Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 1
1
Introduction 1
The Food and Drug Administration (FDA) has defined regulatory sci-
ence as the “science of developing new tools, standards, and approaches
to assess the safety, efficacy, quality, and performance of FDA-regulated
products” (FDA, 2010). The development and application of regulatory
science calls for a well-trained, scientifically engaged, and motivated
workforce. FDA faces challenges in retaining these scientists and provid-
ing them with opportunities for professional development. Stretched thin
by resource constraints and a workload of constantly increasing com-
plexity, FDA scientists are hard pressed to interact with other scientists
and enhance their scientific knowledge base. Moreover, in the private
sector, including industry and academia, the advancement of the science
of innovation in drug discovery and development has not always been
clearly defined, well coordinated, or connected to the needs of the regu -
latory agency. A number of gaps in the regulatory science discipline and
infrastructure have been identified, including workforce and resource
constraints not only within FDA but also in the extramural community;
cultural differences and systemic barriers to collaboration and exchange
among the agency, academia, and industry; and deficiencies in the net -
1 The planning committee’s role was limited to planning the workshop, and the workshop
summary has been prepared by the workshop rapporteurs as a factual summary of what
occurred at the workshop.
1
OCR for page 2
2 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
work and infrastructure necessary to forge the collaboration and com-
munication needed to advance regulatory science.2
In February 2010, the Forum on Drug Discovery, Development, and
Translation within the Board on Health Sciences Policy of the Institute
of Medicine (IOM) held a workshop, “Building a National Framework
for the Establishment of Regulatory Science,” that examined the state
of the science of drug regulation and considered approaches for enhanc-
ing the scientific basis of regulatory decision making (IOM, 2011).
As a follow-on to that workshop, and building on pronouncements
from and developments to advance regulatory science at FDA in the
interim months, the Forum convened a workshop on September 20-21,
2011, entitled “Strengthening a Workforce for Innovative Regulatory Sci -
ence in Therapeutics Development.” This workshop provided a format
for establishing a specific agenda to implement the vision and principles
relating to a regulatory science workforce and infrastructure as articulated
in the 2010 workshop on regulatory science. The broad objectives of the
workshop were (1) to consider opportunities and needs for advancing
innovation in the discipline of regulatory science for therapeutics devel -
opment through an interdisciplinary regulatory science workforce and
(2) to examine specific strategies for developing a discipline of innovative
regulatory science through development of a robust workforce within
academia and industry and at FDA.
Specific objectives included the following:
• efine and discuss the current regulatory science workforce, with
D
particular attention to the disciplines involved, professional train -
ing opportunities, and gaps in the essential components of this
workforce.
• onsider workforce development needs in areas identified as key
C
components of a robust discipline of innovative regulatory science
in therapeutics development.
• xamine the application and advantages of collaborative (multi
E
sector and multidisciplinary) approaches for strengthening the
national regulatory science workforce.
• xplore the resources and stakeholder engagement needed, not
E
only within FDA and other federal agencies but throughout the
extramural sector, to build the discipline and establish career paths
in regulatory science for therapeutics development.
2
The Fiscal Year (FY) 2011 President’s Budget for FDA programs requested $25 million to
support Advancing Regulatory Science for Public Health, and ultimately $17.4 million was
appropriated by Congress for FY 2011 to support regulatory science at FDA.
OCR for page 3
3
INTRODUCTION
In her introductory remarks, the co-chair of the planning committee,
Elaine Gallin, Principal, QE Philanthropic Advisors, remarked that, as the
Forum offers a neutral venue where stakeholders in drug development
can meet to discuss issues of mutual interest and concern, the Forum
and this workshop format can enhance the needed collaboration among
government, academia, industry, foundations, and patient groups that is
critical in enhancing regulatory science.
The other co-chair of the planning committee, Barry Coller, Vice
President for Medical Affairs, Physician-in-Chief, and David Rockefeller
Professor, The Rockefeller University, observed that while everyone has
a sense that regulatory science is important, everyone also has a slightly
different sense of why it is important. Coller emphasized that the focus
of the workshop was on innovative regulatory science in therapeutics
development, which calls for an interdisciplinary workforce to develop
those innovative skills and methodologies. By bringing together stake -
holders from all the sectors interested in regulatory science, the workshop
provided an opportunity to compare diverse perspectives and find areas
of agreement.
SCOPE OF THE WORKSHOP AND
ORGANIZATION OF THE SUMMARY
Over the course of the workshop many participants offered their
individual definitions of the concept of regulatory science in therapeutics
development and elaborated on how regulatory science relates to drug
development more generally. Although the scope of the workshop was
focused on regulatory science in therapeutics development, a number
of workshop discussants offered viewpoints or illustrations that were
relevant to regulatory science more generally (e.g., application of regu-
latory science to regulation of tobacco products; post-approval safety
monitoring of therapeutics). These perspectives were sought to the extent
they could illuminate and elaborate on fundamental principles and com -
ponents undergirding the development and practice of innovative reg -
ulatory science and its application to therapeutics development. This
report summarizes the presentations and discussions of the workshop,
highlighting key themes and identified needs in the development of an
innovative regulatory science workforce for therapeutic development.
• Chapter 2 provides perspectives from FDA, the National Institutes of
Health (NIH), industry, academia, and the patient on the importance
of innovative regulatory science with a primary focus on its role to
support and advance drug development and how to strengthen that
science.
OCR for page 4
4 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
• Chapter 3 examines definitions of innovative regulatory science
for therapeutics development and lists certain “core competencies”
considered part of the multidisciplinary pursuit of regulatory sci -
ence. This chapter addresses difficulties and discordance in defining
regulatory science as identified by many workshop participants.
• Chapter 4 looks at how education and training could be structured
to achieve the development of a regulatory science workforce that
encompasses the needed competencies.
• Chapter 5 samples potential regulatory science career paths inside
and outside academia.
• Chapter 6 considers international dimensions and needs for a regu-
latory science workforce to achieve innovation on a global scale.
• Chapter 7 reviews new collaborative models to strengthen and
support regulatory science research and practice and provides par-
ticipant summaries of the workshop discussions and suggestions
for moving the field forward.
