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PODCAST

Conversations in Drug Development

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.

science life sciences

All Episodes

26:40

Navigating the FDA Landscape: More Changes, and...

Conversations in Drug Development ·

2025/10/23

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 Disease Evidence Principles aimed at accelerating approvals for rare and ultra-rare conditions.They also explore evolving trial endpoints in oncology (including surrogate measures and ctDNA), transparency moves such as the public release of Complete Response Letters and the industry’s reactions, updates

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39:40

At the forefront of innovation: Prof Alan Boyd...

Conversations in Drug Development ·

2025/08/26

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 in drug development. Professor Boyd shares his experiences from pioneering work in gene therapy, the challenges of bringing innovative medicines forward, and the value of projects that helped pave the way for future innovation. He also highlights the importance of maintaining a patient-centric vision

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35:54

Navigating the New FDA Landscape: Opportunities and...

Conversations in Drug Development ·

2025/07/15

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 leadership and staff turnover, and their impact on drug development. They examine the FDA's cautious approach to AI, efforts to reduce animal testing, and the new National Priority Voucher Program aimed at expediting drug approvals. Tune in for an in-depth discussion that offers timely updates and expert

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28:04

From Lab to Launch – Avoiding the Pitfalls of Drug...

Conversations in Drug Development ·

2025/05/29

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

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32:57

Crystal Ball Gazing: What Does the Future Hold for...

Conversations in Drug Development ·

2025/03/17

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, the conversation covers the anticipated trends in the realm of cell and gene therapy, rare diseases, and the increasing role of artificial intelligence (AI).As we look ahead to 2025, Boyds' regulatory experts discuss the evolving regulatory landscape, legislative changes in the US and EU, and the

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52:58

How to Effectively De-Risk your IND Process

Conversations in Drug Development ·

2025/02/11

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

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24:03

Understanding EU Medical Device Regulations: Key...

Conversations in Drug Development ·

2025/01/07

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, particularly within the EU.Eamonn highlights the challenges of developing combination products that integrate devices and pharmaceuticals, the roles of notified bodies and competent authorities, and the importance of early stakeholder engagement. The episode also covers the integration of artificial

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27:24

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

Conversations in Drug Development ·

2024/11/08

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 trials.The conversation covers the increasing significance of patient engagement, highlighting how the industry is recognizing the invaluable contributions of patients in shaping clinical trials and exploring the concept of "patients as partners," which is gaining traction among sponsors, ethics committees,

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29:10

Navigating the Future of EU Health Technology...

Conversations in Drug Development ·

2024/10/16

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 January 2025. The conversation covers the implications of the JCA for drug developers, particularly smaller companies, and emphasizes the importance of early planning and integrated evidence generation. Join us as we uncover the strategies and considerations essential for success in the ever-evolving world

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28:19

A Guide to Marketing Authorisation Applications in...

Conversations in Drug Development ·

2024/09/24

In this episode, host Harriet Edwards is joined by Dr Katherine Bowen to explore the regulatory fundamentals for obtaining marketing authorisation in Europe, focusing on the centralised procedure. Together, they unpack the intricacies of this pathway, comparing it to the FDA application process and emphasising the critical role of thorough dossier preparation and clear communication with regulatory authorities. Key topics include the importance of early engagement with regulators, navigating the

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28:26

Navigating the new EU Clinical Trials Regulation

Conversations in Drug Development ·

2024/08/13

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 transition from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR) and its significant impact on the regulatory environment.Join us for an insightful discussion on how the CTR is shaping the future of clinical research in Europe and the positive impact it aims to have on

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28:10

Advances in Cell-Based Immunotherapies: CAR-T Cell...

Conversations in Drug Development ·

2024/07/25

In this episode of Conversations in Drug Development, 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 cells.Patrick and Monica delve into these cutting-edge treatments, discussing their uses, the complexities of their production, and important safety considerations. They also highlight recent advancements and the exciting future prospects for these therapies in cancer

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25:53

Demystifying Regulatory Designations in Drug Development

Conversations in Drug Development ·

2024/07/10

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 cons of each. They discuss the history of regulatory designations, starting with the Orphan Drug Act of 1983, and explore various designations such as Orphan Drug Designation (ODD), Fast Track Designation (FTD), Breakthrough Therapy Designation (BTD), and Regenerative Medicines Advanced Therapy

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23:44

Exploring Genome Editing Technologies in Drug...

Conversations in Drug Development ·

2024/06/19

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 into the ethical considerations of editing somatic versus germline cells and trace the historical progression of these technologies from agriculture to healthcare. Join us as we discuss the complexity of genome editing methods, the irreversible nature of genetic changes, and the associated risks.

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23:17

The Most Essential Tips for Biotechs Seeking Investment

Conversations in Drug Development ·

2024/06/03

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 discuss a critical topic for early-stage biotech companies: funding challenges and how to overcome them.Dr Nick Myers and Dr Neil Fish, share their extensive experience and insights into navigating the complexities of funding and investment. They delve into what makes an effective pitch deck, the importance

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19:54

The use of ATMPs in oncology clinical trials

Conversations in Drug Development ·

2024/05/21

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 Physician, Dr Harriet Gray Stephens, to delve into the complexities of phase I oncology studies involving advanced therapy medicinal products (ATMPs). Join us as we discuss the unique challenges of ATMPs, such as their different benefit-risk profiles compared to traditional therapies, and the need for

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24:36

How are GMO regulations impacting clinical...

Conversations in Drug Development ·

2024/04/25

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 modified organism (GMO) regulations in clinical trials within Europe. This discussion helps decipher the nuanced environment of GMOs and their associated risks unique within the European framework. Join us as we explore the outdated definition of GMOs, the complexities of their classification, and the impact

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22:38

US drug development: The latest regulatory trends and...

Conversations in Drug Development ·

2024/03/19

In this episode of Conversations in Drug Development, host Harriet Edwards is joined by Katie Rudnick and Dr Julie Warner from Boyds to discuss US regulatory trends and initiatives at the FDA. This episode explores the FDA's recent organizational changes, pilot programs, and focus on innovative clinical trials, including the use of AI in drug discovery. Join us for another Conversation in Drug Development, exploring the dynamic landscape of regulatory trends expected in 2024 and beyond, with a key

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29:37

The regulatory challenges of rare disease drug...

Conversations in Drug Development ·

2024/02/28

To celebrate Rare Disease Day, we are back for 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

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25:40

The drug development landscape: Trends and...

Conversations in Drug Development ·

2024/01/22

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 trends from 2023 in the drug development space and its potential evolution in 2024. Join us as we explore the financial downturn affecting early-stage investment, the rise of cell and gene therapy approvals, and the use of artificial intelligence in various areas of drug discovery and development.

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23 results

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