Trends in Quality Management: 3 Paths to Patient Centricity in Pharma

Patient centricity in pharma is a relatively new reality. Establishing a direct relationship between pharma and consumers has been a long-term desire for many. However, until now there hasn’t been a clear pathway to make this possible. Patient interests have typically come to pharmaceutical companies indirectly. For example, they have been filtered through medical providers, health plans, pharmacies, and even through the U.S. Food and Drug Administration’s primary mandate for public safety.¹

The Context: Patient-Centric Digital Transformation Initiatives

Pharmaceutical industry trends show that things are changing. In fact, they already have as we are all acutely aware in the wake of the COVID-19 pandemic. We were all required to find novel and meaningful ways to connect with one another despite isolation periods. However, even prior to the pandemic, Scott Gottlieb, former commissioner of the FDA, outlined possible ways that the FDA should be transforming its approach to digital health to leverage direct patient feedback – not only during clinical trials, but throughout the course of treatment.² Some of the key tenets of his presentation are outlined below.

• The FDA needs to ensure a regulatory approach that reflects the novel nature of new digital products and encourages and supports their innovation.
• Digital health should be seen as tool with potential to improve the safety and effectiveness of drug delivery.
• Developers can find new ways to use cloud-based services and tools to support patient health and support more effective treatments, tailored to a patient’s needs and preferences.
• Digital tools can help reduce costs by matching products with the patients who are most likely to benefit and can help reduce risk by identifying potentially serious side effects sooner.

The Shift: Patient-Centric Trends in Pharma Quality Management

By definition, patient centricity in pharma requires companies to take an enterprise-wide approach to products, processes, and partnerships that place patient perspectives and patient satisfaction at the center of operations and objectives. Deloitte describes this as establishing a patient-centric ecosystem.³ The time is right according to Accenture. Eighty-four percent of patients believe that pharma companies should be working more closely with patient organizations to help create a seamless patient experience.⁴ This will require some shifts in how quality organizations define and approach their objectives to align more closely with patient-centric trends in quality management.

Pharmaceutical Industry Trends That Enable Patient Centricity

Fortunately, there are several advanced and emergent technologies that are now making this possible. Two broad examples come to mind:

The Internet of Things (IoT)

The proliferation of smart devices made possible by the ubiquitous IoT allows for connectivity and seamless monitoring via highly personalized products in highly personal spaces. Consumers voluntarily choose to engage with the IoT because they feel the devices enhance their lives. The quantity and quality of data being collected and transferred directly from consumers to companies are unprecedented.

Artificial Intelligence (AI)

AI is code designed to handle vast amounts of data in a variety of forms in a very short period of time and deliver analytical and predictive insights or execute actions responsively. The quality of data becomes increasingly important to form the basis of successful integrations between digital and ultimately intelligent solutions. AI can be used to develop products and therapies that can respond in dynamic ways to highly personalized specifications.

The Benefits of Adopting Patient Centricity in Pharma Quality Management

There are advantages to adopting this modality. Pharmaceutical companies that can effectively connect with their consumers directly will be able to gain insights into their products. These insights will allow them to improve their products, mitigate risk factors, and discover novel ways to increase patient satisfaction and work toward sustainable treatments.

Further, the direct link can work to reduce the historical friction and suspicion that some consumers experience in their current relationship with pharmaceutical providers. One study has shown that patient-centric models and technologies may accomplish exactly the opposite and lead to more loyalty from their customer base. The study revealed an emerging pharmaceutical industry trend. Namely, 44% of patients are more willing to share their data with pharmaceutical companies if it can benefit them personally, to improve their health or medication effectiveness for example. Some highly calibrated, data-rich, digital solutions will be required to perform this precision tango gracefully.

The Way: How to Keep Up With Patient-Centric Pharmaceutical Industry Trends in Quality Management

You can keep up with pharmaceutical industry trends in quality management and begin to lay the necessary foundations for a robust patient-centric ecosystem in three practical ways:

Use Cloud-Based Tools to Connect Quality With Patients

Cloud-based technologies and devices that make up the IoT network are an integral part of the patient-centric model. Effective digital quality management solutions must be able to leverage the remote and continuously operational environments characteristic of the cloud. This makes it possible to complete essential quality tasks and deliver products in a timely manner.

Improve Data Integrity and Integrate Systems

Not just data, but entire technologies will need to be integrated, according to Deloitte.⁵ Look to a digital quality management system (QMS) here that offers electronic document management and structured data with preset thresholds that can keep data clean and alert you of problems with both your data and processes, as well as suggest ways to fix them.

Automate Secure and Compliant Change Control Management

A truly patient-centric QMS must be responsive and flexible enough to meet patient needs and demands – all while remaining compliant to standing regulations as well as privacy and security requirements. As time goes on these will not be competing requirements. However, they may be continuously evolving. A pharmaceutical QMS with a centralized document repository, master templates, and versioning control is crucial here.

References:

1. "Striving to become more patient-centric in life sciences,” Ryan Myers, Casey Korba, and Margaret Anderson, Deloitte, January 20, 2022.
2. "Transforming FDA's Approach to Digital Health,” Scott Gottlieb, FDA, April 25, 2018.
3. Supra note 1.
4. "Connecting Patients to the Services They Need,” Anthony Romito, Jennifer Spada, and Laura Hatch, Accenture, January 11, 2021.
5. Supra note 1.