Discuss Intellectual Properties and Interactions with Regulatory agencies (FDA, EMA,CFDA, etc.).

You will use the approved topic (Lupus) to follow and submit a final 13-15 page report on the therapeutics in development to include stage of development and probability of making it to market. Review the activities at each stage of develop being covered in the course.
Topics covered:
-Understanding the biology of a disease
-First Steps: Hit to Lead and (Q)SAR
-Hit-to-Lead Validation Process, ADME and Toxicology
-Lead Development through Small and Large Animal Model Studies
-Intellectual Properties and Interactions with Regulatory agencies (FDA, EMA,CFDA, etc.)
-Biologics and CRISPR
-Phase I, II, and III Clinical Trials

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