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

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Patients as Partners: Advocacy's Role in Shaping Drug Development

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 trial...

8 Nov 202427min

Navigating the Future of EU Health Technology Assessments

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 Janu...

16 Okt 202429min

A Guide to Marketing Authorization Applications in Europe

A Guide to Marketing Authorization Applications in Europe

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...

24 Sep 202428min

Navigating the new EU Clinical Trials Regulation

Navigating the new EU Clinical Trials Regulation

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...

13 Aug 202428min

Advances in Cell-Based Immunotherapies: CAR-T Cell Therapy vs TCR Therapy

Advances in Cell-Based Immunotherapies: CAR-T Cell Therapy vs TCR Therapy

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...

25 Juli 202428min

Demystifying Regulatory Designations in Drug Development

Demystifying Regulatory Designations in Drug Development

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...

10 Juli 202425min

Exploring Genome Editing Technologies in Drug Development

Exploring Genome Editing Technologies in Drug Development

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...

19 Juni 202423min

The Most Essential Tips for Biotechs Seeking Investment

The Most Essential Tips for Biotechs Seeking Investment

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...

3 Juni 202423min

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