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

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.

• Summarizes formulation and device lifecycle management activities that enable customer-centric and sustainable drug delivery for biotherapeutics
• Describes the pharmacokinetic-based clinical development pathway for subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies
• Details established clinical development pathways supporting the approval of automated subcutaneous injection devices and proposes novel concepts
• Discusses how to realize home- and self-administration of biotherapeutics in cancer care
• Highlights aspects of multidisciplinary formulation and device lifecycle management that can be leveraged across different disease areas and introduces a decision architecture on when and how drug developers should embark into related development activities

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

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.