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 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 regulators early, and how to approach patent protection and manufacturing for advanced therapies. Whether you're preparing an IND or planning scale-up, this episode delivers clear, actionable guidance grounded in industry know-how.

A must-listen for biotech teams, clinical leads, and anyone involved in the drug development process.

EPISODE OUTLINE

00:00:14 – Introduction to Drug Development 00:00:22 – The Importance of Having a Plan 00:04:27 – Insights from a Successful Company Journey 00:08:22 – Manufacturing Challenges in Drug Development 00:09:11 – Regulatory Strategies for Drug Approval 00:18:03 – The Role of Clinical Strategy in Development 00:26:25 – Conclusion and Future Insights

Jaksot(24)

The Use of ATMPs in Oncology Clinical Trials

The Use of ATMPs in Oncology Clinical Trials

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...

21 Touko 202419min

How are GMO Regulations Impacting Clinical Development in Europe?

How are GMO Regulations Impacting Clinical Development in Europe?

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...

25 Huhti 202424min

US Drug Development: The Latest Regulatory Trends and Initiatives

US Drug Development: The Latest Regulatory Trends and Initiatives

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 ...

19 Maalis 202422min

The Regulatory Challenges of Rare Disease Drug Development

The Regulatory Challenges of Rare Disease Drug Development

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...

28 Helmi 202429min

The Drug Development Landscape: Trends and Predictions for 2024

The Drug Development Landscape: Trends and Predictions for 2024

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 ...

22 Tammi 202425min

Off-the-Shelf Cell Therapies: Breaking Barriers and Revolutionizing Patient Care

Off-the-Shelf Cell Therapies: Breaking Barriers and Revolutionizing Patient Care

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...

4 Joulu 202320min

The Future of Drug Development: AI’s Role in Revolutionizing the Industry

The Future of Drug Development: AI’s Role in Revolutionizing the Industry

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...

8 Marras 202322min

Recent Trends in Oncology Drug Development

Recent Trends in Oncology Drug Development

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...

4 Loka 202325min

Suosittua kategoriassa Tiede

tiedekulma-podcast
rss-mita-tulisi-tietaa
rss-poliisin-mieli
rss-metsantuntijat-podcast
utelias-mieli
rss-duodecim-lehti
mielipaivakirja
filocast-filosofian-perusteet
rss-astetta-parempi-elama-podcast
rss-tiedetta-vai-tarinaa
rss-luontopodi-samuel-glassar-tutkii-luonnon-ihmeita
university-of-eastern-finland
docemilia
menologeja-tutkimusmatka-vaihdevuosiin
rss-bios-podcast
rss-ylistys-elaimille
rss-lapsuuden-rakentajat-podcast
rss-lihavuudesta-podcast
rss-sosiopodi
rss-miljonaarien-tasavalta