Presenter Name 1

Presenter Name 2

Presenter Name 3

Month DD, YYYY

Penny M. Heaton, MD

May 16, 2017

Introducing Gates Medical Research Institute

HIV-AIDS

LRI

Diarrhea

Malaria

TB

© Bill & Melinda Gates Foundation | 3

Two vaccines WHO PQ’ed but

nearly 50% of GAVI budget.

Solutions?

1. Multi-dose vials

2. More low-cost suppliers

3. Dose reduction

4. Alternate conjugation

strategies

Children <5 years Adults >65 years

Pneumococcal Conjugate Vaccine

4

130 COUNTRIES HAVE INTRODUCED PNEUMOCOCCAL CONJUGATE

VACCINES INCLUDING 57 GAVI COUNTRIES (2016)

IVAC VIEW-Hub and Gavi

(130)

POLIO ERADICATION IS WITHIN REACH 5 CASES SO FAR THIS YEAR VS. 12 IN SAME TIME FOR 2016

2014 2017 2018 2020 2019 2016 2015

tOPV-bOPV

Switch Last use

of bOPV Global

Certification

bOPV + 1 dose IPV in routine

immunization

IPV-2 doses

HIV-AIDS

LRI

Diarrhea

Malaria

TB How can we make the

same progress against other

diseases?

Bill and Melinda Gates Medical

Research Institute (Gates MRI)

GATES MRI: GUIDING PRINCIPLES – WORKING DRAFT

BELIEF

PURPOSE WHO WE ARE AND WHAT WE

ARE ABOUT

VISION THE WORLD WE WANT

TO SEE

OUR CONTRIBUTION HOW WE ARE UNIQUE

MISSIONS THE OUTCOMES THAT HELP US

ACHIEVE OUR VISION

OUR VALUES HOW WE WORK

ALL LIVES HAVE EQUAL VALUE

We are committed to saving lives by harnessing science and technology to combat diseases

in the poorest populations

Improved lives for the world’s poorest populations through novel drugs, biologics, vaccines

and diagnostics

Top talent, deploying

cutting-edge science

to age-old problems

An agile, fast-to-

decision approach

A cross-cutting view

of disease areas and

modalities

Integration of data to

inform decisions

Develop effective therapeutics,

vaccines and diagnostics for

focus disease areas

Achieve PST disease area

goals

Continuously learn from

successes and failures

Collaboration Innovation Urgency Rigor “Truth seeking”

and learning

© Bill & Melinda Gates Foundation | 10

A FULLY INTEGRATED, NON-PROFIT ORGANIZATION FOCUSED ON TRANSLATIONAL PRODUCT DEVELOPMENT

Focus: Development from preclinical

candidate selection to clinical proof of

concept

Modalities: drugs, vaccines, antibodies,

biomarkers, and combination products

Fit-for-purpose for complex targets with

product development challenges but high

potential for impact

“Learn the truth in the shortest time and

at the lowest cost possible”

Translational development Discovery / research

Late phase

development

GMRI

Target HTS2 Hit to

lead

Lead

opt. Pre-clinical Ph I / IIa Ph IIb/ III

Vaccines

Biomarkers/

Diagnostics2 Disease area

Small

molecules Biologics3

TB

HIV

Pneumonia

NTD

EDD

Malaria

Polio

MNCH-D

ITS

Family Planning

© Bill & Melinda Gates Foundation | 11

WE’RE IN THE DESIGN PHASE…

What will stay the same?

Our approach to product development

• Strive to maximize impact in the shortest amount of

time

• Use data to inform decisions and increase the

probability of success

• End-to-end planning

Disease

Strategy

Prioritize

Portfolio

Target

Outcomes

Generate Data

Program

Strategy

Product

Development Modeling/ Quant.

Sciences

Integrated Planning

Monitor

Progress

Go/ No-

Go Go/ No-

Go

What will be different?

Can we close the gap between new

discoveries and application to our most

difficult diseases?

0%

20%

40%

60%

80%

100%

0 2 4 6 81012141618202224

Perc

enta

ge o

f countr

ies t

hat

have

u

niv

ers

ally

intr

oduced v

accin

e

Years since first introduction

Hib High-income country

Hib Low-income country

12 © Bill & Melinda Gates Foundation |

We are at the beginning of a multi-phase journey

Conceptual design Operational design

▪ Mission / vision /

objectives for GMRI

▪ Scope and key

capabilities required at

GMRI

▪ “Rules of engagement”

between GMRI and

BMGF and external

stakeholders

▪ Initial portfolio

▪ Detailed requirements

by function (resourcing,

infrastructure, etc)

▪ Alignment on decision-

making rights / RACIs

▪ Recruitment plan and

HR strategy

▪ Plan for Business

Operations support

Establishment

▪ Top leadership hires

▪ Infrastructure

▪ Key processes and

compliance established

▪ Executed agreements

with upstream partners

for portfolio assets

Execution on initial

focus areas

▪ Development of initial

portfolio

▪ Pipeline assets

transferred at

appropriate milestones

Expansion and

refinement

▪ Pipeline growth

▪ Additional focus areas

(disease, modality)

▪ Additional capabilities

Today Operations begin

Mid April – End July

Stay tuned…

…and thank you!