Principles of Biomedical Sciences and Industry

This practical guide to four major areas within the biomedical industry (pharmaceuticals, diagnostics, biomaterials, medical devices) covers the entire product lifecycle, from translating a scientific result into a prototype to product launch and portfolio management.

Autorentext
Markus Hinder studied medicine at the Universities of Heidelberg, Paris and Zürich and obtained a doctoral degree in pharmacology from Heidelberg University. After graduation he trained in clinical pharmacology, cardiology and emergency medicine. He underwent postgraduate training in clinical trial methodology and statistics at the Universities of Basel and Brussels. He joined the pharmaceutical industry more than 20 years ago and held senior leadership positions in clinical pharmacology, translational medicine, clinical development, medical affairs and project management. He has been lecturing pharmacology and pharmaceutical R&D since 2004. In 2010 he was appointed professor at Cardiff University/ Hochschule Fresenius. He serves as a reviewer for several journals and associate editor for the Journal of Translational Medicine. Alexander Schuhmacher graduated in biology from the University of Konstanz (Germany), in pharmaceutical medicine at the University of Witten/Herdecke (Germany) and did a Ph.D. in molecular biology at the University of Konstanz; he is also a graduate of the Executive MBA program at the University of St. Gallen (Switzerland). Alexander holds a full professorship in life science management at the Technische Hochschule Ingolstadt (Germany). His research focus is on biopharmaceutical innovation management with a specialization on R&D efficiency, artificial intelligence and open innovation. Prior to that, Alexander worked 9 years as professor at Reutlingen University (Germany) and 14 years in various R&D leadership positions in the pharmaceutical industry. Jörg Goldhahn received his M.D. 1997 from the Friedrich-Schiller University in Jena, Germany, finished a postgraduate course (MAS) in Medical Physics and Biomechanics at the ETH Zurich in 2000, received the postdoctoral lecture qualification (Habilitation) in 2008 and became a faculty member of the department for health sciences and technology (D-HEST) as adjunct professor 2014. He worked as a translational medicine expert at the Novartis Institutes for Biomedical Research (NIBR) in Basel in addition to more than 15 years in clinical research. He is currently the head of the Institute for Translational Medicine and medical director of the bachelor in medicine at ETH in Zurich, Switzerland. Dominik Hartl studied Medicine at the Universities of Regensburg, Munich and Melbourne and obtained his doctoral degree in Immunology from Munich/LMU University. He is board certified in Pediatrics and Infectious Diseases and worked as Physician Scientist/Post-Doc Scholar at Yale University. He joined the pharmaceutical industry more than 6 years ago and gained extensive experience in his positions in Drug Discovery, Translational Medicine, Biomarkers and Precision Medicine/Personalized Healthcare in Biotech and Big Pharma. In addition to working in the pharmaceutical industry, Dominik is a Professor for Pediatric Immunology/Infectious Diseases at the University of Tübingen.

Inhalt
Biopharmaceutical Innovation at a Glance Pharmacology and Drug Targets - The Basis of Therapeutics Principles and Methods of the Pharmaceutical Drug Discovery Process - From Idea over Target to a Development Candidate Biomarkers - Definitions and Utility for Drug Development Toxicology and Managaing Safety and Risks Introduction to Chemistry Manufacturing and Controls - From Compound and Development Candidate to Drug Translational Medicine - The Bridging Discipline: Role and Tools in the Drug Development Process Decision-Making - What Are the Key Drivers Around Decision-Making in Drug Development? Clinical Drug Development - Clinical Characterization for Regulatory Approval Regulatory Affairs - Communicating with Health Authorities Regulatory Affairs in Device Development - How to Design Medical Devices Capable to Enter the Market Market Entry and Reimbursement - Making Drugs Available for Patients After Drug Approval Pricing in Germany - Key Learnings for Optimising Price Potential After the Introduction of AMNOG Project, Risk and Portfolio Management - Managing R&D Project Costs and Risks Intellectual Property - How to Protect Innovation in the Biopharmaceutical Industry Patents in the Biomedical Sciences and Industry - The Case of Swiss Life Science Company Prionics Pharmaceutical Business Development & Licensing - Overview of a Cross-functional and Multifaceted Role and Its Key Elements in Biopharmaceutical Industry The Entrepreneur's Guide Through the Galaxy of Biotech Funding Medical Technologies - Key Learning from Two Case Studies Diagnostics - Tools for Clinical Decision Making and Clinical Trial Endpoints Vaccination - Towards an Improved Influenza Vaccine