DIA: Driving Insights to Action

Risk Inherent in Benefits of Drug/Device Products?

Dr. Steven Murray, Group Vice President & Principal Engineer in the Electrical & Data Sciences Group for Exponent, assesses and analyzes potential risk and failure of products from underground lateral piping to surgical heart catheters. “In drugs and medical devices, developers really need to consider where their product lies on the scale of risk: Is this a product where it is impossible to disentangle the benefits from some other risk? Or is this a product that, if anything is even a little bit wrong, the benefit doesn't justify it?” he asks. “We're much more accepting to risks in things like cancer drugs or AIDS drugs, where the risk of death is highly present and you're averting it.”

EU Business and Data Needs Converge Through Telematics

Telematics has evolved since the first joint HMA/EMA Telematics strategy in 2014. “The vision for EU telematics is an IT collaboration that will deliver cost-effective, efficient, and interoperable services to the European regulators and to its stakeholders,” suggests Bernd Misselwitz, Director and Regional Head, Regulatory Submission Management, Bayer AG (Germany). “Maybe from an IT perspective, it was the technical problem first and business was second; now that you've seen how people want to get value out of it, it's starting to shift where the business problem comes first,” explains Vada A. Perkins, Executive Director, Regulatory Policy & Intelligence at Bayer Pharmaceuticals (Global). Vada and Bernd will help lead the DIA Europe 2020 session Telematics Strategy in the EU: Global & Regional Considerations for 2020-2025.

RIM Accelerating Efficiencies in Regulatory Pathways

As drug development and market approval grow more connected and complex, effective regulatory information management (RIM) is more essential than ever. “The ideal state would be to leverage regulatory data as a corporate asset,” suggests Venkatraman “Bala” Balasubramanian, Senior Vice President of Life Sciences, Orion Business Innovation. “Regulatory teams will be able to better advise portfolio teams on probability of regulatory success in any given market, so you’re going to have higher success rates from a regulatory perspective going forward,” concurs Pat Shafer, Managing Director, FTI Consulting. Bala and Pat serve in the Working Group developing the Regulatory Information Management reference model discussed at DIA's 2020 Regulatory Submissions Information & Document Management Forum.