detecting and removing poor quality medicines that harm the most vulnerable patients and damage public health

Our Team

Joseph Amoako-Mensah

Joseph Amoako-Mensah founder of Medicrime Alert International was the Senior Scientist at Fresenius Kabi Oncology PLC, a subsidiary of the pharmaceutical parent company Fresenius Kabi - a global healthcare company that specializes in life-saving medicines and technologies for infusion, transfusion and clinical nutrition. He has gained a wealth of experience in areas including but not limited to quality control, control of substances hazardous to health (COSHH), abbreviated new drug applications (ANDAs), writing of standard operating procedures and quality assurance of medicines.  Through diverse roles, and in his capacity as Senior Scientist, Joseph has mastered Good Manufacturing, Laboratory and Automated practices (GMP, GLP and GAMP) in accordance with governing/relevant pharmacopoeias and regulatory requirements. Having actively and successfully been part of audit teams during numerous regulatory inspections from the U.S Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), Joseph undertook a self-study course on pharmaceutical regulatory affairs in the European Union and the United States. The acquisition of this enhanced skill set led to an increased role in various internal and cross site audits in India and Indonesia on behalf of Fresenius Kabi, focusing on data integrity and the identification of falsified results for active pharmaceutical ingredients and or excipients within drugs. In his role as quality control consultant, representing Fresenius Kabi in a joint project, he was instrumental in the establishment of a cytotoxic laboratory for Pharmadox Healthcare Limited based in Malta. Joseph was also a key member of the Fresenius Kabi Oncology PLC site waste management team.

Further, Joseph has worked within the pharmaceutical industry for over ten years with companies such as Pharmasol Ltd and Wyeth Pharmaceuticals. He is also a certified Lean/Six Sigma black belt professional.

 

Marya Lieberman

Professor Marya Lieberman is the director of the PAD project at the University Of Notre Dame (bio), where she has been a member of the Department of Chemistry and Bio chemistry since 1996. Her scientific background and training is in the area of surface and analytical chemistry, and she has over 50 peer-reviewed publications on self-assembled monolayers, interactions between DNA and surfaces, and the use of electron-beam lithography for high-resolution patterning. In 2010, she began providing analytical support for a project that Notre Dame sponsors in Haiti to produce and distribute salt that is fortified with iodine and a medication that controls spread of lymphatic filariasis. She developed an assay for the medication that could be completed with minimal lab facilities. This project highlighted the many urgent analytical needs in developing countries and the failure of existing technology to achieve scalability in these settings. She began developing paper analytical devices (PADs) interfaced with a cell-phone based image recognition program. These PADs can be used by untrained people, enabling crowdsourcing of chemical analysis in the service of developing countries that struggle with low-quality or counterfeit pharmaceuticals, environmental challenges, and shortages of micronutrients. By engineering the surface chemistry of paper substrates and loading reagents at specific locations, PADs can be designed to carry out dozens of qualitative inorganic and organic tests at once, or even to do a titration. Field sampling of antibiotics, analgesics, and antimalarial drugs is currently underway in Kenya, where Dr. Lieberman collaborates with pharmacists at AMPATH (Academic Model Providing Access To Healthcare) in Eldoret and with the Kenyan Pharmacy and Poisons Board. Over 8,000 PADs have been produced for internal testing and analysis of pharmaceuticals and iodized salt samples in Kenya, Haiti, Uganda, South Africa, Burkina Faso, and the Philippines. Current work focuses on synthetic biology as a tool for creating arsenic, estrogen, and antibiotic biosensors to embed in the paper and on techniques for trace (ppm, ppb) analysis of micronutrients and ground level air pollutants. In 2014/2015, the AMPATH/UND team discovered five lots of antibiotics lacking a critical active ingredient in Western Kenya. These products constituted a third of our sample pool in 2014. We reported theproducts to the KPPB and WHO RapidAlertsystem; and they are now under quarantine in all 47 counties in this nation of 45 million people. The project has attracted international attention and was highlighted on the BBC International Health Check program in May 2015.