Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers

ISBN-13: 9780128237410 / Angielski / Miękka / 2022

Johannes Schmidt; Beate Bittner

Spis treści

1. Enabling customer-centric and sustainable drug delivery-formulation and device lifecycle management of biotherapeutics
2. Clinical development of subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies-pharmacokinetic-based bridging approach
3. Clinical development of automated subcutaneous injection devices-established pathways and novel concepts
4. Enabling a flexible care setting in oncology-how to realize home- and self-administration of biotherapeutics in cancer care
5. Formulation and device lifecycle management of biotherapeutics-leveraging synergies across therapeutic areas
6. Formulation and device lifecycle management of biotherapeutics-decision architecture
7. Summary and outlook

O autorze

Dr. Beate Bittner (Formulation and Device Franchise Leader, F. Hoffmann-La Roche) is a Pharmacist, and holds a PhD in Pharmaceutical Technology and Biopharmaceutics and Diploma in European Market Access. She has work experience as a Laboratory Head (Preformulation), Drug Metabolism and Pharmacokinetics Project Leader, Clinical Pharmacologist, Early Research and Development Project Leader, Clinical Team Leader, Global Development Team Leader, Product Optimization Director, and Senior Portfolio Strategy Director in enabling science-based strategic decision-making across all phases of drug discovery, development, and commercialization and in leading global strategic initiatives, clinical and cross-functional development, and project teams. Her major focus was on expanding access to medicines through optimized drug delivery. She also worked as a lecturer in pharmacology, developing new drugs and personalized healthcare (Baden-Wuertemberg Cooperative State University). Dr. Beate Bittner has more than 45 scientific publications and review articles in her name covering formulation and device lifecycle management. Dr. Johannes Schmidt (Global Head Product Optimization, F. Hoffmann-La Roche) is a Chemist, and holds a PhD in Organic Chemistry and Diploma in Pharmaceutical Medicine Development. He has work experience as a Laboratory Head (Analytics), Technical Development Leader, Early Research and Development Project Leader, Clinical Team Leader, and Lifecycle Leader in leading both small molecule and biotherapeutic programs in all phases of drug development and commercialization across multiple therapeutic areas, in guiding establishment of customer-centric target product profiles and implementation of innovative development strategies to maximize patient access; and in guiding strategic initiatives and multifunctional project teams related to formulation and device lifecycle management. His major focus was on maximizing product differentiation and patient access to medicines.