Nonclinical & Early Clinical Development
With 20 years in diverse areas of the pharmaceutical industry, Dr. Carlo Chiavaroli has considerable expertise in the drug development process.
Upon completing a PhD program in Biochemistry at the University of Geneva in 1992, Carlo proceeded with a postdoctoral research in cell signaling at the National Institute of Environmental Health Sciences (NIEHS) Center for Environmental Health in Research Triangle Park, NC, USA.
Carlo then joined the pharmaceutical industry in 1995 where he gained experience from both sides of the CRO/Client relationship. First in Geneva, as Research Scientist for the American CRO Battelle and later as Pharmacologist with OM Pharma, a Swiss pharmaceutical company now part of Vifor Pharma.
At OM Pharma, Carlo gained considerable amount of experience in immunotherapy, vaccine development, immunology, and oncology. During 12 years Carlo was very much involved in the treatment of cancers by immunotherapy (at the nonclinical and clinical level), and in immunology projects using lipid-A derivatives to modulate the host immunological status. In addition, Carlo worked considerably on the elucidation of the mechanism of action of immune-modulating bacterial extracts approved for the prevention of respiratory and urinary tract infections.
In 2009, Carlo became a management team member at Med Discovery, a Swiss biopharmaceutical company dedicated to the discovery and the development of highly specific treatments for uro-genital cancers, where he was in charge of Clinical Development. Carlo had specific responsibility for evaluating and selecting clinical CROs and vendors, writing development plans and major clinical documents as well as organizing scientific and clinical advisory boards with key opinion leaders in oncology.
Carlo joined Voisin Consulting Life Sciences in January 2011, and has worked since on approximately 200 different life-sciences projects. As Director, he is consultant and/or project manager in multi-disciplinary teams and thus acts as a key contributor to projects where Nonclinical and Early Clinical considerations are particularly challenging. In particular, Carlo has conducted gap analyses, wrote or commented on development plans, Investigator Brochures, CTD Modules (2.4, 2.5, 2.6), and prepared packages for Scientific Advice with EMA and National Agencies. These projects concerned New Chemical Entities, Well Established Products, Combination Products, Biologics, Biosimilars, and Gene Therapy Medicinal Products.
At Voisin Consulting, the main projects in which Carlo is involved concern the following therapeutic areas: Oncology, CNS disorders, Autoimmune, Ophthalmology, Respiratory Disease, Inflammation, Muscular Dystrophies, Dermatology, Vaccines, Pain, Stroke, (cardio)vascular Disorders, and Reproduction.