Africa’s Potential for Clinical Research

Population Diversity, Expanding Therapeutic Area Expertise and Long-Standing Stakeholder Engagement

In this webinar, our panel of Africa-based researchers discuss the strong clinical research foundation, community-centered approach and increasing regulatory harmonization in Africa.

What we cover in this webinar:

Africa has a strong clinical research foundation, based on collaborative approaches with numerous stakeholders, complex studies with long-term follow-up and a community-centered approach to fostering enrollment and retention. Listen to our panel of South Africa-based researchers as they discuss these and other advantages of conducting clinical trials in Africa:

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About the Presenters

Dr. Mookho Malahleha, MBChB, MPH
CEO, Synergy Biomed Research Institute

As the CEO for Synergy Biomed Research Institute (SBRI), Dr. Mookho Malahleha uses her experience in clinical research to support and guide their team of investigators. Dr. Malahleha works closely with the community, community advisory boards and research teams to ensure that research is conducted with excellence and integrity.

Dr. Malahleha is a medical doctor with a masters in public health and a diploma in HIV management. She has more than 12 years of experience in HIV prevention and tuberculosis (TB) clinical research. Dr. Malahleha served as deputy CEO at Setshaba Research Centre for 11 years before taking the helm as CEO at SBRI.

Dr. Malahleha served as a co-chair on the HIV Vaccine Trials Network (HVTN) 702 HIV Vaccine Study and is a member of the Advancing Care and Treatment (ACT) for TB/HIV Consortium, RTI International’s Steering Committee of Multipurpose Technology and TB Alliance’s Stakeholder Association (SHA). She has been awarded the HVTN Mentorship Award in 2018 in recognition of her efforts to train and mentor research staff on HIV vaccine research. She has also served as an investigator on three COVID-19 vaccine studies, including serving as principal investigator on the Johnson & Johnson ENSEMBLE COVID-19 Vaccine Trials.

Sanchia Theron, MBChB
Global Head, Medical Affairs, FHI Clinical

In her role as global head of medical affairs for FHI Clinical, Sanchia Theron is responsible for leading a dispersed global team in the development and execution of all medical affairs activities, including medical monitoring, pharmacovigilance and medical writing.

Theron previously served as associate medical director at Triclinium Clinical Development (TCD) and led the company’s business development program prior to its acquisition by FHI Clinical. In addition, during her time at TCD, she held roles including research physician and head of medical affairs where she served as a medical and pharmacovigilance expert on several large projects with local and international sponsors, ensuring all activities occurred in accordance with ICH GCP, SA GCP and global regulatory guidelines.

After completing her medical degree, Theron gained valuable hands-on clinical experience working in both the public and private health sectors in South Africa. She also acted as investigator on several clinical trials before joining TCD. Although her therapeutic area experience includes a wide range of indications, most is focused on infectious disease and vaccine trials, especially in vulnerable populations, including children and pregnant women.

Theron received her Bachelor of Medicine and Bachelor of Surgery (MBChB) degrees from the University of Pretoria.

Joseph Lemao, MBA
Senior Project Manager, FHI Clinical

Joseph Lemao is a senior clinical project manager at FHI Clinical in South Africa, where he manages all aspects of clinical trials, from study set-up to site close-out. Lemao prepares many of the necessary trial-related documents such as the monitoring, communication, risk management and safety plans and monitors adherence to all relevant requirements — making sure studies stay on track.

Before starting in the clinical research industry in 2008, Lemao held various positions in the healthcare and medical aid industries. Lemao gained experience working as a clinical research associate (CRA) for various contract research organizations (CROs) and multinational pharmaceutical companies. He was promoted to senior CRA in 2013 and appointed the local delivery lead at a multinational pharmaceutical company. In 2020, he was elected chairperson of the Transformation Change and Champion Committee for a multinational pharmaceutical company. Lemao’s therapeutic area experience includes endocrinology, gastroenterology, hematology, infectious diseases, psychiatry and respiratory.

Lemao is a registered professional nurse with a diploma in nursing science and a bachelor’s degree in occupational health nursing. Additionally, Lemao has obtained a bachelor’s degree in pharmaceutical science and a Master of Business Administration (MBA) degree from the Tshwane University of Technology.

About the Moderator

Vice President, Global Strategy, FHI Clinical

With more than twenty years of experience in clinical research monitoring and management, Ghiorghis Belai serves as FHI Clinical’s Vice President, Global Strategy. In this role, Belai is responsible for managing FHI Clinical’s relationships with sponsors and sites, and he works on project feasibility to ensure optimal implementation of trials.

Belai previously served as Director of Clinical Operations for FHI 360, where he managed the clinical research unit based in Nairobi, Kenya, while supervising and mentoring the FHI 360 Africa Regional Clinical Research Unit. In this role, Belai was responsible for reviewing study protocols, coordinating study implementation of multi-center and multi-country trials in Africa, and ensuring that studies adhered to protocol requirements and applicable regulations and guidelines.

With a background in clinical research, Belai has also worked as a clinical research associate for PharmaNet Development Group, Inc., and PPD, where he participated in multiple multi-center clinical research studies, assisted with project data clinical review and management, and presented at investigator meetings for assigned studies. In addition, Belai monitored sites according to applicable standard operating procedures and Food and Drug Administration guidelines and reviewed case report forms for adherence to protocol requirements.

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