Conversations in Drug Development

In this episode, Katherine Bowen and Shalini Gupta discuss the EU pharmaceutical legislation reform — a comprehensive update to regulations and directives that will affect drug approval, orphan and paediatric rules, exclusivity incentives, EMA structure and timelines, supply obligations, environmental risk assessments, and transparency requirements.

Hosts outline the timeline, key practical impacts for sponsors, and recommended next steps: begin preparing now, align regulatory, market‑access and supply strategies, and monitor EMA guidance during the transition period.

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.

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.

Welcome and Introductions (00:00:05)

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

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

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, 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.