- Dr. Gerhard Hager
- Head of Toxicology
- Shire, Austria
Gerhard is a non-clinical development expert with extensive experience in design and management of preclinical programs. He has broad expertise in early drug development ranging from small molecules to biologics, vaccines and ATMPs. After almost 20 years in the Contract Research Organisation (CRO) and Pharma industry, he is today director of The NCD Company, providing 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 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 (e.g. 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 and leading global pharmaceutical outsourcing, Gerhard he is familiar with all aspects of subcontracting in drug development. The NCD Company provides a wide range of non-clinical services from CRO identification and management of single studies, to fully integrated management of non-clinical drug development programs including preparation of submission documents for biotech companies, research institutes and the pharmaceutical industry.
- Dr. Paolo Rossato
- Senior Scientist and Pharmaceutical Researcher
- Shire, Austria
After his degree in Chemistry, Paolo worked for more than 20 years in an international large pharmaceutical company in the Drug Metabolism and Pharmacokinetics (DMPK) Department. He has experience of working in both Drug Discovery and Development phases, mainly in CNS diseases and small molecules. Over the years, he has taken many roles, including (but not limited to): LCMS Bioanalyst, Pharmacokineticist, Toxicokineticist and Study Director.
He was Laboratory Head for more than 10 years with the responsibility for many 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 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 where he expanded his experience to other therapeutic areas and types of molecules.
- Dr. Louise Mawer
- Quality assurance Consultant and Auditor
- 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 Honours). 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 as a Quality Assurance Associate, with responsibility for overseeing Study GCP compliance. She left Leicester to move to Harrogate, North Yorkshire, and a large Contract Research Organisation, 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.
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 large Pharmaceutical companies, small biotech companies and those in the non commercial sector, including Universities and the NHS. She is Board Member for Strategy for The Research Quality Association.