By Max Bronstein and David Beier
This article ran in BioCentury on March 7, 2020
As the world eyes a return to post-COVID crisis ‘normalcy,’ a robust global recovery will depend on effective treatments and ultimately a vaccine. Yes, more than 400 research and clinical programs are already under way, but coordinating these efforts is a major challenge.
That’s why when NIH announced the formation of a public-private partnership among biopharmaceutical companies, the CDC, and global regulatory authorities, the news offered real hope for COVID drug development (see “Collaborating to Clobber COVID-19”).
Nothing as important as this has occurred since World War II when the U.S. created the Arsenal of Democracy by government partnering with industry to convert auto manufacturing into aircraft and tank production.
Every well-intentioned partnership or collaboration rises or falls on whether the interests of the parties are aligned. We propose concrete public policy reforms that rebalance risks and rewards with the singular goal of rapid discovery and development of new medicines and tools to respond to one the most significant global health crises in 100 years.
Seats at the Table
Drug development is a risky and capital-intensive endeavor, a process riddled with inefficiency stemming from industry competition. The NIH effort aims to smooth and speed the process by encouraging pre-competitive collaboration.
It’s a bold initiative, but building a successful public-private partnerships hinges on ensuring the right stakeholders have a seat at the table.
In this case, that group includes patients and patient organizations. Their input will go a long way to informing clinical development and bolstering clinical trial enrollment — a significant challenge when so many therapeutic candidates are in play.
If you look at the HIV/AIDS epidemic for guidance, involving patients in development efforts became a turning point in advancing clinical trial and treatment efforts.
We also must include the perspectives of frontline healthcare providers who have gone above and beyond to serve patients at great personal risk. Incorporating their perspectives will help ground-truth trial efforts by informing sponsors of the real-world challenge of running a clinical trial in a COVID environment.
As development efforts advance, so will our sense of which therapeutic treatments are most promising.
We must be prudent in managing expectations around treatments. Even today, early efficacy studies are getting attention, but preliminary data risks causing runs on drug supplies that may be ineffective or unsafe for COVID-patients, while disrupting the supply for indicated uses.
The NIH partnership can help mitigate this challenge by reinforcing recent treatment guidelines for early product candidates. Furthermore, the NIH partnership should be closely coordinating messaging with key members of the Coronavirus Task Force on the results of studies.
Early clinical data can be confusing, jargon-laden, and in some cases, outright contradictory as various data sources emerge, which creates an information gap. This gap allows for all manner of claims to be made with no basis in science or evidence. We need to do better at communicating which drugs show promise and which are no better than snake oil.
The truth is a safe and effective COVID treatment will likely require dozens if not hundreds of development efforts. That’s why targeted incentives can help bring even more treatments into the pipeline while also encouraging current stakeholders to boost investments in existing COVID efforts.
By pledging to purchase successful products when ready for broad use, government can play a central role in incentivizing development.
There is even discussion of a new initiative, Operation Warp Speed, which among other activities, could help companies avoid the significant financial risk that comes with failed vaccine candidates.
Other models include the “prize” approach, which we were pleased to see deployed in the recent NIH RADx initiative — offering up to $500M for rapid testing technology. Similar prizes should be leveraged to facilitate efforts to develop drugs as well as vaccines.
A third option would be to award vouchers that can be bought or sold to speed approval of future products. These sweeteners can be meaningful, especially to smaller biopharmaceutical companies that have been powerhouses of biomedical innovation. Even modest incentives can help unlock billions of dollars of investment in additional innovative potential.
Broadening the Partnership
While the NIH partnership is among the most ambitious to date, it is also important for this this effort to coordinate with existing collaborative programs to avoid duplication.
George Scangos, CEO of Vir Biotechnology, has stepped up to lead the Biotechnology Innovation Organization’s (BIO) working group on COVID-19.
Separately, 15 top pharma companies have joined together in an unprecedented pre-competitive collaboration to share data and expedite the creation of therapies and vaccines (see “Pharmas Align Behind Crowdsourcing Solution”).
The Coalition for Epidemic Preparedness Innovations (CEPI) is in the process of raising funds dedicated to vaccine development.
Meanwhile the Gates Foundation, with support from Wellcome and Mastercard, has announced the COVID-19 Therapeutics Accelerator, aimed at finding and scaling repurposed or novel treatments.
Last week alone, a Coronavirus Global Response event raised more than $8 billion to support COVID efforts.
These global collaborations are pivotal for advancing therapeutics, but it’s critical for these stakeholders to be plugged into the NIH effort as well. An external advisory council might be a useful mechanism for keeping NIH informed and ensuring development efforts proceed as efficiently as possible.
Addressing the Intellectual Property Challenge
Ideally, these efforts will yield multiple therapeutic options. Some may be breakthroughs, developed expressly for treating COVID, while others may be repurposed therapies. IP challenges will no doubt emerge, especially in cases of combination therapies with compounds and IP owned by different companies.
One solution to this challenge is the use of voluntary patent pools, whereby owners may license multiple technologies to a third party in order to create the desired therapeutic.
As a useful first step, the Department of Justice and Federal Trade Commission have released a joint antitrust statement intended to provide clear guidance on R&D collaborations. The statement should help pave the way for unfettered data sharing. Some academic efforts are already underway to help facilitate licensing agreements for any COVID-related products.
COVID-19 poses a challenge that is unprecedented in the modern world. The new NIH partnership reveals the heart of the US innovation ecosystem, reminding us that we are at our best when government, business and the nonprofit sector come together to address grand challenges.
Only partnership can deliver a world where COVID-19 becomes one of a long list of diseases defeated by science. Getting there will require bringing the right stakeholders to the table and targeted incentives that enable a research effort unlike any the world has seen.