20.201
Fundamentals of Drug Development
Team-based exploration of the scientific basis for developing new drugs. First portion of term covers fundamentals of target identification, drug discovery, pharmacokinetics, pharmacodynamics, regulatory policy, and intellectual property. Industry experts and academic entrepreneurs then present case studies of specific drugs, drug classes, and therapeutic targets. In a term-long project, student teams develop novel therapeutics to solve major unmet medical needs, with a trajectory to a "start-up" company. Culminates with team presentations to a panel of industry and scientific leaders.
Fall 2013 · Mechanisms of Drug Actions
Topics
- Introduction and Fundamentals
- Overview of Drug Development 1
- Overview of Drug Development 2
- Fundamentals
- Biochemistry Review Exercise
- Uptake and Distribution
- Dr. Keith Hoffmaster, Novartis: Drug Transporters 1
- Dr. Keith Hoffmaster, Novartis: Drug Transporters 2
- Drug Metabolism 1
- Drug Metabolism 2
- Drug Toxicity 1
- Lecture Review Session
- Drug Toxicity 2
- Pharmacokinetics
- Case Study: Omeprazole Pharmacogenetics
- Overview of Drug Development 3
- Case Study
- Case Study: Antibiotics
- Project Help Session
- Dr. Alex Wood, MIT Senior Lecturer / Novartis: Case Study: Oncology Drugs
- Case Study: Statins
- Case Study: GWAS and Statin Toxicity
- Dr. Bernard Fermini, Pfizer: Case Study: Cardiotoxicity
- Dr. Teresa Wright, Shire Pharmaceuticals: Preclinical Drug Development
- Dr. Keith Hoffmaster: Case Study: PK / PD
- Case Study: Sarilumab Phase III Clinical Result
- Prof. Doug Lauffenburger: Systems Pharmacology
- Dr. Tess Schmalbach, Schmalbach LLC: The Clinical Size of Drug Development
Readings
- Gilman, A. G., T. W. Rall, et al. Goodman and Gilman’s The Pharmacological Basis of Therapeutics . McGraw-Hill Professional, 1996. ISBN: 9780070262669.
- Widmaier, Eric, Hershel Raff, and Kevin Strang. Human Physiology: The Mechanisms of Body Function . 7 Sub ed. William C Brown Pubulication, 1998. ISBN: 9780070670655.
- Bloom, William, and Don W. Fawcett. A Textbook of Histology . 10th ed. W. B. Saunders, 1975. ISBN: 9780721617572.
- [C&D] = Klaassen, Curtis. Casarett & Doull’s Toxicology: The Basic Science of Poisons . 8th ed. McGraw-Hill Professional, 2013. ISBN: 9780071769235.
- SES #: L1 · TOPICS: Introduction and Fundamentals · READINGS: [Golan] Chapter 1
- SES #: L2 · TOPICS: Overview of Drug Development 1 · READINGS: [Golan] Chapter 49
- SES #: L3 · TOPICS: Overview of Drug Development 2 · READINGS: [Golan] Chapter 49
- SES #: R1 · TOPICS: Fundamentals · READINGS: [Golan] Chapters 1 and 2
- SES #: L4 · TOPICS: Biochemistry Review Exercise · READINGS: No readings for this session.
- [Golan] Chapters 2 and 3
- [C&D] Chapter 5
- [Golan] Chapter 4
- [C&D] Chapter 7
- [Golan] Chapters 5 and 41
- SES #: R3 · TOPICS: Lecture Review Session · READINGS: No readings for this session.
- [Golan] Chapter 6 and 46
- SES #: R5 · TOPICS: Overview of Drug Development 3 · READINGS: [Golan] Chapter 49
- SES #: L13 · TOPICS: Case Study · READINGS: No readings for this session.
- [Golan] Chapters 32, 33, and 34
- SES #: R6 · TOPICS: Project Help Session · READINGS: No readings for this session.
- SES #: L15 · TOPICS: Case Study · READINGS: No readings for this session.
- SES #: R7 · TOPICS: Project Help Session · READINGS: No readings for this session.
- [Golan] Chapter 19
- SES #: R8 · TOPICS: Project Help Session · READINGS: No readings for this session.
- SES #: L19 · TOPICS: Dr. Bernard Fermini, Pfizer: Case Study: Cardiotoxicity · READINGS: No readings for this session.
- SES #: R9 · TOPICS: Project Help Session · READINGS: No readings for this session.
- SES #: L20 · TOPICS: Dr. Teresa Wright, Shire Pharmaceuticals: Preclinical Drug Development · READINGS: [Golan] Chapter 49
- SES #: R10 · TOPICS: Project Help Session · READINGS: No readings for this session.
- SES #: L21 · TOPICS: Dr. Keith Hoffmaster: Case Study: PK / PD · READINGS: No readings for this session.
- SES #: R11 · TOPICS: Prof. Doug Lauffenburger: Systems Pharmacology · READINGS: No readings for this session.
- SES #: L23 · TOPICS: Dr. Tess Schmalbach, Schmalbach LLC: The Clinical Size of Drug Development · READINGS: [Golan] Chapters 50 and 51
Prerequisites & course information
Prereq: Permission of instructor G (Fall) 4-0-8 units
Sources
- Course catalogue ↗2026–2027
- MIT OpenCourseWare ↗Fall 2013
- MIT OCW calendar ↗
- MIT OCW syllabus ↗
- MIT OCW readings ↗
- Historical MIT OpenCourseWare offering. Named reading entries and schedule topics are automatically extracted from the linked source pages.