New Course on Pharmaceutical Development: From Drug Lead to Drug Product
A new, interdisciplinary short‐course for doctoral students engaged in pharmaceutical research at Georgia Tech, Mercer, Emory, Georgia State and other Atlanta‐area universities offered Summer 2012 (May 29 – June 11).
- Instructor: Mark Prausnitz (head instructor) with co‐instructors and guest lecturers from Atlanta‐area universities and companies
- Prerequisites: Graduate standing with intent to pursue a PhD focused on pharmaceutical research.
- Course credit: 3 units
- Course meeting time: 9 AM – 5 PM on May 29, 30, 31; June 1, 4, 5, 6, 7, 8, 11
- Course meeting location: Georgia Tech campus
- Course number: CHBE 8803 (at Georgia Tech) or IBS 500R/course number 2073 (at Emory) (Students from other universities should cross register at Georgia Tech; see requirements)
Doctoral students from biochemistry, bioengineering, pharmacology, pharmacy, and other fields will work as part of interdisciplinary teams to simulate the drug development process starting with a druggable lead and ending with a report to “upper management” giving the scientific and business plan for development into an approved drug product. The course will follow an intensive, all‐day, short‐course format for ten consecutive weekdays with faculty lectures and student project teamwork. The goal of the course is to teach students the multifaceted process needed to bring a drug from concept to market in the context of open‐ended, student‐driven, collaborative projects addressing real‐world problems in pharmaceutical development.
May 29 - Introduction to class and pharmaceutical development Elements of an IND and NDA Design and discovery of druggable molecules
May 30 - From drug lead to drug molecule Project teamwork and communication
May 31 - Target indication, patient population
June 1 - Drug manufacturing scale up and GMP
June 4 - Formulation, route of administration, drug delivery systems
June 5 - Design of IND‐enabling studies: CMC, PK/PD and toxicology
June 6 - Clinical trial design
June 7 - Pharmaceutical marketing
June 8 - Oral presentations and reports / business plan
June 11 - Final presentations
Partial list of confirmed speakers: Ajay Banga (Mercer), Andy Bommarius (Georgia Tech), Mark Prausnitz (Georgia Tech), Jaipal Singh (Emory/SJTRI), Charlie Thompson (Axtria), Wes Wynens (Georgia Tech) and others.