The next frontier in drug delivery

At the confluence of Moore’s law and Metcalfe’s law the next frontier in drug delivery becomes data-driven, personalised and outcome-based- Dr Ramin Rafiei, director of digital healthcare at SHL Group writes. 

Over the past few decades, the cost of bringing new drugs to market has been doubling every nine years. This exponential trend, measured as the number of FDA approvals per billion USD spent on R&D, is known as the Moore’s law of the pharmaceutical industry and labelled Eroom’s law¹ – Moore spelt backwards. Compounding this diminishing return on pharmaceutical R&D investments is the gap between clinical efficacy of medications as determined in a randomised controlled trial (RCT) setting and their real-world effectiveness.

Medication adherence is the key factor for the gap between RCT efficacy and real-world effectiveness as typically 50% of patients with chronic conditions fail to take the recommended therapeutic dose consistently, resulting in poor health outcomes and increased healthcare costs². As a result, solely relying on the clinical efficacy of new medications is not the solution to chronic disease management; rather, we need to find ways to help patients self-manage existing conditions. This also presents pharmaceutical companies with a $600 billion-plus opportunity, which is otherwise lost revenue due to medication non-adherence³.

Moore’s law, attributed to co-founder of Intel Gordon Moore, has transformed computing through exponentially decreased costs and increased performance. There are already a number of examples across the healthcare industry where the impact of Moore’s law has resulted in exponential change, such as the cost of genome sequencing, adoption of DNA testing and utilisation of telehealth services⁴. As technology continues to get smaller, lighter, more efficient and intuitive, computers and sensors are also making their way into drug delivery devices. Today, connected injectable therapies are still in their infancy when compared to respiratory and oral therapies. However, studies across these three therapeutic categories have consistently demonstrated that when drugs are augmented through sensors and connectivity, patient adherence and health outcomes improve. So could the application of Moore’s Law to drug delivery be the solution to medication non-adherence?

Adherence is multifactorial and stems from the diversity of patient behaviours and barriers. Connected drug delivery devices, which measure dose-level (true) adherence in real-time, are the necessary first step towards a solution. However, improvements in adherence can only be realised when real-world data (RWD) from connected devices is applied effectively towards supporting patients with self-managing their condition outside the clinic setting.

The first application is behavioural support by targeting and tailoring interventions designed to change behaviour and improve patient adherence to therapy. RWD from connected devices create a feedback loop by providing a mechanism to learn which interventions are most effective. Today machine learning models are being applied to deliver interventions, measure the effect of each intervention on the target behaviour, and improve the accuracy of the next intervention based on real-time adherence data. Dose-level adherence data also enhances remote treatment support, in which the data is used to improve clinical treatment decisions, and support ongoing dose titration until the optimal treatment regimen for each patient is reached.

Metcalfe’s law, proposed by Robert Metcalfe the inventor of Ethernet, states that the value of a network grows exponentially as a function of network size⁵. When RWD is actively used to improve the patient experience, increase their engagement with their care plan, and improve adherence to therapy, Metcalfe’s Law predicts its value will grow exponentially for all stakeholders across the care continuum. For pharmaceutical companies, this benefit will best manifest itself in an ability to measure and improve the real-world effectiveness of drugs. This next frontier in drug delivery combines Moore’s and Metcalfe’s laws to become data-driven, personalised, outcome-based, and accessible. This next frontier is connected therapeutics (CTx).

^References 

^{1: Vinay Kini, P Michael Ho, “Interventions to improve medication adherence”. JAMA, 2018; Vol 320(23), pp 2461-2473.}

^{2: Thomas Forissier and Katrina Firlik, MD, “Estimated Pharmaceutical Revenue Loss Due to Medication Nonadherence”. Health Prize and Capgemini Consulting, 2012.}

^{3: Thomas Forissier and Katrina Firlik, MD, “Estimated Pharmaceutical Revenue Loss Due to Medication Nonadherence”. Health Prize and Capgemini Consulting, 2012.}

^{4: Shubham Singhal and Stephanie Carlton, “The era of exponential improvement in healthcare?” McKinsey Insights, 2019}

^{5: Rich Karlgaard, “Ten Laws of The Modern World”. Forbes, 2005}