What a trip! Edward Kerwin’s fascinating professional journey led him from physics undergrad to NASA scientist to medical school and on to an allergy practice, to principal investigator involved with at least 750 clinical trials to $10 million Southern Oregon winery owner to becoming part of one of the emerging private equity-backed “Super Sites” in the United States. Dr. Kerwin, now 63, has signed up for the clinical trial of a lifetime, leading Oregon’s effort with the Phase 3 Moderna COVID-19 vaccine clinical trial. Beautiful and even a little mystical, better known for a rural like existence, fine wine, and a world-class Shakespeare festival, the Rogue Valley now spearheads a global response in the form of a major clinical trial targeting the most severe public health crisis in modern times.
Thanks to a recent piece by JoNel Aleccia covered by Oregon Live, Edward Kerwin’s life trajectory was shared for more to appreciate. Now part of a new and aggressively growing private equity-backed research site organization called Velocity Clinical Research, Dr. Kerwin’s connection with NASA goes back to 1979-1984 when he utilized his undergraduate degree in physics from Colorado College to contribute to the national space program. Kerwin at the time decided to head on in a different direction, to earn a History of Science degree from Princeton and then took on the challenge of earning an MD from the University of Colorado Medical School, completing internal medicine studies at the University of Iowa and specialized allergy training at National Jewish Center, Denver. Relocating to Medford in 1993, he commenced the building of a trial site practice by 1994. The multifaceted, bucolic, self-sustaining lifestyle was irresistible, and with a little success derived from research trials, Kerwin was also able to assemble the capital to launch Bel Fiore, a winery and vineyard featuring a 19,000 square-foot chateau.
Rogue Valley: A Special Place
Dr. Kerwin’s connectivity to the Rogue Valley can only be understood by those that have spent a little time in this charmed and what some might call a mystical pocket of southern Oregon. This author experienced the Rogue Valley first hand while visiting a childhood friend from San Francisco. Much like Dr. Kerwin, an incredibly accomplished and multifaceted talent, this friend relocated up there (near Ashland) in probably a similar spirit to that of Kerwin to go back to the basics, including the purchasing of a farm, fully loaded with orchards, crops, and livestock. The Rogue Valley brought out a whole new side to this thoroughly urban chap, with a dear wife and two wonderful kids, an accomplished filmmaker, and active with Native American communities. It was here visiting him that this author discovered the friend turned farmer learned how to deliver calves via a YouTube video while still a comfortable 10-minute drive to enjoy a high-end cafe latte.
Done via the backdrop of the majestic Pacific Northwest mountainous forest, calming farm and ranch settings with adjacent lively and culturally quaint towns is the Rogue Valley. With the famous Oregon Shakespeare Festival nearby, the growing tinge of hipness in the air appears balanced by rural dirt. One can start to appreciate the Rogue Valley for what it truly represents. And apparently, others are well as the population now reaches 300,000.
Clinical Research Institute of Southern Oregon (CRISOR)
So it was this interesting, eclectic and scenic setting that by 1997 Dr. Kerwin founded Clinical Research Institute of Southern Oregon (CRISOR) to leverage not only his board certifications in Respiratory, Allergy, and Clinical Immunology, but also growing relationships throughout this area as well as beyond with clinical research organizations and pharmaceutical companies. Since then, he went on to build a very successful clinical research site organization, serving personally as the Principal Investigator in over 700 clinical trials, not to mention helping many industry sponsors (e.g., pharma or biotech companies) to conduct research, co-write papers and review clinical study reports and protocols. With a team of investigators, regulatory, quality control, coordinators, and more, their client base includes a “who’s who” of big pharma, including GSK, Novartis, AstraZeneca, Janssen, Merck, Sanofi, Teva and more.
In 2019 CRISOR became part of Velocity Clinical Research, a private equity-backed research site organization TrialSite has covered before, seeking to combine scale and consolidated systems and processes with localization to build a new kind of site organization that someday could possibly even rival a clinical research organization (CRO). Dr. Kerwin didn’t make that decision easily but undoubtedly understood the dynamics and trends unfolding in the world of research sites: that sponsor or CRO clients were looking for heretofore not available efficiencies and capabilities with their site partners and that becoming part of something bigger, yet keeping the local presence just that, local, made sense.
COVID-19 and Vaccine Trials
By this Spring, Kerwin got the call from headquarters in North Carolina that CRISOR was one of 90 sites across the nation that could take on the trial of a lifetime. Hence the Medford-based clinical site would be the only one in Oregon to take on COVID-19. A large-scale, Phase 3 clinical trial investigating an advanced, mRNA-based vaccine candidate known as mRNA-1273 as one of the lead COVID-19 vaccine candidates.
The overall study seeks 30,000 volunteers, and Dr. Kerwin’s site commenced enrolling as many as 40 Rogue Valley volunteers per day, leading to as many as 700 total volunteers hopefully by the end of this month. Now on a mission to determine if mRNA-1273 can elicit a powerful defense against SARS-CoV-2, the situation is dire as over 5.2 million have been infected, with over 166,000 dead since the pandemic onset since March.
In the recent Oregon Live article, Kerwin suggested, “It may seem like a surprise” that Medford in the Rogue Valley is a clinical trial site targeting “the world’s biggest medical challenge in a century.” But it makes sense because of the types of individuals that this very special location attracts, whether brilliant filmmakers turned farmers, or NASA scientists turned principal investigator and winemaker.
‘A Challenge Like No Other’
When considering the totality of the situation, Dr. Kerwin hearkens to his core training and emphasizes, “It’s a perfect opportunity for science to come to the rescue” but humility sets in with this one: with COVID-19. America, and for that matter, the world, hasn’t had to battle such an egregious pathogen-based onslaught in the modern era.
So far, the study is going well. According to the recent Oregon Live press, the site “has attracted intense interest.” Additionally, Velocity Clinical Research, again, the parent of CRISOR, pays participants $,1962 for the 24-month clinical trial. Luckily, Kerwin and the team have vocational certainty locally, backed by national Velocity Clinical Research resources and assets, leading to a formidable trial site operation.
Call to Action: Sponsors interested in covering the Pacific Northwest somewhere between Seattle and San Francisco and catching a play during the summer, contact CRISOR (part of Velocity Clinical Research).