Adapted from a phone interview on September 15, 2020.
Q: Give me a picture of your work before the pandemic.
I’ve been in the pharmaceutical industry for almost two decades. I head the technology team for global clinical development at Bristol Myers Squibb. We’re responsible for all aspects of the technology, digital, and data strategy to ensure the overall delivery, support, and reliable operations of clinical trials. The company has operations in 39 countries and our clinical trials are conducted globally.
Coming into this year, Bristol Myers Squibb had just completed one of the largest-ever mergers in the biopharmaceutical industry when we acquired Celgene at the end of last year. We were really at the beginning of a very active integration process for our organizations’ manufacturing, people, processes, and technology. My team was working on integration of the various technologies and capabilities that support clinical trials.
Then, COVID happened.
Q: How did COVID shape your work?
Along with various other technology teams within Bristol Myers Squibb, my team identified the processes and technological capabilities required to expedite COVID research, including clinical operations capabilities and patient recruitment capabilities, as well as the platform that is required for electronic data capture once a study enrolls patients.
We’re also facilitating how we process the data internally and then how we exchange data with other companies.
Q: Where does the exchange of data with other companies come in?
Early this spring, the National Institute of Health (NIH) formed a public-private partnership to develop a coordinated research strategy. It’s called ACTIV for Accelerating COVID Therapeutic Interventions and Vaccines. A number of government agencies, several nonprofits, and about 20 biopharmaceutical companies are involved. It is coordinated by the Foundation for the National Institutes of Health (FNIH). All the parties came to the table to establish a collaborative framework that prioritizes drug candidates to screen, streamlines clinical trials, and coordinates regulatory processing.
Some examples of what’s coming from the collaboration: we’re rapidly screening vast global libraries of medicines that are available within each of the companies with a goal of identifying potential treatments and other clinical tools to fight COVID.
There’s been a proactive and productive sharing of learnings coming out from various clinical trials, mostly in real time. That information is being shared with governments and companies to advance the overall therapy picture.
The companies are also making commitments to not only share knowledge but also to share the available manufacturing capacity to ramp up operations once a successful medicine or vaccine is developed.
Q: Why is the data sharing valuable?
Clinical trials generate a lot of data about the safety and efficacy of a product and how patients are responding. It helps the company understand how the treatment works. It’s part of regulatory approval. During non-COVID times the data will eventually be published in scientific journals.
In the current circumstances, when we share data collectively and collaborate with each other, it saves valuable time. We know what’s working and what’s not working. From a development standpoint, it speeds things up. From the regulatory perspective, with the agencies looking at this data, they become a partner in this journey along with the life sciences companies. They understand what type of research has been conducted and why one path forward is chosen over another. They are a party to this overall dynamic conversation.
Q: How unusual is this sort of collaboration?
In the past, companies have collaborated to develop a specific medicine. We’ve also seen nonprofit partnerships to advance treatments for cancer and any number of other diseases. This is taking all of that a step further. The real differentiation is that ACTIV developed a national strategy for COVID disease response.
Q: Bristol Myers Squibb is not currently working on a vaccine. What is the company working on for COVID?
We’re looking at treatments for COVID, particularly in the hospital setting. Bristol Myers Squibb has identified more than a thousand proprietary compounds to be made available to collaborators to screen for possible molecules for treating COVID.
We’ve been particularly interested in molecules from our portfolio that may have an impact on the inflammatory immune response associated with COVID. For example, Bristol Myers Squibb has a proof-of-concept clinical trial in progress to assess the safety and efficacy of Orencia (abatacept), originally approved for adults with rheumatoid arthritis, in hospitalized patients with COVID-19 due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We’re still early in the process, but it’s an example of potentially advancing an available molecule for this new purpose.
To give a sense of the scale of this global effort, a clinical trial tracker being produced through several universities and backed by the Gates Foundation shows over 2,300 clinical trials underway globally.
Q: Beyond the research into vaccines and treatments, what is the industry doing to move forward?
There’s a holistic framework being thought through. The whole globe has been disrupted because of COVID. Life sciences companies have to ensure that they’re protecting the integrity of the pharmaceutical supply chain and keeping our plants open to maintain a steady supply of non-COVID medicines because people are dependent on them for their health and wellbeing.
“I’m hoping some of these partnerships will continue beyond COVID for the broader good of society. There are plenty more healthcare challenges for us to take on in this way.”
At the same time, the industry is looking at expansion of manufacturing capabilities and sharing capacity once a cure is identified for COVID. The large biopharmaceutical companies have a good capacity and solid expertise in scaling up manufacturing and distribution. It is quite a complicated journey, but they are partnering up with manufacturing groups, even contracting manufacturing organizations, in anticipation of developing a cure.
Q: Do you expect the collaborative approach to continue after the pandemic?
We’re seeing some structural changes as a result of this partnership. I’m hoping some of these partnerships will continue beyond COVID for the broader good of society. There are plenty more healthcare challenges for us to take on in this way.