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
![Advances in Cell-Based Immunotherapies: CAR-T Cell Therapy vs TCR Therapy](https://pbcdn1.podbean.com/imglogo/image-logo/17136537/Final_logo_mrcx7u_300x300.jpg)
2 days ago
2 days ago
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 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.
![Demystifying Regulatory Designations in Drug Development](https://pbcdn1.podbean.com/imglogo/image-logo/17136537/Final_logo_mrcx7u_300x300.jpg)
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.
![Exploring Genome Editing Technologies in Drug Development](https://pbcdn1.podbean.com/imglogo/image-logo/17136537/Final_logo_mrcx7u_300x300.jpg)
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.
![The Most Essential Tips for Biotechs Seeking Investment](https://pbcdn1.podbean.com/imglogo/image-logo/17136537/Final_logo_mrcx7u_300x300.jpg)
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.
![The Use of ATMPs in Oncology Clinical Trials](https://pbcdn1.podbean.com/imglogo/image-logo/17136537/Final_logo_mrcx7u_300x300.jpg)
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.
![How are GMO Regulations Impacting Clinical Development in Europe?](https://pbcdn1.podbean.com/imglogo/image-logo/17136537/Final_logo_mrcx7u_300x300.jpg)
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.
![US Drug Development: The Latest Regulatory Trends and Initiatives](https://pbcdn1.podbean.com/imglogo/image-logo/17136537/Final_logo_mrcx7u_300x300.jpg)
Tuesday Mar 19, 2024
US Drug Development: The Latest Regulatory Trends and Initiatives
Tuesday Mar 19, 2024
Tuesday Mar 19, 2024
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 discovery. Join us for another Conversation in Drug Development, exploring the dynamic landscape of regulatory trends expected in 2024 and beyond, with a key emphasis on the US scope.
![The Regulatory Challenges of Rare Disease Drug Development](https://pbcdn1.podbean.com/imglogo/image-logo/17136537/Final_logo_mrcx7u_300x300.jpg)
Wednesday Feb 28, 2024
The Regulatory Challenges of Rare Disease Drug Development
Wednesday Feb 28, 2024
Wednesday Feb 28, 2024
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.
![The Drug Development Landscape: Trends and Predictions for 2024](https://pbcdn1.podbean.com/imglogo/image-logo/17136537/Final_logo_mrcx7u_300x300.jpg)
Monday Jan 22, 2024
The Drug Development Landscape: Trends and Predictions for 2024
Monday Jan 22, 2024
Monday Jan 22, 2024
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.
![Off-the-Shelf Cell Therapies: Breaking Barriers and Revolutionizing Patient Care](https://pbcdn1.podbean.com/imglogo/image-logo/17136537/Final_logo_mrcx7u_300x300.jpg)
Monday Dec 04, 2023
Monday Dec 04, 2023
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.
![Image](https://mcdn.podbean.com/mf/web/kynr8x/Website_news_cover_image_size_51_3a76a29a-1e7f-29e3-3933-c81442f58481.png)
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.