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FAQ

FREQUENTLY ASKED QUESTIONS (FAQ)

A. African economies are growing rapidly and the healthcare market size is expected to double to US$ 45 billion by 2020. Moreover, sub-Saharan Africa holds out one of the most-attractive business opportunities in the future. Africa has 11% of the world’s population and is growing rapidly at 5-8% per annum. Significantly, 6/10 of the world’s fastest growing economies are in Africa.

A. The location of the NampEVA BioTherapeutics (NBT) is strategically located in Uganda because it is at the interchange hub and gateway-point to the entire Great Lakes Region in East Africa, and in consolidated markets with Kenya in the east, to South Sudan in the north, Democratic Republic of Congo to the west, Rwanda and Burundi to the south west and Tanzania to the south by the new road and Standard Gauge Railway network currently under construction. In addition, the high literacy in Uganda is exceptional for the region since English is taught and spoken from kindergarten to University. Moreover, science and technology skills and knowledge for the sustainability and growth of the pharmaceutical sector is exceptional and will ensure its growth into the next generation.

A. The Founder and President of NBT is a highly innovative and accomplished world-renowned R&D scientist and visionary executive academic leader with 18+ years of exceptional executive leadership experience spearheading strategic planning, basic science research, drug development, clinical trials, training, education and commercialization initiatives. The NBT Management Team brings a unique understanding of the geopolitical climate plus are extensively networked in the business, healthcare and technical communities in Uganda, the Great Lakes Region and Africa. The Management Team also have a strong and detailed understanding of the market structure (informal and formal), have well long and well-developed relationships and understand the needs of the Ugandan government, have personal contacts with local generic pharmaceutical manufacturing facilities. Importantly, the NBT Management Team take a long-term view on this project.

A. WHO cGMP-C is a certification system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. WHO cGMP-C covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written Standard Operating Procedures (SOP) are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made. WHO has established detailed guidelines for good manufacturing practice.

http://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/index.html

A. WHO cGMP-C requires 18 months of manufacturing data.

A. There are only 4 in the whole continent of Africa. Located in Uganda, Kenya, South Africa and Nigeria. All are involved in the manufacture of HIV/AIDS, Malaria and Hepatitis medicines. Importantly, without WHO cGMP-C certification governments in LMIC cannot use funds donated by international agencies to purchase life- saving medicines.

A. Malignant tumors were responsible for 12% of the nearly 56 million deaths worldwide from all causes. In many countries, more than a quarter of deaths are attributable to cancer; 5.3 million men and 4.7 million women developed a malignant tumor and altogether 6.2 million died from the disease. The report also reveals that cancer has emerged as a major public health problem in developing countries, matching its effect in industrialized nations, with 2.2 million deaths annually in the African Region. Approximately, US$1.16 trillion is the estimated total annual economic cost of cancer in 2010. Importantly, 30-50% of cancers could be prevented (WHO’s World Cancer Report. http://www.who.int/mediacentre/news/releases/2003/pr27/en/).

A. Although new cancer drugs are continually getting approved and used, the value that these drugs add is very debatable. Because of the skyrocketing cost of the new drugs, each new approval represents a multi-billion-dollar market. However, unlike other branches of economics, cancer drugs are intricately associated with socio-political issues, emotional overlay, public pressure, industry manipulation and propaganda. Costs of oncology therapeutics and supportive care drugs grew to reach $107 billion globally in 2015, an increase of 11.5% over 2014 (on a constant dollar basis) and up from $84 billion in 2010, as measured at invoice price levels. These costs are expected to reach $150 billion globally by 2020.


Copyright © 2020 NampEVA BioTherapeutics LLC | All Rights Reserved
Copyright © 2020 NampEVA BioTherapeutics LLC | All Rights Reserved