TrialSite reported recently that Moderna’s COVID-19 vaccine candidate known as mRNA-1273 fared quite well thus far based on an interim analysis of data from the Phase 3 COVE study shared by the National Institutes of Health (NIH)–appointed Data Safety Monitoring Board known as the DSMB. With 90 cases analyzed, the DSMB reported a safety efficacy of 94.5%, a compelling data point besting the already exciting news from Pfizer and BioNTech that their jointly developed vaccine, BNT162b2, has to date a 90% efficacy rate. In Moderna’s recent press release the Cambridge, Massachusetts-based biotech company made it a point to share that their contract research organization (CRO) PPD was “essential to the successful execution of the COVE study.” This acknowledgement emphasizes the vital importance CROs play now in not only managing clinical trials on behalf of the pharmaceutical or biotech company (biopharmaceutical) but also across the drug development value chain.
The Phase 3 COVE study has been conducted under unprecedented conditions, in the eye of a pandemic storm, one unlike the modern world has seen or experienced. And it wasn’t the only clinical trial as multiple major clinical trials are underway in the United States from Modern with help of PPD to AstraZeneca (AZ1222) and its partner IQVIA, as well as Pfizer/BioNTech, Eli Lilly, Regeneron and many others. But successful drug and vaccine development in pandemic times requires unprecedented collaboration across the public and private sectors, including non-profits.
Federal Involvement Contributes
Although the federal government has been criticized for not being as forceful and comprehensive in pandemic response, in some areas it’s done a marvelous job. The federal government has inserted itself in meaningful and important ways, including the reorganization of major trial site networks to rationalize and streamline the patient enrollment process. The COVID-19 Prevention Network, for example, is the result of the National Institute of Allergy and Infectious Disease (NIAID), a part of the NIH, that sought to capitalize on the existing infectious disease expertise networks by targeted and focus all effort on vaccines and monoclonal antibodies targeting SARS-CoV-2, for instance.
Importantly, Operation Warp Speed (OWS) has also played a vital role that TrialSite called out upon its first announcement. Although not transparent enough, it represented a vital orchestration and marshalling of federal power to concentrate and accelerate vaccine and drug development efforts targeting SARS-CoV-2. TrialSite noted, “A Game Changer” if run and led in the right way.
CROs Run Clinical Research
Moderna’s acknowledgment of PPD made sense and of course in today’s world of drug development the dependence on the CRO is a norm. The pivotal Phase 3 COVE study (NCT04470427) involved a target of 30,000 volunteers and about 100 trial site organizations. Sponsored as well by NIAID and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), COVE is no ordinary study. Actually, the result of an unparalleled public-private collaboration in the middle of the worst pandemic in a century, the underlying messenger RNA life science-based technology may usher in a new generation of vital therapeutics heretofore not possible.
It’s hard enough to pull off such a large-scale clinical trial in normal conditions but during the COVID-19 crisis the parties also had to ensure that sufficient levels of underrepresented demographic groups, such as African Americans and Hispanics were included in this monumental investigation.
PPD, the Wilmington North Carolina-based CRO provides comprehensive, integrated drug development, laboratory and lifecycle management services to biotechnology and pharmaceutical sponsors.
PPD operates at the top of the CRO food chain, up there with IQVIA, Lab Corp (Covance), Syneos Health (merger of INC Research & inVentiv Health), PAREXEL, PRA Health and a few others. By 2018, PPD was serving all of the top 50 biopharmaceutical companies worldwide. According to their recent S-1 disclosure, the company (PPD) was involved with 66 drug approvals in 2018 alone! They too have recognized the growing trend of smaller biotech’s commercializing disruptive gene and cell therapies, establishing the PPD Biotech model.
True Value Proposition of CROS
Ultimately bringing new drugs from “bench to bedside” is an incredibly complex, time-consuming, expensive and risk proposition. Although CROs struggle on a number of fronts (employee turnover for example), they exist to bend the time and cost curve as time and costs for drug development affect speed to market as well as profitability.
The faster a biopharmaceutical company can drive drug development the longer the patent exclusivity period, meaning greater profits. This of course incentivizes investors to accumulate shares, all things being equal, and the biopharmaceutical company does it all over again, benefitting the health consumer (e.g. the patient). By involving end-to-end expert services while investing in innovative technologies, the CRO such as PPD seeks to help the biopharmaceutical client accelerate the development of safe and effective therapeutics in the bid to help that sponsor maximize returns on their R&D investments.
It certainly appears that PPD has been doing a good job on Moderna’s COVE study.