The idea of a “one-click” Biologics License Application (BLA) has become the ultimate benchmark for what AI could enable in drug development — a world where data moves seamlessly from discovery to submission, with every result, dataset, and citation verified, traceable, and regulator-ready. But how far are we actually from that reality?
This session explores the technologies, infrastructures, and cultural shifts needed to bring automation to one of the most complex and high-stakes processes in life sciences: regulatory submission. The discussion will cut through the hype to define what “submission-grade AI” really means, the challenges that still stand in the way of full automation, and what it will take to build the regulatory trust required to get there.
Join us as we examine the future of AI-driven submissions — and ask the provocative question: could the next BLA really be submitted with a single click?
Farouk Daher
Subha Madhavan
Dr. Eliezer Katz
Dr. Katz is an experienced transplant surgeon and a leader in clinical development in the pharmaceutical industry. Currently, Dr. Katz is the chief medical officer of Eledon Pharmaceutical. Before joining Eledon, Dr. Katz was CMO of eGenesis, a company in the xenotransplantation field. Previously, Dr. Katz served as Vice President and clinical development lead at Viela Bio and Horizon Therapeutics, where he was responsible for developing novel medications for autoimmune-related diseases and organ transplantation.
Dr. Katz earned his MD degree from the Hebrew University-Hadassah Medical School in Jerusalem, Israel.
Dr. Katz joined Viela Bio/Horizon following 30 years of combined academic and pharmaceutical career in the areas of organ transplantation, immunology, and immune-induced diseases.
His academic career as a transplant surgeon spanned 20 years, including directorship of two transplantation programs. The director of the abdominal transplantation division at Integris Baptist Medical Center in Oklahoma City, and an associate professor of surgery and the director of the liver transplantation division at the University of Massachusetts Medical Center, Worcester, MA. During his tenure as a transplant surgeon, Dr. Katz implemented techniques for split liver and living donor liver transplantation, was actively involved in policy making related to organ donation and allocation and led efforts to increase organ donation.
After joining the pharmaceutical industry, Dr. Katz served as the vice president at CTI clinical trial and consulting services, as senior director in transplantation at Medicine Development Group, Pfizer Inc., and at Medimmune/AstraZeneca as a senior director at RIA (respiratory, inflammation, and autoimmunity), where he oversaw clinical development in neuro-inflammation, inflammatory bowel disease, and myositis.
Dr. Katz is an author of more than 60 peer-reviewed publications.
Reed Few
Reed Few is Director of External Innovation for Data Science and Digital Health at Johnson and Johnson Innovative Medicine, R&D. With a background spanning real-world data, predictive modeling, and precision medicine, Reed is passionate about finding ways to combine data and AI to bring therapies from concept to approval, faster. In her current role, she looks for partnerships that will help to design better, more diverse clinical trials, improve operational efficiencies, and find digital endpoints that better reflect how patients live and feel in the real world. As of late, her focus has been on initiatives applying generative AI and large language models to accelerate document creation across preclinical, CMC, and clinical domains – advancing smarter, faster, and more connected drug development.
Bluenote
Website: www.bluenotehealth.com
Bluenote helps scientists, researchers, and medical writers accelerate critical workflows by 50–75%—so you can spend less time on paperwork and more time advancing life-saving therapies.
