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May 17, 2011
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Adaptive Study Design

Speakers for this event:
  • Michelle L. Combs, PhD, Vice President, Clinical Pharmacology Sciences Learn More
  •     Faster to Patient - Current Trends in Adaptive Study Designs in Early Clinical Research

  • Elliot Offman, BSc Pharm, MSc, Director, Clinical Pharmacology Sciences Learn More
  •     Maximizing Output and Information from Adaptive Studies in Early Clinical Research

    Accelerating drug development timelines is a key priority for many companies. Adaptive study designs offer a useful means to achieve this priority, and allow a number of objectives to be assessed simultaneously. In early clinical research, adaptive designs can be effectively used to shorten timelines, answer multiple questions, and identify if an efficacy signal can be detected in the patient population as quickly as possible.

    Study designs for clinical pharmacology studies have become increasingly innovative. In this webinar, Celerion's clinical pharmacology scientists will describe recent trends in adaptive designs, highlight areas where innovative approaches resulted in more robust clinical study results and discuss the challenges sometimes faced with these designs. Through case studies, the audience will learn key advantages for using adaptive study designs in early clinical research, understand challenges for this approach and how to maximize the amount of information gained from data in the least amount of time.

    Archive available - click on the link for more information
    April 28/11
    Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Value of Early Safety Assessments
    To request this webinar archive contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com
    May 17/11
    Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Adaptive Study Design
    Archive available - click on the link for more information
    June 8/11
    Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Microtracer Studies


    VPs, Directors, and Managers in the following areas:

    • Clinical Pharmacology or PK/PD or DMPK
    • Clinical Research or Clinical Development
    • Clinical Operations
    • Drug Development
    • Research & Development
    • Outsourcing

    Plus Presidents, CEOs, Chief Medical Officers and Chief Scientific Officers for pharmaceutical and biotech companies worldwide


    Michelle L. Combs, PhD, Vice President, Clinical Pharmacology Sciences

    Dr. Combs serves as the Vice President of Clinical Pharmacology Sciences. In this role Dr. Combs is responsible for modeling and simulation, protocol development, data management, biostatistics, pharmacokinetics, and medical writing. Dr. Combs has over 18 years' experience in clinical research and has done extensive research in a variety of areas with publications and presentations on topics focusing in safety, tolerability, pharmacokinetics, and efficacy of new compounds and formulations.

    Dr. Combs joined MDS Harris in 1997 and held positions of increasing responsibility in Biostatistics and SAS® programming before leading the Global Clinical Pharmacology Sciences Department at MDS Pharma Services.

    Previously in her career, Dr. Combs 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, as well as a Bachelor of Science degree in Mathematics and Statistics from the University of Nebraska at Kearney.

    Elliot Offman, BSc Pharm, MSc, Director, Clinical Pharmacology Sciences

    Mr. Offman is the Director of Clinical Pharmacology Sciences at Celerion. In this role, Mr. Offman leads the North American team of clinical pharmacology scientists focused on protocol development, pharmacokinetics, pharmacodynamics, statistical data analysis and report production. Prior to joining Celerion, he was the Director of Clinical Pharmacology at MDS Pharma Services. Mr. Offman also worked as the Director, Biopharmaceutics and Scientific Affairs at Genpharm, where he led clinical activities for biopharmaceutics studies in support of drug product registration in Canada, the US and Australia..

    Mr. Offman has over 15 years’ experience in clinical research, hospital and retail pharmacy and pharmaceutical product development and reimbursement. He has contributed to several publications, manuscripts and presentations.

    Mr. Offman holds a Master’s Degree in Pharmacology and Toxicology from the University of Western Ontario and a Bachelor of Science in Pharmacy, from the University of Manitoba. He also completed a Residency Program in Clinical and Hospital Pharmacy at the London Health Sciences Centre in Ontario, Canada.


    Celerion is the premier provider of innovative early stage clinical research solutions. Formed through the acquisition of the early stage development operations of MDS Pharma Services, Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phase 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com

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