Drug Discovery, Development, & Commercialization

In this class, the students write articles to complete stubs on Wikipedia. These articles discuss medical uses of drugs, adverse effects, mechanism of action, pharmacology and pharmacokinetics, use in pregnancy and breastfeeding, research, cost and utilization. In addition, because this course covers commercialization, the articles will also discuss:

1. Commercial Aspects (who makes the drug, who sells the drug, company financials and capital structure, investment banking, VCs, crowdfunding, drug contribution to EBITDA, utilization strategies, M&A, JVs, marketing, risks, etc.)

2. Intellectual property (patents, provisionals, PCT, utility, life, jurisdictions. coverage, landscape, whitespace, trademarks, composition of matter, method)

3. Regulatory information (other exclusivity, cGMP, BLA, NDA, manufacturing, news articles, recalls, )

a. Preclinical info (tox, safety pharmacology, efficacy)

b. Clinical Trials (populations, countries, size, personalized medicine)

c. NDA status (IND, generic competition)