Tag: clinical development

Company News: Anergis Appoints Kim Simonsen as Chief Development Officer

– Senior Biotech Executive brings over 25 years of drug development expertise

Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, today announced the appointment of Kim Simonsen, MD, as Chief Development Officer. Mr. Simonsen will head Anergis´ global product development from preclinical development to registration, including CMC, clinical development, regulatory affairs and global project management.

Kim Simonsen joins Anergis from Ablynx NV, where he was Chief Operations Officer. Prior to that, he was Senior Director, Global Clinical Development, at ALK Abello A/S, where he led the clinical development of Grazax®, the first marketed grass pollen allergy immunotherapy tablet. From 2000 to 2005, Mr. Simonsen was Chief Executive Officer of the CRO Medicon A/S after having held various clinical development roles at big pharmaceutical companies, e.g. as Medical Director of Novartis Healthcare A/S, Director of Clinical Operations at Novo Nordisk A/S, and as Medical Director and Clinical Expert at Sandoz A/S.

Prior to joining the biopharmaceutical industry in 1986, Mr. Simonsen trained as an MD at Copenhagen University and worked for five years at two different clinics in the Copenhagen area, focusing on internal medicine (gastroenterology, respiratory, cardiology). During his career, Mr. Simonsen has gained extensive experience in clinical drug development, including regulatory affairs, clinical pharmacology, and the design and management of clinical trials and pharmacovigilance. His expertise covers an extensive range of disease indications, incl. allergy immunotherapy, immunology, oncology, rheumatology, and cardiovascular and pulmonary diseases.

Company News: Merus Appoints Setareh van Driel Shamsili as Chief Medical Officer

Merus B.V., a biopharmaceutical company focused on innovative human antibody therapeutics, today announced the appointment of Setareh van Driel Shamsili, MD, Ph.D., as Chief Medical Officer (CMO).

Setareh van Driel Shamsili has more than 22 years of experience in general medicine, internal medicine and medical oncology. For the past 13 years, she has focused on both translational and clinical cancer research. She has more than eight years of experience in the pharmaceutical industry, including drug development, R&D, medical affairs, drug safety and pharmacovigilance and holds a PhD in Neuro-Oncology from Erasmus University Rotterdam.

Prior to joining Merus, Setareh van Driel Shamsili was Global Medical Leader Oncology at Astellas Pharma Global Development.

Company News: Aleva Neurotherapeutics Closes EUR 9.5 Million Series A Financing Round

– Novel Products for Deep Brain Stimulation (DBS) to Be Advanced Into the Clinic –

Aleva Neurotherapeutics, a company developing next-generation implants for Deep Brain Stimulation (DBS) in major neurological indications such as Parkinson´s disease or depression, today announced the closing of a Series A financing round totaling EUR 9.5 million. Aleva was founded in 2008 as a spin-off from the Ecole Polytechnique Fédérale de Lausanne (EPFL) Microsystems Laboratory.

The round was funded by a group of seasoned industry specialists and co-led by BioMedInvest AG (managed by BioMedPartners AG, Basel, Switzerland) and BB BIOTECH VENTURES III, L.P. (advised by Bellevue Asset Management AG, Kuesnacht, Switzerland). Initiative Capital Romandie (Lausanne, Switzerland) and renowned private investors also participated in the financing.

The proceeds will be used to support the development of Aleva’s pioneering product pipeline for neurostimulation, which is based on the company’s proprietary microDBS™ technology. microDBS™ is a next-generation technology addressing Deep Brain Stimulation therapy, currently a US$ 450 million market with strong double-digit growth rates.

Aleva’s microDBS™ technology for target-specific stimulation has been developed to significantly reduce the side effects and potential complications as well as the costs of DBS therapy. Moreover, its features allow for expanding the existing DBS market to new indications which cannot be addressed by currently available technologies.

The company is developing three products based on its microDBS™ technology: directSTIM™, an intelligent electrode compatible with existing DBS platforms; spiderSTIM™, a full solution for both intra-surgical and long-term therapeutic use; and the cortiSTIM™ device for cortical stimulation. All products will be compatible with marketed pulse generators. Clinical trials of the lead product, directSTIM™, are scheduled to start later this year.