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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.
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Thank you for subscribing to our podcast series. Aptuit will continually update the series with interviews from experts across the entire drug development continuum.
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Patients as Partners: Advocacy's Role in Shaping Drug Development
27:24
27:24
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27:24
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 contribution…
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Navigating the Future of EU Health Technology Assessments
29:10
29:10
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29:10
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 ea…
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A Guide to Marketing Authorisation Applications in Europe
28:19
28:19
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28:19
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 …
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Navigating the new EU Clinical Trials Regulation
28:26
28:26
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28:26
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…
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Advances in Cell-Based Immunotherapies: CAR-T Cell Therapy vs TCR Therapy
28:10
28:10
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28:10
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 cells. Patrick and Monica delve into these cutting-edge treatments, discussing their uses, the complexities of their production, and important safety con…
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Demystifying Regulatory Designations in Drug Development
25:53
25:53
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25:53
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 a…
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Exploring Genome Editing Technologies in Drug Development
23:44
23:44
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23:44
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 …
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The Most Essential Tips for Biotechs Seeking Investment
23:17
23:17
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23:17
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 extensiv…
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1
The Use of ATMPs in Oncology Clinical Trials
19:54
19:54
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19:54
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). Jo…
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1
How are GMO Regulations Impacting Clinical Development in Europe?
24:53
24:53
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24:53
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 r…
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US Drug Development: The Latest Regulatory Trends and Initiatives
22:38
22:38
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22:38
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 episode explores the FDA's recent organizational changes, pilot programs, and focus on innovative clinical trials, including the use of AI in drug dis…
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The Regulatory Challenges of Rare Disease Drug Development
29:37
29:37
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29:37
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…
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The Drug Development Landscape: Trends and Predictions for 2024
25:40
25:40
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25:40
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…
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Off-the-Shelf Cell Therapies: Breaking Barriers and Revolutionizing Patient Care
20:30
20:30
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20:30
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 treat multiple recipients. While these therapies offer scalability and the potential to treat larger patient populations, they also carry risks such …
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The Future of Drug Development: AI’s Role in Revolutionizing the Industry
22:13
22:13
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22:13
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 applications in data analysis and toxicity prediction, and its potential to reduce animal testing. Join us in this conversation, as we discuss the challenges o…
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Recent Trends in Oncology Drug Development
25:14
25:14
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25:14
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, as we cover the key shifts in the field over the past few decades, regulatory challenges, FDA initiatives and future developments in oncology drug d…
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In this episode, Dr. Stephen Byrn, Head of Aptuit Scientific Advisory Board, speaks about the critical path problem in drug development and how a designed molecular delivery system can improve the drug development process.
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In this episode, Bob Burford Ph.D., Managing Director, Aptuit Consulting discusses the relationship between drug developers and CROs, including current market conditions, the changing needs of drug developers, how to choose an outsourcing provider, expectations of a CRO, and the future of this important relationship.…
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In this installment of the series, Doug Meyer, Senior Director for Aptuit Informatics, discusses the role and importance of informatics in today’s clinical trial environment.
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