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<ul><li><p>Presenter Name 1 </p><p>Presenter Name 2 </p><p>Presenter Name 3 </p><p>Month DD, YYYY </p><p>Penny M. Heaton, MD </p><p>May 16, 2017 </p><p>Introducing Gates Medical Research Institute </p></li><li><p>HIV-AIDS </p><p>LRI </p><p>Diarrhea </p><p>Malaria </p><p>TB </p></li><li><p> Bill &amp; Melinda Gates Foundation | 3 </p><p>Two vaccines WHO PQed but </p><p>nearly 50% of GAVI budget. </p><p>Solutions? </p><p>1. Multi-dose vials </p><p>2. More low-cost suppliers </p><p>3. Dose reduction </p><p>4. Alternate conjugation </p><p>strategies </p><p>Children 65 years </p><p>Pneumococcal Conjugate Vaccine </p></li><li><p>4 </p><p>130 COUNTRIES HAVE INTRODUCED PNEUMOCOCCAL CONJUGATE </p><p>VACCINES INCLUDING 57 GAVI COUNTRIES (2016) </p><p>IVAC VIEW-Hub and Gavi </p><p>(130) </p></li><li><p>POLIO ERADICATION IS WITHIN REACH 5 CASES SO FAR THIS YEAR VS. 12 IN SAME TIME FOR 2016 </p><p>2014 2017 2018 2020 2019 2016 2015 </p><p>tOPV-bOPV </p><p>Switch Last use </p><p>of bOPV Global </p><p>Certification </p><p>bOPV + 1 dose IPV in routine </p><p>immunization </p><p>IPV-2 doses </p></li><li><p>HIV-AIDS </p><p>LRI </p><p>Diarrhea </p><p>Malaria </p><p>TB How can we make the </p><p>same progress against other </p><p>diseases? </p></li><li><p>Bill and Melinda Gates Medical </p><p>Research Institute (Gates MRI) </p></li><li><p>GATES MRI: GUIDING PRINCIPLES WORKING DRAFT </p><p>BELIEF </p><p>PURPOSE WHO WE ARE AND WHAT WE </p><p>ARE ABOUT </p><p>VISION THE WORLD WE WANT </p><p>TO SEE </p><p>OUR CONTRIBUTION HOW WE ARE UNIQUE </p><p>MISSIONS THE OUTCOMES THAT HELP US </p><p>ACHIEVE OUR VISION </p><p>OUR VALUES HOW WE WORK </p><p>ALL LIVES HAVE EQUAL VALUE </p><p>We are committed to saving lives by harnessing science and technology to combat diseases </p><p>in the poorest populations </p><p>Improved lives for the worlds poorest populations through novel drugs, biologics, vaccines </p><p>and diagnostics </p><p>Top talent, deploying </p><p>cutting-edge science </p><p>to age-old problems </p><p>An agile, fast-to-</p><p>decision approach </p><p>A cross-cutting view </p><p>of disease areas and </p><p>modalities </p><p>Integration of data to </p><p>inform decisions </p><p>Develop effective therapeutics, </p><p>vaccines and diagnostics for </p><p>focus disease areas </p><p>Achieve PST disease area </p><p>goals </p><p>Continuously learn from </p><p>successes and failures </p><p>Collaboration Innovation Urgency Rigor Truth seeking </p><p>and learning </p></li><li><p> Bill &amp; Melinda Gates Foundation | 10 </p><p>A FULLY INTEGRATED, NON-PROFIT ORGANIZATION FOCUSED ON TRANSLATIONAL PRODUCT DEVELOPMENT </p><p> Focus: Development from preclinical </p><p>candidate selection to clinical proof of </p><p>concept </p><p> Modalities: drugs, vaccines, antibodies, </p><p>biomarkers, and combination products </p><p> Fit-for-purpose for complex targets with </p><p>product development challenges but high </p><p>potential for impact </p><p> Learn the truth in the shortest time and </p><p>at the lowest cost possible </p><p>Translational development Discovery / research </p><p>Late phase </p><p>development </p><p>GMRI </p><p>Target HTS2 Hit to </p><p>lead </p><p>Lead </p><p>opt. Pre-clinical Ph I / IIa Ph IIb/ III </p><p>Vaccines </p><p>Biomarkers/ </p><p>Diagnostics2 Disease area </p><p>Small </p><p>molecules Biologics3 </p><p>TB </p><p>HIV </p><p>Pneumonia </p><p>NTD </p><p>EDD </p><p>Malaria </p><p>Polio </p><p>MNCH-D </p><p>ITS </p><p>Family Planning </p></li><li><p> Bill &amp; Melinda Gates Foundation | 11 </p><p>WERE IN THE DESIGN PHASE </p><p>What will stay the same? </p><p> Our approach to product development </p><p> Strive to maximize impact in the shortest amount of </p><p>time </p><p> Use data to inform decisions and increase the </p><p>probability of success </p><p> End-to-end planning </p><p> Disease Strategy </p><p>Prioritize </p><p>Portfolio </p><p>Target </p><p>Outcomes </p><p>Generate Data </p><p>Program </p><p>Strategy </p><p>Product </p><p>Development Modeling/ Quant. </p><p>Sciences </p><p>Integrated Planning </p><p>Monitor </p><p>Progress </p><p>Go/ No-</p><p>Go Go/ No-</p><p>Go </p><p>What will be different? </p><p> Can we close the gap between new </p><p>discoveries and application to our most </p><p>difficult diseases? </p><p>0%</p><p>20%</p><p>40%</p><p>60%</p><p>80%</p><p>100%</p><p>0 2 4 6 81012141618202224</p><p>Perc</p><p>enta</p><p>ge o</p><p>f countr</p><p>ies t</p><p>hat </p><p>have</p><p> u</p><p>niv</p><p>ers</p><p>ally</p><p> intr</p><p>oduced v</p><p>accin</p><p>e </p><p>Years since first introduction </p><p>Hib High-income country</p><p>Hib Low-income country</p></li><li><p>12 Bill &amp; Melinda Gates Foundation | </p><p>We are at the beginning of a multi-phase journey </p><p>Conceptual design Operational design </p><p> Mission / vision / objectives for GMRI </p><p> Scope and key capabilities required at </p><p>GMRI </p><p> Rules of engagement between GMRI and </p><p>BMGF and external </p><p>stakeholders </p><p> Initial portfolio </p><p> Detailed requirements by function (resourcing, </p><p>infrastructure, etc) </p><p> Alignment on decision-making rights / RACIs </p><p> Recruitment plan and HR strategy </p><p> Plan for Business Operations support </p><p>Establishment </p><p> Top leadership hires Infrastructure Key processes and </p><p>compliance established </p><p> Executed agreements with upstream partners </p><p>for portfolio assets </p><p>Execution on initial </p><p>focus areas </p><p> Development of initial portfolio </p><p> Pipeline assets transferred at </p><p>appropriate milestones </p><p>Expansion and </p><p>refinement </p><p> Pipeline growth Additional focus areas </p><p>(disease, modality) </p><p> Additional capabilities </p><p>Today Operations begin </p><p>Mid April End July </p></li><li><p>Stay tuned </p><p>and thank you! </p></li></ul>