Interview with Healthcare Operations & Clinical Research Expert Sean Walsh: Navigating Clinical Research Ecosystems, Drug Development, and Patient Recruitment Strategies
Below is an excerpt of the full interview conducted with Sean Walsh. Listen now for the full discussion.
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About Sean Walsh
Sean is an experienced healthcare operations leader with over 20 years of experience in the healthcare services industry.
Sean has held senior positions for multiple research sites for WCG, ClinEdge/GuideStar Research, and Raleigh Neurology Associates among other hospital settings. At Raleigh Neurology Associates, an award winning research site, he led direct clinical research operations for over 100 separate CNS research projects worth with 15 direct professional staff coordinating hundreds of active patients. Sean has extensive experience in developing and executing training programs for healthcare teams ranging from regulatory operators to c-suite executives. As the Manager, Business Operations and Finance at Rex Hematology/Oncology Associates, he managed clinical operations in the business office and 19 direct staff during facility expansion and technology migration to a new EMR system, which incorporated state of the art clinical treatment and drug trial information.
Previously, Sean was a Managing Director at BEK Health where he led the development team in the creation, operation, and deployment of procedures for a patient recruitment software system that directly searched EMR structured and unstructured data. Previously, he was the Senior Advisor for Global Alzheimer’s Platform where he led the development of a key protocol for a clinical trial globally and worked closely with major pharmaceutical companies worldwide.
Sean started his career in the US Air Force, where he served for 17 years. He led seven primary care outpatient clinics serving 310K eligible beneficiaries and designed, constructed, and executed a production plan for the largest family practice, internal medicine, and pediatric specialist residencies in the military. He has published over 20 clinical research articles and is a seasoned speaker at national industry conferences.
Sean graduated with a BA from Boston University and an MBA from Webster University. He is affiliated with the American College of Healthcare Executives and the Association of Clinical Research Professionals.
And so firstly, Sean, what is clinical research? What’s the purpose and what is the ecosystem? We know pharma companies and we know practices, but what are the different players in the ecosystem? What are the roles that they play to execute on these clinical research trials?
Why, who and how? I like it. So the purpose of clinical research is drug development. That’s really the only purpose. There are other purposes within the system that provide income, provides exposure, publications, but the entire purpose of research is to develop drugs for prescription after approval of FDA. The players in this ecosystem are threefold really right? At the high level, it’s the sponsor, which is a pharmaceutical company. The CRO, which is 80% of the time used by the sponsor, which is a third party vendor that conducts the study for the sponsor on a global level. And then the third is research site principal investigator, who actually has the patients who can enroll in the study and those three players or categories if you will, are the high level three people, if you will also, to run clinical trial systems.
The ecosystem also has subsets. For example, there’s the IRB Institutional Review Board, no clinical trial moves forward without the IRB approval on all levels. So, that is a key player. Another key player is the recruitment vendors. They are key to get patients enrolled and get their data to get the study approved after the NDA, new drug application. The site side also has a responsibility to brand themself and as well as the study, and one at a time. So the ecosystem at a high level is sponsor, CRO and site. When I say site, that includes the principal investigator, whether it be one or 100 principal investigators. So those players provide a key role. And without those three players, there is no study. Of course the FDA is a key player as well, once the data’s collected and the NDA goes through, but they’re the regulatory body that makes that approval.
