Like many conferences in the COVID era, DPHARM, the annual conference based in Boston and focused on disruptive innovations in clinical trials, moved from in-person to a virtual setting this week, due to local spikes of the Delta variant. To date, I’ve largely avoided these events because they lack the same authentic networking opportunities of live events. It’s becoming increasingly clear that the horizon for live events is unknown. So, I bit the bullet and attended the conference virtually. I was pleasantly surprised. The interface was clean, the sound and picture clarity good, and the interactivity solid. In fact, I even had one of my questions posted to the chat box read live and answered by the speaker. Cool!
Then and Now
I have attended DPHARM previously in person, and have always found the conference to be incredibly interesting, as it gave innovators a chance to show off their wares to the industry. It has been a showcase for entrepreneurs, up and coming businesses, and innovation teams at larger companies to discuss and demonstrate their new approaches to driving efficiency in clinical trials. Most often, these new approaches were focused on simplifying clunky elements of study conduct and improving the experience of patient participants. Think at-home study visits, remote wearable data collection devices, virtual trials, field-based trials, and more.
This was a community focused on breaking through the long-standing stodginess of our industry and driving down drug development cycle times. While it was always exciting, and it promised a new age of research – one that would encourage risk taking and patient-centricity, and ignore the oft-used excuse of regulation and bureaucracy – adoption of these new approaches remained depressingly low. Outside of observational studies, smaller pilot programs, and other test-approaches, usage was low and traction slow.
Enter Covid.
Accelerating Advances
The emergence of COVID over the past 18 months has single-handedly been the kick start the industry needed. The cause it never wanted, but the cause it would’ve likely required to push through old boundaries and truly embrace clinical operations innovation. Urgency over perfection in process became the new rallying cry. The industry embraced change at a speed never seen before in the modern era of clinical trials. The DPHARM conference in 2021 became the premier show-and-tell event for all of the companies that once talked about (or piloting) innovation and was now living it at a blistering speed. It did so at the point of highest pressure, when all the chips were on the table and the world wouldn’t take “slow” for an answer. Each presentation was another example of how companies exercised past demons of “follow-the-SOP or fail” as they were forcibly driven to explore a new way.
In the keynote session, Rob Goodwin, Pfizer vice president, Operations Center of Excellence, global product development, and Steve Cutler, CEO of Icon, walked the audience through the painstaking process their teams went through to collaborate and innovate in real time to drive speed on Pfizer’s vaccine development. Their teams worked nights and weekends, and tested, onboarded, and integrated innovative systems to bring the various trial components to life. They accomplished all this despite not being able to operate study sites and see patients in the classic brick and mortar model.
At one point they were enrolling more than 1,000 patients a day into the study, while wondering why they couldn’t do the same for other trials in the future. One of the most profound things I heard from them was their talk about the importance of true partnership throughout the process. Issues and problems will happen and you “can’t escalate all of them. You have to expect setbacks and work through them.” It made me reflect on some of the strongest partnerships we have with our clients here at Imperial. How governance, communication, and constantly looking at and improving the process of how our teams work together, is the key to a successful partnership with longevity.
Take Time to Celebrate
They also spoke about mindset – and how everyone needs to have the mindset that we will figure it out. They found that celebrating was almost as critical as problem solving. They had to mark and note and celebrate their victories to ensure continued motivation and recognition of what they were accomplishing. The process of executing the trial had to involve a variety of approaches that did not have a strong proof-of-concept background, but would be required to work if the trial was to work.
Innovation in Action
Here are some of the steps Rob and Steve reviewed, that I captured, which really brought to life the need for innovation, technology interoperability, regulatory cooperation, global support, partnership, and more:
- Implementing an e-consent platform for initial consent, but also re-consent for protocol amendments
- Patients going home with an e-diary
- If symptoms emerge, they would have a telemedicine visit, so they had to test, implement, and execute a telemedicine platform across multiple countries
- Couriers picked up swabs, sent to lab for assessment for virus – testing challenging logistics services in a shut down COVID environment
- Moved to a remote monitoring approach:
- Monitors in 25 countries monitoring sites in six countries
- 5,000 patients enrolled in Argentina, with monitors in Japan monitoring the data
- At one point – 12 monitors on site and 87 remote reviewing data for Argentina
- Sites and regulators helped, from clearing obstacles to utilizing a myriad of newer approaches for trial execution
Rob and Steve also called to light the importance of collaboration in innovation. Not just between Pfizer (sponsor) and ICON (CRO), but sites and patients as well. They needed to ensure that everyone was aware of the approaches they were using, and that everyone was onboard and getting what they needed from the technology.
A Recurring Theme
While the example given above was the most pronounced and largest in scale, many other presentations echoed a similar theme: COVID created the impetus needed for scaling new technologies and approaches to drive trial speed at a time the world desperately needed it.
Representatives from various companies stepped forward to the virtual podium to share stories about record enrollment in large scale COVID trials, and how technology, innovative approaches, and the open-mindedness and flexibility of regulators paved the way for breakneck study completion, FDA review, and approvals.
Attending the DPHARM event offered many reasons to be hopeful about the future of clinical trials. We had our breakthrough moment and things would be better going forward. Unfortunately, I’m more realistic than that, and I believe many of my industry colleagues are as well.
What’s Next?
The skeptical side of me says that COVID was a red herring. The entire world was singularly focused on the goal of a vaccine. Clinical trials became a household term, because COVID was a household problem that was impacting everyone’s lives. Everyone — from presidents to Big Pharma CEOs to rival governments — had a stake in the outcome, and because of that, mountains were moved.
I have spoken to quite a few CEOs and senior business leaders of younger companies over the past 12 months who have experienced wild success early on, strictly through their work on COVID trials. They are now using that success as their proof of concept for other vaccine and trial work across diverse therapeutic areas.
But is any of our success an indication of what happens next? I am choosing to think yes. I am choosing to be positive and I encourage you to be as well. We got a (perhaps) once in a career opportunity to test and prove novel approaches and we will piggyback on those successes to launch into other areas.
Rob Goodwin (or was it Steve Cutler — the downside of my chicken scratch note writing and translation) said it best at the end of their session: “We need to be a little realistic about whether we can do something like this going forward, but we’ve moved the chains forward. Our mindset has evolved. It might not have to take two months to six months to get a study started. In this case, we had approvals from regulatory authorities over the weekend. We might not hit that speed, but we can’t go back.”
We’ve tasted what it’s like to innovate in a way that other industries do. For the sake of global population health improvement, diversity in clinical trials, and meeting the challenge of the next pandemic, we must expect more from ourselves and the entire clinical trials apparatus.
I look forward to seeing you down the road, hopefully in person, at the next DPHARM summit.
