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Value, Access and Regulatory Strategy Workshop

Session 5: Evolution of Product Development to Respond to the Future Needs

Session Chair(s)

Angelika Joos, MPharm

Angelika Joos, MPharm

  • Executive Director, Global Regulatory Policy
  • Merck Sharp & Dohme (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)

Julie Lepin

Industry Perspective

Julie Lepin

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

Regulator's Perspective

Michael Berntgen, PhD

  • Head of Product Development Scientific Support Department
  • European Medicines Agency (EMA), Netherlands
Antje Behring, PhD

HTA Body's Perspective

Antje Behring, PhD

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

Patient's Perspective

François Houyez

  • Treatment Information and Access Director, Health Policy Advisor
  • European Organisation for Rare Diseases (EURODIS), France
Rosa Giuliani, MD

Physician's Perspective

Rosa Giuliani, MD

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