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.
Episodes
Friday Nov 08, 2024
Patients as Partners: Advocacy's Role in Shaping Drug Development
Friday Nov 08, 2024
Friday Nov 08, 2024
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, and regulatory bodies.
Wednesday Oct 16, 2024
Navigating the Future of EU Health Technology Assessments
Wednesday Oct 16, 2024
Wednesday Oct 16, 2024
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 of health technology assessments.
Tuesday Sep 24, 2024
A Guide to Marketing Authorisation Applications in Europe
Tuesday Sep 24, 2024
Tuesday Sep 24, 2024
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 challenges of Module 1, developing risk management plans, and addressing current regulatory issues.
Tuesday Aug 13, 2024
Navigating the new EU Clinical Trials Regulation
Tuesday Aug 13, 2024
Tuesday Aug 13, 2024
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 patients.
Thursday Jul 25, 2024
Advances in Cell-Based Immunotherapies: CAR-T Cell Therapy vs TCR Therapy
Thursday Jul 25, 2024
Thursday Jul 25, 2024
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 considerations. They also highlight recent advancements and the exciting future prospects for these therapies in cancer treatment and other areas.
Tune in for an insightful discussion on the future of cell-based immunotherapies, examining both the hurdles and the potential of these innovative treatments.
Wednesday Jul 10, 2024
Demystifying Regulatory Designations in Drug Development
Wednesday Jul 10, 2024
Wednesday Jul 10, 2024
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 Designation (RMAT).
Tune in to gain valuable insights from their experience and advice and learn how to navigate the regulatory landscape effectively.
Wednesday Jun 19, 2024
Exploring Genome Editing Technologies in Drug Development
Wednesday Jun 19, 2024
Wednesday Jun 19, 2024
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.
Monday Jun 03, 2024
The Most Essential Tips for Biotechs Seeking Investment
Monday Jun 03, 2024
Monday Jun 03, 2024
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 of presentation skills, and the role of a well-organized data room. Additionally, they offer valuable advice on matching fundraising activities to the right investors and the impact of market trends on investment strategies.
Tuesday May 21, 2024
The Use of ATMPs in Oncology Clinical Trials
Tuesday May 21, 2024
Tuesday May 21, 2024
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 innovative dose escalation and efficacy evaluation methods as well as the potential of ATMPs to meet unmet needs in cancer treatment.
Thursday Apr 25, 2024
How are GMO Regulations Impacting Clinical Development in Europe?
Thursday Apr 25, 2024
Thursday Apr 25, 2024
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 of genome editing technologies.
This podcast series features candid conversations from the expert team at Boyds, who are at the forefront of cutting-edge drug development in the pharmaceutical and biotechnology sector.
Our experts and special guests will share their stories, experiences, and expertise, offering a behind-the-scenes look at the cutting-edge research, clinical trials, regulatory hurdles, and numerous other factors that shape the drug development landscape. Whether you’re a healthcare professional, a patient, a researcher, or simply curious about the world of medicine, this podcast promises to expand your understanding of the complex journey from molecule to medicine.
Join us as we explore the dynamic and ever-evolving field of drug development, one conversation at a time.