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Medical Product Development and Translational Biomedical Research

HST.962

1-0-3

About the Class

Faculty

HST.962 Medical Product Development and Translational Biomedical Research Explores the translation of basic biomedical science into therapies. Topics span pharmaceutical, medical device, software, and diagnostics development. Exposes students to strategic assessment of clinical areas, product comparison, regulatory risk assessment by indication, and rational safety program design. Develops quantitative understanding of statistics and trial design. Based on interviews with over 50 experts in medical product development. Course URL: http://web.mit.edu/hst962/www/index.html Brief Syllabus 1. Strategy 2. Reimbursement 3. Proof of Concept 4. Intellectual Property 5. Trials and indications 6. Quality 7. Quality and clinical trial conduct 8. Medical Devices 9. Diagnostics 10. Biomarkers 11. Wearable Devices 12. Software 13. Target Selection and Drug Delivery 14. Toxicity 15. Formulation 16. Stability 17. Parenteral products 18. Biologics