With JPM’s 41st annual conference wrapping up, we took the time to sit down with our peers to find out what exactly were the big themes and takeaways from this year’s conference.
Clinical Research Will Bring us Closer to Patients in the Next Ten Years
There continues to be movement in the industry in focusing clinical trials around the patient experience. With CVS and Walgreens entering the retail market, pharma is pioneering new models for how to better reach and involve patients. Many companies, including Medable, have already begun working with pharma to bring the “patient voice” in at key moments, such as protocol design, to better shape trials around patient needs.
Decentralized Clinical Trial (DCT) Guidance and Harmonization are Coming in 2023 as Regulators Indicate Support for DCTs
With the passing of the 2023 US Funding Bill on Clinical Trial Diversity and Modernization and the EMA Recommendation Whitepaper on Decentralized Elements in Clinical Trials, sponsors should expect regulation in 2023 focusing on codifying the approach to decentralized clinical trials.
Previously, the FDA alongside other regulators has expressed support regarding DCTs in the context of trial diversity and patient-reported outcomes (PROs) in Oncology trials.
DCT Continues to Become Mainstream, Driving Value Across Portfolios
With Tufts CSDD’s July peer-reviewed paper showcasing the value of decentralized trials, discussions around time, cost, and savings were at the forefront of many sessions.
Medable CEO Michelle Longmire noted that the DCT market is following the infamous “Innovation S-Curve” in which markets must first ferment in order to expedite the time to take off, before reaching maturity.
Tufts CSDD’s findings, paired alongside adoption by companies like GSK showcases the belief in DCT’s abilities to generate up to 13X ROI for Ph. 3 studies and 5X for Ph. 2 studies.
2023’s Focus is on Organizing for Sustainable Scalability
2023 is about realizing how trials can scale in a sustainable fashion. Both product vision and enablement will be key in equipping the industry with the tools needed to realize the findings in Tufts CSDD’s DCT whitepaper. Additionally, digital data flows between multiple devices, biomarkers, labs, and retail datapoints must be standardized in order to expedite trials and help realize these new efficiencies.
Trials will Continue to Expand Into New Areas Like Retail to Garner More Participants, Better Data, and Faster Timelines
With retail giants like CVS and Walgreens entering the market, clinical trials will look to leverage increased data such as treatment and pharmacy records to deliver precision recruitment, generate types of real-world evidence that were not previously possible, and dramatically reduce drug development timelines.
The Future of Pharma Revolves Around Building Trust With Trial Participants
With pharma moving increasingly towards novel forms of medicine like gene therapy and personalized medicine, there must be an increased focus on building trust with research participants. Retail companies like CVS and Walgreens are already tackling this from the ground up, and it’s critical that pharma leverage community and education on the importance of clinical research in order to meet its goals.
Many CEOs expect that COVID-19 will continue to stick around
Top executives believe that current flu vaccines offer a good model of what the world can expect for the future of the disease. Likewise, other executives noted that the virus is still quite prevalent, with infection creating a very “short-lasting immunity.” As such, many clinicians expect COVID-19 to remain prevalent for the foreseeable future, with vaccine rates evening out and the possibility of more severe symptoms driving future treatments.
The FDAs Rules Around Accelerated Approval are Changing
Sponsors utilizing the accelerated approval timelines should note that the FDA may now require additional “confirmatory trials” either before or after an accelerated approval, prior to the drug hitting the market. Speaking in person, FDA Commissioner Rob Califf noted that “I think it’s really important we need to be able to move quickly to either verify or disprove the concept of the treatment, [whether] its benefits outweigh its risks, as inherent in accelerated approval is a great degree of uncertainty.”