Ensuring an Open Channel with Regulatory and Medical Policy Opinion Leaders During COVID

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Many companies, particularly new entrants into the U.S. pharma arena, are facing some level of disruption or impact on their projected timelines for seeking FDA licensure, gathering data from trials for filing, conducting health economics analyses needed to demonstrate improved outcomes, or conducting real-world evidence studies that can help inform medical societies’ deliberations on clinical guidance for their health practitioner membership.

Much of the medical and clinical knowledge and expertise—particularly with regards to chronic health conditions, ie, heart disease, diabetes, or lung disease, as well as other risk factors (eg, obesity, sex, age, race and/or lack of access to care/being a member of an underserved population)—is rooted in a pre-pandemic medical/scientific knowledge base.

Consequently, pharma companies’ R&D, licensure, and public affairs’ plans are being affected by emerging clinical experience with COVID-19 infection and are striving to keep pace with the virus’ impact on these conditions, and designs and outcomes of trials, as well as risk factors related to public health. For the rare disease category, this situation can be even more complex to traverse.

And while infectious disease experts, public health officials, and chronic condition specialists and researchers diligently work to incorporate the emerging and rapidly shifting clinical experience associated with this pandemic, it will take time for them to answer the essential PICO* questions designed to help inform intervention strategies. In short, current medical policy and clinical guidelines are rooted in pre-pandemic medical knowledge which must now contend with a highly variable virus.

What does this mean for industry? Pharma companies have an opportunity to improve external relationships with key stakeholders by keeping in lock step with regulators, medical opinion leaders, and medical societies vis-à-vis research programs, data-collection activities and information sharing.

Critical questions to be considered include:

  • How does COVID impact the related health condition? Does the condition have worse health outcomes?
  • How has COVID impacted the off-label use of their product(s)? Is there an opportunity to discuss with regulators the possibility of pursuing new indications as a result?
  • Do R&D and Medical Affairs professionals believe there is a study opportunity either for a new or mature product that could enhance care during this pandemic? Do they need help making the case to senior management and commercial colleagues internally?
  • Have patient and provider behaviors shifted the dynamic of a well-visit and how does that impact the trajectory of the uptake of a drug (for treatment or preventative) in the market?
  • Are medical opinion leaders identifying concerning outcomes and/or non-compliance issues among patients that could offer an opportunity for pharma companies to deepen their engagement with advocacy and medical groups?

Pharma companies would do well to conduct a 360-degree audit of their portfolio, both licensed and pipeline candidates. This could help them to pinpoint opportunities to breathe new life into existing products, reassess pipeline molecules, identify possible future issues, and find ways to advance their offerings to medical professionals and other stakeholders in a given disease category. To accomplish this, many companies are turning to external expert consultants to help them reassess the situation with a ‘clean pair of eyes’—even when it comes to what was perceived (pre-COVID) to be well-trodden terrain with regard to a product’s planned life cycle.

Are you considering landscape analyses, opinion leader mapping, or an internal 360-degree audit to help inform pathways forward during this pandemic?

Please contact us to explore how we may be able to help.

*PICO: P=Patient, Problem or Population; I=Intervention; C=Comparison, Control or Comparator; O=Outcome

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We know there are numerous considerations when it comes to the impact of COVID-19 on clinical trials and what this means for your organization. We are here to help.