Abstract
Innovative antibody research and development (R&D) is the vanguard of a variety of science, technology, and medical fields that require substantial investment of both time and money. However, new information from these fields has translated into new products at a slow pace. For example, although the overall level of R&D investment in therapeutics development has risen dramatically over the past decade, the number of new medicines reaching the market has decreased during this period. Valuable resources are wasted because government, academic, and industry R&D programs are not coordinated. Over the past few years, numerous groups, including academic centers, government agencies, and commercial firms located across the globe, have been asking the same question: What can be done to improve the efficiency of the innovation process?
Innovative antibody research and development (R&D) is the vanguard of a variety of science, technology, and medical fields that require substantial investment of both time and money. However, new information from these fields has translated into new products at a slow pace. For example, although the overall level of R&D investment in therapeutics development has risen dramatically over the past decade, the number of new medicines reaching the market has decreased during this period. Valuable resources are wasted because government, academic and industry R&D programs are not coordinated. Over the past few years, numerous groups, including academic centers, government agencies and commercial firms located across the globe, have been asking the same question: What can be done to improve the efficiency of the innovation process?
In the US, the government agency qualified to provide an answer is the Department of Health & Human Services (HHS). A number of highly influential organizations, including the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS) and the Agency for Healthcare Research and Quality (AHRQ), are part of HHS. Through a series of meetings, the agency is actively educating the public about their efforts to both identify and overcome obstacles to innovation (http://hhs.gov/deputysecretary/innovationconference). HHS's information is valuable to those interested in innovation at points during the R&D process and beyond, including basic and translational research (purview of NIH), public health and safety of healthcare products (purview of FDA), reimbursement regulations and policy (purview of CMS), and comparative effectiveness research (purview of AHRQ).
The role of NIH in supporting basic research is well known. The agency is now working on strategic investments to optimize its research portfolio; the overall plan is described in the NIH Road Map for Medical Research. The NIH also engages in translational programs, public-private partnerships, and support for small companies. Specifically, the Clinical and Translational Science (CTSA) program focuses on efforts to turn basic research into better treatments for patients, NIH facilitates collaborations through the Public-Private Partnership Program and small business are supported in their efforts to commercialize technology or product candidates through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Although the role of FDA as gatekeeper for drug approvals is familiar, the agency is also engaged in numerous activities intended to reduce uncertainty and improve efficiency in the medical product development process. These include directed initiatives such as the ECG Warehouse (annotated Electrocardiogram waveform data storage and review system) and the Janus Clinical Data Repository (data collection and analysis warehouse for clinical trial data), as well as broader efforts such as the Critical Path Initiative (CPI) and the Sentinel System. Through the CPI, FDA seeks to modernize the science and tools used to develop, evaluate, manufacture and use FDA-approved products, while Sentinel is an advanced surveillance system designed to assess the safe use of medical products. Overall, the scope of FDA's initiatives is quite broad and the agency is encouraging input from all stakeholders to optimize outcomes.
CMS and AHRQ also affect innovation, although somewhat less directly than the NIH and FDA. CMS encourages innovation by providing a predictable path to government coverage, coding, and payment for new and emerging medical products and technology. CMS's Council on Technology and Innovation is tasked with facilitating discussions on relevant issues of unusual complexity or controversy. AHRQ conducts and supports health services research, but has a broader mission to improve the quality, safety, efficiency, effectiveness and cost-effectiveness of health care.
The message of HHS's dynamic role in promoting and facilitating innovation bears examination because of the extensive influence of HHS policies, initiatives and programs. According to HHS' budget (www.hhs.gov/budget/09budget/2009BudgetInBrief.pdf), fiscal year 2009 outlays for this agency will total $737 billion, with CMS's programs such as Medicare and Medicaid accounting for $636 billion (86%) of the total. NIH and FDA budget outlays are listed as $29 billion and $1.7 billion, respectively. Through a wide variety of initiatives, HHS is providing funding, forming collaborations and seeking input from stakeholders in order to improve the efficiency of innovation. However, real progress will be slow without a strong commitment to the maintenance of the initiatives. Lack of cooperation between institutions, failure to communicate with stakeholders and disregard of the input given will discourage participation. Another important factor is the upcoming change in leadership within the agency. A new HHS Secretary, NIH Director, FDA Commissioner and CMS Director will be appointed soon, and each of these individuals will have an opportunity to influence current practices and future directions.
All organizations involved in antibody R&D should be aware of government agencies that might influence their work, and be involved in the initiatives that will affect important outcomes. However, the US government is only one participant in the ongoing global efforts to improve the efficiency of the innovation process. Future editorials will focus on activities in Europe and other regions. Please contact me with your comments about these important issues.