Dr. Gerhard Hager
The NCD Company, Austria
Gerhard is a non-clinical development expert with extensive experience in the design and management of preclinical programs. He has a broad expertise in early drug development ranging from small molecules to biologics, vaccines to ATMPs. After almost 20 years in the CRO and Pharma industry, today he is director of The NCD Company, which provides non-clinical drug development services to the pharmaceutical industry.
Gerhard holds a PhD from the Ludwig-Maximilians-University Munich. After 10 years in Neuroscience, he started his industrial career by leading a full-service non-clinical CRO for Pharmacology, ADME, Bioanalytics and Toxicology. In 2015 he left the CRO and became Head of Toxicology at Baxalta Innovations GmbH (later Shire PLC). Gerhard has extensive experience in the interdisciplinary design and management of early drug development programs integrating research, pharmacology, ADME and toxicology for different indications such as tumor, inflammation and hematology and substance classes (e.g. small molecules, biologics, biosimilars, antibodies, cell and gene therapy).
As facility manager for pharmacological research and GLP-compliant work in various countries and as a leader in outsourcing in the pharmaceutical industry, he is familiar with all aspects of subcontracting in drug development. The NCD Company now provides all kinds of non-clinical services from CRO identification and management of single studies up to the fully integrated management of non-clinical drug development programs, including preparation of submission documents to biotech companies, research institutes and the pharmaceutical industry.
Dr. Paolo Rosato
Senior Scientist, Non-clinical Development Drug Discovery
Paolo is a pharmaceutical scientist with long experience in a Big Pharma company and also in a Contract Research Organization. Currently he works in Drug Discovery in Takeda Austria in the Hematology field and on both small and large molecules. He is a non-clinical project team member and is also responsible for non-clinical due diligences for in-licensing compounds.
After earning his degree in Chemistry, Paolo worked for more than 20 years in a Big Pharma company in the Drug Metabolism and Pharmacokinetics Department, in both Discovery and Development phases, mainly in CNS diseases and small molecules. Over the years, he covered almost all the roles in the Department (LC-MS Bioanalyst, Pharmacokineticist, Toxicokineticist and Study Director). He was Laboratory Head for more than 10 years with the responsibility of almost all in vitro and in vivo DMPK/ADME studies. He was a Senior Scientist in PK, PK/PD and TK data analysis, modeling and simulation and a DMPK Project Representative for 15 years in different Project Teams, in various therapeutic areas.
After this experience, he worked for 3 years in a Contract Research Organization, always in the DMPK Department. Here he expanded his experience in almost all therapeutic areas and types of molecules.
GXP Auditor and Trainer
Mirabilitas Ltd, United Kingdom
Louise is a quality assurance auditor and trainer with extensive experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and, more recently, Good Pharmacovigilance Practice (GVP). She studied at Leicester Polytechnic (Science of Medicinal & Cosmetic products) and The Open University (BSc Honors).
Working initially in inhalation formulations research and development, Louise moved into Quality Assurance in 1995, where she was employed by a UK Phase I unit with responsibility for overseeing Study GCP compliance. She left Leicester to move to Harrogate, North Yorkshire, and a large Contract Research Organization, working in the field of GLP. Following 10 years as an auditor, Louise joined the UK Medicines and Healthcare Products Regulatory Agency (MHRA) as a GCP Inspector, where she cross-trained as a GLP Monitoring Authority (GLPMA) Inspector
As an active participant at the European Medicines Agency (EMA) GCP Inspectors Working Group, Louise supported the development of guidance on risk-adapted clinical trial methodologies, bioequivalence and clinical laboratory inspections, and GCP for Advanced Therapy Medicinal Products. Louise also participated in joint working with US FDA Investigators for GCP and contributed to Clinical Trial Transformation Initiative meetings. She currently provides Quality Assurance and training support to those involved in pharmaceutical development, including pharmaceutical companies, biotech companies and those in the non commercial sector. She is currently the Chair of the Auditors’ Working Party for the European Forum for GCP and is a member of The Research Quality Association.