Conversations in Drug Development – Détails, épisodes et analyse

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.

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.

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 as immune reactions. Dr. Ginty highlights the importance of addressing these risks and mentions techniques like gene editing to improve safety. Join us in this conversation as we discuss the regulatory challenges in developing these therapies, emphasizing the importance of early engagement with regulators and compliance with donor testing requirements.

To discuss this episode of Conversations in Drug Development with a member of the team, visit www.boydconsultants.com.

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 of regulating AI in this rapidly evolving field and the need for collaboration between regulators and developers. Is AI pushing the boundaries of what's possible? 

To discuss this episode of Conversations in Drug Development with a member of the team, visit www.boydconsultants.com.

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 development, including the impact of AI, machine learning, and CRISPR technologies.

To discuss this episode of Conversations in Drug Development with a member of the team, visit www.boydconsultants.com

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.

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.

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.

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.

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.