While fewer than 10% of compounds successfully achieving Phase 1 to FDA approval status1, researchers are increasingly seeking data and methods to address key challenges, such as:

  • Overcoming the data scarcity issue

  • Improving disease understanding

  • Increasing scientific certainty

With increasing competition for patients, the ability to effectively and efficiently execute on clinical development plans has increased focus on alternative data sources. Historical clinical trial and real-world datasets have emerged as attractive options to power synthetic controls that can aid in: trial design, replacement/augmentation of control groups, identifying differentiation in treatment effects across subpopulations and discovery of endpoint correlations.

As promising as these can be, the nuances and implications need to be well understood in a heavily regulated industry.

In this one-hour session attendees will hear from former FDA leaders and industry experts who will address:

  • What is a Synthetic Control and how can it be leveraged in clinical development?

  • What makes for a "good" dataset when building a synthetic control?

  • What are the different types of methods utilized?

  • What is the regulatory perspective on the evolution and adoption of synthetic controls?

  • Has there been a historical usage of synthetic controls in pharma?

  • Where are they seeing the application of synthetic controls take place?

1. Clinical Development Success Rates 2006-2015, BIO Biomedtracker, Amplion

Featured Speakers

Ruthie Davi

Statistician and Vice President of Data Science
Acorn AI

Ruthie Davi is a Statistician and Vice President, Data Science at Acorn AI, a Medidata company, and has a background in pharmaceutical clinical trials with more than 20 years working as a Statistical Reviewer, Team Leader, and Deputy Division Director in the Office of Biostatistics in CDER at FDA. At Acorn AI Ruthie is part of a team creating analytical tools to improve the efficiency and rigor of clinical trials, an example of which is the Synthetic Control work. Ruthie holds a Ph.D. in Biostatistics from George Washington University.

Arnaub Chatterjee

Senior Vice President of Product and Ecosystem
Acorn AI

Arnaub Chatterjee is Senior Vice President of Product and Ecosystem at Acorn AI, a Medidata Solutions company. Medidata is a global provider of cloud based and analytic solutions in life sciences and in his role, he is driving efforts around the development, go-to-market, and delivery of capabilities that help life science clients accelerate their innovation. In addition, Arnaub also serves as a Teaching Associate in the Department of Health Care Policy at Harvard Medical School and Lecturer in the Department of Policy Analysis and Management at Cornell University.

Lisa Ensign, PhD.

Director of Statistics, Statistical Innovation Group

Formerly Biostatistician MD Anderson Cancer Center, Director of Statistics & PMS Telectronics, Co-founder and Product Director NetRegulus. Current Instructor, Clinical Science Program, CU Anschutz Graduate School.


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