September 9, 2024
HJF, together with Montgomery County, Maryland, and BioBuzz, hosted the first in a series of networking and educational discussions by featuring a panel of experts on the regulatory process for the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
The four experts with research advisory committee experience from EEEC Corp Group; FDA Map, LLC; QuRA Solutions, LLC; and Salmandra, LLC, discussed regulatory topics of interest to help attendees understand the process for FDA submission when seeking review and approval for new devices and drugs.
Panelist Carrie Kuehn, MA, MPH, DLP, RAC, from EEEC Corp Group, said attaining regulatory input early in the development process can be very helpful for researchers trying to attain FDA approval for their innovation. Dr. Kuehn has more than 25 years of experience in research epidemiology, medical devices, regulatory and clinical affairs, and patient-focused policy. She mentioned two best practices that can help set up productive collaboration with the FDA.
“First, make sure to provide the FDA information that allows them to answer your questions, and, second, come prepared with your plan,” Dr. Kuehn said. “The FDA can be very collaborative and helpful.”
The panelists also included FDA Map’s Mukesh Kumar, Ph.D., RAC, a certified regulatory affairs professional who consults on regulatory affairs and quality assurance in the development of pharmaceutical, biotechnology and medical device products; QuRA Solutions’ Jaspreet Seth, PhD, a quality and regulatory affairs expert, with more than 20 years of experience in the life sciences and medical devices sector; and Salamandra’s Director for Regulatory Affairs and Clinical Development, Tenecia Sullivan, RAC US, who has more than 20 years of experience in the preparation, management, and submission of investigational and marketing applications across multiple therapeutic areas.
HJF’s Senior Director of Technology Transfer, Allen Morris, Ph.D., MBA, acknowledged the difficulty in getting products to market. “I’ve learned it takes a community, and that’s why we’re here,” he said. HJF has the expertise in technology transfer that is available to strategically help move innovations from the lab to development and then to market for the warfighter and patient. “We’re here to bring in partners, work together and use our resources. I want to see these innovations get out there.”
HJF President and CEO Joseph Caravalho and Montgomery County Executive Marc Elrich, both thrilled by the partnership, are raising awareness about life sciences in Montgomery County with the new creation of a co-branded “HJF Innovation Labs at Montgomery County, Maryland.” HJF and Montgomery County are committed to bringing partners together to bring innovations from the lab to commercialization that ultimately help the warfighter. BioBuzz Media, a regional life sciences marketing company, also helps raise awareness by connecting the workforce to life science ecosystem employers like HJF and Montgomery County.