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November 5, 2008
Leveraging a Multiphase QT Strategy to Expedite Development and Reduce Investment Risk: Cost Effective Design, Execution and Analysis

Speakers for this event:
  • William Wheeler, MD, FACC,  Global Medical Director, Centralized Cardiac Services, MDS Pharma Services Learn More
  • Michelle L. Combs, PhD,  Vice President, Global Clinical Pharmacology, MDS Pharma Services Learn More
  • Nathan S. Teuscher, PhD,  Director, PK/PD, MDS Pharma Services Learn More
  • Joy Olbertz, PharmD, PhD,  Director, Cardiac Safety Services, MDS Pharma Services  Learn More
  • Leveraging a Multiphase QT Strategy to Expedite Development and Reduce Investment Risk: Cost Effective Design, Execution and Analysis

    Satisfactory completion of a Thorough QT/QTc Study (TQTS) is a requirement of nearly every new compound. By developing a QT strategy early in a compound lifecycle, drug developers can reduce investment risks and set the platform for cost effective trial planning and execution.

     

    Intensive ECG monitoring in early stage studies, also known as a QT Intensive or Robust QT study, is a powerful tool for drug developers in anticipation of a TQTS and is often done in single ascending dose or multiple ascending dose studies.  This allows for earlier drug development decisions and potential cost savings when planning and executing the TQTS. Robust QT-type designs also allow QT assessment of toxic compounds, such as cytotoxic agents, that can not be administered to healthy volunteers.   

     

    Leveraging the appropriate methodologies early can limit the financial risks associated with later development phases and provide critical data for protocol planning and execution.

     

    This webinar is part of a series sponsored by MDS Pharma Services

    For more information about Webinar 1 (On Demand Archive available)
    October 23/08
    First-In-Human Studies: Science-Driven Strategies
    Webinar 2 (current page)
    November  5/08
    Leveraging a Multiphase QT Strategy to Expedite Development and Reduce Investment Risk: Cost Effective Design, Execution and Analysis
    For more information about Webinar 3 (On Demand Archive available)
    April 23/09
    Quality On Time™ results with APOLLO:RDA™ (Remote Data Access)
    For more information about Webinar 4 (On Demand Archive available)
    June 18/09
    Advances in Oncology Drug Development: Linking Drug Response Phenotypes to Multiplex Molecular Signatures
    THIS PROGRAM IS INTENDED FOR:

    Employees of Pharmaceutical, Biotechnology, Biopharmaceutical companies including:

     

    • Directors (or Presidents/Vice Presidents/Assistant/Associate Directors) of Clinical Operations
    • Directors (or Presidents/Vice Presidents/Assistant/Associate Directors) of Clinical Research
    • Clinical staff
    • Assistant/Associate Directors of Oncology
    • Project Managers
    • Sourcing/Outsourcing Managers/Directors (or Assistant/Associate Directors)
    • Program Managers
    • Chief Medical Officers
    • Medical Directors
    • Chief Scientific Officers
    • Contract Managers
    • Directors of Drug Development
    • Presidents and CEOs (Biotechnology companies)
    • Vice Presidents of Research and Development

    ABOUT OUR SPEAKERS:

    William Wheeler, MD, FACC,  Global Medical Director, Centralized Cardiac Services, MDS Pharma Services 
    William Wheeler, MD, FACC is a board-certified cardiologist and industry expert with 30 years’ experience in medicine, clinical development, research, business and academia. He is Global Medical Director for the Centralized Cardiac Safety Services at MDS Pharma Services.

    Dr. Wheeler came to MDS Pharma Services from Spacelabs Healthcare Clinical Trials Services where he was Chief Medical Officer. Prior to that, he served as Vice-President and Chief Medical officer for Aderis Pharmaceuticals and Vice President of Cardiovascular/Critical Care at Quintiles. He began his industry career at Burroughs Wellcome and Co. He received his medical degree from UCLA, completed internship and residency at the Los Angeles County/USC Medical Center and cardiology fellowship at Cedars-Sinai in Los Angeles.

    Michelle L. Combs, PhD,  Vice President, Global Clinical Pharmacology, MDS Pharma Services 

    As Vice President, Global Clinical Pharmacology, Dr. Michelle Combs is responsible for PK/PD, Biostatistics, Data Management, and Protocol/Medical Writing services at MDS Pharma Services.  Dr. Combs has over 15 years experience in clinical research, specializing in Early Clinical Research over the past 10 years.  Dr. Combs has done extensive research in a variety of areas with publications and presentations on topics focusing on safety, tolerability, pharmacokinetics and efficacy of new compounds and formulations.

    Dr. Combs joined MDS Pharma Services in 1997.  Prior to joining MDS, she was a member of the research team at the University of Iowa Clinical Trials Data Management Center, where she participated in the planning, analysis and interpretation of several Phase III clinical trials.  Dr. Combs holds Master’s and PhD degrees in Biostatistics from the University of Iowa, where her dissertation was entitled “A method for including dropouts in the analysis of clinical trial data using a two-sided truncation model”.  She is a member of the American Statistical Association and has recently served as President of the Nebraska Chapter of the ASA.

    Nathan S. Teuscher, PhD,  Director, PK/PD, MDS Pharma Services 

    Dr. Nathan Teuscher is Director of Pharmacokinetics and Pharmacodynamics at MDS Pharma Services. Within MDS, he previously served as Associate Director of PK/PD and Pharmacometrics. Before joining MDS, he was a Clinical Pharmacokineticist and a Drug Metabolism Scientist.

    Dr. Teuscher’s interests include population pharmacokinetics, biomarker analysis, pharmacokinetic/pharmacodynamic relationships, and modeling and simulation. His experience over the past 10 years includes transporters, small molecule development, peptide development, drug candidate selection, toxicokinetics, and clinical pharmacokinetics. He also has a strong background in scientific instruction, with his pharmacokinetic training program having received an award from the Smithsonian Institute.

    At MDS Pharma Services, Dr. Teuscher has contributed to building internal expertise in population analysis and providing ongoing pharmacokinetic training to our world-class scientists.

    He is a member of the American Association of Pharmaceutical Scientists, the International Society for Neurochemistry, the American Society for Clinical Pharmacology and Therapeutics, and the American College of Clinical Pharmacology.

    Joy Olbertz, PharmD, PhD,  Director, Cardiac Safety Services, MDS Pharma Services 

    As the Director of Cardiac Safety Services, Dr. Joy Olbertz has played a key role in the development of the MDS Pharma Services Cardiac Safety Center of Excellence and in the evolution of Thorough QT trial protocols and procedures. She has taken on additional responsibilities in process improvement at MDS as a LeanSigma Green Belt. Recently, Dr. Olbertz was selected as one of 20 industry scientists featured in the February 2008 edition of R&D Directions magazine. The magazine chose her because of her LeanSigma project to improve the efficiency and quality of large cardiac safety trials.

     

    Before taking on her current role, Dr. Olbertz was a Clinical Research Pharmacist at MDS Pharma Services. Prior to joining MDS, she was a Staff Pharmacist at the Portneuf Medical Center in Pocatello, Idaho, and a Research Assistant at Idaho State University. She was also an Instructor at the University in their Pharmacy and Nursing departments.

     

    Dr. Olbertz holds a Pharmacy Degree from Idaho State University, where she was named Teva Outstanding Pharmacy Student in 2002. She received her Ph.D. in Pharmacology from Idaho State University, where she won a three-year Research Assistant Award as well as graduate student research grants.

    Dr. Olbertz has also been honored with the American Society for Cell Biology Pre-Doctoral Travel Award, the Idaho BRIN Research Conference (second place for graduate student presentation), and BRIN Research Assistant Award.

    ABOUT OUR SPONSORING PARTNER:

    MDS Pharma Services offers a full spectrum of resources to meet the drug discovery and development needs of the pharmaceutical and biotechnology industries. We are committed to meeting your drug discovery and development milestones with Quality. On Time.  With numerous facilities strategically located around the world, we apply advanced scientific and technological expertise  throughout the drug discovery and development process – from lead optimization, pre-IND research, early stage development: clinical research (bioequivalence, phases I-IIa) and early stage development:  bioanalysis through to global clinical development (phases IIb-IV), central lab and centralized cardiac services.  For more information, visit our website at www.mdsps.com.

    MDS Pharma Services is a business unit of MDS Inc. (TSX: MDS; NYSE: MDZ), a global life sciences company that provides market-leading products and services that our customers need for the development of drugs and diagnosis and treatment of disease.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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