From biochemistry major at Berkeley, to Harvard Medical School graduate, to cancer surgeon at Johns Hopkins Hospital, Dr. Kenneth A. Kern has been on a trajectory of professional growth his entire life. He’s currently a senior medical director at a pharmaceutical company, designing and overseeing clinical trials that test novel compounds in the treatment of a variety of cancers.
In keeping with Kern’s constant pursuit of excellence, and given that regulatory affairs is an integral part of any drug development program, he recently earned his Master of Science in Regulatory Affairs through San Diego State University’s online program.
“I enjoyed the program so much,” said Kern, “that had a Ph.D. in Regulatory Affairs been available, I would have been the first to sign up for it.”
Kern gives us a closer look at his journey.
Please recap your education and career.
I graduated from the University of California, Berkeley as a biochemistry major, after which I obtained my medical degree from Harvard Medical School. I then trained as a cancer surgeon at Johns Hopkins Hospital, and the Surgery Branch of the National Cancer Institute, a division of the National Institutes of Health. I specialized in research in cancer-related metabolism, and I also spent an additional year of research training in cancer metabolism and nutrition from the University of Cincinnati. After completion of this training, I was a clinical professor of surgery, and obtained a master’s degree in Public Health, from the University of Connecticut.
About 12 years ago I decided to change career paths and, given my background and training in oncology, biochemistry, and metabolism, a career in pharmaceutical drug development focused on oncology was a natural choice. I have worked for two large pharmaceutical companies in early- and late-phase drug development of small molecules in oncology.
What was your goal in entering SDSU’s Master of Science in Regulatory Affairs program, and how did it meet your expectations/objectives?
Regulatory affairs is an integral part of any drug development program. While there are specialized divisions within pharmaceutical companies focused solely on regulatory matters, I believe it’s important that those working on clinical trials not in these divisions to have a thorough understanding of the entire process of drug development. This would include an understanding not only of how to create medications, but also what is involved with registering pharmaceutical drugs for use by physicians and patients, including small molecule drugs and biologics. This principle also applies to medical devices.
A thorough education of this type would include a study of manufacturing, pre-clinical testing, clinical testing, quality control and quality assurance, advertising, interacting with the FDA and EMA, and how to write clearly and effectively.
My objective in entering the SDSU Master of Science in Regulatory Affairs program was to broaden my theoretical and technical skills in all of the areas mentioned above, to help me perform my job even better as a clinical trialist. On a technical level, it meant obtaining more in-depth understanding of Good Manufacturing Practice [GMP], Good Laboratory Practice [GLP], Good Clinical Practice [GCP], and the workings of the FDA in assuring the U.S. public that drugs and devices are both safe and effective for human use. As I mentioned earlier, I have a master’s degree in Public Health, and since the FDA is the world’s largest public health organization, the function and workings of the FDA in protecting the public health are of great interest to me.
I found that the SDSU Regulatory Affairs program did an outstanding job in presenting a comprehensive and thorough education in all aspects of the regulation of drug development. It has helped greatly in my viewing the FDA and its interactions with pharmaceutical companies not as adversarial, but as a collaborative effort to protect the health of the American public.
What are small molecule drugs and biologics, and how do they differ?
“Small molecules” is a generic term for drugs produced by organic chemistry methods, using complex chemical synthesis and organic chemistry reactions in the laboratory.
“Biologics” is a generic term for drugs that are produced from living organisms, for example, therapeutic antibodies. Biologics can only be created from living organisms, as there is no known way to synthesize an antibody in the laboratory. Instead, large (huge) vats of living organisms are genetically engineered to produce specific types of antibodies by altering or inserting specific DNA instructions.
How did you find out about the SDSU’s Master of Science in Regulatory Affairs program?
Through an online search for regulatory affairs programs.
What do you think are the program’s key strengths?
The program is online entirely, yet it sacrifices nothing in quality of its training. This is a critical strength to allow for a working professional to take part in classes. There are some live, web-based meetings, which is also a strong point. The quality of the teaching in each of the 13 classes required to obtain the M.S. degree is extremely high. The material for each of the classes was well researched, always highly relevant, and despite the online aspect it still felt like this was live, classroom training. The program’s training has allowed me to interact with colleagues in all aspects of drug development, even from its earliest stages, and that to me is another of its greatest strengths.
How long did the program take? And if it hadn’t been online, could it even have been an option?
It took me 2.5 years to complete the program, entirely online. I would not have been able to do this without the online option.
What was your thesis project?
An Analysis of Endpoint Thresholds for Granting Breakthrough Therapy Designation and Accelerated Approval in Oncology.
Could you briefly explain your study?
We are fortunate to live in an era when some drugs provide really remarkable treatment effects for cancer patients, far beyond anything seen in prior decades. These types of drugs are felt to provide truly unique therapy because they are so highly effective, generally providing twice the tumor control rates as seen in the past. These drugs are said to reach “breakthrough therapy” levels based on these substantially improved treatment effects seen in clinical trials.
In an effort to register and move drugs reaching “breakthrough” levels of therapeutic effect into the clinic as fast as possible, Congress created regulations in 2012 that are administered by the FDA allowing for special administrative recognition and oversight of the registration process for highly effective medications. These drugs are designated by the FDA as achieving “Breakthrough Therapy Designation” (BTD) and often follow an accelerated regulatory approval pathway.
The exact criteria used by the FDA to determine if a drug should be granted BTD have never been outlined by the FDA. My thesis explored the history and rationale for BTD, and then studied the specific types of clinical trials and treatment effects seen in nine oncology drugs achieving BTD and later 10 accelerated regulatory approvals. The study determined that BTD medications achieve, in general, at least a doubling of tumor control effects on cancer as measured by tumor response rates, progression-free survival rates, or hazard ratios for relapse.
I submitted part of the thesis to the Journal of Oncology Practice, and it was accepted for publication within the next few months. This work will help those in drug development to understand what benchmarks need to be reached by new drugs to achieve the designation of BTD.
How did you feel about the caliber of SDSU’s instructors and their accessibility?
The caliber of the instructors was extremely high, and they were always readily accessible by email.
How has your M.S. degree in Regulatory Affairs impacted your career?
I am involved on a daily basis with decisions related to virtually every aspect of drug development and clinical trial designs in oncology. These discussions span the gamut from the earliest formulation of a drug, such as understanding timelines for API and the creation of research drug formulations, to late-phase, critical decisions and discussions with the FDA when answering questions related to a final protocol, or protocol amendment.
The breadth of training from the SDSU Regulatory Affairs program has really made my job easier, more effective, and more enjoyable, as the training has helped me find common ground with colleagues in all aspects of drug development.