Conversations in Drug Development
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.
Episodes

Monday Mar 17, 2025
Monday Mar 17, 2025
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.

Tuesday Feb 11, 2025
How to Effectively De-Risk your IND Process
Tuesday Feb 11, 2025
Tuesday Feb 11, 2025
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.

Tuesday Jan 07, 2025
Tuesday Jan 07, 2025
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.

Friday Nov 08, 2024
Patients as Partners: Advocacy's Role in Shaping Drug Development
Friday Nov 08, 2024
Friday Nov 08, 2024
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 partners," which is gaining traction among sponsors, ethics committees, and regulatory bodies.

Wednesday Oct 16, 2024
Navigating the Future of EU Health Technology Assessments
Wednesday Oct 16, 2024
Wednesday Oct 16, 2024
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 and considerations essential for success in the ever-evolving world of health technology assessments.

Tuesday Sep 24, 2024
A Guide to Marketing Authorisation Applications in Europe
Tuesday Sep 24, 2024
Tuesday Sep 24, 2024
In this episode, host Harriet Edwards is joined by Dr Katherine Bowen to explore the regulatory fundamentals for obtaining marketing authorisation 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 the importance of early engagement with regulators, navigating the challenges of Module 1, developing risk management plans, and addressing current regulatory issues.

Tuesday Aug 13, 2024
Navigating the new EU Clinical Trials Regulation
Tuesday Aug 13, 2024
Tuesday Aug 13, 2024
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 research in Europe and the positive impact it aims to have on patients.

Thursday Jul 25, 2024
Advances in Cell-Based Immunotherapies: CAR-T Cell Therapy vs TCR Therapy
Thursday Jul 25, 2024
Thursday Jul 25, 2024
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 prospects for these therapies in cancer treatment and other areas.
Tune in for an insightful discussion on the future of cell-based immunotherapies, examining both the hurdles and the potential of these innovative treatments.

Wednesday Jul 10, 2024
Demystifying Regulatory Designations in Drug Development
Wednesday Jul 10, 2024
Wednesday Jul 10, 2024
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 Designation (BTD), and Regenerative Medicines Advanced Therapy Designation (RMAT).
Tune in to gain valuable insights from their experience and advice and learn how to navigate the regulatory landscape effectively.

Wednesday Jun 19, 2024
Exploring Genome Editing Technologies in Drug Development
Wednesday Jun 19, 2024
Wednesday Jun 19, 2024
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 irreversible nature of genetic changes, and the associated risks.

This podcast series features candid conversations from the expert team at Boyds, who are at the forefront of cutting-edge drug development in the pharmaceutical and biotechnology sector.
Our experts and special guests will share their stories, experiences, and expertise, offering a behind-the-scenes look at the cutting-edge research, clinical trials, regulatory hurdles, and numerous other factors that shape the drug development landscape. Whether you’re a healthcare professional, a patient, a researcher, or simply curious about the world of medicine, this podcast promises to expand your understanding of the complex journey from molecule to medicine.
Join us as we explore the dynamic and ever-evolving field of drug development, one conversation at a time.