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In this episode, “How to Maximize Valuation for Minimal Cost,” we explore a critical question: Are you focused on regulatory approval, or on maximizing value? Your answer could determine the path your clinical trial takes, and the outcome it delivers.
Our moderator, Dr. Ken Park, is joined by an exceptional group of speakers: Tracy Newbold, VP of Clinical Operations at Lexicon Pharmaceuticals; Terry Athreya, SVP and Global Head of Clinical Operations for Fortrea; and Alaric Jackson, Chief Technology and Data Officer at Fortrea.
This episode is part of the 'Project Optimus' series exploring oncology trial reform.
Overview: Behind every optimized dose is a robust framework of modeling, simulation, and thoughtful study design. Host Abigail Beanie returns to guide listeners through the technical backbone of Project Optimus. This episode explores how data-driven tools are transforming oncology trials and enabling more precise, patient-centric dosing decisions.
Participants:
· Host: Abigail Beanie
· Dr. Mark Lovern, Executive Director of Medical Science Services, Fortrea
· Dr. Richard McNally, Director of Biostatistics, Fortrea
This episode is part of the 'Project Optimus' series exploring oncology trial reform.
Overview: Description:
How do you bring Project Optimus from concept to clinic? In this episode, Dr. Shanthi Sundaramoorthy, Senior Director of Fortrea’s Strategic Growth and Delivery Team in Oncology, shares actionable insights on how sponsors can adapt early-phase trial designs to align with the FDA’s evolving expectations. Learn how smarter dosing strategies can lead to better outcomes and more efficient development.
Participants:
· Dr. Shanthi Sundaramoorthy, Senior Director of Fortrea's Strategic Growth and Delivery Team in Oncology, Fortrea
This episode is part of the 'Project Optimus' series exploring oncology trial reform.
Overview: What is Project Optimus, and why is it reshaping the future of oncology drug development? In this kickoff episode, we unpack the FDA’s initiative to modernize dose optimization in cancer trials. Join host Abigail Beanie as she speaks with Audrey Finesso, Senior Director of Clinical Regulatory Strategy, and Luca Cantini, Medical Director of Oncology at Fortrea. Together, they explore the implications for sponsors, regulators, and—most importantly—patients.
Participants:
· Host: Abigail Beanie Global Data reporter for Clinical Trials Arena
· Audrey Finesso, Senior Director of Clinical Regulatory Strategy, Fortrea
· Luca Cantini, Medical Director, Oncology, Fortrea
Join us for the fourth episode of our "Sustainability in Clinical Trials" series!
🎧 This 2-part episode delves into the crucial role of partnerships in challenging established thinking of sustainability and clinical trial design. Host John Kennett is joined by Caleb Tuten, Lisa Moneymaker, Fiona Adshead, and Marlene Knupfer to discuss how organizations can collaborate to share resources and best practices. Discover the benefits of partnerships and what it takes to develop a common language and common goals for sustainability in clinical trials. 🤝
Don't miss the third episode of our "Sustainability in Clinical Trials" series!
🎧 In this 2-part episode, host John Kennett and panelists Caleb Tuten, Lisa Moneymaker, Fiona Adshead, and Marlene Knupfer discuss the vital role of partnerships in driving adoption of sustainable thinking in clinical trial design. They emphasize how organizations across sectors can come together to share resources, knowledge, and best practices, and on what it will take to develop a common language and shared goals for sustainability in clinical trials across our industry. 🌿
Tune in to the second episode of our "Sustainability in Clinical Trials" series!
🎧 This 2-part episode delves into how sustainability strategies drive speed and efficiency in drug development. Host John Kennett is joined by Carly Santer, Andrea Robinson-Smith, Ida Corneliusson, Keith Moore, Claire Campbell-Cooper, and Marlene Knupfer to discuss the obstacles slowing progress and share their thoughts on what listeners can do today to make a difference. They also share delightful anecdotes about where things have gone wonderfully right.🌳
Dive into our first episode of the "Sustainability in Clinical Trials" series!
🎧 In this 2-part episode, we explore innovative strategies to drive sustainability and profitability in tandem. Join host John Kennett and our expert panelists Carly Santer, Andrea Robinson-Smith, Ida Corneliusson, Keith Moore, Claire Campbell-Cooper, and Marlene Knupfer as they discuss the current state of sustainability in clinical trials, industry focus areas, and the impact on patients. Discover where progress is being made and how designing clinical trials through the lens of sustainability is making a difference! 🌍
Overview: In this 2-part episode, we look a little beyond clinical trials, taking a complex systems view on how sustainability thinking is shaping the future of healthcare as a whole, and the role that our industry must play in informing and promoting this way of thinking.
Participants:
· Host: John Kennett, Director, Global Marketing at Fortrea
· Jason Laroche, Director of Innovative Health and Environmental Sustainability and Clinical Research at Johnson and Johnson Innovative Medicine
· Dr. Ashton Harper, Head of Medical Affairs for the UK and Ireland at Roche Diagnostics
· Emma Iovoli, MD, Lead for Medical Sustainability at Bayer
· Marlene Knupfer, Instrument and Translation Manager at Fortrea
Part 2: Our panelists continue the discussion of sustainability in healthcare, expanding to carbon tunnel vision, systems thinking, and sharing personal perspectives about what they would do to improve patient outcomes while achieving a greener future.
Overview: In this 2-part episode, we look a little beyond clinical trials, taking a complex systems view on how sustainability thinking is shaping the future of healthcare as a whole, and the role that our industry must play in informing and promoting this way of thinking.
Participants:
· Host: John Kennett, Director, Global Marketing at Fortrea
· Jason Laroche, Director of Innovative Health and Environmental Sustainability and Clinical Research at Johnson and Johnson Innovative Medicine
· Dr. Ashton Harper, Head of Medical Affairs for the UK and Ireland at Roche Diagnostics
· Emma Iovoli, MD, Lead for Medical Sustainability at Bayer
· Marlene Knupfer, Instrument and Translation Manager at Fortrea
Part 1: Our panelists discuss what a sustainable healthcare model is and provide examples of it in action. They also talk about societal attitude change regarding sustainability from the medical industry and patient perspectives.