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...
Crystal Ball Gazing: What Does the Future Hold for Regulatory Affairs in Drug Development for 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.
--------
32:57
How to Effectively De-Risk your IND Process
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.
--------
52:58
Understanding EU Medical Device Regulations: Key Insights for Developers and Innovators
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.
--------
24:03
Patients as Partners: Advocacy's Role in Shaping Drug Development
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.
--------
27:24
Navigating the Future of EU Health Technology Assessments
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.
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.
France