SCHEDULE

Please check back often for more details.

Tuesday, November 17, 2009
12:00-1:00 pm	Registration for Afternoon Workshops – Staffordshire Room
1:45 pm-5:45 pm	Workshops (included with your registration fees)
1:00-2:15	Workshop 1 How will Health Reform Impact your Biopharma Business? Plummeting deal values. Disappearing IPOs. Fewer M & As. Increasingly high hurdles for proving a drug works. You know the bad news. But help may be on the way-from an unlikely place-Washington DC. A new regulatory model is developing that may help revive the biotech business model. And health care reform holds the promise to turn the US into the world's largest emerging market. Its not just that the US market will get bigger as insurance coverage expands. Consider: Patients will likely have predictable and/or lower co-pays for expensive drugs that may have previously been economically out of reach Pharma companies could start getting paid for drugs that they once subsidized through assistance programs - in effect a price increase Health reform also promises an end to discrimination against those with pre-existing conditions We could see a regulatory pathway for follow-on biologics, including 12 years of market exclusivity Eliminate the intellectual property uncertainty for biologics players, particularly those working with highly niche products. Attend this workshop and hear about all the major changes coming your way which will likely affect how you structure your next deal and fill your R & D pipeline. Workshop Leaders: Ramsey Baghdadi Editor in Chief, The RPM Report Bureau Editor, “The Pink Sheet” Ian Spatz Founder Rock Creek Policy Group
2:15-2:45	Networking and Refreshment Break
2:45-4:00	Workshop 2 Presented by: Edwards Angell Palmer & Dodge LLP Structuring and Negotiating Pharma/Biotech Collaborative Agreements In View of Follow-on Biologics Structuring deals that incorporate follow-on biologics terms into the agreement Exploring the future regulatory pathway: what will it look like? What will be the impact on competition and anticipating competitive challenges into the agreement? Richard B. Smith, Esq. Partner, Life Science Practice Edwards Angell Palmer & Dodge LLP
4:00-4:30	Networking and Refreshment Break
4:30-5:45	Workshop 3 Campbell Alliance What Happens When You Fail: Re-assessing Your Portfolio In the Face of Clinical Trial Misses As products move through the clinical development process, many challenges and issues can derail the strategy or overall direction of a product. In fact, many products often receive negative data at some point during clinical trials, and many may even face the reality of a failed late-stage pivotal study. But what do you do when you fail? In order to successfully continue the development of a product, it is important for companies to take a step back, reevaluate their current portfolio, and determine what are the costs and risk—or chance of success—in moving this compound forward. And if you decide to move forward, do you have the available resources to do so effectively? In this session, we will explore case studies of approved products that successfully overcame development challenges on their way to market. We will compare the different considerations of smaller companies with larger companies in reevaluating their strategy, situation, and portfolio. Strategy Reevaluation Risk / Chance of Success Portfolio Analysis Cost of Moving Forward Available Resources Funding Internal External – VC or Partner Value Proposition Development Communicate Your Story Jonathon Fendelman Associate Practice Executive Campbell Alliance
6:00-7:30	Registration and Welcome Reception – Essex Ballroom Foyer All TA attendees and speakers are invited to attend our welcome reception.

Wednesday, November 18, 2009

7:30 am

Registration & Continental Breakfast – Essex Ballroom Foyer

8:20

Welcome Remarks

8:30

Opening Address - Staffordshire

Roche and Genentech: Designing and Implementing the Collaborative Model

Hear first hand the nuts and bolts of how the two collaborating business development organizations will operate, and the wider strategic planning for the entire merged organization. Find out about the types of projects, stages of development and therapeutic areas they are interested in, to the ways in which development partnerships will be arranged and partnered products commercialized. The driving force behind designing and implementing the collaborative model by which Roche and Genentech’s partnering organizations now work discuss:

Biotech, big Pharma or both?
Who to talk to about partnering
Early stage, late stage and TAs, who does what deal
Strategic priorities in the merged company
Commercializing licensed products after the merger

Wendy Diller
Co-Chief, Business Bureau, Biopharma Group
Elsevier Business Intelligence (moderator)

Mary Graves

Executive Director

Roche Pharma Partnering

Suzy Jones

Senior Director of Business Development

Genentech Partnering

9:15-10:15

Who is your Best Partner?: How Deals Differ in Various Therapeutic Areas

Is it better to do a regional deal?
What TA deals are people interested in? How they approach partnering?
What are some drivers and benefits associated with early stage vs. late stage dealmaking in the therapeutic area?
How is the company set up to filter therapeutic area deal opportunities?
Which technologies within the therapeutic area are driving the most interest and why?
Where is Big Pharma’s growing interest in biologics driving the biggest deals?

Ben Bonifant
VP, Business Development Practice
Campbell Alliance (moderator)

Michael Lytton
EVP, Corporate and Business Development
Biogen Idec

Dr. Susan Rohrer

Senior Director, External Science Affairs

Merck and Company

Gary Gabrielsen

Vice President of Business Development

Astellas US LLC

10:15-10:30

Networking and Refreshment Break – Essex Ballroom Foyer

10:30

Track 1 NEUROSCIENCE

Track 2 INFLAMMATORY/AUTOIMMUNE

Track 3 ONCOLOGY

Track 4 CARDIOVASCULAR/METABOLIC

Top 10 Projects to Watch: Most Licensable Products

The Top 10, with each area analyst explaining the selection process and criteria and briefly describing the programs and companies chosen.

10:30-11:00

Track 1 - Essex North West

NEUROSCIENCE

Matchmaking in Neuro Drug Partnering: Identifying the Right Drugs and the Right Partners

Challenges in identifying good neuro science
Market statistics and market potential
Competitive landscape
Where the most promising neuro drug programs are coming from

Harry M. Tracy, PhD, President, NI Research

Track 2 – Essex North Center

INFLAMMATORY/AUTOIMMUNE

Matchmaking in Metabolic Drug Partnering: Identifying the Right Drugs and the Right Partners

Challenges in identifying good metabolic science
Market statistics and market potential
Competitive landscape
Where the most promising Metabolic drug programs are coming from

Presented by Harris Kaplan, President & CEO, Healogix and Jun Huangpu, Cobbs Creek Healthcare, LLC

Track 3 – Essex North East

ONCOLOGY

Matchmaking in Oncology Drug Partnering: Identifying the Right Drugs and the Right Partners

Challenges in identifying good oncology science
Market statistics and market potential
Competitive landscape
Where the most promising oncology drug programs are coming from

Presented by Ben Bonifant, Campbell Alliance

Track 4 – St. George C&D

CARDIOVASCULAR/METABOLIC

Matchmaking in CV Drug Partnering: Identifying the Right Drugs and the Right Partners

Challenges in identifying good CV science
Market statistics and market potential
Competitive landscape
Where the most promising CV drug programs are coming from

Presented by Michael Rice, Senior Consultant, Defined Health

11:00-12:00

Track 1

NEUROSCIENCE

Best Practices in CNS Clinical Development

Strategies for Developing Neuroscience Advances into Viable Products

The most problematic and most exciting mechanisms now under development
Catching CNS drug issues early on: minimizing later costs and risks
CNS trial design issues: which add to cost and risk?
Designing partnerships to share risks and responsibilities more effectively—who should do what?

Harry M. Tracy, PhD

President

NI Research (moderator)

H. Christian Fibiger, Ph.D.

Chief Scientific Officer and Senior Vice President

Biovail Laboratories International SRL (BLS)

David Michelson MD
Vice President, Clinical Neuroscience and Ophthalmology
Merck Research Laboratories

Peter Høngaard Andersen, Cand.Scient., Dr.Med.

Executive Vice President, Head of Research

H.Lundbeck a/s

Betsy Garofalo M.D.

Global Therapeutic Area Leader, CNS

Astellas

Track 2

INFLAMMATORY/AUTOIMMUNE

Challenges and Opportunities of Translating Inflammatory Disease Advances into Prescribed Drugs

Your view of the most problematic and most exciting mechanisms now under development
Reviewing metabolic drug development issues early: the substantial impact on the development of the drug that might save you on cost and risk later
Practical advice on how to help minimize the cost and risk of the metabolic drug development
Why most metabolic trials are more complicated and harder to execute per patient than drug trials
Avoiding pitfalls in metabolic drug development

Harris Kaplan, President & CEO, Healogix (moderator)

Dr JC Gutierrez-Ramos

SVP and Head, Immuno-Inflammation Centre of Excellence for Drug Discovery

Glaxosmithkline

Sandy Retzky

Global Business Development

Wyeth

Dr. Joern-Peter Halle
Vice President Early Stage Licensing
Portfolio Development Merck Serono

Track 3

ONCOLOGY

Challenges and Opportunities of Translating Oncology Advances into Prescribed Drugs

Your view of the most problematic and most exciting mechanisms now under development
Reviewing oncology drug development issues early: the substantial impact on the development of the drug that might save you on cost and risk later
Practical advice on how to help minimize the cost and risk of the oncology drug development
Why most oncology trials are more complicated and harder to execute per patient than drug trials
Avoiding pitfalls in oncology drug development

Ben Bonifant, VP, Business Development Practice, Campbell Alliance (moderator)

Dimitris Voliotis

Vice President for Oncology Global Clinical Development

Bayer HealthCare Pharmaceuticals

Dr Fiona McLaughlin

VP, Research

Antisoma

Jeff Hanke

Vice President, Cancer Research

AstraZeneca

Track 4 CARDIOVASCULAR/METABOLIC

Challenges and Opportunities of Translating Cardiovascular/Metabolic Advances into Prescribed Drugs

Who's got the most exciting mechanisms now under development?
How to respond to cardioprevention
outcomes issues? Are we ready to narrow our labels?
Can we change the CV drug development process to establish earlier proof of concept and safety?
What are we going to do with all those patient samples? How will novel biomarkers be validated and become clinically useful?
Do oncology drug development models have anything to teach us?

Ed Saltzman, President, Defined Health (moderator)

Dr. Michele Mercuri

VP, Acting Head of the Dept. of Cardiovascular Medicine, Global Development

Daiichi Sankyo

Eric L. Hagestad, Ph.D.
Executive Director, Strategic Transactions
Bristol-Myers Squibb

12:00-1:00

Lunch – Essex South

1:00-5:00

1-on-1 Partnering Meetings – Essex Center

Top 10 Sessions

Track 1-Top 10 Neuroscience Projects to Watch

Track 1-Top 10 Inflammatory/Autoimmune Projects to Watch

Track 2-Top 10 Oncology Projects to Watch

Track 2-Top 10 Cardiovascular/Metabolic to Watch

1:00-1:15

EnVivo Pharmaceuticals, Inc.

HDAC inhibitor EVP-0334 for Alzheimer’s, Huntington’s

Enzo Biochem

The EGS 21 for Nash and Immune Regulations

TransMolecular

I-TM601 (Chlorotoxin) for Glioblastoma

Aryx

Budiodarone for Atrial Fibrilation

1:15-1:30

NeurAxon, Inc.

NXN-188 for migraine therapeutic

Almirall

LAS 186323 for Multiple sclerosis, Rheumatoid arthritis

AngioChem

ANG1005 for Glioblastoma

XOMA

XOMA-052 for Diabetes and Cardiovascular Disease

1:30-1:45

Allon Therapeutics

AL-108 for Alzheimer’s, frontotemporal dementia, schizophrenia

Orexo

OX 914 for Asthma, Chronic obstructive pulmonary disease, Seasonal allergic rhinitis

Ariad

AP24534 for CML, AML

Array Biopharma

ARRY 403 for Type 2 diabetes mellitus

1:45-2:00

Alexza

AZ-004 (NDA) inhalation for psychotic agitation

Allostera Pharma, Inc.

APG2305, an oral IL23-receptor inhibitor, targeting psoriatic arthritis, psoriasis, Crohn's disease, and rheumatoid arthritis

Allos

Pralatrexate for Peripheral T-cell lymphoma

TransTech Pharma

TTP 355 for Type 2 diabetes mellitus

2:00-2:15

AFRAXIS

Fragile X for Autism

Bayhill Therapeutics

BHT-3009 for Multiple sclerosis

Gloucester

Romidepsin for Cutaneous T cell lymphoma

Zafgen

Zafgen's Obesity programme

2:15-2:45

Break

2:45-3:00

Karo Bio

KB9520 preclinical oral ERbeta modulator for depression, neuroprotection

Chelsea Therapeutics

CH 1504 for Inflammation

Oncothyreon

PX-866 for Advanced metastatic cancer

Vitae

Renin inhibitor (VTP-27999) for Hypertension

3:00-3:15

CeNeRx

TriRima; selective MAO-A inhibitor for depression

Synta Pharmaceuticals
Oral, small-molecule IL-12/23 inhibitors for inflammatory diseases

Rexahn

Archexin for Pancreatic cancer

Celladon

Congestive heart failure gene therapy

3:15-3:30

Trophos

TRO19622 for ALS

LifeCycle Pharma

Tacrolimus - LifeCycle Pharma for Autoimmune disorders, Liver transplant rejection, Renal transplant rejection

Biothera

Imprime PGG for mCRC and NSCLC

Metabolex

MBX 2982 for Type 2 diabetes mellitus

3:30-3:45

Prana Biotechnology

PBT-2 for Alzheimer’s

Lexicon Pharmaceuticals

LX 2931 for Rheumatoid arthritis

Infinity Pharmaceuticals

IPI-504 for NSCLC

Alnylam Pharmaceuticals

ALN-PCS for hypercholesterolemia

3:45-4:00

Braincells

BCI-540, neurogenesis activator for depression

Cornerstone Pharmaceuticals

CPI-613 for Pancreatic Cancer

4:00-6:00

Networking Reception and Table Tops – Essex Foyer

Thursday, November 19, 2009
8:00 am	Registration & Continental Breakfast
9:00	Deal Structures that Allow Large and Small Companies to Share Risk – Staffordshire Drug development seems to have more ways of failing than ever before – scientifically, in front of regulators, and now, increasingly, at the reimbursement stage. As drug companies increase their attrition estimates on new projects, biotechs are feeling the burden – and often find themselves signing risk-sharing deals. Some of these deals cut their upside; some actually increase it. But all of them make biotechs and their investors take on more of the program risks. This panel will talk frankly about the positives and negatives of these deals for both biotechs and pharmas, what’s likely to happen if the public market environment changes – and detail some of the most creative risk-sharing structures signed to date. Peter Wirth Executive Vice President, Legal and Corporate Development Genzyme Corporation Jeremy Levin, M.D., Ph.D. Senior Vice President, Strategic Transactions Bristol-Myers Squibb Anna Protopapas Senior Vice President and Head, Corporate Development and Strategy Millennium: The Takeda Oncology Company Charles Wilson Vice President, Global Head of Strategic Alliances Novartis Institutes for BioMedical Research
10:00-10:45	Roger Longman on Therapeutic Alliances Is Pharma the Only Game in Town for Biotech? Which recent deals predict the emerging dealmaking landscape? How are today’s companies reworking old and successful deal structures? How are pharma’s diversified and focused strategies doing? What can we expect in terms of biotech exits? Why does health-care reform and the changes at FDA tilt the field toward biotech products? Roger Longman, Managing Director Windhover Information Elsevier Business Intelligence
10:45-1:00	One-on-One Partnering Meetings – Essex Center
1:00	Lunch
2:00	Conference Concludes

* invited