Conversations in Drug Development Boyds

n 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 medicinical products (ATMPs).

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 Join us as we explore the outdated definition of GMOs, the complexities of their classification, and the impact of genome editing technologies.
 

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.

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.

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.

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.