œCourse Introductionœ@

-Background-

The development of new drugs, vaccines and diagnostics is complex, requiring many different skills. Each individual involved in a part of product R&D must be aware of the process overall and be able to relate their activities to it and to the needs of the other participating scientists and clinicians. Research scientists seek the discovery and confirmation of new knowledge by initiating or creating a hypothesis and then transforming it first into a theory and later into a new discovery. Product developers turn such discoveries into full-grown products which address public health needs through long and quite different processes. Generally, research and development are two different disciplines. People working in these two areas do not think alike; they have different cultures. Often they work in isolation from each other, so they do not understand each other well. However, both disciplines are essential for the development of new drugs, vaccines and diagnostics. Furthermore, discovery of new knowledge is meaningless if it is not translated into new products that meet the needs of the public health.

Currently, there are only few courses in the north that give a good overview of the entire drug discovery and development process such as post-graduate courses at University of Cardiff, ECPM at University of Basel, University of Lyon and may be a few others. In majority of countries around the world, most of the topics related to product R&D are scattered throughout the various university curricula, including basic science, organic chemistry, immunology, pharmacy, pharmacology, vaccinology and clinical pharmacology. However, everyone involved in research or development must know their responsibilities and able to relate their tasks to all the others which make up the process of product R&D. The objective of the proposed course is to pull together the various components needed for product R&D into a dedicated MSc-PhD course. Discussions between different universities who are interested in this project have taken place on several occasions. Recently, six universities in four countries (The School of Pharmacy, University of Tokyo/ Nagasaki University from Japan, Thammasat University/ Chlalongkong University from Thailand, China Second Military Medical University from China and The University of Antioquia from Colombia) have started working together to draft the content of the curriculum.

The curriculum is designed to provide basic knowledge of the product R&D process. It aims to demonstrate that new product discovery and the various development activities such as chemistry, toxicology, clinical investigations and regulatory practices are related as a continuous process, and that one discipline cannot carry out the whole process on its own.


-Contents of the course-

This part of the course will begin with a general overview of product R&D (drugs, vaccines and diagnostics), continue with a series of lectures on discovery research, transitioning between research and development, CMC (chemical, manufacturing and control) requirements, toxicology requirements from development to product license, pharmaceutical and analytical development, pharmacokinetics and metabolic studies, clinical studies - phase I-IV trial design and protocols - project planning and management, handling of safety data in development, regulatory requirements, post regulatory clinical studies, patents issues and other aspects of product development i.e. international standards of good practice, ethics in clinical research, DSMB (Data and safety Monitoring Boards), commercial and marketing activities, and public health implementation.