About Us
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CEO, Co-Founder
BS
Mr. Barnes is a clinical researcher and drug development professional with three decades of experience providing operational oversight and support for drug development programs. He has held senior roles in pharmaceutical and biotechnology companies as well in Clinical Research Organizations. He most recently held a senior position at Virpax Pharmaceuticals leading all of the operational activities for the company’s pre-clinical program. He holds a Bachelor of Science from Virginia Polytechnic Institute and State University.
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President, Co-Founder
PhD, JD, MBA
I am a highly regarded Regulatory Strategist, specializing in drug discovery and development, with over 20 years’ experience in start-ups, mid-size, and large pharmaceutical companies providing regulatory strategy, extensive experience in research and development in bringing NCE’s and 505(b)(2)’s to market with visionary leadership, and communication to the US FDA. Furthermore, I have an excellent record of accomplishment and business acumen demonstrated through development and management of programs. My contribution to this program is critical to ensuring development of protocols, meeting Health Authority requirements and execution of preclinical and clinical studies. I am responsible for the operational efficiency of the various CRO’s we engage with throughout the drug development process to successfully complete pre-clinical studies, clinical studies, and other research and development activities supporting the program. I have worked in all phases of clinical development from proof of concept and Phase 1 through large scale Phase III and Phase IV studies. During my tenure in the pharmaceutical industry, I have collaborated with world-renowned researchers and key opinion leaders in drug research, drug development, and commercialization of drug products. My overall experience covers a wide range of therapeutic areas, dosage forms, and formulations on a global scale. At a former company, I was mentored by a former FDA Commissioner, which strengthened my understanding of the thinking at the Agency and how to better facilitate product development.
Throughout my career in the pharmaceutical industry, I have provided delivery of innovative proactive regulatory strategies in collaboration with corporate team members and global business partners to enable expedient and successful global product registration and optimal product-life cycle. I have achieved this through proactively and systematically, developing and delivering robust USA and Global Regulatory Strategy and tactics to guide efficient product development. I have successfully provided regulatory expertise and support from pre-clinical, clinical, and post marketing of products. I have led the submission of two New Drug Applications (NDA), two supplemental NDA’s (sNDA’s) and was pivotal in a Health Canada NDS and other worldwide regulatory filings. I have led numerous meetings with the FDA that include Pre IND, EOPI, EOPII, pre-NDA and CMC focused meetings and interactions as well as Written Response Only (WRO) and FDA Advisory Committee Meetings. I have had extensive experience working with European, Japanese, and Canadian Health Authority applications. I have established a track record of collaboration with global business partners to enable expedient and successful global product registration and optimal product life cycle. This includes fast track designation applications, orphan drug designation, and priority review of applications, annual reports, REMS, and other lifecycle regulatory documents. Part of my product development has also included regulatory strategy for a mobile health technology and a 510k submission. Further expertise has been shown by being a Co-author of multiple Journal articles, “Effective Partnering between Small Biopharmaceutical Companies and Their Service Providers” published in DIA Global, July 2023; “Patient Safety and Innovation Are Complementary and Necessary for the Development of Health” published in Therapeutic Innovation and Science, August 2014.