Hoss A Dowlat RA VP

Hoss leads an international team of drug development Principal Consultants at his self-owned PHARMABIO CONSULTING. His experience encompasses strategic regulatory support and Due Diligence to 70 Pharma client companies from across Europe, America, Canada, China, Korea, Taiwan, Japan, and India and to the financial sector New York US and London UK.

Hoss was until 2010 Vice-President, Technical, Drug Development and Regulatory Global Strategy Services, at the leading CRO PAREXEL International. In PAREXEL CONSULTING 2000-2010 he provided a direct consulting service to more than 50 Pharma client companies Prior to this he was leading drug development programs and registrations in several international Pharma companies.

Hoss is British-Canadian educated in England to B.Sc. and PhD level, and was also a recipient of a Post-doctoral European Royal Society Fellowship award in organic chemistry. He has more than 31 years of drug development experience in over 15 therapeutic areas in the European and North American pharmaceutical industry, 21 years of which have been in regulatory affairs.

His strength is in therapeutic proteins such as novel and biosimilar monoclonal antibodies. He has substantial Orphan Drugs development experience additionally, and is applying it to niche area of orphan biosimilars. Has unique insights into the FDA-EMA requirements. Extensive experience preparing clients for FDA meetings and has led, managed and attended across FDA meetings, in particular, formal Type B, NDA/BLA and BsUFA ABLA presubmission meetings. Highly experienced with EU: MAA presubmission EMA meetings, MAA presubmission Rapporteur/Co-rapporteur, D120 and D180 Clarification meetings SAWP/CHMP/EMA Scientific Advice.