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UC Berkeley BioExec Institute

From Wednesday, November 07 2012
To Thursday, November 08 2012
Every day

Module B: Managing Value - November 7-8, 2012
Day 3: Strategic Product Positioning
Companies often start development on new or improved products because of great technological innovations in the lab. But, ultimately, it is the market - the customer - who decides whether your product is valuable or not. Planning for commercial success starts at the research stage and parallels the entire R&D process. During this session, industry leaders will explore product commercialization, second generation products and potential exit strategies, all in an effort to determine the best way to optimize the value of innovation over time. The content in this session will range from high-level strategic trade-offs to detailed calculations of value (both quantitative and qualitative) and from debating options to understanding the path for optimizing your company's assets.
Featured Topics:
•    Critical commercial decision points during the research and development phase of drugs
•    Research and development decisions that have substantial commercial impact in the future
•    Benefits and risks associated with commercial decisions during the development process
•    Appropriate assessment of the commercial value of your asset
•    Recognizing key commercial value drivers
•    Value appropriate and relevant commercial input in the value chain
•    Gain an appreciation for the pre-launch/launch and post-launch marketing activities
•    Recognizing the critical commercial input to optimize your asset
•    Martin Babler, CEO, Principia Biopharma
Day 4: Successfully Operating in a Global Regulatory Environment
Bringing products to market requires overcoming significant regulatory challenges for the goal of delivering on the safety and efficacy of the product. This session deals with the many gray areas of moving the product through the regulatory process, and understanding the various stakeholders' goals and political trade-offs in making the decision of whether or not to approve the product. Understanding the key questions that are core to each of the stakeholders unveils the secrets to getting a drug approved and plays an important role to a company's commercialization strategy.
Featured Topics:
•    Discussion on how policy and regulation works in the FDA
•    Expand on our policy and regulation discussion using actual examples from food labeling, the approval of drugs for serious and life threatening diseases, and tobacco regulation
•    Engage participants in the current state and thinking regarding targeted therapies as a variation of personalized medicine and what it will take for adoption
•    Aspects and considerations on how targeted therapies are chosen for development and what considerations go into driving the acceptance from a policy standpoint (social, economic, and governmental) as well as the challenges faced from a regulatory standpoint for review and approval
•    Examine how companies can drive the re-launch of a product that has encountered difficulties using actual examples
•    Provide and solicit views on the future leading practices for driving product acceptance from a safety perspective
•    George Serafin, Managing Director, Health Sciences Governance Regulatory & Risk Strategies, Deloitte & Touche LLP
•    Barbara J. Cassens, FDA District Director, San Francisco
•    Diane Hagerty, Genentech


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