PSA08-LP

CAPTURING VALUE:
What business models are next for the biopharma world?

On Sept. 23-25, 2008, at the New York Marriott downtown in New York City, we plan to celebrate PSA’s 18th annual program that promises to make this year’s event our best ever.

Pharmaceutical Strategic Alliances is simply where you will meet the most important people in the business. This year, the theme is Capturing Value: What business models are next for the biopharma world?

Even the optimists in the pharma and biotech worlds don’t see much future for business-models-as-usual. They may not agree on the model – but they agree that what they’ve got isn’t right. The 2008 PSA Conference focuses on what’s next for the broader biopharma worlds – models that break down the walls between Big Pharma, biotech and spec pharma pipelines, and open up the financing opportunities to a much broader investment audience. PSA looks at these innovative ways of developing medicines and capturing value. You can expect to hear all of this and more at the 18th annual PSA!

Our agenda to date

The New Business Models: What’s Possible?
What we’ve got isn’t working. So what could we have? This groundbreaking analysis will look at some of the radical possibilities Pharma should be considering – as well as the shareholders and management implications of these dramatic changes.

McKinsey & Co.

Exit/No Exit: Alliances in an Era of M&A Dreams?
Stephen H. Sands / Managing Director, Lazard Capital Market (chairperson and moderator)

As we wrote in the April IN VIVO, investors don’t like alliances, especially ones that force early stage companies to give up development rights. Under what conditions — if any — are alliances accretive?

Download IN VIVO article here FREE

Kenan Turnacioglu, PhD* / Managing Director, Duquesne Capital Management: What Investors Like and Don't Like in Big Pharma Deals
Ad Rawcliffe / Senior Vice President, Worldwide Business Development, GlaxoSmithKline: Why GSK Adds Value
Martin Tolar, M.D., Ph.D / Chief Business Officer, CoMentis: Why the Astellas/CoMentis deal is truly accretive

Has Roche Killed the Roche-Genentech Model?

The Roche/Genentech relationship has been the most admired relationship in the history of biotech. But does Roche's move to acquire its junior partner ring the death-knell for the model? In any event, biotech still faces huge funding challenges and pharma huge pipeline deficits – problems that the Genentech/Roche model seemed almost uniquely able to solve. So is Roche’s move the natural end of a relationship that could only work temporarily – but which can be duplicated by other companies? Or was something inherently wrong or too risky about the model, which after all has never been duplicated? This panel brings together a group of highly successful biotech executives who have wrestled with all the financing and dealmaking problems to address the questions.

John Mendlein / Executive Chairman, Fate Therapeutics & Former CEO, Adnexus Therapeutics
Rick Winningham / President and CEO, Theravance
George Scangos / President and CEO, Exelixis
Peter K. Wirth / Executive Vice President, Legal & Corporate Development, Genzyme Corp.

Two Views of the Successful Pharma: Focus (Bristol-Myers Squibb) vs. Diversification (Novartis)
Bristol, once one of the most diversified of companies, has been shedding non-prescription pharma businesses (Convatec, Mead Johnson, OTC) and out-partnering primary-care programs, in order to narrow its focus on specialty medicines. Novartis is going the opposite direction: convinced it can win both in the high-value specialty markets like oncology but also making big bets in consumer medicine and devices, like its Alcon investment.

Jeremy M. Levin, PhD / Senior Vice President, Strategic Transactions, Bristol-Myers Squibb

Revitalizing Big Pharma R&D
Roger Longman, Managing Partner, Windhover Information (moderator)

A no-holds-barred discussion of the incremental and radical new approaches executives are now discussing to transform how R&D is done in Big Pharma – from out-partnering and development networks to external project financing.

Martin Mackay / President, Global Research & Development, Pfizer
Steven Paul MD / President, Lilly Research Laboratories
Paul Stoffels PhD / Chairman, Worldwide R&D, Johnson & Johnson

FDA in 2009 and Beyond: What Will Change, and What It Means for Dealmaking
How pharma companies are reevaluating their BD strategies in the wake of reimbursement challenges and an ever more safety-conscious FDA.

Michael McCaughan, Senior Editor, The RPM Report
Mervyn Turner / Senior Vice President, Worldwide Licensing & External Research, Merck
Thomas Hofstaetter / Senior Vice President, Corporate Business Development, Wyeth
Gino Santini / Senior Vice President, Corporate Strategy & Policy, Eli Lilly & Co.

State of Alliances Address
Deal Trends and Strategic Opportunities

Roger Longman, Managing Partner, Windhover Information

Financing the Pipeline
Everyone’s feeling the budgetary pressures on R&D – big and small companies. Investors are proposing a variety of solutions, many of which leverage corporate assets the market isn’t otherwise valuing – like future and current royalty streams. We’ll discuss some of the most interesting structures and the pros and cons of pursuing them.

Richard Smith / Partner, Edwards, Angell, Palmer & Dodge
Lionel Leventhal / General Partner, Paul Capital Partners
William Robb / Vice President, NovaQuest (Quintiles)
Ian Smith / CFO, Vertex

Biologics: The Convergence of Follow-ons and “Me Betters”
Start-ups developing platform technologies to produce so-called "biobetters”, essentially second-generation biologic products, have been hot acquisition candidates. For many pharma companies, the biologics opportunity is in taking novel, protected technology and using it to attack an already well-validated target to create a new molecule, though one that is significantly de-risked. But how different is this strategy from the one Teva plans to employ now that it has brought CoGenesys into its fold?

Kate Rawson / Senior Editor, The RPM Report: Regulation, Policy & Market Access; FDA Bureau Chief, FDC-Windhover
Stephen Kaldor / CEO, Ambrx
Ken Cacciatore / Managing Director and Senior Research Analyst Pharmaceutical Research Group, Cowen & Co.

China: Pharma’s Opportunity
As pharma looks to broaden its capabilities beyond its four walls, companies are looking east to China. Already many companies are taking advantage of cheaper labor costs, outsourcing chemistry to established CRO players such as WuXi PharmaTech. But accessing cheaper labor is just one reason multi-nationals want to build presence in China. The other main reason: This is one of the fastest — if not the fastest — growing markets for pharmaceuticals. Expect to see more “In China, For China”-type strategies, where pharma companies focus on diseases with high prevalence in that country.

David DeMarco PhD /Principal and Global Pharmaceutical Account Leader, Ernst & Young (moderator)
Xiaolin Zhang / Head, AstraZeneca China Innovation Center
Mark Lotter / President & CEO, NovaMed Pharmaceuticals
Jonathan Wang, PhD / Managing Director-Asia, OrbiMed
Samantha Du / President, Hutchinson MediPharma
James Huang / Partner, Vivo Ventures

Remaking the Commercial Model
It just won’t work any more: the traditional Big Pharma commercial model is way too top heavy not merely for the kinds of drugs Big Pharma is developing, but also for most of the drugs they’re in-licensing from biotech. A lively discussion not merely on what the model is evolving to – but how it’s going to evolve in the first place.

Adam Schechter / President of US Human Health, Merck & Co.

* invited

FREE WORKSHOPS included with your registration!

Transforming Pharma’s Business Model to Ensure Success
Sponsored by IMS Health
After years of prosperity, growth and profitability, and some of the most staggering scientific discoveries, the pharmaceutical industry has entered an era of unprecedented turmoil, driven by change in technologies, competition, economics and public policies. All have had a significant impact on the industry value drivers and industry leaders must adapt quickly to survive. The pharma business model in unambiguously broken and no clear template for success has evolved. In this workshop session, IMS will:

Provide an overview of today’s market environment and how the top organizations are responding
Compare and contrast current pharma business models of the largest companies and the winning business model of tomorrow
Discuss the pockets of opportunity – emerging markets, specialty, consumer health and generics
Provide key insights for driving a fundamental market shift through the delivery of whole product solutions, cost reengineering, and a improved commercial efficiencies

Jerry Cacciotti / Vice President, Portfolio Strategy, IMS Health

Phase II Baby Boom: Can the Industry Afford to Develop the Next Generation of Late-Stage Products?
Sponsored by Campbell Alliance

If there is a bright spot in the industry pipelines, it's in the early stages. Over the past five years, the pharmaceutical and biotech industry has made vast investments in early-stage technologies and committed unprecedented resources to the development of products aimed at new targets and pathways. Millions of dollars later, the industry is ripe with a surprising flourish of phase II compounds in development. It will be some time before we learn whether these compounds will overcome their clinical and regulatory hurdles. However, if this generation of phase II products is at least as effective as its predecessors, success rates will overwhelm budgets for phase III investment.

In moments of candor, most development executives will admit that portfolio prioritization remains as much art as science. The best available information is used, but there is always a wish that more facts had been available. The resulting worry about “the one that got away” keeps development executives awake at night. More hard calls about phase II assets could mean more sleepless nights in the near future.

Fortunately, a range of alternatives is emerging for dealing with the Phase II Baby Boom. Companies are packaging assets, capturing venture investment, and spinning out new companies. Others are applying “rapid review” development processes to cost effectively learn more about their phase II assets. Still others have employed models in which they license products to companies with development activities to companies in low-cost countries—and hold on to rights to recapture the assets if they perform well.

During this interactive workshop, senior executives will discuss the broad impact of the Phase II Baby Boom and answer questions including:

Is there quality among this next generation of pipeline products?
Have companies developed new screening approaches to better inform decisions to move to phase III?
What innovative models are being used to help companies hold on to value when they can’t afford to develop an opportunity?
What makes a spin-out model successful? What are the pitfalls?
What types of clawback provisions are acceptable to investors?
Why engage in a licensing program rather than just contract with a CRO in a low-cost country?

Ben Bonifant / Vice President, Business Development Practice, Campbell Alliance (moderator)

Al Altormari / Former Chief Executive Officer, Barrier Therapeutics (now Stiefel Laboratories)
Paul Biondi / Vice President, R&D Operations, Bristol-Myers Squibb
Eric Nelson, Ph.D. / Global Head, Business Development Marketing and Strategy, Advinus Therapeutics

THE MOST senior level case studies for dealmaking and strategy

Network with the most important people in the business!

Maximize your strategic alliance opportunities by hearing CEOs, senior R&D and senior business development executives who share lessons learned, practical advice and strategies on how to build your R&D pipeline-both internally and externally.

By attending PSA, you can:

Meet your potential partner and find out how to approach them

Understand externalization models and see if your approach would fit your potential partner's positioning

Benchmark your deal-making strategy against what your competitors are doing and why

Learn about the deal values and deal specifics to calibrate dealmaking metrics

And as always, you’ll be able to network and exchange ideas with an elite group of your peers, your colleagues, your partners and your competitors.

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18th Annual Pharmaceutical Strategic Alliances

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MEET the TEAMS
from these attending companies to date:

4-Antibody AG
Abbott Laboratories
Ablynx NV
ActoGeniX NV
Adnexus Therapeutics
Affectis Pharmaceuticals AG
Agile Therapeutics Inc.
Aisling Capital LLC
Allergan Inc.
Allos Therapeutics Inc.
Alseres Pharmaceuticals
Alvine Pharmaceuticals
Alzheimers Institute
Ambit Biosciences
Ambrx Inc.
Amgen Inc.
Amicus Therapeutics
Amira Pharmaceuticals Inc.
Amylin Pharmaceuticals Inc.
Anesiva Inc.
Angelini Pharmaceuticals Inc.
Anthera Pharmaceuticals Inc.
Antisoma PLC
APG Investments
Arana Therapeutics
Arena Pharmaceuticals Inc.
ARYx Therapeutics
Astellas
AstraZeneca
AstraZeneca Canada Inc.
Bain Capital
Battelle Ventures LP
Baxter
Bayer Healthcare Pharmaceuticals
Bayer Schering Pharma AG
Bayhill Therapeutics Inc.
Biolex Inc.
BioLineRx USA Inc.
Bioniche Pharma
BioSante Pharmaceuticals Inc.
Bracco Diagnostics Inc.
Bridge Laboratories
Bristol-Myers Squibb Co.
Campbell Alliance Group
Capital Royalty
Ceregene Inc.
Cerenis Therapeutics SA
Chaucer America Inc.
Chugai Pharmaceutical Co. Ltd.
Cipher Pharmaceuticals Ltd.
Citi Smith Barney
CJ CheilJedang Corp.
CombinatoRx
CoMentis Inc.
Covidien
Cowen & Co. LLC
Crucell NV
CyDex Inc.
Dainippon Sumitomo Pharma America Inc.
Decode
deCODE chemistry & biostructures
Dicerna Pharmaceuticals Inc.
Duquesne Capital Management
Edwards Angell Palmer & Dodge LLP
Eisai Inc.
Eli Lilly & Co.
Elusys Therapeutics Inc.
Endo Pharmaceuticals Inc.
Enzo Therapeutics Inc.
Essex Woodlands Health Ventures
Ethypharm
Eurand
Evoke Pharma
Evotec
Exelixis Inc.
Expression Genetics Inc.
Forest Laboratories Inc.
Frazier Healthcare Ventures
Genentech
Generans Bioventures
Genzyme Corp.
GlaxoSmithKline
Glycomimetics
Golden Biotechnology Corp.
Hana Biosciences Inc.
Hovione
Human Genome Sciences Inc.
Hutchison Medipharma Ltd.
Hydra Biosciences Inc.
ImClone Systems Inc.
IMS Health
In Silico Biosciences Inc.
Indevus Pharmaceuticals
Infinity Pharmaceuticals Inc.
Innate Pharma
InNexus Biotechnology Inc.
Inotek Pharmaeceuticals
Intercept Pharmaceuticals
InterMune Inc.
Ironwood Pharmaceuticals
JARO Biosciences LLC
Jazz Pharmaceuticals Inc.
Jerini Ophthalmic
Johnson & Johnson
Johnson & Johnson Development Corp.
KAI Pharmaceuticals
KaloBios Pharmaceuticals
Laboratorios Almirall S.A.
Latona Life Sciences Inc.
Lazard Capital Market
Lexicon Pharmaceuticals
Licensing Executives Society
LifeCycle Pharma
Lilly Singapore Centre for Drug Discovery Pte. Ltd.
Lux Biosciences Inc.
MannKind Corp.
Marcadia Biotech
McKinsey & Co.
Medarex Inc.
Medco Health Solutions Inc.
Merck & Co. Inc.
Merck Research Laboratories
Meritage Pharma Inc.
Millennium Pharmaceuticals Inc.
MolMed SpA
Montgomery & Co.
Mpex Pharmaceuticals Inc.
Neurocrine Biosciences Inc.
Neurokos
New York City Economic Development Corp.
NKT Therapeutics Inc.
Nova Quest
NovaMed Pharmaceuticals Inc.
NovaQuest
Novartis Pharma AG
Novartis Pharmaceuticals Corp.
Novo Nordisk A/S
Novo Nordisk Inc.
NuPathe
Nuvo Research Inc.
Nycomed GmbH
NYU Medical Center
Onyx Pharmaceuticals
Orbimed Advisors LLC
OSI Pharmaceuticals Inc.
Osprey Pharmaceuticals Ltd.
Ovation Pharmaceuticals Inc.
Path Finder Diagnostic Ltd.
Paul Capital Partners
Pfizer Global R&D
Pfizer Inc.
Portola Pharmaceuticals
Pozen Inc.
Prospect Venture Partners
Protein Pathways
Proteolix
Purdue Pharma LP
QuatRxPharmaceuticals
Quintiles Inc.
Reckitt Benckiser Pharmaceuticals
Regeneron Pharmaceuticals Inc.
Rib-X Pharmaceuticals Inc.
Roche
ROXRO Pharma
RXi Pharmaceuticals
Salix Pharmaceuticals
Sangamo Biosciences
Sanofi Aventis
Sanofi Aventis Singapore PTE Ltd.
Schering-Plough Corp.
SciDose LLC
Sequel Pharmaceuticals Inc.
Shire Pharmaceuticals
Signum Biosciences Inc.
Sirtris Pharmaceuticals Inc.
Skyepharma Inc.
Solvay Pharmaceuticals Inc.
Stiefel Laboratories Inc.
Supernus Pharmaceuticals Inc.
Sutro Biopharma Inc.
Symphogen A/S
Synergy America Inc.
Talecris Biotherapeutics
Targacept Inc.
The Invus Group LLC
Theravance Inc.
Tragara Pharmaceuticals
Transcept Pharmaceuticals
Transport Pharmaceuticals
Trubion Pharmaceuticals Inc.
Upsher-Smith Laboratories Inc.
Vatera Capital LLC
VentiRX Pharmaceuticals
Vertex Pharmaceuticals Inc.
Victory Pharma
Vifor Pharma Aspreva
Vitae Pharmaceuticals
Vitreoretinal Technologies Inc.
Wolfe Laboratories Inc.
Wyeth Pharmaceuticals

SPONSORSHIP OPPORTUNITIES AVAILABLE

PSA is where you will reach the largest concentration of senior level CEOs, business development and R&D executives. If you wish to showcase your core competencies to this audience, strengthen existing relationships, and position your company as a market leader, choose a tailored sponsorship package that meets your corporate objectives. For sponsorship opportunities, please contact Collette McMullen at (707) 773-3623, or cmcmullen@windhover.com.

Global Sponsors:
Lazard / Edwards, Angell, Palmer & Dodge

Gold Industry Sponsor:
McKinsey & Co.

Silver Industry Sponsors:
Merck & Co.
Astra Zeneca
NovaQuest
Johnson & Johnson

Event Partner:
Pfizer Inc.

Workshop Sponsors:
Campbell Alliance / IMS

Major Supporting Publications:
IN VIVO: The Business & Medicine Report™
Start-Up: Emerging Medical Ventures™
The Pink Sheet

Association Sponsors:
LES
NYBA

Media Sponsors:
Current Partnering
Report Buyer
European Life Science pharmalicensing.com
CanBiotech

Supporting Organization:
Defined Health