Novartis Live Magazine_March2017

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    Building science capacity in Africa

    Marcelo Gutierrez was born and raised in a developing country. He knows first-hand what the lack of access to medicine means, and this experience was a key driver for his professional career in the phar- maceutical industry. Marcelo became a clinical pharmacologist and is now head of Global Scientific Development in the Global Health unit of the Program Office at NIBR. In this position he connected with leading African health institutes and a group of Novartis volunteers to help build the capacity for local First-in-Human and bioavailability trials in Africa, among other projects. by Michael Mildner

    A doctor and a nurse checking on a patient in a Congolese hospital. Building local capacity for clinical trials will contribute to better treatment options in Africa.



    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 wasnt 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 Marcelos 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 Marcelos 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 countrys 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






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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 programs 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.