UC Berkeley BioExec Institute

The UC Berkeley BioExec Institute will take place in three separate modules:

Module A: Creating Value – October 9-10, 2012

Day 1: Models of Innovation

The problem of research productivity in bipharma is well understood. Big Pharma is not seeing a return on R&D expenditure; impatient institutional investors want R&D reduced, and the cash liberated to be returned as dividend or in share buybacks. VC’s are finding it increasingly difficult to attract investors to new funds focused on innovation — the limited partners do not want to see their capital tied up in illiquid assets for long periods of time at a time of general financial uncertainty and with the IPO market remaining closed. Yet in spite of this, the rate of discovery in the biological sciences is accelerating. Resourceful investors — both strategic and financial — are looking for ways to translate discovery sciences into innovative products using new models of funding with different partners. The day will focus on discussing some examples.

Featured topics:

• Where does innovation come from
• Emerging business opportunities in healthcare
• New models of early stage innovation
• The sustainability of the biopharma business model

Speakers:

• Mervyn Turner, Ph.D., Consultant, MJ Turner Consulting
• Bernard Munos, Founder, InnoThink Center for Research in Biomedical Innovation

Day 2: Managing Innovation

A focus on innovative and/or niche models represented at specific companies which may or may not evolve into mainstream strategies. A high-level view of where current strategic investments are being made by ‘traditional’ biopharmas.

Featured topics:

• Innovative therapies and models including delivery, price-point, and product service models
• Outcomes-based contracts for specialty medications
• Virtual company models
• Innovative R&D ecosystems
• Personalizing therapies

Speakers:

• Matthew Hudes, U.S. Managing Principal, Biotechnology, Deloitte Consulting LLP
• David Kirn, M.D., Founder, President & CMO, Jennerex Biotherapeutics, Inc.

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

Speakers:

• 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

Speakers:

• George Serafin, Managing Director, Health Sciences Governance Regulatory & Risk Strategies, Deloitte & Touche LLP
• Barbara J. Cassens, FDA District Director, San Francisco
• Diane Hagerty, Genentech

Module C: Growing Value – December 6 – 7, 2012

Day 5: Deal-maker for a Day

Licensing and partnering are an integral part of the Biopharmaceutical industry. The formerly distinct pharmaceutical and biotechnology industries are merging into one interdependent Biopharmaceutical Industry. Partnered products are the future of innovation leading to a significant increase in attempts to acquire and/or license innovation from others. Big pharmaceutical companies will control fewer and fewer of their new products from discovery through line extension or OTC. This Day explores the underlying economics of deals; the different strategies for measuring risk; and how decisions are made amidst uncertainty.

Featured Topics:

• Financial trends in and pressures on the biopharma industry
• The deal market today and coming up
• The Buy-Side: What gets Big Pharma excited about an NME, regardless of who currently owns it?
• The Sell-Side: How to prepare an asset and a biotech company to get the best deal possible?
• De-risking the commercial prospects of a molecule
• How the molecule’s commercial value impacts the deal
• Success after the deal closes: Effective alliance management and post-acquisition integration issues

Speakers:

• Eric Walczykowski, Managing Director, Deloitte Recap LLC
• Gene Kinney, Vice President & Head of Research, Janssen Alzheimer Immunotherapy Research & Development
• Felix Karim, Vice President, Business Development, KAI Pharmaceuticals, Inc.

Day 6: CEO for a Day

Being CEO sounds glamorous, but is it really? When a biotech advances a project into the clinic, signs a licensing deal or announces an acquisition, there are kudos for all. But when a biotech needs to down size, discontinue a project or simply close the doors, you can be certain that the CEO is feeling the pain and probably accepting the blame. On Day 6 of the BioExec Institute you will not only have the opportunity to dialogue with some of the industries most respected CEOs who will provide detailed and candid accounts of what really happened, but you will become a CEO for the day. Using case studies, participants will have the opportunity to navigate three critical and common inflexion points for a biopharma company. This is your opportunity to be CEO for a Day.

Speakers:

• Dave Summa, Chief Business Officer, Acumen Pharmaceuticals, Inc.
• Susan M. Molineaux, Ph.D., President and CEO, Calithera Biosciences
• Troy Wilson, Past President and CEO, Intellikine
• Franz Hefti, CEO, Acumen

Information and registration at http://executive.berkeley.edu/programs/bioexec-institute.