Drug Discovery Through Preclinical Development offers an in-depth look at the discovery, design, and development in the preclinical phase (up to the IND application and entry into humans) of small molecule and biologic drugs. Focusing on concepts, the course is a combination of instructor-led classroom lectures and a series of guest lectures on special topics by scientists, clinicians and managers from industry.
An important part of this course is student participation in a series of four group presentations on a target or drug of the student’s choosing, starting with target selection and validation, continuing with lead generation and optimization and preclinical phase development studies, and ending with a phase 1 clinical proposal.
In addition to target biology, lead generation/optimization and drug metabolism-pharmacokinetics, some of the topics covered in this course are: use of genomics in target selection and validation; biologic drugs and the use of bioinformatics; structural biology and molecular modeling in drug design and optimization; translational medicine; phase I clinical trial planning, including use of biomarkers, patient stratification, and proof-of-concept studies; scaling up small molecule synthesis – issues in process development; general aspects of animal models and a discussion of stroke and multiple sclerosis models; aging related disorders, including disorders of the circadian rhythm; addressing reasons for phase 3 failures early in the program.
Other timely special topics include: new drugs targeting HCV; the mechanisms of bacterial, viral and tumor resistance to drugs; and managing pharma-university alliances. Some topics will be assigned as self-study (for e.g. GLP, maintaining notebooks; some disease animal models).