How Does COVID-19 Change Clinical Pipeline Prioritization?

Gauging The Impact Of COVID-19 For Your Organization

The healthcare industry faces specific hurdles, resulting in reduced physician-patient interactions and lower procedure volume. Pharmaceutical and medical device organizations face several unique barriers as COVID-19 persists, highlighting the potential need to adjust strategic planning for both new and existing products. One of those barriers is the disruption to clinical study timelines, including delayed initiation of new studies and challenges to completing ongoing studies safely and efficiently. Depending on the severity of a delay or obstacles to initiation, certain programs may need to be deprioritized. Corporate leaders, clinical development decision-makers, and new product teams must consider what the new normal may look like and assess their pipelines, adapting their plans accordingly.  

Analyzing COVID-19 Challenges

We see pipeline prioritization as an iterative process that is necessary to maximize growth potential and manage risks for all biopharma and medical device companies. COVID-19 poses several disparate challenges for clinical companies as they adjust estimates for development costs, timing, risk tolerance, and strategic priorities within their pipelines:

• The changes made in response to COVID-19 may have a long-lasting impact: Healthcare provider closures and a rise in telemedicine may foreshadow future patterns. Oral treatments for severe conditions are seeing strong adherence and higher-quantity refills to minimize person-to-person contact. However, we anticipate a slowdown for recently launched products and potential discontinuations for therapies that require regular physician office or hospital visits for administration or dose titrations
• External funding hurdles may emerge: External continued pipeline financing advancement exists, but pre-revenue companies will continue to experience an increased pressure to showcase their unique capabilities in a competitive market. Clinical organizations will need to show that their innovative treatments can attain clinical trial results in a socially-distant era
• Ongoing clinical trial challenges will persist: Both small and large biotech companies are experiencing clinical trial disruptions, as new risks to patient and provider safety have emerged.  These disruptions include trial site closures, increased safety precautions for patients, delayed assessments, and supply shortages. Additionally, Institutional Review Boards may be unable or unwilling to review new protocols or amendments, halting further clinical progress

Pipeline Prioritization During COVID-19

As we continue to monitor the lasting impact of COVID-19, strategy, clinical development, and new product teams must analyze and monitor these hurdles and their effect on business:

• Analyze the magnitude of impact on your unique organization: How these considerations fit together internally and within the competitive landscape is unique to each organization – for larger organizations, incremental timeline extensions and associated costs will be manageable, while small biotech companies may be at risk of missing milestones to generate data to support follow-on fundraising. This analysis provides a foundation to segment your pipeline
• Rethink your timeline and identify potential program tradeoffs: Re-examine your path to launch based on newly emergent clinical development hurdles and their impact on your business. Teams should also assess what program tradeoffs can be made regarding project timelines and costs. Additionally, organizations should consider the extent to which current and planned programs are adaptable to this disrupted environment through remote monitoring, data collection, and investigational drug management
• Revisit Net Present Value (NPV) inputs for development costs and commercial opportunities: The attributes most desirable in a clinical development program under normal circumstances are primarily associated with our lower impact category. Still, changes on the margin may impact overall forecasting of clinical development costs and peak commercial opportunities and must be considered

Kx Advisors Is Here For You

With biopharma expertise and corporate strategy experience, Kx Advisors can guide you through the impacts of the pandemic. Our team of healthcare experts will help you evaluate your pipeline, revise critical timelines, assess tradeoff decisions, and identify new ways to take advantage of new opportunities within the fluid global landscape.

Contact Our Team Today