ilsi health and environmental sciences institute:...

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

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HESI’s First Annual Meeting in Europe

Thank you for being part of it

2012 AOM Meeting Welcome

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• 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

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This Meeting: Tripartite in Action

HESI Annual Meeting - 2012 Participation

academia

Government

Industry

Consultants

NGO


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

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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

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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

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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

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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.

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Syril D. Pettit, MEM HESI Executive Director

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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

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HESI’s Scientific Programs

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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.

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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)

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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

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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

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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!

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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

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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)

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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

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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

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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

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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

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Nominations to the


(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)

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Election of

public and private sector

Science Advisor nominees

to the

HESI Emerging Issues Committee.

ACTION:

(motion, second, and vote)

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Vice Chair Nomination to the


(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)

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Election of public sector

Vice Chair nominee

to the

HESI Emerging Issues Committee.

ACTION:

(motion, second, and vote)

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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)

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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)

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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

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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.

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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)

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• 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

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2012 HESI Annual Meeting

Assembly of Members Meeting

FINANCIAL REPORT

Norbert Kaminski, PhD

HESI Treasurer

June 13, 2012

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• 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

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• 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

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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

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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

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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

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(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

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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

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• Any questions?

• Any comments?

• Thanks!

2012 Financial Report Q & A


Sciences Institute



Revisions to HESI’s ByLaws

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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?

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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

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BRIEF SUMMARY OF CHANGES

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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

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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

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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

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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

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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

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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

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• Questions or Comments?


Sciences Institute



State of the Science

HESI Genomics

Committee

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• See Separate Slide Deck from

Aubrecht and Paules

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Break!


Sciences Institute



HESI Mini-Symposium

Drug Safety Issues

in Europe

Chair, Dr. Ruth Roberts, AZ

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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)

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• See separate slide deck from R.

Roberts

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Silva- Lima Slides

• See separate slide deck from

Silva-Lima

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Goldman Slides

• See separate slide-deck from

Goldman

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FINAL REMARKS

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THANK YOU FOR YOUR

ATTENTION

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