Day 1 | Day 2
8:30-9:00 am Short Course Registration and Morning Coffee
Morning Pre-Conference Short Course
9:00 am to 12:00 pm
Predicting Outcomes in Pre-Clinical Development
John Arrowsmith, Ph.D., Executive Director and Head, Competitive Intelligence, Pfizer Global Research and Development and Philip Miller, CMR International, Thomson Reuters
The course will explore some of the fundamental factors that go into a POC decision. It will analyze the underlying science that drives those decisions and how to influence investments and behaviors to make more of the right choices and fewer wrong choices.
This interactive short course will cover:
• Introduction to the general idea of attrition, pointing out obvious productivity and economic impacts.
• Investigate causes of attrition.
• Focus on Phase II attrition specifically and the importance of POC.
• Group discussion on defining a POC and how far in advance of a POC the decision criteria need to be agreed.
• Discuss how and why things go wrong when a POC fails.
• Novel and non-novel POC's, the Proof of Mechanism and translation from pre-clinical to clinical for safety and efficacy measures.
• Types of risk being taken on at POC, since all are not are born equal.
• Group discussion around planning and executing POC's.
• Leveraging benchmark data and use after action reviews.
• Final wrap up discussion and Q&A.
*Separate Registration Required
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12:00-1:25 pm Main Conference Registration
Main Program
DAY ONE: TUESDAY, OCTOBER 13, 2009
1:25 Chairperson’s Opening Remarks
Michael Barratt, Ph.D., Technology Lead, Pfizer Indications Discovery Research Unit
1:30 Pfizer Indications Discovery: Separating the Wheat from the Chaff
Michael Barratt, Ph.D., Technology Lead, Pfizer Indications Discovery Research Unit
Pfizer’s Indications Discovery Research Unit was established to reposition failed compounds as well as to identify additional indications for our active clinical candidates. To this end, we have implemented a systematic approach to uncover and pre-clinically validate additional therapeutic applications prior to progressing into Phase 2 POC studies. Over the last two years, we have conducted a significant multi-assay screening campaign and pre-clinically evaluated dozens of opportunities. Now, as we prepare to enter the clinic with our lead programs, we will use case studies to share some of our exciting discoveries and key learnings to date. We will also highlight areas where opportunities exist to partner with groups outside Pfizer.
2:00 Trans-National Drug Repositioning: Pursuing the Benefits of “Not Invented Here”
Mondher Toumi, Ph.D., Founder and Chief Executive Officer, Marco Polo Pharmaceuticals, Inc.
Emerging markets are an important source of drug candidates for repositioning, but successfully finding, licensing, developing and commercializing drugs from emerging markets is more complex than hopping on a plane to negotiate a licensing deal. Opportunities to use existing research and clinical knowledge, as well as conducting clinical trials within the country where the drug was developed, can rapidly deliver substantial benefits, often at far lower cost than could be achieved elsewhere. In this talk we discuss how to develop a local presence, the advantages of in-country clinical research, the key success factors we have observed, and several cases based on our own experiences in Eastern Europe and Russia.
2:30 Networking Refreshment Break with Exhibit and Poster Viewing
3:10 Sponsored Presentation (Opportunities Available)
3:40 Phenotypic Screening with a High-Throughput in vivo Pharmacology Platform as an Effective Mode of Drug Discovery and Drug Repositioning
Andrew G. Reaume, Ph.D., MBA, CoFounder & President & Chief Executive Officer, Melior Discovery
Despite significant advances in medical research over the last several decades, there remains a poor understanding of the spectrum of biology influenced by any given therapeutic target. The traditional pharma industry discovery paradigm is principally based upon a hypothesis-based approach utilizing this incomplete knowledge base. Melior Discovery has pioneered a complementary non-hypothesis-based approach termed, “phenotypic screening”. The approach is now validated through Melior’s success in building a proprietary drug pipeline and the numerous pharmaceutical and biopharmaceutical collaborations that the Company has consummated. The company’s lead compound for diabetes, MLR-1023, now entering the clinic, is illustrative of the power of phenotypic screening.
4:10 Using Computational Neuropharmacology to Support Repositioning Strategies in CNS Disorders
Hugo Geerts, Ph.D., Bach Med, MBA, Chief Operating Officer, In-Silico Biosciences
Computational Neuropharmacology is a mathematical and mechanistic disease model, based upon combining existing computational neurology models with the physiology of 23 membrane targets, the interaction of drugs with these targets using their documented pharmacology and the introduction of human pathology from imaging and postmortem data. After introduction of the pharmacology of an existing drug, the model can anticipate the clinical effects on schizophrenia or cognitive clinical scales. The model also simulates virtual patients, based upon actual genotypes and allowed comedication, therefore optimizing the clinical trial design. We will show examples of possible marketed drugs on clinical outcome in schizophrenia and cognitive disorders. We believe this technology is a cheap, safe and powerful tool to rank order the clinical effects of stand-alone or combinations of existing drugs.
4:40 VVP808 - Repositioning an Old Molecule as a New Insulin Sensitizer Using the Gene Expression Signature (GES) Platform
Vincent Wacher, Ph.D., Chief Executive Officer, Verva Pharmaceuticals Ltd.
Verva’s VVP808 is a non-TZD, non-PPAR-modulating insulin sensitizer entering clinical proof-of-concept testing in type 2 diabetes. It was previously marketed in North America in an unrelated indication. VVP808 was discovered using Verva’s Gene Expression Signature platform; a target- and mechanism- independent screen ideally suited to unlocking unrecognized therapeutic value from existing clinical products and proprietary compound libraries.
Sponsored by
5:10 Networking Reception with Exhibit and Poster Viewing
6:10 Close of Day One
For more information, please contact:
Christina Lingham
Cambridge Healthtech Institute
T: 781-972-1346
E: clingham@healthtech.com
For partnering and sponsorship information, please contact:
Arnie Wolfson
Business Development Manager
781-972-5431
awolfson@healthtech.com