Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Radisson Blu

Oct 25, 2017 8:00 AM - Oct 26, 2017 3:30 PM

Steinentorstrasse 25, 4001 Basel, Switzerland

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

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)

Julie  Lepin, MA

Industry Perspective: Julie Lepin, MA

Vice President, Regulatory Affairs Oncology

Amgen, United States

Michael  Berntgen, PhD

Regulator's Perspective: Michael Berntgen, PhD

Head of Scientific Evidence Generation

European Medicines Agency, Netherlands

Antje  Behring, PharmD, PhD

HTA Body's Perspective: Antje Behring, PharmD, PhD

Head, 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 (EURORDIS), 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

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.