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Decentralized: The Decentralized Trials & Research Podcast

Decentralized: The Decentralized Trials & Research Podcast

A space for all who want to improve access for clinical research and participation.

Evidence of Impact in Decentralized Trials

2023-04-21 Join us to hear from DTRA Initiative Leaders Caroline Redeker (Advanced Clinical) and Naveen Goje (ZS) on the great work their team did to gather evidence of impact of DCTs into a data repository to promote education and adoption. Amir Kalali and Jane Myles joined for the conversation.You can find the full data repository and report here.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.
June 7, 2023

1572s & Draft DCT Guidance

2023-06-02 Join us as we discuss the recently released FDA Draft Guidance on DCTs and its impact on the 1572 Form. Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by DTRA Co Lab Members on this topic, Becky Kottschade (Mayo Clinic) and Shaheen Limbada (Veristat) for the discussion.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.
June 6, 2023

ChatGPT Meets DCT

2023-01-27 Join us as we discuss ChatGPT and the place it may have in the decentralized clinical trials space. Our hosts, Craig Lipset, Amir Kalali, and Jane Myles were joined by Joe Dustin (Medable) and Ritesh Patel (FINN Partners) for this riveting conversation.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.
May 31, 2023

New Research on Patient Preference in Clinical Trial Participation

2023-01-20 On this episode of TGIF-DCT, our hosts Craig Lipset & Jane Myles were joined by Jon Meyer (Life Sciences Strategy Group) to discuss his research on patient preference. 2/3 of study participants want to see trial have more in-home features and only 9% want fewer. And in-home activities in trials were associated with greater patient satisfaction than those involving travel.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.
May 31, 2023

Patient Optionality & Choice in DCTs

Join hosts Craig Lipset and Amir Kalali as they discuss Patient Choice & Optionality in DCTs. Joined by Michelle Shogren (Innovate in what you do!), Kelly McKee (Medidata), Alexander Pastuszak (Now Contraline, preiously Vault Health), and Angela Radcliffe (BMS).Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.
May 26, 2023

Walgreens and the Commitment to Trials

The commitment of pharmacy to address clinical trials has been a recurring topic this week. Craig Lipset was joined by Kendal K. Whitlock, MPH, Head of Digital Optimization, RWE Clinical Trials from Walgreens to discuss the state of the industry, commitment to the field, and progress to-date.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.
May 23, 2023
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Decentralized: The Decentralized Trials & Research Podcast

Decentralized: The Decentralized Trials & Research Podcast is brought to you by the Decentralized Trials & Research Alliance (DTRA). This is a space for all who want to improve access for clinical research and participation. New topics are covered every week live on Clubhouse with guest speakers in the industry to talk about the latest ways to make research and clinical trials more inclusive, accessible, resilient, and sustainable by using decentralized methods.

Team

Craig Lipset

Craig Lipset

Craig Lipset (he/him/his) leads at the forefront of innovation in clinical research and medicine development. He is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). During that time, Craig designed and launched multiple industry firsts -- from the first fully remote/virtual clinical trial for a new medicine to the first returning of results and data to research participants.

He currently serves on the Board of Directors for the Decentralized Trials & Research Alliance (Co-Chair), Foundation for Sarcoidosis Research and the MedStar Health Research Institute, and, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Craig is an Adjunct Assistant Professor in Health Informatics at Rutgers University, and an Adjunct Instructor at the University of Rochester Center for Health + Technology.

Craig has received the red jacket 'hall of fame' recognition among the PharmaVOICE most inspiring people in the life sciences. He has been recognized among Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, the Medicine Maker Power List and the AlleyWatch Who's Who in eHealth. He studied Music at Brandeis University and earned a Master of Public Health from Columbia.
Amir Kalali, MD

Amir Kalali, MD

Dr. Kalali is a physician-scientist, recognized globally as a leading innovator at the intersection of life sciences and technology, and a convener of collaborative high-impact forums. He is a board director of both private and publicly traded companies, and advises companies in the life sciences and technology sectors, universities, and investment groups. Dr. Kalali is the Co-Chair of the Decentralized Trials and Research Alliance (DTRA), Chairman and Chief Curator of the CNS Summit, a forum focused on the future of life sciences, and was the Founding Chairman, and sits on the Executive Committee of the International Society for CNS Drug Development (ISCDD), one of the first independent non-profits to bring together leaders in drug development to collaborate, and on the Executive Committee of the International Society for CNS Clinical Trials and Methodology (ISCTM).

He is a Professor of Psychiatry at the University of California San Diego, Editor of the journal Innovations in Clinical Neuroscience, and the Lead Editor of the book Essential CNS Drug Development., published by Cambridge University Press. He has authored over 250 peer-reviewed publications, and numerous book chapters. He has been involved in initiatives by the Institute of Medicine, as well as the NIH FAST and the NIH NCATS programs. Previously, for almost 20 years, he was the Global Head of the Neuroscience Center of Excellence at Quintiles, now known as IQVIA.

In this role, he led the enterprise-wide strategy for neuroscience, encompassing drug development and health care services. He was responsible for numerous successful drug development programs that have led to dozens of approved new treatments for patients. Dr. Kalali regularly speaks at national and international scientific meetings on topics including drug development, clinical trials, innovation, technology, digital medicine, biohacking, and health. Dr. Kalali’s contributions have been recognized by life sciences media including The Medicine Maker’s Power List and the PharmaVOICE magazine’s Inaugural Red Jacket award, recognizing those who have been most lauded by their peers

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