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Biosimilars Conference


Session 8: Streamlining and Harmonizing Biosimilar Development

Session Chair(s)

Christopher J. Webster, DVM, PhD, MS, MSc

Christopher J. Webster, DVM, PhD, MS, MSc

  • Principal
  • BioApprovals, United States
Vast experience has been gained in the development of biosimilars over the past decade, which can enable the streamlining of biosimilar developments by allowing specific reductions of regulatory requirements without compromising the quality or safety of the product. Moreover, there is a broad interest of patients that such opportunities are pursued vigorously, as the elimination of unnecessary regulatory requirements contributes to competition within the biosimilars’ market and the eventual affordability of, and access to, biosimilars. This session will examine new proposals for streamlining the development of biosimilars and consider the circumstances under which such new approaches might be introduced and the issues to be confronted in harmonizing these approaches across the world.
Learning Objective : Upon completion of this session, the participant should be able to:
  • Be aware of potential new directions for the evolution of regulatory requirements for the development of biosimilars and the scientific bases for them
  • Understand how such new regulatory requirements might be introduced into current development paradigms
  • Be able to design efficient global development plans for biosimilars taking advantage of new regulatory approaches

Speaker(s)

Christopher J. Webster, DVM, PhD, MS, MSc

Efficient Development of Biosimilars: A Rumsfeldian Approach

Christopher J. Webster, DVM, PhD, MS, MSc

  • Principal
  • BioApprovals, United States
Martin  Schiestl, PhD

Tailored Clinical Biosimilar Development

Martin Schiestl, PhD

  • Global Head Regulatory Policy and Intelligence
  • Sandoz GmbH, Austria
Guido  Pante, PhD

Update on the WHO Pilot Procedure for Prequalification of BTPs: Rituximab and Trastuzumab

Guido Pante, PhD

  • Technical Officer
  • World Health Organization , Switzerland
Guido  Pante, PhD

Panel Discussion: Streamlining Global Biosimilar Development

Guido Pante, PhD

  • Technical Officer
  • World Health Organization , Switzerland
Martin  Schiestl, PhD

Panel Discussion: Streamlining Global Biosimilar Development

Martin Schiestl, PhD

  • Global Head Regulatory Policy and Intelligence
  • Sandoz GmbH, Austria
Christopher J. Webster, DVM, PhD, MS, MSc

Panel Discussion: Streamlining Global Biosimilar Development

Christopher J. Webster, DVM, PhD, MS, MSc

  • Principal
  • BioApprovals, United States
Elena  Wolff-Holz, MD, PhD

Panel Discussion: Streamlining Global Biosimilar Development

Elena Wolff-Holz, MD, PhD

  • Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP
  • European Medicines Agency, Netherlands
Sarah  Yim, MD

Panel Discussion: Streamlining Global Biosimilar Development

Sarah Yim, MD

  • Acting Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
  • FDA, United States

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