Reed Tech attended RAPS 2020 Euro Convergence – this year live and online. Like most of 2020, conferences and trade shows have been all about adapting. Industry has done a commendable job of adjusting and embracing what is frequently referred to as the “new normal” and Euro Convergence was no different. Though the event was fully virtual, we were able to connect and share ideas with our colleagues, customers and leading industry experts at our booth, during networking hours and through live sessions.
In addition to adapting, another common theme of 2020 has been unprecedented innovation. Like adaption, Euro Convergence embraced this theme. We were able to attend a session focused on Supporting Innovation from both the FDA Perspective and the EMA Perspective. The featured speakers in this session were Stephanie Omokaro, MD – Division Deputy Director, Office of Medical Policy at the U.S. Food and Drug Administration (FDA) – and Tony Humphreys – Head of Regulatory Science & Innovation Task Force at the European Medicines Agency (EMA).
Ms. Omokaro gave us a high-level overview of the pharmaceutical industry and the current era of innovation. Some important statistics shared include:
- Total Nominal Spending on Medicines in the U.S. in 2019: $511.4B USD
- Total Branded Drugs Share of Total U.S. Pharmaceutical Revenue in 2019: 80%
- Total U.S. Pharmaceutical Preparation Manufacturing Gross Output: $217.5B USD
These statistics easily frame just how important innovation is in this rapidly growing industry. One of the most important innovations on the horizon is the evolution of clinical trials and how the landscape will begin to look different including: Complex Innovative Designs, Master Protocols, Decentralized Trials, Real World Data & Evidence, Modeling & Innovation and Novel Stakeholder Engagements. As you can see, big data and artificial intelligence will be paramount to this innovation and product safety will be amplified by applied data and predictive solutions.
Mr. Humphreys of the EMA then discussed many of the same aspects of innovation while noting that the “pace of innovation has accelerated dramatically in recent years.” The EMA seemingly has developed more specific goals regarding the regulatory future but, even so, their sentiments seem to echo those of the FDA. The five specific goals set forth by the EMA are:
- Catalyzing the integration of science and technology in medicine developments
- Driving collaborative evidence generation
- Advancing patient-centered access to medicines in partnership with healthcare systems
- Addressing emerging health threats and availability/therapeutic challenges
- Enabling and leveraging research and innovation in regulatory science
The common threads we saw within the FDA and EMA response to innovation and the regulatory future are that industry response must be unified globally and rely on big data and real-world evidence. Industry has been preparing for these trends and this preparation is a particularly important initiative to us at Reed Tech. We have developed two powerful, encompassing big data tools to help customers fill knowledge gaps and make informed, data-driven decisions— Navigator for Drug Labels and Navigator for Medical Devices. As big data becomes more important globally, it is important to rely on solutions to reduce time and effort. It is with this in mind that we are continually developing and improving both Navigator solutions to provide actionable insights. As industry evolves, Reed Tech will be on the forefront and make sure that the tools we provide to our customers are evolving as well.