HESI Emerging Issues Session

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1 HESI Emerging Issues Session Dennis J. Devlin, PhD (Exxon Mobil Corporation) HESI President HESI Annual Meeting 12 June 2012 Prague, Czech Republic

2 Meeting Goals Acknowledge incoming and outgoing HESI Emerging Issues Committee (EIC) Science Advisors. Outline the Emerging Issues Process. Give reports on existing HESI Emerging Issues Subcommittees. Explore new topic areas for consideration by HESI constituency. 2

3 2012 EIC PARTICIPATION 3

4 EIC Leadership (to be elected by HESI Assembly on 13 June 2012) CHAIR: Stephen J. Newsholme BSc, BVetMed, MMedVet (Path), Diplomate ACVP, MRCVS GlaxoSmithKline (term expires 2014) VICE CHAIR: Hal Zenick, PhD US Environmental Protection Agency (term expires 2015) PAST CHAIR: Karen L. Blackburn, PhD The Procter & Gamble Company (term expires 2013) 4

5 EIC Public Sector Science Advisors (to be elected by HESI Assembly on 13 June 2012) Dr. Darlene Dixon NIEHS (term ends 2014) Dr. Jesse L. Goodman US FDA (term ends 2014) Dr. George Gray George Washington University (term ends 2014) Dr. Toshihisa Ishikawa re-elected RIKEN Yokohama (term ends 2015) Prof. Ian Kimber University of Manchester (term ends 2013) Dr. James E. Klaunig Indiana University (term ends 2013) Dr. José E. Manautou newly elected University of Connecticut (term ends 2015) Dr. Derek C.G. Muir Environment Canada (term ends 2013) Dr. Russell S. Thomas newly elected Hamner s (term ends 2015) 5

6 EIC Private Sector Science Advisors (to be elected by HESI Assembly on 13 June 2012) Dr. Cynthia A. Afshari Amgen Inc. (term ends 2014) Dr. Robert A. Barter re-elected ExxonMobil Biomedical Sciences (term ends 2015) Dr. Daniel A. Goldstein newly elected Monsanto Company (term ends 2015) Dr. Patrick D. Guiney SC Johnson & Son, Inc. (term ends 2014) Dr. George Pugh, Jr. The Coca-Cola Company (term ends 2013) Dr. Ruth A. Roberts newly elected AstraZeneca (term ends 2015) Dr. Mark A. Tirmenstein Bristol-Myers Squibb Co. (term ends 2013) 6

7 Outgoing EIC Participants (terms ending June 2012) Thanks to all! Dr. B. Bhaskar Gollapudi (Past Chair) The Dow Chemical Company Dr. Gary M. Williams (Public Sector Science Advisor) New York Medical College Dr. Werner H. Bomann (Private Sector Science Advisor) Bayer CropScience 7

8 EMERGING ISSUES PROCESS 8

9 Emerging Issues Process: Issue Identification Annual Survey: Distributed to HESI stakeholders (membership and a broad cross-section of the international scientific community). In proposing new topics, respondents are asked to consider topics in the the context of linkages with issues found on the HESI Combined Challenges Map (see meeting book for Map). 9

10 Emerging Issues Process: Issue Identification, continued Results from the survey are examined by the EIC. Using established criteria, the EIC determines which proposals are presented at the HESI Annual Meeting. After the Annual Meeting, HESI stakeholders vote on the highest priority issue for HESI action that year (see yellow form in today s meeting notebook). 10

11 Criteria for Issue Identification and Prioritization 1. The issue should be critical for the general scientific community, as well as for current and potential member companies, and should have current public health significance. 2. The issue should have reasonable potential for resolution. 3. The issue should be an area for which HESI has or can identify expertise to contribute. 4. HESI s efforts to address the issue should not be duplicative of other groups. 11

12 Emerging Issues Subcommittee Formation and Operation Based on voting results (post-annual Meeting), the EIC selects one emerging issue for HESI action. A Subcommittee is formed. Funding: Year One: $50,000 in funding from HESI; no fees for participation. Year Two: HESI matches funding raised by committee up to $50,000. Beyond Year Two: If desired, participants petition HESI Board for Project or Technical Committee status; project is then funded entirely by participant dollars. 12

13 EXISTING EMERGING ISSUES SUBCOMMITTEES 13

14 Subcommittee Reports Evaluating causality in epidemiologic studies Dr. J. Michael Wright (US Environmental Protection Agency, National Center for Environmental Assessment) Subcommittee Co-Chair Sustainable Alternatives Dr. Robert A. Barter (ExxonMobil Biomedical Sciences, Inc.) Subcommittee Member 14

15

16 NEW TOPIC PRESENTATIONS ONE TOPIC WILL BE SELECTED FOR HESI ACTION IN

17 New Topic Presentations The utilization of dried blood spot to reduce animal usage in non-clinical studies Dr. David Ackley (Pfizer Drug Safety R&D) Dr. Ernie Harpur (Newcastle University) Translational safety biomarker assessment of neurotoxicity Dr. Andreas Jeromin (Banyan Biomarkers, Inc.) Dr. Jesse Goodman (US Food and Drug Administration) 17

18

19 NEXT STEPS 19

20 Requested Action: Prioritization and Voting Reminder: Only one topic will be selected for HESI action in Return the yellow prioritization form to HESI staff today, or return the form to HESI by or fax by 16 July The prioritization form will also be distributed electronically to HESI s full contact list next week. 20

21 Thank you! Děkuji! 21

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