PharmAust, a clinical-stage biotechnology company, has appointed Dr Herbert Brinkman as head of Manufacturing as the company prepares for commercialisation.
Dr Brinkman’s appointment coincides with the rapid development of monepantel (MPL) for treating patients with Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS).
The ASX-listed company said it has finalised manufacturing process development agreements with global leaders Syngene International and Catalent Pharma Solutions to initiate validation and registration batches at scale.
These efforts aim to support regulatory approval and the commercialisation of monepantel.
Based in Denver, Colorado, Dr Brinkman brings over 30 years of experience in the pharmaceutical industry to his new role.
He has a strong track record in preparing Chemistry Manufacturing and Control (CMC) sections for various regulatory filings, including with the United States Food and Drug Administration (FDA) and European agencies.
Dr Brinkman has also been instrumental in the launch of nine commercial products spanning multiple therapeutic areas and has contributed to numerous regulatory filings.
Meanwhile, Dr Michael Thurn, CEO of PharmAust, remarked on the significance of Dr Brinkman’s appointment.
“This is a significant appointment for PharmAust. Herb has considerable expertise in product development, manufacturing, and launching pharmaceutical products.”
He highlighted the importance of scaling up the company’s Good Manufacturing Practice (GMP) capabilities to support potential accelerated approval and the rapid deployment of products upon approval.
PharmAust revealed it is on the cusp of potentially receiving accelerated or full approval for monepantel in the treatment of MND/ALS, positioning itself as a leading developer of neurodegenerative medicines.
Dr Thurn expressed his anticipation in collaborating with Dr Brinkman as the company advances towards its commercialisation goals.
