The Global Coalition for Regulatory Science Research (GCRSR)

Transcription

1 The Global Coalition for Regulatory Science Research (GCRSR) Co-chair: William Slikker Jr., PhD, ATS National Center for Toxicological Research, US-FDA The views presented do not necessarily reflect those of the FDA

2 Outline Definition of Regulatory Science About the Global Coalition for Regulatory Science Research (GCRSR) GCRSR activities Organizing the Global Summit on Regulatory Science (GSRS) conference GCRSR working groups Future Plans

3 Regulatory Science Regulatory Science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of regulated products. 2010

4 Today, we are neither effectively translating scientific discoveries into therapies nor fully applying knowledge to ensure the safety of food and medical products. We must bring 21 st century approaches to 21 st century products and problems. We need better predictive models to identify concerns earlier in the product development process to reduce time and costs. But this will require collaborations and partnerships with academia, industry, and other government agencies. 4

5 Institute of Medicine Report: Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad: (April, 2012) Strong National Regulatory systems are essential FDA should facilitate workforce development for regulators in developing countries Develop a global Curriculum in regulatory science

6 What is GCRSR? Global Coalition for Regulatory Science Research (GCRSR) Is an international coalition of global regulatory bodies Facilitates and promotes the development of regulatory science research as a tool for advancing regulatory science applicable to the public health impacts of safe food and medical products Established in 2013 Missions: exploring the future of regulatory science research as a tool for advancing regulatory science, food safety, medical technologies, and public health; discussing and describing the role of global research collaborations in advancing regulatory science and its impact on public health; emphasizing the importance of developing scientists for the global regulatory science research enterprise; and advising or informing the future direction of regulatory science research and innovation to promote global health.

7 GCRSR Members

8 GCRSR Activities Organizing an annual Global Summit on Regulatory (GSRS) conference to provide a platform for discussion and communication Establishing Working Groups (WGs) to address issues important for uptake of new tools in the regulatory decision-making and to advance regulatory science

9 GCRSR Activities: 1. GSRS Conferences An international conference with a goal of advancing regulatory science research in the global context Discussion of innovative technologies, collaboration and partnerships to enhance translation of basic science to regulatory applications, development of common understanding An opportunity for international scientists to objectively assess the regulatory implication of emerging technologies such as nanotechnology, omics, next-gen sequencing, bio-imaging, etc. A platform where regulators and bench scientists from various countries can exchange views on how to develop, apply, and implement innovative methodologies into regulatory assessments in their respective countries, as well as harmonizing strategies via global collaboration.

10 GSRS11 - The 1 st GSRS Theme: Global Summit on Regulatory Science Research and Innovation Date/Venue: August 11, 2011 in Little Rock, Arkansas 91 scientists/researchers/physicians from 14 countries attended the meeting

11 Outcomes: GSRS11: Accomplishments Recognized Research as a critical component of Regulatory Science Recommended formation of a Coalition of Regulatory Science Researchers to build knowledge, promote development of regulatory science research, discover novel ways to clearly define research needs and improve public health

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14 GSRS12 Theme: Modernizing Toxicology 5 keynote speakers from 4 different countries >80 participants from 10 countries

15 GSRS12: Accomplishments - Focus on Modernizing Toxicology Explored the future of regulatory science research as a tool for advancing regulatory science, food safety, medical technologies, and public health; Discussed and described the role of global research collaborations in advancing regulatory science and its impact on public health; Emphasized the importance of training scientists for the global regulatory science research enterprise; Determined future directions for regulatory science research and innovation to promote global health.

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17 GCRSR/GSRS13 Establishment of GCRSR (Global Coalition for Regulatory Science Research) Commissioner sent invitation letters to regulatory colleagues in 17 countries September 10, 2013 First meeting 19 members from 9 countries Followed by GSRS-13 Nanotechnology

18 GSRS13 Nanotechnology Practical presentations on the state of science Emphasize need and type of characterization Efforts to develop standards Clearly identified areas for global consensus on approaches Panel presentations by Center representatives on regulatory needs Innovative science to improve public health 18

19 GSRS14 Theme: Regulatory Genomics and Beyond Venue: Montreal Canada Date: August

20 GSRS14 Discussion Role of genomics is regulatory decision making Genomics applications in Food safety and medical product development Challenges and issues to reach and international consensus on genomics driven safety analysis Innovative science to improve public health 20

21 GSRS14 Outcome Initiated dialogue for genomics in regulatory science and the role of regulatory science in advancing the uptake of genomics. Technical and logistic challenges to use genomics technologies for the regulatory sciences use were highlighted. Training needs were identified as an important mechanism in achieving internationally consistent outcomes. Innovative science to improve public health 21

22 GSRS14 Regulatory Genomics Innovative science to improve public health 22

23 Theme: Regulatory Bioinformatics Venue: Parma, Italy Host: EFSA Date October 12-13, 2017 GSRS15 Innovative science to improve public health 23

24 GSRS15 Regulatory Bioinformatics Discussions on standardized and transparent bioinformatics framework to support the implementation of existing and emerging technologies in regulatory decision-making. Regulatory bioinformatics principles were presented with respect to global trends, initiatives and case studies

25 GSRS15 Outcome It was recognized the ensuring high quality data, validated tools and standardized processes, is essential for safe introduction and effective use of Regulatory Bioinformatics applications. Challenges were highlight for integration of big data sets that have different degrees of data integrity and standardization Challenges associated with the application of different software and computational methods must be resolved to get international consensus.

26 GSRS15 Regulatory Bioinformatics

27 GSRS16 Theme: Nanotechnology Standards and Applications Venue: Bethesda, Maryland, USA Date: September

28 GSRS16 Discussion Discussion on need of education of broad group of stakeholders on the state of the art in nanotechnology science, measurement methods, and standards for regulatory applications. Most immediate needs in nanotechnology science, measurement methods, and standards relevant to regulatory applications were identified Need of coordination between stakeholders in the development of standards

29 GSRS17 Theme: Emerging Technologies for Food and Drug Safety Host: ANVISA Date: September 18-20, 2017

30 GSRS17 Discussion Discussion on current structures of global regulatory landscape in food and drug safety. Discussion on new technologies and methodologies implemented in regulation of food safety risk assessments. Standards and reproducibility issues associated with safety risk assessments were highlighted. Panel discussion was conducted to identify opportunities, challenges and future perspective on science based regulatory practice

31 Invitation to the Global Summit on Regulatory Science (GSRS18) Location: Beijing, China When: September, 26-27, 2018 Proposed theme: Bioinformatics and dietary supplements Scientific program committee: members of the GCRSR Executive Committee and the Bioinformatics Working group Local organizers: National Institute for Food and Drug Control (NIFDC), CFDA

32 GCRSR Activities: 2. GCRSR Working Groups Establishing working groups to address specific areas of need for translation of emerging technologies for global regulatory application: Emerging technologies WG Bioinformatics WG Nanotechnology WG Cross-training WG

33 Nanotechnology WG developed the white paper on advancing Nanotechnology Standards in regulatory application

34 The Bioinformatics WG developed/published the best practices document for microbial genomics in application for regulatory food safety

35 Regulatory Science Cross-Training Working Group Vision The Cross-Training Working Group (CTWG) will foster international capacity building and collaborations by encouraging interactions among Coalition members through targeted personnel exchanges, scientific collaborations, and sharing best practices.

36 Regulatory Science Cross-Training Working Group (CTWG) Scope: The CTWG proposes to focus on laboratory support and emerging new science Objectives: Strengthen personnel training through the establishment of a network for the sharing of relevant training opportunities Build capacity and promote scientific collaboration within the Coalition by enabling discussions on strategic personnel exchanges

37 Proposed Functional Planning Action Q1 Q2 Q3 Q4 Establish working group; generate awareness & interest Establish Secretariat, structure and draft Terms of Reference Hold inaugural teleconference meeting to discuss strategic action plan Survey landscape for existing training opportunities, compile catalogue Quarterly meeting #2, discuss gaps/interests Engage guest speakers to address topics of interest at each meeting Compile existing resources to identify gaps/interests Quarterly meeting #3 Year 1 Review, Face to Face meeting at GCRSR 18

38 GCRSR Accomplishments 1) Established the GCRSR Executive Committee/Co-chairs. 2) Agreement: membership, fundamental structure, function. 3) Agreed to focus initial efforts on building consensus on new and emerging research efforts that hold promise for improving food and medical products safety assessments. 4) Strategic Workgroups formed to develop common approaches for research tools that are accepted globally. 1) Bioinformatics (GSRS15 meeting held in Montreal) 2) Nanotechnology (GSRS16 meeting held in Bethesda) 3) Emerging Technologies (GSRS17 meeting held in Brasilia) 4) Cross-training (formally adopted September 2017) 5) Global Summits held annually to build common understanding on selected regulatory science research topics. Innovative science to improve public health 38

39 GCRSR Future Plans 1) Identify knowledge gaps hindering the use of new technologies in regulatory decision-making. 2) Foster collaborative research needed to move forward technology or approaches used in regulatory decision-making. 3) Foster common understanding of technologies and approaches through white papers, workshops and training. 4) Establish the Cross-Training Working Group Innovative science to improve public health 39