The Australian Pharmaceutical Biostatistics Group welcomes members and guests to attend our 2024 AGM and End of Year meeting on 3rd December at The Macquarie Business School CBD Campus, level 24/123 Pitt St, Sydney from 9am-11.30am as well as online. Please RSVP to apbgsteering@gmail.com for the link.

Prior to the formal AGM, former FDA employee, Ken Quinto, who will provide an FDA Real World Evidence update. Following morning tea, the formal AGM proceedings will begin. After the meeting, members are invited to join the steering committee for lunch.

Date/Time
3rd December, 9-11.30am

Location
The Macquarie Business School CBD Campus, level 24/123 Pitt St, Sydney, and online

Agenda
9am – 10 am FDA RWE Update
10-10.30 am Morning Tea
10.30-11.30 am AGM
12pm Lunch – optional and at own cost, The Rook Rooftop Bar Sydney

FDA Real World Evidence Update

Speaker: Ken Quinto M.D., M.P.H. Executive Director focused on RWE for regulatory use at Lilly’s Center of Innovation within Value, Evidence, and Outcomes

Abstract: In this talk, I will give an overview of FDA’s Real World Evidence program including a background of the program, demonstration projects, guidances, and FDA’s Advancing RWE program.

Biography: 

Currently, I serve as Executive Director focused on RWE for regulatory use at Lilly’s Center of Innovation within Value, Evidence, and Outcomes. Prior to joining Lilly in October 2023, I served as a senior medical advisor in the Real-World Evidence Analytics Staff in the Office of Medical Policy at FDA’s Center for Drug Evaluation and Research from 2018 to 2023. My main duties included leading demonstration projects intended to support the agency’s evaluation of real-world evidence, evaluating real-world evidence sponsor submissions across all therapeutic areas, and contributing to medical policy development mandated by the 21st Century Cures Act. Key focus areas included pragmatic trials and replication of clinical trial results with non-interventional study designs. Also during my 11-year career in the U.S. government, I served as a medical officer at FDA’s Office of Pediatric Therapeutics reviewing post-market safety and adverse event reporting of drugs, biologics, vaccines, and medical devices used in children, as an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention’s National Center for Health Statistics, and as a medical officer/claims analyst at the Centers for Medicare and Medicaid Services.