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 November, 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.
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!
Advisory Board
- Dr. Rakesh Dixit, Vice President R & D, Global Head, Biologics Safety Assessment, Pathology & MedImmune Inc.
- Bruce J. Kimelblatt BS, Pharm.D, MBA, Director, Clinical Research, Janssen Research & Development LLC
- Benjamin Locwin, Director - Business Strategy, Operations, and Performance, Biogen
Early-confirmed speakers:
- Prof. Andrea Laslop, Head of Scientific Office, Austrian Agency for Health & Food Safety
- Agnes V. Klein MD, Director CERB, Biologics and Genetic Therapies Directorate, Health Canada
- Dr. Rakesh Dixit, Vice President R&D, Global Head Biologics Safety Assessment, MedImmune Inc.
- Ashutosh Pathak MD, PhD, Senior Director, North America Medical Affairs - Oncology & Biosimilars, Teva Pharmaceuticals
- Benjamin Locwin, Director - Business Strategy, Operations, and Performance, Biogen
- Vincent Fung-Sing Chow, Principal Scientist Clinical Pharmacology, Modeling and Simulation, Amgen
- Boris Gorovits, Ph.D., Senior Director, Pfizer
- Joseph C. Marini, Ph.D., Scientific Director, PK/ADA/PD Bioanalysis, Janssen
- Michael Reilly, Executive Director, The Alliance for Safe Biologic Medicines
- Michael Retsky, Research Associate, Department of Environmental Health, Harvard T.H. Chan School of Public Health
- Candida Fratazzi, President, Boston Biotech Clinical Research
- Danny Chou, Senior Research Scientist I, Biologics Development, Gilead Sciences
- Michael Leach, Therapeutic Area Lead - Biosimilars and Centers for Therapeutic Innovation, Pfizer Inc.
- Vincent Capuano, Partner, Duane Morris LLP
- Dr. Shein-Chung Chow, Professor of Biostatistics and Bioinformatics, Duke University
- Thomas Sullivan, President & Editor, Rockpointe | Policy and Medicine
Please fill in your name and email to receive the conference agenda of this event.
Pre-Conference Workshop Day - Monday March 21, 2016
- WORKSHOP A: Compare, Contrast and Comply with US and EU Regulations that Govern Biosimilar Product Development
9:30AM-11:30AM - WORKSHOP B: Establishing Pharmacological Comparability With Effective Preclinical Characterization Methods
12:00PM-2:30PM - WORKSHOP C: Effective Clinical Study Design for Detecting Differences Between Biosimilar and Innovator Products Among Sensitive Populations
3:00PM-5:30PM
Main Conference Day One - Tuesday March 22, 2016
- Including: Morning Networking Break, Networking Lunch Break, Afternoon Coffe Break
Main Conference Day Two - Wednesday March 23, 2016
- Including: Morning Networking Break, Networking Lunch Break, Afternoon Coffe Break
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
Venue & Accommodation
Venue to be confirmedBoston, MA
AccommodationMore information to follow...
Please note: We will never recommend, approve or appoint any third party rooming service to act on our behalf. Please be extremely wary if you are approached by any such companies. We will always endeavour to negotiate the best available rates for you so please use the Hotel´s website link provided.
