Incannex has appointed a former Pfizer and now Novo Nordisk A/S executive to its board to help steer regulatory approvals for its key cannabinoid and psychedelic medicinal therapies.

Clinical stage pharmaceutical cannabinoid and psychedelics company Incannex Healthcare (ASX:IHL) has appointed international pharmaceutical regulatory heavyweight Robert B. Clark to its board as a non-executive director.

Clark is a senior-level strategic regulatory affairs expert with more than 38 years of US and global regulatory experience in a move the company believes is a vote of confidence in their business.

He worked with global pharmaceutical giant Pfizer (NYSE:PFE) for more than 20 years and was vice president of worldwide regulatory strategy and US regulatory affairs at the company.

Clark led a team of up to 150 regional regulatory professionals supporting drug development.

At Pfizer he led or supported US Food and Drug Administration (FDA) approval of many new medicines and represented the company at critical interactions with FDA, and other global health authorities, including key project milestone meetings.

Clark joined Danish multinational pharmaceutical powerhouse Novo Nordisk A/S (NYSE:NVO, CPH:NOVO-B) in 2012, where he is currently vice president, US regulatory affairs.

Novo Nordisk has a market cap of ~US$185 billion, and is one of the world’s biggest companies.

Clark is an internationally recognised expert on FDA and the European Medicines Agency (EMA) liaison interactions, US pharmaceutical advertising practices and regulatory aspects related to healthcare professionals and sales force activities.

At Novo Nordisk, Clark provides strategic leadership to more than 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 12 significant new drugs since he started at the company a decade ago.

Proven track record to be applied to ‘medcan’ and psychedelics

Clark has senior level experience in managing regulatory aspects of large-scale pharmaceutical acquisitions, significant compliance matters and business development due diligence.

He has documented success with FDA accelerated approval programs including fast-track, orphan drug, breakthrough therapy designations, and priority reviews, which are areas of interest for IHL management due to the nature of its drug candidate mix.

Clark’s appointment follows IHL’s landmark acquisition of leading cannabinoid biotech company APIRx Pharmaceuticals (APIRx), which further strengthens its global position in the cannabinoid and psychedelic sectors.

Independent validation from a pharmaceutical superstar

IHL CEO and managing director Joel Latham describe Clarke as among the best credentialed regulatory affairs experts globally and said his appointment to the board of directors is a strong vote of confidence in its drug candidates and development strategy.

“He brings to Incannex deep knowledge of the US regulatory environment and decades of experience at the highest level of large pharmaceutical organisations,” Latham said.

“His experience will be invaluable to us now that our interactions with FDA have become more frequent whilst we pursue our mission to bring cannabinoid and psychedelic pharmacological solutions to patients with unmet medical needs.”

Clark said he was looking forward to being a part of the burgeoning cannabinoid and psychedelic medicines sector through his IHL appointment.

“I look forward to working with the board and the management team, and I am excited about the broad Incannex portfolio of products to treat patients who have few or no other available treatments,” he said.

“Cannabinoid and psychedelic pharmacotherapies represent a growing area of research and hold the potential to treat various conditions for which effective options are limited.”

This article was developed in collaboration with Incannex Healthcare,a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.