Parallel Forums: Click on title to see full description (Scroll down for Rapid Pharmaceutical Development Forum description)
Anthony Ridgway, Health Canada
Nadine Ritter, Biologics Consulting Group, Inc.
Martin Schiestl, Sandoz Biopharmaceuticals
Thomas Schreitmüller, F. Hoffmann - La Roche Ltd.
Biosimilar products are becoming an increasingly important area of interest for the pharmaceutical industry and regulatory agencies. The high complexity of these products and the inability to demonstrate identity to a level typically possible for small molecules require specific scientific and regulatory approaches to ensure a high degree of similarity that is sufficient to reflect the safety and efficacy of the reference product. The regulatory landscape is evolving globally and FDA guidelines, based on the Biologics Price Competition and Innovation Act (BPCI Act), are also expected soon.
The purpose of this Forum is to highlight the scientific and regulatory challenges in developing and assessing biosimilar products and to discuss industry opportunities regarding various classes of biosimilars. Case studies of experiences gained with the first biosimilar products, e.g., in Europe and Canada, and examples addressing the recent efforts in developing biosimilar monoclonal antibody products as well as specific regulatory guidance will be presented.
On the basis of these cases, the Forum will provide the opportunity to discuss development challenges and regulatory expectations associated with the biosimilar approach, such as: the analytical characterization of biosimilar and reference product; pre-clinical and clinical aspects around the evaluation of biosimilarity; the demonstration of interchangeability; and the life cycle approach as applicable to biosimilars.
John Dougherty, Eli Lilly and Company
Anthony Mire-Sluis, Amgen Inc.
Michelle Frazier-Jessen, Micromet, Inc.
Shilpa Kaushik, Eli Lilly and Company
Joseph Kutza, MedImmune
The concept of "Rapid Product Development" is usually associated with small companies who are looking to maximize limited resources in order to achieve a proof-of-concept that can lead to co-development or out-licensing opportunities. The reality is that all companies - small, medium and large sized - are looking for any opportunities they can find to speed development to market. Both industry and regulators have the common goal of safely getting life-saving and life-changing drugs to patients in need sooner rather than later; however with ever increasing resource constraints experienced by both parties, there can be significant challenges to rapidly moving a product through development, into the clinic and onto the market. The goal of this Forum is to identify and discuss issues that can both accelerage development and hold it back in ordeer to develop a winning formula for global best practices. Critical path items that are identified will be discussed with an emphasis on mitigation of associated risks to get them off of the critical path and onto the right path. The right path is a way forward that attempts to increase the overall efficiency of the development program by maximizing resources, shortening timelines with the objective of achieving program goals (e.g., benefits for patients via marketing authorization or out-licensing). Whenever possible, the use of modern pharmaceutical concepts will be discussed such as risk management, appropriate design and prior product knowledge with an eye towards getting it right the first time (or at least minimizing time lines). Case studies from industry will be presented to review ongoing projects that fit these goals. Regulatory authorities will provide comments specific to these programs as well as general guidance and insight on developing better products faster using innovation while ensuring regulatory compliance.