Education and Training in Biopharmaceutical Development

One does not have to look very far these days to see dramatic changes in the pharmaceutical industry. The basic science needed to understand therapeutics 20 years ago has been eclipsed by entirely new fields, such as pharmacogenomics.

Philip R. Mayer, PhD

Our knowledge of possible pharmacologic targets has broadened our view of the receptors and pathways available for drug therapy. Even manufacturing a relatively simple and well-understood small molecular weight protein, such as insulin, has been revolutionized from the animal-extraction methods employed a few decades ago. Also, many diseases are multifaceted and therefore, involve complex pathophysiology and subsequent pharmacologic intervention.

Many of these changes have been most apparent in the area of biopharmaceuticals. Every area of pharmaceutical R&D is markedly different when one increases the molecular weight by a log scale or even more dramatically. A small molecule synthesized on a laboratory bench is much less complicated than a protein with more unique chemical bonds and multiple conformational attributes.

Understanding these trends, it is important for all of us to be well versed in the new sciences that impact the development of protein therapeutics. Someone coming out of college might have had a biochemistry training course to learn the basics of proteins, but needs practical knowledge of the field. An old-timer like myself may have many years of drug-development experience, but needs a new scientific base to contribute on a project team developing a monoclonal antibody or vaccine.

The American Association of Pharmaceutical Scientists (AAPS) is initiating a web-based training course to satisfy these educational objectives for our membership and for the pharmaceutical community at large. AAPS Biotechnology 101 consists of 25 online lectures organized into five modules: Introduction and Overview of Tools; Chemistry, Manufacturing, and Controls of Biopharmaceutical Development; Preclinical Development; Early Clinical Development; and Late Clinical Development and PostApproval Changes.

The lectures will be presented by experts in their field and reviewed by other experts for content. The contents of each module are packed with the current crucial knowledge with minimal overlap. The viewer will be educated on topics in an easy-to-follow format and may take the entire training course or specific modules or lectures according to one's interest. An online training course offers flexibility for the audience and the ability to review content more than once. Questions following each topic are available to test learning and retention.

AAPS Biotechnology 101 will be available for purchase by the end of 2011. AAPS has been pleased with the enthusiasm of the training course organizers, presenters, and the scientists awaiting this material. We hope that this training course will be the first of several needed to provide extended pharmaceutical education for the scientific community.

Biopharmaceuticals are here to stay. In fact, their use will only continue to increase, because of a huge unmet medical need for effectively developing large proteins to treat many diseases. We must be certain that the ability of trained scientific staff is not one of the limiting factors impeding the effort to meet this need. All of us have much to learn and will have many opportunities to apply this knowledge.

Philip R. Mayer, PhD, is president of the American Association of Pharmaceutical Scientists.