Conversations in Drug Development

In this episode, experts at Boyds, Chris Moore and Shalini Gupta break down the UK Clinical Trial Regulation (UK CTR), exploring why the reform was introduced and highlighting the practical changes sponsors need to know - including new terminology, updated timelines, notifiable trials, transparency obligations, safety reporting, and labelling updates.

Listeners will gain insight into how these changes will affect trial set-up and operations, what to prepare for ahead of the 28 April 2026 implementation date, and where opportunities exist for faster, more predictable approvals.

In this episode of Conversations in Drug Development, host Harriet Edwards is joined by Kelsey Lennoch and Eamon McGowran to discuss the EU Biotech Act, a major regulatory proposal aimed at revitalizing Europe’s biotech sector. They explore the act’s goals to streamline clinical trial processes, harmonize regulations, and boost funding for late-stage biotech companies. The conversation highlights key changes for medicines and medical devices, the act’s potential impact on innovation and competitiveness, and the importance of ongoing engagement as the EU’s regulatory landscape evolves. For more information, visit www.boydconsultants.com.

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)

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

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