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 Director of Regulatory Affairs at Boyds, joins our host Harriet Edwards to explore the need for early stakeholder involvement, the complexities of pediatric clinical trials, including ethical considerations and regulatory requirements and to touch on FDA initiatives supporting rare disease therapeutics and the evolving landscape for cell and gene therapies. To discuss this episode of Conversations in Drug Development with a member of the team, visit www.boydconsultants.com.

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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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