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Session 5: Evolution of Product Development to Respond to the Future Needs
Session Chair(s)
Angelika Joos, MPharm
Executive Director, Global Regulatory Policy
MSD, 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, MA
Amgen, United States
Vice President, Regulatory Affairs Oncology
Regulator's Perspective
Michael Berntgen, PhD
European Medicines Agency, Netherlands
Head of Scientific Evidence Generation
HTA Body's Perspective
Antje Behring, PharmD, PhD
Federal Joint Committee (G-BA), Germany
Head, Early Benefit Assessment, Pharmaceuticals Department
Patient's Perspective
François Houyez
European Organisation for Rare Diseases (EURORDIS), France
Treatment Information and Access Director, Health Policy Advisor
Physician's Perspective
Rosa Giuliani, MD
European Society for Medical Oncology (ESMO), Switzerland
Consultant in Medical Oncology, S. Camillo-Forlanini Hospital, Italy
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