Strategy highlights the need to bolster partnerships and recruit expert personnel.

FDA released a report outlining its plans to advance regulatory science. It covers seven areas in which advancements can help deliver better products: quicker assessment of new medicines, pediatric and child health, emerging infectious diseases and terrorism, use of informatics, protecting the food supply, modernizing safety testing, and regulating tobacco.

Additionally, the report, entitled “Advancing Regulatory Science for Public Health,” lays out a four-part strategic framework to advance regulatory science and leverage its potential through collaborations:

• Ensure leadership, coordination, strategic planning, and transparency to support science and innovation

• Provide support for mission-critical applied research, both at FDA and collaboratively

• Provide support for scientific excellence, professional development, and continued learning for FDA staff.

• Bolster programs for the recruitment and retention of outstanding scientists

FDA’s independent science board pointed out that while the world of drug discovery and development has undergone revolutionary change—shifting from cellular to molecular and gene-based approaches—FDA’s evaluation methods have remained largely unchanged over the last half-century.

Under the Regulatory Science Initiative, the agency will work to develop new tools, standards, and approaches for assessing the safety, efficacy, quality, and performance of FDA-regulated products. “The aim is to gather the best possible data to make the best possible decisions,” asserted FDA commissioner Margaret A. Hamburg, M.D., during her presentation to the National Press Club on Wednesday, October 6.

With the President’s $25 million budget request for 2011, FDA plans to expand ongoing efforts within the agency and build additional partnerships with academia, industry, and government organizations. A new office dedicated to regulatory science will lead strategic development and coordination within FDA, and early efforts will focus on recruiting key personnel and building senior leadership.

In 2011, the bulk of the budget will be used to mobilize external collaborations and partnerships and support studies in four major regulatory science research areas:

1. Transforming Product Development for Patients: Bringing Progress to Patients (e.g., modernizing toxicology, biomarkers for personalized medicine, the stem cell initiative, and updating drug review standards)

2. Science to Address Emerging Technologies in FDA-Regulated Products (e.g., nanotechnology and expertise to regulate new animal biotech products)

3. Information Sciences for Health Outcomes (e.g., medical device registry and scientific computing for data analyses)

4. Addressing Unmet Public Health Needs (e.g., nutrition and public health)

Activities in 2011 will also set the stage for a network of Centers of Excellence in Regulatory Science to be integrated with expanded intramural FDA research and with other clinical research networks.

Funding for external programs would be competitive and focus on pilot and feasibility studies to form Centers of Excellence.

FDA believes that it can speed up the delivery of new treatments to patients particularly in terms of finding effective pain medications with less potential for abuse as well as new preventive and therapeutic methods for drug-resistance tuberculosis and diagnostics tools for the disease. Another initiative is to make generic drugs more available by developing validated methods for determining bioequivalence. Lastly, it believes that modernizing manufacturing and product quality will also accelerate review and approval of novel therapies.

To improve pediatric and child health, FDA will continue working on projects that are examining the effects of sedatives and anesthetics on children and infants. And with more than 17% of those under age 20 being obese, FDA will also focus on food labeling, which was extended to chain restaurants and vending machines under President Obama’s health reform legislation. Additionally, FDA’s National Center for Toxicological Research will be committed to identifying toxins in food and medicines and reducing the risk of resulting adverse health effects.

To protect against emerging infectious diseases and terrorism, one focus will be on developing new approaches to evaluate product efficacy, like improved predictive models and use of surrogate measures. Another initiative will look into the use of platform technologies across a broader range of products and to scale-up production more rapidly. To save time and resources, the agency will leverage cell culture and in silico modeling to predict safety or efficacy. FDA also plans on working to develop a bioinformatics database for emerging infectious diseases that are potential threats to the blood supply.

In fact, leveraging informatics has been identified as a key part of FDA’s overall strategy to advance regulatory sciences. For real-time monitoring, the agency plans on expanding and harmonizing its electronic systems and data mining tools for receiving, processing, storing, and analyzing adverse-event reports and other safety information for FDA-regulated products. The agency is also the developing the Sentinel System, which will monitor post-approval product safety.

FDA is also striving to modernize safety testing, with initial investments aimed at bolstering new technologies, specifically biomarkers, to improve both animal and nonanimal models and lessen the gap between them. The goal would be to replace or refine exposure experiments with predictive markers. The agency will also utilize in vitro and, potentially, computer-based modeling systems for toxicology.

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