Tri-Conference 2008
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Fluidigm
Thermo
Aviva Systems Biology
Biobase
Caprion Proteomics
Expression Analysis
Ingenuity
Scientia Advisors
Theranostics Health
Tripos
Wafer GEN
CROWNBIO
Leomics Associates
PCO
BioCentury
Bio IT World
SCIENCE AAAS
TheScienteist


プレカンファレンス

プレカンファレンス - 3月25日(火)

基調講演
 Diagnosing the Disease: Disruptive Innovation in Healthcare
Clayton M. Christensen, DBA, Robert and Jane Cizik Professor of Business Administration, Harvard Business School

Clayton M. Christensen is the Robert and Jane Cizik Professor of Business Administration at the
Harvard Business School, with a joint appointment in the Technology & Operations Management
and General Management faculty groups. His research and teaching interests center on managing innovation and creating new growth markets.

Professor Christensen became a faculty member at the Harvard Business School in 1992. He is author or co-author of five books: The Innovator's Dilemma (1997), which received the Global Business Book Award for the best business book published in 1997; The Innovator's Solution (2003), also a New York Times best seller; and Seeing What's Next (2004). In addition, he has edited two case books on innovation: Innovation and the General Manager (1999) and Strategic Management of Technology and Innovation, 4th edition (2004). He presently is completing two books that examine the problems of our healthcare and public education systems through the lenses of his theories. These also will show how the problems in these industries can be resolved.

Professor Christensen's writings have won a number of additional awards, including the Best Dissertation Award from The Institute of Management Sciences; the Production and Operations Management Society's William Abernathy Award for the best paper in the management of technology; the Newcomen Society's award for the best paper in business history; and the 1995 and 2001 McKinsey Awards for articles published in the Harvard Business Review.

A seasoned entrepreneur, Christensen has founded three successful companies. The first, CPS
Corporation, is an advanced materials manufacturing company that he founded in 1984 with several MIT professors. The second, Innosight, is a consulting and training company focused on problems of strategy, innovation, and growth that Christensen founded with several of his former students in 2000. Innosight Capital, the third firm, was launched in 2005. From 1979 to 1984 he worked with the Boston Consulting Group (BCG). In 1982 Professor Christensen was named a White House Fellow, and served as assistant to U.S. Transportation Secretaries Drew Lewis and Elizabeth Dole.

第11回
バイオテック・ファーマ・パートナーシップ

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, pre-conference workshop will identify best practices for effective partnership. Through instructive lectures and an interactive panel, a faculty of seasoned professionals will provide vital "how-to" information 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 Worldwide Business 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 am Opening Remarks

10:25 Partnering for a Healthier World
Michael T. Clark, Ph.D., Senior Director, Strategic Alliances, Pfizer Global Research and Development

  • Why partner?

  • What does Pfizer partner for?

  • Who does Pfizer partner with?

  • 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

  • Due diligence

  • Term sheets

  • Negotiations

  • Contracting/writing

  • Structuring the deal

11:40 Networking Coffee Break

12:00 pm Approaching Potential Partners: How To Capture the Attention of a Potential Partner and Increase Your Chances of Securing a Deal
G. Garrett Vygantas, M.D., Senior Associate, Burrill & Company

  • Know thyself and your potential partner:
    What type of organization is your target partner, and what is their current and future corporate strategy? What are they looking for?
    What is your competitive advantage? IP position?

  • Approaching a partner: Perfecting the pitch

  • Follow-up best practices: What can help you versus put you at a disadvantage?

12:30 Avoiding IP Surprises
John P. Iwanicki, Esq., Senior Partner, Banner & Witcoff, Ltd.

  • Due diligence before collaborating

  • Joint collaboration agreements and sorting out who owns what

  • Material transfer agreements and reach through rights

  • 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

  • Designing implementable contracts

  • Setting up for success

  • Align or complement?

  • 5 key activities for effective Alliance Management

3:35 Adapting to a Shifting Industry: How Are Deals Evolving?
Stefanie A. Hansen, J.D., Director, Strategic Alliances, Pfizer Worldwide Business Development

  • Companies are reaching out more than ever to fill their pipelines

  • More competition for products and platforms

  • Biotech business plans and goals are changing

  • Deals are getting earlier -- reaching into preclinical and IND-stage compounds

  • Deals are becoming more complex

  • More use of quids/out-licensing

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:

  • Preparing for a partnership

  • Approaching big pharma

  • Presentation essentials

  • Realistic expectations

  • Managing risk

  • Navigating IP territory

  • Structuring the deal

  • Managing the partnership over time

  • Unwinding an alliance

  • Commercialization and market positioning

...and more!

5:25 Closing Remarks

5:30 Close of The Biotech Pharma Partnership

ショートコース 午前

(SC1) BIOMARKERS ARE US: INTERACTIVE SHORT COURSE ON HOW BIOMARKERS WILL IMPACT THE FIELD OF ONCOLOGY
バイオマーカー: バイオマーカーが腫瘍学の領域にどのように影響を与えるかについて議論する双方向のショートコース
Moderator: 
Jorge A. Le, Ph.D., President, Leomics Consulting
Richard A. Bender, M.D., FACP, Senior Vice President and Chief Medical Officer, Spectrum Pharmaceuticals

Experts in oncology will address the following issues:

  • What is a biomarker?

  • What does a biomarker have to comply with?

  • Where do they come from?

  • How do you validate a biomarker?

  • What is a good biomarker?

  • How do you implement?

  • Will it be reimbursed?

  • How do you market?

  • What are the next generation biomarkers?

  • Who are the industry players in this fi eld?

  • Case studies in breast, lung, ovarian, bladder cancer

  • How to form alliances?

(SC2) THE CHALLENGE OF THE BLOOD-BRAIN BARRIER ・A MEDICINAL CHEMISTRY PERSPECTIVE
血液脳関門の課題: メディシナルケミストリー（医薬品化学）の見地から

  • In this course you will learn・/font>

  • An introduction to the physiology of the blood-brain barrier (BBB)

  • Implications of the BBB for drug discovery

  • Computational methods for predicting BBB permeability

  • Analysis of compound physicochemical properties that favor BBB permeability

  • In vitro methods for predicting BBB permeability

  • In vivo methods for measuring brain exposure and/or target occupancy

  • The implications of active transport (effl ux and uptake) at the BBB

  • Case studies where structural modifi cations has lead to changes in:

a) Improved passive diffusion across the BBB
b) Suppression of passive diffusion across the BBB
c) Active effl ux or uptake

  • Prodrug approaches

  • In detail the application of one particular in vivo model (P-gp

  • Knockout Mouse) that is used extensively to study the BBB

(SC3) ADMET CASE STUDIES FROM A MEDICINAL CHEMISTRY PERSPECTIVE
メディシナルケミストリー（医薬品化学）から見たADMETケーススタディ

a) Why ADME assays in drug discovery?
b) Strategic use of in vitro ADME assays and preclinical pharmacokinetic studies in drug
    discovery
c) Current status of ADME in drug discovery and future developments

  • Solubility, Data Integration, in vitro/in vivo Correlations

a) In vitro/in vivo correlations
b) ADME QSAR models

  • In vitro Toxicity Assays That Have in vivo Relevance

a )Systems biology approach
b) Tiered assays add value
c) Predicting in vivo effects
d) The power of databases

(SC4) THE EPIGENETICS STEM CELL SIGNATURE
エピジェネティクス幹細胞の特性

(SC5) IMMUNOLOGICAL BIOMARKERS: "HOW TO" AND THREE CASE STUDIES
免疫バイオマーカー
Moderator: Eric Wakshull, Ph.D., Senior Scientist/Group Leader, Development Sciences, Genentech Inc.

10:15   HLA and T Cell Response as Biomarkers Linked to the Immunogenicity of Protein Therapeutics
Annie De Groot, M.D., Chief Executive Officer, EpiVax, Inc. and Brown University
Immunogenicity elicited by protein therapeutics can cause serious side effects in humans. We affirm that immunogenicity can be predicted and patients who are at increased risk of developing adverse immune responses can be identified using immunoinformatics tools.. We have used EpiMatrix, an in-silico epitope-mapping tool, and iTEM, an 妬ndividualized T cell epitope measure・to determine whether protein therapeutics will elicit an immune response. In a recent published case, we identified promiscuous epitopes (摘piBars・ in the C-terminal region of a recombinant fusion protein (FPX) consisting of two identical, biologically active, peptides attached to human Fc fragment. On administration of FPX in 76 healthy human subjects, 37% developed antibodies after a single injection. A memory T-cell response against the carboxy-terminus of the peptide was both predicted and observed. Promiscuity of the predicted T-cell epitope(s) was confirmed by representation of all common HLA-alleles in antibody positive subjects. And finally, as predicted by iTEM (individualized T cell epitope measure), HLA-haplotype DRB1*0701/1501 was associated with the highest T-cell and antibody response.

10:45   Case Study of GDNF: Characterizing the Immune Response Against Protein Therapeutics
Michael Moxness, Ph.D., Principal Scientist Clinical Immunology, Amgen
A case study of GDNF will be used to demonstrate a risk-based strategy for designing assays to detect antibodies against protein therapeutics. Methods to characterize isotype, subclass and neutralizing activity will be discussed. The role of non-clinical studies, T-cell epitopes, and pre-existing antibodies will also be examined in the context of clinical development.

11:15   Break

11:45   Case Study of DR 0701: Genome-Wide Pharmacogenetic Investigation of a Hepatic Adverse Event Without Clinical Signs of Immunopathology Suggests a Underlying Immune Pathogenesis
Karin Cederbrandt, Ph.D., Molecular Toxicology, AstraZeneca
One of the major goals of pharmacogenetics is to elucidate mechanisms and identify patients at increased risk of adverse events (AEs). To date, however, there have been only a few successful examples of this type of approach. In this paper, we describe a retrospective casecontrol pharmacogenetic study of an AE of unknown mechanism, characterized by elevated levels of serum alanine aminotransferase (ALAT) during long-term treatment with the oral direct thrombin inhibitor ximelagatran. The study was based on 74 cases and 130 treated controls and included both a genome-wide tag single nucleotide polymorphism and large-scale candidate gene analysis. A strong genetic association between elevated ALAT and the MHC alleles DRB1*07 and DQA1*02 was discovered and replicated, suggesting a possible immune pathogenesis. Consistent with this hypothesis, immunological studies suggest that ximelagatran may have the ability to act as a contact sensitizer, and hence be able to stimulate an adaptive immune response.

12:15   Case Study:
Assessing Immunogenicity in an Emerging Biological Class, Adnectins
Eric Furfine, Ph.D., Senior Vice President, Research & Preclinical Development, Adnexus, a Bristol-Myers Squibb R&D Company
Adnexus is leading the advancement of Adnectins, a novel, proprietary class of targeted biologics that are derived from a well-characterized, high-concentration, plasma protein, human fibronectin. Adnectin-based products offer various potential advantages as compared to traditional protein therapeutics, including speed of discovery, ease of manufacturing, and multi-functionality. Angiocept (CT-322) is an inhibitor of VEGFR-2, and is the first Adnectin in clinical trials. Angiocept has a low-risk immunogenicity profile based on clinical data to date. In addition, Adnexus has identified an early-stage, potent Adnectin that blocks an important cancer target with low immunogenic potential using a combination of our PROfusion discovery engine and Epivax in silico technology. Results of these programs will be discussed as case examples of how one can successfully manage or improve immunogenicity risks within a new biologics class.

12:45   Panel Discussion with Q&A

ショートコース　午後

(SC6) CIRCULATING TUMOR CELLS
循環腫瘍細胞
Moderator: Minetta C. Liu, M.D., Assistant Professor of Medicine and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Hospital

Insights into the Biology of Circulating Tumor Cells
John W. Park, M.D., Associate Professor, Medicine, University of California, San Francisco

Circulating Tumor Cell Applications in the Pre-Clinical Phase of Drug Development
Gerald V. Doyle, DDS, MS, Senior Director, Clinical Research, Immunicon Corp.

CTCs: A Reliable Assessment of Treatment Efficacy in Metastatic Breast Cancer
Minetta C. Liu, M.D., Assistant Professor of Medicine and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Hospital

Clinical Utility of CTCs for Prostate Cancer
Howard I. Scher, M.D., D. Wayne Calloway Chair in Urologic Oncology, Chief, Genitourinary Oncology Service, Department of Medicine, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan-Kettering Cancer Center

(SC7) CANCER STEM CELLS
癌幹細胞
Moderator: Craig T. Jordan, Ph.D., Director, Hematologic Malignancies Translational Research Program, James P. Wilmot Cancer Center and Associate Professor of Medicine, University of Rochester
School of Medicine

  • Techniques for isolating cancer stem cells

  • Methods to characterize cancer stem cells

  • Approaches for developing anti-cancer stem cells compounds

(SC8) MODELS FOR EVALUATING DRUG-DRUG INTERACTION POTENTIAL IN PRECLINICAL DEVELOPMENT
前臨床開発における薬物間相互作用の可能性評価モデル
This course will cover:

  • An overview of drug-drug interactions from the clinical perspective, withdrawn drugs and the overall impact on development

  • CYP inhibition and induction methods and in vitro/in vivo correlations

  • Transporter models and in vitro/in vivo correlations

(SC10) BEST PRACTICES FOR COMPILING A REGULATORY DOSSIER FOR REGULATORY BODIES IN INDIA: A HANDS-ON WORKSHOP
インド規制団体への申請・承認書類の準備に関するベストプラクティス: 実践的ワークショップ
Brijesh Regal, C.E.O., Apothecaries Clinical Research, New Delhi, India (Former WHO Consultant to Drugs Controller General of India, and coordinated the development of Schedule Y)
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