“Discoveries in technology and science are giving us a greater chance of having a positive impact on disease and creating drugs that are safer than they’ve ever been.”
— Edward Rozhon, former senior manager of clinical trials for autoimmune, infectious, and ophthalmologic diseases at Genentech, Biosciences Instructor, Chair, Biotechnology, Bioinformatics, and Clinical Trials Design and Management certificate programs
In the complex world of biopharmaceutical research, the people who are discovering new drug treatments, devices and products for the health industry face significant regulation and oversight.
“The qualification of people doing their particular function has become more important than ever before, especially in the field of regulatory clinical quality work,” says Clarisa Tate, vice president of product development and regulatory affairs at AIRx Medical, a young virtual startup. Tate is also an instructor in several UCSC Silicon Valley Extension biosciences certificate programs: Regulatory Affairs; Medical Devices; and Clinical Trials Design and Management.
Clinical Trials Essentials
Tate will join seven other bioscience professionals in the industry to teach “Clinical Trials Essentials: An Intensive One-Week Course” starting March 12. The course brings together experts in their fields to provide a high-level overview of what it takes to bring a drug or device from discovery to Food and Drug Administration (FDA) approval and on to market.
The intensive overview of 12 topics, promises to give people with very different backgrounds a sense of what to expect and what to prepare for in the field.
“A bachelor’s degree doesn’t mean that you’re fit to work the job,” Tate says. “Companies want you to have continual learning and training. The clinical field is extremely complex.” The industry is an ongoing collaboration between scientists, technologists, entrepreneurs, and government regulators. Employees involved in clinical research “need to be able to bridge the gap between those industries to conduct clinical trials successfully.”
Diversity & Collaboration
UCSC Extension’s annual Clinical Trials Intensive draws people working in the biopharmaceutical and medical device industries as well as members of the biomedical community who interface with or conduct clinical research. Participants often include new clinical research associates and study coordinators, medical directors, physicians, nurses, pharmacists, inventors, intellectual property lawyers, computer programmers, biomedical scientists, statisticians and database administrators, and business professionals.
“Those completing the course frequently comment that they had no idea how complex it is to bring a new drug to market,” says Edward Rozhon, former senior manager of clinical trials for autoimmune, infectious, and ophthalmologic diseases at Genentech. Rozhon, a UCSC Extension instructor, serves as chair of three UCSC Extension certificate programs: Biotechnology, Bioinformatics, and Clinical Trials Design and Management. “There are people employed in the biotech industry who are essential to specific activities in drug development, but don’t have a complete understanding of the overall process to obtain FDA approval to market a new drug in the United States. They’re in the forest but are only seeing a couple of trees in the drug development process.”
A clinical researcher can work in numerous industries, says Tate who specializes in getting new products from concept to commercialization and had numerous roles in the clinical trials process.
As the device industry grows, especially in the field of in vitro diagnostics, technology is increasingly embedded into new devices. Regulation demands higher levels of evidence—even the software applications essential to clinical research.
“I can’t think of a more exciting time to be involved in companies that are doing this kind of research,” Rozhon says. “There are many new drug targets that have been identified through genomic sequencing technologies. Recent discoveries in technology and science are giving us a greater chance of having a significant positive impact on human disease with drugs that are more specific for their disease target and safer than many previously approved new drugs.”
The Clinical Trials Essentials intensive will be taught by: Edward Rozhon, Mike Huston, Narinder Singh, Gerri O’Riordan, Peter Shabe, Savita Sinha, Clarisa Tate, and Frances Ann McKenney.
Learn more about Clinical Trials at: http://bit.ly/2t5i43y
Learn more about our various bioscience courses and certificate programs at: http://bit.ly/2FJ7i5z