Conversations in Drug Development

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.