At a moment when the entire pharmaceutical industry and its stakeholders are demanding greater evidence of a drug’s value, the newly created QuintilesIMS is doubling down to help fuse data streams from clinical trials, patient outcomes, prescription patterns and provider electronic health records (EHRs) into tangible packets of value-added data to help bring drugs through clinical development with greater efficiency and insight than ever before.
“The drug development and healthcare industry is at a tipping point toward real-world evidence (RWE) and patient outcome data,” said Laura Marquis, vice president and global head of Emerging Biopharma at QuintilesIMS. She went on to explain that while there is tremendous opportunity, there is a lot of work in bringing broader awareness of the value and applicability of RWE, particularly within emerging biopharma organizations.
“Real-world data and evidence is a powerful tool for smaller pharma organizations,” said Marquis, “and particularly for these sponsors operating in constrained resource environments, the ability to engage a broader set of stakeholders with these data and show product value is tremendous.”
At the recent 2016 BIO-Europe® meeting in Cologne, Germany, Marquis moderated a panel on these opportunities for emerging biopharma sponsors. Together with colleagues from QuintilesIMS, the panel painted the picture clearly—RWE is now expanding into the clinical development side of the product lifecycle.
By using these data earlier in the life cycle, better study designs can be developed, identification of key stakeholder groups, and go to market targets are just a few of the possibilities. And particularly for emerging companies, the ability to substantiate the full value of a product earlier in the asset life cycle can help drive their partnering and investment strategies.
“It is no longer good enough to just demonstrate efficacy and safety for an EBP’s investor base. They also need to demonstrate product value, and that means understanding patient usage and perceptions from these data that exists in the real world,” said Marquis. That, in turn, can help a small pharma or biotech organization better explain their value proposition, their asset “story,” which ultimately strengthens their pitch to investors and partners.
“There are some regulatory changes and overall a greater openness to using real-world evidence, such that more and more this will become an integral part of the clinical development plan and can shape a smaller company’s exit strategy including partnering and their filing strategy,” Marquis said.
Part of the changes include a much greater focus in healthcare providers’ usage of electronic health records now that this data is available and increasingly there are efforts to tie together different data sources, she said.
It is early, she said, but we are at a point where we now have an ability to pull the data together for insights into how to best assess a drug candidate and how to assess the value it can bring to patients.
“The challenge is knowing how to apply this data. Specifically, how does EHR information help you to better define the right patient pool, and how can records tell us exactly where these patients are located. This information then ties to QuintilesIMS data about which physicians are experienced in running which clinical trials; it becomes a powerful view for recruiting sites,” Marquis said.
Having the right data available improves a company’s ability to predict what is going to happen and when. Selecting the best study site and appointing the right clinical investigator for a trial means a company is more likely to meet enrollment goals, which impacts the study timeline, which in turn affects the ability to make a filing on time, or even early.