Professor, University of Southern Denmark
Drug formulation and product development
Dr. René Holm received his pharmaceutical training at the Royal Danish School of Pharmacy, now the school of pharmacy at University of Copenhagen, Denmark, in 1998 and his PhD in biopharmaceutics from the same institution in 2002. Dr. Holm joined H. Lundbeck A/S in 2001 and then moved to Janssen in 2016, where he headed drug product development for parenteral and liquid formulations. Dr. Holm has worked within pharmaceutical development and the associated process development, developability in drug discovery, physical chemistry and material science covering both small and large molecules and have been deeply involved in several INDs with advantaged drug delivery. As of 2021 Dr. Holm has been a full professor in Pharmaceutical physical chemistry at the university of Southern Denmark.
Dr. Holm is (co-) author of more than 240 original articles in peer-reviewed journals and patents in the field of biopharmaceutics, preformulation, formulation and physical pharmacy and is an honorary professor in physical chemistry at the Department of Science and Environment, University of Roskilde, Denmark.
Consultant for biopharmaceutical industry
Oligonucleotide and regulatory toxicology
Kenneth Loveday received his BS in physics from Yale University and earned his PhD in microbiology from the Massachusetts Institute of Technology. After completing a postdoctoral fellowship in human genetics at Children’s Hospital Medical Center (Boston, MA), he started a laboratory in genetic toxicology for a contract research organization (CRO). While working in several CROs, he served as a principal investigator in several NIEHS-sponsored projects to improve in vitro chromosomal aberration assays. He subsequently expanded his expertise to include animal toxicology and earned his DABT certification in 1992.
From 1996 to 2023, he worked in the biopharmaceutical industry and helped develop a variety of new drugs, which have been approved worldwide, including a bone-healing protein, replacement enzymes, clotting factors, and receptor trap/fusion proteins. In addition, he has worked on the development of several ASOs, including Spinraza (nusinersen) for the treatment of spinal muscular atrophy, which received the Prix Galien Award in 2017 for Best Biotechnology Product. Since late 2023, he has worked as a consultant to the biopharmaceutical industry, specializing in the design and execution of preclinical programs to support IND and NDA filings.
Seasoned life science executive & entrepreneur
CMC regulatory considerations for oligonucleotide drug products
Dr. Christoph Rosenbohm has over 20 years of experience in biotechnology and drug development, working across Europe and the United States. He has led the development of oligonucleotide-based technical programs from preclinical research to Phase III clinical supplies and has built and optimized supply chains for critical raw materials to support internal research, strategic partnerships, and GMP production for clinical trials. With a background spanning both large pharmaceutical companies and biotech startups, Dr. Rosenbohm combines a deep understanding of scientific innovation with strategic leadership. He has been instrumental in advancing cutting-edge technologies and driving innovation processes that have contributed to the development of new therapeutic solutions.
Dr. Rosenbohm holds a PhD in Bioorganic Chemistry and a Master’s degree in Organic Chemistry from the University of Southern Denmark. He has further enhanced his expertise with an Executive MBA from Copenhagen Business School, equipping him with a unique ability to bridge technical excellence and strategic business insight.
Department of Neurology, IRCCS San Raffaele Pisana Roma Italy
Expert in Parkinson’s disease and movement disorders
Fabrizio Stocchi, MD, PhD, is Professor of Neurology, Consultant in Neurology and Director of the Parkinson’s disease and Movement disorders research centre and director of the drug development research centre at the University and Institute for Research and Medical Care IRCCS San Raffaele Rome. He is also Scientific advisor of the Institute for Parkinson’s Disease Research in Vicenza. Professor Stocchi was awarded his MD from the University of L’Aquila and his PhD from the University of Catania. Professor Stocchi’s research activities have centred on neuropharmacology in the field of movement disorders and neurodegenerative diseases.
Professor Stocchi pioneered (along with Dr. Obeso and Tom Chase) in the 80’s the concept of “continuous dopaminergic stimulation” for Parkinson’s disease and started the subcutaneous and intraintestinal infusion of dopaminergic drugs. He designs and conducts a large number of clinical trials in Parkinson’s disease and actively participate to studies aimed to understand pathophysiology of PD and other movement disorders. He has published many books and papers on the genetics, clinical diagnosis, characterisation and treatment of Parkinson’s disease, as well as in preclinical research into the disease. He is an active member of 11 societies, including the Movement Disorders Society, the WFN society where is member of the extrapiramidal committee, the European Clinical Neuropharmacology Society and the European Accademy of Neurology.
Co-founder, expert drug developer, seasoned biotech entrepreneur
Early pharmaceutical development
Dr. Mikael Thomsen has more than 25 years of experience from the pharma and biotech industry and worked within different major pharmaceutical companies including Novartis Pharma, Switzerland, Novo Nordisk, Denmark as well as at the U.S. Food and Drug Administration. He is co-founder of numerous international biotech companies including Contera Pharma. He is an experienced Clinical Pharmacologist and has had roles as Head of Clinical Pharmacology, VP Development, Chief Development Officer and Chief Scientific Officer, where he managed departments organizing all the activities leading a drug from late Discovery trough clinical development. He has been involved in several product filings as well as interactions with authorities from EMA, FDA and MHLW (Japan).
Mikael Thomsen has two M. Sc. degrees (Pharmacy and Human Biology; from University of Pharmaceutical Sciences, Copenhagen and University of Copenhagen, Medical Faculty) and has a PhD in Pharmacology and Toxicology (University of Copenhagen and FDA site, Arkansas, US) and a degree in Pharmaceutical Medicine (ECPM, Basel, Switzerland). He is a member of several pharmaceutical societies and has authored or co-authored more than 50 publications/abstracts related to drug development as well co-author of several patents.