“Big Bang Ideas.”

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
• James Schaeffer, Executive Director of Licensing & External Research, Merck Research Labs
• Manuel Lopez-Figueroa, Ph.D., Vice President, Bay City Capital
• George Golumbeski, Ph.D., Senior Vice President, Business Development, Celgene Corporation
• Richard Searbrook, Ph.D., MBA, Head of Business Development, Technology Transfer, The Wellcome Trust
• Joseph Vacca, HEad of Early Success Sharing Partnerships, WuXi AppTec

Day 2 - October 11, 2013
Disruptive Innovation - The External Insurrection

"High risk - high reward bets on 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.

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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.
• Amit Agarwal, Principal Life Sciences & Healthcare, Deloitte
• Michael Lytton, Executive Vice President, Corporate Development and Strategy, Patheon
• Carl Handelsman, Managing Director, Life Sciences, CMEA

Module B - Managing Value

Day 3 - November 6, 2013
Strategic Product Positioning

“Creation of commercial value for any asset starts at the research stage and parallels the entire R&D process.”

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
• Casper de Clercq, Partner, Norwest Venture Partners
• Brian Pelkowski, Director, Marketing, Seattle Genetics
• Kuo Tong, President and Founder, Quorom Consulting

Networking Reception - November 6, 2013
Mid-Point Networking Reception | Berkeley, CA 94704     

Day 4 - November 7, 2013
Successfully Operating in a Global Regulatory Environment

“From initial product launch to re-launch, and from personalized medicine to pandemic prevention, elected officials, other policymakers and the general public, are counting on the biotechnology industry in the coming decades.”

Bringing safe and effective pharmaceutical, medical device and diagnostics products to market requires careful navigation through significant regulatory challenges in a manner that is cost effective and timely. This session will provide an overview of the global regulatory framework as well as emerging trends and enforcement within the life sciences industry. Through real world experiences and case studies, you will gain an understanding of how companies can successfully operate within the global regulatory environment across the product value chain – Research & Development, Supply Chain and Manufacturing, and Commercial as well as explore some of the gray areas of moving the product through the complex and evolving regulatory process.

Featured Topics:

• Overview of FDA and international regulatory requirements including how these agencies work together to promote public health and safety
• Promoting Innovation, Product Safety, Quality, and Compliance in Product Development
• How does a company build quality into its upstream supply chain and manufacturing operations?
• Encouraging Good Promotional Practices and Compliance in Sales and Marketing
• Panel discussion regarding emerging regulatory trends and future challenges facing the life sciences industry.

Speakers:

• George Serafin, Managing Director, Health Sciences Governance Regulatory & Risk Strategies, Deloitte & Touche LLP
• Barbara J. Cassens, FDA District Director, San Francisco
• Diane Hagerty, Vice President, Global Quality System & Process, Genentech
• Dipak Panigrahi, M.D., VP of Medical Affairs, Sucampo Pharmaceuticals
• William Gould, Partner, Holland and Knight

Module C - Growing Value

Day 5 - December 4, 2013
Deal-Maker for a Day

"How do different stakeholder's needs and roles shape the deal, the price and the commercialization pathway for a new therapy?”

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.

Networking Reception - December 4, 2013
Closing Networking Reception | Berkeley

Day 6 - December 5, 2013
CEO for a Day

"Making science into a company then scaling and selling ”

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
• Peter Hirth, Founder and CEO, Plexxikon
• Kenneth Hillan, Chief Medical Officer and CEO, Achaogen