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  • Approach
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Our bottom line: lives saved.
Helping the lives of people with the greatest need...
...by combining breakthrough science and cutting-edge product development.

Mission

THE POTENTIAL OF TRANSLATIONAL MEDICINE

The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, diarrheal diseases and improve outcomes in maternal and newborn health — major causes of mortality, poverty, and inequality in Low- and Middle-Income Countries (LMIC). The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world's poorest people.
Our focus is translational medicine: advancing novel drug and vaccine candidates from the laboratory to human studies. Funneling many possible ideas into a few viable solutions is the most challenging stage of the research and development process, but we embrace this challenge. We learn continuously from everything we do. If one or two or 100 ideas don't turn into solutions today, they yield insights that help us succeed tomorrow.

Leadership

Our Explorers

We bring interdisciplinary experience to the pursuit of saving lives.

Penny M. Heaton, M.D.

Chief Executive Officer

Inspires and enables the organization to achieve its global mission

My role is to set the vision for the Gates MRI and inspire the organization to achieve it. I am responsible for mission clarity, steering our strategy in the right direction, and ensuring there are sufficient resources to reach our goals.

I am at the Institute because I fervervently believe that everyone should have the opportunity to live a productive life. My passion for infectious diseases is life-long, stemming from my father’s near-death from tuberculosis. The results of a surveillance study I conducted in western Kenya further ignited this passion; there I witnessed firsthand the high mortality from diarrheal and respiratory diseases that can occur in a setting with limited healthcare resources. These experiences drove me to a career in the private sector, where I spent nearly fifteen years developing vaccines against diseases such as rotavirus, a diarrheal disease that once claimed the lives of half a million infants and young children annually. The impact of rotavirus vaccines globally has been nothing short of phenomenal, projected to save 1.7 million lives over the next 10 years. I want to see that same extraordinary outcome for other infectious diseases. Although technically more difficult, why can’t we find solutions for tuberculosis, malaria, and other enteric diseases?

Every day I think what an incredible privilege it is to lead an organization whose sole reason for existing is to use cutting-edge technology and science to find solutions for these diseases, and make them accessible to all.

Expertise Building and leading teams and organizations, leading strategy development and execution.

Integrated product development, clinical trials, vaccinology, infectious diseases, global health.

Credentials Director, Vaccines Development,
Bill & Melinda Gates Foundation

Global Head, Clinical Research Clusters,
Novartis

Chief Medical Officer & VP, Development
Novavax

Senior Director, Vaccines Clinical Research
Merck & Co.

Claire Wagner, M.D., MBA

Chief of Staff

Advances strategic priorities to deliver on our mission.

As Chief of Staff, I support the CEO in driving the rhythm of the organization, and in developing and advancing strategic initiatives to help realize our vision as a global health biotech. In line with the Bill & Melinda Gates Foundation stance that all lives have equal value, our job at the Gates MRI is to apply the latest breakthrough science and technology to some of the world’s most intractable diseases affecting the poor.

Prior to joining the Gates MRI, I worked on multiple healthcare initiatives in Mali and in Tanzania between 2007-2009. I later served in Kigali, Rwanda from 2010-2013 as Research Fellow to Rwanda’s Minister of Health, Dr. Agnes Binagwaho and to Harvard University Professor Dr. Paul Farmer. Returning to the United States, I consulted for industry and non-profit entities on global access to oncology products and services, leading multi-country studies and coordinating an effort resulting in the 16-drug expansion of the World Health Organization’s Model List of Essential Medicines for Cancer. Building on experience and training in global health, medicine, and business management, I was drawn to the Gates MRI by its vision to chart a new course forward in pharmaceutical product development. My goal is to contribute to the Gates MRI’s efforts to make a tangible and enduring impact across the globe.

Expertise Global health equity and health systems strengthening

Access to products and services in low- and middle-income countries

Building and strengthening public-private partnerships

Business management and strategic planning

Credentials M.D. / M.B.A. Harvard Medical School and Harvard Business School

Co-author of 40+ scientific publications, published in journals including Lancet, Nature, NEJM

Fellowships with the Union for International Cancer Control in Geneva, Harvard Business School’s Arthur Rock Center for Entrepreneurship, Harvard Medical School’s Center for Global Health Delivery-Dubai and its Department of Global Health and Social Medicine

Michael Dunne, M.D., FIDSA

Chief Medical Officer, Head of Development

Responsible for Clinical Development

Throughout my career I’ve been involved with public health, both globally and locally in anti-infective drug development. The Bill & Melinda Gates Medical Research Institute is largely devoted to infectious disease as well as other areas, and I felt I could meaningfully contribute to the health and well-being of the world’s poorest populations. As founder, board member and Chief Science Officer at Iterum Therapeutics, my group proudly developed the antibiotic sulopenem. Prior to that, as a founder and Chief Medical Officer of Durata Therapeutics, we developed the antibiotic dalbavancin. Before joining Durata, I worked at Pfizer, and engaged in the in the development and registration of a number of antibacterial, antifungal, antiviral and HIV therapeutics. I served as a member of the Scientific Advisory Committee for the Global Alliance for TB Drug Development as well as a member of the Expert Scientific Advisory Committee of the Medicines for Malaria Venture. I currently chair the Board of Health in my local community.

I studied economics as an undergraduate at Northwestern University and earned my MD from the SUNY Health Sciences Center, Brooklyn. I was a resident in Internal Medicine at Hartford Hospital and Yale New Haven Hospital and completed fellowship training at Yale in Infectious Diseases and Pulmonary Medicine.

Every day I think what an incredible privilege it is to lead an organization whose sole reason for existing is to use cutting-edge technology and science to find solutions for these diseases, and make them accessible to all.

Expertise Leadership of a biotechnology enterprise

Anti-infective drug development

Infectious diseases

Credentials Chief Scientific Officer, Iterum Therapeutics

Vice President, R&D, Actavis, plc

Chief Medical Officer, Durata Therapeutics

Vice President, Therapeutic Area Head of Clinical Development, Pfizer, Inc

Venice Herring, M.S.

HUMAN RESOURCES BUSINESS PARNTER

Cultivates a mission-driven team.

I work across the institute to instill a high-energy environment staffed with leaders at every level of the organization. My work involves designing and delivering people strategies and solutions, including advising clinical and business leaders on forecasting workforce needs, providing strategic staffing solutions to improve labor productivity measures, leadership coaching, diversity, equity & inclusion, facilitating leadership development at all levels of the organization; talent review, succession, organizational design as well assessing the impact of strategic initiatives to ensure that appropriate change and transition plans are in place to engage, inspire and support successful change. With a career spanning over 30 years, I’ve held leadership positions to help employers and their employees succeed. My experiences include working in the health care industry, professional services industry with Deloitte and Touche, manufacturing, as well as in consumer products with Elmer’s Products.

As human resources leader, I support the Gates MRI HR team, as well as continue to lead HR for the Global Health Division at the Bill & Melinda Gates Foundation.

Expertise Workforce Planning

Leadership Development

Change Management

Organizational Design

Engagement & Culture

Data and Analytics

Credentials Society for Human Resource Management, Member

Healthcare Businesswomen’s Association, Member

Mentor to graduate and undergraduate students at The Ohio State University

MS in Human Resources, Fisher College of Business, The Ohio State University

Manfred Lauchart, Ph.D

Head of Program & Portfolio Management

Ensuring delivery of highly needed medicinal products by driving strategic planning and execution of development programs.

Understanding the mechanisms that make complex systems work has always been a passion of mine. Applying these insights to research and the development of prophylactic and therapeutic products to solve global health challenges has been the key focus of my professional career. I believe that a planful approach to managing a portfolio of programs and integrating complex drug development processes is instrumental in ensuring the success of the end product. Enabling organizations to deliver transformational, life-saving medicinal products has always been my priority. To that end, I have devoted my energy to planning, coordinating and optimizing the development of life saving therapies in a nimble, digestible, efficient and deliverable manner.

At the Gates MRI, I am privileged to be able to apply my professional focus to accelerate product development for populations with high unmet needs. It takes a well-integrated and aligned team with broad research, clinical, regulatory, quantitative, technical and operational expertise to complete this challenging task. I am thrilled to be part of this effort and to work with those who have devoted their lives to helping underserved populations globally!

Expertise New Product Development (biologics, small molecules, device and drug-device combination products)

Program and Portfolio Management

Project Management Best Practices

Building, developing and mentoring effective teams

Credentials VP, Program Management, Intarcia Therapeutics

Head Business Operations, Global Clinical Development, Baxalta

Sr. Director, Program Management Office R&D, Baxter Medical Products

Director, Global Program & Portfolio Management Vaccines, Baxter BioScience

Ken Miller, J.D.

Lead Counsel

Description: Drives and executes practical legal strategies to enable impact

I am responsible for delivering efficient and reliable legal guidance, managing legal risk, and supporting the development of solutions that accelerate impact. My team collaborates across the Gates MRI with a laser focus on developing and using legal agreements, tools, and strategies in practical and creative ways that advance our mission. In structuring deals, our focus is the lives of people with greatest need.

I am a business, technology, and global health attorney with 20+ years’ experience working with highly innovative companies and nonprofits to achieve their business and charitable objectives. For five years, I supported the Global Health Division of the Bill & Melinda Gates Foundation, where I helped to structure and negotiate some of the foundation’s most substantial investments and collaborations in TB, HIV, and vaccine development.

As Lead Counsel, I remain a member of the Bill & Melinda Gates Foundation legal group, but my entire focus is leading the Gates MRI legal team.

Expertise Corporate, IP and non-profit law

Biotechnology

Deal making

Team building

Credentials Associate General Counsel, Global Health, Bill & Melinda Gates Foundation

Partner, Technology Transactions & Privacy Group, Perkins Coie LLP

Jared Silverman, Ph.D.

Discovery Leader

Drives the progress of drug and vaccine discovery

My team's role is pretty straightforward: work closely with our partners around the globe to ensure that a steady stream of exciting assets are ready to move into clinical development to treat the most serious diseases and help the neediest patients.

I accidently ended up in the Chlamydia laboratory at the University of Texas the summer I was 15, and I was immediately hooked on microbiology and research. I'm lucky to have found my passion early and to have been able to pursue it throughout my career. My time at Cubist gave me the opportunity to do everything from target selection to meeting with physicians to talk about our drugs; most importantly, it gave me the chance to meet people whose lives had been saved by our antibiotics. There is no greater reward for a scientist than to know that their work has changed lives, and it is the desire to do this on a global scale that drew me to the Gates MRI, and inspires me every day.

I get up in the morning, and go to bed each night, asking questions.

Expertise Drug Discovery

Microbiology

Antibiotic mechanism of action and mechanism of resistance

Microbiome

Credentials SVP, Research,
Kaleido Biosciences

Vice President, Biology,
Cubist Pharmaceuticals

Editor,
Antimicrobial Agents and Chemotherapy

Board of Directors,
Auspherix

Jorg Thommes, Ph.D.

Drug Supply Leader

Makes innovative medicines accessible and affordable to all

Pharmaceutical supply chains are unique among industries, because failure to deliver medicines when and where they’re needed means not just disappointment but suffering. At Gates MRI our urgency is especially acute, because we are serving the poorest and most vulnerable.

While scientific innovation is the basis of our work, in the end we must provide a tangible product in the form of a pill, a vial, a syringe, maybe an autoinjector. The Drug Supply team is focused on effectively translating the science into physical drugs, vaccines, and monoclonal antibodies and finding ways to guarantee affordable access for everyone. Innovation in our manufacturing methods and supply chain is a must, because access and affordability are so critical. I've spent my career in pharmaceutical operations, both in academia and industry, thinking about cost and efficiency of pharmaceutical manufacturing. While pharmaceutical operations has been a major driver of value in our industry over the past decades, I firmly believe that with the patients we seek to serve, efficiency and cost of drug supply has a level of criticality that is very much different from what I’ve seen before.

We cannot pursue innovative medicine that is not accessible to all the people we strive to serve. I can’t tell you how excited I am to meet this challenge head on.

Expertise Process and analytical development, pharmaceutical manufacturing, engineering

Credentials Senior Vice President,
Pharmaceutical Sciences & Technology, Visterra

Senior Vice President Engineering & Technology,
Biogen

Habilitation "Technische Biochemie," University of Dusseldorf, Germany

Debra Weiss, RN, MSN

QUALITY LEADER & ENTERPRISE OPERATIONS

Enables a quality culture & efficient enterprise operations

In my role as Head of Quality Assurance & Enterprise Operations at Gates MRI, I’m responsible for enabling and sustaining a culture built on quality principles and committed to protecting the safety and rights of investigational study participants, quality in investigational product development and manufacturing, and compliance with all applicable laws, regulatory requirements and guidance ensuring data integrity in study conduct. As a registered nurse by training, I believe that everyone has the right to access to treatments that will either treat their condition or cure them. In our discovery of these treatments, we must take caution in continuing to protect the rights of those participating in our clinical trials, especially those in the vulnerable populations. Towards our ongoing objective of ensuring efficiency and productivity I also oversee centralized operations including Compliance & Risk Management, Finance, Procurement, IT, and systems support, Facilities, Strategy, Administrative Support, Regulatory Operations and Human Resources Operations.

My diverse background ranges from conducting clinical trials in an academic environment to working in large and small pharmaceutical companies, where I travelled worldwide auditing clinical trial activities and leading global QA organizations. I know the importance of partnering with others to ensure a clear understanding of good pharmaceutical practices and how to implement them across regions to ensure success.

As a leader, inspiring teams to deliver their best every day is equally critical to success.

I’m honored to be part of the institute's commitment to quality in service of saving lives of the world's poorest and most vulnerable populations.

Expertise Leading QA strategy and execution to compliantly achieve business objectives

Credentials Group VP, R&D Quality Assurance,
Shire Pharmaceuticals

QA Professional at Merck & Co., Inc

Adjunct Professor,
GCP Temple University

Penny M. Heaton, M.D.
Claire Wagner, M.D., MBA
Michael Dunne, M.D., FIDSA
Venice Herring, M.S.
Manfred Lauchart, Ph.D
Ken Miller, J.D.
Jared Silverman, Ph.D.
Jorg Thommes, Ph.D.
Debra Weiss, RN, MSN

Chief Executive Officer

Penny M. Heaton, M.D.

Inspires and enables the organization to achieve its global mission

My role is to set the vision for the Gates MRI and inspire the organization to achieve it. I am responsible for mission clarity, steering our strategy in the right direction, and ensuring there are sufficient resources to reach our goals.

I am at the Institute because I fervervently believe that everyone should have the opportunity to live a productive life. My passion for infectious diseases is life-long, stemming from my father’s near-death from tuberculosis. The results of a surveillance study I conducted in western Kenya further ignited this passion; there I witnessed firsthand the high mortality from diarrheal and respiratory diseases that can occur in a setting with limited healthcare resources. These experiences drove me to a career in the private sector, where I spent nearly fifteen years developing vaccines against diseases such as rotavirus, a diarrheal disease that once claimed the lives of half a million infants and young children annually. The impact of rotavirus vaccines globally has been nothing short of phenomenal, projected to save 1.7 million lives over the next 10 years. I want to see that same extraordinary outcome for other infectious diseases. Although technically more difficult, why can’t we find solutions for tuberculosis, malaria, and other enteric diseases?

Every day I think what an incredible privilege it is to lead an organization whose sole reason for existing is to use cutting-edge technology and science to find solutions for these diseases, and make them accessible to all.

Expertise Building and leading teams and organizations, leading strategy development and execution.

Integrated product development, clinical trials, vaccinology, infectious diseases, global health.

Credentials Director, Vaccines Development,
Bill & Melinda Gates Foundation

Global Head, Clinical Research Clusters,
Novartis

Chief Medical Officer & VP, Development
Novavax

Senior Director, Vaccines Clinical Research
Merck & Co.

Close

Discovery Leader

Jared Silverman, Ph.D.

Drives the progress of drug and vaccine discovery

My team's role is pretty straightforward: work closely with our partners around the globe to ensure that a steady stream of exciting assets are ready to move into clinical development to treat the most serious diseases and help the neediest patients.

I accidently ended up in the Chlamydia laboratory at the University of Texas the summer I was 15, and I was immediately hooked on microbiology and research. I'm lucky to have found my passion early and to have been able to pursue it throughout my career. My time at Cubist gave me the opportunity to do everything from target selection to meeting with physicians to talk about our drugs; most importantly, it gave me the chance to meet people whose lives had been saved by our antibiotics. There is no greater reward for a scientist than to know that their work has changed lives, and it is the desire to do this on a global scale that drew me to the Gates MRI, and inspires me every day.

I get up in the morning, and go to bed each night, asking questions.

Expertise Drug Discovery

Microbiology

Antibiotic mechanism of action and mechanism of resistance

Microbiome

Credentials SVP, Research,
Kaleido Biosciences

Vice President, Biology,
Cubist Pharmaceuticals

Editor,
Antimicrobial Agents and Chemotherapy

Board of Directors,
Auspherix

Close

Drug Supply Leader

Jorg Thommes, Ph.D.

Makes innovative medicines accessible and affordable to all

Pharmaceutical supply chains are unique among industries, because failure to deliver medicines when and where they’re needed means not just disappointment but suffering. At Gates MRI our urgency is especially acute, because we are serving the poorest and most vulnerable.

While scientific innovation is the basis of our work, in the end we must provide a tangible product in the form of a pill, a vial, a syringe, maybe an autoinjector. The Drug Supply team is focused on effectively translating the science into physical drugs, vaccines, and monoclonal antibodies and finding ways to guarantee affordable access for everyone. Innovation in our manufacturing methods and supply chain is a must, because access and affordability are so critical. I've spent my career in pharmaceutical operations, both in academia and industry, thinking about cost and efficiency of pharmaceutical manufacturing. While pharmaceutical operations has been a major driver of value in our industry over the past decades, I firmly believe that with the patients we seek to serve, efficiency and cost of drug supply has a level of criticality that is very much different from what I’ve seen before.

We cannot pursue innovative medicine that is not accessible to all the people we strive to serve. I can’t tell you how excited I am to meet this challenge head on.

Expertise Process and analytical development, pharmaceutical manufacturing, engineering

Credentials Senior Vice President,
Pharmaceutical Sciences & Technology, Visterra

Senior Vice President Engineering & Technology,
Biogen

Habilitation "Technische Biochemie," University of Dusseldorf, Germany

Close

QUALITY LEADER & ENTERPRISE OPERATIONS

Debra Weiss, RN, MSN

Enables a quality culture & efficient enterprise operations

In my role as Head of Quality Assurance & Enterprise Operations at Gates MRI, I’m responsible for enabling and sustaining a culture built on quality principles and committed to protecting the safety and rights of investigational study participants, quality in investigational product development and manufacturing, and compliance with all applicable laws, regulatory requirements and guidance ensuring data integrity in study conduct. As a registered nurse by training, I believe that everyone has the right to access to treatments that will either treat their condition or cure them. In our discovery of these treatments, we must take caution in continuing to protect the rights of those participating in our clinical trials, especially those in the vulnerable populations. Towards our ongoing objective of ensuring efficiency and productivity I also oversee centralized operations including Compliance & Risk Management, Finance, Procurement, IT, and systems support, Facilities, Strategy, Administrative Support, Regulatory Operations and Human Resources Operations.

My diverse background ranges from conducting clinical trials in an academic environment to working in large and small pharmaceutical companies, where I travelled worldwide auditing clinical trial activities and leading global QA organizations. I know the importance of partnering with others to ensure a clear understanding of good pharmaceutical practices and how to implement them across regions to ensure success.

As a leader, inspiring teams to deliver their best every day is equally critical to success.

I’m honored to be part of the institute's commitment to quality in service of saving lives of the world's poorest and most vulnerable populations.

Expertise Leading QA strategy and execution to compliantly achieve business objectives

Credentials Group VP, R&D Quality Assurance,
Shire Pharmaceuticals

QA Professional at Merck & Co., Inc

Adjunct Professor,
GCP Temple University

Close

Chief Medical Officer, Head of Development

Michael Dunne, M.D., FIDSA

Responsible for Clinical Development

Throughout my career I’ve been involved with public health, both globally and locally in anti-infective drug development. The Bill & Melinda Gates Medical Research Institute is largely devoted to infectious disease as well as other areas, and I felt I could meaningfully contribute to the health and well-being of the world’s poorest populations. As founder, board member and Chief Science Officer at Iterum Therapeutics, my group proudly developed the antibiotic sulopenem. Prior to that, as a founder and Chief Medical Officer of Durata Therapeutics, we developed the antibiotic dalbavancin. Before joining Durata, I worked at Pfizer, and engaged in the in the development and registration of a number of antibacterial, antifungal, antiviral and HIV therapeutics. I served as a member of the Scientific Advisory Committee for the Global Alliance for TB Drug Development as well as a member of the Expert Scientific Advisory Committee of the Medicines for Malaria Venture. I currently chair the Board of Health in my local community.

I studied economics as an undergraduate at Northwestern University and earned my MD from the SUNY Health Sciences Center, Brooklyn. I was a resident in Internal Medicine at Hartford Hospital and Yale New Haven Hospital and completed fellowship training at Yale in Infectious Diseases and Pulmonary Medicine.

Every day I think what an incredible privilege it is to lead an organization whose sole reason for existing is to use cutting-edge technology and science to find solutions for these diseases, and make them accessible to all.

Expertise Leadership of a biotechnology enterprise

Anti-infective drug development

Infectious diseases

Credentials Chief Scientific Officer, Iterum Therapeutics

Vice President, R&D, Actavis, plc

Chief Medical Officer, Durata Therapeutics

Vice President, Therapeutic Area Head of Clinical Development, Pfizer, Inc

Close

Chief of Staff

Claire Wagner, M.D., MBA

Advances strategic priorities to deliver on our mission.

As Chief of Staff, I support the CEO in driving the rhythm of the organization, and in developing and advancing strategic initiatives to help realize our vision as a global health biotech. In line with the Bill & Melinda Gates Foundation stance that all lives have equal value, our job at the Gates MRI is to apply the latest breakthrough science and technology to some of the world’s most intractable diseases affecting the poor.

Prior to joining the Gates MRI, I worked on multiple healthcare initiatives in Mali and in Tanzania between 2007-2009. I later served in Kigali, Rwanda from 2010-2013 as Research Fellow to Rwanda’s Minister of Health, Dr. Agnes Binagwaho and to Harvard University Professor Dr. Paul Farmer. Returning to the United States, I consulted for industry and non-profit entities on global access to oncology products and services, leading multi-country studies and coordinating an effort resulting in the 16-drug expansion of the World Health Organization’s Model List of Essential Medicines for Cancer. Building on experience and training in global health, medicine, and business management, I was drawn to the Gates MRI by its vision to chart a new course forward in pharmaceutical product development. My goal is to contribute to the Gates MRI’s efforts to make a tangible and enduring impact across the globe.

Expertise Global health equity and health systems strengthening

Access to products and services in low- and middle-income countries

Building and strengthening public-private partnerships

Business management and strategic planning

Credentials M.D. / M.B.A. Harvard Medical School and Harvard Business School

Co-author of 40+ scientific publications, published in journals including Lancet, Nature, NEJM

Fellowships with the Union for International Cancer Control in Geneva, Harvard Business School’s Arthur Rock Center for Entrepreneurship, Harvard Medical School’s Center for Global Health Delivery-Dubai and its Department of Global Health and Social Medicine

Close

HUMAN RESOURCES BUSINESS PARNTER

Venice Herring, M.S.

Cultivates a mission-driven team.

I work across the institute to instill a high-energy environment staffed with leaders at every level of the organization. My work involves designing and delivering people strategies and solutions, including strategic workforce planning, leadership coaching, diversity & inclusion, talent review, succession, and organizational design. With a career spanning over 30 years, I’ve held leadership positions to help employers and their employees succeed. My experiences include working in the health care industry, professional services industry with Deloitte and Touche, manufacturing, as well as in consumer products with Elmer’s Products.

As human resources leader, I support the Gates MRI HR team, as well as continue to lead HR for the Global Health Division at the Bill & Melinda Gates Foundation.

Expertise Workforce Planning

Leadership Development

Change Management

Organizational Design

Engagement & Culture

Data and Analytics

Credentials Society for Human Resource Management, Member

Healthcare Businesswomen’s Association, Member

Mentor to graduate and undergraduate students at The Ohio State University

MS in Human Resources, Fisher College of Business, The Ohio State University

Close

Head of Program & Portfolio Management

Manfred Lauchart, Ph.D

Ensuring delivery of highly needed medicinal products by driving strategic planning and execution of development programs.

Understanding the mechanisms that make complex systems work has always been a passion of mine. Applying these insights to research and the development of prophylactic and therapeutic products to solve global health challenges has been the key focus of my professional career. I believe that a planful approach to managing a portfolio of programs and integrating complex drug development processes is instrumental in ensuring the success of the end product. Enabling organizations to deliver transformational, life-saving medicinal products has always been my priority. To that end, I have devoted my energy to planning, coordinating and optimizing the development of life saving therapies in a nimble, digestible, efficient and deliverable manner.


At the Gates MRI, I am privileged to be able to apply my professional focus to accelerate product development for populations with high unmet needs. It takes a well-integrated and aligned team with broad research, clinical, regulatory, quantitative, technical and operational expertise to complete this challenging task. I am thrilled to be part of this effort and to work with those who have devoted their lives to helping underserved populations globally!

Expertise New Product Development (biologics, small molecules, device and drug-device combination products)

Program and Portfolio Management

Project Management Best Practices

Building, developing and mentoring effective teams

Credentials VP, Program Management, Intarcia Therapeutics

Head Business Operations, Global Clinical Development, Baxalta

Sr. Director, Program Management Office R&D, Baxter Medical Products

Director, Global Program & Portfolio Management Vaccines, Baxter BioScience

Close

Lead Counsel

Ken Miller, J.D.

Drives and executes practical legal strategies to enable impact

I am responsible for delivering efficient and reliable legal guidance, managing legal risk, and supporting the development of solutions that accelerate impact. My team collaborates across the Gates MRI with a laser focus on developing and using legal agreements, tools, and strategies in practical and creative ways that advance our mission. In structuring deals, our focus is the lives of people with greatest need.

I am a business, technology, and global health attorney with 20+ years’ experience working with highly innovative companies and nonprofits to achieve their business and charitable objectives. For five years, I supported the Global Health Division of the Bill & Melinda Gates Foundation, where I helped to structure and negotiate some of the foundation’s most substantial investments and collaborations in TB, HIV, and vaccine development.

As Lead Counsel, I remain a member of the Bill & Melinda Gates Foundation legal group, but my entire focus is leading the Gates MRI legal team.

Expertise Corporate, IP and non-profit law

Biotechnology

Deal making

Team building

Credentials Associate General Counsel, Global Health, Bill & Melinda Gates Foundation

Partner, Technology Transactions & Privacy Group, Perkins Coie LLP

Close

Approach

How We Work

Scientific discovery followed by product development and delivery is one formula for saving lives. It has turned HIV from a death sentence into a disease people can live with. It turned smallpox into a disease no one has to live with.

Right now, scientists know more about human biology than they ever have before. They have the computing power to simulate complex biological processes, and to do it incredibly quickly. The universe of the possible keeps expanding.

However, the necessary funding, tools and commitment have only rarely been brought together to serve the needs of the world’s poorest people. It’s time to use the latest innovations to improve all lives. We will combine advances in biomarker profiling of the immune system and infectious organisms and bioassays, quantitative sciences and statistical computing, and expertise in chemistry and manufacturing to move potential solutions from the laboratory into human trials.

We are part of a large community with shared goals, and we know we will reach those goals faster together. We rely on academic researchers, biotechnology and pharmaceutical companies, and global health organizations as partners in our work. We will share what we learn with our partners to accelerate the cycle of innovation.

Research

Priorities

  • Malaria
  • Tuberculosis
  • Diarrheal Disease
  • Maternal, Newborn, and Child Health
Eradicate malaria

Malaria may have killed half the people who have ever lived1. Every year, it kills almost 500,000 people and makes more than 200 million sick. As we drive toward zero deaths and zero cases, we will need a next-generation vaccine and drugs that combat resistance. See diagram attributions.

Accelerate the end of tuberculosis

Tuberculosis is currently the leading cause of death from infectious disease2. The treatment regimen we use today is long and complicated, and hundreds of thousands of cases are resistant to the standard drugs. To control the disease, we need a shorter, simpler course of treatment that works for both drug-sensitive and drug-resistant TB. Eventually, we need an effective vaccine. See diagram attributions.

End diarrheal deaths

Diarrhea is the second leading cause of death among children3. Virtually all those deaths occur in low-income countries. A recently developed vaccine for rotavirus, once the leading cause of diarrhea, has started to reduce mortality. Now, we need to tackle diarrhea's many other causes. See diagram attributions.

Improve outcomes in maternal and newborn child health

Globally, more than 2 million babies are still-born every year, and a similar number of babies die within the first month of life. Preterm birth is a major contributor to neonatal deaths, and many preterm babies die because their lungs are not ready for life outside the womb. Provision of antenatal corticosteroids and supplementation of lung surfactant have the potential to save many babies born prematurely. See diagram attributions.

Pipeline

 Preclinical


MRI TBD05 (SPR720)
MRI TBD01 (Sutezolid)
MRI EDV01 (Shigella Synthetic Conjugate Vaccine)
MRI MND01 (Dry Powder Lung Surfactant)
MRI RSM01 (RSV mAb)

 Phase 1

 Phase 2/3


MRI TBV02
(M72/ASO1)
MRI TBV01-201
(BCG REVAX)
TBD06
(TB Drug Regimen)
MRI TBD03-201
(TBA 7371)
TUBERCULOSIS
MALARIA
DIARRHEAL DISEASES
MATERNAL, NEWBORN, AND CHILD HEALTH
RESPIRATORY SYNCYTIALVIRUS
TUBERCULOSIS
MALARIA
DIARRHEAL DISEASES
MATERNAL, NEWBORN, AND CHILD HEALTH
RESPIRATORY SYNCYTIALVIRUS

Malaria, diarrheal diseases, and tuberculosis kill five people every minute.4

We believe we can help end this crisis.

Our bottom line is lives saved.

Gates MRI

FAQ

What is the relationship between the Gates MRI and the Bill & Melinda Gates Foundation?

  • The Gates MRI is subsidiary of the Bill & Melinda Gates Foundation funded by a grant from the foundation.
  • The Gates MRI is aligned with the vision of the Bill & Melinda Gates Foundation and guided by the belief that all lives have equal value.
Where is the Gates MRI located?

The Gates MRI is headquartered in Cambridge, Massachusetts.

Where can I find more information or inquire about job opportunities?

Further information about job opportunities and other updates about the Gates MRI can be found on the organization's careers page. If you would like to submit your resume to our human resources department, please send to [email protected]

How large is the Gates MRI? How many employees does Gates MRI have?

The Gates MRI plans on operating as a fully integrated, non-profit biotech organization staffed appropriately to advance a pipeline of programs in the prioritized disease areas from pre-clinical testing through human proof of concept studies. We expect we will scale up to 80 to 120 full-time employees over the next several years.

Does the Gates MRI provide research grants?

No, the Gates MRI is a non-profit biotech organization focused on accelerating product development for diseases that affect the world’s poorest populations. We do not anticipate making grants at this time.

Does the Gates MRI accept donations?

The Gates MRI does not solicit donations from the public. We are proud of our mission to develop products to fight malaria, tuberculosis, and diarrheal diseases, and encourage people who share our passion for saving lives to donate to causes aligned with their values.

What is the distinction between the Gates MRI and the Coalition for Epidemic Preparedness Innovations (CEPI)?

CEPI is focused on accelerating the development of vaccines for emerging infectious diseases. The Gates MRI will focus on developing interventions to fight persistent epidemics, such as malaria, tuberculosis, and enteric and diarrheal diseases.

Do you have a pool of product candidates to research? What is the Gates MRI pipeline of programs?

The team at Gates MRI is currently evaluating a number of products under development with foundation partners. Once this analysis is completed, we will share the pipeline.

How will the Gates MRI share its findings?

The Gates MRI will adhere to the foundation’s global access and open access policies.

  • Global Access, a core value of the foundation, rests on two principles: (a) prompt and broad dissemination of knowledge and information; and (b) access to products at an affordable price to people most in need. Gates MRI will manage our research activities in accordance with Global Access to ensure impact for its intended beneficiaries.
  • Open Access enables unrestricted access and reuse of all peer-reviewed published research that has been funded by the foundation, including underlying data sets, and removes the publisher pay wall for access to this information.
What research and development partnerships will the Gates MRI pursue?

Focused on serving as a convener and connector in the research and development community, the Gates MRI will collaborate with foundation product development partners, academia, pharmaceutical and biotech companies, LMIC manufacturers and non-profit organizations on upstream and downstream activities. We will establish partnerships that leverage assets, capabilities and expertise in order to accelerate product development for our disease areas of interest. The Gates MRI actively and continuously engages directly in the conduct of medical research in conjunction with one or more hospitals for the purpose of addressing major causes of illness and death in LMIC.

Will the Gates MRI only take product development to phase 2? Assuming a viable candidate is developed, how will the Gates MRI identify partners to bring products through to commercialization?

The Gates MRI will focus on translational product development, (defined as preclinical candidate selection to human/clinical proof of concept in the target population). Once a candidate has achieved human proof of concept, the plan is to partner the program with an organization that has late-stage development and commercial expertise. Late-stage development partners may include non-profit product development partners, LMIC manufacturers, and pharmaceutical companies.

How will the Gates MRI ensure that products developed by the organization will be made available to the world's poorest populations at an acceptable volume and affordable price?

The Gates MRI will adhere to the foundation's Global Access policy. Organizations that partner with the foundation agree to Global Access, which requires that the knowledge and information gained from a funded project will be promptly and broadly disseminated, and that funded developments will be made available and accessible at an affordable price to people in need within LMIC.

CAREERS

Join Our Team

The Gates MRI is a diverse group of passionate change-makers, creative fixers and relentless advocates. We are committed to saving lives by improving the pace and predictability of translational medicine in global health. We will relentlessly seek out innovative strategies to develop the best drugs, biologics, and vaccines to fight some of the toughest, most complex disease problems in the world. Our focus is translating findings from basic science into potential solutions that will fill the product pipeline for malaria, tuberculosis, and enteric and diarrheal diseases to start.

Our culture thrives on our five mantras:

  • Urgency: Strive every day to do better than your last best accomplishment.
  • Collaboration: Solving the world’s most complex disease burdens is a team effort.
  • Innovation: Uncover new methods, approaches and solutions to achieve unprecedented results.
  • Rigor: Follow the science with passion and perseverance.
  • Courage: Pursue progress boldly to deliver on our bottom line: lives saved.

We are bringing together top talent from diverse scientific backgrounds to work across a range of disease areas and modalities, building upon the best work being done in scientific discovery, constantly pushing the envelope, and embracing new methodologies.

The Gates MRI aims to use quantitative sciences; to develop strong biomarker strategies upfront, and understand production issues early on to drive greater rigor in global health clinical research, enabling potentially faster development of products for diseases of the poorest. We will seek to publish our learnings, so that they will be available to all research and development communities through our commitment to open access.

If you share our belief that all lives have equal value, and that science and technology can change lives for the better, we would love to connect with you. Please review our Current Opportunities through the link below and apply directly for consideration: LinkedIn or submit your resume to human resources at [email protected].

Get Involved

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REFERENCES
1. Whitfield J. Portrait of a serial killer. Nature. 2002. doi:10.1038/news021001-6.
2. Global Health Observatory (GHO) data: Tuberculosis (TB). World Health Organization Web site. http://www.who.int/gho/tb/en/. Accessed May, 2018.
3. Global Diarrhea Burden. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/healthywater/global/diarrhea-burden.html. Updated December 17, 2015. Accessed May, 2018.
4. WHO Diarrhoeal disease fact sheet, updated May 2017; WHO Malaria Policy and Advisory Committee Meeting Report 2018; WHO Global Tuberculosis Report 2017.
* This is an estimation based on data from the World Health Organization (WHO), Global Health Observatory (GHO) and Centers for Disease Control and Prevention