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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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Welcome to ”The Business of Drug Development Operations Podcast” hosted by Sheila Mahoney-Jewels, a seasoned professional in the pharmaceutical industry. In this insightful podcast, Sheila explores the dynamic and complex world of drug development operations, offering a unique perspective on the business aspects that drive innovation in the pharmaceutical field. From navigating regulatory landscapes to optimizing clinical trial processes, each episode delves into the challenges and opportuni ...
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How are GMO regulations impacting clinical development in Europe?
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In this episode of Conversations in Drug Development, our host Dr 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 associate…
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US drug development: The latest regulatory trends and initiatives
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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
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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 Power of the Crowd: NASA's Innovation Model and Its Lessons for Pharma with Steve Rader
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In this episode, I talk with Steve Rader from NASA's Center for Excellence. Steve, an Open Talent advocate, explores how NASA's innovation aligns with pharmaceutical, given shared traits like confidentiality and regulations. Despite challenges, NASA taps into 'the power of the crowd.' Join us for insights on NASA’s 'Future of Work,' overcoming outd…
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Navigating Independence: Insights into Consulting, Small Business, and Drug Development with Jeff Fielhauer
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Drug sponsors face challenges with independent consultants. Jeff Fielhauer of Greenforce Medical Writing discusses the corporate ladder's limitations and the perks of small businesses, covering incorporation, tax considerations, & 1099 vs. W2 economics. He refutes the notion that consultants are pricier than full-time employees. Topics include vari…
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The drug development landscape: Trends and predictions for 2024
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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
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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
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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
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In this episode of Conversations in Drug Development, 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 f…
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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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