Kemet Modular Medication Manufacturing

Drug shortages continue to be a serious and growing concern within global healthcare systems, especially in Africa:

• 1.6M preventable African deaths/year from Malaria, HIV/AIDS and TB
• Only 40-60% of population have access to essential meds
• Prices inflate up to 30X due to mismatched supply and demand
• Substitute or counterfeit medications may cause adverse health outcomes
• COVID-19 pandemic has increased global shortages

Kemet helps solve drug shortages by predicting and producing essential medications with prefabricated facilities and adaptive digital technology.

Kemet’s multi-faceted adaptive solution uses: a) KemNet digital AI/IIoT/Analytics technologies to predict local drug shortages, and b) decentralized prefabricated “factory in a box” KemBox facilities to produce essential medications in low-resource settings.

KemNet as an early warning drug shortage predictive system, and KemBoxes as nimble and hyperlocal drug manufacturing capacity, can help communities prepare for, detect, and respond to emerging pandemics and health security threats.

Drug shortages are a serious, growing problem within global healthcare systems – especially in Africa. Africa accounts for 25% of the total global disease burden, with 90% of the world’s malaria deaths, 75% of HIV/AIDS cases, and more than 25% of tuberculosis (TB) deaths. Despite this, Africa only consumes 1% of global healthcare spending.

In most African countries, the availability of essential medicines is only 40-60%. Drug shortages have dire consequences on patient health outcomes, as many of the deaths in Africa can be prevented or treated with timely and affordable access to medication. Shortages also lead to the circulation of dangerous or deficient substitute or counterfeit medications. 

Most African countries still lack sufficient pharmaceutical manufacturing and rely on imports from large international manufacturers for 70-90% of their medication. Purchasing power is often low due to fragmented demand and rigid expiry dates, which lead to unfillable small batch requests.

The COVID-19 pandemic has amplified the drug shortage problem. In July 2020, 73 countries were at risk of antiretroviral (ARV) stock outages, and a WHO model projected that a 6-month disturbance in ARV access could result in 500,000 extra AIDS-related deaths in sub-Saharan Africa alone, by December 2021.

Kemet is transforming drug manufacturing by developing modular pre-fabricated drug manufacturing facilities – KemBoxes and KemPlexes – that can be transported directly to parts of the world that do not have access to essential medications. 

Establishing local medication manufacturing reduces global supply-chain dependence and allows for local small-batch and personalized production of essential drugs at the point of consumption, resulting in improved health outcomes, health system strengthening, job creation, and reduced greenhouse gases from shipping.

Data will be gathered primarily from an app – KemNet – will allow pharmacies, hospitals and long-term care facilities to self-report their shortages directly to Kemet, which will then be manufactured or filled through compounding. Kemet will harness this data to predict shortages in certain regions, send warnings to facilities that may not yet be experiencing shortages, and optimize the modularized drug processing units for the most efficient production.

The African Union has identified home-grown pharmaceutical manufacturing as an opportunity for local development that will have positive social, economic and health impacts. Kemet advances vulnerable countries’ health security and builds their resilience to future pandemics and other supply-chain disruptions.

Kemet’s founder Morẹ́nikẹ́ Ọláòṣebìkan was born in Ikeja, Lagos, Nigeria with dreams of becoming a physician, like her father. She grew up witnessing entire communities of parents succumbing to HIV and AIDS and hearing of mothers passing the disease to their children despite taking prophylactic medications. Unfortunately, Nigeria was, and continues to be an epicentre of counterfeit drugs–she later learned that the medications these patients were taking were made of baking soda.

When Ọláòṣebìkan was 19, she contracted tuberculosis, a curable and preventable disease that almost exclusively affects individuals in developing countries. She attended a clinic every month, which also treated HIV patients, to endure nine months of TB quadruple therapy. There she witnessed, first-hand, how poorly HIV patients were treated, and how devastating the disease can be within inequitable healthcare systems.

It was then that Ọláòṣebìkan found her life’s purpose: to advocate for every individual’s access to safe and affordable medications. Today, she is a pharmacist working to achieve health equity.

Drug shortages continue to be a serious problem in African countries; Africa imports up to 90% of its medications. Only 40% to 60% of the population has access to many essential medications, and some 1.6 million people needlessly die every year because they do not have access to lifesaving drugs for HIV and AIDS, tuberculosis and malaria. (Even developed countries are impacted by drug shortages: here in Canada, almost 80% of pharmacists report increasing drug shortages – including the supply of complementary COVID-19 treatments, such as hydroxychloroquine and salbutamol, which were so low that patients who regularly use them to treat autoimmune diseases and asthma, respectively, couldn’t get their prescriptions filled.)

These are pre-pandemic statistics.

The pandemic has intensified drug shortages across the globe. In July 2020, 73 countries were at risk of antiretroviral (ARV) shortages due to decreased manufacturing activity and supply chain disruptions. The World Health Organization projected that a six-month disturbance in access to ARVs could result in 500,000 extra AIDS-related deaths in Africa alone, by December 2021.

To effectively address the drug shortage problem, we need to change how medications are manufactured and delivered. So, what is the solution?

Decentralized, globally interconnected medication manufacturing.

Kemet is developing modular, prefabricated drug manufacturing facilities that can be transported to any part of the world experiencing essential medication shortages. These hyperlocal facilities will be connected by a digital network of individuals and institutions to enable streamlined drug manufacturing, agile decisions and group purchasing power. This network will support real-time drug shortage reporting and changes to manufacturing to meet demand; as well as the collection of data to help predict drug shortages in the future. In addition to reducing supply chain reliance and energy intensive shipping and distribution, this system will drastically improve health outcomes, create jobs, empower local communities and support health equity.

All countries are different but COVID-19 has highlighted common issues. Botswana and Chad represent best-case and worst-case African healthcare scenarios, respectively. Both countries have struggled in handling COVID-19 but in different ways. Botswana has a well-regarded health system but the bureaucracy behind it worsened the impact of the pandemic. Chad, on the other hand, is one of the world’s poorest nations and has a particularly weak and strained healthcare system. Our solution is adaptable to this variance and will help inform the longer-term expansion of it to multiple other African countries.

Africa imports up to 90% of its medications from international producers, which, at the best of times, pay relatively little attention to African market needs. The COVID-19 pandemic not only showed how vulnerable the global pharmaceutical supply chain is, it has sadly demonstrated that Africans are last in line when shortages arise due to disruption.

Kemet instead takes an Industry 4.0 “modern modular medication manufacturing” approach.  KemNet as an early warning drug shortage predictive system, and KemBoxes as nimble and hyperlocal drug manufacturing capacity, can help communities prepare for, detect, and respond to emerging pandemics and health security threats.

Since 2016, Kemet has carefully charted out a roadmap that sensibly navigates the various complexities of the pharmaceutical industry and international export markets. 

To date, Kemet has performed extensive R&D with advisors, political delegates, and industry professionals in Canada, Botswana, Kenya, Chad, and Mauritius, and we have secured Letters of Intent.

We are currently building a prototype compounding facility (KemPound) at the Edmonton Research Park, securing licensing (Health Canada and subsequently the Botswana Medicines Regulatory Authority and the South African Health Products Regulatory Authority), and, soon, producing medications for Canadian pharmacies. KemNet software design and development is underway.

With support from this MIT Solve Pandemics Challenge, Kemet is prepared to construct KemBox modules at Edmonton International Airport (YEG) airport, export them to a local team in Botswana, and, with support from the country’s Chief Pharmacist, pilot the solution there in the Selebi Phikwe Economic Development Zone.

Kemet offers three main macro benefits:

1. Transformative: Kemet’s new approach – Transportable Continuous Modular Medication Manufacturing – revolutionizes manufacturing by decentralizing medication manufacturing and embedding a manufacturing sector in African countries. Kemet essentially takes African countries from never experiencing the first industrial revolution to leapfrogging them into the fourth industrial revolution, which is hyperlocal and at the same time globally interconnected. In doing so, Kemet allows for fast time-to-market and decreased global supply chain reliance, which lowers prices and stock outages, while consuming fewer local resources in a sustainable, environmentally conscious way.

2. Adaptive: Just-in-time manufacturing allows changes in production to meet demand, especially as a disaster/emergency preparedness solution. The decentralized network allows for optimization across all regions, while further lowering costs through pooled procurement via the network’s collective buying power. For example, Botswana could save more than $100M (15% of $750M) in shipping costs and shrink procurement lead time from 12 months to 24 hours!

3. Social Impact: Health outcomes will improve from superior and timely access to readily available and affordable life-saving medications – such as Ferrous Sulfate / Folic Acid to treat Anemia, Metronidazole to treat infections, and Paracetamol for fever and moderate pain (the three most shorted medications in Chad). Local manufacturing will empower communities that produce the drugs by providing training and skilled employment opportunities in STEM. Each KemBox will directly create 100 high-skill jobs and 180-250 indirect jobs. The local nature of Kemet supports the balance of trade in African countries.

At the time of the KemPound prototype facility launch later this quarter in Edmonton, Kemet will serve 17,000 Canadians who are affected by drug shortages. We estimate that this number will increase to 170,000 by June 2022. 

With each market entry in Africa, we estimate serving a minimum of 380,000 people living with HIV (based on the initial volumes of ARVs we aim to produce in each country). By 2026, we expect to supply up to 80% of Botswana’s annual drug tender and potentially all of Chad's supply at its Central Medical Store, which would put our reach at more than 18 million people. Kemet is a highly scalable and versatile solution.

As we move towards prototype launch and revenue, we aim to be guided by progress measures aligned with several UN Sustainable Development Goals – in particular to SDGs 3, 8, and 9.

SDG 3-Good Health & Wellbeing

• Number of shorted medications compounded (easily gathered in our digital platform, KemNet)
• Delivery times of compounded essential medications to rural areas (we'll be able to track baseline levels and measure as they improve over time)
• Chronic disease medication compliance as related to shorted medications (we'll need collaborating pharmacies to track this indicator)
• Number of rural areas served
• Volume of medications compounded and supplied to rural Alberta

SDG 8-Decent Work & Economic Growth

• Number of STEM jobs created  – generally, per country, and for women
• Number of international pharmacy graduates internships per annum
• Number of internationally trained engineering internships/co-ops per annum
• New Market - Drug Shortage Revenue generated per annum

SDG 9-Industry, Innovation & Infrastructure

• Number of partners/members added into networks for decentralized manufacturing and to develop infrastructure in rural areas
• Number of prefabricated facilities built per annum
• IP generated and protected/ Number of patents secured (as appropriate) for complex “Made in Canada” technology

• Full-Time: 2
• Part-Time: 2
• Contract: 12
• Advisors: 12
• On-the-Ground Liaisons: 9

Kemet is driven by a brilliant team of social innovators pursuing a systems-level solution to global drug shortages. As complex problems require the practice of humility in collaboration, Kemet is working with key stakeholders, allies and supporters toward profitable social impact.

Kemet is led by Morẹ́nikẹ́ Ọláòṣebìkan, CEO, BSc. Pharm, RPh:

• 29+ years entrepreneurial experience, including Owner and pharmacist of a retail pharmacy with annual revenue of $4M, 25 Staff, 10.7% 2019/20 YOY revenue growth
• Founded Ribbon Rouge, a social innovation in three countries working to achieve health equity; with Total Program Funding of $1.6M (3 years); 13 fellows and 10 staff
• Her experiences in global health has taught that the lack of medication access and youth unemployment are significant drivers of the HIV burden in African countries. She has committed her life to contribute sustainable solutions to these issues.

KemMeds Manager is Aziz Belfarrache

• 15+ years in business and economics and 5+ years in pharmaceutical sciences
• A community pharmacist at Shoppers Drug Mart in Canada

KemBox Manager is Tawfiquer Raihan, BPharm, MSc:

• 28+ years in formulation, process development and manufacturing of solid, semi-solid, liquid dosage forms
• Experience packaging pharmaceutical products; scale-up; commercialization; planning, monitoring and controlling manufacturing and packaging operations according to c-GMP

KemNet Manager is Melinda Jacobs, MA:

• 8+ years in social innovation, technology management, and ethical AI products
• Deep experience in global financial services industry as a tech cofounder and internal product developer within Canada’s largest bank

Kemet is a globally dispersed (North America and Africa) team of multidisciplinary, multicultural, and critically diverse pharmacists, researchers, engineers, builders, entrepreneurs, and students. Diversity is our greatest strength.

It begins with Kemet’s founder, Morẹ́nikẹ́ Ọláòṣebìkan, one of the only Black Woman founders and CEOs of a global medication manufacturing company. This is noteworthy due to the global exclusion of racialized women from STEM, and the fact that STEM jobs tend to be high paying and high GDP contributing jobs. Ọláòṣebìkan already has three Black female mentees working with her on the KemPound prototype in Canada. 

Kemet maintains a preferential hiring policy whereby candidates are reviewed for their fit-to-job criteria, and considerations are made to hire preferentially people who identify as people of African Descent, People of Colour, Black, Indigenous, immigrant, queer, women, transgender, non-binary folks, people living with HIV, neurodivergent persons, and people living with disabilities.

As a company with social impact goals focused on those who experience medication access inequitably, including mothers and children in the African context, it is important that our organization embeds EDI in its hiring and culture.

We applied to the MIT SOLVE Health Security & Pandemics Challenge as much for the prestige and potential connections with MIT as for the prize money. As an early stage venture, though, the funds would be tremendously helpful in accelerating our pace of growth as a global problem solver.

Prize money from MIT SOLVE will help fund the hiring of a world-class Chief Technology Officer. The CTO role will be a critical one for Kemet Group, with the person we hire being responsible for executing on  a technically sound production plan based on Manufacturing Assessment Readiness Levels (MRL), Technology Assessment Readiness Levels (TRL), and a FEED Study, as well as overseeing the integration and expansion of KemNet into AI-enabled Big Data Analytics.

We’re also hopeful that MIT SOLVE may be a catalyst in overcoming some of the barriers outlined earlier. In particular, our success will rely on forging a plenitude of real collaborative relationships and partnerships with public and private institutions, international associations, and key stakeholders around the world.

There is a tension between Just in Time Manufacturing and the various cGMP (Current Good Manufacturing Practice) regulations built into the KemBox’s concept. We seek partners with international regulatory implementation expertise who are able to work with us as we bring these two schools of thought together. The opportunity to build and test out Kemet’s contract manufacturing organization model for generic drugs within our miniaturized facilities and across different legislative, regulatory and social contexts across Africa, will be invaluable over the course of the next few months. 

Kemet has deep diplomatic and governmental relationships to support market entry across Africa over the next decade, and to support these relationships and partners who are able to nurture these relationships as we quantify and qualify our global impact. Over time, an extensive amount of data will be collected in the KemNet platform for sensemaking. We look forward to unusual partnerships that also humanize and tell our stories beyond the quantitative.

Partnerships with major philanthropic providers to African countries will aid in the expansion of Kemet’s client base beyond our current foothold within federal governments and private entities.

Kemet is functionally a bricolage of collaborations and partnerships, to which we aspire to expand. These are some of the many potential partners we would like to partner with:

• International Federation Of Biosafety Associations: To pull on their extensive global networks including their collaborations with national animal and health authorities, with regional and international agencies and organizations (e.g. ASEAN, WHO, OIE, BWC, UN1540, Interpol, Stop TB Partnership, JEE Alliance, Chatham House), to create cross-functional teams that are responsive to local African contexts as we problem solve through various regulatory hurdles in each country. An IFSA partnership could also serve as a funnel for a network of highly skilled certified biorisk management professionals, scientists, laboratory personnel, architects, engineers, academics and policy makers who enable knowledge transfer (reversing the African STEM brain drain that currently exists for medication manufacturing) and also enables each technology transfer into each African country. Knowledge transfer could be built into KemNet as well in this collaboration.

• Guaranteed offtake/procurement agreements: With GLOBAL FUND, USAID, AMREF, KEMSA CAPITAL, UNFPA, PEPFAR, Clinton Health Initiative, Mercy Corp, FHI, MSH, CIHP, APIN, IHVN, Bill & Melinda Gates Foundation.

• Medicines for All Institute: To work on modular active pharmaceutical ingredient manufacturing processes from > 2023 

• United Nations Capital Development Fund, UNITAID and Grand Challenges Canada: For additional funding opportunities.

Kemet’s longer-term roadmap includes expanding our activities into multiple countries and diversifying our approach into various specific applications – such as veterinary use, rollout to rural Indigenous communities, and medical infrastructure to support refugees.

Kemet’s mobile and modular approach is ideal for refugee settlements. We can deploy quickly to emergent situations in most international locations and then tailor production to the needs of the affected population.

The Andan Prize would help advance both our R&D and our partnership networks as each relates to refugee situations and use-cases. This prize would accelerate Kemet’s readiness through earlier, concerted work on a business model that is more aligned with international and emergency aid dynamics.

According to UNAIDS, “women continue to bear the brunt of the HIV epidemic. In sub-Saharan Africa, young women are twice as likely to become infected with HIV as their male counterparts.” HIV/AIDS is just one example of how drug shortages disproportionately affect women. Simple compounds like Magnesium Sulfate, necessary to manage pre-eclampsia in 2-8% of all pregnancies, is estimated to be available to only 50% of all women that need it.  

Kemet is led by Morẹ́nikẹ́ Ọláòṣebìkan, who grew up in Nigeria listening to stories about entire villages of parents being wiped out by HIV and mothers passing HIV to their babies while consuming counterfeit medications made of baking soda. In 2006, she founded Ribbon Rouge Foundation, a grassroots foundation focused on Health Equity for the African, Caribbean, and Black communities. Now as a pharmacist and social innovator in Canada, she is creating bold new stories of hope and health.

Not only is Kemet led by a brilliant and driven female founder, it is advancing a type of distributed production and data harnessing that disproportionately benefits women. Kemet’s offerings are heavily aligned with the Sustainable Development Goals (SDGs), particularly SDG 3-Good Health & Wellbeing, SDG-5 Gender Equality & Women’s Empowerment, SDG 8-Decent Work & Economic Growth, and SDG 9-Industry, Innovation & Infrastructure. Women and girls will benefit from better local access to essential medications and, with the support of this Prize, Kemet hopes to facilitate STEM skills training and jobs for them at our KemBox and KemPlex facilities.

“One can’t change what isn’t measured.” 

When it comes to Big Data, there is much missing. The majority of formal academic and industry experts are in North America, Europe and Asia. Africa is often excluded, which can entrench unintended algorithmic biases and build discrimination into AI/ML products. 

The absence of Black data, generally, in AI is a large source of bias and inequity in technological solutions. In few areas is this as important and life-affecting as healthcare and essential medications. 

Through KemNet, pharmacists and healthcare providers worldwide – including Africa – can both contribute and benefit from the at-scale analysis of pharmaceutical usage patterns, global trends, local concerns, acute emergencies, and widespread pandemics much more fully, inclusively, and actionably. 

We’ve identified two ways that AI will be employed in service of the mission: demand prediction and mass customization. 

Mass customization is an especially significant point in the African context. Many drugs that are available mainstream are researched in W.E.I.R.D (Western, Educated, Industrialized, Rich and Democratic) subjects and so there are several cases in which these drugs simply do not work the same in Black populations. For example, HIV variants in Africa do not respond to the available mainstream medications. It can be argued that the need for pharmacogenomics and personalized medicine is higher in African countries but that the data/tech is not yet available there to enable it.

Smarter supply chains smartly serving personalized medications could have a profound impact on health outcomes in low-resource settings.

The focus of The Global Fund Prize is exactly the focus of Kemet, in particular through our KemNet application.

KemNet will allow pharmacies, hospitals and long-term care facilities to self-report their shortages directly to Kemet, which will then be filled through compounding and/or manufacturing. 

KemNet will deliver a streamlined and accessible online storefront, available to pharmacists via web and mobile and can be used in all internet-connected settings (including low bandwidth areas) and allowing for easy communication and order status tracking. 

The back-end has dynamic order fulfillment. A weighted algorithm will assist clinicians to determine the most expedient compound order to fulfill. Ranked order processing allows for efficient and streamlined fulfillment, including time savings and increased profitability per order.

By anticipating systemic medication shortages via visibility to orders from throughout a region, Kemet can then accelerate production of specific drugs being ordered by multiple pharmacies in a given region and shorten the duration and persistence of essential drug shortages. 

We would use the Prize to accelerate development of the app and to localize it for the specific languages, customs, regulations, and process of additional markets. The Prize can significantly help increase KemNet’s wider adoption, which will in turn generate more useful insights and proactive outputs – especially for borderless emergencies like pandemics.