Applied Drug Development Core Curriculum - Course Description

Unique Course Design

This course features two tracks: 1) the CMC (chemistry, manufacturing and controls) aspects of development, as carried out by pharmaceutical chemists and technologists, industrial pharmacists and engineers; and 2) the biology side of the development process as carried out by toxicologists, pharamacologists, pharmacokineticists, clinical project managers, and others. In each track, the course looks at the scientific and regulatory requirements as well as the interaction required by all stakeholders in the technical development of a new drug entity and their activities as driven by regulatory requirements. During the last day, teams of participants will be formed to develop a project plan for a new chemical entity and present the plan to a management team and regulatory authorities composed of course faculty.

Who Should Attend

Scientists and technical managers who are either new to drug development or who are interested in obtaining a contemporary review of the drug development process. Attendees should include BS/MS/PhD level pharmaceutical scientists, chemists, biochemists, engineers, and biologists (toxicologists, pharmacokineticists, pharmacologists) and related scientists in the R&D environment, as well as manufacturing, clinical and regulatory affairs specialists, project managers involved in drug development, and their respective technical management.

Goals & Objectives

The purpose of this course is to provide the learner a survey of the process of non-clinical drug development from lead molecule characterization and preclinical evaluation, to the FDA approval of a new drug product. Within this context, the learner will become familiar with the key science and technologies that support the drug development process. The course will use examples for both small and large molecules and will address issues from discovery to NDA/BLA filings.

This focus on the science of drug development is intended to help the learner better understand how, where and with whom to follow up appropriately with his/her work responsibilities. Upon completion of the program the learner will be able to:

1. Contribute to the overall development plan with activities that are relevant to his/her respective discipline;
2. Better understand and explain the relationships and interdependencies between the chemical, biological and clinical disciplines that must collaborate effectively;
3. Better anticipate the challenges, choices and key decision-making steps that face the development team in bringing a new drug product to market; and
4. Apply a broader understanding of the development process to bring about more effective problem solving to the development program.