This white paper discusses partnering solutions that are specifically tailored for emerging biopharma. Given tremendous advances in this segment of the overall biopharmaceutical market, even though each company may only have one or two assets, the total pipeline is equivalent to roughly two-thirds of the entire global industry pipeline. Emerging biopharma is well served by fully collaborative outsourcing arrangements with service providers. In an increasingly complex drug development and healthcare environment, it is extremely important for companies to be able to demonstrate value, even if their intention is to be acquired or to out-license their asset following proof-of-concept. Transitioning from transactional to fully integrated outsourced partnering options can be extremely beneficial in this regard, since it enables the company to leverage their partner’s therapeutic expertise, resourcing capabilities, and organizational infrastructure.
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 companies typically have a laser focus on one or two assets, ranging from start-up to more mature, and formal to virtual organizations. Their pipelines are robust, with over 4,700 drug indication programs under development, equivalent to 71% of the entire global industry pipeline according to a recent BIO Industry analysis.
With EBP companies serving as a high-growth innovation engine, large and mid-biopharma organizations, public and private investors and other stakeholders are demanding a strong strategy aimed at demonstrating, driving and delivering the highest possible return on investment. The modern day EBP executive team seeking novel approaches to achieve this is increasingly exploring fully collaborative outsourcing arrangements with service providers as a major component of their overall organizational strategy.
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.