Joseph M. Fortunak is an Emeritus Professor of Chemistry and Pharmaceutical Sciences (joint) at Howard University, USA. Dr. Fortunak developed/co-developed post-graduate MSc programs in Current Good Manufacturing Practice (CGMP), drug manufacturing, and Regulatory Science for multiple countries in Africa, Asia, and South America. Professor Fortunak has worked in several countries to promote local pharmaceutical production and develop manufacturing processes optimized for the local environment and clinical needs. He has worked with many individual companies and National Drug Regulatory Authorities (NDRAs) to assure quality and compliance to the ICH Guidance(s) on process development, risk assessment, risk management, and validation of pharmaceutical manufacturing. Dr. Fortunak is an author of approximately 200 publications/patents and hundreds of presentations.
Professor Fortunak has worked with many major NGOs (WHO, GFATM, USAID, UNAIDS, GDF, UNIDO, UNITAID, TB Alliance, CHAI) in the Access to Medicines space. He has also worked directly with 30+ pharmaceutical companies in India, China, and across Africa to assess and manage risk, assure quality and CGMP compliance, and validate production processes. His university research is represented in manufacturing processes to produce the Active Pharmaceutical Ingredients (APIs) in tenofovir disoproxil fumarate (TDF), efavirenz (EFV), emtricitabine (FTC), and a key regulatory starting material for dolutegravir (DTG). His current research includes new chemistry for producing the API lenacapavir, a promising new candidate for Pre-Exposure Prophylaxis (PrEP) in the End HIV Strategy. Awards he has received include the American Chemical Society “Heroes of Chemistry,” a USFDA Honor Award for Excellence/Innovation in Africa, and an African Union Award for Corporate Social Responsibility.
Dr. Fortunak previously worked in the pharmaceutical industry as a bench scientist and manager. He has led organizations of up to 500 scientists and budgets of $195M with varied responsibilities across drug discovery, drug development, and manufacturing of both APIs and finished products. He participated in and managed the launch of 15 new and 25+ generic products with sales of over $300B to those companies. Dr. Fortunak directly managed the commercial production of dozens of Active Pharmaceutical Ingredients (APIs) and Finished Dose Forms (FDFs) with sales of over $2B/year. He has experience in small molecules, peptides, natural products, fermentation/semi synthesis, and antibody biologics. Dr. Fortunak is presently the CEO of two startup companies in the fields of complementary/alternative medicines and orphan diseases.