By Lee Taurman and Jaime E. Hernandez, M.D.
In the year since COVID-19 made landfall in our lives, life sciences companies have pivoted quickly to address what has become the largest global public health crisis of the century. The industry is pouring tremendous energy and resources into this effort. To date, the U.S. Food and Drug Administration (FDA) has reviewed more than 350 trials for potential therapeutics. Here at Syneos Health®, we are supporting more than 80 active COVID-19 research and development (R&D) projects, including vaccines and therapeutics.
While the current environment has defied most attempts to predict what’s next, a few key learnings from a clinical development perspective suggest where we might be headed. It seems clear, for example, that vaccines are unlikely to eliminate the need for therapeutics in the near term. We need multiple therapeutic options across disease severities, and we need them now. Mortality rates (inpatient) and hospitalization rates (outpatient) will continue to be key endpoints of interest. We need far more representation from high-risk groups in clinical trials. Clinical mindsets and practices will vary (by region, institution and among HCPs). Key stakeholders will all demand to “show me” not only safety and efficacy but the real world evidence needed to support potential new products. After COVID stabilizes, the need will grow for long-term safety and efficacy data.
Pivoting fast amidst disruption
From a commercialization perspective, however, the reality for drug and vaccine developers is that no one quite knows where we will be in six months. Events are moving so fast and the need is so urgent that a milestone signaling promise or disappointment for one COVID-19 asset has the potential to alter, in real time, the road map to commercial success for many others.
It can feel a bit like trying to predict where a hurricane is likely to make landfall. For that, you need information on wind currents, water temperatures and data from multiple other air, land and sea-based sources. In the same way, companies in this fast-moving environment require comprehensive, constant surveillance and dynamic insights to facilitate rapid pivots in COVID-19 asset development strategy and execution.
Similar to being on hurricane watch and trying to predict its path, multiple disrupters are likely to influence a COVID-19 asset’s forward trajectory in real time and with immediate implications, including:
- Scientific developments
- Competitive entrants
- Political and socio-economic factors influencing patients (especially given the disruptive impacts of the pandemic itself)
- Regulatory shifts
- Reimbursement trends (government and other payers)
- Broadening treatment spectrums
- Vaccine launches
All of this information will come from many disparate inputs including structured data sources, subject matter expertise, external expert validation and field team insights, to name just a few. Cross-disciplinary experts need to be accessible who can interpret that data, provide perspective and help commercial teams determine what it means for their current strategy and execution plans.
At Syneos Health, we call this capability our Dynamic Control Room—a collaborative insights network to support COVID-19 asset development.
Dynamic Control Room provides unique access to data and cross-functional experts who “read through” the noise, translating insights into actionable guidance for our customers. Regular cross-functional engagement between our lab-to-life Clinical and Commercial teams enables us to read the pulse of market events and guide ongoing refinement of strategic plans and resource optimization decisions.
Navigating the COVID-19 landscape requires new levels of data integration, expert interpretation and shared insights—plus the ability to respond with agility. Contact us to learn more about using Dynamic Control Room to help steer your asset through the rapidly changing COVID-19 product development landscape.
About the Authors
Lee Taurman is Global Head, Commercial Innovation and Solutions at Syneos Health, offering customers of all sizes the broadest and most fully integrated end-to-end commercial capabilities in the industry.
Jaime E. Hernandez, M.D, FACP, FIDSA is Executive Medical Director, Infectious Diseases and Vaccines at Syneos Health and leads the Syneos Health COVID-19 Accelerated Response Team, a cross-functional technical and scientific support team designed to expedite clinical study start up within 30 days.