Harnessing Data to Shape the Future of Regulatory Affairs

As the complexity of our global healthcare environment increases, the significance of integrating novel strategies to address today’s regulatory challenges is a top priority. With Janssen Research & Development, LLC, Global Regulatory Affairs (GRA) – an organization of approximately 900 high-qualified regulatory experts – is shaping the future regulatory pathway by utilizing approaches to adapt within an ever-evolving health care environment, while remaining focused on the needs of patients, health care professionals and caregivers around the world.

One of the driving forces behind the innovative problem-solving efforts with Janssen GRA is a newly established Data Science team that will focus on advancing the use of real-world evidence data, digital data sources and tools, modeling and simulation, and clinical trial innovation, in addition to an emphasis on enhancing regulatory operation processes.

Driving Regulatory Innovation at DIA 2019

I’m excited these and other important topics will be covered at the DIA 2019 Annual Global Meeting, a conference bringing together thousands of innovators to focus on efforts to influence action on critical policy discussions and bring new insights and developments to the public sphere. Janssen’s GRA team has a large presence at this year’s conference (June 23-27), reflecting our expertise and commitment in drug policy innovation. I am encouraged by the presence of my colleagues in San Diego as they share insights on a number of key focus areas for regulatory affairs, including career development, pediatric policy, starting material designation, gene therapy, digital technology and real world data quality.

See a full listing below for what to expect from the Janssen GRA team, and links for more details on each session:

• “The Courage of Career Transitions,” presented by Jasminder Kumar, PharmD, Manager, Global Regulatory Affairs, Oncology
• “Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504,” presented by Pamela Simpkins, MBA, Senior Director & Strategy Lead, Child Health Innovation Leadership Department (CHILD)*
• “Challenge of Regulatory Starting Material Designation and Its Implication on the Global Markets for the Post Approval Process,” presented by Xuhong Cheng, DrSc, PhD, Associate Director, GRS-RA
• “Digital Technology Advances Labeling Management and Patient Access,” chaired by Vicky (Fengyun) Han, Senior Director, Asia Pacific Regulatory Policy Group Lead, Asia Pacific
• “The Evolving Gene Therapy Regulatory Framework: A Brave New World,” chaired by Snehal Naik, PhD, MA, Associate Director, Global Regulatory Affairs, Scientific Innovation Projects
• “Real World Data Quality for Regulatory Decision-Making,” presented by Rebecca Lipsitz, PhD, Associate Director, Global Regulatory Policy and Intelligence

* Developed with Karen Weiss, MD, MPH, VP GRPI 

I’m very proud of these colleagues for sharing their expertise on these topics. We understand the long-term commitment to building a brighter tomorrow and look forward to using a data science platform to work towards solving problems, creating evidence for regulatory review, driving efficiencies and discovering insights.

Afterall, “a journey of a thousand miles begins with a single step.” – Chinese Proverb