Taren Grom, Editor
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COVID-19 has stretched our industry to adjust to all types of new “normals,” yet amid all of the disruption and loss of life, there are pockets of light that are expected to lift the life sciences and its people to new heights.
Of all the industries that have been impacted across the globe, the life-sciences and pharmaceutical industries have the greatest opportunity to change the trajectory of world health. As the world awaits the approval of the first COVID-19 vaccines, questions remain as to how effective they will be and how widely they will be adopted and distributed. During this uniquely severe global crisis, this is an awesome responsibility that has leaders across the board adopting new operating models to respond quickly to the rapidly shifting environment and sustaining their organizations through the many business complexities that lie ahead. McKinsey & Company analysts say the magnitude of the uncertainty organizations face in this crisis — defined partly by the frequency and extent of changes in information about it — means that operating models must enable continuous learning and flexible responses as situations evolve. The duration of the crisis, furthermore, has already exceeded the early predictions of many; business planners are now expecting to operate in crisis mode for an extended period. Leaders should therefore begin assembling the foundational elements of this operating model so that they can steer their organizations under conditions of extreme uncertainty.
We know the worldwide health crisis has led to company layoffs, bankruptcies, and untold disruptions, yet we also know that companies within the life-sciences ecosystem have banded together in unprecedented ways — one of the silver linings to COVID-19 — to respond to the needs of the global community all in an effort to address patient needs.
We asked our PharmaVOICE community of leaders to inspire us with some of the positives that have come from the COVID-19 pandemic. (PV)
COVID-19 Silver Linings
If there’s one thing this year has proven, it’s that humans are resilient. Even in a year like this one — where we’ve had so much thrown at us, collectively, for a seemingly endless period of time with no clear end in sight — you only need to look around you, or even within you, to see that there are still good things that sustain us and keep us strong.
The world “shutting down” was, in a way, an opportunity. Staying home not only meant more time for family, but more time for meaningful one-on-one interaction with our families. We were compelled to find things to do right at home, whether that was baking bread, riding bikes more, taking up gardening, having a competitive video game-a-thon, or a lazy day streaming shows.
Professionally, as more of us worked from home, that work/life balance blended together as we learned more about our clients as their cats strolled in front of their webcam or their kids interrupted a meeting with a request to help them tie a shoe. We learned to be more human and kind to each other, and to reach out to each other if we could sense — even through a video call, if someone’s body language or tone was off — that someone needed us to ask how they were really holding up.
In all the apocalyptic movies and novels, it’s usually an outside invader — zombies or aliens or enemy troops — who force humans to bond together to find their commonality and humanity. But this year, it was an invisible enemy — a microscopic virus — that stopped the world in its tracks and made us all rediscover the critical importance of connections.
On a personal level, my eldest daughter is home and we have bonded and hiked about 50 miles together in the last few months. On a professional level, I have to say I have seen more of my colleagues on any given day via Zoom than I did in the office, which is surprising. I also don’t have to commute a couple of hours a day, which has been nice.
VP, Solution Expert
I’ve worked from home on a permanent basis for the last 10 years or so. When the UK went into lockdown earlier in the year not much changed for me from a work perspective, other than the cessation of international travel for conferences and client meetings. The biggest change came when the schools closed, and my young children were forced into home schooling. It was great to see how well they coped with such an unprecedented situation, as well as to have a stronger connection to their schooling and deeper insight into their school lives. It was also heartening to see the sense of community that developed throughout lockdown and the acts of pure selflessness instigated to help those in difficult situations, often by those that were dealing with their own challenges.
From a professional perspective, clearly onsite monitoring has been tremendously impacted by the inability to physically visit sites. Sponsors have increased their reliance on centralized monitoring and techniques to ensure data integrity and quality that don’t require placing people at a site. In this respect, COVID-19 has accelerated a movement within the industry that became important with the release of ICH E6 (R2) and has helped to drive change away from inefficient, legacy practices. It’s also heartening to hear organizations commit to adopting these data-driven approaches as their permanent operating practices, with no intent to revert back in the future.
Chief Commercial Officer
COVID-19 has changed our current view of how care is delivered, received, and influenced and will affect the view in the future. Technology and healthcare had been accelerating toward a convergence before COVID-19, but the pandemic has expedited this combination for HCPs, patients, and companies. HCPs have embraced technology during this time, seeing and treating patients in a safe and effective way. Additionally, the adoption of telehealth has exploded in 2020. This is captured in patient surveys, which shows patients embracing delivery of care, with 83% expected to continue to use telemedicine, according to Medical Economics Research.
Lastly, the traditional marketing mix and tactics need to be reexamined in this new treatment environment. Marketers need to be nimble and targeted in their messaging, delivering the right message to the right customer. This all adds up to assisting how HCPs deliver the right therapy to the right patient. This challenge isn’t negligible or easy, so deep customer insights and market knowledge are paramount.
Co-Founder and CEO Vineti
The forced decentralization of managing through COVID-19 has allowed for far more adoption of telehealth and other remote-monitoring tools in clinical trials and in patient management, more broadly. While some procedures and their management will always require in-person clinical care, the opportunities to drive efficiencies and to build “ownership” among patients in their outcomes with greater participation via technology is overall a very positive trend that came about because of the force of tragedy — and will continue when COVID-19 has finally released its grip.
President, Regulatory and Commercial Sciences
One personal silver lining is that I am no longer traveling on a weekly basis, although there may be weeks when my teenage boys wish I could hit the road again. But this is a faint silver lining on a dark cloud when we consider the number of families around the world adversely impacted by COVID-19, either directly through ill health or indirectly via economic displacement. On a professional note, 2020 has taught us that we can operate successfully with a dispersed global workforce. My colleagues have been amazing in their ability to adapt and perform, even during peak periods of the pandemic. My respect for them has soared even higher this year. I can’t wait to interact with clients and colleagues in person again, when it is safe to do so in 2021.
Chief Innovation Leader
LevLane Life Sciences
Our employees are “family.” This has always been our thought process and how we have rolled for more than 35 years. So when the pandemic hit, we needed to move quickly to give comfort to our LevLane family as well as their own families. We needed to provide calm in the wake of a storm.
We actually got ahead of the curve as the COVID-19 pandemic was growing back in January/February. We moved quickly to prepare for all of our folks to work virtually in early March and got 100% of our agency resources fully “certified” working in the Microsoft Teams environment. We had tutorial working sessions and reference documents prepared in advance of the working environment change. By the time we moved to a virtual environment, we were prepared for all internal and external communications using Teams. We even enabled our clients and other partners to communicate with us through the Teams environment. Our IT folks were instrumentally involved and worked seamlessly throughout the process.
While not perfect, we have not missed a beat; internal staff meetings take place, deliverable dates are met, new business happens, staff town halls occur, and folks are engaged with each other. And we recognize that our LevLane family has to take care of their individual families, with kids, with parents, or with both. We get it. We understand their needs and the sacrifices they need to make. We stand by our ‘who loves ya’ proposition.
Although it is small consolation, the COVID-19 crisis has forced healthcare organizations and clinical researchers to relook at what can be done remotely.
Telemedicine has grown dramatically, and the use of decentralized trials and similar technologies has been greatly accelerated. Change that would normally have taken years was accomplished in weeks. Much of this change has the potential to provide great long-term benefits for providers, researchers, and patients. Some of it, perhaps even most, was put on as a band-aid to get through the current crisis, but at least it proved that such change was possible. We hope that the increased adoption of telemedicine will stick so that we will all be better off in the long run.
President and CEO, Avania
We work in an innovative, fast-moving, global industry. When the pandemic started, I could no longer do what I have always done — the way I had and for the reasons I thought I had to — and I got a chance to reevaluate the what, why, and how questions. Some things, on reflection, are being done right and I’ve recommitted to them. Other things might be done best by following a new approach, and I’m working on those, too. The silver lining of the pandemic, for me, has been not just having the chance to — but being forced to — examine much in my personal and professional life I had taken for granted.
Michelle Longmire, Ph.D.
CEO and Co-founder
When COVID-19 hit, my instincts as a practicing physician kicked in first. How can we help patients get treatment? How can we help pharma and biotech companies get therapies and vaccines to market quickly and safely? And how can we help them ensure progress with other in-flight clinical research now that everyone is mandated to stay at home?
As an entrepreneur, I am used to moving fast, but suddenly, everything became urgent. My company Medable enables biopharma companies to manage clinical trials in a decentralized way using digital technology. In other words, patients can participate in trials without being tied to clinical sites. They can manage most of the process remotely, from home, and use technology to stay engaged with doctors and clinical researchers. What we do as a business immediately became mission critical. We gathered the team and went into crisis mode, ensuring that at-risk trials were supported, teams were trained, patients were enabled and provisioned for remote access. We worked night and day, together with our partners, doing remote training from our own living rooms with doctors and clinicians worldwide. Before COVID, this type of patient-centric research was an essential future state. With the pandemic, direct-to-patient research immediately shifted from edge case to the main case.
We are already seeing the impact of remote and decentralized clinical trials. For instance, we partnered with the largest site network in the world to enable them to go from in-person recruitment and screening to remote and decentralized. This led to a threefold increase in study enrollment compared with the site network’s longstanding site-based methodology. In other areas of the clinical trial process, we are seeing similar improvements in patient access, compliance, and retention.
COVID-19 showcased what I already knew about our technology and our team – this is no longer a future state. It is vital and valuable today. I’m proud of what we’ve accomplished in the last six months, together with our valued customers and partners. Decentralized trials are an essential shift that will reduce clinical trial timelines — and the reaction to COVID has accelerated that market adoption by five years.
VP, Chief Strategy
and Marketing Officer
The devastation of the pandemic, compounded by other social issues, has made 2020 a time for transformation in many regards. In the realm of clinical trials, we’ve been talking about patient-centricity for quite some time. However, it’s only with the demands of the pandemic thrust upon us that we made a significant shift in that direction. Due to stay-at-home orders and social distancing mandates, the industry was forced to accelerate its adoption of virtual clinical trial technologies. This enabled the industry to continue and start up important studies but, more importantly, it put in place processes that greatly benefit the human participants.
There is some bias involved in traditional, site-based clinical trials, in that recruitment is restricted to a certain radius from the physical research site patients must visit on a regular basis. With technology-enabled virtual visits and data collection, geographical constraints are eliminated, opening up participation to more diverse populations and would-be participants who have travel-related challenges.
Many steps in the clinical trial process can be conducted from the comfort of participants’ homes, starting with recruitment and consent. Medications and equipment can be shipped directly to patients with associated training and education conducted via video conference or phone. Participants can complete online questionnaires from anywhere they have internet access, either themselves or with the help of a staff member. And, where appropriate, assessments that require a clinician can be conducted via video communication.
The silver lining of COVID-19 is that it has forced more human-centric trials. There is some irony here as it comes with fewer in-person interactions, but between the demands of the pandemic, the consumer technologies we all have in our homes, and advanced clinical technologies, we are finally more engaged in the patient experience.
President and Cofounder
COVID-19 has accelerated a trend toward telemedicine and virtual, decentralized clinical trials that was already under way before the outbreak began. The pandemic has made it more difficult to conduct trials that are dependent on traditional visits to brick-and-mortar sites. As the Lancet reported in August, about 80% of non-COVID-19 trials had to be stopped or delayed because of the pandemic. Conference cancellations, supply chain delays, and reallocation of medical staff from research to emergency care for COVID-19 patients have all contributed to the tremendous and widespread disruption.
To keep vital trials going as a result of all this, the industry has had to embrace technology in a way it never did before, quickly learning to integrate both existing and new tools that reduce friction and the burden on patients, clinicians and investigative sites.
While COVID-19 won’t last forever, the new ways our industry is using technology as a result of the pandemic will become more “mainstream.” Patients will demand greater flexibility, such as having the choice between going to clinical trial sites or participating in studies remotely. That doesn’t mean that virtual trials will be the norm everywhere and for all studies, particularly not for serious diseases such as cancers or involving drugs that have high toxicity.
However, what we’ll likely see is more of a mixed approach, a combination of in-person and virtual site visits, as well as home monitoring.
The patient-centric tools, platforms, and integrations enabling this shift will continue to shape the future of clinical research.
The ecosystem traditionally led by operations-focused CROs will soon be led by the innovators behind the next generation of pioneering technologies, as we’ve started to see with eConsent, eCOA, mHealth, and AI-based solutions. The world is changing, and we must adapt and truly embrace this new momentum to make a meaningful difference for patients.
John Potthoff, Ph.D.
COVID-19 has accelerated industry adoption of the innovative processes and solutions that will benefit patients for decades to come. The pandemic has ushered in a true paradigm shift — a meaningful, focused emphasis on patient-centricity. I feel thankful to be working on diagnostics, treatments, and vaccines for COVID-19, helping to bridge the distance between technology, resources, and the patients who need them so urgently.
Executive Managing Director, Head of Global Commercial Advisory Group
“Embrace the suck,” said the ultra-runner. Years later, my research to understand its origins and relevance of the phrase led to Prussian General Carl von Clausewitz’s treatise, which led to the creation of the term “the suck.”
Clausewitz called it, “friction” — “Everything in war is very simple… the simplest thing is difficult… difficulties accumulate and end by producing a kind of friction that is inconceivable unless one has experienced war.” In contemporary military jargon, I understand “embrace the suck” to mean — having the discipline and the mental fortitude to see the hard work through to the end. You continue moving forward and never give up. The COVID-19 experience makes us “embrace the suck” every day.
I am very proud of how, each day, my team demonstrates resiliency by adapting to the new normal. Be it the heightened level of connection with our colleagues and clients, the use of technology platforms to make our engagements more interactive and focused, or by being more vulnerable by bringing a more “human” approach to our engagements. In some ways, the pandemic has made us more understanding and allowed us to pay more attention to others’ well-being.
The first three months of the pandemic were particularly challenging. One example of how we got through the period was the curation of the “Remotely Funny Tip of the Day,” a collaborative effort by many of our leadership team members to create a simple self-deprecating humorous video, with supporting fun-facts/links about the COVID experience. This became an instant hit, kept our team engaged, and in fact went viral across the organization. It also brought a much-needed daily distraction during a very uncertain period.
There is so much good that we have experienced during this shared experience. I hope much of our positive behavior change becomes the status quo.
A silver lining of this tragic mess we’ve experienced this year is how the industry and the world’s research landscape have taken down many of the walls they maintain around their data to enable the potential of artificial intelligence for repurposed medicines like IL-6 inhibitors to save the lives of thousands of people who end up in the ICU.
In April, we saw how fast government policies can be updated in an emergency. Driven largely by nonprofit organizations and industry companies working together, new guidelines to increase access and reimbursement for telehealth were published in hours — not weeks or months.
These events showed us we know how to change the rules of the game and respond to patients’ needs with urgency when their lives are on the line. It’s up to us to now ensure we don’t forget that millions of lives are always on the line, and that patients always need to come first.