Project: TMA2016IF- Shibeshi Alemayehu

Acronym WOHU (Reference Number: TMA2016-1778)
Duration 01/06/2018 - 28/02/2020
Project Topic The purpose of EDCTP-TDR Clinical Research and Development Fellowships is to support development of clinical trial capacity in Low and Middle Income Countries like Ethiopia where fellows acquire specific skills in clinical research and development in pharmaceutical company settings which offers soft skills which are not found in academic settings. As a PhD level pharmacologist, I am currently interested to develope better medicinal products for povertyrelated infectious diseaes such as malaria, tuberculosis, HIV/AIDS, and human African trypanosomiasis, which are among focus areas listed in call text, and also priority areas of Ethiopia and Africa. The EDCTP-TDR Clinical Research and Development Fellowships will enable to acquire soft skills in several aspects of clinical trials and transform my current knowledge in clinical research and development by supporting stipend during placement at Merck KGaA, and covering research-associated costs and post-training reintegration activities. To achieve my training goals, i will work at Merck KGaA with global project teams, and will learn key clinical trial competencies including basic scientific concepts, ethical issues, medicines development and regulation, design and conduct of clinical rials across all phases of clinical development, clinical/laboratory practices, project management, data management and communication. I will also gain scientific and technical know-how and experience through exposure to laboratories for PK-PD modeling and simulation, participation in team meetings, local workshops at Merck KGaA and its partners. In addition,i will participate at Internal company Learning & Development trainings. The point that i am magnificently interested to shape my career in clinical research and development, my excellent personal commitment and qualification to achieve planned goals, strong support from my home institution to preserve my job and my committment to return after training, and scarcity of staff qualified with such skills, relevance of this training to Sub-Sahara Africa and particularly to Ethiopia and my placement at Merck KGaA, a global research and development company with diverse scientists, experiences and facilities are the best combinations that make realization of my career development and future goals. My career development and future goal is to be an authority in Infectious Diseases Pharmacology with research focus typically including study of safety and efficacy of existing products in Ethiopian population, new lead development from natural sources, PK/PD study and modeling to re-define doses for best efficacy and minimum risks( dose optimization), design and conduct of trials in special population like pediatrics and pregnant women who usually lack optimal dosage regimens and repurposing of existing drugs for new indications among others. The EDCTP-TDR Clinical Research and Development Fellowships, through mechanisms described above, will be the best instrumental expereince to help the attainment of my career goals. After completion of placement at Merck KGaA for one year, i will return to my Home Institution(Addis Ababa University) and play key roles in the development of clinical research capacity. I will apply and disseminate the experience gained through variety of planned activities and develop my career at my institution as outlined below in discrete points: 1. i will implement reintegration plans immediately after return, these activities will be performed within 6 months ,and they are quite feasible to do and delivered in a form of capacity development training workshops. Several junior staff members/postgraduate students will be recruited for participation in training. Training needs will be identified with clear learning objectives, modules will be developed , and participative trainings will be administered in a form conducting lecture on basics of clinical research/trial, group discussion, case presentation, independent leanrning, etc. Compiled learning materials will be distributed. The training course will last for 3 days. Certificates will be issued by School of Pharmacy/College of Health Sciences at the end of training. 2. The college of Health Sciences of Addis Ababa University has recently established Clinical Trial unit (CTU), and Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), this center has developed MSC curriculum in Clinical Trial which is under approval process by our university. I asume that i will be an ideal teaching/research faculty in this program and i will mentor MSC students related to courses and resarch projects in areas of clinical trials. This activities may or may not start within the first six months after my return, depending on approval and launching of this graduate program. I will also be pivotal in supporting currently available clinical pharmacology graduate program in my department. 3. I will effectively use my fellowship duration for establishing different networks with scientists in Merck KGaA and its external partners with similar interest for potentially triggering collaborations and attracting external funding for conduct of clinical research in infectious diseases typically responding to proposal calls from different emerging funders including EDCTP. 4. Currently the Ethiopian Goverment started a good step to support research funding through Thematic Research Grants of University, Ministry of Science and Technology, Ministry of Health (Grand Challenge Ethiopia), so i will write grants for investigator initiated trials and apply for soliciting funding from these emerging local sources of funding. I will extend my hands for collaboration also with previous fellows of EDCTP-TDR in Ethiopia some of whom are already working with me. 5. Using reintegration funds from EDCTP which helps to purchase small research inputs/instruments or services, and soliciting funding through above sources/activites, i will lead team formation for Infectious Disease Pharmacology Research Group, and take several PhD /MSC graduate students who will be guided and supported. Laboratory for clinical research will be strengthened. 6. Local pharmaceutical industries are flourishing in Ethiopia, with clear strategic plans of Pharma sector, so i will also extend my consultative support in R & D efforts to this growing sector. 7. I will serve as a bridge for initiation of linkage of big pharmaceutical industries like Merck KGaA with our University, i imagine potentially to draft proposals for innovative sandwich academic-industry educational programs on the grounds of bilateral interest. 8. Finally, i will evaluate my performance periodically in terms of achievement of set career goals and try to mitigate emerging chalenges.
Network EDCTP2
Call EDCTP-WHO/TDR Clinical Research and Development Fellowships

Project partner

Number Name Role Country
1 Addis Ababa University Coordinator Ethiopia