Conversations in Drug Development

Navigating the FDA Landscape: More Changes, and What's Next?

In this episode, Eric Hardter and guest Kelsey Lenoch discuss recent US FDA developments, including leadership changes at CBER and CDER, staffing impacts on orphan product reviews, and the new Rare Disease Evidence Principles aimed at accelerating approvals for rare and ultra-rare conditions.
They also explore evolving trial endpoints in oncology (including surrogate measures and ctDNA), transparency moves such as the public release of Complete Response Letters and the industry’s reactions, updates on the National Priority Voucher Program, and the FDA Pre-Check initiative to boost domestic drug manufacturing.
Tune in for an in-depth discussion offering timely updates and expert perspectives on what may be ahead for drug development stakeholders.
🎧 Chapters
Welcome and Introductions (00:00:05)Recap and Recent US Regulatory Affairs Developments (00:01:00)Dr. Vinay Prasad’s Removal and Return to FDA CBER (00:01:20)New Appointments at FDA CDER (00:02:17)FDA Staffing Shortages and Impact on Orphan Products (00:04:22)Rare Disease Evidence Principles Announcement (00:05:29)FDA’s Rare Disease Innovation Hub and Ultra-Rare Disease Focus (00:07:19)Novel Endpoints in Oncology Drug Development (00:09:31)FDA/AACR Joint Meeting on Novel Endpoints (00:10:12)Challenges with Overall Survival as an Endpoint (00:10:36)FDA’s Evolving Guidance on Endpoints (00:11:04)Post-Licensure Requirements and Surrogate Endpoints (00:11:48)Case Study: Myelofibrosis Drug and Patient-Reported Endpoints (00:12:49)Standardization Challenges for New Endpoints (00:13:55)Circulating Tumor DNA as a Biomarker (00:14:51)FDA’s Release of Complete Response Letters – Phase Two (00:16:06)Pros and Cons of Public Complete Response Letters (00:17:19)Industry Pushback and Sponsor Transparency (00:19:22)Case Study: Lycos Therapeutics and Psychedelic Drug Approval (00:21:09)Accessing and Mining Complete Response Letter Data (00:22:34)National Priority Voucher Program Update (00:23:43)FDA Pre-Check Program for Domestic Manufacturing (00:24:26)Closing Remarks and Future Outlook (00:25:12)

At the forefront of innovation: Prof Alan Boyd reflects on the last 20 years in drug development

In this special episode of Conversations in Drug Development, host Harriet Edwards sits down with Professor Alan Boyd, founder and CEO of Boyds, to reflect on the company’s remarkable 20-year journey in drug development. Professor Boyd shares his experiences from pioneering work in gene therapy, the challenges of bringing innovative medicines forward, and the value of projects that helped pave the way for future innovation. He also highlights the importance of maintaining a patient-centric vision and the role this has played in Boyds’ success on a global scale.
 
With stories from Boyds' involvement in pivotal projects - from the early work on the first gene therapy developed for brain cancer to contributions to the Covid-19 vaccine - the conversation offers a rare, behind-the-scenes look at how scientific innovation and evolving regulation have shaped modern medicine.
Whether you’re closely involved in drug development or simply interested in how new medicines reach patients, this episode offers unique insights and reflections from someone who has spent a lifetime at the forefront of the industry.
 
00:00:13 – Introduction to Conversations in Drug Development
00:00:30 – Welcoming Professor Alan Boyd Back
00:01:43 – Reflecting on 20 Years of Boyds
00:02:49 – The Journey to Founding Boyds
00:06:05 – Early Challenges in Gene Therapy
00:07:26 – Manufacturing Gene Therapy Products
00:10:35 – Achievements in Cell and Gene Therapy
00:15:39 – Highlights from Two Decades
00:19:46 – Changes in Drug Development
00:23:32 – Evolution of Clinical Trials
00:28:17 – The Role of the Team at Boyds
00:31:43 – Personal Interests Beyond Medicine
00:38:12 – Future of Drug Development
00:38:42 – Closing Thoughts and Reflections

Navigating the New FDA Landscape: Opportunities and Challenges Ahead

In the latest episode of Conversations in Drug Development, Dr Katherine Bowen and Dr Eric Hardter discuss the ever-changing US regulatory landscape under the new administration, including new leadership and staff turnover, and their impact on drug development. They examine the FDA's cautious approach to AI, efforts to reduce animal testing, and the new National Priority Voucher Program aimed at expediting drug approvals. Tune in for an in-depth discussion that offers timely updates and expert perspectives on what might be in store for drug development stakeholders.
 
EPISODE OUTLINE
 
00:00:14 – Welcome to Conversations in Drug Development00:01:16 – US Regulatory Environment Update00:02:35 – Changes in FDA Leadership00:03:19 – The Impact of Staffing Changes00:05:54 – New Perspectives with Vinay Prasad00:07:50 – Future of Cell and Gene Therapy Approvals00:10:03 – Market Reactions and Funding Concerns00:11:45 – Implications of FDA Cuts00:12:29 – Marty McCary’s Vision for the FDA00:14:46 – Navigating Conflicting Perspectives00:15:45 – FDA Workforce and Operational Changes00:17:21 – Review Process and Efficiency Challenges00:20:43 – ELSA: AI in FDA Operations00:22:54 – Reducing Animal Testing in Drug Development00:25:05 – National Priority Voucher Programme Insights00:31:21 – Future Outlook and Next Steps

From Lab to Launch – Avoiding the Pitfalls of Drug Development

In this episode, Dr Neil Fish and Dr Ami Patel dive into the real-world challenges of drug development - from early-stage planning to regulatory hurdles and everything in between. Drawing on decades of experience, they share personal stories and expert insights that reveal why a solid strategy and the ability to pivot are essential for success.
They explore the value of strategic flexibility, the importance of engaging with regulators early, and how to approach patent protection and manufacturing for advanced therapies. Whether you're preparing an IND or planning scale-up, this episode delivers clear, actionable guidance grounded in industry know-how.
A must-listen for biotech teams, clinical leads, and anyone involved in the drug development process.
 
EPISODE OUTLINE
 
00:00:14 – Introduction to Drug Development00:00:22 – The Importance of Having a Plan00:04:27 – Insights from a Successful Company Journey00:08:22 – Manufacturing Challenges in Drug Development00:09:11 – Regulatory Strategies for Drug Approval00:18:03 – The Role of Clinical Strategy in Development00:26:25 – Conclusion and Future Insights

Crystal Ball Gazing: What Does the Future Hold for Regulatory Affairs in Drug Development for 2025

In this episode, Harriet Edwards from Boyds hosts a discussion on 2025 predictions in drug development and regulatory affairs. Joined by regulatory experts Dr. Katherine Bowen and Dr. Eric Hartder, the conversation covers the anticipated trends in the realm of cell and gene therapy, rare diseases, and the increasing role of artificial intelligence (AI).
As we look ahead to 2025, Boyds' regulatory experts discuss the evolving regulatory landscape, legislative changes in the US and EU, and the importance of patient-centric approaches.
Join us for this insightful journey as we uncover what 2025 has in store for drug development and regulatory strategies. 

How to Effectively De-Risk your IND Process

In this episode, Dr. Nick Meyers and Dr. Eric Hardter, discuss effective strategies for de-risking Investigational New Drug (IND) applications.
Discover key insights on how to navigate the complexities of IND submissions, including the importance of pre-IND meetings, optimizing your non-clinical and CMC packages, and understanding FDA expectations. Gain valuable tips on engaging with regulatory agencies, addressing potential issues, and ensuring your IND is well-prepared to avoid clinical holds. Whether you're a seasoned professional or new to the field, this episode offers practical advice to help streamline your drug development process.

Understanding EU Medical Device Regulations: Key Insights for Developers and Innovators

In this episode, host Harriet Edwards is joined by Eamonn McGowran, an expert in medical device regulations, to explore the complex and rapidly evolving regulatory landscape for medical devices, particularly within the EU.
Eamonn highlights the challenges of developing combination products that integrate devices and pharmaceuticals, the roles of notified bodies and competent authorities, and the importance of early stakeholder engagement. The episode also covers the integration of artificial intelligence in medical devices and the evolving UK regulatory framework post-Brexit.

Patients as Partners: Advocacy's Role in Shaping Drug Development

In this episode, host Harriet Edwards and Senior Clinical Project Manager, Chris Moore, discuss the vital role of patient and public involvement in drug development, particularly within clinical trials.
The conversation covers the increasing significance of patient engagement, highlighting how the industry is recognizing the invaluable contributions of patients in shaping clinical trials and exploring the concept of "patients as partners," which is gaining traction among sponsors, ethics committees, and regulatory bodies.

Navigating the Future of EU Health Technology Assessments

In this episode, host Dr Julie Warner is joined by experts from Decisive Consulting, Esther Nzenza, and Kevin Asher to discuss the upcoming joint clinical assessment (JCA) process set to begin in January 2025. The conversation covers the implications of the JCA for drug developers, particularly smaller companies, and emphasizes the importance of early planning and integrated evidence generation. Join us as we uncover the strategies and considerations essential for success in the ever-evolving world of health technology assessments.

A Guide to Marketing Authorization Applications in Europe

In this episode, host Harriet Edwards is joined by Dr Katherine Bowen to explore the regulatory fundamentals for obtaining marketing authorization in Europe, focusing on the centralised procedure. Together, they unpack the intricacies of this pathway, comparing it to the FDA application process and emphasising the critical role of thorough dossier preparation and clear communication with regulatory authorities. Key topics include the importance of early engagement with regulators, navigating the challenges of Module 1, developing risk management plans, and addressing current regulatory issues.