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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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Project Orbis is a global collaborative review program intended to facilitate faster patient access to high-impact cancer therapies and standardize pivotal oncology clinical trials. The program’s first action was in 2019, and since then, it has continued to evolve in scope. Unlike most expedited approval pathways, Project Orbis is not a regulatory route that the sponsor can choose. The FDA selects companies based on clinical significance, and companies are required to take prompt action in a short timeframe. When selected, sponsors have presented the option to coordinate expedited approvals in parallel to their US FDA review in all (or a subset) of participating countries, including Australia, Canada, Singapore, Switzerland, Brazil, the UK, and, recently, Israel.
This session will provide:
A live Q&A portion with the speaker will follow the presentation.
Any industry representatives working with Priority Review Therapeutics in Oncology
Learning Level: Advanced
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speakers will follow the presentation.
Mark Lane PhD, VP Development Consulting and Scientific Affairs, Principal Consultant, PharmaLex US
Mark Lane is vice president of development consulting and scientific affairs, and principal consultant at PharmaLex US, a global strategic regulatory and quality consultancy. In this role, he heads the company’s product development and regulatory affairs team. Lane’s expertise includes clinical and regulatory strategy, and program, project and portfolio management for drug development in multinationals, ventures and with the National Institutes of Health (NIH), and he has coauthored more than 100 peer-reviewed publications. Lane has more than 25 years of experience including small molecules, biologics, biosimilars and medical devices across multiple therapy areas.
Lynn May Brown, PhD, Senior Director, Global Regulatory Affairs, Merck
Lynn is the Global Regulatory Lead for the Keytruda Gynecological program for Merck. In partnership with Eisai, she led the first Project Orbis pilot, leading to simultaneous FDA, Health Canada, and Australian TGA decisions for use of Keytruda plus Lenvima for the treatment of endometrial carcinoma. Her recent experience with FDA reviews of the endometrial phase 3 confirmatory trial and for use of Keytruda for treatment of cervical cancer have broadened her perspective on the evolution of the Project Orbis FDA pilot program. Lynn has been with Merck in various regulatory functions for over 20 years.
Susan Mayer Executive Director of Regulatory Strategy – Oncology, Eisai Inc
Susan Mayer is an Executive Director Regulatory Strategy within the Oncology Business Group at Eisai Inc. She is a regulatory professional with over 30 years in the pharmaceutical industry, 22 of which have been in developing and implementing U.S. and global regulatory strategies. Susan has supported clinical development and clinical quality assurance functions prior to her regulatory strategy roles. In addition to supporting drug development in oncology, she has worked in therapeutic areas that include women’s health care, cardiovascular, and anesthesia products. Susan has been with Eisai Inc. for over 14 years.
Ajay Acharya Senior Director, Regulatory Affairs CMC at Merck & Co., Inc. (Merck)
Ajay has more than 25 years of pharmaceutical industry experience, mainly in Regulatory Affairs CMC, both at Schering-Plough and at Merck. Prior to working in RA, Ajay worked as a QC chemist, compendial affairs, and in change management. Those experiences helped shape his focus on regulatory intelligence and networking, which help in new situations (such as Project Orbis). His most recent NDA approval was for Welireg, but he has overseen approvals for Koselugo (collaboration with AZ) and earlier oncology programs (Temodar). He also has led multiple development programs and is the key CMC SME for the EU Clinical Trials Regulation.
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