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Novel Health Strategies to Host Webinar on Biosimilars & Biobetters: Market Access Opportunities and Regulatory Challenges


Novel Health Strategies, LLC, a leading life sciences strategy consulting firm is co-hosting webinar entitled, "Biosimilars & Biobetters: Market Access Opportunities and Regulatory Challenges” The webinar will be held at 1 p.m. EDT on Wednesday, August 17, 2011. Registration link of the webinar is:

Given the near-term loss of exclusivity for many best-selling biologics, global manufacturers are exploring the possibility of producing biosimilars or biobetters to extend product pipelines and increase availability of safe and effective lower cost products.During this webinar, panel of experts will explore the current regulatory, scientific and market access challenges facing industry engaged in developing biosimilars or biobetters.They will focus on recent US legislation, emphasizing an abbreviated regulatory pathway yet to be defined by FDA, existing EU regulatory framework and new policies implemented by global public and private payers. They will also provide case studies on lessons learned from approval, pricing and uptake of biosimilar products.Topics that will be covered include:

  • Discover global investment opportunities for biosimilar and biobetter molecules
  • Discuss manufacturing and scientific challenges and strategies for the development
  • Discuss how “interchangeability” could impact approvals
  • Lessons learned from recent launches and analogs

About the panelists:

Carolyn Finkle
VP Regulatory Consulting for North America , Catalent Pharma Solutions
Ms. Finkle has over 25 years scientific and industry experience including 15 years in management of drug and biologic development, quality and regulatory affairs for companies in the U.S. andCanada . Ms. Finkle holds a M.Sc. Chemistry from the University of Toronto, Canada and has a B.Sc. Chemistry from the University of Ottawa, Canada. She has worked in research at Stanford University , the Toronto General Hospital and spent a year as a Foreign Researcher in Chiba University , Japan , prior to her industry managerial appointments.          

Saurabh Aggarwal, PhD
Principal, Novel Health Strategies
Saurabh Aggarwal, PhD is a Principal at Novel Health Strategies. Dr. Aggarwal’s expertise areas include pricing strategy, market access, HEOR, cost effectiveness modeling and comparative effectiveness research. He has led strategy projects on several blockbuster oncology, infectious disease, inflammation, cardiovascular and rare disease products. Previously, he was at Sanford Bernstein, IMS Health and Parxel, where he led international and US based projects on drug and device products. Dr. Aggarwal has published articles on the biologics market including ‘What’s fueling the biotech engine’ series in Nature Biotech.  This series has been cited and quoted by more than hundred peer-reviewed publications.  Dr Aggarwal holds a PhD from The Johns Hopkins University, where he won two awards and patents for his dissertation research.  

Ronny Gal
Specialty Pharmaceutical Industry Analyst, Sanford C. Bernstein & Co., LLC
Aaron Gal (Ronny) is the specialty pharmaceutical industry analyst at Sanford C. Bernstein & Co., LLC, a leading independent research firm based in New York and London . Mr. Gal provides research and investment insight on specialty and generic pharmaceutical stocks to institutional clients around the world. His work has been recognized in third party surveys such as Institutional Investor and Greenwich Associates. Prior to joining Bernstein, Mr. Gal was spearheading Canon’s business development in the life sciences business. Previously, he spent six years with the Boston Consulting Group, advising clients in the Pharmaceutical and health care delivery sectors. Mr. Gal was awarded a PhD from the Massachusetts Institute of Technology and holds a B.Sc from Emory University

About Novel Health Strategies
Novel Health Strategies, LLC (“Novel Health”) is a team of experienced professionals who have expertise in healthcare strategy, research, policy, publications,  health economics and outcomes research, modeling, and pricing and market access strategy. Novel Health team has led strategy projects for majority of Top 50 pharmaceutical, biotech and device companies. Novel Health has large network of internal and external stakeholders and has published several thought leading strategy perspectives. 


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