How to Effectively De-Risk your IND Process

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.

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Jaksot(27)

EU Pharma Reform 2026: What Every Developer Needs to Know

EU Pharma Reform 2026: What Every Developer Needs to Know

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 pa...

7 Loka 37min

Live Biotherapeutics: Navigating the Next Frontier in Drug Development

Live Biotherapeutics: Navigating the Next Frontier in Drug Development

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-bas...

22 Kesä 32min

UK Clinical Trial Regulation: What Sponsors Need to Know About UK CTR 2025

UK Clinical Trial Regulation: What Sponsors Need to Know About UK CTR 2025

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 sp...

8 Huhti 25min

How Will the EU Biotech Act Transform Biotechnology Regulation in Europe?

How Will the EU Biotech Act Transform Biotechnology Regulation in Europe?

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 revitalizi...

10 Maalis 30min

Navigating the FDA Landscape: More Changes, and What's Next?

Navigating the FDA Landscape: More Changes, and What's Next?

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...

23 Loka 202526min

At the forefront of innovation: Prof Alan Boyd reflects on the last 20 years in drug development

At the forefront of innovation: Prof Alan Boyd reflects on the last 20 years in drug development

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 ...

26 Elo 202539min

Navigating the New FDA Landscape: Opportunities and Challenges Ahead

Navigating the New FDA Landscape: Opportunities and Challenges Ahead

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...

15 Heinä 202535min

From Lab to Launch – Avoiding the Pitfalls of Drug Development

From Lab to Launch – Avoiding the Pitfalls of Drug Development

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...

29 Touko 202528min

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