Incannex Healthcare appoints big pharma regulatory affairs expert to board of directors
Novo Nordisk executive Robert B Clark has joined Incannex Healthcare’s board as a non-executive director.
Incannex Healthcare (ASX: IHL) has appointed experienced pharmaceutical executive Robert B Clark to its board as a non-executive director.
Mr Clark is a strategic regulatory affairs expert with over 38 years of experience in United States and global markets, including more than two decades with Pfizer Inc and more than 10 years with Danish multi-national Novo Nordisk, which has a market capitalisation of US$185 billion (A$264 billion).
He is an internationally-recognised authority on US Food and Drug Administration (FDA) and European Medicines Agency (EMA) interactions, US pharmaceutical advertising practices and regulatory aspects related pharmaceutical sales activities.
In his current role of vice president (US regulatory affairs) at Novo Nordisk, Mr Clark leads a team of over 50 regulatory staff and scientists in the development of new medicines. Mr Clark and his team have secured FDA approvals for 12 new drugs over the past 10 years since his tenure began in 2012.
Major coup for a small cap
Incannex chief executive officer Joel Latham welcomed Mr Clark to the board in recognition of his major league experience in successful drugs approvals for big pharma companies.
“Bob is amongst the best credentialed regulatory affairs experts in the world, and join our board is a strong vote of confidence in our drug candidates and development strategy,” he said.
“He brings a deep knowledge of the US regulatory environment and decades of experience at the highest level of large pharmaceutical organisations his experience will be valuable to us now that our interactions with FDA have become more frequent.”
Mr Latham said Mr Clark will assist the company to pursue its mission of bringing FDA-approved cannabinoid and psychedelic drugs at the cutting edge of drug development to the market.
In the announcement, Mr Clark said he looked forward to working with the board and management team.
“Cannabinoid and psychedelic pharmacotherapies represent a growing area of research and hold the potential to treat various conditions for which effective options are currently limited,” he said.
Pfizer experience
Prior to joining Novo Nordisk, Mr Clark worked for Pfizer in the role of vice president (worldwide regulatory strategy and US regulatory affairs) leading a team of up to 150 regional professionals supporting the drug development continuum.
During this time, he led FDA approvals for many new medicines and represented Pfizer at critical interactions with other global health authorities.
Mr Clark has senior level experience in managing regulatory aspects of large-scale pharmaceutical acquisitions, significant compliance matters and business development due diligence activities.
He also has documented success with FDA accelerated approval programs including fast-track, orphan drug, breakthrough therapy designations and priority reviews.
These are also areas of interest for Incannex management due to the nature of its drug candidate mix, which includes more than 20 research and development projects.