BioEntrepreneurship - Clinical Trials Strategy

COURSE DESCRIPTION

Whether you intend to carry your product to regulatory approval or to out-license or partner at an earlier stage, it is important to determine your clinical development strategy. Many products have failed or been delayed due to poor clinical trial design. Optimal design can reduce the time to market as well as the costs associated with clinical development. A potential commercialization partner will evaluate not only the viability of your product but also the efficiency of your strategy for the approval of this product. This course will focus on early phase clinical development but also provide you with the background on how to establish a Clinical Development Plan.

SPEAKERS

  • Wendy Hill , Gap Strategies
  • Sue Gilbert Evans, Ventana Clinical Research Corporation
  • Beatrice Setnik, Ventana Clinical Research Corporation
  • Miklos Schulz, SciAn Services Inc.

TOPICS ADDRESSED

  • Innovative strategies for clinical development that meet both regulatory guidelines and enhance licensing opportunity
  • The importance and components of Clinical Development Plan
  • Interpretation of preclinical pharmacology and pharmacokinetics in the selection of doses or dose ranges for Phase I development
  • Innovative Phase I and Phase II designs which overcome barriers to low toxicity and provide information early on product efficacy
  • The logistical and practical issues of conducting a Phase I clinical study including the costs, timelines, strategies for recruitment and challenges

DATE | TIME | LOCATION

February 12, 2007 - February 12, 2007
6:00PM - 9:00PM
MaRS Collaboration Centre
101 College St, Toronto

ABOUT THE SPEAKERS

Wendy Hill

Wendy Hill, M.Sc. has over 20 years experience in clinical development and regulatory affairs in a variety of therapeutic areas including cancer, inflammation, infectious and cardiovascular disease. Previous positions include Director of Research at Knoll Canada, Senior Director, Clinical Research at GlycoDesign and R&D Director, Inflammation and Neurology at Amgen Canada. Since founding Gap Strategies in the spring of 2004, Wendy has been assisting biotechnology companies prepare and execute strategic clinical and regulatory development plans for products and devices.

Sue Gilbert Evans

Sue Gilbert Evans, M. Sc. has more than 10 years experience in the design and conduct of clinical trials across a range of therapeutic areas including pain, depression, virology and dermatology. As the Director, Project Management with Ventana Clinical Research, Sue is responsible for the timely and efficient conduct of complex early phase studies. Sue is currently completing a Doctor of Philosophy, Neuropsychopharmacology and has published numerous research papers and abstracts.

Beatrice Setnik

Beatrice Setnik, Ph.D. currently holds a position as a Research Scientist at Ventana Clinical Research Corporation. In her role, Dr. Setnik is responsible for the design, analysis and interpretation of various specialty phase I trials, including abuse liability, and drug- and alcohol-interaction studies. During her doctoral studies, Dr. Setnik used an animal model of depression to identify a series of genetic and biochemical changes that were associated with depressive symptomatology. Dr. Setnik graduated from the University of Toronto and holds an Hon.B.Sc. and a Ph.D. in the area of pharmacology and toxicology.

Miklos Schulz

Dr. Miklos Schulz is the President and Senior Consultant of SciAn Services Inc., a Canadian CRO established in 1986, specializing in trial management, bio-statistics, data management and information systems.

Dr. Schulz’s professional career began at a European pharmaceutical company where his interest in the design and analysis of clinical trials evolved. He later collaborated with a clinical research group focusing on diabetes mellitus. This research became the basis of his Ph.D. thesis in individualized, optimal drug therapy. He completed his Ph.D. research at the Hospital for Sick Children in Toronto. Following his post-graduate work, he returned to the Hospital for Sick Children as a senior scientist conducting investigations in intermediary metabolism and diabetes as well as designing and analyzing clinical studies. Five years later, he established SciAn Services Inc., which over the years, has evolved into a respected force in the CRO field.

Dr. Schulz has some 45 publications and abstracts to his credit in the fields of applied statistics and metabolism. His continuing research interests lie in applied bio-statistics and pharmacokinetics. Currently he is involved in exploring the applicability of unique Bayesian and sequential designs in clinical trials.

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