We’re in a new era when the pharmaceutical industry is adopting various innovations to enhance patient centricity, increase efficiency, reduce the cost of drug development, and swiftly bring new medicinal products with high value propositions to markets. The length of time to identify and successfully bring molecules to market is affected by complex global regulatory frameworks, increasing costs, and price control mechanisms.
These are challenges to innovation. But there are lessons to be learned from other innovative industries.
Successful disruptors in non-pharmaceutical sectors (such as Airbnb and Uber in travel, for example) show that they have enhanced the human experience by “direct human impact,” by applying technology and innovative business models. These types of disruption may not be replicated exactly in the pharmaceutical industry due to the complexities inherent in drug development. However, pharmaceutical companies can implement the technologies supporting these disruptive innovations in new product development to reduce waste, cost, and time to bring effective and safe medicinal products to patients.
Examples include adopting Internet of Things (IoT)-based clinical trials, data-driven targeted patient identification for clinical trials, and subscription-based payment models, where long-term treatment costs can be paid at regular intervals to ease patient access to and reduce the cost burden for a product or service. Such disruptions will enhance the patient experience and consequently drug development.
The pharmaceutical industry has not adopted agile methodologies. Adopting agile methods within company processes can “relax” strict adherence to process and add flexibility. Relaxing process adherence and implementing “fit for purpose” will reduce time spent on complex processes and increase employee participation and engagement.
Agile models can be effective in clinical trials. For example, while protocols were traditionally designed to meet scientific and ethical purposes, including patient-centric perspectives in protocol design (e.g., flexibility in visits and medical assessments, remote vital signs monitoring methodologies, use of augmented/virtual reality technologies in patient education) will reduce patient burden, enhance the patient experience, and quite possibly accelerate drug development.
Clinical trials are a great avenue to reach out to patients and give them more confidence, knowledge, and advantages in accessing potential new treatments. There are regulatory requirements for informing patients about medical research; however, existing methods of patient education and protection can be improved by emerging technologies (such as augmented/virtual reality) to connect with patients without compromising their privacy and confidentiality.
For patients to become more engaged in the clinical research experience, the outcome of clinical trials should be shared. This will facilitate their decision making and create productive and mutually beneficial connections between pharmaceutical companies and patients.
While regulatory compliance is unavoidable in the drug development process, not all discovery or new technology adoption activities in the pharmaceutical industry require adherence to regulatory frameworks. For example, data-driven patient hot spot analytics applications for identifying eligible clinical trial patient populations, digital smart contract implementation, digital tools to support democratization of clinical trials, augmented reality, virtual reality and mixed reality-based applications to understand treatment progress (tumor progressions, device implants, graft acceptance in transplant surgeries, etc.), and patient education and engagement tools can be adopted in an “innovate first and regulate later” model to balance innovation with regulation.
As the structure of drug discovery and development favors incremental innovations within regulatory frameworks that do not support disruptive innovations, this tension results in challenges to small pharmaceutical and biotech companies attempting to shorten the traditional innovation path without compromising regulatory compliance. To foster innovation, large service providers or pharmaceutical companies can support promising drug innovations from small biotech and pharmaceutical companies through investment-based partnership models. For example, therapeutically aligned innovator companies can partner through shared research, such as data sharing and market access. Similarly, large clinical research organizations (CROs) can support smaller biotech and pharmaceutical companies by conducting clinical trials in return for stock in the molecule’s market value. This opens opportunities for large CROs to benefit from drug products outside their specific service area.
In non-healthcare industries, new entrants have made significant disruptions to enhance their consumers’ experience, and the products or services offered by disruptive innovators often provide the best customer experience at a lower cost. Though drug discovery and development are relatively resistant to disruption because of their inherent complexities, existing models should be evaluated for suitability to patient-centric and/or value-based disruptions.
Disclaimer: The opinions expressed in the paper are solely of the author do not represent the views of 3AI. This article is being republished here with author’s consent. This article was originally published in https://globalforum.diaglobal.org/issue/december-2019
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