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Tuesday, November 9, 2010

7:45 am Morning Coffee or Sponsored Breakfast Presentation

(Opportunity Available. Contact Arnie Wolfson: 781.972.5431, awolfson@healthtech.com)



8:20  Chairperson’s Opening Remarks: Looking to the Future of Prediction: The Promise and the Reality of New Technologies

Ihor Gussak, M.D., Ph.D., FACC, Chief Medical Officer and Vice President,  NewCardio, Inc.

8:30 Quantitative Intravital Multiphoton Microscopy of the Liver

Marwan GhabrilMarwan Ghabril, Ph.D., Assistant Professor of Clinical Medicine, Gastroenterology/Hepatology, Indiana University

Multiphotn microscopy allows imaging of the rodent liver in vivo at subcellular resolution, providing a physiologically meaningful context for the study of drug induced liver injury. Using this technique we are developing quantitative assays of liver function such as hepatobiliary transporter function and microcirculation. In a pilot study of rifampin induced hyperbilirubinemia, we were able to demonstrate derangements in hepatic transporter function and to better understand the mechanism of hyperbilirubinemia, while gaining novel insights into how transporters may be affected in this model. The novel use of this powerful imaging technology may provide novel insights into mechanisms of drug hepatotoxicity.

9:00 Cardiac Functional Assessment: A Comparison of Invasive vs. Non-Invasive Techniques with a View to Improved Translational Applicability

Pierre LaineePierre Lainee, Ph.D., Principal Scientist, Preclinical Safety, AstraZeneca

Facing the challenge of preparing Phase I trials in patients with potential compromised cardiac function (such as in Oncology or Infection areas), the assessment of cardiac contractility is now performed during preclinical studies. However, few contractility parameters are measured in early clinical studies, making the translation of inotropic effects from animal models to humans very challenging. This presentation will to present the outcome of translational exercises aiming to correlate preclinical and clinical end-points, mainly through the use of echocardiography.

9:30Sponsored by
Predicting Serious Adverse Events Using Mechanism of Action

Aris PersidisAris Persidis, Ph.D., President, Biovista, Inc.

Rare or unpredictable adverse events account for many delays and increased costs of drug development. Using a very deep description of the mechanism of action (MoA) of a drug, it is possible to compare its MoA against that of all 23,000 indications and 6,000 AE’s tracked by medicine. Case studies in oncology and CNS will be discussed, as well as Biovista’s collaboration with the FDA on predicting safety signals based on mechanism.

9:45 Networking Refreshment Break

10:30 Drug-Induced Mitochondrial Dysfunction Yields a Novel Model of Idiosyncratic Toxicity

James Dykens, Ph.D., Group Leader, Investigative Cell Toxicity, Drug Safety R&D, Pfizer, Inc.

Off target mitochondrial impairment is increasingly recognized as an important component in the etiology of many adverse drug responses. A model based on such impairment, bioenergetic scope and mitochondrial biogenesis neatly explains many of the observations that have confounded scientists studying idiosyncratic reactions. This is an important new area of understanding in drug toxicity, and the model of idiosyncratic responses is both intuitive and testable. Attendees will gain an appreciation of key factors that need to be addressed pre-clinically to avoid late stage attrition, and a clear understanding of how this pathology accounts for many idiosyncratic events.

11:00 Idiosyncratic Liver Injury: Challenges and Approaches

Paul WatkinsPaul B. Watkins, M.D., Director, The Hamner-UNC Institute for Drug Safety Sciences, Verne S. Caviness Distinguished Professor of Medicine, University of North Carolina at Chapel Hill

The Hamner-UNC Institute for Drug Safety Sciences, established in June 2009, has been building novel research programs to provide the science to underpin regulatory decisions based on drug safety. The highest initial priority is to understand, predict and ultimately reduce the burden of idiosyncratic DILI. The Institute capitalizes on the exceptional basic science infrastructure and expertise of the Hamner Institutes, formerly the Chemical Industry Institute for Toxicology (CIIT), and access to biospecimens from various patient populations and ongoing clinical trials. A translational bridge is provided between basic and clinical research by novel art mouse models, including the Collaborative Cross panels of inbred mice and mice with humanized immune systems and livers. Novel biomarker discovery is facilitated by in house access to serum and urine from patients experiencing ALT elevations that do not portend progressive liver injury (exposure to heparins and therapeutic doses of acetaminophen) as well as from patients who are experiencing serious liver injury. The Institute is also partnering with several pharma companies to study proprietary drugs that have looked safe in preclinical testing but were from development due toxicities. A partnership is developing the DILI Physiolab platform, a computer-based model of liver physiology and DILI that will incorporate all relevant data to ultimately explain and predict DILI. A two year goal for the project is to provide a fully integrated and referenced knowledge base that should form the platform for discussions between regulators and sponsors when liver safety issues surface at any point in a drug’s life cycle.

Sponsored by
11:30 Novel 3-dimensional ECG/VCG Cardiac Safety Markers in the Early Clinical Development
Gussak_I_PTX Ihor Gussak, M.D., Ph.D., FACC, Chief Medical Officer and Vice President,  NewCardio, Inc.
NewCardio’s quantitative, 3D-based electrocardiology and novel 3D-based ECG/VCG analytical algorithms allows significantly improve: (a) the accuracy, reproducibility, and variability of all ECG timing intervals measurements, (b) identification of drugs that affect cardiac electrical activity (atrial and ventricular de,- and repolarization) and drugs that may carry a proarrhythmic risk.

12:00 pm Use of Informatics Approaches for Establishing a Threshold of Toxicological Concern

Sandeep Modi, Ph.D., Cheminformatician, Safety & Environmental Assurance Centre, Unilever; former Research Associate, GlaxoSmithKline

This presentation will cover a rigorous, and also a practical approach that is necessary to allow early risk characterization of chemicals. The approach will cover use of various tools in data mining, QSAR, cheminformatics and bioinformatics. The talk will also cover few case studies where we have been able to highlight at every early stage of development safety concern associated with exposure to these chemicals for which no toxicological information was available. This presentation will highlight recent advances in in silico and informatics approaches. The audience will learn what can be done at early stages and will also better understand advantages and limitations of these informatics approaches.

12:30 End of Mitigating Safety Risks Conference or Lunch on Your Own and Return at 1:40 for Closing Session on INTEGRATING DRUG SAFETY KNOWLEDGE

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