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Why do clinical development in Canada?

Why do clinical development in Canada?. François Charette MD, MBA Senior Vice President and Chief Medical Officer Bioniche Life Sciences Inc. Back to basics. QUALITY. TIME. COST. Should we do it in Canada?.

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Why do clinical development in Canada?

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  1. Why do clinical development in Canada? François Charette MD, MBA Senior Vice President and Chief Medical Officer Bioniche Life Sciences Inc.

  2. Back to basics QUALITY TIME COST

  3. Should we do it in Canada? • Quality (the way the protocol is followed) is generally not a country issue (GCP, ICH) • It is less costly (expenses for doing the trial) to go outside Canada • Time (and the associated cost of losing time) can be quite different but that is not a given

  4. COST

  5. Should we do it in Canada? • It depends . . . (GAAP) • Development Phase • Product investigated • Comparator • Experience • Competition • Indication • Study population • Ethics • Marketing • . . .

  6. 2 Registration Trials Refractory to BCG (105 patients), second line Comparative to BCG (800 patients), first line An example: Bladder Cancer

  7. Refractory to BCG Not outside North America Specialized centres (“We do refractory”) Opportunity to attract Opinion Leaders Must follow NA guidelines Must have received quality BCG Relatively small number of patients Genetics may explain non-responsiveness Environment may explain non-responsiveness An example: Bladder Cancer

  8. Comparative to BCG Outside North America 800 + patients First line, naive patients Patients interested Physicians motivated Centralized healthcare system Less competition for investigators Global market target Genetic differences Regulatory and politics Malpractice & liability An example: Bladder Cancer

  9. Comparative to BCG But, Do they use BCG? Can we export the BCG we will be using? Reliance on CRO Equipment, Medical practice Central pathology Highest recruiters, publication Population Environment Ethics Quality of Life Distance, Language, Culture An example: Bladder Cancer

  10. Should we do it in Canada? It depends . . .

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