Despite the looming threat of shrinking drug pipelines, drug development during the past few years has not been as productive
as it should be, which has left many pharmaceutical companies at risk. To combat this issue, pharmaceutical companies are
partnering with third parties, such as contract service providers, universities, and not-for-profit organizations to consolidate
development processes, drive down costs, and increase output. This strategy is not as simple as it sounds, and issues, such
as confidentiality and ownership, can be challenging. When handled properly, however, cross-company collaboration can result
in a more efficient and profitable use of data and staff.
In an industry where developing one efficacious drug can take more than 12 years, cost $1 billion in laboratory and clinical
research, and has a 95% chance of failure, making the right strategic decisions to maximize the quantity and quality of new
compounds is paramount.
Pharmaceutical companies not only complete with their end-products (drugs), but also in processes and technologies. In the
thrust to become leaders in drug development, companies have turned to external specialists for help. This strategy has been
effective, but it has led to a leveling of the playing field. CROs have been given an increasing proportion of clinical trial
and regulatory activities, often managing the entire clinical process for a drug, or even all drugs of a given company. In
turn, consulting and system integration firms have been hired to help optimize processes and implement large clinical, regulatory,
and management systems, such as enterprise resource planning systems, with the goal of bringing drugs to market more quickly
and at lower cost.
This experience has resulted in a relatively small number of top-tier CROs and consulting firms that have implemented systems
from a small and consolidating roster of IT companies. Pharmaceutical companies are becoming similarly "best in class" in
process, technology, and offshoring and outsourcing resources.
Pharmaceutical companies acknowledge that they share the same issues with respect to patent expiries, high R&D costs, and
suboptimal R&D output and, therefore, should collaborate to mitigate these challenges. This realization has introduced the
concept of precompetitive collaboration or "co-opetition," whereby pharmaceutical companies parter with each other or with
Co-opetition across the globe
One of the first initiatives of this type, the Clinical Data Interchange Standards Consortium (CDISC), was set up in 2000
by 32 global companies, as an open, multidisciplinary, nonprofit organization. Now with more than 200 members, it has established
open standards to support the electronic acquisition, exchange, submission, and archive of clinical research data and metadata.
This standardization has helped to make pharmaceutical R&D and regulatory approval more efficient by allowing collaboration
among researchers, easier review of product applications by regulatory authorities, and development of clinical and regulatory
software by vendors.
Regulatory authorities, such as FDA and its European and Japanese counterparts, the European Medicines Agency and the Pharmaceuticals
and Medical Devices Agency of Japan, have also been early drivers of collaborative projects. Following publication of FDA's
"Critical Path Initiative," (1) the Critical Path Institute (C-Path) was formed in 2005 as a public–private partnership between regulators and the medical-product industry. The aim was to accelerate the pace and reduce the
costs by creating precompetitive standards for data, measurement, and methods for evaluating drug efficacy and safety. In
October 2012, CDISC, C-Path, and FDA formed the Coalition for Accelerating Standards and Therapies (CFAST) to work with pharma
and IT companies on developing and maintaining data standards tailored to individual diseases and therapeutic areas.
In September 2012, 10 pharmaceutical companies founded TransCelerate BioPharma as a nonprofit, precompetitive drug company,
to develop shared industry clinical-trial solutions (2). Such collaborative initiatives offer potential benefit to the whole
industry in terms of cost and productivity. Member companies may find it difficult adjusting to collaborative models and may
initially be hesitant to share insights that could help competitors get to market faster. Companies with healthier product
pipelines might also be less willing to collaborate with those with leaner ones. The gains to all companies, however, are
likely to outweigh any perceived drawbacks.