Operation Warp Speed—the New Standard for Clinical Trials

Clinical Trials and Operation Warp Speed

248 days. From the time scientists first sequenced the genome of the COVID-19 virus and published it online, it took just 248 days for the clinical trials industry—working closely with government agencies under “Operation Warp Speed” (OWS)—to develop two emergency-use vaccines to stem the tide of the pandemic. Other vaccines would be developed soon afterward.

 

With 5.2 million deaths and counting attributed to the COVID-19 pandemic worldwide, the loss of life alone has been staggering. Sadly, the Omicron variant will add to this devastating toll. Despite our desperation to put this pandemic behind us and return to “normal,” the clinical trials industry and its regulatory agency partners have a golden opportunity to implement some of the best aspects of OWS as the new industry standard. In so doing, the delivery of new therapies in record speed to patients desperately in need—those with diseases such as Alzheimer’s, Parkinson’s, Cancers—would stand as an enduring tribute to the lives lost to COVID-19.      

 

Formed May 15, 2020, OWS was a partnership between the federal departments of Health and Human Services (HHS), Department of Defense (DOD), and select private sector drug development sponsors. At its outset, the daunting goal of OWS was to accelerate vaccine development through 2020 so that, starting in January 2021, 300 million COVID-19 vaccine doses could be approved by the FDA, manufactured, distributed, and available to the U.S. general public by mid-2021.

 

At the inception of OWS, vaccine clinical trials were already underway with Pfizer, Moderna, Novavax, Sanofi/GSK, Janssen (J&J) and AstraZeneca. However, these trials were in the early stages, with no guarantees regarding timeline or successful outcome. And here was this lofty goal of full vaccine deployment in less than a year. For the nearly 75% of the U.S. adult population who have now been inoculated against COVID-19 and are currently contemplating booster shots, it may be easy to forget the audacity of such a compressed drug development timeline. But for those with experience in the clinical trials industry, this ambitious goal may have seemed flat out impossible!

 

If you look at the pre-pandemic statistics, the clinical trials industry has operated against a backdrop of 153,000 global deaths per day, 7,000 compounds in the drug development pipeline, and almost 12 years in clinical trials before new therapies reach patients—at an average cost of $2.6 billion! Defying the seeming inevitability of decades-long cycle times, OWS proved that an accelerated timeline was possible with an unprecedented level of process and performance transparency as well as cooperation between drug developers in the clinical trials industry and government. But what factors enabled this never-before-seen public/private cooperation to achieve the impossible, and how could those factors be standardized for future clinical trials in order to compress development cycle time and achieve faster breakthroughs in our most serious diseases?   

 

Allow each partner/stakeholder to play to its strengths  

In large part, OWS succeeded because at the outset, there was an understanding and acceptance as to which roles and responsibilities were best suited to private enterprise vs. government. For example, the heads of large government agencies such as HHS, DOD, and the State Department accepted that highly motivated, private drug development enterprises were best left to their own devices to do what they do best: execute on clinical process development and manufacturing plans—assuming successful vaccine creation.

 

For their part, the government agencies working within the OWS partnership deemed that their critical role was to mobilize the full capacity of the U.S. government to clear all roadblocks. Their job was to ensure that no technical, logistical, or financial hurdle would hinder vaccine development or deployment. For example, DOD and HHS collaborated to mitigate supply-chain disruptions of critical manufacturing supplies and equipment. HHS even worked closely with one vaccine company to identify a much-needed additional manufacturing partner. The U.S. Army Corps of Engineers was tasked with overseeing construction projects to expand capacity at some manufacturing plants. Incredibly, DOD even sent 16 public servants to fill quality control positions at two vaccine manufacturing sites until the companies could hire the required private sector replacements!

 

Certainly, promising early-stage clinical trial data should meet an agreed-upon threshold to merit such an all-out mobilization. But shouldn’t we lay down the policy guidelines now if only so drug developers and the public know that enormous public/private support will be there when a breakthrough inevitably comes? There are countless people with devastating diseases such as Alzheimer’s—which many experts caution is a developing tsunami given our aging population and longer life expectancies—waiting for just such a crucial breakthrough in treatment. 

Leverage technology-enabled solutions and data sharing to align stakeholders

Extraordinary cooperation by otherwise fierce competitors in the pharmaceutical industry became standard in the OWS effort to develop the COVID-19 vaccines. BioNTech collaborated with Pfizer for its mRNA-based vaccine. Sanofi worked in tandem with GlaxoSmithKline (GSK) and Merck manufactured J&J’s vaccine. Beneath these high-profile partnerships was one significant factor that helped OWS succeed: data-sharing. Specifically, the competitors developing vaccines on one of the four approved platforms selected by OWS—the mRNA platform, the replication-defective live-vector platform, the recombinant-subunit-adjuvanted protein platform, or the attenuated replicating live-vector platform—actually relied on data from other vaccines using the same platforms. For as much criticism as the pharmaceutical industry too often receives, this level of sharing and cooperation between fierce rivals to help swiftly combat a deadly virus preying on many of the world’s most vulnerable has, in my humble opinion, not been heralded enough.  

 

As the CEO and Co-Founder of an innovative cloud-based software provider to the clinical trials industry, I have long advocated for more process and performance transparency (as those who know me in the industry can attest). That said, let me be clear: as an entrepreneur and fierce defender of risk taking and free market capitalism, I am not in any way advocating for pharmaceutical industry sponsors and their CRO partners to share the valuable intellectual property behind new therapies they took great risk to develop and advance through clinical trials. Beyond a passion for improving the human condition and eradicating disease, respect for the rule of law and protecting intellectual property are paramount to ensuring therapeutic breakthroughs like we’ve just experienced with the COVID-19 vaccines.

 

However, in the same collaborative spirit of Operation Warp Speed, there are opportunities to use technology to better align—both operationally and clinically—all clinical trial stakeholders, from patients to investigative sites to CROs and sponsors. On the clinical side, for example, technology that uses artificial intelligence to scour EMR data and match eligible patients to clinical trial protocols is beginning to proliferate. In addition, even during the development of clinical trial protocols, predictive analytics are being leveraged to model trial feasibility based on the protocol, thereby allowing for protocol adjustments to ensure a greater degree of success in the clinical trial phase. Operationally, the pandemic has hastened promising technological advances to cut cycle time and, ultimately, costs to deliver new therapies to patients. Remote and risk-based monitoring of clinical trials is poised to become (or already is) the new norm. And of course, at Devana Solutions we provide technology to connect central trial operations teams with decentralized site staff and clinicians or “bring the site into the patient’s own community”. Devana also highly automates clinical trial process workflows and capture site metrics for analysis and improvement in speeding new therapies to patients.

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It is within our power to take from the urgent, can-do, cooperative partner-mindset that was adopted by the clinical trials industry and government agencies during the pandemic—best exemplified by Operation Warp Speed. The industry and regulators should seize the lessons of this moment, and lay down a framework to accelerate the speed of delivery as soon as the next major therapeutic breakthrough against a serious disease is realized. To miss the next opportunity to speed a lifesaving vaccine or cure to those patients by leveraging the collective fighting spirit this pandemic has engendered would be tragic. Rising to meet this challenge would honor the millions of lives cut short by this pandemic.

 

Book a demo with Devana Solutions today to learn more about our cloud-based data analytics software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.