Navigating the FDA's Draft Guidance on DCTs— A Roadmap for Trial Sponsors

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Event Overview:

In May of 2023, the FDA released a new Draft Guidance on decentralized clinical trials (DCTs). This important Draft Guidance offers recommendations for trial sponsors as they navigate the incorporation of virtual trial elements, ushering in a new era of innovation. The FDA recognizes that DCTs offer significant benefits and recommends the use of virtual conduct to help increase diversity and inclusiveness in trial populations, stating that "remote clinical trial visits and clinical trial-related activities are important strategies to make trials more convenient and more accessible to trial participants."

Join Science 37 and a group of clinical trial sponsors for a conversation on how to implement decentralized clinical trials that align with regulatory guidelines.

Key Learning Objectives:

Deliver study execution and oversight to meet regulatory guidelines
Expand patient recruitment beyond traditional research sites
Leverage local HCPs for trial-related procedures

Who Should Attend:

Pharma, BioPharma and CROs

Featured Speakers

Jonathan Cotliar

Chief Medical Officer

Science 37

Jonathan Cotliar, MD, has been Chief Medical Officer of Science 37 since November 2016. Prior to assuming this role (from November 2016 to May 2019) Jonathan served as Vice President of Medical Affairs for Science 37, where he contributed as an investigator on a number of virtual clinical trials in addition to his work in support of business development and regulatory strategy. Dr Cotliar currently serves as Director of Inpatient Dermatology at Harbor-UCLA Medical Center, with previous full-time faculty appointments at the David Geffen School of Medicine at UCLA, Northwestern University Feinberg School of Medicine, and City of Hope National Medical Center. He was Chief of the Division of Dermatology at City of Hope, previously. Dr Cotliar earned his BA from Trinity College, MD from the University of Kentucky College of Medicine, and completed his training in dermatology and internal medicine at the David Geffen School of Medicine at UCLA. While at UCLA, he completed a NIH-sponsored K30 Fellowship in translational investigation. Dr Cotliar is also board-certified in both internal medicine and dermatology.

Email: jonathan@science37.com

Irena Lambridis

VP, Global Head of Quality Assurance & Compliance

Science 37

Irena Lambridis has spent nearly 20 years working in quality-focused leadership roles, primarily for small and mid-sized CROs building teams and leading global trial quality oversight. Throughout her career, she has focused on creatin g an environment of logical and meaningful quality processes that support organizations in gold standard execution of the trials they support. Now leading Science 37's quality function as VP, Head of Quality Assurance & Compliance, Irena continues to bring her QA toolbox and years of quality experience to Science 37 as they build the future of clinical trials within a decentralized space, ultimately serving the people who need life changing and lifesaving therapies the most.

Email: irena.lambridis@science37.com

Amy Bohn

Director, DCT Operations

Bayer

Amy Bohn, Director, DCT Operations at Bayer works with clinical and operational teams to implement Decentralized Clinical Trials. Amy’s journey to DCT Operations began in 2005, when she joined a start-up organization pioneering remote central ratings to address the high failure rate of clinical trials in CNS indications. Over the course of a decade, she held leadership roles scaling the operations from small start-up to global CRO provider. Her experience with remote ratings, telemedicine, eCOA, and digital platforms is a natural transition to the modern day decentralized clinical trial.

Email: amy.bohn@bayer.com

Krystyna Kowalczyk

Chief Executive Officer

OncoBay Clinical

Krystyna Kowalczyk is the Chief Executive Officer at OncoBay Clinical, a global contract research organization (CRO) with a focus on complex oncology including immuno-oncology and cell therapy. With offices in Spain, Italy, Poland, India and the United States, she retains responsibility for the CRO’s strategic direction and performance across the globe and within all functions of the organization. Ms. Kowalczyk, has over 30 years of clinical research operations and management experience in both large and small CROs and SMOs. Her expertise and experience include developing strategic partnerships with pharma and biotech to drive innovation and development. In her leadership roles she has been responsible for evaluating and incorporating unique and innovative methodologies, platforms and concepts to accelerate and improve clinical development methods. Prior to joining OncoBay, Ms. Kowalczyk was a founding member of Novella Clinical, an oncology-focused CRO and the first exclusively using electronic data capture. She continued implementing her creative vision by establishing Optimal Research, an oncology enrollment optimization engine leveraging the just-in-time model. She held the role of COO of the division from inception until acquisition by a top-tier CRO. Kowalczyk has overseen more than 200 clinical trials during her career.

For any technical questions, please contact Kristina Dunphey: kdunphey@mjhevents.com

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Navigating the FDA's Draft Guidance on DCTs— A Roadmap for Trial Sponsors

Aired: Wed, Aug 16, 2023 11:00 AM EDT{LOCAL_TZ}

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