Address

868 106th Ave North Naples, FL 34108

Alfred W. Schweikert, Ph.D., RAC

Senior Regulatory Consultant

Biography

Dr. Alfred W. Schweikert joined NEMA Research, in September 2020 as a Senior Regulatory Consultant. Dr. Schweikert has more than 35 years of experience in the pharmaceutical industry, including over 25 years devoted to management of regulatory affairs supporting new drugs, medical devices and biologic development. Prior to joining NEMA, he was Vice President of Regulatory Affairs for Vero Biotech and was responsible for the NDA approval in December 2019 and their Emergency Use-Expanded Access approval in March of 2020 for the treatment of COVID-19. He worked at MonoSol LLC (now Aquestive) prior to Vero Biotech and was responsible for numerous FDA submissions including NDA’s, IND’s and Orphan Drug approvals for their pharmaceutical film technology, including Diazepam, Clobazam, Rizatriptan, Tadalafil, Riluzole and Suboxone. Prior to that Al served as Head of Regulatory Affairs at Orexo US, Inc. as part of the US start-up team. Dr. Schweikert built and managed the Orexo US Regulatory Affairs Department responsible for Zubsolv® a medication containing buprenorphine and naloxone used to treat adults with opioid dependence. Dr. Schweikert has extensive global regulatory experience with drugs, medical devices and biologics covering the life-cycle management from development to post marketing and has collaborated and authored more than 30 scientific papers. Dr. Schweikert held senior positions at Johnson and Johnson where he was a member of the development team to market the first HIV and Hepatitis infectious disease tests, Titan Pharmaceuticals where he developed neural cell transplantation technologies for Parkinson’s disease globally, ImClone Systems registration supplements for ERBITUX®, and Baxter Healthcare and Ikaria where he was responsible for numerous critical care product global submissions including anesthesia and nitric oxide. Dr. Schweikert received his Ph.D. in Biochemistry at the University of Tennessee, Health Science Center, Masters Study at West Virginia University in Microbiology and received his B.S. degree at Wesleyan College. Dr. Schweikert is certified in global device and drug regulatory affairs by the Regulatory Affairs Professionals Society (RAPS).