PharmaChk

A simple, affordable and accurate tool to ensure the quality of medicines in the field

Poor quality medicines are estimated to account for $75B out of a $962B global pharmaceutical market, exposing millions of people to poor quality medicines and causing over 700,000 preventable deaths every year. In Africa, Latin America, and Asia, estimates indicate that 30–50% of drug sales are poor quality out of a $230B pharmaceutical market. While many poor quality medicines are due to falsification or poor manufacturing practices, there is a large portion of medicines that degrade over time. In the absence of proper storage and transportation facilities, drugs that initially pass quality testing may deteriorate before the point of sale. The ineffectiveness of sub-therapeutic medicines not only impacts the health of individual patients; poor quality antibiotics facilitate the emergence of drug resistant pathogen, a growing public health concern that is estimated to put 10 million lives at risk by 2050. There is thus an urgent need to improve medicine quality in low and middle income countries through the rapid quantitative evaluation of drug quality throughout the supply chain.

Presently, there are several limitations to testing medicine quality in the field. Current field testing technologies are costly, time-intensive and require a high level of scientific expertise and lab support to use. These technologies also do not provide quantitative information on active pharmaceutical ingredient content or tablet release properties. In order to get quantitative and tablet release information, medicine samples must be sent to a centralized laboratory for testing, which are sparse in low-income countries and are often backlogged with requests.

In response to these limitations, PharmaChk provides instantaneous assessment of medicine quality through an easy-to-use platform that can operate at any point in the supply chain. PharmaChk offers its users quantitative results on the active ingredient levels and tablet release characteristics of a variety of medicines and formulations, presenting a cost-effective solution that provides the most valuable medicine quality of any field-test on the market.

PharmaChk is a portable, quantitative, and user-friendly instrument for drug quality screening in the field. The platform is composed of four major components including: a tablet dissolving apparatus, light-emitting probe, millifluidic cartridge, and a signal detector. The millifluidic cartridge mixes incoming solutions of the dissolved tablet and light-emitting probe to release a light signature that is specific to the drug molecule being tested. This light is then captured as an image and compared against a reference to calculate active pharmaceutical ingredient (API) content. Through field testing in Accra, Ghana, we were able to demonstrate accurate and repeatable API quantification of multiple brands of antimalarial tablets; results were accurate to within 3% compared to HPLC testing (gold standard) and were obtained more rapidly compared to MiniLab® (field standard). In contrast to existing technologies, PharmaChk is the first field-based solution to quantitatively assess medicine quality through rapid chemical analysis of the drug, effective in identifying counterfeit, falsified and substandard medicines.

Poor quality medicines account for at least 10% of drugs globally, and 30-50% in low income countries, causing over 700,000 annual deaths, financial burden and increased incidence of antimicrobial resistance. Monitoring the quality of drugs throughout the supply chain has been challenging even with field-based testing technologies. Current drug testing methods are either prohibitively expensive, provide qualitative results, and/or require a high-end laboratory setting to conduct. PharmaChk is a fully-automated and portable platform for medicine quality screening and the only technology capable of providing quantitative analysis in the field, increasing the capacity for testing throughout the supply chain.

PharmaChk is currently the only technology capable of performing comprehensive, quantitative quality testing for medicines in a field-ready format. Trials in Ghana demonstrated accurate and repeatable drug content analysis for both tablets and liquid medications. The instrument is portable, fitting in an overhead compartment on an airplane, and user-friendly, with rapid and fully automated testing guided by a touchscreen interface, allowing non-technical staff to test medicines on the platform. The PharmaChk technology will allow medicine regulators to easily and quickly test medicines throughout the supply chain, helping to ensure the health and safety of the public.

Over the next 12 months, our goals are: 1) to finalize the third generation prototype, 2) to expand our testing portfolio to include oxytocin, antibiotics, and additional antimalarial drugs, 3) to conduct field trials and user testing using the new prototype, and 4) to develop a sustainable business strategy  and commercialization plan for PharmaChk. PharmaChk v3.0 maintains the same testing precision, while integrating drug release analysis capabilities, and incorporating a simplified reagent system.

Over the next three to five years, we plan to scale our innovation, both geographically and through our drug portfolio, expanding throughout Sub-Saharan Africa and into Southeast Asia. We expect to have tests developed for oxytocin, and most frontline antibiotics, antimalarials, anti-TB and anti-HIV drugs. We would like to pilot PharmaChk in at least 5 countries in sub-Saharan Africa, and expand pilots into at least 2 countries in Southeast Asia. During this period, we will also establish larger-scale manufacturing of the platform, in order to decrease costs and make the unit more affordable for LMIC.

While there are multiple stakeholders interested in drug quality, our main customers will be medicine regulatory agencies (MRA), pharmaceutical companies, hospitals and pharmacy chains. Through leveraging our relationship with USAID, we’ve been able to connect with a number of MRA to learn more about the gaps in field-based testing and gain their input on the PharmaChk instrument. We’ve also forged relationships three multinational pharmaceutical companies interested in ensuring the quality of their drugs through post-market surveillance. We plan to retain customers by maintaining in-country representatives for product service and continually expanding our testing portfolio based on customer needs.

We are at a field testing stage, as we want to ensure that our solution is rigorously tested by us, and independently by others, to ensure long-term safety, sustainability and success. As a result, we are not in the market yet, but will be in the next 1-2 years.

PharmaChk provides a process-based solution, empowering countries to assess medicine supply chains in order to ensure only quality medicine reaches consumers. Therefore, while its difficult to estimate how many individuals would be served ensuring poor quality medicines did not reach the market, we can estimate that ultimately hundreds of millions of consumers will be served across multiple countries. If in the next three years we are able to introduce PharmaChk in Ghana, Tanzania, Kenya,as well as Indonesia, we could help ensure the quality of a number of lifesaving medicines for 393 million people.

Our team is comprised of members from industry and academia with expertise in device development, engineering, and global health. We have scientific expertise in assay development and microfluidic engineering, and support from external consultants on translating innovation from the lab to the market. Our team has experience working in low-income countries across Africa and Asia, and has successfully leveraged our relationship with USAID and U.S. Pharmacopoeia to engage key decision makers in these regions.

Our current model is to sell the PharmaChk unit at cost or with a small margin, and generate sustained revenue through the sales of the disposable, single-test cartridges. Currently, quantitative, lab-based tests cost upwards of $150-200/test; we predict we can price test consumables at $8-10/test (an order of magnitude cheaper than the current standard) and make a profit. We plan to reinvest profits into the development of additional probes and expansion into new markets.

Protecting drug quality is a truly global challenge, making PharmaChk relevant in medicine supply chain management in practically all low and middle-income countries. Many countries are mandated to regularly test medicine quality; while the demand for testing is present, the technology to do so in an easy, effective and affordable way has yet to come to market. As PharmaChk grows and expands our testing portfolio, we will leverage our current (and growing) network to make connections with regulators and decision makers in markets where we predict we can have the most impact.

We’re seeking mentorship on how to identify and successfully seek sustainable funding that will help the growth of our innovation. We’ve had early-stage discussions with social investors, but needs help in solidifying a business plan before re-engaging private sector investment. We’re also looking to expand our network, both with fellow early-stage innovators and with influential stakeholders who can help us make important connections. Finally, we’re seeking funding to conduct a field trial in Africa using the v3.0 platform. Based on feedback from current sponsors, demonstration of the new platform in the field is essential for securing future funding.

PharmaChk needs guidance on the business plan development, and mentorship on how to approach funders from both the public and private sectors to transition our innovation to scale. We also hope to expand our network; while we have strong relationships with MRA in Ghana and Kenya, we want to connect with multilateral donor agencies who provide funding for medicines testing and/or who influence global testing protocols. Finally, we are looking for funding to conduct a field trial and user experience study with our most recent prototype and assays before seeking our next round of funding in 2019.