Cultivating the pharm
Career of Grad School alumnus dedicated to drug safety and efficacy
Amid the scientific rigor, the extensive regulations, the staggering investments, and the exciting promise of an emerging therapy, Daniel J. McDermott, PhD ’69, has found the essence of pharmaceutical clinical trials is in the patients who participate. The view from the bench or the board room doesn’t always include a direct line of sight to patients, so Dr. McDermott values his opportunities to interact with patient populations, something he believes offers special insight into the impact of such research.
While with 3M Pharmaceuticals in the 1990s, Dr. McDermott was a Program Director for the Immune Response Modifiers (IRM) family of drugs and led the team that performed the work to gain approval for the topical formulation of Aldara, first used to treat genital warts caused by HPV. To gain a better understanding of how women were affected by the disease, Dr. McDermott was involved in a nationwide focus group conference call where trial participants discussed their experiences living with genital warts and the effect they thought a new treatment might have for them.
Dr. Dan McDermott talks with Graduate Student Association President Scott Canfield and representative Jessica Priestley at the Medical College of Wisconsin. The Association was host to Dr. McDermott as he received the inaugural Graduate School Alumnus of the Year Award on April 16.
“All but one had not been treated adequately for removal of genital warts. Their relationships were all in varying degrees of decay, and the disease had become a personal catastrophe,” he said. “During a break in the session, I suggested the ladies all talk with each other so we could ‘eavesdrop’ to gain a better understanding of the initial population for which this drug would be used. For many of these women, it was their first interaction with anyone who had sympathy for the devastation they were experiencing. Having interaction with the patients for whom this drug would be useful was just a moving, remarkable experience.”
Dr. McDermott’s 40-year journey in pharmaceuticals underscores the industry’s challenges and proves the worth of its rewards. His professionalism and distinguished body of work throughout this time led the Medical College of Wisconsin/Marquette Medical Alumni Association to name him its inaugural Graduate School Alumnus of the Year.
Dr. McDermott can count Aldara (imiquimod) among the successes to which his work at 3M contributed. The drug made a significant difference for patients with genital warts, he said. It subsequently was approved for several skin cancers, which now represents the most common use for the drug, evidence of the industry’s fluidity and how projects do not always follow the initial application.
Although serendipity can aid science, surprises can also detour or derail a promising project. As an investigator in pharmaceuticals, Dr. McDermott said it is as important to learn from failures as it is to enjoy successes.
“There are disappointments associated with this work, and everything does not turn out as you anticipate,” he said. “You have to understand those disappointments will occur, and you can’t allow them to inhibit your enthusiasm.”
Reveling in teamwork
Dr. McDermott experienced success early in his career when he joined G.D. Searle & Co. in Skokie, Ill. He was serving on the Medical College of Wisconsin faculty as Assistant Professor of Physiology after earning his PhD, when a “persuasive recruiter” convinced him to visit the Chicago-area company. He was impressed by the man who would become his mentor, Dr. Scott Smith, and was soon overseeing the clinical development of an antiarrhythmic drug named Norpace (disopyramide).
He accepted responsibility for the final work of the oral formulation of Norpace and was involved with its intravenous formulation. The studies he led resulted in FDA approval of the drug in 1977. It is still in the market today.
Dr. McDermott said the process was his first exposure to the immense scope of collaboration necessary to develop a drug: chemists, toxicologists, pharmacologists, molecular biologists and pharmacokineticists in industry who interacted with teams in academic medicine in the areas of cardiology, cardiac electrophysiology and pharmacokinetics in the U.S. and Europe.
To implement the global introduction of Norpace, he also interfaced with management teams and academic faculty around the world, including one whirlwind trip to Tokyo, Singapore, Sydney, Melbourne, Zurich and London. Meeting with scientific opinion leaders from various nations and cultures enhanced his understanding of the multiple cultural differences that must be overcome by the goals shared by these physician-scientists.
“The projects I’ve been involved with are the consequence of multidisciplinary teams of people in industry and academic medicine who come together in the common goal of studying the safety and efficacy of certain drugs in target populations,” he said.
Across various industry roles and dealing with dissimilar drugs, Dr. McDermott’s work fundamentally has required an understanding of disease conditions and the ability to interface effectively with people in academe who will be interacting with patients. Compliance with all of the ethical and scientific dictates of the clinical protocol is central to the completion of a successful clinical trial, he said.
Without protocol compliance, unnecessary variability is introduced and uniformity lost. This results in flawed data about the safety and efficacy of a drug. That can lead to millions of wasted dollars and FDA rejection.
Dr. McDermott experienced some of the pitfalls in pharmaceutical development following his transition from Searle to Smith Laboratories, a start-up founded by his mentor. The small team set out to develop and introduce chymopapain, an enzyme derived from the papaya plant, for the treatment of patients with a herniated nucleus pulposus of the lumbar spine. Venture funding was obtained, and as Vice President and Medical Research Director, Dr. McDermott helped lead the work to obtain FDA approval. After a massive education program for spine surgeons, the drug was provided to select hospitals.
According to Dr. McDermott, litigation eventually ensued due to alleged misuse of the drug in the clinical setting, leading to a decline in enthusiasm for the procedure. Although the drug was shown to be an effective alternative to surgical care, Dr. McDermott said, it was eventually discontinued and is no longer commercially available.
After leaving Smith Laboratories in 1986, he spent several years with the Boots Company, which was developing a balanced vasodilator (flosequinan) for patients with refractory congestive heart failure. The drug had FDA approval, but because a subsequent study showed greater mortality with the drug when compared to placebo, the company elected not to take it to market.
Dr. McDermott subsequently joined San Diego-based Gensia Pharmaceuticals, where he was involved with acadesine, a drug that decreased ischemia in the heart by causing increased release of the vasodilator adenosine. Its initial application was for patients undergoing coronary artery bypass graft surgery.
The first phase II clinical trial for efficacy showed acadesine was extremely effective in reducing myocardial infarction vs. placebo.
As the drug moved toward a phase III trial, however, Dr. McDermott said he began to develop grave reservations about the course of the research to definitively evaluate the drug. He chose to leave prior to the program’s completion, and his concerns became reality when ensuing studies showed conflicting results, leading to an FDA request for another trial. The investors chose not to provide additional funding, so the development of the drug was terminated.
“The disappointments I’ve had in industry have not been associated with the drugs but with the lack of appreciation for what is needed to get a drug approved and the benefits versus the risks of the process,” he said.
After Gensia, Dr. McDermott made his move to 3M, where he eventually became Manager of Clinical Pharmacology. Since 2005, he has been serving as a consultant in pharmaceutical and medical device development.
As he transitions toward retirement, Dr. McDermott is enjoying spending time with his wife of 43 years, Jan, in their home state of Minnesota.
“I am truly grateful for the training and education that the Medical College of Wisconsin provided, which launched me on my lifetime adventure,” he said.
Graduate School memories
In addition to being a scientist, Daniel J. McDermott, PhD ’69, is also a veteran. While in industry, he had the opportunity to pursue his avocation in the U.S. Navy, first serving on active duty during the Cuban Missile Crisis and then in various positions as a Surface Warfare Officer on Reserve ships home-ported in the Great Lakes. He later served on fleet staffs and in the Pentagon. He retired with the rank of captain. He still sometimes navigates the Great Lakes, but on his sailboat, which he launches from his summer home in Michigan.
“My Medical College of Wisconsin memories are wide ranging and include an appreciation of the supportive yet demanding Graduate School faculty who came from a multitude of backgrounds and justifiably took great pride in research and teaching,” said Daniel J. McDermott, PhD ’69, the 2012 Graduate School Alumnus of the Year. “In lectures to medical students and graduate students, faculty members from other basic science departments were all present at the presentations of their peers. The entire faculty was really engaged in the aspect of teaching.
“There was a willingness of staff in different basic science and clinical disciplines to collaborate and address problems. They formed multidisciplinary teams of great intellectual power. From this experience, I learned principles and applied them in pharmaceutical development in the clinical teams I was involved with in the pharmaceutical industry.
“I am honored to have been chosen the first Graduate School Alumnus of the Year because I know there are many alumni from the Graduate School of Biomedical Sciences of the Medical College of Wisconsin who have pursued distinguished careers in academia, the private sector and industry. I am also humbled because I know my successes have always been a consequence of the contributions from many collaborators who were part of a multidisciplinary team effort.”
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