Novartis Live magazine highlight our clinical capability building efforts in Africa

1. INNOVATION
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Building science
capacity in Africa
MarceloGutierrezwasbornandraisedinadevelopingcountry.Heknowsfirst-handwhatthelackof
accesstomedicinemeans,andthisexperience wasakeydriverforhisprofessional careerinthephar-
maceuticalindustry.Marcelobecame aclinicalpharmacologist andisnowheadofGlobalScientific
Development intheGlobalHealthunitoftheProgramOfficeatNIBR.Inthispositionheconnected with
leadingAfricanhealthinstitutesandagroupofNovartisvolunteers tohelpbuildthecapacityforlocal
First-in-Human andbioavailability trialsinAfrica,amongotherprojects. by Michael Mildner
Adoctor andanursechecking onapatientinaCongolesehospital.Buildinglocalcapacityforclinicaltrialswillcontribute
tobettertreatment optionsinAfrica.

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When Marcelo Gutierrez was young, he lived on the Island
of Cebu in the Philippines. One day, when he was seven years
old, his mother grabbed all the money she could find, put it in
his hands and told him to go to the nearest pharmacy to buy
medicine for his sister who was seriously sick. Marcelo ran as
fast as he could. At the pharmacy, the lady looked at his money,
then looked at the young kid, shook her head and finally told
him that it just wasn’t enough to buy the drugs his sister need-
ed so badly.
“I still remember how sad I was not being able to help my
sister at that time,” the now 50-year-old says. Marcelo was
born and raised in a developing country, and on top of that in a
very poor family. “So I know unmet medical need first-hand and
what it means not to access medication,” he adds. “These ex-
periences are a part of me and motivated me to become what
I am today.”
Gratifying experiences
Marcelo’s luck changed when he became holder of a scholar-
ship in the United States that allowed him to join his grandpar-
ents there and to study bioengineering and therapeutic scienc-
es in San Francisco. Afterwards he relocated to New York where
he pursued a career in clinical pharmacology over the next 10
years. “The work was interesting but I increasingly found myself
wanting to contribute more directly to efforts that help get es-
sential medicines to patients in vulnerable populations.”
Based on his experiences in the Philippines, Marcelo had
become a scientist because of very specific reasons. He want-
ed to help ensure access to medicines for people in need so
they could lead a better and healthier life. “So after working for
10 years in New York, I left and spent four years in Central and
South America where I joined a number of medical missions. I
taught hygiene to school children and raised funds to support
the basic needs of communities there. That period of my life
was extremely gratifying.”
Building bridges
In 2008 Marcelo rejoined industry, intent on working in thera-
peutic areas that were close to his heart. “I joined Actelion in
Basel for four years as deputy head of Clinical Pharmacology
mainly because I could work in the field of tropical infectious
diseases. This was something I could personally relate to as I
have been sick with malaria myself,” he says.
When Novartis knocked on Marcelo’s door in 2012 and of-
fered him a position in the NIBR Program Office as head of
Global Scientific Development, he knew immediately that this
was the job he had always been looking for as it allowed him to
bridge drug discovery, development and access to healthcare.
This was definitely the right environment for him. “I was ex-
cited at the opportunity to help scientists and clinicians, enable
them to provide access to medicines for families in need – like
it happened to me when I was a little boy being sent away from
the pharmacy without any medication.”
Focus on Phase-I-Studies
Just three weeks after joining Novartis, Marcelo and Colin Pil-
lai, Head of Global Scientific Capabilities CoE in Global Drug
Development, connected with Dr. Bernhards Ogutu Ragama in
Kenya. Dr. Ogutu is chief research officer at the Kenya Medical
Research Institute (KEMRI) in Nairobi, which cooperates close-
ly with the Center for Research in Therapeutic Sciences (CRE-
ATES) at the Strathmore University in the same town.
During a workshop on clinical pharmacology in Kenya,
Dr. Ogutu explained his view on what some of his country’s
biggest scientific needs are. “We have an urgent need to do
Phase I clinical trials in Africa,” Dr. Ogutu said. “Drugs are pro-
filed only in the United States or Europe, but local factors such
as genetics, environment, co-morbidities and diet may affect
variability in drug response.”
Although late-phase clinical trials are routinely done in Af-
rica, clinical pharmacology studies are not yet widely per-
formed, in part because of limitations in technical expertise
and infrastructure. According to Dr. Ogutu, “Phase I capacity in
Kenya will allow the country and the East African region to par-
ticipate in the full circle of product development and help the
Kenyan Ministry of Health fulfill the legal requirement for bio-
equivalence studies for locally produced generic products.”
Enabled by the strong partnership with Dr. Ogutu in Africa
and an immediate understanding of needs on the ground,
Marcelo led the design and implementation of a new scientific
capability-building effort focused on Phase I clinical trials in
Africa.
This was conducted first at KEMRI and then with partners
in five other countries, including the Kintampo Health Research
Center in Ghana, the Division of Clinical Pharmacology at the
University of Cape Town in South Africa, the Ifakara Health

3. INNOVATION
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Institute in Tanzania, the Regional Bioequivalence Centre at
Addis Ababa University in Ethiopia and the African Institutes of
Biomedical Science and Technology in Zimbabwe.
Encouraging results
The transcontinental collaboration was made possible by a
multidisciplinary, cross-divisional team of volunteers at
Novartis that included bioanalytics, quality assurance, clinical
operations and preclinical safety specialists. Even though the
program often required extra efforts, Marcelo found that the
volunteering associates were eager to contribute.
“Building science capacity to assist our colleagues who are
hard at work in less fortunate settings, and ultimately to help
patients, is something that many people became profoundly
inspired by,” noted Marcelo.
The results are encouraging. Since 2012 close to 250 Afri-
can scientists have participated in educational workshops, in-
cluding laboratory technicians, scientists, clinicians, nurses,
pharmacists and regulators. Many new operating procedures
were developed according to the needs of each site. In Kenya,
a novel mobile electronic platform was introduced to stream-
line data collection and management.
The program’s activities were instrumental in helping part-
ners to conduct their own studies, including a pharmacokinet-
ic study in healthy volunteers in Kenya, and a First-in-Human
clinical trial of a novel anti-malarial compound discovered in
South Africa. Other sites are currently in the planning stages
for bioequivalence and pharmacogenetics studies.
“I increasingly
found myself wanting
to contribute more
directly to efforts that help
get essential medi-
cines to patients in vul-
nerable populations.”
Marcelo Gutierrez
Step by step
Marcelo believes there are many take-home lessons from this
capacity-building initiative: “Expanding clinical pharmacology
research capacity in Africa was mainly achieved through a mul-
tifaceted approach. This involved scientific mentorship, infra-
structure development, and educational programs.
Fundamental for the success of these efforts were Novartis
scientists who volunteered their expertise as well as the highly
motivated local partners who had basic infrastructure and
staffing already in place, Marcelo says.
Future work will include determining how to best ensure sus-
tainability of clinical pharmacology research capacity in these fa-
cilities and how to guarantee continued networking with the ulti-
mate goal of contributing to the improvement of health in Africa.
Marcelo will never forget the moment when the first pa-
tients in the Kenyan Phase I study were dosed. “This was very
satisfying for me. It was such an important step to help improve
the state of clinical pharmacology in Africa. We hope that the
seeds we have helped to plant at individual sites will grow and
ultimately intertwine, such that an African clinical trials network
is established through which sites in different countries can
independently support each other.”
These might seem to be small steps in light of the enor-
mous amount of work to be done to improve science capacity
in Africa. But Marcelo has seen how marginal advances pave
the way for much larger ones. “At the core of this work are
strong partnerships,” says Marcelo. “When the right team
comes together then anything is possible.”