Formulation and Device Lifecycle Management of Biotherapeutics - Bittner, Beate;Schmidt, Johannes
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Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home…mehr

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Produktbeschreibung
Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home dosing and self-administration for eligible patients.

Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the various aspects of improving drug delivery of biological medicines with the ultimate goal to reduce dosing complexity associated with parenteral administration and, thus, enhance patient experience and drug administration-related healthcare capacity. The target audience are multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development. This includes pharmacology and medical experts in charge of generating nonclinical and clinical data to support approval of novel dosing regimens, and drug delivery scientists and engineers responsible for technical particulars of product optimizations. Moreover, professionals in market access and commercial functions are expected to benefit from the discussions about the impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution.
Autorenporträt
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.