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Challenges and opportunities for the future of monoclonal antibody development: Improving safety assessment and reducing animal use.

ABSTRACT: The market for biotherapeutic monoclonal antibodies (mAbs) is large and is growing rapidly. However, attrition poses a significant challenge for the development of mAbs, and for biopharmaceuticals in general, with large associated costs in resource and animal use. Termination of candidate mAbs may occur due to poor translation from preclinical models to human safety. It is critical that the industry addresses this problem to maintain productivity. Though attrition poses a significant challenge for pharmaceuticals in general, there are specific challenges related to the development of antibody-based products. Due to species specificity, non-human primates (NHP) are frequently the only pharmacologically relevant species for nonclinical safety and toxicology testing for the majority of antibody-based products, and therefore, as more mAbs are developed, increased NHP use is anticipated. The integration of new and emerging in vitro and in silico technologies, e.g., cell- and tissue-based approaches, systems pharmacology and modeling, have the potential to improve the human safety prediction and the therapeutic mAb development process, while reducing and refining animal use simultaneously. In 2014, to engage in open discussion about the challenges and opportunities for the future of mAb development, a workshop was held with over 60 regulators and experts in drug development, mechanistic toxicology and emerging technologies to discuss this issue. The workshop used industry case-studies to discuss the value of the in vivo studies and identify opportunities for in vitro technologies in human safety assessment. From these and continuing discussions it is clear that there are opportunities to improve safety assessment in mAb development using non-animal technologies, potentially reducing future attrition, and there is a shared desire to reduce animal use through minimised study design and reduced numbers of studies.

SUBMITTER: Sewell F

PROVIDER: S-EPMC5524158 | biostudies-other | 2017 Jul

REPOSITORIES: biostudies-other

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Project description:BackgroundMedical training through specialization and even subspecialization has contributed significantly to clinical excellence in treating single acute conditions. However, the needs of complex patients go beyond single diseases, and there is a need to identify a group of generalists who are able to deliver cost-effective, holistic care to patients with multiple comorbidities and multi-faceted needs. Community hospitals (CHs) are a critical part of Singapore's shift toward a community-centric care model as the population ages. Community Hospitals of the Future ("CHoF") represent a series of emerging conversations around approaches to reimagine and redesign care delivery in a CH setting in response to changing care needs.MethodsAn environmental scan in the CH landscape using semi-structured interviews was conducted with 26 senior management, management, and working-level staff from seven community hospitals in Singapore. This environmental scan aims to understand the current barriers and future opportunities for CHs; to guide how CHs would have to shift in terms of (i) care delivery and resourcing, (ii) information flow, and (iii) financing; and to conceptualize CHoF to meet the changing care needs in Singapore.FindingsThe analysis of all transcripts revealed four broad sections of themes: (i) current care delivery in CHs, (ii) current challenges of CHs, (iii) future opportunities, and (iv) challenges in reimagining CHs. An emerging theme regarding the current key performance indicators used also surfaced. Resource limitations and financing structure of CH surfaced as limitations to expanding its capability. However, room for expansion of CH roles tapping on the current expertise were acknowledged and shared.ConclusionWith the current issues of (i) rapidly aging population, (ii) specialist-centric healthcare system, and (iii) fragmentation of care ecosystem, there is a need to further understand how CHoF can be modeled to better tackle them. Therefore, several important questions have been devised to land us in a microscopic view on how to develop CHoF in the right constructs. Demographic changes, patient segmentation, service and regulatory parameters, patient's perspective, care delivery, and financial levers (or lack of) are some of the categories that the interview questions looked into. Therefore, the data gathered would be used to guide and refine the concept of CHoF.

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Challenges and opportunities for the future of monoclonal antibody development: Improving safety assessment and reducing animal use.

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