National Academies Press: OpenBook
« Previous: Front Matter
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.
×

1

Introduction
1

The field of endeavors known as “regulatory science” has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. The U.S. Food and Drug Administration (FDA) defines regulatory science as “the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality, toxicity, public health impact, or performance of FDA-regulated products.”2 Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline.

Since its inception, the Forum on Drug Discovery, Development, and Translation (the Forum) of the National Academies of Sciences, Engineering, and Medicine (the Academies) has focused on the need for strengthening the scientific basis of drug regulation. In February 2010, the Forum

___________________

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. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not necessarily endorsed or verified by the Forum or the Academies, and they should not be construed as reflecting any group consensus.

2 See http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm268095.htm (accessed April 11, 2016).

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.
×

held a workshop that was summarized in the Institute of Medicine (IOM) report Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary (IOM, 2011), which examined the state of the science of drug regulation and considered approaches for enhancing regulatory science. In September 2011, the Forum convened another workshop that was summarized in the report Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary (IOM, 2012), which considered opportunities and needs for advancing innovative regulatory science through workforce and career development.

Over the past several years, models to support the discipline of regulatory science have advanced. FDA’s Centers of Excellence in Regulatory Science and Innovation (CERSIs) enhance training and educational opportunities for regulatory scientists. Private funders have also established programs; for example, in 2011, the Burroughs Wellcome Fund launched its Innovations in Regulatory Science Awards (IRSA) initiative, which aims to strengthen regulatory systems capacity by funding regulatory science–based research and collaborations.

On October 20–21, 2015, the Forum held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline’s success, and avenues for fostering collaboration across sectors. The workshop, co-sponsored by the Burroughs Wellcome Fund, held discussion panels that explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development.

The field of regulatory science is broad and touches many aspects of research. This workshop did not attempt to comprehensively discuss all the challenges and opportunities facing the field. To focus the discussions, the planning committee adopted the theme of innovation in regulatory science through integration of information. Presenters and participants were invited to examine and discuss how large-scale generation of information, particularly in light of the recent advent of “big data,” presents new opportunities to strengthen the connections among the regulatory science disciplinary components and advance the field (see Box 1-1 for the full Statement of Task).

ORGANIZATION OF THIS REPORT

This report is a summary of the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the Forum or the Academies, and they should not be construed as reflecting any group con-

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.
×

sensus. The workshop was webcast live, and online participants were able to contribute to the discussions through the hashtag #RegulatoryScience. The presentations, videos, and tweets are archived on the Forum website.3

___________________

3 For more information, see http://nationalacademies.org/hmd/Activities/Research/DrugForum/2015-OCT-20.aspx (accessed April 5, 2016).

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.
×

The summary is organized as follows:

  • Chapter 2 characterizes the current landscape of information integration in regulatory science presented at the meeting.
  • Chapter 3 summarizes discussion of four case studies of regulatory science applications that served as focal lenses to illuminate how enhanced approaches to obtaining, accessing, and integrating information could advance the science throughout and across medical product development. The four case studies were as follows:
    • Identification and Development of Meaningful Biomarkers
    • Integrating Clinical Trial Data
    • Next-Generation Surveillance
    • Innovative Modeling for Integrating Data
  • Chapter 4 describes needs for regulatory science infrastructure and workforce.
  • Chapter 5 summarizes challenges, opportunities, and key focus areas for advancing regulatory science offered by individual workshop participants.
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.
×
Page1
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.
×
Page2
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.
×
Page3
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.
×
Page4
Next: 2 Characterizing the Regulatory Science Landscape »
Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary Get This Book
×
Buy Paperback | $40.00 Buy Ebook | $32.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline.

In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!