In 2021, CombiGene’s epilepsy project CG01 will focus on the final preclinical studies, not least the important biodistribution and toxicology studies, with the aim of starting studies in humans, so-called clinical studies, in 2022. A central area for both the final preclinical studies and future clinical studies is the GMP manufacturing of CG01. CombiGene has therefore recruited Martin Linhult, as the company’s CMC expert (Chemistry, Manufacturing and Controls) starting in December 2020. In addition to his expertise in the CMC field, CombiGene will benefit greatly from his experience in taking pharmaceutical products all the way to market.
Martin Linhult holds a PhD in molecular biology at Royal Institute of Technology (KTH) in Stockholm (1998-2003) and holds a Master of Chemical Engineering from the same university. In addition, Martin has extensive experience from a number of senior positions in the Swedish pharmaceutical industry and is used to interacting with regulatory authorities at an international level, including the FDA and EMA. Martin has worked in all parts of the production process of biological drugs and was responsible for building up the production unit at Octapharma. Martin will primarily work on the various aspects of the manufacture of the drug candidate CG01, which is now entering a very intensive development phase. Martin will report to CombiGenes Chief Research and Development Officer Karin Agerman.
“I am incredibly pleased that we have succeeded in recruiting Martin Linhult to CombiGene”, says Karin Agerman. “Martin has exactly the deep knowledge in all aspects of the production of biological drugs that we are looking for and has, in addition to this, experience of taking a product all the way to market. His broad international experience in regulatory matters will be of great benefit in the further development of CG01.”
CombiGene is now continuing the process of strengthening the company with one or two more people.