BioPharm America™ 2012 Program Overview

Shareholder activism doesn't just happen by accident. Companies that attract activist shareholders are companies that have become vulnerable for one reason or another—sometimes through bad management decisions or management decisions that investors don’t see as in their interest, sometimes through no fault of their own. This panel looks at several cases where companies attracted shareholder activists, including the events that led to activist shareholders becoming involved and the actual details of the back and forth involved in the proxy fights. And we'll look at the outcome of these fights and consider whether the companies and shareholders are better off.

This session is off the record and therefore not open to members of the press.

Moderator:
Karen Bernstein – Co-Founder, Chairman and Editor-in-Chief, BioCentury

• Andrew Bednar – Partner, Perella Weinberg Partners
• Jay Kranzler – Chairman Emeritus, Cypress Bioscience
• George A. Scangos – CEO, Biogen Idec
• Martin Shkreli – Chief Investment Officer, MSMB Capital Management LLC

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Win a one-to-one meeting with senior executives from big pharma. Each member of the audience will have 30 seconds to present their company or technology to a star-studded panel of pharma BD executives. The top picks will be selected for a second round that includes an additional two to three minutes of presentation and/or Q&A time with the panel. The first place winner will receive a free presentation slot at a future EBD Group meeting plus a full 30-minute private follow-up meeting with the panelist of their choice. Second place will receive a full 30-minute private follow-up meeting with the panelist of their choice.

• Participants will have only 30 seconds to pitch their company, product, technology or service to the panel.
• Participants will be judged on the quality and effectiveness of the overall pitch.
• Remember, the primary goal of an elevator pitch is to spark interest for a follow-up meeting.
• Pre-workshop coaching is available from the moderator (contact: doug@macbiocom.com).
• Practice, practice, practice!

Moderator:
Douglas MacDougall – President, MacDougall Biomedical Communications

• David Donabedian – GlaxoSmithKline
• John Gustofson – AstraZeneca
• Tomas Landh – Novo Nordisk
• Deanna Petersen – Shire
• John Sorvillo – Amgen
• Steven Xanthoudakis – Merck Canada

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Moderator:
Bruce Booth – Partner, Atlas Ventures

• George Golumbeski – Senior VP, Business Development, Celgene
• Anna Protopapas – Executive VP, Global Business Development, Takeda
• Angus Russell – CEO, Shire

As healthcare heads away from the blockbuster model towards personalized care and individualized medicine, biotech and pharma companies need to engage in nontraditional partnerships with a diverse group of players. This session will explore models for collaboration within the entire healthcare value chain. The speakers will discuss the new order among the different players in the healthcare system: biotech, pharma, diagnostics, payors, health IT and the paradigms these collaborations create for drug development and healthcare delivery.

Moderator:
Thomas Barker – Partner, Foley Hoag

• Charlie Baker – Entrepreneur-in-Residence, General Catalyst Partners
• Gary L. Gottlieb, MD – President and CEO, Partners HealthCare System
• Jose Carlos Gutierrez-Ramos – Senior VP, BioTherapeutics R&D, Pfizer

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Over the past two years the biotech business model has changed dramatically. In 2011 we have seen an upswing in VC funding, but that does not mean that biotech is back to pre-2008 "business as usual." In order to succeed in the new normal, companies have to be creative about capital efficiency and paths to liquidity. This panel will feature start-ups that have raised capital with a “lean and mean” strategy as well as larger companies that have found ways to build a sustainable business despite the economic slowdown. Panelists will discuss how to be lean but viable, how to leverage emerging markets and manage virtual teams, and how to work with investors in challenging times.

Moderator:
Dave DeMarco – North East Pharmaceutical Leader, Ernst & Young

• Alexis Borisy – Partner, Third Rock Ventures
• James O'Mara – VP, Corporate Development, Ironwood Pharmaceuticals
• John Oyler – Founder and CEO, BeiGene
• Adelene Q. Perkins – President and CEO, Infinity Pharmaceuticals
• Steve Tregay – Founder, President and CEO, FORMA Therapeutics

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Traditional valuation models are under pressure. According to the 2011 Dealmakers' Intentions Survey, many dealmakers anticipate an overall increase in the number of deals this year. While this may be true, dealmakers also recognize that several forces are driving down valuations, including price, share of patients, discount rates, and the cost of clinical trials. This combination of factors has led some large pharma in-licensors to focus more on therapeutic areas and mechanisms that are traditionally more resistant to valuation challenges—those with niche patient populations, some deemed orphan indications. Ironically, those are the exact areas where an ambitious biotech management team can envision pursuing an independent commercialization strategy. Join us for a panel discussion to understand the compelling market dynamics causing a shift toward orphan drugs and what large pharma in-licensors and emerging biotechs need to consider to remain competitive in this space.

Moderator:
Jim Hall – VP, Business Development, Campbell Alliance

• Suzanne Bruhn – Senior VP, Strategic Planning and Program Management, Shire Human Genetic Therapies
• Randall Carpenter – Co-Founder, President and CEO, Seaside Therapeutics
• Steven Laux – Senior Director, Business and Corporate Development, Discovery Labs
• Gary Pasternack – CEO, Asklepion Pharmaceuticals

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Fostering relationships with academic institutions is becoming increasingly important to big pharma, and terms like "pre-competitive collaborations" and "open innovation" are often used to characterize these partnerships. Is this the new reality of drug development and a viable model to generate innovation in the future? This panel will look at a few specific collaborations and discuss where interests among pharma and academia are aligned, and where they differ.

Moderator:
Christopher J. Denn – Partner, Life Sciences, Goodwin Procter

• Erik Halvorsen – Director, Technology and Business Development, Children's Hospital Boston
• Tomas Landh – Director, Strategy and Sourcing, Diabetes Research Unit, Novo Nordisk
• Polly Murphy – VP, Business Development, R&D, Pfizer
• Steven Xanthoudakis – Director, Licensing and External Research, Merck Canada
• Daphne Zohar – Founder, Managing Partner, PureTech Ventures

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John Carroll, Editor, FierceBiotech, will talk to several CEOs from this year's soon-to-be-unveiled Fierce 15, its ninth annual listing of the most successful private biotech companies in the industry. Industry leaders examine what it takes these days to attract venture backing and top partners in a tough financing environment.

Moderator:
John Carroll – Editor-in-Chief, FierceBiotech

• Ed Kania – Managing Partner and Chairman, Flagship Ventures
• All other panelists to be announced on September 6, 2011

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Early stage discoveries occurring in academic laboratories constitute the font of innovation for the life science industry. In fact, the innovation pipeline that the pharmaceutical industry is desperately seeking lives in the discoveries coming out of academia (funded by the government). Yet, the conversion of these early stage discoveries into clinical candidates requires attaching clinical context. This panel will tackle the alignment of current translational medicine with clinical correlates necessary to advance early stage discoveries into cost effective, safe and efficacious personalized medicine opportunities.

Moderator:
Richard P. Kivel – Chairman and CEO, Rhapsody Biologics

• Beth Anne Baber – Co-Founder and CEO, The Nicholas Conor Institute
• Mike Cooper – Chief Medical Officer, Constellation Pharmaceuticals
• Horst Domdey – Managing Director, BioM
• David Nelson – President and CEO, Epic Sciences

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The business models around personalized medicine remain opaque, driven in large part by downstream uncertainties relating to regulatory approval, healthcare reform, and disruptors to the payor system. Deal structures and valuations between diagnostics and therapeutics companies reflect this uncertainty. This panel will discuss how deal structures and valuations will potentially evolve as clarity is gradually gained over market factors.

Moderator:
Harry Glorikian – Managing Partner, Scientia Advisors

• Bryan Dechairo – Senior Director, Head of Extramural R&D, Medco Research Institute
• Lee McCracken – Former Corporate Head, Business Development, Prometheus Laboratories (acquired by Nestle Health Science)
• Chris Varma – CEO, Blueprint Medicines

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Of all the therapeutic indications, oncology has experienced the most progress in personalized medicine by taking advantage of biomarkers. The advances in oncology show that it is possible to reduce costs and risks at the front end, making an impact on overall healthcare costs on the back end by coupling better diagnostics with the right therapeutics to eliminate trial-and-error medicine. Despite this progress, setbacks abound. This panel provides an opportunity to look back, analyze and ask the simple question, "How and what can we do better in oncology?"

Moderator:
Mara Aspinall – President and CEO, Ventana, Inc. (commencing Sept. 11, 2011); Global Head, Roche Tissue Diagnostics

• Geert Kolvenbag – Global Product VP, AstraZeneca
• Kyle Kuvalanka – VP, Corporate Strategy and Development, Millennium Pharmaceuticals
• Juswinder Singh – Founder and CSO, Avila Therapeutics
• Bruce R. Zetter, PhD – Charles Nowiszewski Professor of Cancer Biology, Harvard Medical School, Children's Hospital Boston

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As the pace of technology accelerates exponentially, it pushes the limits on existing business models, regulations, and policy around personalized medicine, especially in the field of oncology. This session will explore the challenges around the introduction of next generation sequencing. On the side of industry, the lack of clear business models, and indeterminacy regarding clinical acceptance of next generation sequencing, leaves major stakeholders watching from the sidelines on where value is accreting. On the side of academia, major institutions and hospitals are becoming central aggregators of diverse clinical data sets supported by powerful bioinformatics and sequencing, making them attractive business collaborators for pharma. How will value be created for early stage algorithm-based diagnostics companies to attract investments? Will value continue to remain with therapeutics, while diagnostics are positioned as loss leaders? And in the end, on the side of partnering, will pharmaceutical companies place attenuated value on diagnostics as they partner with academia to build their PM franchises? Join this thought-provoking discussion as we consider how technological disruption around diagnostics will forge surprising business partnerships with, perhaps, unlikely partners.

Moderator:
Dan Rhodes – CEO, Compendia Bioscience

• Kevin Krenitsky – COO, Foundation Medicine
• Joseph Monforte – Executive VP and CSO, AltheaDx
• Robert J. Penny, MD, PhD – CEO, International Genomics Consortium; Founding CEO, Molecular Profiling Institute
• Dietrich A. Stephan – Founder and CEO, Institute for Individualized Health

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The final and most dramatic phase of the patent cliff coupled with the wreckage from attrition have left the pharma industry grappling with something more difficult than protecting the balance sheet. In a world so thoroughly dominated by generic medicines, pharma is now struggling just to stay relevant. Biotechs seeking to partner based on early stage data also need to focus hard on proving the unquestioned relevance of any proposed new therapy—even if data do not yet exist to support proof of concept for the program. Just as importantly, due to today's shortened capital runways, these companies will need to address the challenge of de-risking on early data in small numbers of patients, which means their knowledge of relevant biomarkers must be at least equal to that for the mechanism/target. This presentation will highlight some strategies for successfully navigating the rough waters ahead.

• Ed Saltzman – President, Defined Health

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Successful development of antiviral therapies for HIV, RSV and HCV has enabled this sector to grow toward estimated 2016 sales of around USD 30 billion worldwide. Going forward, some key issues for players and would-be players in the antiviral market include genericization of HIV agents and the potential for new MOAs in HCV and new treatments for influenza, CMV, West Nile and other insect-borne viral disorders. This panel will highlight these issues, discuss deal activity in the antiviral space and point to some potential "sleepers" in the pipeline.

Moderator:
Jeffrey M. Bockman – VP, Defined Health

• Kevin Anderson – Global Head, Virology Partnering, Roche
• Donnie McGrath – Global Head, Virology Strategic Transactions, Bristol-Myers Squibb
• Michael Robertson – Senior Director, External Scientific Affairs, Merck

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Disease-modifying therapies in MS targeting a relatively small patient population (approximately 400,000 WW with relapsing MS) achieved USD 11+ billion in revenue globally in 2010. The greatest unmet need in MS is protection and regeneration of damaged neurons to address progressive forms of the disease; however, plenty of need remains in terms of the symptoms of MS. MS-associated fatigue, cognitive dysfunction and depression are considered by many patients to be even more disabling than symptoms directly related to nerve damage. This panel will explore the pipeline compounds and approaches to address the unmet needs in MS and related comorbidities.

Moderator:
Ginger S. Johnson – VP, Defined Health

• Irina Antonijevic – Director, Clinical Research Investigational Medicine, Immuno-Inflammation, Sanofi
• R. Philip Kinkel – Director, Multiple Sclerosis Center, Beth Israel Deaconess Medical Center; Harvard Medical School
• Gilmore O’Neill – VP, MS Clinical Development, Biogen Idec
• Maurice Zauderer – President and CEO, Vaccinex

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Breakthrough therapies have transformed the management of patients with blood cancers and created blockbuster markets that have grown to represent four of the top ten oncology revenue producers, with sales for 2010: Gleevec/Glivec (USD 4.3 billion, Novartis), Rituxan/MabThera (USD 6.1 billion, Roche), Revlimid (USD 2.5 billion, Celgene) and Velcade (USD 1.8 billion, J&J). As the oncology clinical development landscape has become intensely competitive, drug developers have become increasingly interested in hem/onc as a “white space” area in which they can potentially address high unmet medical needs of niche malignancies for which standards of care are poorly established. This panel will discuss progress in hematological malignancies and benign blood disorders, investigate remaining white space areas within hem/onc and highlight promising development stage assets in the hem/onc pipeline.

Moderator:
Michael C. Rice – Senior Consultant, Defined Health

• Kenneth C. Anderson – Kraft Family Professor of Medicine, Harvard Medical School; American Cancer Society Clinical Research; Director, LeBow Institute for Myeloma Therapeutics and Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute
• Louis J. DeGennaro – Executive VP and Chief Mission Officer, The Leukemia & Lymphoma Society
• Mark Velleca – Senior Advisor, Gilead Sciences

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@EBD group has recently entered the Twitterverse! Join and interact with moderator Steve Dickman, CEO of @cbtadvisors, and a panel of social-media-savvy dealmakers in a lively roundtable discussion about using social media to help achieve your business objectives. Topics to be covered:

• "Do I link or do I tweet?" i.e., Which social media platforms are acceptable for which types of activities?
• Using data gleaned from social media to improve deal strategy
• Positioning yourself and your company through social media
• Staying on the right side of FDA in social media activities
• Etiquette for blogs, links and tweets
• The future of social media

Moderator:
Steve Dickman – CEO, CBT Advisors (@cbtadvisors)

• Bruce Booth – @LifeSciVC Partner, Atlas Venture
• Cynthia Clayton – Senior Director, Investor Relations and Corporate Communications, @Alnylam
• @adamfeuerstein – Senior Columnist, TheStreet
• @JohnCFierce – Editor-in-Chief, FierceBiotech
• @Michael_Gilman – CEO, Stromedix
• Carlos N. Velez – Managing Partner, @LacertaBio
• @daphnezohar – Founder, Managing Partner, PureTech Ventures

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Moderator:
Raju Kucherlapati – Professor, Harvard Medical School

• Murali Gopalakrishnan – Head, Global External Research, Abbott Pharmaceuticals
• Martin Mackay – President, R&D, AstraZeneca
• Philip Vickers – Senior VP, R&D, Human Genetic Therapies, Shire

Moderator:
Brock C. Reeve – Executive Director, Harvard Stem Cell Institute

• Edward Lanphier – President and CEO, Sangamo BioSciences
• Geoff MacKay – President and CEO, Organogenesis
• Garry Neil – Corporate VP, Corporate Office of Science and Technology, Johnson & Johnson
• Matthew Vincent – Director, Business Development, Advanced Cell Technology

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Moderator:
John McNeish – Founder, Boston Stem Cell

• Stephen Chang – VP, Research and Development, The New York Stem Cell Foundation
• Mitchell H. Finer – CSO, bluebird bio
• Robert J. Palay – CEO, Cellular Dynamics International
• Alan O. Trounson – President, California Institute for Regenerative Medicine
• Leonard Zon – Director, Stem Cell Research Program, HHMI/Children's Hospital Boston