2nd Annual Translation Medicine: Bridging Discovery and Clinical Developme

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Tony Rook
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2nd Annual Translation Medicine: Bridging Discovery and Clinical Developme

Presenting Companies Include:
AstraZeneca
Centocor R&D
GlaxoSmithKline
Hoffman-La Roche
Inspire Pharmaceuticals
Journal of Translational Medicine
Millennium Pharmaceuticals
National Institutes of Health
Novartis Research Institute GmbH
NV Organon
Pfizer

* What is Translational Medicine - Do We All Mean the Same Thing?
* Funding: The NIH's Effort to Stimulate and Promote Translational Science
* Translational Medicine: An Interactive Process between Preclinical and Clinical Investigation
* Translational Biomarkers and Molecular Profiling to Increase Success in Clinical Development
* Enabling the Preclinical Scientist and Clinician Working Relationship

PLUS

SPECIAL INTERACTIVE PANEL DISCUSSION
Reducing $900M/NCE - Translational Medicine's Potential Impact in Reducing the Costs of NCEs

Tuesday, February 28, 2006

8:00 Pre-Conference Tutorial Registration

8:30 Pre-Conference Tutorial

Bridging the Gap: Understanding and Proactively Enabling the Preclinical Scientist and Clinician Working Relationship
As organizations look to strategies that require significant interaction and
collaboration between preclinical scientists and clinicians, they are finding that the promise of those efforts often runs into a series of hard realities which, if not adequately addressed, fundamentally undermine the likelihood of success. Differences in conclusions, risk preferences and assumptions about markets /
scientific efficacy, etc. need to be fully and robustly engaged to create joint
learning and common understanding of data and reasoning paths. "Pocket veto's" and any unwillingness to fully engage or to share and consider concerns must be eliminated. Alignment among decision-makers and key constituents must be achieved. Decisions must be made in the face of uncertainty, ambiguity and
inherently non-specific decision-making criteria. Managers need to decide how best to balance the need for speed - and what can therefore feel like a need for hierarchical decision-making - with the need to set the stage for implementation - which can feel like all involved need to agree prior to making a decision. Taken together, these needs represent a formidable challenge for individuals and
organizations - handled well, they can enable breakthrough thinking, effective cross role relationship management and, ultimately, scientific and R&D success.
In this interactive workshop you will:
Learn about the key challenges and dynamics that make working together across the scientific and clinical boundaries particularly challenging
Gain a series of tools and skills that managers can use to manage their organizations through these challenges, coach others, and provide their direct reports
Discuss with peers organizational strategies for how best to bridge the gap between preclinical scientists and clinicians

Workshop Presenter
Stuart Kliman is a founder and director of Vantage Partners. He works with clients - particularly those in the Pharmaceutical and Technology industries - to help them maximize the value they get out of key, complex relationships. In addition to his work at Vantage Partners, Stuart has taught at the Harvard Program on Negotiation.

12:00 Close of Tutorial

Main Conference

12:00 Main Conference Registration

1:00 Chairperson's Opening Remarks
Giuseppe Bianchi, Professor of Renal Medicine, University Vita-Salute, San Raffaele Hospital, Milan and Scientific Director, Prassis Sigma-Tau Institute

1:15 What is Translational Medicine - Do We All Mean the Same Thing?
The definition of Translational Medicine primarily requires the following components, all targeting the goal of improving phase 2 survival through activities between lead development and proof of concept:
Translation of animal biomarker and model knowledge into predictions and decision criteria for humans
Translation of preclinical biomarkers and other types of
pharmacodynamic endpoints and assays into human assays and endpoints
Development of clinical methods that mimic animal pharmacology models to test mechanistic activity of novel compounds
Development of outcome biomarkers and linkage to outcome for mechanism and target biomarkers plus utilization of novel study designs (human experiments) to predict efficacy and safety outcomes
Bruce H. Littman, M.D., Vice President, Global Translational Medicine, Pfizer Global Research and Development

2:00 The Role of Discovery in Shaping Clinical Attrition
Models and PK/PD relationships
Human Target, pathway and mechanism biomarkers in PK/PD relationships
Animal disease and PK/PD relationships
Bridging animal model systems and human disease in discovery and development to fail compounds early
Andrew J. Nichols, Ph.D., Vice President, Discovery Project Leadership, Millennium Pharmaceuticals, Inc

2:45 Translational Medicine: an Interactive Process between Preclinical and Clinical Investigation
Challenge of confirming mechanism of action and understanding of therapeutic index for novel compounds entering clinical development
The value of translational research in early drug development when knowledge based on preclinical data can be bridged into the clinic, and when human data can be translated back to animals using validated biomarkers with both animal and human relevance
Developing a common understanding of principles with examples of bridging translational research
Using animal models to determine relative immunogenicity
Claudio Carini, M.D., Ph.D., Vice President, Global Head of Biomarkers, Global Development, L. Hoffman-La Roche Inc.

3:30 Networking Refreshment Break

4:00 Can the Following Activities be Optimally Shared between "Discovery" and "Development?"
Scale-Up and manufacturing of GMP lots of API for toxicology and clinical trials
Formulation of material for late animal studies and first human studies
Toxicology testing
ADME work in animals including asssay development
Method development and stability testing
Pre-IND meeting
IND writing and assembly
Or does it require a dedicated group?
Donald Kellerman, Ph.D., Senior Vice President, Development, Inspire Pharmaceuticals

4:45 Using data Intergration to manage knowledge between preclinical & clinical
To Be Announced

5:30 Networking Reception & ROUNDTABLE DISCUSSIONS

Roundtable 1: Translational Medicine for CNS Indications
Facilitator: Sanja Novakovic, M.D., Principal Research Scientist, Central Nervous System, Roche Palo Alto
Roundtable 2: Informatics Perspectives on Translational Medicine
Facilitator: James Lyons-Weiler, Ph.D., University of Pittsburgh Cancer Institute
Roundtable 3: Bridging knowledge between animal models and response in human patient populations
Michael Breider, Ph. D., Senior Director, Pathology, Pfizer Global Research and Development

Roundtable 4: Tomograms of proteins - a new approach facilitating translation medicine
Facilitator: Anders berg, Ph.D., Chief Scientific Officer, Sidec Technologies AB, Sweden

Wednesday, March 1, 2006

8:00 Morning Coffee

8:30 Chairperson's Opening Remarks and Roundtable Report Outs

9:00 Use of Biomarkers in Proof of Concept Trials
Exploration of novel therapeutic principles
Shifting failure earlier
Investigation of pharmacological selectivity in patients
Anton Stuetz, Ph.D., Head, Translational Medicine, Late Phase Products, Novartis Research Institute GmbH

9:45 Translational research at the molecular level using Protein Tomography
Translational medicine is being driven by pharma's need to improve R&D productivity, and especially to avoid costly late-stage failures
Drug developers need a better, earlier picture of the biology at work to determine whether the drug is doing what it is intended to do
Furthermore, the knowledge gained in model systems must apply also in human biology
Dr berg will review current status in structural biology, one of the fundamental areas for gaining a detailed understanding of molecular mechanisms in different specimen.
Anders berg, Ph.D., Chief Scientific Officer, Sidec Technologies AB, Sweden

10:30 Networking Coffee Break

11:00 The Use of Marker Endpoints in CNS Drug Development: Why Translational Science?
Set up common strategies for investigating animal and human pharmacology before initiating large-scale and long-term clinical investments: extrapolation of animal models of disease to human pathology is uncertain, and false positives and/or false negatives often occur
The relation between marker endpoint and intervention should have biologically plausible explanations: novel targets may require novel markers/models
Only reliable markers can be used to guide decisions to progress compounds to further development: understanding the reasons for clinical failures is a critical step enabling intelligent redirection of discovery efforts
Vincenzo Libri, M.D., Ph.D., Medical Director and Head of Exploratory Medical Science, CPDM & NGI CEDD, GlaxoSmithKline
11:45 Interactive Panel Discussion: Reducing $900M/ NCE - Translational Medicines Potential Impact In Reducing The Costs Of NCES
Moderator: Francesco Marincola, M.D., Editor-in-Chief, Journal of Translational Medicine & Director, Transfusion Medicine, NIH

12:30 Lunch And Learn Workshop (Sponsorship Available) or Lunch on your own

1:45 Translating Translational Science into Pharma
Integrating translational science into decision making practice
Utility of biomarkers to support our decision making process - historic examples
Keeping a lid on the biomarker hype
Organizational challenges in implementing translational science in the structure of R&D
Potential operational models for optimizing translational science
Andrew Hughes, Ph.D., M.D, FFPM, Clinical Director of Discovery Medicine- Cancer & Infection, AstraZeneca Pharmaceuticals

2:30 Funding: The NIH's Effort to Stimulate and Promote Translational Science
The NINDS funding perspective for translational science
Different Mechanisms
Supported Projects
The Anticonvulsant Screening Program - An Example of a Translation Effort in the Field of Epilepsy
Success: An example of a funded translation effort from bench to bedside in the field of Epilepsy
NIH Roadmap and blueprint activities complimenting scientific exploration and translational efforts
James Stables, Program Director, Technology Development, National Institutes of Health, NINDS

3:15 Networking Refreshment Break

3:30 Translational Biomarkers and Molecular Profiling to Increase Success in clinical development
Value of pharmacogenomic studies using preclinical models
Value of biomarkers identified from preclinical studies using relevant tissue samples
The utility of preclinical animal disease models
Xiao-yu R. Song, M.D., Ph.D., Assistant Director, Head of Biomarker/Novel Target Research, Centacor R&D Inc.

4:15 Translational Medicine through Comparative Genomics and Data Integration
In silico approaches using phylogenomics as the basis to explore differences and similarities between model organisms to explore drug effects in relation to efficacy and adverse effects
Data integration using heterogeneous datasets from whole genome approaches would allow for more insight in issues as mentioned above
The concept has been described already before by David Searls from GSK in 2003, and this project aims at bringing this concept into practice
The talk would cover the concept, the real life cases, but also show the immediate needs for changes in current data handling and storage to actually enable the pharmaceutical industry to get a hand on translational medicine.
Peter M.A. Groenen, Ph.D., Project Leader Bioinformatics & Pharmacogenetics, Department Molecular Design & Informatics,NV Organon

5:00 Close of executive forum