In early February, TransCelerate had a highly engaging Annual Meeting with FDA colleagues to discuss our 2020 plans and look for promising ways to accelerate and evolve new areas of clinical research. By early March, the entire world—our industry included—went into shock as COVID-19 travelled the globe, hitting humanity in extraordinary ways. 2020 has impacted the world with an unprecedented degree of disruption. We were all, in many ways, unprepared for the challenges that 2020 has brought.
However, the shock was only momentary for the biopharmaceutical industry. As COVID-19 became the most pressing public health issue in recent memory, it forced the ecosystem to rise beyond its comfort zone and catalyze new ways to get medicines to needy patients faster. Our call to action became clearer than ever.
Extraordinary Degree of Collaboration
We saw some truly remarkable collaborations formed during the early months of the pandemic as we banded together to respond to this world health crisis. Sponsors formed a targeted partnership to pool deep expertise and advance scientific technologies to accelerate COVID-19 research. The COVID R&D Alliance was established to identify and accelerate promising candidates across a broad spectrum of therapies and vaccines. Many of TransCelerate’s Member Companies are taking part in this collaboration.
TransCelerate played a crucial role in jumping into action and launched a COVID-19 data sharing module via the secure, cloud-based DataCelerate® platform to enable sharing of patient-level data. The International COVID-19 Data Alliance (ICODA) is using analytic tools from the Bill and Melinda Gates Foundation to give researchers access to global datasets from international clinical trials, along with biomedical and health research in their quest to find a solution to COVID-19.
As for clinical trials themselves, we saw multiple large-scale master protocol trials launched across the globe: RECOVERY, ACTIV, I-SPY COVID, and SOLIDARITY are a few notable ones. For more than a decade, leaders in our industry have advocated for the novelty and efficiency which master protocols offer. As we attempted to study this new coronavirus with little known data, master protocols came into the spotlight quickly, offering accelerated paths to share meaningful data across multiple treatments and reducing the overall burden on patients. Master protocols challenge not only mindsets, but also behavioral changes of all stakeholders involved; we’ve witnessed exceptional progress made on this front in 2020.
Studies have shown that commonly in times of crisis, human nature tends to operate in a risk-averse, siloed manner. Yet we saw the opposite across our ecosystem this past year. Everyone felt the need to rise and reach as the biopharmaceutical industry has perhaps the most important role in navigating humanity out of this pandemic.
TransCelerate–20 Companies Strong
Extraordinary times calls for extraordinary actions by all. TransCelerate, 20 companies strong, acted promptly in our pandemic response. By late March, we mobilized “boots on the ground” operational leaders to share ongoing learning as our members tackled real-time operational trial continuity challenges as they sought to ensure enrolled patients continued to receive their needed treatments, despite the multitudes of disruptions experienced across the globe.
With a fire hose of information flowing and new data surfacing by the minute, TransCelerate jumped into action and collaborated on practical solutions to help with clinical trial continuity within the first few months of the pandemic. In addition to launching the COVID-19-specific DataCelerate® module and expanding access to non-Member Companies, TransCelerate developed and released the following:
- Clinical Study Reports Considerations for Studies Disrupted by the COVID-19 Pandemic was created by clinical scientists, pharmacovigilance experts, data scientists, and other experts to identify the important topics for clinical researchers and research sponsors to consider as they adapt their studies and clinical study reports due to disruptions caused by COVID-19.
- A Protocol Deviations Toolkit to help stakeholders navigate multiple aspects of protocol deviation management. These tools were developed with feedback from Sites, CROs, and Health Authorities.
- The Patient Considerations Guide provides insights on patient perspectives and key considerations for using technology in clinical trials. The guide provides considerations to aid a sponsor’s decision to use technology with patients to help in the current environment if participants cannot make it to investigator sites.
The Role of Leadership in A Crisis
One awe-inspiring reflection throughout this trying year is how I consistently observed leadership being demonstrated all around me. Leadership starts at the top, and this year TransCelerate’s Board of Directors unequivocally advocated for drastic change in not only mindset, but also behavior, as TransCelerate responded to the pandemic as a collective, working with various health authorities and industry groups around the globe. Our Member Company initiative leads showed up as active leaders by staying more united than ever in this collaboration to tackle pandemic-related challenges. A united voice of 20 sponsors is a powerful one, especially in volatile times.
Leadership is called upon in different ways in times like this. I was particularly inspired by a recent discussion with Dr. Thomas Senderovitz (Director General, Danish Medicines Agency), in which we shared candid reflections on how critical leadership is in times of crises to bring people together. We talked about the intricacy of balancing between the need for fast decision making and the need to pause, reflect, and gather diverse input. Dr. Senderovitz and I shared a common belief, that we both firmly believe diverse thinking is the foundation to true innovation. “Actively, genuinely fostering diversity in teams and encouraging different ways of thinking are undeniably one of the most important priorities for any leader,” said Dr. Senderovitz.
Preparing for the Future
At the forefront of everything we do, we aim to improve patients’ experiences and protect patient safety. We have witnessed astounding changes this year as our industry pivoted into new ways of working and we now have a real opportunity to make some of these changes sustainable. How do we design and execute trial operations differently in the future to accommodate the fast-changing landscape around technology advancements, patient privacy needs, and evolving regulatory requirements?
TransCelerate launched the Modernizing Clinical Trial Conduct initiative this year with this in mind. We seek to unite and evolve our processes and mindsets to better prepare our industry for the next disruption. That work has already started, building on the impetus for change we saw this year. We cannot afford to wait for the next pandemic to hit us.
While we are not out of the woods yet, I am hopeful that there are bright days ahead. Science will lead us out of this pandemic. With so many leaders across our ecosystem, banding together and working tirelessly to pool resources and expertise, we are close to beating COVID-19, while pivoting the ways in which we conduct trial research in the future. I am incredibly hopeful for what 2021 will bring.
By Janice Chang, Chief Operating Officer, TransCelerate BioPharma
Janice Chang is the Chief Operating Officer at TransCelerate BioPharma Inc. Janice has been involved with the organization since its inception. In her current position, Janice works closely with the CEO and the Board of Directors to shape the long-term strategic vision and priorities for the organization and its 30+ initiatives. Janice defines and guides TransCelerate’s overall external engagement strategy with global health authorities, governmental agencies, industry groups, and TransCelerate’s country network spanning across 30 countries. She has accountability overseeing TransCelerate’s corporate operations and works closely with her team to drive strategic delivery of TransCelerate’s portfolio.