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- Regulatory Science and Health Economics<\/a> (May 2025)<\/li>\n
- Introduction to Regulatory Affairs<\/a> (Dec 2024)<\/li>\n<\/ul>\n
Preamble<\/h3>\n
Apart from the popular belief of being an obstacle, a robust regulatory system makes innovation trustworthy. This program covered regulatory science, market access, and health economics, from how Investigational New Drugs (INDs)<\/a> move through approval to how evidence packages get built for reimbursement.<\/p>\n
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<\/p>\nAccess, IP, and who gets left out<\/h4>\n
Patents, by way of negative rights, drive access inequality. It was such a fresh air to learn about alternatives like regulatory exclusivity (the right to use a product dossier for market access) as a way to reward development without locking a drug behind price. The Drugs for Neglected Diseases initiative (DNDi)<\/a> is a good example of coordinated R&D filling a gap the patent system won’t. However, open science approaches to drug discovery, if not applied mindfully, can also reproduce old extractive practices. This is why frameworks like OCAP principles<\/a> and Nagoya Protocol<\/a> matter for cross-site and Indigenous data sovereignty in any data-sharing model.<\/p>\n
Balancing Early Access with Evidence Standards<\/h4>\n
A critical perspective on policies like Health Canada\u2019s Notice of Compliance with Conditions (NOC\/c)<\/a> allows many promising radiopharmaceuticals and biologics for early market entry. While this accelerates access, it also risks reduced rigour in evidence reporting by solely relying on single-arm Phase II trials. The ethical trade-off between speed and certainty presents challenges in patient safety and public trust. This highlights the importance of post-market monitoring (phase IV), and other Canadian reforms, such as Agile Licensing and the Advanced Therapeutic Product framework, to highlight the need for risk-based regulation.<\/p>\n
Trial design and evidence under uncertainty<\/h4>\n
Adaptive trials appealed to me for their efficiency and patient-centeredness by reallocating participants to efficacious treatments, and stopping early when a proposed regiment does not. The\u00a0STAMPEDE<\/a> (a multi-arm, multi-stage trial in advanced prostate cancer that evaluated several treatment combinations simultaneously); and BATTLE-2<\/a> (biomarker-integrated trial for non-small cell lung cancer) trials demonstrate this spirit: they reassigned patients to therapies based on real-time response data. While this raises the cost of running the trial, that cost is offset by improved patient prognosis.<\/p>\n
That same tension between innovation and evidence scarcity shows up in health economics. BC’s Personalized OncoGenomics (POG)<\/a> is a good local example. While genomics-informed treatment is promising, reimbursement decisions still need to account for real uncertainty in outcomes. Adaptive pricing and monitoring helps managing such patient-reported outcomes (PROs) for responsible reimbursement. Agencies like Canada\u2019s Drug Agency \u2013 Agence des m\u00e9dicaments du Canada (CDA\u2013AMC)<\/a> increasingly welcome this type of analysis to support transparent, value-based decisions.<\/p>\n
See more<\/h4>\n
- Introduction to Regulatory Affairs<\/a> (Dec 2024)<\/li>\n<\/ul>\n