Title: How Synthetic Data Is Unlocking a Decade’s Worth of Clinical Trial Data to Power a New Era of Drug Development
When: November 4, 3 PM GMT / 11 AM EDT / 8 AM PDT
Historical clinical trial data (HCT) is emerging as an important source of evidence across clinical development. Data from past trials is often superior to real-world data from EMR records etc. as it is more structured, complete, 100% traceable and contains the typical endpoints and covariates captured in a clinical trial.
Regulators have lately been supportive of the use of HCT data with both the FDA and EMA approving hybrid trials: phase 3 trials where patients from the control arm have been replaced by synthetic patients from past trials. This talk will explore methodologies and use cases for Synthetic Patients – ‘digital twins’ of real patients that replicate their behavior to a very high degree. Synthetic Patients enable easy sharing of patient-level data without risk of subject-level or sponsor disclosure while allowing data scientists to mine deep insights on patient characteristics and behavior.
Jacob Aptekar, MD Ph.D., is Senior Director of Product Management at Acorn AI, a Medidata Solutions company and part of Dassault Systemes. Dr. Aptekar has over 10 years of experience as a basic science researcher, business leader, and data scientist. He most recently served as an Associate at McKinsey & Company within their Digital McKinsey practice—working with public and private sector clients who use technology to deliver healthcare and develop therapies. Previously, he founded and led Qurator Inc, a data science company focused on the progression of chronic kidney disease and care planning for dialysis. Dr. Aptekar received an MD from the David Geffen School of Medicine at UCLA, his Ph.D. from UCLA in Neuroscience under the mentorship of Mark Frye, an investigator with the Howard Hughes Medical Institute, and an AB in Physics from Harvard College.
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