Conversations in Drug Development

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 medic...

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 releas...

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 f...

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 regulat...

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 regula...

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...

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 enga...

In this episode, host Harriet Edwards and Senior Clinical Project Manager, Chris Moore, discuss the vital role of patient and public involvement in drug development, particularly within clinical trials.

The conversation covers the increasing significance of patient engagement, highlighting how the industry is recognizing the invaluable contributions of patients in shaping clinical trials and exploring the concept of "patients as pa...

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...

In this episode, host Harriet Edwards is joined by Dr Katherine Bowen to explore the regulatory fundamentals for obtaining marketing authorization in Europe, focusing on the centralised procedure. Together, they unpack the intricacies of this pathway, comparing it to the FDA application process and emphasising the critical role of thorough dossier preparation and clear communication with regulatory authorities. Key topics include t...

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.

Join us for an insightful discussion on how the CTR is shaping the future of clinical res...

In this episode, host Harriet Edwards is joined by two regulatory experts from Boyds, Dr Patrick Ginty and Monica Pianella, to discuss cell-based immunotherapies, focusing on CAR-T cells and TCR-T cells.

Patrick and Monica delve into these cutting-edge treatments, discussing their uses, the complexities of their production, and important safety considerations. They also highlight recent advancements and the exciting future prospect...

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 D...

In this episode, host Dr. Katherine Bowen, is joined by Harriet Edwards, Associate Director in Regulatory Affairs, to explore the fascinating world of genome editing technologies. Together, they delve into the ethical considerations of editing somatic versus germline cells and trace the historical progression of these technologies from agriculture to healthcare. Join us as we discuss the complexity of genome editing methods, the ir...

Welcome to a special edition of Conversations in Drug Development, brought to you by the team at Boyds.  In this episode, our host Harriet Edwards hands over the mic to two of her colleagues to discuss a critical topic for early-stage biotech companies: funding challenges and how to overcome them.

Dr Nick Myers and Dr Neil Fish, share their extensive experience and insights into navigating the complexities of funding and investment...

How can phase I studies with ATMPs address unmet needs in oncology and what are the challenges? In this episode of Conversations in Drug Development, Dr Katherine Bowen is joined by Pharmaceutical Physician, Dr Harriet Gray Stephens, to delve into the complexities of phase I oncology studies involving advanced therapy medicinal products (ATMPs). Join us as we discuss the unique challenges of ATMPs, such as their different benefit-r...

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 definit...

In this episode of Conversations in Drug Development, host Dr Harriet Edwards is joined by Katy Rudnick and Dr Julie Warner from Boyds to discuss US regulatory trends and initiatives at the FDA. This episode explores the FDA's recent organizational changes, pilot programs, and focus on innovative clinical trials, including the use of AI in drug discovery. Join us for another Conversation in Drug Development, exploring the dynamic l...