everything.study
20.201

Fundamentals of Drug Development

4-0-8 units · Graduate

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

Prerequisites & course information

Prereq: Permission of instructor G (Fall) 4-0-8 units

Sources