricity, and the potential effect of novel excipients. The panel of experts involved in this discussion were Anita Solanki and Dr. Jnanadeva Bhat, both from ACG Group; Cornell Stamoran, from the Catalent Applied Drug Delivery Institute; Dr. Ali Rajabi-Siahboomi from Colorcon; Brad Gold, from Metrics Contract Services; Hanns-Christian Mahler, from ten23 health and swissfillon; and Anil Kane, from Thermo Fisher Scientific.
In this episode of the Drug Solutions podcast, Felicity Thomas, European Editor, talks to a panel of experts on drug dosage forms trends that have been impactful in recent years and those that may have an impact in the future. Some talking points include recent overarching dosage form developments, the value and importance of patient-centricity, and the potential effect of novel excipients. The panel of experts involved in this discussion were Aneeta Solanki and Dr Jnanadeva Bhat, both from ACG Group; Cornell Stamoran, from the Catalent Applied Drug Delivery Institute; Dr Ali Rajabi-Siahboomi from Colorcon; Brad Gold, from Metrics Contract Services; Hanns-Christian Mahler, from ten23 health and swissfillon; and Anil Kane, from Thermo Fisher Scientific.
Supply chain fragility and geopolitical instability discussed as background to in-shoring pharmaceutical manufacturing by Dr. Fernando Muzzio, distinguished professor of chemical and biochemical engineering, Rutgers University and Frederic Kahn, VP Sales, Wavelength Pharmaceuticals. This discussion covers reforming regulations and economics, while introducing novel flow chemistries, robotics, digitalization, and a heightened agility for investment in education, national strategy and communications.
In this episode of the Drug Solutions podcast, Chris Spivey, editorial director, and Meg Rivers, senior editor, interview Sean Tucker, PhD, chief scientific officer of Vaxart, on developing oral recombinant vaccines, including developing this type of vaccine and how it differs from injectable vaccines, an inside look into the manufacture for clinical trials, what pathogens oral recombinant vaccines may be a better treatment option for, longevity of protection, and how this type of vaccine could impact the pharmaceutical industry.
In this episode of the Drug Solutions podcast, Chris Spivey, editorial director, and Meg Rivers, senior editor, interview experts on up-and-coming 2022 trends in the bio/pharma industry.
The experts who shared their insight include:
Peter Walters, Director of ATMP, CRB
Yvonne Duckworth, Automation Engineer, CRB
Cary Martin, VP of Marketing, August Bioservices
Gabe Longoria, Chief Commercial Officer, Astrea Bioseparations
Merrilee Whitney, Head of Biocontinuum Platform, MilliporeSigma
Helen Anderson, Commercial Lead, USA, Aspen
San Kiang, CTO, Porton Pharmatech/J-Star Research
Anil Kane, Global Head of Technical Scientific Affairs, Pharma Services, Thermo Fisher Scientific
Matthias Buserius, Head of Activities and Formulation, MilliporeSigma
Jeff Woodhead, Senior Scientist, Simulations Plus
Gregory Lane, PhD, Senior Research Investigator, Bristol-Myers, Squibb