KEY pieces of the puzzle for clinical and commercial success: 2016-2021
As biosimilars to treat rheumatic diseases begin to get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, stressing the need to understand this rapidly changing landscape. What is the real potential for clinical and health-economic benefits offered by these agents?
Driving effective, efficient and fit-for-purpose clinical trial designs requires an acute understanding of the varying nuances in targeted regional areas as compared to the global marketplace, as well as a strategy to drive successful post-approval commercialization across a range of biosimilar markets.
Join this webinar to develop a deeper understanding of the current biosimilars landscape, the typical development pathway and key regulatory issues expected during the next five years. From discovery to commercialization, you’ll learn about the end-to-end considerations and strategies that will help advance biosimilars in rheumatology.
Presented by
Mark P. Fletcher, MD,
Executive Medical Director, Inflammation, Infectious Diseases and General Medicine
Mark Fletcher provides clinical and medical and strategic expertise across the company in the areas of immune-mediated inflammatory diseases (IMID), autoimmunity, immunology, biosimilars development, as well as advanced therapies.
Dr. Fletcher chairs the Covance Biosimilars Expert Working Group, supports Covance's Biosimilar Solutions business program and chairs the Covance Scientific Council's Advanced Therapies Expert Working Group. He has contributed advice/input on the World Health Organization's 2009 Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). At Covance, he also serves as global project physician and/or senior consultant on multiple Phase Ib-III trials of autoimmune and inflammatory conditions, and provides training in IMID, autoimmunity, immunology, biosimilars and advanced therapies areas across Covance and LabCorp.
Alicia M. Baker,
Director, Global Regulatory Affairs Strategy
Ms. Alicia M. Baker is a director in global regulatory affairs strategy at Covance. With over 20 years of industry experience, she has spent over 17 years in global regulatory affairs developing regulatory strategies across many therapeutic areas in all phases of development. She has been responsible for the registration of multiple products in more than 90 countries.
Prior to joining Covance, Ms. Baker worked at Merck in quality assurance before moving in to global regulatory affairs. While at Merck, she was responsible for regulatory strategy and development for NCEs and biologics as well as mature products.
Ms. Baker has a bachelor of science in biology from Saint Joseph's University, a master of science in quality assurance/regulatory affairs from Temple University, a master of science degree in regulatory science from the University of Southern California and is currently completing her doctorate of regulatory science at the University of Southern California.
John Carlsen, MHA,
Vice President, Covance Market Access Services
John Carlsen leads Covance’s market access-focused biosimilars initiatives. He provides reimbursement planning, market access strategy and health policy analysis consulting to clients in the pharmaceutical, biotechnology and medical device industries. Mr. Carlsen specializes in assessing the impact of changes to Medicare and managed care payment systems on the reimbursement of biologics, drugs and devices. His focus includes products facing complex reimbursement issues and market access barriers.
