Conversations in Drug Development

• 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

  --------  

  39:40

  --------

  39:40
• 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 Development 00:01:16 – US Regulatory Environment Update 00:02:35 – Changes in FDA Leadership 00:03:19 – The Impact of Staffing Changes 00:05:54 – New Perspectives with Vinay Prasad 00:07:50 – Future of Cell and Gene Therapy Approvals 00:10:03 – Market Reactions and Funding Concerns 00:11:45 – Implications of FDA Cuts 00:12:29 – Marty McCary’s Vision for the FDA 00:14:46 – Navigating Conflicting Perspectives 00:15:45 – FDA Workforce and Operational Changes 00:17:21 – Review Process and Efficiency Challenges 00:20:43 – ELSA: AI in FDA Operations 00:22:54 – Reducing Animal Testing in Drug Development 00:25:05 – National Priority Voucher Programme Insights 00:31:21 – Future Outlook and Next Steps

  --------  

  35:54

  --------

  35:54
• 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 Development 00:00:22 – The Importance of Having a Plan 00:04:27 – Insights from a Successful Company Journey 00:08:22 – Manufacturing Challenges in Drug Development 00:09:11 – Regulatory Strategies for Drug Approval 00:18:03 – The Role of Clinical Strategy in Development 00:26:25 – Conclusion and Future Insights

  --------  

  28:04

  --------

  28:04
• 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. 

  --------  

  32:57

  --------

  32:57
• 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.

  --------  

  52:58

  --------

  52:58

More Health & Wellness podcasts

Trending Health & Wellness podcasts

About Conversations in Drug Development