When the Deepwater Horizon rig exploded in April 2010, releasing nearly 5 million barrels of oil into the Gulf of Mexico, fisheries were closed in more than one-third of US Gulf waters. Scientists had to test hundreds of samples of seafood for hydrocarbon contamination, but existing chemical tests took a week to yield results.

Credit: IMAGES.COM/CORBIS

Researchers at the US Food and Drug Administration (FDA) and other agencies joined forces to develop a speedier assay that would let them rate seafood as safe or unsafe within two days. By refining methods that already existed, the agencies were able to get a new test up and running by July 2010. Fisheries reopened and seafood was back on menus weeks earlier than would have been possible with the original test. Such quick, collaborative problem-solving exemplifies the benefits of regulatory science done not only in government agencies, but also in industry and academia.

Regulatory science is “not a new thing, it's just a new term”, says Erin Wilhelm, project director at the Center for Excellence in Regulatory Science and Innovation (CERSI) in Washington DC, launched in 2011 by the FDA and Georgetown University. “It's really an umbrella term for all different kinds of science that impact drug development or device development or food science or tobacco regulation.”

People wanting to work in regulatory science mostly need expertise in a relevant branch of science, but focused regulatory training is also available (see 'Learning the ropes'). Jobs may involve reviewing applications for product approval, as well as a variety of research topics, such as identifying biomarkers for drug activity, gauging risks to public health during the drug-approval process or tracking a drug's effects after it has reached the market. Companies and industry groups that need to gain approval for their products are seeking team members who understand the regulatory world. Jobs are available in many countries, especially in the United States, where the field has garnered interest in government and other sectors.

Most people distinguish between regulatory science and regulatory affairs, which focuses on making sure that regulations are followed. “We're talking real science,” says Hans-Georg Eichler, senior medical officer at the European Medicines Agency (EMA) in London. People who do regulatory science have diverse backgrounds, ranging from biochemistry to statistics. And they tend to think of themselves as statisticians or biochemists, not 'regulatory scientists', he says.

“It's not been an area of high profile,” notes John Burris, president of the Burroughs Wellcome Fund in Research Triangle Park, North Carolina, which funds biomedical research. “People aren't winning Nobel prizes in it.” Yet the results of regulatory science have the potential to make enormous impact, he says. For example, a job in basic research identifying biomarkers for disease could help scientists running clinical trials to identify who is responding well to treatment. And by testing drugs in model systems, researchers may be able to learn about the efficacy and side effects of a compound before taking on the cost and risk of human trials.

Model systems currently under development by regulatory scientists include the 'human on a chip,' which simulates ten different organs for drug-safety testing. Another is the virtual family — anatomically correct digital models of male and female adults and children, based on body scans of volunteers and used in computer simulations. The virtual family is already being applied to predict body-temperature changes in the tissues surrounding implanted devices when people are exposed to radio waves or microwaves.

Opportunities arising

Governments and institutions have started to take note of the field. The Burroughs Wellcome Fund is evaluating applications for its first Innovation in Regulatory Science Awards — grants for academics addressing regulatory topics — which it initiated to kick-start investment in the area. It has received applications from about 60 faculty members in North America, and it plans to endow at least five projects with up to US$500,000 each over five years. If the programme is successful, Burris hopes to make it an annual call for proposals.

The FDA does not offer many research grants, although it partnered with the US National Institutes of Health in 2010 to offer a total of US$6.75 million for a few three-year projects in regulatory areas such as disease biomarkers. Last year, it also issued a call for external contractors to conduct regulatory research.

In Japan, the Pharmaceuticals and Medical Devices Agency established an Office of Regulatory Science in 2009. The Ministry of Health, Labour and Welfare offered ¥1.2 billion (US$12 million) in grants in the regulatory field in 2012.

In Europe, the Innovative Medicines Initiative (IMI) in Brussels supports public–private collaborations on topics such as biomarkers and disease models in the hope of improving the drug-development process.

The blooming interest in regulatory science has not necessarily translated into job opportunities at the FDA or EMA, however. Eichler says that the EMA's job market was growing rapidly until 2009, when the economy began its downward spiral and hiring stalled. IMI executive director Michel Goldman, by contrast, sees opportunities worldwide, including in Europe, Japan and China. And a 2012 review by the non-profit Partnership for Public Service in Washington DC found that the FDA hired 2,221 people in 2010, up from 817 in 2007. However, many positions are temporary. And although FDA chief scientist Jesse Goodman anticipates hiring more people as the older generation of employees retires, this year's federal budget cuts have the potential to hit the agency hard. The FDA spends the majority of its money on staff and related costs. Although no forced unpaid leave or lay-offs are expected, the budget cuts could lead to delayed hiring and reduced travel and overtime.

Petri dishes and paperwork

A regulatory agency is the obvious — although not the only — place to start a career in regulatory science. Some FDA employees have left experimentation behind, whereas others split their time between research projects and reviewing applications for product approvals.

In some ways, working in regulation is like being a principal investigator, says Candice Jongsma, a regulatory-science fellow at the FDA Center for Tobacco Products in Rockville, Maryland. She may not do the experiments herself, but she reviews data, asks questions and makes recommendations. One of her projects is to compare the lists of ingredients in new and existing tobacco products and determine whether the new recipe raises health questions that will need to be addressed before approval.

It's a field that you would enjoy if you don't want to think one-dimensionally.

Ernest Kwegyir-Afful was a neuroscience postdoc when he applied for a two-year fellowship at the FDA in the hope of getting to conduct research that would have an immediate impact. At the FDA's Center for Food Safety and Applied Nutrition in College Park, Maryland, Kwegyir-Afful worked on estimating the risk that small quantities of food allergens might endanger sensitive consumers. He came up with a computational method for risk analysis that was closely tailored to allergens. After finishing his fellowship last September, Kwegyir-Afful accepted a permanent position at the centre, doing similar work. Regulatory science is “a field that you would enjoy if you don't want to think one-dimensionally,” he says, noting that he works with experts in topics such as toxicology or law. Communication skills and a team-oriented approach are essential, says Frances Richmond, director of the International Center for Regulatory Science at the University of Southern California in Los Angeles.

Regulatory-strategy units at pharmaceutical companies are good places to explore the regulatory side of industry, says Robert Meyer, who directed the FDA Office of Drug Evaluation before becoming vice-president of global regulatory strategy for Merck at its campus in Upper Gwynedd, Pennsylvania. Company regulatory scientists would do well to understand the relevant laws for FDA reviewers, which can help company scientists to do the right experiments and to offer the FDA the data it needs to make decisions, says Meyer. That is especially true for people working at small companies, because they participate in many aspects of product development, says James Polli, co-principal investigator of an FDA CERSI at the University of Maryland in Baltimore.

Academic scientists, too, can address regulatory questions or advise the FDA. Subha Madhavan, a bioinformatician at Georgetown University, is building databases that will be used by FDA scientists looking to understand why people respond to drugs in different ways, and how vaccines might be linked to autoimmune disease. She regularly meets FDA staff to explore their needs, and expects to publish the work.

“Regulatory science is the field of the future, if you will, in terms of drug development and device development,” says Wilhelm. “At some point, it will mean something to say, 'I am a regulatory scientist'.”