Dr. Hoss Dowlat
Vice President of PharmaBio Consulting, Regulatory Affairs EU-USA
REGULATORY AFFAIRS EU-EMA/USA-FDA, LICENCING MAA/NDA/BLA (351a)/BLA (351k), BIOLOGICS, BIOSIMILARS, ORPHANS, SCIENTIFIC ADVICE OF MEDICINES. PHARMACEUTICAL AND CLINICAL DEVELOPMENT CTAs/INDs. CORPORATE DUE DILIGENCE.
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 circa 100 client Pharma companies and international management consulting and pharmaceutical service companies from across Europe, America, Canada, Australasia, China, Korea, Taiwan, Japan, and India and the financial sector New York US and London UK.
Dr. Hoss was 2000-2010 Vice-President, Technical, Drug Development and Regulatory Global Strategy Services, at the leading CRO Parexel International provided providing direct consulting. Prior to this he managed 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 aminoglycoside chemistry. He has more than 35 years of drug development experience in over 15 therapeutic areas in the EU and North American pharmaceutical industry, 25 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 FDA meetings across Divisions/Offices, in particular, formal Type B and Type C, NDA/BLA and BsUFA BLA (351k) Advice (Advisory and Types 1, 2, 3 & 4) and presubmission meetings. Highly experienced with EU: MAA presubmission EMA, MAA presubmission Rapporteur/Co-rapporteur, D120 and D150 Clarification meetings, Oral Explanations, and SAWP/CHMP/EMA Scientific Advice.
Pioneer in European biosimilar approvals, starting as regulatory lead to one of 2 EU Biosimilar MA hGH approvals in April 2006.
Hoss has published 5 milestone articles on biosimilars in 2012; March (US), April (EU), May (EU), May (US) and July (US), and a RAPS book biosimilars chapter in 2013, and broadcasts to US and EU monthly thought leadership professional webinars 2011-present. The latest international article in progress 2015 is on “Interchangeability among reference insulins and their biosimilars: regulatory framework, study design, and clinical implications”.
He is also a well-established international trainer (to Pharma and Regulatory Agencies) and conference and webinar presenter in EU/US regulatory affairs, biologics/biosimilars, orphans, combination drugs/biologics, scientific advice, the Common Technical Dossier (MAA/NDA/BLA), labeling (prescriber and patient), clinical safety, pharmaceutical development.