by Terri Cooper, PhD, Principal, Federal Health Sector Leader, Deloitte Consulting LLP
As of this week, the Ebola outbreak in West Africa has killed more than 3,000 people across Guinea, Liberia, Nigeria, Senegal, and Sierra Leone.1 It marks the largest Ebola outbreak in history. One clear focus throughout the outbreak has been on finding a cure. In light of this health crisis and the increasing concern about the rising prevalence of serious chronic diseases, it seems a perfect time to redouble our efforts on shifting to a translational strategy in life sciences—a strategy that could help bring innovative and cost-effective products to market more quickly.
Traditionally, the research and development (R&D) processes within the life sciences value chain – discovery, development, and delivery – have occurred in silos with limited sharing of data and effective practices from one step to the next, and little or slow looping back to earlier phases with insights and information that might inform future iterations of improvement and innovation at each stage. Today and through the current process, translation of scientific evidence from discovery into health care practice typically takes 17 to 23 years.2 Companies, governments, and people are losing time, money, and opportunities – opportunities to improve health outcomes around the world, as well as chances to revive the global competitiveness of the U.S. However, forces within the health care landscape, such as legislation, regulation and the rise of big data and analytics, are pushing stakeholders to look differently at how they approach the value chain.
Shifting to a translational approach – in which a more dynamic, integrated, and continuous process of data sharing occurs between the traditional steps in the R&D value chain – holds great opportunity for accelerating iterations of scientific discovery and development, implementing evidence in practice more efficiently and effectively, acquiring a deeper knowledge about product safety and effectiveness, and reducing overall R&D costs. It’s hard to think of anything that could be “lost in translation” if companies were to refine their R&D process in the ways that a translational approach suggests.
What would a translational approach to R&D look like?
Moving toward a system of translational medicine would create a continuous flow of data between the discovery, development and delivery processes of the R&D value chain. By increasing data sharing between these steps, a continuous and systematic process improvement cycle is established. That cycle can then provide critical information than might be typical for decisions arising along the value chain, resulting in the earlier termination of unsuccessful compounds, improved trial design and recruitment, better understanding of disease and care pathways, and improved post-marketing surveillance capabilities.
How can we move faster?
Speeding up the R&D process will require action on several fronts. Progress is occurring in many areas, but acceleration is needed to address growing health threats and recent declines in the global competitiveness of the U.S. Deloitte recently had the opportunity to engage with Congress on this process by producing a report, “Deloitte’s Path to 21st Century Cures: A Call to Action.” In it, we identify several ideas for achieving a translational approach to the R&D value chain:
- Increase incentives to use translational approaches in biopharmaceutical R&D by increasing or refocusing government funding; adjusting legal and regulatory frameworks and policies; and modifying reimbursement policies in ways that support increased collaboration and data sharing between the discovery, development and delivery phases.
- Encourage multi-stakeholder collaboration and teaming models to strengthen cooperation and increase dissemination of scientific and market-derived information across the R&D value chain. Public-private partnerships and consortia could be leveraged to improve and accelerate research. Patient-centered care advocacy organizations could help coordinate and accelerate research through patient-focused research initiatives, patient education, or through patient reach via social networks. Improved regulator-industry communication could provide more timely and relevant guidance and inputs.
- Leverage health information technologies and integrate data sources to gain new insights regarding consumer behavior, product safety and efficacy, and potential directions for biopharmaceutical innovation. Wearable and implantable medical and personal health devices, electronic health records, websites and email, mobile applications, and social networking are increasing the connectivity between patients, providers, and developers and creating vast amounts of data. This data could be used not just for monitoring, but also for predictive analytics at the population level and to drive development and improvement of drugs. Electronic medical records could be used to understand comparative (i.e., relative) benefits of a new product versus the standard of care or improve clinical trial recruitment. Social media networks could be leveraged to communicate treatment efficacy to patients.
- Pursue the development of innovative study designs and advanced statistical methods that can increase speed-to-market for some product applications and provide valuable insights to cycle back to discovery and development. While randomized controlled trials will likely always be required for initial product approval, non-randomized observational and quasi-experimental studies that use real-world data collected for other purposes may be sufficient for determining safety and efficacy of supplemental applications. Stakeholders should also consider enabling comparative effectiveness research, leveraging clinical trial data, and accelerating biomarker and surrogate endpoint validation.
- Strengthen adverse event reporting by establishing a broader system that incorporates a variety of detection sources and methods, such as electronic medical records, the internet, and social media networks, or uses validated biomarkers to identify an adverse event.
As Congress and the president call for increased funding and more resource investment in the area of Ebola research, we are at a point where speeding up life sciences innovation has never felt more urgent.
While there are challenges that need to be addressed, including balancing priorities, dealing with limited resources and protecting privacy and security, I believe overcoming them will be well worth the resources and effort that the strategic, organizational and operational change will likely require. And, the investments we make to strengthen data sharing and insight exchange across the R&D chain will have benefits beyond bringing more products to market faster. The collaborative and information connections we begin to put in place today phases could not only bolster life sciences R&D global competitiveness, they could also have a positive and lasting impact on business sustainability and growth for life science companies and improved health care quality and outcomes for consumers.
Read more in Deloitte’s Path to 21st Century Cures: A Call to Action.
Dr. Terri Cooper is a Principal of Deloitte Consulting and is the leader of the Federal Health Practice. She has two decades of experience working in various capacities relating to the Life Sciences Healthcare Business. For the past 18 years she has worked as a consultant to the industry. Prior to joining Deloitte Consulting she was a partner in the Global Pharmaceutical/Life Sciences Practice within IBM Business Consulting practices, where she had responsibility for leading the Global R&D Pharmaceutical/Life Sciences Practice. In her current client relationship role she has responsibility for product and service offerings in research and development to selected global pharmaceutical companies headquartered in the U.S. Dr. Cooper is a frequent participant at industry conferences where she frequently speaks on topics relating to the issues affecting pharmaceutical research and development.
 CDC, 2014 Ebola Outbreak in West Africa, accessed on September 26, 2014 http://www.cdc.gov/vhf/ebola/outbreaks/guinea/index.html;  Balas EA, Boren SA. Managing clinical knowledge for health care improvement. In: Bemmel J, McCray AT, eds. Yearbook of Medical Informatics. Stuttgart, Germany: Schattauer Publishing; 2000:65‐70.