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Tuesday, March 25
7:00am Registration (Open until 5:30pm)
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8:00 Plenary Keynote Introduction
 Harry Glorikian, Managing Partner, Scientia Advisors
8:15 Diagnosing the Disease: Disruptive Innovation in
Healthcare
 Clayton M. Christensen, DBA, Robert and Jane Cizik Professor of Business Administration, Harvard Business School
In the absence of the ability to precisely define a disease, the care of patients is best undertaken by highly skilled professionals, whose intuition is based on deep experience. This describes the history of health care, and we call this the practice of intuitive medicine. Molecular biology holds the promise of transforming medical practice into a new phase that we call precision medicine. It promises to dramatically reduce cost and increase the predictable effectiveness of therapy. |
9:45 Coffee Break
Partnering considerations are integral to an emerging life science company's business strategy. CHI's Biotech Pharma Partnership provides companies with a unique opportunity to gain insight into how to successfully initiate, negotiate, and maintain a partnering agreement. This one-day, intensive workshop will identify best practices for effective partnership. Through instructive lectures and interactive panels, a faculty of seasoned professionals will provide vital 蘔ow-to�Einformation and advice.
Confirmed Faculty:
Michael T. Clark, Ph.D., Senior Director, Strategic Alliances, Pfizer Global Research and Development
Teresa N. Faria, Ph.D., Associate Director, Alliance Management, Bristol-Myers Squibb
Christine T. Fischette, Ph.D., Head Negotiation, Neuroscience Business Franchise Board, Global Business Development and Licensing, Novartis Pharmaceuticals Corporation
Stefanie A. Hansen, J.D., Director, Strategic Alliances, Pfizer Global Research and Development
John P. Iwanicki, Esq., Senior Partner, Banner & Witcoff, Ltd.
William F. Mongan, Executive Director, Healthcare Innovation, AstraZeneca
G. Garrett Vygantas, M.D., Senior Associate, Burrill & Company
10:15 Opening Remarks
10:25 Partnering for a Healthier World
Michael T. Clark, Ph.D., Senior Director, Strategic Alliances, Pfizer Global Research and Development
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Why partner?
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What does Pfizer partner for?
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Who does Pfizer partner with?
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What process do we go through to partner with a 3rd party?
10:55 Negotiating the Partnership
William F. Mongan, Executive Director, Healthcare Innovation, AstraZeneca
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Due diligence
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Term sheets
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Negotiations
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Contracting/writing
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Structuring the deal
11:40 Networking Coffee Break
12:00pm Title TBA
G. Garrett Vygantas, M.D., Senior Associate, Burrill & Company
12:30 Avoiding IP Surprises
John P. Iwanicki, Esq., Senior Partner, Banner & Witcoff, Ltd.
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Due diligence before collaborating
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Joint collaboration agreements and sorting out who owns what
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Material transfer agreements and reach through rights
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Licensing know-how and show-how
1:15 Lunch on Your Own
2:30 Opening Remarks
2:35 Recent Case Studies
Speaker TBA
3:05 Alliance Management: How Can Large and Small Companies Work Together?
Teresa N. Faria, Ph.D., Associate Director, Alliance Management, Bristol-Myers Squibb
3:35 Adapting to a Shifting Industry: How Are Deals Evolving?
Stefanie A. Hansen, J.D., Director, Strategic Alliances, Pfizer Global Research and Development
4:05 Networking Refreshment Break
4:25 Interactive Panel Discussion, Q&A with Faculty
Advisors
Speakers take the floor to field your questions, which may include those related to:
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Preparing for a partnership
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Approaching big pharma
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Presentation essentials
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Realistic expectations
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Managing risk
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Navigating IP territory
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Structuring the deal
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Managing the partnership over time
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Unwinding an alliance
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Commercialization and market positioning
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...and more!
5:25 Closing Remarks
5:30 Close of The Biotech Pharma Partnership
Wednesday, March 26
7:00am Registration (Open until 5:30pm)
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8:00 Plenary Keynote Introduction
 Edward G. Heidig, General Counsel and Deputy Secretary, Business, Transportation and Housing Agency
8:10 Risk Diagnosis for Disease Prevention
 C. Thomas Caskey, M.D., F.A.C.P., Director and Chief Executive Officer, Brown Foundation Institute of Molecular Medicine, University of Texas Health Science Center
There are an increasing number of presymtomatic diagnostic options which include: genetic, imaging, and analyte technology. Examples of linking a specifi c diagnostic to a therapeutic decision and FDA approval have fueled the activity for personalized medicine. It must be appreciated that diagnos-tic capacity emerges far more rapidly than an approved safe therapeutic. Thus the personalized medicine goal has a bottle neck for broad utility. A strategy of studying approved drugs for maximal effi cacy is realistic and reasonable toward that goal since it is estimated that many approved drugs are effective in less than 50% of patients. These approaches will be discussed.
8:55 Disruption of the Pharmaceutical Industry: Moving from Products to Solutions
 Theodore J. Torphy, Ph.D., Corporate Vice President & Head, Science & Technology, Johnson & Johnson
The pharmaceutical industry is bracing itself for a period of unprecedented challenges. This new era for our industry is being brought on by the confluence of several environmental factors, both internal and external to the industry, including; 1) non-sustainable increases in healthcare expenditures, 2) spiraling costs and decreasing productivity of R&D, 3) reimbursement driven by medical and economic outcomes, and 4) the proliferation and redistribution of healthcare outcomes information. Although all of these factors threaten to disrupt our industry, it is the evolving transparency in healthcare outcomes information that represents the most unsettling threat to our current business model, as well as the largest opportunity to transform our industry. For this transformation to take place, it is imperative that we change from an industry in which the sole mission is to provide products to one that provides broader, cost-effective solutions to areas of major healthcare needs. |
9:40 Grand Opening Refreshment Break in the Exhibit Hall
11:00 Chairperson's Remarks
11:10 Valuing Discovery Platforms and Drug Candidates: Estimating NPV with Imperfect Information
Robert Freeman, Ph.D., Professor, Pharmaceutical Sciences, Texas A & M University Health Science Center
Most financial models require product candidates in a portfolio to be present before net present values can be estimated. Since emerging biotechnology companies must secure additional funding to move from discovery to development, better models are necessary to assign value to platforms and candidates. Existing models are reviewed during this presentation and modifications to existing frameworks are presented to address this issue.
11:55 Valuation Creation by Biomarkers in Product Development & Marketing
Eddie Blair, Ph.D., Corporate, Integrated Medicines Ltd
This presentation will describe the potential cash value of early decision making to a product development portfolio, with particular emphasis on the translation of biomarkers into value-adding companion diagnostic-type tests for pharmaceuticals reaching the market. Case studies will be presented.
12:40pm Q&A with Session Speakers
1:10 Walk & Talk Luncheon in the Exhibit Hall
2:15 Chairperson's Remarks
Sandor Szalma, Ph.D., Director, Discovery Informatics, Centocor R&D, Inc.
2:20 The Winding Path(ways) to Biomarker Discovery
Sandor Szalma, Ph.D., Director, Discovery Informatics, Centocor R&D, Inc.
The number of molecular platforms enabling translational research for biomarker discovery is steadily increasing. So does the plethora of algorithms and approaches aimed at interpreting the data from these different experimental modalities. We have selected a set of closely related autoimmune disorders - psoriasis, psoriatic arthritis and rheumatoid arthritis - to illustrate the challenges and possible solutions on the path towards biomarker discovery. The strengths and weaknesses of the applied informatics solutions - including statistical as well as integrative biology tools - in pharmaceutical drug discovery settings are discussed in great depth.
2:50 Predictive Response Biomarkers �ETheory and Practice
Hans Winkler, Ph.D., Senior Director, Oncology, Johnson and Johnson B.I.O.
Targeted cancer medicines have been shown to be highly effective, albeit in a limited percentage of patients in any indication. It is therefore highly desirable to be able to identify patients with high likelihood of clinical benefit from a particular treatment. Two distinct approaches will be discussed: a target expression/activity approach, as exemplified by ErbB1 and ErbB2 therapies as well as novel approaches to discovery and clinical validation of molecular profiles of tumor and blood components. The latter comprises the classification of markers based directly on patients�Ebenefit.
3:20 The Challenges of Biomarker Validation in the Clinical Setting
Stephen M. Hewitt, M.D., Ph.D., Clinical Investigator, and Chief, Tissue Array Research Program, Laboratory of Pathology, Center for Cancer Research, National Cancer Institute
There are a multitude of biomarker discovery platforms, each which produce useful but complex data. Reducing these potential clinically relevant biomarkers to clinical utility remains a bottleneck. The demands of diagnostic pathology and clinical medicine limit the utility of many potential biomarker platforms. The path toward clinical utility requires examination of analyte specification as well as assay performance to generate a useful biomarker. Routinely, assays are ported to new platforms and assays are modified to optimize performance in a clinical sample.
3:50 Expression of Genes and microRNAs as Biomarkers of Hematopoietic Stem Cell Potency
David Stroncek, M.D., Chief Blood Bank, Department of Transfusion Medicine, National Institutes of Health
CD34+ cell counts are most often used as a measure of the potency of clinical hematopoietic progenitor cell components. However, stem cells make up a small proportion of CD34+ cells and this proportion differs among various sources of hematopoietic progenitor cells. Molecular assays including gene expression profiling and microRNA expression profiling are providing more precise information that may lead to the identification of better stem cell biomarkers.
4:20 Reception in the Exhibit Hall
(Sponsorship Available)
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5:00 �E6:00 Break-out Discussions in the Exhibit Hall
Translational Science Across the Globe: Needs, Opportunities and Challenges
Paul de Koning, Ph.D., Vice President, Exploratory Development, Astellas
This breakout session will discuss whether there are cultural differences between USA, Europe and Asia in the adoption of Translational Medicine. Practical examples will be provided of experiences of implementing Translational Medicine in a Japanese company with R&D sites in Japan, Europe and USA.
Use of Biomarkers to Make Go / No-go Decisions �EAre We Ready?
Hong Wan, Ph.D., Associate Director, Clinical Translational Medicine, Wyeth Research
This breakout session will discuss how pharmaceutical companies utilize biomarker information on internal decision making for drug development programs. Issues include the validity of the biomarker, tolerance of risk and how the biomarker data should be interpreted and used.
How Translational Medicine Can Contribute to Early R&D Productivity Using a Standards of Evidence Approach
Keith Ortiz, Partner, VantagePoint Consulting Group
Understanding how scientists develop, communicate and receive evidence is critical to our success in translational medicine. In general, the pharmaceutical industry is far behind other disciplines in this understanding (e.g., behavioral sciences no longer measure success in simple 㺸bjectives vs. outcomes�Eterms). Participants in this session will learn about Standards of Evidence (i.e., what does it take for us to believe evidence?) and how SOE can be used to improve productivity in Early R&D. We will review related initiatives (e.g., the National Academies of Sciences Standards of Evidence working group, the American Evaluation Society's educational efforts) and we will discuss how Translational Medicine staff can initiate SOE discussions across Early R&D. |
Thursday, March 27
8:25am Chairperson's Remarks
Linda McAllister, M.D., Ph.D., Director, Technology Management, US Chief Technology Office, Roche Diagnostics
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8:30 Regulation of Diagnostic Tests
Daniel G. Schultz, M.D., Director, Center for Devices & Radiological Health, Food & Drug Administration
With the convergence of many scientific and technology breakthroughs, the pace of medical device innovation is accelerating, inspiring hope for better health outcomes with less invasive procedures and shorter recovery times. Cutting edge medical devices, including device-drug and device-biologic combination products, are in-creasingly incorporating cutting edge technologies that hold great promise for advancing patient care by mak-ing treatments safer, more effective, more convenient, or more comfortable. CDRH is expanding efforts to promote scientific innovation in product development, focusing device research on cutting edge science, mod-ernizing the review of innovative devices, facilitating a least burdensome approach to clinical trials, and work-ing to transform and strengthen the way it currently monitors the safety of medical devices. Effective and on-going communication among CDRH, industry, patients and clinicians is essential for fostering device innovation. Dr. Schultz will address CDRH's accomplishments, expectations and opportunities for the coming year. |
9:00 Personalized Health Care at Roche: Development of Tests for Response Prediction in Oncology
Gerd Maass, Ph.D., Head of Research & Development, Roche Applied Science
Our understanding of which compounds and indications will benefit from the application of predictive response test has increased significantly. The major challenge is gaining early access to a test which allows sufficiently accurate prediction of response and can be integrated practically and economically into clinical practice. Roche begins the search for potential response markers very early in the lifecycle of a new compound. In many cases, parallel assessment of multiple markers is required. To cope with this increasing complexity, Roche has invested in a comprehensive portfolio of cutting-edge technologies. A case study will be presented.
9:30 Disseminated Clinical Molecular Diagnostics
John L. Bishop, Chief Executive Officer, Cepheid
A number of factors are driving increasing clinical interest in utilizing molecular diagnostics including the emergence of drug resistant and virulent organisms, and the recognized need for test results in less time. There is a growing interest in expanding clinical molecular diagnostics testing capability outside of the traditional central lab setting to the emergency department, intensive care units, and the doctors office. The dissemination of clinical molecular diagnostics capability through the use of multiple system platforms will lead to a growing problem with correlation of test results with the Central Lab.
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10:00 Technology Spotlight |
Sponsored by
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10:15 Technology Spotlight
(Sponsorship Available)
10:30 Poster Competition & Refreshment Break in the
Exhibit Hall
11:30 Clinical Translation of Personalized Medicines:
Opportunities and Challenges
Munir Pirmohamed, Ph.D., Professor, Clinical Pharmacology, University of Liverpool
The ultimate aim of pharmacogenomic research is to improve the use of medicines to maximise benefits and minimize harms. The uptake of pharmacogenomics into healthcare however has been very slow and erratic. There are many reasons for the lack of clinical translation, the most important of which has been the lack of a robust evidence base that has allowed us to demonstrate clinical validity and clinical utility. The challenges and opportunities in this exciting field of healthcare will be discussed in the presentation using case studies where genetic tests have either succeeded or failed in improving drug therapy.
12:00pm Development and Commercialization of a PharmacoGenetic Companion Diagnostic to Predict Response to the Beta-blocker Bucindolol
David M. Johnston, Ph.D., Vice President LabCorp, and Chief Scientific Officer, Esoterix Clinical Trials Services
Bucindolol is a beta blocker indicated for the treatment of moderate to severe chronic heart failure. Sustained cardiac adrenergic stimulation has been implicated in the development and progression of heart failure. Release of norepinephrine is controlled by negative feedback from pre-synaptic adrenergic receptors, and the targets of the released norepinephrine on myocytes are adrenergic receptors. In transfected cells, a variant of the a2C adrenergic receptor (ADRA2C; a2C Del322-325) has decreased function, while the Arg389 variant of the adrenergic receptor b1 (ADRB1) has increased function. Studies indicate that this combination of receptor variants results in increased synaptic norepinephrine release and enhanced receptor function at the myocyte, predisposing such patients to heart failure. Clinical trial data demonstrates an association between the b1 and a2C adrenergic receptor genotypes and response to treatment with Bucindolol. This session will describe the validation of the pharmacogenetic biomarker, the development of a companion diagnostic for Bucindolol, and the unique partnership and business model created to commercialize the test with lower costs and faster timelines than traditional models.
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| 12:30 Presentation I:
Optimizing Microarray-Based Diagnostic Assays for FFPE Specimens |
Sponsored by
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Thomas Goralski, Ph.D., Vice President of Operations Expression Analysis
Raji Pillai, Ph.D., Associate Director, Clinical Programs, Pathwork Diagnostics
RNA isolated from formalin-fi xed, paraffi n-embedded (FFPE) tissues is often degraded and not amenable to mi-croarray techniques. Expression Analysis has successfully adapted its Affymetrix GeneChip?procedures for FFPE-derived specimens using NuGEN's RiboSPIA�Etechnology. This sample type also shows promise with mi-croarray-based molecular diagnostics, including the Pathwork�ETissue of Origin Test. |
1:00 Presentation II (Sponsorship Available) |
1:30 Break
1:45 Expert Panel:
ASSESSING AND CAPTURING VALUE IN COMPANION DIAGNOSTICS
(Shared session with Molecular Diagnostics)
Moderator: Jorge A. Le鏮, Ph.D., President, Leomics Consulting
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What component drives the process, the drug or the diagnostic? Where does the ownership lie?
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When a diagnostic is linked to a targeted therapeutic, how is each component valued by the diagnostic? By the pharma?
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How is the value measured by the payer? How they conduct a cost-economics study, to see how populations with or without molecular diagnostics compare?
William J. Welch, Senior Vice President and Chief Commercial Offi cer, Monogram
Biosciences, Inc.
Joseph V. Ferrara, Executive Vice President, Boston Healthcare Associates, Inc.
Kathryn A. Phillips, Ph.D., Professor of Health Economics & Health Services Research,
School of Pharmacy, Institute for Health Policy Studies, and UCSF Comprehensive
Cancer Center (tentative)
Hakan Sakul, Ph.D., Senior Director and Global Head of Diagnostics, Translational and Molecular Medicine Group, Worldwide Development, Pfizer Global R&D
2:30 Expert Panel:
PUTTING PERSONALIZED MEDICINE INTO CLINICAL
PRACTICE: Perspectives From The Stakeholders
(Shared session with Molecular Diagnostics)
Moderator: David S. Lester, Ph.D., Senior Vice President, Strategy & Corporate Development, Gene Express, Inc.
Panelists:
Brian E. Ward, Ph.D., FACMG, Senior Vice President, Development, Genomic Health Inc.
Deborah Kilpatrick, Ph.D., Vice President, Market Development, CardioDx, Inc.
Robert A. Schueren, Ph.D., Head of Diagnostics, Genentech
3:20 Plenary Keynote
4:00 Ice Cream Refreshment Break in the Exhibit Hall with BEST OF SHOW AWARDS
4:45 Expert Panel:
MEASURING DEVELOPING MARKETS
(Shared session with Molecular Diagnostics)
Moderator: Deborah C. Burgess, Ph.D., Senior Program Officer, Global Health Technologies, Bill & Melinda Gates Foundation
Panelists:
Allen L. Hammond, Vice President for Innovation & Special Projects, World Resources Institute
Giorgio Roscigno, M.D., Chief Executive Officer, FIND Diagnostics
Tala V. de los Santos, M.S., M.B.A., Commercialization Officer, Commercialization and Corporate Partnerships, PATH
Steven A. Harvey, Ph.D., Senior Quality Assurance Advisor, University Research Co., LLC
5:00 End of Conference
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