ANDREW PAPAS is the vice president of and leads the NSF Health Science Regulatory Affairs practice in Washington, DC with extensive experience providing strategic leadership and guidance on global regulatory affairs, quality, and drug development programs. He has over 40 years of combined industry and FDA scientist expertise that encompasses FDA-regulated pharmaceutical, biotechnology, cell and gene therapy, and combination products. Dr. Papas’ primary areas of regulatory expertise include US Regulatory Affairs; regulatory strategy from early-stage clinical development to marketing applications and on through to post approval changes; leading, reviewing, and/or authoring FDA submissions (IND, NDA, BLA, ANDA, 505(b)(2), combination product RFD, etc.) and leading agency meetings (ex. PIND, EOP2, PNDA, type C, etc.) for pharma/biotech drug clients. Additional experience includes serving as US Agent for foreign clients, regulatory expectations for developing biosimilars, orphan and breakthrough designations, global CMC requirements, US combination products and international requirements for biologics.