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Here's How We Can

Here's How We Can: Co-Creating Solutions as Regulatory Professionals


Today, we sit at the crossroads of important changes in the healthcare ecosystem. We embrace new science, digitization and the evolving healthcare environment reshaping our industry and existing business models. As Janssen’s Global Regulatory Affairs (GRA) team, we recognize the key role we play in empowering such innovation. We promote a culture of "here’s how we can." We have a mindset of co-creation and an ambitious strategy to deliver transformational medicines.

We are working to further optimize the development and delivery of medicines to patients. Specifically, COVID-19 sparked change in the healthcare regulatory process like we’ve never seen before. The extent of this change was summed up well by Mathai Mammen, M.D., Ph.D., Executive Vice President, Pharmaceuticals, R&D, at Johnson & Johnson, in a previous leadership blog post, when he explained: "We came together as an industry in a way that I thought would not be possible to produce therapies and vaccines for SARS-CoV-2. It was heart-warming. Competitors collaborated, united by the imperative of the common goal."

So, the question on everyone’s mind is, "What now?" Now that we have successfully joined forces as industry and regulatory bodies, how can we sustain this momentum? What best practices have we gleaned that must be enacted moving forward?

The answer, to me, begins with data. From society’s perspective, real-world evidence has arrived, and it’s time to make better use of it. Together, we must:

  • Integrate real-world data (RWD) and real-world evidence (RWE) to facilitate the development of medicines by helping to understand the natural course of diseases, identifying existing standards of care for diseases and refining clinical trial inclusion and exclusion criteria.
  • Further the use of RWE to complement clinical trials in supporting regulatory authority decisions about medicines throughout the product lifecycle.
  • Use cloud technology to better collaborate with industry partners and health regulators through streamlined data sharing.

These solutions can sound daunting in theory—but the good news is, they’ve already been put into practice with encouraging results, and the infrastructure to accelerate their arrival exists. Now, it is a matter of investing in talent development to accelerate diversity of thought and build key capabilities, creating a united front, and achieving synergies across healthcare stakeholder groups throughout the drug development process.

The Drug Information Association's (DIA) Global Annual Meeting, taking place in Chicago this year from June 19–23, plays a critical role in shaping the future of healthcare as a neutral convener of leaders from healthcare organizations, regulatory bodies, academic institutions and patient advocacy groups. Together, we work to solve the most pertinent challenges faced as a life science community.

I’ve had the opportunity to be part of DIA Global as a participant, a session chair, and a board member. The insights we obtain and the solutions we co-create have the potential to immediately and tangibly impact patients’ lives.

It is energizing to see how the industry’s brightest minds come together to work through real-world problems they are facing in their daily work and lives. My colleague, Filip Mussen, Ph.D., Vice President, Regional Regulatory Affairs, Janssen, will be participating in a panel discussion titled "Approaches to Health Authority Collaboration: Are They Fit-for-Purpose and How Should They Evolve Post-Pandemic?" Filip and his fellow panelists will be evaluating the impact of work-sharing approaches amongst regulators on global access to medicines, learnings from the pandemic and novel frameworks and policies that will enable sustainable work-sharing and cooperation across agencies in the future.

What makes this session and all engagements at DIA so important is participants come from a broad range of backgrounds and career experiences, and they are all working toward a common goal—delivering quality medicines to patients faster while maintaining the highest regulatory standards. Patients, after all, are ultimately the group we are all working to support. If we can maintain the momentum we’ve gained over the last two-plus years and continue to come together to co-create solutions that safely speed the regulatory process, we can shape meaningful change for the patients we serve.

This is "how we can."

June 21, 2022