Incremental Advancements Changing Drug Development
In the US the path from life-saving ideas to Food and Drug Administration (FDA)-approved drug and market launch follows a convoluted, friction-filled, multi-year drug development process that is ripe for disruption and innovation. It costs $2.6 billion and between 10 years to as many as 30 years for a pharmacy manufacturer to bring a drug to market. This timeline is hamstrung by two key barriers slowing it down:
- Conservatism—Despite 90% of pharma leaders working in commercializing new drugs saying that their corporate culture encourages them to explore innovations, according to InCrowd data from 2018, 50% say those on their team are afraid that it will hurt their careers if team members try something new and it doesn’t go well.
- Digital Maturity—In a world gone digital, top consulting firm McKinsey ranked pharma next to the bottom for digital maturity—only slightly above public sector agencies—because they base strategic decisions often in the absence of meaningful data, that should be accessed and leveraged on a regular basis.
However, incremental innovations are finding their way into the process and making an impact on patients, researchers, and drug development. Four areas of note hold near-term promise for a faster molecule-to-market path:
- Protocol Development—Agile process changes in drug development, such as adaptive trials used in the development of blockbuster treatments like Merck’s Keytruda, have helped bring medications to market faster by building iterative learning and planned course corrections into the process.
- Digital Health—Monitoring patients is foundational to drug development and chronic care management. The onset of wearables, digital devices, app-based support and coaching, and wirelessly connected condition-specific devices for diabetes, COPD, cancer, among other conditions, empower patients to fully participate in clinical trials, as well as manage their own care. The FDA is providing guidance to manufacturers with the Digital Health Innovation Action Plan (DHIAP). The plan offers direction on the medical software requirements of the 21st Century Cures
- Direct-to-Patient (DTP), Virtual Clinical Trials, and Cyber Studies—Traditional clinical trials are fraught with friction, patient inconvenience, discomfort, and frustration. As noted, the onset of foundational, remote tools has been critical to trial participation. Smart phones, mobile nurses, telemedicine, e-consent, and apps are simplifying the onerous process of clinical trial participation for patients, making it easy for the 80% of ill patients who wish to participate in clinical trials—70% of whom live over two hours away from a site—to do so. Companies like Science 37 have harnessed remote tools to bring these patients into the process, making participation easier while enlarging the sample size by removing barriers to a fixed-site trials. The trials for Sanofi’s 3-G capable, wireless glucose meter demonstrates the possibilities for virtual clinical trials. The glucose monitor automatically sends physicians diabetic patients’ blood glucose levels, allowing for real-time interventions if needed.
- Solutions Supporting DTP clinical trials—QuickSTAT, for example, allows DTPs to safely transport patient samples to investigators when patients participate remotely. Telehealth options support similar efforts by removing barriers to patient participation from electronic informed consent to eVisits. Companies like AMC Health are offering platforms designed to integrate bi-directional video, biometric sensors, subjective data capture, and text capabilities that offer a rich clinical trial experience and data set, while making it easier for all stakeholders to participate.
Unlike stem-cell research or personalized medicine, these new offerings don’t reinvent the wheel—each offers a better, faster, and in most cases, cheaper approach to a traditional method with very few, if any, tradeoffs.
All pharma stakeholders in the process need to consider where they can try new methods with potential sizable gains and continuously iterate on them until they get it right. They need to up their games, because the industry is running out of time, as are the patients who are waiting for their cures. All players should be asking themselves, is there friction that can be removed in what I do? The innovation may already exist to answer that questions.