3 Ways to Rethink Regulatory Change in Personalized Medicine

In 2020, personalized medicines, or precision medicines, accounted for 39% of the new drugs approved by the U.S. Food and Drug Administration (FDA), according to a report released by the Personalized Medicine Coalition (PMC) earlier this year.1 Personalized medicines have now accounted for more than a third of new drug approvals for three of the last four years.

“The pace of progress in personalized medicine continues to accelerate as the U.S. Food and Drug Administration more regularly and rapidly approves diagnostic tools and treatments that expand the frontiers of the field,” the PMC report states.

The landscape for the regulation of personalized medicine continues to evolve as the innovation in personalized medicine increases. In addition to the 20 new personalized drugs and biologics approved by the FDA in 2020, the agency also issued seven guidance documents related to precision medicine. The guidance documents include the agency’s thinking on gene therapy manufacturing and clinical development, as well as orphan drug policy for gene therapies.

As the field of personalized medicine grows and evolves, and regulatory agencies such as the U.S. Food and Drug Administration (FDA) take steps to address regulatory oversight in the field, affected organizations should brace themselves for change and use it to their advantage.

Approaching Regulatory Obstacles as Opportunities

As advances in personalized medicine increase, so will new regulatory oversight. Here are three ways that companies in personalized medicine can approach regulatory obstacles as opportunities instead:

1. Embrace evolving regulations. As the FDA and other health agencies develop clearer regulatory pathways in precision medicine, life sciences companies must prepare for and adopt rapid shifts in regulations related to personalized health care. Ways to prepare include: evaluating outdated, paper-intensive processes and tools; becoming paperless and making software validation a strength; and combining a continuous-readiness model supported by digital technology with compliance risk assessments to enhance the effectiveness of compliance activities.
2. Simplify regulatory processes. There is a sizable opportunity for companies in personalized medicine to simplify their approach to regulatory compliance. The FDA itself recommends “streamlining regulatory processes and removing or reducing unnecessary burdens associated with FDA regulatory activities.”2 Digitizing quality systems and regulatory processes can help reduce redundancies in regulatory submissions, lessen the burden of medical device reporting, and streamline other regulatory processes to improve efficiency. The cloud can also be used to improve regulatory approval processes.
3. Take a data-centric approach. As regulatory expectations evolve and new regulatory requirements go into effect, the FDA and other regulatory bodies are putting greater emphasis on risk, shifting from a one-size-fits-all regulation mindset to a data-driven, segmented approach. Shifting from a document-centric approach to a data-centric approach to compliance requires digital solutions capable of connecting data across processes and systems. Integrated digital tools help provide real-time information regarding product compliance, reducing the amount of paperwork involved while also ensuring accuracy.

To quickly get personalized, life-improving medicines to those who need them, organizations must take the necessary steps and integrate the appropriate digital tools to better adapt to a changing regulatory landscape. Embracing regulatory change can turn compliance into a competitive advantage.

References:

1. "Personalized Medicine at FDA: The Scope & Significance of Progress in 2020," Personalized Medicine Coalition, February 2021.
2. "The Least Burdensome Provisions: Concept and Principles," U.S. Food and Drug Administration, February 2019.
3. "The Cloud Imperative in Life Sciences," Accenture, December 2020.