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White Paper - August 2, 2012 - pdf
By: Deepa Dahal, MBA; John Doyle, Dr.P.H., MPH; Jeanne Hecht, MBA, PMP
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As the market for biosimilar products continues to grow, many biopharmaceutical companies trying to enter the space are struggling to overcome the unique challenges that developing such products presents. From navigating the complex global regulatory landscapes to ensuring optimal access, the development road for biosimilars is riddled with questions:
The potential demand for biosimilars certainly creates an enormous opportunity for biopharmaceutical companies. But unlike the development of progenitor biologics—or generic versions of chemical-based medications—biosimilar development and commercialization is a uniquely difficult endeavor requiring precision, stepwise planning to ensure timely regulatory approval and optimal market access.
Even those companies looking to protect the market share of a branded biologic product are struggling to adapt to the increased competition from biosimilars. In all cases, the uniqueness of biosimilars necessitates that an integrated, strategic development plan—which includes expert analysis and input on the key regulatory, commercial and clinical considerations—must be put in place in the very early stages of any biosimilar development program.
This paper explores further the following key messages:
Deepa Dahal, MBA, is Principal Consultant, Commercial Strategy, Biosimilar Intelligence Team, Consulting at Quintiles. Deepa Dahal brings to Quintiles Consulting over 6 years of marketing and strategic consulting experience within the pharmaceutical and life sciences industries. Her background lies in commercial strategy, market development, brand planning, product launch, life cycle management, and managed care contracting. At Quintiles, she has focused on developing commercial strategies for multiple clients in the biologics and biosimilar space, including innovator biologics as well as biosimilars in development. She has also played a leading role in defining Quintiles’ own global biosimilar strategy. Prior to joining Quintiles, Deepa was a Senior Consultant at both Campbell Alliance and IMS Health. At Campbell, she focused on Marketing and Brand Management strategy among pharmaceutical and biotech companies. At IMS, she worked on Managed Care Contracting and Compliance with pharmaceutical clients. Deepa has a bachelor’s degree in Business from the University of Idaho and an MBA from the University of New Hampshire.
John Doyle, Dr.P.H., MPH, is Vice President and Practice Leader for Market Access with Consulting at Quintiles. Previously, he was president and a founder of Analytica International, a global reimbursement, outcomes and market access consulting firm. He previously led the Oncology and Immunology Economics Research Group at Bristol-Myers Squibb. Since 1993, Dr. Doyle has authored over 50 original research articles and abstracts, in a variety of therapeutic areas. As a health economist and epidemiologist, he has lectured on research methodologies for academic and commercial audiences in the U.S., Canada, Europe and Latin America. He has consulted global pharmaceutical and biotech firms on strategic concerns regarding product development, pricing, reimbursement, market valuation and other commercialization issues. Dr. Doyle received a Bachelor of Science degree in Applied Economics with a concentration in the Life Sciences from Cornell University. He received a Master of Public Health degree and a Doctor of Public Health degree in Epidemiology from the Mailman School of Public Health at Columbia University.
Jeanne Hecht, MBA, PMP, is Vice President, Head of Sales and Strategic Planning for Asia. In this role Ms. Hecht is responsible for planning and implementing business development and sales strategies to increase revenues, market share and drive profitable growth. Ms. Hecht recently assumed the role of Executive Sponsor for the Quintiles Biosimilar Unit. Ms. Hecht leads a team of over forty sales executives across Australia, China, India, Japan, Singapore, South Korea, the United Kingdom, and the United States. She is a member of the Asia Management Leadership Team and resides in Singapore. Prior to assuming this role Ms. Hecht served as Vice President, Strategic Accounts, based in RTP, North Carolina responsible for the general management of five key accounts at Quintiles representing over $1 billion in backlog. In this role she was responsible for governing the assets, resources, technology, and processes required to support all trials, service lines, corporate strategy and initiatives globally. Ms. Hecht has over 20 years experience in healthcare working in various functions across academia and industry. She is a certified Project Manager and during her tenure in this capacity she successfully ran several large multiservice complex programs spanning the globe. Ms. Hecht is a graduate of the University of Michigan with Bachelors in Biology and a Masters in Business Administration.