Featured Speakers :

Prof. Andrea Laslop
Prof. Andrea Laslop
Head of Scientific Office
Austrian Agency for Health & Food Safety
 Agnes V. Klein MD
Agnes V. Klein MD
Director CERB, Biologics and Genetic Therapies Directorate
Health Canada
 Dr. Rakesh Dixit
Dr. Rakesh Dixit
Vice President R&D, Global Head Biologics Safety Assessment
MedImmune Inc.
Dr. Ashutosh K. Pathak MD, PhD, MBA, FRCP (Edin)
Dr. Ashutosh K. Pathak MD, PhD, MBA, FRCP (Edin)
Senior Medical Director
Teva Pharmaceuticals
 Benjamin Locwin
Benjamin Locwin
Director - Business Strategy, Operations, and Performance
Biogen
 Vincent Fung-Sing Chow
Vincent Fung-Sing Chow
Principal Scientist Clinical Pharmacology, Modeling and Simulation
Amgen
 Joseph C. Marini, Ph.D.
Joseph C. Marini, Ph.D.
Scientific Director, PK/ADA/PD Bioanalysis
Janssen
 Michael Retsky
Michael Retsky
Research Associate, Department of Environmental Health
Harvard T.H. Chan School of Public Health
 Candida Fratazzi
Candida Fratazzi
President
Boston Biotech Clinical Research
 Danny Chou
Danny Chou
Senior Research Scientist I, Biologics Development
Gilead Sciences
 Michael Leach
Michael Leach
Therapeutic Area Lead - Biosimilars and Centers for Therapeutic Innovation
Pfizer Inc.
 Vincent Capuano
Vincent Capuano
Partner
Duane Morris LLP
 Thomas Sullivan
Thomas Sullivan
President & Editor
Rockpointe | Policy and Medicine

Welcome to the Biosimilars Clinical Studies & Analytical Similarity Summit—Boston

With patents for dozens of biologic drugs expected to expire within the next five years, the value of bringing biosimilar alternatives to the market has never been clearer for drug manufacturers. In the United States, the FDA has created an abbreviated licensure pathway for biosimilars, but many pharmaceutical companies and biotech firms struggle in understanding how-to:

  • Provide the pre-clinical and clinical data needed to demonstrate similarity
  • The speed and complexity of advancing a biosimilar drug development project
  • Design comprehensive clinical trials needed to prove safety and efficacy in humans

It’s because of this that we’re bringing you the Biosimilars Clinical Studies & Analytical Similarity Summit. This March, we’ll be providing key insights from thought leaders into the biggest challenges in the analytical and clinical phases of biosimilar drug development, from responding to additional regulatory challenges, demonstrating the quality attributes needed to prove interchangeability, and successfully moving through the third phase of clinical trials.

Is your company looking to streamline the processes for?

Analytical/Pre-Clinical

Clinical

Engineering quality attributes in your biosimilar to demonstrate chemical characterization.

Designing effective clinical trial protocols that move your product from Phase I to Phase III.

Proving product comparability at the In Vivo and In Vitro testing stages.

Optimizing your operations for managing different clinical trial sites.

Managing the additional bioanalytical data required by the FDA in the pre-clinical phase.

Demonstrating effective parameters for safety, purity, effectiveness and potency to the FDA.

The summit’s key presentations include such sessions as:

Pre-Clinical/Analytical:

  • Managing the functional assay testing for quality attributes that regulators value
  • Best practices for navigating the abbreviated licensure pathway for interchangeability
  • Leveraging the FDA’s “Totality of Evidence” Methodology for Using Reference Products

Clinical Phases I-III

  • Developing effective Three-Way PK-Bridging Studies for Global IND Strategy
  • Effective Clinical Trial Monitoring to Prepare for Post-Marketing Pharmacoviligance
  • Streamlining the Process for First-in-Human Clinical Trials of Biosimilar Products

And Many More!


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