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Cambridge Healthtech Institute's Inaugural De-Risking Drug Discovery conference at the 2012 Molecular Med Tri-Con will bring scientists from academia, industry and government together to present and discuss the latest strategies, methods and technologies available to reduce the risk associated with pharmaceutical candidates, both pre-clinical and clinical. De-risking strategies have evolved to provide evaluation of risk, assignment of risk to better allocate resources (personnel, funds, time) and lower the overall attrition rates for pharmaceutical products, but this is not enough. Meet experts from across pharma and biotech, in both small and large molecules, as they begin to break down the steps, technologies and business approaches you can use to de-risk.  Is it better to bring in de-risked lead compounds or install the process in an organization? What are the different business model approaches and how have they been effective? Learn how to utilize the expertise within contract research organizations. Explore drug repositioning and repurposing as opportunities for failed or high risk projects.  Participate in discussions on the importance of target vs. molecule de-risking and why different strategies might be needed. Novel technologies and novel applications of current technologies can be used to improve risk or to establish risk values early. Listen to experts from drug discovery, drug safety and toxicology, and translational medicine as they describe their methodologies and experiences.   Meet with industry and academic experts during networking events to share your own experiences and expertise.

Tuesday, February 21

7:00 am Registration

Sponsored by
 

9:40 Grand Opening Refreshment Break in the Exhibit Hall with Poster Viewing

DE-RISKING: SAFETY ASSESSMENT TARGETS

11:00 Chairperson's Opening Remarks

Michael Forstner, M.Sc., Ph.D., Integrated Safety Risk Manager, PDS, Roche

KEYNOTE PRESENTATION

11:40 Reducing Attrition: Combining Predictive in silico and in vitro Safety Assays to Guide Design Chemistry

Thomas Schroeter, Ph.D., Senior Principal Scientist, Compound Safety Prediction, Pfizer

The greatest challenge facing the pharmaceutical industry today is developing more effective decision making tools and strategies to reduce the attrition rate of novel compounds during candidate selection and clinical development.

12:10 pm Integrated Safety Management Planning as a Tool for Proactive Risk Minimization

Michael Forstner, M.Sc., Ph.D., Integrated Safety Risk Manager, PDS, Roche

Safety risk management of new drugs should commence before entry into humans and be maintained in a comprehensive way throughout development. By a combination of risk analysis and RM methods with an integrated approach to the detection/evaluation of safety issues, it is possible to identify important risks.

Sponsored by12:40 Luncheon Presentation
Overcoming ‘Rubbish In: Rubbish Out’: Effectively Supporting Target Identification & Validation Using Target Insights, a New Product from Elsevier

Jabe Wilson, MBA, Ph.D., Senior Product Development Manager, Elsevier (Pharma & Biotech Group)In target identification/validation the fundamental questions are how is a target identified, and the hypothesis developed using the scientific literature? Reducing time & money investments in literature searching to get to a go-no go decision is crucial. Target Insights from Elsevier is a new online decision support tool for biologists dealing with these issues.
 

1:45 Dessert in the Exhibit Hall with Poster Viewing

2:15 Chairperson's Remarks

Michael Forstner, M.Sc., Ph.D., Integrated Safety Risk Manager, PDS, Roche

2:20 Safety as a Component of Target Selection

Anne Ryan, D.V.M., Ph.D., Diplomate ACVP, Executive Director, Drug Safety Research and Development, Pfizer, Inc.

Understanding the biology and safety of a proposed target; Understanding Target Expression and Tissue Distribution; Developing a Risk Management strategy early target de-risking studies.

2:50 Early in vitro Safety Screening: Impact in Drug Discovery

Mike Rolf, Ph.D., Associate Principal Scientist, Global Safety Assessment, AstraZeneca

Pre-clinical toxicity and clinical safety are one of the major contributors to attrition. To address this, AstraZeneca has created a Safety Screening Centre to identify and mitigate safety hazards early in discovery using automated in vitro safety screens. The benefits and challenges will be presented.

3:20 Pearls (and Perils) of Staged Empirical Pre-Clinical Cardiovascular De-Risking Strategies

Gary Gintant, Ph.D., Research Fellow, Integrative Pharmacology, Chair, Abbott QT/Proarrhythmia Working Group, Abbott Laboratories

Detection of compounds early and later during drug discovery can reduce later stage compound attrition. This talk will focus on strategies and examples of "frontloading" safety pharmacology studies for cardiovascular liabilities, a prominent source of continuing concern in drug development.

Sponsored by
 3:50 Using Mechanism of Action to Predict Safety Signals and Understand Sub-PopulationsAris Persidis, Ph.D., President, Biovista 
Mechanism of action (MoA) can be used to predict potential system-driven safety signals. it can also guide the selection of the right sub-populations in clinical trial design. Examples of inclusion/exclusion criteria will be given.

4:20 Reception in the Exhibit Hall (Sponsorship Available) 

5:20 Breakout Discussions in the Exhibit Hall

Concurrent problem solving breakout discussions, open to all attendees, speakers, sponsors, and exhibitors, provide a forum for discussing key issues and meeting potential collaborators. Plan to take part and explore these topics in-depth. Please pick a topic of your choice, find your table and join in.

Network Pharmacology for Cancer Drug Discovery: Are We There Yet?

Asfar S. Azmi, Ph.D., Research Associate, Pathology, Karmanos Cancer Institute, Wayne State University

It’s Never Too Early to De-Risk Your Lead Compounds!

Glenn Short, Ph.D., Director, Discovery Sciences, Zalicus, Inc.

• Cell-based approaches to de-risking potential lead compounds in discovery phase
• Utility of cell-based disease models
• Assay strategies for indication selection, target/mechanism i.d. and triage for potential lead molecules
   

6:20 Close of Day

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