Expedited regulatory pathways are designed to accelerate access to safe and effective innovative medicines for patients in need. Through early and enhanced interactions between sponsors and the regulatory agencies, and/or accelerated review process, these frameworks serve as powerful tools for life sciences companies aiming to bring important new treatments to market in a timely manner.

In this engaging and insight-packed webcast, seasoned regulatory experts will delve into the strategic, regulatory and operational aspects of expedited routes to market in pharmaceutical and biotech settings.

Learning Objectives

• Opportunities and challenges presented by EMA and FDA expedited pathway, including Fast Track, Breakthrough Therapy, PRIME, and Accelerated Approval.
• How to effectively leverage the full toolbox of expedited pathways.
• Practical guidance on dossier preparation, agency interactions, and common pitfalls to avoid.
• Whether you are in regulatory affairs, clinical development, or strategic operations, this session will provide you with the insights and tools needed to navigate accelerated pathways – helping you bring innovation to patients faster.

Who Should Attend?

Regulatory Affairs Professionals

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Speakers

Bruno Flamion, MD, PhD
Member and Consultant in Regulatory Affairs and Drug Development Strategy

Bruno Flamion, MD/PhD, is a consultant in regulatory affairs and drug development strategy with clinical experience in internal medicine and nephrology. He worked for the European Medicines Agency (EMA) for 12 years as a member of the Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) representing Belgium. He also served as Chair of the Pharmacokinetics Group, and was Chair of the Scientific Advice Working Party for 6 years. He is currently head strategic development at Viatris Innovation, Switzerland. Prior to this, he held a similar position in Actelion and Idorsia Pharmaceuticals. He was full professor of physiology and clinical pharmacology at the faculty of ,edicine of the University of Namur, Belgium, for 26 years.

Patricia Carlos
Senior Vice President, Regulatory Affairs and Quality, Jasper Therapeutics

Patricia Carlos has over 25 years of experience in the biotech and pharmaceutical industry, with a proven track record of success in driving global strategy, regulatory affairs, and strategic partnerships. Her expertise spans early development through approval and post-marketing in multiple therapeutic areas. Prior to joining Jasper Therapeutics, she was chief regulatory, quality and safety officer at Agenus, an immuno-oncology company. Previously, she served as senior vice president of regulatory and quality at Arcus Biosciences, where she built out the regulatory, quality and safety functions and led the global regulatory strategy. Prior to Arcus, Patty held leadership roles at Bellicum Pharmaceuticals, BeiGene, Medivation-Pfizer, Gilead Sciences, and Bayer

Delphine Wagner, Ph.D.,
Senior Director, Regulatory Affairs, Clinigen

Delphine Wagner, PhD, has over 15 years of experience working in Global Regulatory Affairs. At Clinigen, she provides regulatory expertise and leadership to clients across a range of projects, including regulatory applications in Europe, the US and at EU National Competent Authorities and advises clients on regulatory strategy for early to late-stage development assets. Delphine has extensive experience in leading teams in the preparation and execution of regulatory submissions and regularly engages with regulatory agencies. Prior to Clinigen, she worked at Kinesys Consulting and at Amgen, where she held roles of increasing responsibility. Delphine has a PhD in medicinal chemistry from the University of Bath and has held post-doctoral research positions at Sanofi-Aventis and at the University of Oxford.

Gerry McGettigan
Regulatory Affairs Consultant, Clinigen

Gerry McGettigan has over 30 years' experience in the biotechnology and pharmaceutical industries, in regulatory affairs, clinical development and business development, as well as in various non-executive director roles. Gerry founded the European regulatory affairs and product development consultancy company, GMG BioBusiness Ltd, which was acquired by a top-five CRO in 2005. He subsequently founded Kinesys Consulting, which was acquired by Clinigen in 2024. Gerry has worked with many EU, US and other clients on projects ranging from early-stage regulatory strategy for emerging biotechs to advising on strategy and operations for major developments of large pharma firms.