Pharmaceutical Workforce Goes “Back to School”at UMDNJ
words by Susan Glick
Barbara Gladson, PhD professor, physical therapy UMDNJ – School of Health Related Professions Associate professor of pharmacology and physiology UMDNJ – Graduate School of Biomedical Sciences
The Biopharma Educational Initiative, a collaboration of academia and industry, provides training to enhance career advancement.
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hen Merck needed someone to help educate employees who put together the company’s clinical trials, who did they call? UMDNJ, and specifically, Barbara Gladson, PT, PhD, of UMDNJ-School of Health-Related Professions (SHRP).
That call was made in 2004. “Merck asked us to provide training in patient recruitment sciences for a group of 12 employees,” says Gladson. “We felt the time was right to move forward with an educational program geared towards this industry.”
The Biopharma Educational Initiative (BEI), launched in fall 2006, offers three 15-credit certificate programs in Clinical Recruitment Science (the recruitment of human subjects for clinical trials), Clinical Trial Informatics and Regulatory Affairs. The courses are primarily Web-based. They are taught by faculty from SHRP, UMDNJ-School of Nursing and UMDNJ-School of Public Health, as well as pharmaceutical professionals from Bayer, Merck and other companies. Students can sign on for one of the certificate programs or take individual courses to increase their skills in a variety of fields. A Master of Science program in Clinical Trial Sciences is also being developed, with launch tentatively scheduled for next fall.
Gladson, who is a professor of physical therapy at SHRP and associate professor of pharmacology and physiology at UMDNJ-Graduate School of Biomedical Sciences, is director of biopharma education and curriculum development for BEI. She notes that there are many advantages to this powerful partnership between academia and industry. “The collaboration has the added benefit of boosting clinical trial experience at UMDNJ, giving our faculty the expertise to execute their own clinical trials as well as trials from the outside. It will also build professional relationships between University faculty and pharmaceutical colleagues and demonstrate our great potential as an academic partner.”
The collaboration between the University and New Jersey’s pharmaceutical companies has led to other interesting initiatives, including a potential pilot project called the Virtual Lab, a database containing consenting patients pre-approved for clinical trial participation. Anyone conducting a clinical trial would be able to access the database to determine whether the study could be conducted at UMDNJ. Such databases exist at other institutions, including the Cleveland Clinic and the University of Pennsylvania.
Thus far, feedback on BEI has been positive. Former student Susan Tempest, PharmD, who manages clinical trials at Merck, recently completed the Certificate in Clinical Recruitment Science program. Addressing her own desire for additional training, she says, “There’s an assumption that if you work in the pharmaceutical industry, you have in-depth knowledge of key aspects of drug development. That’s not always the case. Drug development is such a complex process that it is difficult to get the big picture.”
Tempest says she learned a great deal from the program. “As someone with five years of experience in clinical trials monitoring, I wasn’t sure how I’d benefit from the Overview of Clinical Trials course,” she continues. “This class made me realize how much I did not know. The instructor, David Hom, reviewed clinical trial design in a clear and logical manner with many examples from literature to illustrate key points.”
Tempest also found courses on data management, medical informatics and the epidemiology of disease to be particularly helpful. “When planning recruitment strategies, it’s crucial to understand the epidemiology of the disease process you’re studying,” she says. “The knowledge I gained from the epidemiology course has shown me the importance of knowing country-specific information on disease incidence in relation to site selection for studies.”
“One reason the program is off to such a good start is because we have proven to ourselves, to Merck and to other collaborating companies that we do what we say we will do, on time,” says Gladson. “We’ve built a level of trust between UMDNJ and the pharmaceutical companies that will provide us with a good foundation for moving the program forward.”