Value, Access and Regulatory Strategy Workshop

Session Chair(s)

Angelika Joos, MPharm

• Executive Director, Global Regulatory Policy
• MSD (Europe) Inc., Belgium

Industry is responding to society's call for innovative medicine development addressing high unmet medical needs. As a consequence, the traditional medicine development paradigm is undergoing fundamental changes. For example, new immuno-oncology medicines are developed using new scientific methodologies, such as platform trials and single arm studies to accelerate the clinical development and make new treatment options available to patients as quickly as possible. The clinical development programs progress with unprecedented speed and the complexity of the programs is increasing. They often include platform trials testing multiple compounds to identify the best target or combination therapy trials that could potentially offer cures. The panel will be invited to discuss the impact of the new scientific methodologies on the current regulatory and value assessment frameworks:

• How to make clinical development more efficient to support early access to market
• Managing multiple/new indications
• Product used in combination with other product
• How to evaluate the value of multiple indications and the combination

Speaker(s)

Industry Perspective

Julie Lepin

• VP, Global Regulatory Affairs, TA Head, Oncology and InVitro Diagnostics
• Global Regulatory Affairs & Clinical Safety, Merck, United States

Regulator's Perspective

Michael Berntgen, PhD

• Head of Product Development Scientific Support Department
• European Medicines Agency, European Union, United Kingdom

HTA Body's Perspective

Antje Behring, PhD

• Team Lead, Early Benefit Assessment, Pharmaceuticals Department
• Federal Joint Committee (G-BA), Germany

Patient's Perspective

François Houyez

• Treatment Information and Access Director, Health Policy Advisor
• EURORDIS, France

Physician's Perspective

Rosa Giuliani, MD

• Consultant in Medical Oncology, S. Camillo-Forlanini Hospital, Italy
• European Society for Medical Oncology (ESMO), Switzerland