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Health and Environmental
Sciences Institute
ILSI Health and Environmental
Sciences Institute: HESI
HESI Annual Meeting
Assembly
Wednesday June 13, 2012
ILSI Health and
Environmental Sciences
Institute 2
HESI’s First Annual Meeting in Europe
Thank you for being part of it
2012 AOM Meeting Welcome
ILSI Health and
Environmental Sciences
Institute 3
2012 AOM Meeting Welcome
• First HESI Annual Meeting in Europe
Annual Meeting 2011: North America Location
Annual Meeting 2012: Europe Location +25% European involvement!
Europe
US
Japan
Europe
US
Japan
ILSI Health and
Environmental Sciences
Institute 4
This Meeting: Tripartite in Action
HESI Annual Meeting - 2012 Participation
academia
Government
Industry
Consultants
NGO
ILSI Health and Environmental
Sciences Institute
1156 15th Street, NW
Second Floor
Washington, DC 20005
USA
1.202.659.3306 office
1.202.659.3617 fax
www.hesiglobal.org
AGENDA
8:15 a.m. I. Call-to-order & State of the Organization Address Dr. Dennis Devlin 8:30 a.m. II. Organizational Business and Planning
Nominating Committee Report & Elections Dr. Ken Wallace
Emerging Issues Committee & Elections Dr. Ken Wallace
Financial Report Dr. Norbert Kaminski
Revisions to By-Laws Dr. Jay Goodman 9:15 a.m. IV. HESI Program Strategy and Stewardship: HESI’s Commitment to Scientific Rigor Dr. Ron Hines
9:45 a.m. V. State of the Science: HESI Genomics Committee Dr. Jiri Aubrecht,
Dr. Rick Paules 10:30 a.m. Coffee Break 10:45 a.m. VI. Mini-Symposium on Drug Safety Issues in Europe
- Challenges in Safety Science – Drug Attrition Analysis, Impact and Improving Predictions of Human Toxicities - Dr. Ruth Roberts – AstraZeneca (20 min)
- Systems Toxicology Approaches to Drug Safety in Europe - Dr. Beatriz Silva-Lima, Chair EU Safety Working Party (35 min)
- The Innovative Medicines Initiative: Approaching drug safety through public-private partnership, Dr. Michel Goldman, Executive Director Innovative Medicines Initiative, Europe (45 min)
12:30 p.m. IX. Final Remarks and Thanks Ms. Syril Pettit 12:35 p.m. X. Adjourn Dr. Dennis Devlin
ILSI Health and
Environmental Sciences
Institute 6
2012 AOM Meeting Welcome
In the AOM book, you will find:
HESI and Tripartite Statement
ILSI Anti-trust Statement
ILSI Code of Ethics
Copy of ‘draft’ minutes for June 2011
List of Attendees to 2012 AOM Meeting
2012 HESI Scientific Portfolio
Info on Nominees for Trustee Positions
ILSI Health and
Environmental Sciences
Institute 7
ACTION: Approval of 2011 minutes
(in the AOM packet)
HESI Assembly of Members Meeting
‘draft minutes’ June 2011
We have a quorum of the AOM – we need a motion, a second and a vote
ILSI Health and
Environmental Sciences
Institute 8
Communicating HESI State of the Organization
High level overview to begin the AOM
Invite (urge!) you to attend all open sessions • New Strategic Directions (yesterday)
• Emerging Issues (yesterday)
• Board of Trustees:
o Executive Director’s Organizational Update and Strategic Initiatives
o Committee reports: Nominations; Finance; Membership Development; Communications & Outreach; Program Strategy & Stewardship; Executive
o Objectives and Milestones
Tools for ongoing communication • HESI Website
• HESI Activities Report
• HESI Webinars - Committee PSSC Technical Reviews and ‘Asia Outreach’
• HESI Insights
• HESI “Success Stories” – in progress
ILSI Health and
Environmental Sciences
Institute 9
Organizational Changes: new HESI Executive Director
21 qualified candidates 6 countries
careers in academia, government, industry, nonprofits
backgrounds in science, medicine, law, public policy
3 exceptional finalists
1 new Executive Director
Special thanks to the Search Committee: Marc Bonnefoi, Alan Boobis, Dennis Devlin, Nancy Doerrer, Laurie Hanson, Ron Hines, Ken Wallace, with support from Beth-Ellen Berry, Marianna Knight and Shawn Sullivan.
ILSI Health and
Environmental Sciences
Institute 10
Syril D. Pettit, MEM HESI Executive Director
ILSI Health and
Environmental Sciences
Institute 11
2012 HESI Staff
Syril D. Pettit, MEM Executive Director Nancy G. Doerrer, MS Associate Director
Michelle R. Embry, PhD Senior Scientific Program Manager
Raegan O’Lone, PhD Scientific Program Manager
James Kim, PhD, DABT Senior Scientific Program Manager
Jennifer Young, PhD Scientific Program Manager Jennifer Pierson, MPH Scientific Program Associate
Eric L. Moore Exec. Assistant & Multimedia Specialist Cynthia J. Nobles Senior Executive Assistant Regina G. Graham Executive Assistant
Positively Impact the Most
Relevant Health and
Environmental Issues
Assure Transparency of Scientific and Communications Processes
A
B
C
D
4
Create Definitive Scientific Solutions
Ensure Recognition of HESI’s Value and
Contributions
Optimize HESI’s Organizational Effectiveness
Focus on Program Areas in
Translational Biology, Risk
Assessment, Environmental
Toxicology, and New Technology
and Approaches
Identify and Prioritize
New Scientific Issues to Increase
Alignment with the Scientific Map
Deliver Quality
Scientific Results
Evaluate and
Continuously Improve
Recognition of HESI’s Value
and Contribution
Develop and Implement a
Proactive Engagement and
Communications Plan for HESI
Increase HESI’s Outreach to
and Recognition With
Key Stakeholders
Align Organizational
Structure with
Strategic Requirements
Attract and Engage
Quality Scientists and Optimize
Tripartite Composition
Ensure Effective Project
Management to Deliver
Outcomes in a Timely Fashion
Ensure Appropriate
Staffing and Financial
Resources to Support
Programs
1 2 3
ILSI Health and
Environmental Sciences
Institute 13
HESI’s Scientific Programs
ILSI Health and
Environmental Sciences
Institute 14
Recent Examples of
Scientific Impact
July 2011 - ACSA approach cited as basis for OECD Guideline for
Extended One-Generation Reproductive Study (previously cited in
two reports of the U.S. National Academies of Sciences).
June 2012- Cardiac Safety Committee and FDA: First public effort
to assess nonclinical to clinical concordance of cardiac
depolarization data for more than >150 new drugs submissions.
June 2012- Animal Alternatives Committee findings serve as basis
for proposed OECD 210 (fish early life stage) test guideline revision.
ILSI Health and
Environmental Sciences
Institute 15
HESI Engagement
23 years experience as a leading resource
16 scientific committees – dozens of projects and programs within them
>30 government research and regulatory bodies participating;
45 sponsoring companies
60 academic institutions participating
More than 150 peer-reviewed publications in last 6 years
Nearly 2000 citations of HESI work products across North America, Asia, Australia, and Europe, (including by National Academy of Sciences)
ILSI Health and
Environmental Sciences
Institute 16
A Vibrant and Viable Organization
• More partners, more visibility, more IMPACT – Expanding outreach efforts
– High impact via publications
– Growing sponsorship base
45
42 41
44
49
36
38
40
42
44
46
48
50
2008 2009 2010 2011 2012
Increase in HESI Sponsor Companies
ILSI Health and
Environmental Sciences
Institute 17
Expanding Outreach
• New Agencies
– First HESI visit to the European Chemicals Agency (ECHA Jan 2012)
• New Agreements
– First HESI Memorandum of Understanding with a government body: Translational Biomarkers Agreement with China Drug Agency
• New Academic Centers: visits and relationships with interdisciplinary academic centers
– Northwestern Chemistry of Life Processes Institute
– Arizona Bio5 Institute
– Singapore National University
• New Professional Scientific Societies
– American Chemical Society
ILSI Health and
Environmental Sciences
Institute 18
HESI Outlook
Strong track record
Positive position at present
Looking Ahead:
• New organizational leadership
• Exciting time to expand HESI’s impact and build
further strengths
Your input and involvement welcome now, and all
year long!
ILSI Health and
Environmental Sciences
Institute 19
2011-12
Nominating Committee
Dr. Kendall Wallace, U Minnesota – Co-Chair
Dr. Dennis Devlin, ExxonMobil – Co-Chair
Dr. Alan Boobis, Imperial College
Dr. Peggy Guzzie-Peck, J&J
Dr. Ron Hines, Medical College Wisconsin
Dr. Tim Pastoor, Syngenta
ILSI Health and
Environmental Sciences
Institute 20
2011 Nominating Cmte Report
(Bios of nominees are in the AOM packet)
HESI Board of Trustees (election by Assembly)
HESI Emerging Issues Committee
(election by Assembly)
ILSI Health and
Environmental Sciences
Institute 21
Dr. Jack Dean, U Arizona.
Dr. Marc Bonnefoi, Sanofi
Dr. Josef Schlatter, Swiss Federal Office of Public Health
Dr. Neil Carmichael, Bayer
Dr. Sunao Manabe, Sankyo
Dr. Peter Moldeus, AstraZeneca
Dr. Bhaskar Gollapudi – Dow Chemical
Dr. Norbert Kaminski – Michigan State
First, thanks for your service: to those leaving the Board
ILSI Health and
Environmental Sciences
Institute 22
Proposed Re-nominees to HESI Board
Dr. Laurie Hanson – Pfizer
Dr. Lois Lehman-McKeeman - BMS
Dr. Herman Autrup – University of Aarhaus
Dr. Shoji Fukushima - Japan Bioassay
Research Center
Dr. Jay Goodman – Michigan State
ILSI Health and
Environmental Sciences
Institute 23
Dr. Douglas Wolf – US EPA
Dr. Jiro Seki – Astellas
Dr. Cynthia Afshari – Amgen
Dr. Ernie Harpur – U Leicester
Dr. Martin Philbert – Michigan School of Public
Health
Dr. Brian Berridge - GlaxoSmithKline
Dr. Bennard van Ravenzwaay - BASF
Dr. Craig Rowlands - Dow
New Nominees to HESI BOT
ILSI Health and
Environmental Sciences
Institute 24
ACTION:
Election of HESI Trustees
HESI Board of Trustees (election by AOM)
We have a quorum of the AOM – we need a motion, a second and a vote
ILSI Health and
Environmental Sciences
Institute 25
Nominations to the
HESI Emerging Issues Committee
(The EIC serves as its own nominating committee.)
Public Sector Science Advisors (3-year terms):
Toshihisa Ishikawa, PhD (RIKEN Yokohama Institute; re-nomination)
José Manautou, PhD, ATS Fellow (University of Connecticut)
Russell S. Thomas, PhD (The Hamner Institutes for Health Sciences)
Private Sector Science Advisors (3-year terms):
Robert A. Barter, PhD (ExxonMobil Biomedical Sciences; re-
nomination)
Daniel A. Goldstein, MD, FACMT (Monsanto Company)
Ruth A. Roberts, PhD (AstraZeneca)
ILSI Health and
Environmental Sciences
Institute 26
Election of
public and private sector
Science Advisor nominees
to the
HESI Emerging Issues Committee.
ACTION:
(motion, second, and vote)
ILSI Health and
Environmental Sciences
Institute 27
Vice Chair Nomination to the
HESI Emerging Issues Committee
(The EIC serves as its own nominating committee.)
Chair (1-year term; rotation from Vice Chair):
Stephen J. Newsholme, BSc, BVetMed, MMedVet
(Path), Diplomate ACVP, MRCVS (GlaxoSmithKline)
Vice Chair (1-year term; new nomination):
Hal Zenick, PhD (US Environmental Protection Agency)
Past Chair (1-year term; rotation from Chair):
Karen Blackburn, PhD (The Procter & Gamble Company)
ILSI Health and
Environmental Sciences
Institute 28
Election of public sector
Vice Chair nominee
to the
HESI Emerging Issues Committee.
ACTION:
(motion, second, and vote)
ILSI Health and
Environmental Sciences
Institute 29
2011 Nominating Committee Report
(for informational purposes only)
HESI Board Officers (to be elected by the HESI Board Thursday)
HESI Executive Committee (to be elected by the HESI Board Thursday)
HESI representatives to the ILSI Board (already elected by the ILSI Board in January 2012)
ILSI Health and
Environmental Sciences
Institute 30
Nominees for HESI Board
Officers
HESI Leadership Succession Plan:
In odd years, elect new Vice President (an industry member)
In even years, elect new Vice Chair (a public member) (2012)
Elect new Treasurer and Secretary, as needed
All officers elected to two-year terms
(Description of leadership roles and responsibilities are in the meeting
materials)
ILSI Health and
Environmental Sciences
Institute 31
Board Leadership Nominees for 2012
(informational)
HESI Chair
Dr. Ronald Hines, Medical College Wisconsin
Past Chair: Dr. Ken Wallace, U Minnesota
HESI Vice-Chair
Dr. Herman Autrup, University of Aarhaus
HESI Treasurer
Dr. Serrine Lau, University of Arizona
HESI Secretary
Dr. Charlene McQueen
ILSI Health and
Environmental Sciences
Institute 32
Nominees for 2012 HESI Executive
Committee (informational)
Dr. Dennis Devlin, President
Dr. Laurie Hanson, Vice President
Dr. Ron Hines, Chair
Dr. Herman Autrup, Vice Chair
Dr. Charlene McQueen, Secretary
Dr. Serrine Lau, Treasurer
Dr. Ken Wallace, Past-Chair
Dr. Herman Autrup, Member-at-Large
Dr. Henry Chin, Member-at-Large
Dr. Ernie Harpur, Member-at-Large
Dr. Tim Pastoor, Member-at-Large.
HESI reps to ILSI Board are ex officio members of Exec.
ILSI Health and
Environmental Sciences
Institute 33
Dr. Jay Goodman, Michigan State
Dr. Alan Boobis, Imperial College
Dr. Henry Chin, Coca-Cola
Dr. Lewis Smith, MRC
Dr. Samuel Cohen, University Nebraska
Elected Chair of the ILSI Board Jan 2012!
HESI Representatives to ILSI Board
(elected by ILSI Board in Jan 2012)
ILSI Health and
Environmental Sciences
Institute 34
• INTRODUCTION – This report is for informational purposes only
• BACKGROUND – The HESI Board approved the 2011 HESI
Budget during a teleconference in January, 2011
• OVERVIEW OF 2012 HESI BUDGET– General operating budget;
Assessing committees; HESI reserve fund; and HESI net assets
• OUTLOOK FOR 2013 HESI BUDGET
• Q & A – As needed
Financial Report
ILSI Health and
Environmental Sciences
Institute
2012 HESI Annual Meeting
Assembly of Members Meeting
FINANCIAL REPORT
Norbert Kaminski, PhD
HESI Treasurer
June 13, 2012
ILSI Health and
Environmental Sciences
Institute
• INTRODUCTION – Budget report is for informational purposes
• BACKGROUND – The HESI Board approved the 2012 HESI
Budget on January 24, 2012 at meeting in Phoenix, AZ
• OVERVIEW OF 2012 HESI BUDGET– General operating
budget; assessing committees; reserve fund; and net assets
• PROPOSALS RE: 2013 BUDGET AND FUNDS
• Q & A – As needed
2012 Financial Report
Outline
ILSI Health and
Environmental Sciences
Institute
• HESI is financially sound and has solid
and growing membership base at this
time.
• Organization is well positioned to cover
anticipated corporate and committee
expense for 2012.
Summary
General Operating Budget
ILSI Health and
Environmental Sciences
Institute
2011 Actual
2012 Projection
2012 Budget
Revenue $1,614,009 $1,607,078 $1,587,938
Expenses $945,016 $1,286,915 $1,446,915
Net Income * $463,993 $270,163 $91,023
Net Assets $759,841 $1,030,004 $850,864
* Net Income includes intra-company transfer to EI committees
Assessing Committees
ILSI Health and
Environmental Sciences
Institute
2011 Budget
2011 Actual
2012 Budget
Revenue $1,844,350 $2,191,040 $1,837,200
Expenses $2,457,384 $2,121,084 $2,531,628
Net Income / (Loss) * ($613,034) $74,956 ($644,428)
Net Assets $666,338 $1,354,328 $709,900
* Net Income /(Loss) includes intra-company transfer from operating budget. Net losses may result when committees expend prior year net asset reserves. Committees have been encouraged to do so.
HESI Reserve Funds
ILSI Health and
Environmental Sciences
Institute
2011
Budget
2011
Actual
2012
Budget
Net Income
/ (Loss) $56,940 ($48,086) $16,550
Transfer from
Operations
for GMF $200,000 $200,000 $0
Net Assets $1,316,866 $1,211,840 $1,228,390
(Includes Reserve Fund, Global Meeting
Fund (GMF) & the ‘Sunsetted’ Committee
Fund)
HESI Net Assets
ILSI Health and
Environmental Sciences
Institute
(HESI’s Total Net Assets = General Operating Budget
+ Assessing Committees + HESI Reserves)
2010
Actual
2011
Actual
2012
Budget
$2,635,146 $3,326,009 $2,789,154
ILSI Health and
Environmental Sciences
Institute
Membership Dues - Hold current dues rate steady
for 2013 given fiscal strength of HESI at this time.
Reassess in 2014.
HESI Reserve Funds + GMF
• Evaluating new investment advisor to reduce
management fees and increase returns;
• Board to consider appropriate use or investment of
funds set aside in operating budget for GMF.
HESI Finance Committee Proposals for 2013
ILSI Health and
Environmental Sciences
Institute
• Any questions?
• Any comments?
• Thanks!
2012 Financial Report Q & A
Health and Environmental
Sciences Institute
ILSI Health and Environmental
Sciences Institute: HESI
Revisions to HESI’s ByLaws
ILSI Health and
Environmental Sciences
Institute 45
HESI’s commitment and enactment of tripartite participation and leadership has
matured over the last several years.
The Board recognized the importance of codifying this commitment and reflecting our
outstanding current practice in our bylaws.
Task Force Charge: To identify and pursue opportunities to ensure that HESI’s
commitment to tripartite engagement and transparency is expressed clearly and
consistently with regard to internal practice and external relations.
February 2011: Engagement Task Force Initiated by BOT Executive Committee
June 2011: Task Force concepts introduced to Assembly
March 2011 – December 2011: Task Force meets and develops revisions.
January 2012 – Revisions presented and approved by HESI Board.
Why Change the By-Laws?
ILSI Health and
Environmental Sciences
Institute 46
Alan Boobis – Imperial College London (Co-Chair)
Jay Goodman – Michigan State U (Co-Chair)
Lewis Smith – Medical Research Council, U Leicester
Dennis Devlin – ExxonMobil
Marc Bonnefoi – Sanofi
Jan Willem van der Laan – Medicines Evaluation Agency
Syril Pettit – HESI Executive Director
Shawn Sullivan – ILSI/HESI Legal Counsel
Task Force Members
ILSI Health and
Environmental Sciences
Institute 47
BRIEF SUMMARY OF CHANGES
ILSI Health and
Environmental Sciences
Institute 48
Previous version of bylaws never use the term ‘tripartite!
Action:
– Preamble added at front of the bylaws to establish the
organization’s commitment to tripartite at the outset.
– Incorporates specific language drawn from HESI’s new mission
and vision statements as developed at the June 2011 Strategic
Planning Meeting.
Impact: The importance of the tripartite principle is
immediately visible to external/internal parties reviewing
HESI’s bylaws.
Framing HESI’s Commitment to
Tripartite
ILSI Health and
Environmental Sciences
Institute 49
Action: Language throughout the bylaws modified to reflect
equal value of public and private input in HESI programs
and leadership; The term ‘Member’ is replaced by ‘Sponsor’.
Impact: All participating scientists on a HESI committee,
regardless of sector, are now equal ‘Members’ (not just
industry participants!)
Recognizing Balanced
Scientific Input
ILSI Health and
Environmental Sciences
Institute 50
Action: Organization’s commitment to tripartite and balance is
codified through new committee leadership requirements.
– The leadership of technical, project, and emerging issues
committees must demonstrate a commitment to tripartite
engagement;
– Committees should be populated in a manner consistent with
commitment to tripartite involvement;
– Membership on a project committee requires contribution of
expertise and time for all involved (public or private sector);
Impact: All HESI Scientific Committees now have public-
private co-chairs and/or steering teams!
Requiring Public-Private
Joint Leadership & Involvement
ILSI Health and
Environmental Sciences
Institute 51
Action: Nominating Committee for Board must now be at least half public
sector (academic or gov’t) Trustees and the remainder from Industry.
Impact: New balance ensures that the nominations are drawn from a
diverse and multi-sector nominating committee.
Action: Assembly will now be presented with a slate of candidates for
trustee (no longer voting on individuals).
Impact: Ensures that voting does not follow ‘party lines’
Balance to Nomination and Election of Trustees to the Board
ILSI Health and
Environmental Sciences
Institute 52
Action: Language defining a ‘public trustee’ revised and
clarified in collaboration with ILSI Board.
Impact:
– Participation on the Board by government scientists is permitted for
those in either non-regulatory OR regulatory roles (regulatory
scientists were technically excluded previously);
– Harmonized language across HESI and ILSI.
Definition of a Public Trustee
ILSI Health and
Environmental Sciences
Institute 53
Action: The Emerging Issues Steering Committee renamed
the Emerging Issues Committee (EIC and not EISC);
Action: Several revisions adopted to ensure balanced
voting and leadership roles for public and private sector
participants on the Emerging Issues Committee.
Impact: Emerging Issues Committee has been populated
and leadership confirmed to balance public-private input.
Emerging Issues Committee
ILSI Health and
Environmental Sciences
Institute 54
• Questions or Comments?
Health and Environmental
Sciences Institute
ILSI Health and Environmental
Sciences Institute: HESI
State of the Science
HESI Genomics
Committee
ILSI Health and
Environmental Sciences
Institute 75
• See Separate Slide Deck from
Aubrecht and Paules
ILSI Health and
Environmental Sciences
Institute 76
Break!
Health and Environmental
Sciences Institute
ILSI Health and Environmental
Sciences Institute: HESI
HESI Mini-Symposium
Drug Safety Issues
in Europe
Chair, Dr. Ruth Roberts, AZ
ILSI Health and
Environmental Sciences
Institute 78
Today’s Speakers
Challenges in Safety Science – Drug Attrition Analysis,
Impact and Improving Predictions of Human Toxicities
Dr. Ruth Roberts – AstraZeneca (20 min)
Systems Toxicology Approaches to Drug Safety in Europe
• Dr. Beatriz Silva-Lima, Chair EU Safety Working Party
(35 min)
The Innovative Medicines Initiative: Approaching drug
safety through public-private partnership
• Dr. Michel Goldman, Executive Director Innovative
Medicines Initiative, (45 min)
ILSI Health and
Environmental Sciences
Institute 79
• See separate slide deck from R.
Roberts
ILSI Health and
Environmental Sciences
Institute 80
Silva- Lima Slides
• See separate slide deck from
Silva-Lima
ILSI Health and
Environmental Sciences
Institute 81
Goldman Slides
• See separate slide-deck from
Goldman
ILSI Health and
Environmental Sciences
Institute 82
FINAL REMARKS
ILSI Health and
Environmental Sciences
Institute 83
THANK YOU FOR YOUR
ATTENTION
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