Industry Pulse Global Life Sciences & Healthcare Practice – Gene Therapy: Pricing and Reimbursement Challenges

By Lydia van der Meulen, Client Partner, Global Head of Life Sciences & Healthcare Practice Group, and Michael Ade, Client Partner, Pedersen & Partners.

Pedersen & Partners conducts regular interactive sessions for its global team, bringing in senior executives from the Life Sciences & Healthcare ecosystem to update the team on developments that impact the global Industry. In our ongoing Market Pulse symposium series, we invite industry leaders to share insights on current market trends.

During the most recent Market Pulse symposium, we had the privilege of hearing from Dr. Hardo Fischer. He shared insights into the current challenges facing Pricing & Reimbursement for Advanced Therapy Medicinal Products (ATMPs), particularly in gene therapy. We were delighted to welcome Dr. Hardo Fischer to our Market Pulse symposium. We are committed to enhancing our knowledge of the industries with which we work, positioning us optimally to serve our global clients in 50 countries, spanning all domains of Life Science innovation.

Website banner for Article LS Michael Ade

Dr. Hardo Fischer is a distinguished authority in the field, having successfully navigated gene therapy products through Regulatory and Health Technology Assessment (HTA) processes in various European countries. With experience at AveXis / Novartis Gene Therapies, he now serves as the Medical Director at GenSight Biologics.

During the symposium, Dr Fischer delved into the diverse regulatory pathways for innovative treatments in the USA, the European Union, and Switzerland, providing valuable insights to the Pedersen & Partners team. He emphasised the significant disparities in definitions of ATMPs, regulatory routes, and timelines across these regions.

Furthermore, he highlighted the promising potential of Digital Endpoints in clinical trials for ATMPs, which can overcome the limitations associated with conventional endpoints such as the Six Minute Walk Test.

Finally, Dr Fischer showcased compelling instances of applying real-world evidence to assess ATMPs, foreseeing the increased use of RWE by global authorities in future Health Technology Assessments and Pricing & Reimbursement negotiations, with the USA leading the way, as is often observed in our industry.

About the Authors:

Lydia van der Meulen is a Client Partner and the Global Head of Life Sciences & Healthcare Practice Group at Pedersen & Partners, based in Amsterdam, the Netherlands.

Lydia van der Meulen

Mrs. van der Meulen has almost 25 years of global end-to-end Life Sciences Executive Search expertise. She draws on an extensive track record gained in senior-level international assignments across a broad range of leadership roles in the Pharmaceutical, Medical Technology, and Biotechnology sectors, as well as in Animal Health and AgriTech. During her career, Mrs. van der Meulen has worked for start-ups, mid-sized organisations and multinationals; publicly listed, privately held, and PE-backed firms. Prior to joining the Executive Search sector, Mrs. van der Meulen worked in Management Consulting in London and in Private Banking in the Netherlands. Between 1989-1990 Ms. Van der Meulen lived and worked in Kuwait. 

Michael Ade is a Client Partner at Pedersen & Partners and a dedicated member of the international Life Sciences and Healthcare Practice Group.

Michael Ade

Following a 14-year international career in the Life Sciences industry, Mr. Ade has been working in Executive Search for almost 15 years, with his expertise in conducting searches for C-Suite level executive and senior management roles in R&D, commercial, and General Management functions for companies in the Biotech, MedTech, and Pharmaceutical industry. He has a strong track record of successful placements across Europe. Prior to joining Pedersen & Partners, Mr. Ade was a Senior Partner with two international search firms, specialising in Life Sciences. He previously worked in senior and international positions in Business Development and Marketing at Ingenium Pharmaceuticals GmbH and Boehringer Ingelheim.