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OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015)
BIOGRAPHICAL SKETCH
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NAME: Gary L. Darmstadt
eRA COMMONS USER NAME (credential, e.g., agency login):
POSITION TITLE: Associate Dean for Maternal and Child Health, Professor, Department of Pediatrics,
Stanford University School of Medicine
EDUCATION/TRAINING
DEGREE
(if
applicable)
Completion
Date
MM/YYYY
California Polytechnic State University (CPSU), San
Luis Obispo
B.S.
06/1979
Crop Science
University of Wisconsin, Madison
M.S.
06/1982
Agronomy
University of California, San Diego (UCSD)
M.D.
06/1989
Johns Hopkins University School of Medicine,
Baltimore, MD
Resident
1992
Pediatrics
Stanford University School of Medicine, Stanford,
CA
Resident
1994
Dermatology
Children's Hospital & Medical Center, University of
Washington School of Medicine, Seattle, WA
Fellow
1997
Pediatric Infectious
Disease
INSTITUTION AND LOCATION
FIELD OF STUDY
A. Personal Statement
I am well-qualified (even uniquely so) to lead the research proposed in this proposal, given my training as a
pediatrician, dermatologist and pediatric infectious disease expert, and the importance of expertise in each of
these disciplines in the design and conduct of the trial. I have extensive experience in clinical child health
research in low resource settings, including in Bangladesh, where I conducted a seminal trial on the impact of
emollient therapy in preterm infants.1 I have been the global leader in the development and testing of topical
emollient therapy for preterm infants, including assessments of impact on skin barrier function and skin
condition, morbidities including sepsis, mortality, and cost-effectiveness.1-4 Thus, the research proposed here
is a natural extension of the extensive work I have done in the past on emollient therapy, and builds on
experimental methods and processes that I am well versed in and pioneered applications for in low resource
settings. I also have extensive experience in child nutrition, having led global nutrition strategy development
and implementation for the Bill & Melinda Gates Foundation (BMGF) as Director of Family Health (overseeing
foundation programs in nutrition, maternal newborn and child health as well as family planning). In this role, I
was responsible for investments supporting intervention development and deployment leading to health
impact, and thus I understand not only how to generate evidence of impact, but also how to utilize that
evidence to influence the policy dialogue that is essential to programmatic adoption and scale-up of an
intervention in low income settings. Note that during the 7 years I was at BMGF (2008-2014), I was a funder of
the research of others and could not conduct research myself; thus, there is a decline in publication of new
research conducted as PI (I continued to write papers on prior research but did not lead research projects
since 2008).
1. Darmstadt GL, Saha SK, Ahmed ASMNU, Chowdhury MAKA, Law PA, Ahmed S, Alam MA, Black RE,
Santosham M. Effect of topical treatment with skin barrier-enhancing emollients on nosocomial
infections in preterm infants in Bangladesh: a randomized controlled trial. Lancet 2005;365:1039-45.
2. Darmstadt GL, Saha SK, Ahmed ASMNU, Choi Y, Chowdhury MAKA, Law PA, Ahmed S. Effect of
topical emollient treatment of preterm neonates in Bangladesh on invasion of pathogens into the
bloodstream. Pediatr Res 2007;61:588-93.
3. Darmstadt GL, Saha SK, Ahmed ASMNU, Ahmed S, Chowdhury MAKA, Law P, Rosenberg RE, Black
RE, Santosham M. Effect of skin barrier therapy on neonatal mortality rates in preterm infants in
Bangladesh: a randomized, controlled, clinical trial. Pediatrics 2008;121;522-9.
4. LeFevre A, Shillcutt SD, Saha SK, Ahmed AS, Ahmed S, Chowdhury MA, Law PA, Black R,
Santosham M, Darmstadt GL. Cost-effectiveness of skin-barrier-enhancing emollients among preterm
infants in Bangladesh. Bull World Health Organ 2010;88:104-12.
B. Positions and Honors
Positions and Employment
1998-1999
Acting Assistant Professor, Division of Infectious Disease, Rheumatology & Immunology, and
Division of Dermatology, Department of Pediatrics, Children's Hospital & Regional Medical
Center; and Division of Dermatology, Department of Medicine, University of Washington School
of Medicine, Seattle, WA
1999-2000
Assistant Professor, Division of Infectious Disease, Rheumatology & Immunology, and Division
of Dermatology, Department of Pediatrics, Children's Hospital & Regional Medical Center; and
Division of Dermatology, Department of Medicine, University of Washington School of Medicine,
Seattle, WA
1998-2002
Adjunct Assistant Professor, Division of Community Health and Health Systems, Department of
International Health, Bloomberg School of Public Health, The Johns Hopkins University (JHU),
Baltimore, MD
2002-2004
Assistant Professor, Department of International Health, Bloomberg School of Public Health,
The Johns Hopkins University (JHU), Baltimore, MD
2005-2008
Associate Professor, Department of International Health; Founding Director, International
Center for Advancing Neonatal Health, Bloomberg School of Public Health, The Johns Hopkins
University (JHU), Baltimore, MD
2008
Senior Program Officer (Feb-Sept), Newborn Health, MNCH Team Member, Integrated Health
Systems Development Division, Global Health Program, Bill & Melinda Gates Foundation,
Seattle, WA
2008-2010
Interim Deputy Director, Strategic Project Team Lead, Maternal, Newborn and Child Health
(MNCH), Integrated Health Solutions Development Division, Global Health Program, Bill &
Melinda Gates Foundation, Seattle, WA
2010-2013
Director, Family Health Programs (MNCH, Nutrition, Family Planning), Global Development
Division, Bill & Melinda Gates Foundation, Seattle, WA
2013-2014
Senior Fellow, Global Development Division, Bill & Melinda Gates Foundation, Seattle, WA
2015-present Associate Dean for Maternal and Child Health, Professor and Co-Director of Pediatric Global
Health, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA
Other Experience and Professional Memberships
2001-2003
Scientific Advisory Group, Project Spring, Procter & Gamble
2001-2002
Member and Neonatal Health Expert, Research Task Force, US Coalition for Child Survival
2008-2009
International Scientific Advisory Council for Prevention of Prematurity and Stillbirths, Global
Alliance for the Prevention of Prematurity and Stillbirths, Seattle Children’s Hospital
2008
Chair, Outputs Task Force, Partnership for Maternal, Neonatal and Child Health
2008-2010
Technical Advisory Group, Simplified Antibiotic Treatment Regimens, World Health
Organization
2008-2010
Technical Advisory Group, Saving Newborn Lives Program
2011 & 2012 Judge, Saving Lives at Birth Development Exchange, Washington, DC & Seattle, WA
2010-2013
Steering Committee, Saving Lives at Birth, A Grand Challenge for Development
2010-2013
Global Alliance for Improved Nutrition, Board of Directors Co-chair and Member
2011-2013
2011-2014
2012-present
2013-present
2013-2014
2013-2014
2013-present
2013-2014
2013-present
2010-present
2013-present
2011-present
2013-present
2014-present
2015
2015
World Economic Forum, Global Action Council on Population Growth
Global Maternal and Newborn Health Training Program, University of Washington, External
Program Oversight Board
Founding Curator, Catapult.org (crowd-funding platform for women’s and girls’ empowerment)
Strategic Advisory Group, Saving Newborn Lives, Save the Children
Advisory Group, Every Newborn Action Plan
Steering Committee, Every Newborn Lancet Series
Steering Committee, Early Child Development Lancet Series
Chair, Evaluation Committee, Partnership for Maternal, Newborn and Child Health (PMNCH)
GlaxoSmithKline-Save the Children R&D Advisory Board
Agros International, Board of Directors
Project Mercy, Board of Directors
Institute of Medicine, Global Health Advisory Board
Executive Committee, Forum on Investing in Young Children Globally, Institute of Medicine
Autism Speaks, Global Action Committee of the Board
Advisory Board, Maternal and Child Health, World Health Organization, South East Asia Region
Steering Committee Chair, Gender in Health and Development Lancet Series
Honors
1978
1975-1979
1979
1987-1989
Phi Kappa Phi Honor Society
President's Honor List, CPSU
Highest Honors, California Polytechnic State University (CPSU) Graduation
UCSD A. Baird Hastings Honor Society, (UCSD Highest Honor for outstanding academic
achievement, in lieu of Alpha Omega Alpha
1991 & 1992 Johns Hopkins Francis F. Schwentker Research Award, Department of Pediatrics, JHU
1994
San Francisco Dermatologic Society Resident Forum, First Place
2008
Paper of the Year, The Lancet
2009
Paper of the Year nomination, British Medical Journal
2010
BRAVO Award (for most outstanding cross-program), India Project Team, Bill & Melinda Gates
Foundation, Quarter 1, 2010; Annual award
2011
Holy Cow Award (for extraordinary contribution in Social and Behavioral Change initiatives
within the foundation), Bill & Melinda Gates Foundation
2012
Top 10 Global Health Milestones of 2012, First Place: London Summit on Family Planning
Ignites $2.6 billion in Commitments, (PSI Impact Magazine, Issue 11, 2012.)
http://psiimpact.com/impact-december-2012.
C. Contribution to Science
1. Emollient therapy
My idea for study of the impact of topical emollient therapy as a public health intervention was novel and
innovative, taking findings at the “bench” to the bedside (and now to the community), and was especially
unique in public health circles where the skin was (and still is) largely overlooked as important for health and
development. The conception, design and conduct of the trial drew on all disciplines in which I have trained:
agriculture, pediatrics, dermatology, pediatric infectious diseases and public health. My observations of deeply
rooted cultural oil massage practices in rural villages in Bangladesh as well as my discoveries in the
laboratory1 inspired the idea for and the design of the study. The studies, initially in Egypt2 and then in
Bangladesh (Lancet 2005), were conducted in resource-poor hospitals and in collaboration with local
practitioners and staff with no previous experience in conducting clinical trials. Infrastructure development and
capacity building in the hospital was required to conduct the study, and the investigators in Bangladesh have
gone on to make many important contributions to the public health literature.
The studies I conducted addressed two major causes of child mortality: complications of preterm birth
(the top cause of deaths globally in under-five children) and serious infections in the neonatal period. Few
options are available for management of serious bacterial infections in newborns in low resource settings. This
study took a novel approach to prevention of infections in preterm infants in Bangladesh, and showed that
topical applications of the widely available, natural vegetable oil - sunflower seed oil (SSO) - to the skin of
preterm infants <33 weeks gestational age reduced the incidence of culture-proven bloodstream infections by
41%. Further analysis of data from this study showed that the intervention reduced mortality by 26%, was
highly cost effective [US$ 61 per death averted and US$ 2.15 per Year of Life Lost averted], and appeared to
act by preserving skin integrity and containing pathogens on the skin surface.3 Findings from these studies
have since been replicated in Pakistan (I served as a co-investigator) and a meta-analysis published this past
year showed that topical emollient therapy reduced neonatal infections by 50% and reduced neonatal mortality
by 25%. This intervention is now being tested in large cluster-randomized, community-based trials in India and
Nepal, and the World Health Organization (WHO) has proposed to test the intervention in sub-Saharan Africa,
to inform the development of global recommendations by WHO regarding emollient therapy. The existence of
widespread oil massage practices in millions of newborns each year in countries throughout South Asia and
sub-Saharan Africa provides a broad platform for spread of improved emollient therapy practices and for
saving hundreds of thousands of lives. The novel extension of this therapy to treatment of children with SAM
(and potentially MAM in the future) could make it a major global child health intervention.
1. Darmstadt GL, Mao-Qiang M, Chi E, Saha SK, Ziboh VA, Black RE, Santosham M, Elias PM. Impact of
topical oils on the skin barrier: possible implications for neonatal health in developing countries. Acta
Paediatr 2002;91:1-9.
2. Darmstadt GL, Badrawi N, Law PA, Alam A, Ahmed S, Husein MH, Winch P, Santosham M, Gipson R.
Topical therapy with sunflower seed oil prevents nosocomial infections and mortality in premature babies in
Egypt: a randomized, controlled clinical trial. Pediatr Infect Dis J 2004;23:719-25.
3. Darmstadt GL, Ahmed S, Ahmed ASMNU, Saha SK. Mechanism for prevention of infection in preterm
neonates by topical emollients: a randomized, controlled clinical trial. Pediatr Infect Dis J 2014;33:1124-7.
2. Chlorhexidine cord cleansing
I played a key role in the design and oversight of a definitive randomized controlled trial in Nepal on impact of
cord cleansing with the antiseptic, chlorhexidine, during the first 10 days of life on cord infections and mortality
in newborns, demonstrating a 75% reduction in serious cord infections and a 24% reduction in mortality. 1-3 In
Bangladesh, we subsequently demonstrated a significant 20% reduction in newborn mortality with a single
application of chlorhexidine to the umbilical cord as soon as possible after birth.3 These studies played a key
role in informing WHO global guidelines on newborn chlorhexidine cord cleansing, and catalyzed the scale-up
of this intervention in numerous countries, which will lead to many newborn lives saved around the world.
1. Mullany LC, Darmstadt GL, Katz J, Khatry SK, LeClerq SC, Adhikari RK, Tielsch JM. Risk of mortality
subsequent to umbilical cord infection among newborns of southern Nepal: cord infection and mortality.
Pediatr Infect Dis J 2009;28:17-20.
2. Tielsch JM, Darmstadt GL, Mullany LC, Khatry SK, Katz J, LeClerq SC, Shresta S, Adhikari R. Impact
of newborn skin-cleansing with chlorhexidine on neonatal mortality in southern Nepal: A communitybased, cluster-randomized trial. Pediatrics 2007;119:e330-40.
3. Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha SR, Adhikari R, Tielsch JM.
Topical applications of chlorhexidine to the umbilical cord prevent omphalitis and reduce neonatal
mortality in southern Nepal: a community-based, cluster-randomized trial. Lancet 2006;367:910-8.
4. El Arifeen S, Mullany LC, Shah R, Mannan I, Rahman SM, Redwanur M, Talukder R, Begum N, AlKabir A, Darmstadt GL, Santosham M, Black RE, Baqui AH. Impact of cord cleansing with
chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial.
Lancet 2012;379(9820):1022-8.
3. Impact of packages of newborn health interventions
I played a fundamental role in creating the evidence base for what works to save newborn lives in low resource
settings. During the 2000s, before joining BMGF, I led and participated in several major trials to develop and
test community-based approaches to improving household and community maternal and neonatal health,
including behavior change management interventions to promote preventive maternal and newborn care
practices.1-4 In the context of these studies, I also demonstrated the capability of well-trained community health
workers to implement packages of maternal and newborn interventions, resulting in reductions in newborn
mortality. The findings from these studies played a key role in the development of global guidelines by WHO on
home visits to promote newborn survival.
1. Darmstadt GL, Choi Y, Arifeen SE, Bari S, Rahman SM, Mannan I, Seraji HR, Winch PJ, Saha SK,
Ahmed ASMNU, Begum N, Lee ACC, Black RE, Santosham M, Crook D, Baqui AH. Evaluation of a
cluster-randomized controlled trial of a package of community-based maternal and newborn
interventions in Mirzapur, Bangladesh. PLoS ONE 2010;5(3):e9696.
2. Kumar V, Kumar A, Das V, Srivastava NM, Baqui AH,* Darmstadt GL. Community-driven impact of a
newborn-focused behavioral intervention on maternal health in Shivgarh, India. Int J Gynecol Obstet
2012;117:48-55.
3. Kumar V, Mohanty S, Kumar A, Misra RP, Santosham M, Awasthi S, Baqui AH, Singh P, Singh V,
Ahuja RC, Singh JV, Malik GK, Ahmed S, Black RE, Bhandari M, Darmstadt GL. Effect of communitybased behaviour change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a
cluster-randomised controlled trial. Lancet. 2008;372(9644):1151-62.
4. Baqui AH, Arifeen SE, Darmstadt GL, Winch PJ, Williams EK, Rosecrans AM, Ahmed S, Santosham
M, Black RE. Effect of a package of community-based newborn care delivered by two strategies in
Sylhet district, Bangladesh: a cluster-randomised controlled trial. Lancet 2008;371:1936-44.
Complete List of Published Work in My Bibliography:
D. Research Support
Impact of emollient therapy on neonatal mortality in the community
Development and evaluation of an intervention and delivery strategy for improved newborn massage with
sunflower seed oil on neonatal mortality: a community based cluster randomized controlled trial in rural India.
Co-investigator; funding: World Health Organization, 2012 – 2016. I contributed to study design, protocol and
data collection instrument development; oversight of project planning and project implementation; and I will
participate in data analysis and summary, and manuscript preparation
Long-term neurodevelopmental impact of newborn care interventions
Effect of a package of community-based essential newborn care, including skin-to-skin care, on
neurodevelopment status at 7-9 years of age. Co-investigator; funding: Grand Challenges Canada, 2012 –
2015. This is a follow-up study on the cohort of children who were enrolled in a randomized controlled trial to
evaluate the effect of a package of essential newborn care on neonatal mortality in Shivgarh, India. I
contributed to study design, protocol and neurodevelopmental assessment and data collection instrument
development; oversight of project planning and selection of key project personnel; oversight of project
implementation; data analysis and summary, report and manuscript preparation.