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Innovation in Clinical Research: AI-based Drug Development Tools and the Regulatory Landscape

Leveraging new technology is critical for accelerating progress in clinical research. In principal, novel drug development tools should undergo regulatory review to ensure validity and safety. An example of an AI-based drug development tool is a Digital Twin. Digital Twins, or AI-generated placebo outcomes created from patient baseline data in clinical trials, can be incorporated into trials to provide patient level insights and enable smaller, more efficient trials. Unlearn continues to work closely with regulators, industry experts, and drug sponsors to navigate a strategic path forward toward regulatory clarity for drug development tools like Digital Twins. Join Unlearn for a panel discussion of industry regulatory experts about the current regulatory landscape and how innovators can help shape the future of how AI is used and regulated in drug development.

In this webinar, you will hear from industry experts about:
  • Regulatory considerations for Digital Twins
  • Current regulatory perspectives on AI and future trends
  • Regulatory strategies for implementing innovative technology in clinical research

this webinar is part #3 of

Powering Clinical Research with AI

Clinical trials are critical for developing new treatments, but face chronic challenges, such as optimal trial design, enrollment, costs, timeline delays, and high failure rates. The gold standard of trial design is randomization, but it is not always ethical or feasible to set up a trial where the control group receives a standard of care or a placebo. Leveraging historical data sets and novel machine learning methods, Digital Twins, or statistically indistinguishable virtual placebo patients, can be generated to match actual patients in clinical studies. Adding external control arms populated with Digital Twins, called Intelligent Control Arms, can streamline clinical trials, increase power, and decrease enrollment, without adding regulatory risk. The FDA has expressed support for innovation in trial design and alternative forms of evidence - Digital Twins are the next frontier for modern trials.

In this 3 part webinar series, you will learn about:

  • AI and Machine Learning
  • Digital Twins, what they are and how they are created
  • Specific use cases for Digital Twins
  • Trial designs and statistical approaches to increase power and accelerate timelines
  • The regulatory landscape and support behind solutions like Digital Twins

Who should attend?

  • Biostaticians and statisticians
  • Business Development/Partnerships, Commercial Teams
  • Data Science
  • Medical Directors, Principal Investigators, Clinical Research Leads
  • Regulatory Affairs
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Charles K. Fisher, PhD

Charles K. Fisher

Founder and CEO of Unlearn.AI

Charles is a scientist with interests at the intersection of physics, machine learning, and computational biology. Previously, Charles worked as a machine learning engineer at Leap Motion and a computational biologist at Pfizer. He was a Philippe Meyer Fellow in theoretical physics at École Normale Supérieure in Paris, France, and a postdoctoral scientist in biophysics at Boston University. Charles holds a Ph.D. in biophysics from Harvard University and a B.S. in biophysics from the University of Michigan.

Diane Shoda

Diane Shoda

CEO, GREYSCALING LLC

Diane is a pharmaceutical industry veteran who is passionate about changing people's lives by helping groundbreaking drugs reach the global market. Previously, Diane served for more than 30 years in various leadership roles in drug development at Pfizer. She has a proven track record of innovative regulatory strategies, including the first approved “virtual” clinical trial. Diane developed and executed regulatory strategies for a broad portfolio of Pfizer’s blockbuster drugs, including Celebrex and Lyrica. Diane holds a B.S. in Chemical Engineering from MIT and serves as Senior Advisor for MIT's NEW Drug Development ParadIGmS (NEWDIGS) program. She is currently an independent consultant with interests in pediatrics, digital health, personalized medicine and working in the grey space of regulatory science.

Wade Ackerman

Wade Ackerman

Partner, Covington

Wade Ackerman is a partner in Covington's FDA Regulatory group and serves as co-lead of Covington’s Digital Health Initiative. Through his previous positions at the Senate HELP Committee and FDA's Office of Chief Counsel, Wade has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. While at the Senate HELP Committee, Wade served as Senior FDA Counsel to Ranking Member Patty Murray (D-WA) and, prior to that, Chairman Tom Harkin (D-IA). He was involved in all major FDA legislative initiatives, oversight hearings, and other HELP Committee activities concerning the FDA, including the 21st Century Cures Act of 2016. Before taking his Senate role, Wade worked for more than five years as Associate Chief Counsel within the FDA’s Office of Chief Counsel (OCC). At FDA, he served on the Agency’s negotiating team for PDUFA V and later helped implement the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the Drug Quality and Security Act (DQSA) of 2013. Wade received his J.D. from Harvard Law School in 2004, and his B.S. from the University of Illinois in 2001.

Arsalan Arif
moderator

arsalan arif

Founder & CEO, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.