Industry is a white knight right now. Don’t throw it away
Editor’s Commentary: Industry’s positive moment will be fleeting if it doesn’t embed the new ways it is operating in for the long term
Biopharma is having a moment. All eyes are on drug, diagnostic and vaccine developers to get us out of this crisis and back to work. Now, companies -- individually and collectively -- must make good decisions, and avoid bad ones, to avoid a post-COVID backslide from savior to villain.
Not all heroes wear capes, goes the saying. Many are wearing white coats and lab goggles, these days. No one is talking about drug pricing. Everyone is talking about vaccines, therapies and diagnostics.
Science is the biggest news story of the day. Words like the R number, specificity and sensitivity, are tripping off the tongue. The public is engaged in the details of biology and medicine and has access to those details like never before. People care because their lives depend on these details.
How different from the narrative of the past couple of decades, where pharma’s indefensible activities on pricing, extensions of patent terms and lack of transparency have led to the perception of pharma as an industry that puts profits over patients.
Today’s White Knight moment doesn’t mean the drug industry has persuaded the public it will behave honorably. The difference now is that industry’s day job of creating medicines is on broad display; and it is appreciated.
Today’s consortia are breaking boundaries, many of which should remain broken.
Moreover, while the public may not see it, industry has fundamentally overturned its basic operating procedure to defeat the pandemic.
Competitors are now collaborators; data are being shared freely; timelines are being shortened without corners being cut; companies are testing their compounds against one another via master protocols; and most of all, infectious disease and diagnostics are the most important topics on the planet.
Through all of this, a new infrastructure is being built and long-standing assumptions are being challenged.
There is a common goal: to get as fast as possible to a short-term solution to halt the new coronavirus, or preferably a long-term solution to stamp it out.
But COVID-19 patients aren’t intrinsically more important than patients with cancer, autoimmune disease or diabetes. There is no moral justification to removing obstacles in drug development for patients with COVID-19 but not those suffering from other diseases.
Data and reality
Some of the norms being shelved during this “wartime footing” must return in the aftermath. Competition breeds innovation. Drug development will not be taken over by large-scale consortia.
However, today’s consortia are breaking boundaries, many of which should remain broken. R&D leaders are communicating frequently, rather than collecting once a year. They are sharing best practices in a way that surrenders little competitive advantage but raises all boats.
Importantly, they are creating platforms to share clinical data as soon as it becomes available. They are talking with regulators and organizations such as The Reagan-Udall Foundation for the FDA to collect real-world data to support control arms and understand the course of the disease.
The impetus is to gain access to clinical results as soon as possible to inform the next trials, and reduce time and patients wasted on MOAs that don’t work.
Industry has an opportunity to rewrite the rules.
There is no reason why clinical trial data for other diseases shouldn’t be made broadly available with the same speed, rather than being locked up in company vaults. This has been a long-standing gripe among investors, researchers and drug developers, who know that access to those data would bring new drugs to patients faster. Game theory has prevented any company from being the first to break the cloak of data secrecy.
With more than 20 pharmas involved in the three big consortia -- COVID R&D, ACTIV and the Gates Therapeutics Accelerator -- industry has an opportunity to rewrite the rules. The data sharing platforms under construction should serve as templates for future data sharing across R&D. Now is the time to define how to anonymize data, how to enable and govern access to it, and how to deploy it to accelerate compound selection and trial design.
Decisions that will shape the future of the industry aren’t only in the hands of large pharmas. SMEs make plenty of choices that can speed up or slow down drug development. Under the pre-COVID paradigm, they have relentlessly poured dear money into individual trials for their compounds rather than risk studying them head to head using master protocols or adaptive trial designs.
These trials have gained prominence in this emergency precisely for the reasons they’ve been touted over the years by BioCentury and many regulators -- they offer a more efficient means of comparing efficacy and safety across products with the same endpoints, and save patients by using a common control arm, and allow learning from the data as results emerge (see “REMAP-CAP Master Protocol Has Lessons for Studying Drug Cocktails”).
Companies shy away from these trials because they see no upside for themselves: their data could prove to be worse than their competitors’.
However, that mindset lends substance to the charge of “profits over patients.” Failing fast is in everyone’s interest. That is true with or without COVID-19.
A new starting line
Companies, and their IP attorneys, will need to continue to evolve their thinking about competitive advantage.
They have already adapted as the IP landscape has changed, such as when they moved the “starting line” from the sequence of a target gene to the structure of the active compound. In many cases, composition of matter can still reign supreme -- sharing clinical trial results or being prepared to test a therapy against its competitors does not mean surrendering information about the structure beyond what is already disclosed in patent filings.
In other cases, method of use or other aspects of the therapy -- such as how it is synthesized or manufactured -- will have to be where advantage is found.
Some parts of drug development inevitably take time. Other parts take time because of inefficiencies, and decisions that don’t put patients first.
The public cannot fathom why drug development takes so long. If pharma succeeds in cutting timelines and producing a vaccine or therapy for COVID-19 in a year or two, and maybe a completely new treatment in record time, how will the industry then explain a reversion to the decade-plus it normally takes?
Whether companies choose to capitalize on this momentum and embed the changes for the long term will determine if this golden moment is a flash in the pan or a true turning point.
Editors’ commentaries do not necessarily reflect the views of BioCentury.