Many workshop participants outlined a vision of a complex and diverse field of regulatory science that includes knowledge of and expertise in basic science, regulatory pathways, and the social sciences, among others. A robust regulatory science infrastructure could, for example, include and foster adequate funding, cross-sector collaboration and information sharing, and innovation in the face of rapidly advancing science and technologies. Perhaps most importantly, expressed Owen Fields, vice president, Regulatory Strategy, Pfizer Inc., is that a robust regulatory science infrastructure includes trained and expert scientists. Yet, regulatory science is often considered only as an alternative career path for basic science and clinical researchers. This chapter summarizes discussions held at the workshop to characterize the components of a well-working and robust regulatory science infrastructure, with an emphasis on training of regulatory scientists.
CHARACTERIZING THE DISCIPLINE OF REGULATORY SCIENCE
Regulatory Science as an “Enlightened Discipline”
Garret FitzGerald, professor of medicine and pharmacology, University of Pennsylvania, noted that the environment in which regulatory science is situated is undergoing a multidimensional shift influenced by many outside factors, including technology, trade, politics, intellectual property, global influence, a desire for transparency, and patient empowerment.
Those who engage in the discipline of regulatory science, whether in industry, government, or academia, often contend with the traditional segregation of seemingly disparate but often intertwined disciplines. One of the major challenges for the conduct of regulatory science is integrating information and expertise across these sectors, noted FitzGerald (see Box 4-1). Regulatory scientists use knowledge derived not only from their own background and expertise, but also from other disciplines that bear weight in the decision-making process, including statistics, informatics, or communication.
Peter Honig, senior vice president and head of worldwide safety and regulatory, Pfizer Inc., distinguished “collective competency” from “collective experts.” The process of regulation relies on a wide collection of disciplinary expertise (collective experts), he noted, but “enlightened” regulatory science also relies on the integrated confluence of these disciplines (collective competency). The most successful regulatory scientists at FDA are those who can leverage and integrate effectively the diverse expertise available at FDA to make informed, enlightened regulatory decisions, he emphasized.
Navigating the Interface Between Science and Society
Regulatory scientists participate in a social discourse that extends far outside of the laboratory and clinic, and correspondingly, regulatory decisions do not influence just the scientific community, but also the public at large, noted Martin Philbert, professor and dean, University of Michigan School of Public Health. Frank Weichold highlighted the importance of communicating priorities and dialogue with external stakeholders, such as policy makers, patient groups, and academia. Mark C. Rogers suggested that a liberal arts background or communications training could aid the regulatory scientist in better communicating to such a broad audience.
Proficiency in the behavioral sciences also underlies success in regulatory science. For example, patient adherence to a prescribed medication regime can have an enormous impact on perceived efficacy and thus can be just as important as other clinical endpoints, observed Stephen Ostroff. To this end, Philbert suggested that regulatory science training curricula integrate the social and behavioral sciences.
TRAINING THE NEXT-GENERATION REGULATORY SCIENTIST
Academic Programs
Speakers discussed difficulties that exist in attracting emerging scientists to the practice of regulatory science. Russ Altman underscored that it is important to adopt a pragmatic approach to accessing universities, medical schools, nursing schools, and Ph.D. programs to attract the next generation of regulatory scientists. Sam Shekar noted that it could prove valuable to emphasize to emerging scientists that the traditional career paths of industry, academia, and government do not necessarily need to be compartmentalized and that collectively the field should look instead toward opportunities for partnerships among these careers, particularly during a scientist’s training period.
Several speakers outlined approaches they are taking to address the challenge of adequately training and preparing scientists for careers in regulatory science. Many of these approaches involve partnering with an FDA-established program. Sandy Allerheiligen described a training program at the University of Virginia that allows students to work at FDA while completing their Ph.D. This program gives graduate students the opportunity to gain technical expertise and simultaneously learn how to apply this expertise in a regulatory setting.
The University of Rochester is also developing a certificate training program that would partner students with FDA, and the university is simultaneously exploring the possibility of partnering with government programs such as CERSIs or Clinical and Translational Science Awards (CTSAs). Scott Steele, director of government and academic research alliances and associate professor of public health sciences, University of Rochester, discussed the content and rationale of the university’s training programs to workshop attendees. He highlighted the importance of significant and complementary training in academia, industry, and regulation.
Steele noted that one potential way to expand opportunities for regulatory science training is by maximizing the shared missions of the CERSIs and CTSAs to improve medical product development by tapping into the CTSA consortia. To investigate potential areas for collaboration between CERSIs and CTSAs, Steele and colleagues established a working group to share best practices. During the course of their work, Steele and colleagues convened a workshop at which they developed 11 core thematic areas of regulatory science (Adamo et al., 2015) (see Box 4-2). These competency areas could be used to evaluate and prioritize components for developing regulatory science training programs.
Industry Programs
Several speakers also discussed industry-driven initiatives to foster the training and career tracks of regulatory scientists. Fields described Pfizer programs, which include internships, temporary assignments, mentoring, and industry-FDA collaborations.
Eileen Cannon, president, PhRMA Foundation, noted that the PhRMA Foundation is in the process of developing regulatory science rotations between industry and academia, as well as a mechanism that will facilitate FDA access to senior academic scientists to discuss current and specific needs. The goal of these training pathways and collaborations is to make the path to regulatory scientists more intentional and less random, both Fields and Cannon emphasized.
Shekar provided a view from another industry. He noted that Northrop Grumman has developed an internal program to foster career advancement for those working in the discipline of data science, the Future Technical Leaders Program. This program allows recent M.S. and Ph.D. engineering graduates to participate in three 1-year rotations on different projects within Northrop Grumman, training under senior technological mentors. Shekar observed that data scientists are foundational for solving regulatory science problems. The discipline of data science represents a confluence of knowledge in mathematics, computer science, and domain expertise. Data scientists can help uncover new information, optimize processes, improve
precision, make better decisions for the organization, and mature an industry along the continuum of analytic sophistication.
INCENTIVIZING AND FUNDING REGULATORY SCIENCE
Workshop discussions included focused consideration of the following career incentives and pathways in the discipline of regulatory science:
- Lack of Recognition and Reward. Bill Potter, senior advisor, National Institute of Mental Health, National Institutes of Health (NIH), noted that many individuals who are actively engaged in regulatory science work are performing it outside of their defined job duties, and it can frequently take nearly a decade to receive recognition in the field. Moreover, in traditional academic research, faculty must publish in high-impact journals to receive promotion or tenure, but publishing regulatory science is very rare, said Martin Landray. The leadership in the regulatory science ecosystem—FDA, NIH, industry—could consider ways to generate rewards and publicize accomplishments outside of the traditional peer-reviewed journal system, said Ostroff.
- Development of Metrics of Success for Regulatory Science. Relatedly, many workshop participants argued that it would be beneficial to identify alternative metrics for gauging success that are specific to regulatory science. Alastair Wood observed that regulatory scientists should not be confined to traditional academic standards, and incentives and career advancement benchmarks could instead be designed specifically for the responsibilities of the position. Wood also suggested expanding the questions that regulatory science addresses, such as including mechanistic questions that arise in development of regulatory science applications, and then rewarding accomplishments in answering those questions.
- Limitations on Funding to Incentivize and Reward Regulatory Science. Securing funding and resources for research endeavors within any field presents difficulties, and regulatory science is no exception. Weichold noted that there is currently scarce funding to develop or implement successful regulatory science research efforts, especially in academic settings. He and other individual workshop participants noted that increasing and targeting funding for regulatory science research could encourage innovation in the field and the development of career regulatory scientists.
- Difficulties in Navigating the FDA Hiring Process. Several participants noted that FDA is required to use the general hiring practices currently approved by the U.S. government, which can present challenges to applicants. Honig referenced the Mission Possible report for a deeper analysis of how monetary compensation, which is tied to the governmental hiring system in place, affects FDA’s ability to recruit talent (FDA, 2015). Darrell Abernethy, associate director for drug safety, office of Clinical Pharmacology, FDA, suggested that the lengthy time involved with applying for and receiving an FDA position might be a burden for applicants.
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