 enables universal access to clinical research for patients and providers by providing decentralized clinical trials through our platform and unified technology.

Science 37

In May of 2023, the FDA released a new Draft Guidance on decentralized clinical trials (DCTs). This important Draft Guidance offers recommendations for trial sponsors as they navigate the incorporation of virtual trial elements, ushering in a new era of innovation. In this webinar, Science 37 and a group of clinical trial sponsors will discuss how to implement decentralized clinical trials that align with regulatory guidelines

https://www.appliedclinicaltrialsonline.com/act_w/decentralized-clinical-trials

In May of 2023, the FDA released a new Draft Guidance on decentralized clinical trials (DCTs). This important Draft Guidance offers recommendations for trial sponsors as they navigate the incorporation of virtual trial elements, ushering in a new era of innovation.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.



Deliver study execution and oversight to meet regulatory guidelines

Expand patient recruitment beyond traditional research sites

Leverage local HCPs for trial-related procedures


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.




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.




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.



Webcasts

Webinar Date/Time:
Wednesday, August 16, 2023 at 11am EDT

Navigating the FDA's Draft Guidance on DCTs—A Roadmap for Trial Sponsors

Articles

On May 1, 2023, the U.S. Food and Drug Administration (FDA) released an updated Draft Guidance on decentralized trials. This release shows that the landscape of clinical research is rapidly evolving. The shift towards decentralized clinical trials presents an exciting opportunity for sponsors to improve patient engagement, enhance data quality, and accelerate clinical research. Are you prepared for what’s to come? Download the insight brief to learn more. 

New FDA Draft Guidance Shows That the Time for Decentralized Clinical Trials is Now.

The pending FDA Guidelines is clear—pharma companies must improve diverse representation in clinical trials. In this whitepaper, Science 37 shares tips and strategies on how to achieve diversity in clinical trials. 

How to Meet the FDA’s Diversity Guidance

The adoption of virtual sites, that are powered by decentralized clinical trial tools, has increased exponentially in the recent years. As adoption accelerates, so do the possibilities that virtual conduct enables. In this webinar, Science 37 will host a conversation with a group of industry leaders to address challenges faced by the industry and discuss how virtual sites can be implemented to improve real-world data access and long-term follow up.

https://www.appliedclinicaltrialsonline.com/act_w/rwe

The adoption of virtual sites, that are powered by decentralized clinical trial tools, has increased exponentially in the recent years. As adoption accelerates, so do the possibilities that virtual conduct enables. Real-world evidence and long-term follow-up studies have especially benefited from decentralized trial elements. In this webinar, Shaalan Beg, MD, MS at Science 37 and Gordon Cummins, VP of RWE COE at Science 37 will host a conversation with a group of leaders to address challenges faced by the industry. The panel will discuss how virtual sites can be implemented to improve real-world data access and long-term follow up. As well as elaborate on the value virtual sites delivered to patients, sponsors, and CROs alike. Learn how virtual site elements are incorporated today, and how the landscape will change in the years to come. Register today.


A discussion on the challenges the industry currently faces with RWE

A look at the latest approaches sponsors leverage for RWE

Use cases, study designs and the value delivered to stakeholders

 brings a wealth of clinical investigator and research expertise to spearhead Science 37’s agile clinical trials program in oncology — building on its mission to enable universal access for patients and providers, anywhere, and executing plans to grow precision medicine and develop strategic partnerships.

A storied researcher and oncologist, Dr. Beg came to Science 37 from the University of Texas, Southwestern Medical Center in Dallas, TX where he served as Medical Director for the Clinical Research Office at the Simmons Comprehensive Cancer Center and held the position of Director Gastrointestinal Medical Oncology and Associate Professor of Hematology and Medical Oncology.

Nationally, Dr. Beg is a member of the American Society of Clinical Oncology (ASCO) and the ECOG-ACRIN Clinical Research Group, having held several committee positions in those organizations. He is a graduate of ASCO’s Leadership Development Program and has been a member of the Pancreatic Cancer Task Force of the National Cancer Institute (NCI) GI Cancer Steering Committee.

Vice President, Real-World Evidence
COE
Science 37

 leads the Real-World Evidence (RWE) division at Science 37. He has worked in the real-world evidence space for over 25 years in research, product development, study design, strategic development, and global operations. Gordon has direct experience with health plans/IDN’s, pharmacy/PBM’s, provider networks, associations, and academic institutions

Gordon was the past ISPOR co-chair for classifications of retrospective databases, past member for scientific journals, and has numerous publications/posters/presentations in real-world evidence across multiple indications. He obtained his Undergraduate degree (Mathematics/Actuarial Science) and Master’s degree (statistics) from Southwest Missouri State University.

Vice President, Cell and Gene
Therapy Center of Excellence
Parexel

 brings 20 years of clinical trial execution and team management experience, Dr. Learn is personally committed, enthusiastic and passionate about translational science. With interests in the strategic development of novel therapeutics, Dr. Learn is a published author and has been a team leader in the registrational buildout, agency submission and regulatory approval of five separate and unique marketed products (YONDELIS®, IMBRUVICA®, KEYTRUDA®, BREYANZI® and ABECMA®).

A former project leader at Duke University, Merck & Co, and Istari Oncology, Dr. Learn has authored numerous clinical trial protocols, including the design, implementation, and execution of a variety of cellular and genetic therapies.

Over the past five years, Dr. Learn has served as a subject matter expert overseeing the clinical development programs of >20 cell and gene therapy programs in rare disease, CNS, pediatrics and oncology for emerging biotech portfolios as well as large cap pharma. His current interests and commitments lie in the phasing of dose, route and administration of cell and gene therapies in the clinic well as how to use innovations in immunotherapy to drive these unique therapies further in terms of improving patient outcomes.

Senior Director Oncology, Data
Science & Digital Health
Janssen



serves as Senior Director on Janssen R&D’s Data Science & Digital Health team, where she leads efforts to apply real-world data and other data science solutions to advance and accelerate Oncology clinical programs. Dr. Bourla holds a strong background in Medical Oncology, Immunology, and Data Science. She spent 6 years at Flatiron Health as a Medical Director and Clinical Trials Lead. In this role, she led research teams executing prospective real-world studies, methodologic and observational research projects, and developed new technologies for sites and sponsors participating in clinical trials.

Dr. Bourla received her MD/PhD training from the Mount Sinai School of Medicine, with a subsequent internship and residency at New York Presbyterian-Columbia University Medical Center, and a Medical Oncology fellowship at Memorial Sloan Kettering Cancer Center. She earned a BA in English Language and Literature from Yale University.


Webinar Date/Time: Wednesday, March 29th, 2023 at 11am | 8am PDT | 4pm BST | 5pm CEST

Virtual Sites—Are they the Future of RWE?

Download the Executive Oncology Clinical Trial Playbook to discover the premier, patient-centric strategy for solving hallmark challenges in oncology trials.