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December 10, 2012

Managing Variability in Pain Studies

Speaker for this Event:
  • Michael Kuss, Vice President, Analgesia, Premier Research Learn More
  • Managing Variability in Pain Studies

    In both acute and chronic pain studies, variability comes from many places sometimes requiring sample sizes to be increased to have a chance of showing a clinically meaningful change from baseline for the test drug over placebo. Variability may come from the patients, the sites and the primary efficacy variables that are measured.

    During this session we will explore ways to minimize the variability in pain studies and methods for increasing the chances of showing a therapeutic effect for the study medication being tested.


    VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:

    • Clinical Affairs
    • Clinical R&D
    • Clinical Research
    • Clinical Pharmacology
    • Clinical Operations
    • Project Management
    • Regulatory Affairs
    • Medical Affairs

    for pharmaceutical, biotechnology and medical device companies


    Michael Kuss, Vice President, Analgesia, Premier Research

    Mr. Michael Kuss is Premier Research’s therapeutic leader in analgesia and rheumatology. He is also responsible for strategic, commercial, organizational and financial aspects of our Clinical Research Centers, which specialize in Proof-of-Concept acute postop pain trials.

    Mr. Kuss has been with Premier since 2001 and has worked as an Executive Director, Clinical Trials Management and Senior Director, Analgesia and Rheumatology. He is responsible for working with customers to help prepare clinical development plans, provide therapeutic expertise, write protocols, manage study teams and participate in the preparation of clinical study reports.

    Prior to joining Premier Research, Mr. Kuss worked for Pharmacia (formerly G.D. Searle) in various positions, the last being Director of Research and Development. Mr. Kuss was responsible for clinical development of several COX-2 inhibitors (celecoxib, valdecoxib and parecoxib) from Phase I through Phase III pivotal studies and NSAIDs (oxaprozin, oxaprozin potassium, diclofenac/ misoprostol) as part of the Arthritis and Inflammation team.

    Mr. Kuss graduated from Wright State University in Dayton, Ohio with a BS in Medical Technology. He received a certification in Medical Technology from the American Society of Clinical Pathology. He is a member of the American Pain Society (APS), International Association for the Study of Pain (IASP) and Drug Information Association. He is a frequent presenter at annual meetings of the APS, IASP and American College of Rheumatology (ACR). He is an author of many publications and posters in the areas of analgesia, rheumatology and infectious disease.

    At Premier Research we focus on doing what we do best, and on putting all the pieces together to take our customers from proof of concept to regulatory approval. To do that, we have developed a surprising concentration of experience for a mid-sized CRO:
    • Over 600 trials for virtually every major class of analgesic, including every NSAID pain medication on the market today.
    • Three times as many medical device studies as the world’s largest CRO.
    • Pediatric experience with both familiar and extremely rare childhood illnesses, including work at PICUs, NICUs, clinics, and ERs – and a hard-to-match track record of successful neonatal studies.
    For the future, we plan on continuing to focus on serving the needs of the small, highly innovative pharmaceutical and biotechnology companies whose developments are changing medical history, especially in the areas of pediatric medicine and rare diseases. We will offer them everything they need to transform brave new ideas into life-saving therapies.

    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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