Business
Incannex Appoints FDA Regulatory Affairs Expert Mr Robert B. Clark to the Board of Directors
Highlights: Highly experienced pharmaceutical executive with 20+ years at Pfizer and 10+ years at Novo NordiskSecured FDA registration and marketing approval
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Highlights: Highly experienced pharmaceutical executive with 20+ years at Pfizer and 10+ years at Novo NordiskSecured FDA registration and marketing approval for 12 significant new drugs in the past 10 years at Novo Nordisk in his capacity of Vice President – US Regulatory AffairsPersonal leadership of more than 15 successful US FDA Advisory Committee Meetings on behalf of Novo Nordisk and PfizerNationally recognized expert on FDA/EMA liaison interactions and US pharmaceutical advertising and promotional practicesDocumented success with FDA accelerated approval programs including Fast-Track, Orphan Drug, Breakthrough Therapy Designations, and Priority Reviews. MELBOURNE, Australia, Aug. 17, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic therapies for unmet medical needs, is pleased to announce the appointment of experienced pharmaceutical executive Mr Robert B. Clark to the Board of Directors. Mr Clark is a senior-level strategic regulatory affairs expert with over 38 years of US and Global regulatory experience, including >20 years with Pfizer Inc. and >10 years with Novo Nordisk A/S. He is an internationally recognized expert on US Food and Drug Administration (‘FDA’) and the European Medicines Agency (EMA) liaison interactions, US pharmaceutical advertising practices and regulatory aspects related to healthcare professionals and sales force activities. Mr Clark is Vice President, US Regulatory Affairs for Novo Nordisk where he provides strategic leadership to a team of over 50 regulatory staff and scientists in the development of new medicines. He advises the global executive team on matters related to drug development programs, FDA liaison strategies, managing FDA-related compliance issues, and monitoring emerging US regulatory trends and opportunities. He and his team manage all interactions with FDA on behalf of Novo Nordisk and have secured FDA approvals for twelve (12) significant new drugs for the company since his tenure began in 2012. Prior to joining Nova Nordisk, Mr Clark was Vice President of Worldwide Regulatory Strategy and US Regulatory Affairs at Pfizer, leading a team of up to 150 regional regulatory professionals supporting the d...