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Need for Vaccines and Research Escalates 

In December, as the U.S. Food and Drug Administration approved emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine, Montgomery College celebrated the graduation of 34 participants in its Clinical Trial Project Management (CTPM) program. Now in its ninth year, the CTPM program provides vital training needs for clinical trials, especially as the world confronts a global pandemic.

The CTPM program provides vital training needs for clinical trials, especially as the world confronts a global pandemic. Photo Credit: Andrew Brookes

The program is a partnership between the College and Amarex Clinical Research, headquartered in Germantown. “Since we started this program in 2012, we have trained nearly 300 students, many of whom have brought new skills to the clinical trial management industry,” said Dr. Sanjay Rai, the College’s senior vice president for academic affairs. “It’s a field that needs skilled professionals more than ever. The program was timely then and it is urgent now. Our graduates will play a critical role in our fight—humanity’s fight—against this pathogen.”

After the 39-hour course, six groups of graduates gave presentations on projects—all related to COVID-19 treatment or vaccines.

“The idea was to work as a team and apply techniques they learned in class,” said Kush Dhody, vice president of clinical operations at Amarex Clinical Research and lead faculty member of the CTPM program.

The judges and guest speakers included Benjamin Wu, president and CEO of the Montgomery County Economic Development Corporation (and former member of MC’s Board of Trustees), and Dr. Gail Wasserman, senior vice president of the biopharmaceutical department at AstraZeneca. Wasserman also serves on the board of directors of Montgomery College’s Pinkney Innovation Complex for Science and Technology.

Since we started this program in 2012, we have trained nearly 300 students. The program was timely then and it is urgent now.

Dr. Wasserman spoke to graduates about entering the field not only at a significant time, but also one in which new technologies open up possibilities.

“You have opportunities like never before. It’s a time for creative optimization in clinical trial management and doing things differently,” Wasserman said. “Companies are looking for people with project management experience who can run device studies, who understand patient perspectives, and those who can apply good clinical practices in a fast and changing environment.”

Detection of the pathogen coronavirus infection in the microbiology laboratory. Photo Credit: Valentin Russanov.

She said the response to the pandemic showed the world that researchers, clinicians, regulators, and governments—all working together—pushed the boundaries of drug development.

Wu underscored the importance of Montgomery County as the epicenter of research. Not only is it home to NIH and the FDA, but life sciences companies in the county received more than $3 billion in funding for coronavirus vaccine research and manufacturing. He said companies are looking for people who can assist them as they move forward in their clinical trials.

Steve Greenfield, MC’s dean of business, information technology, and safety in Workforce Development and Continuing Education, added, “Our clinical trial project management program impacts workforce development as well as economic development. Not only do our students receive new skills and jobs, but also companies can count on us for a pipeline of talent.”

Banner Photo Credit: Poba

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