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Icannex Taps Ex Pfizer, FDA & Regulatory Affairs Expert

Icannex Taps Ex Pfizer, FDA & Regulatory Affairs Expert

附件水龍頭前輝瑞,FDA 和監管事務專家
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.

盈康醫療保健有限公司 (納斯達克:IHL) (ASX: IHL) 任命醫藥行政人員 罗伯特·克拉克 董事會。

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 是一位高級策略性監管事務專家,擁有超過 38 年的美國和全球監管經驗。他是美國食品和藥物管理局和歐洲藥品管理局的聯絡互動,美國藥品廣告做法和與醫療保健專業人員和銷售人員活動相關的監管方面的國際認可專家。

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.

克拉克是美國監管事務部副總裁 诺和诺德 OTCPK: NONOVER)在那裡,他為一個由 50 多名監管人員和科學家組成的團隊提供戰略領導,負責開發新藥。他就藥物開發計劃、FDA 聯絡策略、管理與 FDA 相關的合規問題,以及監察新興的美國監管趨勢和機會等事宜向全球執行團隊提供建議。他和他的團隊代表諾和諾德(Novo Nordisk)管理與 FDA 的所有互動,並自 2012 年任期開始以來,該公司已獲得 FDA 批准,為該公司提供了十二種重要新藥。

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 曾擔任全球監管策略和美國監管事務副總裁, 輝瑞公司 (NYSE: PFE) 領導一支由多達 150 位區域監管專業人員組成的團隊,支援藥物開發連續性。在輝瑞工作期間,他領導或支持 FDA 批准許多新藥,並代表輝瑞與 FDA 以及其他全球衛生部門進行關鍵互動,包括重要的項目里程碑會議。

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.

因為 Incannex 是臨床階段的製藥公司,通常與 FDA 和其他監管機構接觸,因此在皮帶上獲得許多 FDA 批准的人應該證明對公司有益。

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

照片:本辛加; 資料來源:禮貌傑洛特, 林德塞福克斯通過皮克斯

 

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