这份白皮书讨论了专门针对新兴生物制药量身定制的合作解决方案。考虑到整个生物制药市场的这一部分的巨大进步，即使每个公司只有一两个资产，总管道等于整个全球行业渠道的大约三分之二。与服务提供商完全协作的外包安排，新兴的生物制药为新兴生物制药提供了很好的服务。在越来越复杂的药物开发和医疗保健环境中，对于公司而言，即使要获得其意图或在概念验证证明后获得其资必威手机APP产，也非常重要。从交易到完全集成的外包合作选择的过渡在这方面可能非常有益，因为它使公司能够利用其合作伙伴的治疗专业知识，资源能力和组织基础架构。
Today, EBP (emerging biopharma) organizations play an increasingly crucial role in bringing new therapies, devices and diagnostics to healthcare providers and patients across a range of therapeutic areas and unmet medical need.
EBP公司通常将重点放在一个或两个资产上，从启动到更成熟，正式到虚拟组织。根据最近的生物行业分析，他们的管道非常强大，正在开发的4,700多个药物指示计划，相当于整个全球行业管道的71％。
EBP公司充当高增长的创新引擎，大型和中期的组织组织，公共和私人投资者以及其他利益相关者要求采取强大的战略，旨在证明，驾驶和交付最高的投资回报率。现代EBP执行团队寻求新颖的方法来实现这一目标，越来越多地探索与服务提供商的完全协作外包安排，这是其整体组织战略的主要组成部分。
This paper is the first part of a series of articles aimed at helping the EBP executive and his/her team members better assess the value of a “partnered” outsourcing approach across the continuum of development and commercialization, and potential approaches to mapping out the right fit for their organizational needs. Throughout this paper the term “partnered” is used to describe collaborative service engagements between EBPs and global clinical development and commercial service providers, and should not be misinterpreted as a financial investment by a service provider.
DEMONSTRATING VALUE IN AN INCREASINGLY COMPLEX ENVIRONMENT
Operating a start-up, or even relatively mature but still small EBP organization, carries a tremendous weight and wide range of responsibilities. The EBP executive and his or her team are typically “betting the farm” on a singular indication or therapeutic area, a limited number of assets, and a small, highly dedicated organization. This comes with certain advantages – streamlined infrastructure and nimbleness, for example – but also presents unique challenges, i.e., limited/constrained resourcing, expertise gaps in clinical and commercial functions and ability to scale processes and relationships across programs, just to name a few.
EBPs are developing clinical assets through much later stages of development, and in those cases where it has entered into a partnership with larger pharma companies, these organizations are now being asked to carryout Phase II and Phase III development rather than integrating or jointly developing with the larger organization.
Even if the intention is to be acquired or to out-license following proof of concept, the need for strong clinical trial data is essential for sharing with prospective partners. The multi-layered body of evidence required to substantiate a minimal level of value, and even more to substantiate a comprehensive value story in the most compelling manner, spans all phases of development.