BayBio Annual Conference 2011 Track 2: Regulatory and Commercialization
Regulatory and Commercialization Track Sponsor
Integrating Product Development and Corporate Strategies
Day 2 • April 21, 2011 • 10:00am - 11:15am
To preserve precious resources, companies too often are forced to compromise. Those concerned with containing clinical costs tend to focus on simple regulatory approval. However all too often product teams are asked to deliver more, which requires additional metrics to be included in the clinical trials which exponentially increases costs. This session will discuss the corporate and product development strategies and the potential tradeoffs: time, cost, probability of regulatory success and commercial revenue potential. This session will touch upon health economics and address a key question of how to ensure that your development strategy is consistent with your corporate strategy. It will offer smart and practical strategies that companies can deploy to align commercial, clinical and regulatory teams.
Moderator
Vivek Mittal
Manager, Health Advances, LLC
Panel Participants
John Orwin
President and Chief Executive Officer, Affymax, Inc.
Renee Tannenbaum
President, Myrtle Potter & Company, LLC.
Former CCO, Elan Pharmaceuticals, Inc.
Nassim Usman, PhD
Chief Executive Officer, Catalyst Biosciences
Understanding Payers
Day 2 • April 21, 2011 • 11:30am - 12:45pm
Private and government-sponsored healthcare reimbursement plans are quickly becoming the dominant forces in the healthcare market. The payers have the power of the purse and thus increasingly the power over which products advance to the market and which products are shelved. This is quickly becoming a key financing issue, as buyers of assets want to see the value proposition based on how the product will be reimbursed. A panel of key hospital and healthcare insurance decision makers will provide insight into their decision making process and discuss what both commercial and pre-commercial companies need to factor into their product development plans in order to reach patients and to get reimbursed.
Moderator
Preeya M. Noronha
Senior Associate, Health Care and Life Sciences Practice Group, Latham & Watkins LLP
Panel Participants
Mary Bordeaux
Principal, Mary Bordeaux Consulting
Louis Brunetti, MD, JD
Vice President Health Services and Chief Medical Officer Medimpact Healthcare Systems
Kuo Bianchini Tong, MS
President and Founder, Quorum Consulting, Inc.
Forecasting
Day 2 • April 21, 2011 • 2:15pm - 3:30pm
To enter the meeting room with a pharmaceutical suitor and to structure a commercial deal from a position of strength, life science executives need to have a clear understanding of the value of their company portfolio. Knowledge of patient population size and its needs, understanding of competition, motivation of the caregivers and expectations of payers and managed-care organizations help to predict market share and ultimately the value of the technology. Beyond data points, forecasting is about identifying the right set of assumptions and about building the right process inside your company. A panel of seasoned industry professionals will lead an in depth discussion on the best time to forecast, key reasons for forecasting and who should be forecasting. Additionally this session will discuss pricing, managed healthcare and reimbursement practices, and forecasting trends for device, diagnostic and therapeutic companies.
Moderator
David Wolter
Senior Principal, Strategy & Portfolio Analysis, IMS Health, Inc.
Panel Participants
Jennifer Bonilla, PhD
Senior Director, Market Strategy and Portfolio Planning, Genomic Health, Inc.
Daniel Parera
Vice President, Global Head of Development, Novartis Diagnostics
John Selig
Principal, Keelin Reeds Partners, LLC
Sandy Wrobel
CEO & Managing Director, Applied Strategies
Product Launch: An Integrated Approach for Success
Day 2 • April 21, 2011 • 3:45pm - 5:00pm
Early and thorough framing of key decisions during a product’s lifecycle – from early R&D through clinical development, regulatory approval and subsequent launch – is critical to the timing and overall success of the product launch and long term profitability.
Only 62% of the new therapeutic compounds met analyst’s revenue expectations for the launch year. The revenue recovery in the post-launch years dropps off precipitously when products miss their Year 1 projections, with less than a quarter of the compounds able to rebound to initial forecasts within four years, as opposed to 60% for their counterparts with successful launch years.
This session will provide insight into cross-functional integration and product launch planning by developing detailed, comprehensive commercialization plans. A panel of experienced professionals will discuss the importance of deep customer and competitor insights, contingency plans for uncertain situations, well-defined launch governance, effective project management, and comprehensive analytics/metrics to track launch progress.
Moderator
Rachael Lester
Senior Manager, Health Sciences and Government, Deloitte LLP
Panel Participants
Richard Clark
Partner, Archer Strategy
Audrey S. Erbes, PhD
Principal, Erbes & Associates
Adjunct Instructor, Intensive Life Science Business & Marketing Courses, UCSC Extension, Silicon Valley
Rob Etherington
Senior Vice President, Commercial, Actelion Pharmaceuticals
Alan Hirshman
Senior Principal, Commercial Effectiveness, Global Management Consulting Group, IMS Health
Timothy M. Ruane
Chief Executive Officer, InSite Vision Inc.
