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Icannex Taps Ex Pfizer, FDA & Regulatory Affairs Expert

Icannex Taps Ex Pfizer, FDA & Regulatory Affairs Expert

Icannex 聘请了前辉瑞、美国食品药品管理局和监管事务专家
Benzinga Real-time News ·  2022/08/17 11:04

Incannex Healthcare Limited (NASDAQ:IXHL) (ASX:IHL) appointed pharmaceutical executive Robert B. Clark to the board of directors.

Incannex 医疗保健有限公司 纳斯达克股票代码:IXHL)(澳大利亚证券交易所股票代码:IHL)被任命为制药业高管 罗伯特·B·克拉克 到董事会。

Clark is a senior-level strategic regulatory affairs expert with over 38 years of US and Global regulatory experience. He is an internationally recognized expert on US Food and Drug Administration and the European Medicines Agency liaison interactions, US pharmaceutical advertising practices and regulatory aspects related to healthcare professionals and sales force activities.

Clark 是一位高级战略监管事务专家,拥有超过 38 年的美国和全球监管经验。他是国际公认的美国食品药品监督管理局和欧洲药品管理局联络互动、美国药品广告惯例以及与医疗保健专业人员和销售人员活动相关的监管方面的专家。

Clark is vice president, US regulatory affairs for Novo Nordisk (OTCPK:NONOF) 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 significant new drugs for the company since his tenure began in 2012.

克拉克是美国监管事务副总裁 Novo Nordisk (OTCPK: NONOF),他在新药开发方面为由50多名监管人员和科学家组成的团队提供战略领导。他就与药物研发计划、FDA联络策略、管理与FDA相关的合规问题以及监测新兴的美国监管趋势和机遇等事宜向全球高管团队提供建议。他和他的团队代表Novo Nordisk管理与FDA的所有互动,自2012年开始任职以来,已获得美国食品药品管理局对该公司十二种重要新药的批准。

Prior to joining Nova Nordisk, Clark was vice president of worldwide regulatory strategy and US regulatory affairs at Pfizer (NYSE:PFE), leading a team of up to 150 regional regulatory professionals supporting the drug development continuum. During his time at Pfizer, he led or supported FDA approval of many new medicines and represented Pfizer at critical interactions with FDA, and other global health authorities, including key project milestone meetings.

在加入 Nova Nordisk 之前,Clark 曾在 Nova Nordisk 担任全球监管战略和美国监管事务副总裁 辉瑞公司 (NYSE: PFE),领导一支由多达150名区域监管专业人员组成的团队,为药物研发过程提供支持。在辉瑞任职期间,他领导或支持了许多新药的FDA批准,并代表辉瑞参加了与FDA和其他全球卫生机构的重要互动,包括重要的项目里程碑会议。

Being that Incannex is clinical-stage pharmaceutical company, often in contact with the FDA, and other regulatory bodies, getting someone with many FDA approvals on his belt should prove beneficial for the company.

由于Incannex是一家处于临床阶段的制药公司,经常与FDA和其他监管机构保持联系,因此让获得许多FDA批准的人对公司有利。

Photo: Benzinga; Sources: courtesy of geralt, lindsayfox via Pixabay

照片:Benzinga;资料来源:由 Geralt、lindsayfox 通过 Pixabay 提供

 

 

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