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.
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Navigating the FDA Landscape: More Changes, and What's Next? (00:26:40)
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 Di...
At the forefront of innovation: Prof Alan Boyd reflects on the last 20 years in drug development (00:39:40)
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 ...
Navigating the New FDA Landscape: Opportunities and Challenges Ahead (00:35:54)
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 leaders...
From Lab to Launch – Avoiding the Pitfalls of Drug Development (00:28:04)
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 o...
Crystal Ball Gazing: What Does the Future Hold for Regulatory Affairs in Drug Development for 2025 (00:32:57)
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, th...
How to Effectively De-Risk your IND Process (00:52:58)
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 complexitie...
Understanding EU Medical Device Regulations: Key Insights for Developers and Innovators (00:24:03)
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, parti...
Patients as Partners: Advocacy's Role in Shaping Drug Development (00:27:24)
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 trial...
Navigating the Future of EU Health Technology Assessments (00:29:10)
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 Janu...
A Guide to Marketing Authorization Applications in Europe (00:28:19)
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. Tog...
Navigating the new EU Clinical Trials Regulation (00:28:26)
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 tran...
Advances in Cell-Based Immunotherapies: CAR-T Cell Therapy vs TCR Therapy (00:28:10)
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 cel...
Demystifying Regulatory Designations in Drug Development (00:25:53)
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...
Exploring Genome Editing Technologies in Drug Development (00:23:44)
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...
The Most Essential Tips for Biotechs Seeking Investment (00:23:17)
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 discus...
The Use of ATMPs in Oncology Clinical Trials (00:19:54)
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 Phy...
How are GMO Regulations Impacting Clinical Development in Europe? (00:24:53)
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 modif...
US Drug Development: The Latest Regulatory Trends and Initiatives (00:22:38)
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 ...
The Regulatory Challenges of Rare Disease Drug Development (00:29:37)
To celebrate Rare Disease Day, we are back with another Conversation in Drug Development, this time discussing the unique challenges of rare disease drug development. Dr Eric Hardter, Associate Direct...
The Drug Development Landscape: Trends and Predictions for 2024 (00:25:40)
We are kickstarting 2024 with a Conversation in Drug Development with CEO and Founder of Boyds, Professor Alan Boyd. In this podcast episode, our host Harriet Edwards, and Professor Alan Boyd discuss ...
Off-the-Shelf Cell Therapies: Breaking Barriers and Revolutionizing Patient Care (00:20:30)
In this episode of "Conversations in Drug Development", Harriet Edwards and Dr. Patrick Ginty discuss off-the-shelf cell therapies, explaining how these therapies are manufactured and their ability to...
The Future of Drug Development: AI’s Role in Revolutionizing the Industry (00:22:13)
In this episode of Conversations in Drug Development, Dr. Julie Warner and Harriet Edwards discuss the revolutionizing role of artificial intelligence (AI) in drug development, exploring its applicati...
Recent Trends in Oncology Drug Development (00:25:14)
In this episode, Dr Katherine Bowen and Dr Julie Warner delve deep into the ever-evolving world of oncology drug development and the regulatory landscape in the US and EU. Join us in this conversation...
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