Dr. Hoss A Dowlat, RA

VP, Global

PharmaBio Consulting

Specialties: REGULATORY AFFAIRS EU/USA, MAA/NDA/BLA/ABLA, BIOLOGICS, BIOSIMILARS, ORPHANS, Scientific Advice. Pharmaceutical and clinical development CTAs/INDs. Due deligence in/out licencing.

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.

Pioneer in European biosimilar approvals 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 Agencies) and conference and webinar presenter in EU/US regulatory affairs, biologics/biosimilars, scientific advice, the Common Technical Dossier (MAA/NDA/BLA), labeling (prescriber and patient), clinical safety, pharmaceutical development, and combination drugs.
Content Disclaimer

Contents in our website are from external websites. Links to and content from external website are provided for the convenience of users. Biopractice.com takes no responsibility for the content of such links and websites.