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, 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 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

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.

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.

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.

In this episode, host Harriet Edwards is joined by Dr Katherine Bowen and Shalini Gupta to explore the transformative changes in the European Union’s clinical trial landscape. The focus is on the transition from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR) and its significant impact on the regulatory environment.

In this episode, Dr Katherine Bowen and Dr Julie Warner delve into the world of regulatory designations, providing clarity on what these designations offer, the products that qualify, and the pros and cons of each. They discuss the history of regulatory designations, starting with the Orphan Drug Act of 1983, and explore various designations such as Orphan Drug Designation (ODD), Fast Track Designation (FTD), Breakthrough Therapy Designation (BTD), and Regenerative Medicines Advanced Therapy Designation (RMAT). Tune in to gain valuable insights from their experience and advice and learn how to navigate the regulatory landscape effectively.

Dr Nick Myers and Dr Neil Fish, share their extensive experience and insights into navigating the complexities of funding and investment. They delve into what makes an effective pitch deck, the importance of presentation skills, and the role of a well-organized data room.

In this episode of Conversations in Drug Development, our host Harriet Edwards, is joined by Director of Regulatory Affairs, Dr Sabine Ruehle, to discuss the challenges of navigating genetically modified organism (GMO) regulations in clinical trials within Europe. This discussion helps decipher the nuanced environment of GMOs and their associated risks unique within the European framework. Join us as we explore the outdated definition of GMOs, the complexities of their classification, and the impact of genome editing technologies.

To celebrate Rare Disease Day, we are back with another Conversation in Drug Development, this time discussing the unique challenges of rare disease drug development. Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, joins our host Harriet Edwards to explore the need for early stakeholder involvement, the complexities of pediatric clinical trials, including ethical considerations and regulatory requirements and to touch on FDA initiatives supporting rare disease therapeutics and the evolving landscape for cell and gene therapies. To discuss this episode of Conversations in Drug Development with a member of the team, visit www.boydconsultants.com.

In this episode of "Conversations in Drug Development", Harriet Edwards and Dr. Patrick Ginty discuss off-the-shelf cell therapies, explaining how these therapies are manufactured and their ability to treat multiple recipients. While these therapies offer scalability and the potential to treat larger patient populations, they also carry risks such as immune reactions. Dr. Ginty highlights the importance of addressing these risks and mentions techniques like gene editing to improve safety. Join us in this conversation as we discuss the regulatory challenges in developing these therapies, emphasizing the importance of early engagement with regulators and compliance with donor testing requirements. To discuss this episode of Conversations in Drug Development with a member of the team, visit www.boydconsultants.com.

In this episode of Conversations in Drug Development, Dr. Katherine Bowen delves deep into the ever-evolving world of oncology drug development and the regulatory landscape in the US and EU.