Life Cycle Management of BioPharmaceuticals: An Approach and Lessons Learned for an Imperative Business Practice

In today’s biopharmaceutical industry, the need for companies to develop and implement life cycle management (LCM) plans for their portfolio is an imperative. Time windows associated with true product exclusivity are shortening, R&D investment and risk are increasing, and healthcare stakeholders (especially payers) are demanding safety and effectiveness evidence beyond the registration studies to support reimbursement and market access. Customer value perceptions are now central to a company’s ability to communicate its product positioning attributes and fully realize the unique differentiation qualities that ensure maximum product usage and reimbursement. Yet, we have found very few organizations equipped to manage this well today.

With the competitive edge evolving beyond registration studies and first-to-market regulatory approvals to requirements of performance and value in a “real world” patient population, biopharmaceutical companies must approach strategic and operational planning differently. Emerging questions and issues include: What is the value identity of our brands / portfolio? What type of evidence claims are needed to differentiate among other marketplace competitors? What is the full range of options that exist to deliver this claim? What are the anticipated pitfalls or challenges? Who needs to be involved and what are cross-functional operational models that work? What is the business case or rationale to support investment? What level of risk is acceptable and/or appropriate for our company?

This webinar will explore the role of life cycle management and our observations and experiences as they relate to “what’s worked” and “what hasn’t.” Speakers will share insights on strategic and financial objectives and goal-setting, on key functions that are typically critical to LCM planning success, on the role and value of a consistent and codified process at the enterprise-level to evaluate evidence generation options, and on common pitfalls and challenges associated with LCM strategy development and implementation. Where possible, practical applications of LCM strategy and implementation including “Best Practices” will be highlighted.

Join speakers Keith Ruark (AVOS Consulting) and Dr. Bridget Martell (BAM Consulting) as they explore these issues and answer your questions.

Speakers

Keith Ruark, Vice President, AVOS Consulting (an INC Research business)

Keith Ruark serves as Vice President within AVOS Consulting, a strategic advisory consulting business within INC Research. As a founding partner of AVOS, he has 15+ years’ experience in the healthcare industry. In his current capacity, Mr. Ruark leads the US project activity within the AVOS business. He has spent much of his career in roles and functions at the interface of the Research & Development function and commercial groups. With project experience spanning clients from large-cap to small start-up’s, life cycle management strategy has represented an active practice within our AVOS business. Mr. Ruark has led multiple engagements in the life cycle management arena, leading and facilitating activity with client and consultant teams to drive strategic and operational decision-making.

Before joining AVOS, Mr. Ruark held senior management positions within Quintiles Transnational including Executive Director positions in its investment arm, PharmaBio Development (evolved to become Novaquest and now Quintiles Capital), and in the commercial business, Innovex. Prior to joining Quintiles, Mr. Ruark was a senior consultant for The Wilkerson Group, a leading health care consultancy firm acquired by IBM. Earlier in his career, he held commercial / business development and R&D positions at Roche and Procter and Gamble (P&G). Mr. Ruark earned a Bachelor of Science degree in Mechanical Engineering from Purdue University and an MBA from Yale University.

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Bridget Martell, President, BAM Consulting

Bridget Martell is a private consultant who specializes in clinical development and medical affairs consultative services after having touched all aspects of “bench to bedside” medications development in her 12 year career. Most recently she led and built a new Medical Affairs department for Purdue Pharma, LLC where LCM strategy and implementation plans were the cornerstone for the group’s function. Prior to this, she spent 6 years at Pfizer in a number of roles of increasing responsibility along the clinical development paradigm, with her last role as the Biosimilars Medical Head in the Established Products Business Unit.

Dr. Martell began her science career at ImmunoGen, Inc., in Boston MA after completing her Bachelor of Science degree in Microbiology from Cornell University. She went on to get a Masters on Biochemistry at Boston University, an M.D. at Chicago Medical School and completed her specialty training at Yale University in Internal Medicine. Her post-doctoral training included sub-specialization in Addiction Medicine after her work as a Medical Director of an Albert Einstein College of Medicine Methadone Maintenance treatment clinic and while back at Yale as a Clinical Investigator and Robert Wood Johnson Clinical Scholar.

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