Management

President & Chief Executive Officer

Over 25 years of process development, scale-up and manufacturing

Led process development group at Human Genome Sciences

Inventor on StableFastTM and associated patents

Founder and visionary of BioFacturafor over 20 years

Chairman of the Board of Directors & Chief Medical Officer

Serial Biotech and Medtech Entrepreneur/Investor

Graduate of Yale University School of Medicine and Johns Hopkins Carey Business School

Seasoned physician with experience in conducting clinical trials

President Memory Care Communities

Chairman and Founder of the Society of Physician Entrepreneurs

Director - Quality & Regulatory Affairs

30 years of pharmaceutical/biologics quality and operations experience; clinical-to-commercial (MedImmune, Kadmon [Sanofi], Noveome)

Quality/compliance systems development and management

CMC, Regulatory and technical/strategic product development

Director - Analytical Development

30 years in clinical, biotech, andpharmaceuticals (WI State Lab, Meso Scale Diagnostics, Novavax, Paragon Biosciences, Catalent)

Direct analytical method development following FDA, ICH, EMA regulatory guidance to assess CQAS and characterize product

Oversee execution of over 40 in-house methods

Expertise in microbiology, biodefense, biomarkers, biosimilars, and biosafety

Associate Director - Process Development

30 years of chromatography and membrane separations experience

Extensive GMP manufacturing operations

Native/engineered proteins and antibodies, viruses/replicons, and therapeutic live bacteria