Conversations in Drug Development – Détails, épisodes et analyse

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Conversations in Drug Development

Boyds

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Fréquence : 1 épisode/40j. Total Éps: 26

Welcome to Conversations in Drug Development, brought to you by the team at Boyds for our fellow community of scientists and clinicians working in the wonderful world of cell and gene therapy and drug development. This podcast series features candid conversations from the expert team at Boyds, who are at the forefront of cutting-edge science and drug development in the pharmaceutical and biotechnology sector.

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Données mises à jour le 04/07/2026

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Live Biotherapeutics: Navigating the Next Frontier in Drug Development

Épisode 28

lundi 22 juin 2026 • Durée 32:19

In this episode, Boyds' experts explore the emerging field of live biotherapeutic products (LBPs), explaining what they are, how they differ from everyday probiotics, and their roots in microbiome-based therapies, including fecal microbiota transplantation (FMT).

Katherine and Celine discuss the evolving regulatory landscape, comparing the FDA's guidance and recent approvals with the more cautious approach taken by the EMA and national authorities across Europe. They also examine the scientific, manufacturing, and clinical development challenges facing LBP developers, including product consistency, mechanism of action, safety considerations, and clinical trial design.

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UK Clinical Trial Regulation: What Sponsors Need to Know About UK CTR 2025

Épisode 27

mercredi 8 avril 2026 • Durée 25:39

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.

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How Will the EU Biotech Act Transform Biotechnology Regulation in Europe?

Épisode 25

mardi 10 mars 2026 • Durée 30:21

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.

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

Épisode 24

jeudi 23 octobre 2025 • Durée 26:40

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)

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

Épisode 23

mardi 26 août 2025 • Durée 39:40

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

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Navigating the New FDA Landscape: Opportunities and Challenges Ahead

Épisode 21

mardi 15 juillet 2025 • Durée 35:54

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

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From Lab to Launch – Avoiding the Pitfalls of Drug Development

Épisode 20

jeudi 29 mai 2025 • Durée 28:04

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

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

Épisode 19

lundi 17 mars 2025 • Durée 32:57

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.

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How to Effectively De-Risk your IND Process

Épisode 18

mardi 11 février 2025 • Durée 52:58

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.

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

Épisode 17

mardi 7 janvier 2025 • Durée 24:03

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.

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Conversations in Drug Development – Détails, épisodes et analyse

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