EU Pharma Reform 2026: What Every Developer Needs to Know

To celebrate Ada Lovelace Day, women from Boyds share their career journeys, the challenges they’ve overcome and their advice for the next generation of women in science.

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. 🎧 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

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

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.