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Thursday, October 11

8:00 am Morning Coffee

REPROFILING DRUGS

8:30 Chairperson’s Remarks
Marcel van Duin, Ph.D., Executive Director and Head, Department of Pharmacology, NV Organon

8:40 Uncovering Unexploited Biology on Halted Drugs 
Chizuko Koseki, Ph.D., Vice President, Drug Profiling Platform Unit, Sosei Co. Ltd.
In order to look for the potential of second biological target on halted drug candidates, Sosei has established a unique business model, the Drug Reprofiling Platform. Our efforts in the last several years are giving some answers to our original questions, is there any possibility to identify a new use on halted drugs, if so, how? Can we develop it for a new indication which was originally un-identified? Our DRP business model and some outcomes will be introduced.

9:15 Repositioning at Organon - Just for Halted Drugs? 
Anja Garritsen, Ph.D., Executive Director Target Discovery, NV Organon
Repositioning at Organon started with the identification of drugs that were discontinued at various stages of the development process. Based on this compound list, we established a number of collaborations with repositioning companies. This allowed us to exploit a range of philosophies and technologies and explore the possibilities in various therapeutic areas to the fullest. Currently, the concept of exploring the full therapeutic potential of our compounds, also in earlier phases of discovery, is catching on. Efforts range from cross-screening sets of compounds on a variety of targets to a focus search for new indications for compounds. 

9:45 CIPRO: The Creation of a New Blockbuster 
Hans-Joachim Zeiler, Ph.D., Consultant, Innovation, Bayer/HighTech Private Equity 
Ciprofloxacin was identified in 1981 as a new, highly attractive antimicrobial agent. The use of knowledge about properties of older drug classes and the creation of a chemical niche allowed Bayer to build in new properties into such a molecule which made it useful for the treatment of severe systemic infections. This drug became one of the biggest successes in the field of antimicrobial therapy.

10:15 Poster Session, Exhibit Viewing and Coffee Break

10:45 Drug Repositioning Using a Multiplexed in Vivo Platform: Discovery of MLR-1023, A Repositioned Drug Candidate for Type II Diabetes
Michael S. Saporito, Ph.D., Vice President, Research, Melior Discovery Inc.
We have developed a unique repositioning approach involving a platform comprised of multiple in vivo models representing diverse therapeutic areas. The power of this platform is illustrated by our lead compound, MLR-1023. This compound, originally developed for ulcers, exhibits robust activity in a panel of clinically relevant models of type II diabetes and is currently being developed for this indication. Of importance was the identification of a previously unknown molecular target for type II diabetes. This example of Melior Discovery’s approach demonstrates the potential for capturing new indications from existing molecules, and the potential for expanding our understanding of the underlying biological basis of disease.

11:15 Panel Discussion: IP and Practical Issues of Drug Repositioning and Repurposing
Moderator: Kevin Davies, Editor-in-Chief, BioIT World

  • Strategies for partnering, gaining patent protection and freedom to operate
  • Cultural and organizational obstacles in repositioning and repurposing
  • Best practices and success stories for gaining approval

Additional Panelists 
Donald E. Frail, Ph.D.
Thomas Barnes, Ph.D.
Richard B. Smith, Partner, Technology Group, Edwards Angell Palmer & Dodge LLP 

12:00 Luncheon Workshop (Sponsorship Available) or Lunch on Your Own

SCREENING AGAINST MULTIPLE TARGETS
(Shared Session with Compound Profiling)

1:30 Chairperson’s Remarks

1:40 Featured Presentation
Is Repositioning a Viable Option for Creating Differentiated Medicines?
Lee E. Babiss, Ph.D., Global Head, Pharma Research, Roche Inc.
  • How do we create internal buy-in for this concept and how do we establish partnerships with biotech and academia to create a case for investing in repurposed drugs?
  • What are the best wet-lab and in silico technologies that can be applied to identify new disease indications for promising drugs?
  • Once the data suggests a new way forward, how can we make such assets a high priority in our companies and/or use these to gain access to other types of external innovation?

2:15 Automated Robotic Molecular Profiling in Cells for New Therapeutic Directions
Jeremy S. Caldwell, Ph.D., Director of Molecular and Cell Biology, Genomics Institute of the Novartis Research Foundation 
Small molecule cross reactivity against multiple targets can simultaneously afford broad therapeutic utility and problematic non-specific effects in man. Quantitative methods to rapidly characterize molecules in a broad array of cellular assays would reveal the range of functions associated with small molecules and impart a more thorough profile of drug candidates early in the drug development process. Here we describe a high-throughput approach to discover the multiple activities of small molecule libraries analyzed in parallel against a broad array of phenotypic cellular assays, and the robotic infrastructure necessary to perform these measurements.

2:45 Poster Session, Exhibit Viewing and Refreshment Break

3:15 An Efficient Platform for Genetic Target and Compound Positioning
David Grass, Ph.D, Vice President Scientific Operations, Caliper Discovery Alliances and Services, Caliper Life Sciences
Given the challenges facing the biopharmaceutical industry, including
increased drug discovery and development timelines, fewer IND and NDA submissions per R&D dollar investment, and diminishing drug exclusivity timelines, it has become extremely important to identify potential indications for both genetic targets and compounds as early and as efficiently as possible. Caliper Discovery Alliances and Services (CDAS, Xenogen Biosciences) has created a broad platform which uses mice to comprehensively characterize genetic targets and compounds. This platform utilizes in vivo assays that are relevant to most of the major therapeutic areas. For genetic targets, this platform allows for efficient target validation and early positioning of potential therapeutics. For compounds, this platform identifies unanticipated “pre-positioning” opportunities for earlier stage compounds as well as repositioning opportunities for existing therapeutics and clinical development compounds.

3:45 Characterizing the Multiple Activities of Kinase Inhibitors 
Petra Ross-Macdonald, Ph.D., Senior Research Investigator,Applied Genomics, Bristol-Myers Squibb Co. 
Using a novel approach to identify genes that exhibit dose-responsebehavior, we can examine compound potency, selectivity, on- and off-target activities, and underlying biology across the therapeutic doserange. This strategy is being employed to identify distinct activitieswithin and between compounds.

4:15 Ceftriaxone and Results of Large Scale Screening Efforts
Jill Heemskerk, Ph.D., Extramural Research Program Neuroscience, National Institute of Neurological Disorders and Stroke

4:45 Close of Conference

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