Biologics Consulting
Kevin Gilligan is a seasoned expert in the fields of virology, vaccine development, and clinical research. Since August 2018, Kevin has served as a Senior Consultant at Biologics Consulting Group, providing specialized knowledge in CMC, pre-clinical and pre-IND filing processes, with a focus on influenza and coronavirus vaccines and therapeutics. As the Founder and CEO of Gilligan Pharma Consulting LLC since May 2017, Kevin offers comprehensive consulting services in clinical study design and execution, business development strategy, and grant proposal writing. Prior roles include Sr. Director of Medical Affairs at Clinical Research Management, where Kevin led initiatives in infectious disease and clinical trial management, and Unit Chief at the US Department of Health and Human Services, overseeing antiviral drug stockpiles. Kevin's extensive experience includes significant contributions to research and development in various organizations, with a strong academic background that includes a Ph.D. in Virology from the University of North Carolina at Chapel Hill.
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Biologics Consulting
ABOUT Biologics Consulting is a complete FDA regulatory and product development consulting firm for cell & gene therapy, biologics, pharmaceuticals, and medical devices. In the nearly three decades since its founding, Biologics Consulting has become the go-to consulting partner for companies large and small seeking to bring innovative, safe, and effective products to market in the US. Our team of consultants and professional services staff is comprised of subject-matter experts with decades of industry and/or FDA experience that allows us to provide an unparalleled insider perspective. OUR DIFFERENCE The Biologics Consulting difference is all about the unique combination of expertise we have under one roof. Our team has depth of knowledge and breadth of experience across all product types and development pathways. This value proposition allows us to address the full scope of a client’s regulatory and product development challenges. OUR EXPERIENCE AREAS - Biologics - Medical Devices - Pharmaceuticals - Biosimilars OUR SERVICES - CONSULTING – Regulatory, Product Development, Clinical Planning and Quality support. - SUPPORT SERVICES – Medical Writing, ePublishing & Submissions, US Agent Services, Due Diligence OUR CLIENTS Our clients span the industry, from established multi-national pharmaceutical, biotechnology, and medical device companies to academic and research institutions. We also support small biotech and medical device start-ups. Since our founding, we have professionally services over 4,500 clients from 58 different countries.