Alex Veldman

Company: CSL Behring
Alex

Alex is a board certified pediatrician, neonatologist and pediatric cardiologist with more than 10 years of experience in managing critically ill newborns and children in large university hospitals and 3 years of experince in the role as Director in Global Clinical R&D at CSL Behring. His clinical expertise in the area of pediatric and neonatal critical care medicine becomes evident in > 50 pubmed listed research papers that received > 700 citations.

In the last three years, Alex focused on the transition of programs form pre-clinical Proof of Concept into first–in-human Phase 1 studies. Alex is familiar with the scientific and regulatory requirements for pre-clinical toxicology, immunogenicity and dose finding. In his current role as leader of a multifunctional clinical development team in a highly matrixed environment he has successfully designed the key strategy of several clinical development plans for new bio-pharmaceuticals from Phase I to Phase III and negotiated a pathway to registration with the major global regulatory bodies (EMA, TGA, MFDS, PMDA and FDA). Alex is familiar with the process of orphan drug registration in various legislations and has experience in developing pediatric investigational plans (PIP) as required for the market authorization for new medicines in the EU.

Alex has successfully partnered an academic drug development program with a US pharmaceutical company (Alexion Pharmaceuticals, Connecticut, USA) and had the lead responsibility for the clinical part of the due diligence in that process. In addition to his role in industry, he is still holding an academic position as Associate Professor in the Faculty of Medicine, Dept. of Pediatrics at Monash University in Melbourne, Australia.