Dr. Hoss A Dowlat
Dr. Hoss A Dowlat
Vice President, Regulatory & Scientific Affairs – Senior Regulatory Advisor – Global Strategy
hoss.dowlat@pharma-bio.com
Specialties: REGULATORY AFFAIRS EU-EMA/USA-FDA, LICENCING MAA/NDA/BLA (351a)/BLA (351k), BIOLOGICS, BIOSIMILARS, CELLULAR AND GENE THERAPIES, 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 established 10 years ago. His experience encompasses strategic regulatory support and Due Diligence to circa 120 client Pharma companies and international management consulting and pharmaceutical service companies from across Europe, USA, Canada, Australasia, China, Korea, Taiwan, Japan, India, Russia, Ukraine, Switzerland and Israel and the financial sectors 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 36 years of drug development experience in over 16 therapeutic areas in the EU and North American pharmaceutical industry, 28 years of which have been in regulatory affairs.
His strength includes therapeutic proteins such as novel and biosimilar monoclonal antibodies, all insulins (human and analogues) and enzymes. He has substantial Orphan Drugs development experience additionally, and is applying it to niche area of orphan biosimilars as well as Adeno-associated virus (AAV) vectors. Experienced in Advanced Therapeutic Medicinal Product (ATMP) cellular and gene Products. Has unique insights into the Quality, Nonclinical and Clinical FDA-EMA requirements applied to these fields.
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. Successful in Breakthrough Therapies with the FDA and PRIME products development with the EMA. Led AAV vector, CAR T -Cell, and Dendritic Cell therapy meetings with OTAT/CBER/FDA. Led 2021 MHRA ATMP meetings.
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.
Hoss is a Referee for the high impact (above 6) journal mAbs.
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.
Some published biosimilars articles by Dr. Hoss:
Regulatory Focus, Journal of the Regulatory Affairs Professional Society (international) (RAPS):
Biosimilars Breaching Borders: How FDA and EMA Find Common Ground, March, 2012.
How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006, Pt 1, May; Pt 2, July 2012.
Regulatory Rapporteur, The International Journal for Professionals in Regulatory Affairs (TOPRA):
Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Pt 1, April; Pt 2, May 2012.
RAPS, Fundamentals of International Regulatory Affairs, Second Edition, Advancement of Biosimilars Development in Europe, USA, and Internationally, 2013.
A. Dowlat*, M. K. Kuhlmann, H. Khatami & F. J. Ampudia-Blasco, Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications, Diabetes, Obesity and Metabolism 2016 (John Wiley & Sons Ltd). doi:10.1111/dom.12676 3.
Hoss A Dowlat, The opportunities and challenges of biosimilar orphans (editorial), Expert Opinion on Orphan Drugs (Informa publishers), April 2016. Prior to final type print publication: http://www.tandfonline.com/eprint/NHakDzmIvANjIj7eNjj9/full.
Ulrike Hövelmann, Leszek Nosek, Hoss A. Dowlat, Amee Mehta and Tim Heise, Solumarv, a regular human insulin, and Isomarv, a NPH-insulin preparation, show bioequivalence to EU-marketed insulins, 76th Scientific Sessions, American Diabetes Association (ADA), New Orleans, USA, June 10-14, 2016.
Hoss Dowlat, Carsten Brockmeyer, Fiona Greer, Rick Lozano, Editorial by Stephanie Sutton, I’m a (Biosimilars) Believer!, Four biosimilar gurus discuss successes and tackle the issues head on, Medicine Maker, May 2018, Issue #0518.
