Optimal Strategix Group, USA
Title: Commercialization considerations for biosimilars
Steve Lehrer is an Executive Vice President and Leader of the Life Sciences Practice at Optimal Strategix Group. He has over 25 years of experience starting, growing and running life science based businesses focused on commercializing new technology. He has extensive experience in biosimilars and led efforts at developing and commercializing biosimilars at four different pharmaceutical companies during the past 20 years. His experience covers R&D, regulator, manufacturing, pricing, reimbursement and commercial marketing. In addition, he has performed due diligence on several biosimilar opportunities. He currently sits on the board of 2 life science companies and provides strategy advice to several CEO/senior management teams on a wide range of topics from commercial strategy through operations /business development and portfolio planning. He has a Master's Degree from The Graduate School of Business at Harvard University and a BSE in Chemical Engineering and a BA in Economics from the University of Maryland, College Park.
Biosimilars have been in the market for years driven by early products such as recombinant insulin and human growth hormone. European approval of biosimilar GCSF and erythropoietin combined with approval for Dr. Reddy's Reditux has driven the expectation of a large market opportunity for biosimilars. Many companies have entered the space ranging from major international pharmaceutical and biopharmaceutical companies to scores of companies in emerging markets. OSG will outline the market opportunity in both developed and developing/pharmerging markets and highlight key elements required for building a success biosimilar business including; selection of therapeutic areas for development, determining the best customer segments for commercialization, developing robust clinical and regulatory plans, defining the patient experience and ensuring market access. OSG will leverage its unique insights into the decision by physicians, patients and payers to use biosimilars coupled with its team's 20 year history with biosimilar development and commercialization.