In today’s era of expansive (and expensive) biopharmaceutical R&D, public and private industry stakeholders are often looking for cost-effective ways to leverage their respective strengths and resources to accelerate innovation in patient treatment and care. Increasingly, biopharma company researchers are collaborating with a diverse set of health care players to address scientific and technological challenges, create greater efficiencies in R&D, and accelerate the discovery, production, and delivery of critical new treatments.
The Pharmaceutical Research and Manufacturers of America (PhRMA) asked Deloitte to analyze the various types and number of biopharma partnerships created over the past several decades, which resulted in a comprehensive database of partnerships formed between 1980 and 2014. We found that R&D-focused partnerships that often take the form of joint ventures (JVs) and consortia – most notably, non-asset-based models, which do not center on a specific drug candidate – have grown substantially over the last decade (see infographic). This highlights the growing role and importance of more open, collaborative approaches that can bring R&D innovation to life.
Each step in the R&D process often requires a unique and increasingly differentiated set of capabilities to advance innovation. Collaborating can help biopharma companies of all sizes (and their partners) navigate complex scientific, technological, and regulatory hurdles in a more efficient and timely way, and deliver new innovations to patients faster.
Collaborations may include two, three, or more parties. They are often comprised of a mix of stakeholders: biopharma companies, academic institutions, federal research organizations, health care providers, investors, non-profits (including patient advocacy groups and disease-focused communities), regulators, health plans, and others. Biopharma companies often serve as integrators in this collaborative ecosystem, bringing together the various players and providing scientific, regulatory and delivery system insights, operational capabilities, and financial resources.
Already, a number of consortia are delivering positive results in advancing innovation, addressing unmet medical need, and getting patients access to novel therapies; among them:
- The Alzheimer’s Disease Neuroimaging Initiative (ADNI) was formed in 2004 to advance understanding of this devastating disease in order to develop new treatments to slow or stop Alzheimer’s progression. The initiative, formed by the National Institutes of Health (NIH), National Institute on Aging (NIA), FDA, and numerous industry, academic, and non-profit organizations, has made tremendous strides in Alzheimer’s Disease (AD) detection. This is helping to elucidate the underlying pathways of AD progression, and improve efficiency of clinical trials related to addressing AD.1
- The non-profit Cure Huntington’s Disease Initiative (CDHI Foundation) was created in 2002 by several biopharmaceutical, academic, and contract research organizations (CROs) to focus on developing therapeutics to track and slow the progression of Huntington’s Disease HD).2 CHDI has made significant strides toward understanding and treating HD. This includes partnering with a biopharmaceutical company to discover and develop an antisense drug – the first potential therapy intended to directly target the cause of the disease by reducing the production of the protein responsible for HD3 – and developing an assay to measure the build-up of a protein known to be harmful for patients with Huntington’s.4
- The Lung Master Protocol (Lung-MAP) consortium is a public-private partnership formed in 2014 by several biopharmaceutical companies, government, and nonprofit advocacy organizations to develop a novel, multi-drug clinical trial for patients with a specific, difficult-to-treat form of advanced lung cancer (squamous cell carcinoma). The trial design leveraged genetic profiling, which assigned patients to one of five trial arms.5 Applications of this type of study design have helped to advance precision medicine in oncology. Adopting a personalized approach in tackling difficult cancers has also generated interest from many biopharmaceutical companies and others.
Our research points to growing recognition of the value and importance of collaboration across the biopharma R&D ecosystem. In the coming years, we expect to see continued expansion in disease area-focused consortia, including increased emphasis on more “open” arrangements with respect to structure, control, risk sharing, and product development.
1 Alzheimer’s Disease Neuroimaging Initiative website; accessed June 30, 2016.
2 CHDI Foundation website; accessed June 30, 2016.
3 CHDI news release, “Isis Pharmaceuticals initiates clinical study of ISIS-HTTRx in patients with Huntington’s disease”, July 21, 2015.
4 CHDI news release, “New assay measures pathogenic protein in Huntington’s disease patients’ spinal fluid”, April 7, 2015.
5 “Ambitious Lung-MAP Trial Launched With Five Novel Drugs,” Onclive.com, July 31, 2014.