Resilient Systems: Where Life Sciences and Homeland Security Intersect

“How an institution responds to a variety of crises…is one of the most challenging and consequential aspects of leadership.  Understanding what a crisis is, when you are in it, and what skills are needed to manage through it is an essential skill for government and private sector leaders.  To understand crisis response takes more than skills in communication, leadership or incident command; though necessary, it also takes an understanding of the complex political, regulatory, international, ethical, and legal regimes that govern the incident and the skills to manage these different and sometimes conflicting concerns… This course will provide to all students a deeper understanding not merely of the mechanics of crisis response but how the law, politics, and policy empower and hinder our capability to respond.”

This is the course description for “Mitigating and Managing a Crisis”, a class offered during my final semester of obtaining a Master of Public Health at the Harvard TH Chan School of Public Health.  I was looking for something different from my typical purview of hospital management, payment systems, and healthcare innovation – a foray into the world of crisis management seemed like a fun twist to add to my transcript.  Better yet, the instructor, Juliette Kayyem, was an author, mother, entrepreneur, CNN analyst, and former Secretary for Intergovernmental Affairs in the Department of Homeland Security for the Obama Administration.  Neat!  It was January of 2019 when I hit “enroll” on my registration portal – little did I know that 12 months later, humanity would be gripped by a global pandemic, and industries across the planet would be frantically reworking operations and activating incident command units to adapt to a profoundly challenging new environment.

Professor Kayyem’s class was fantastic, and the best academic diversion I’ve taken – her expertise was as humbling as her expectations were high.  When I turned in my final exam for Professor Kayyem’s class, I’d also just accepted a job as a management consultant in the life science industry with Halloran Consulting Group.  In that moment, I could have never predicted that one year later I’d be sifting through my notes from class in search of frameworks and guidance to help Halloran’s clients persist through the COVID-19 crisis that humanity is working to mitigate.  Turns out there’s much about how the Department of Homeland Security approaches managing attacks, hurricanes, oil spills, and cyber threats that can be applied to how clinical operations manages drug and device development both on an organization-level and on a trial-level; especially when it comes to building resilient systems.

Resilience is “the capacity of social, economic, and environmental systems to cope with a hazardous event or trend, disturbance, response, or re-organization”.  Systems are the processes, procedures, expectations, and norms that, when integrated effectively, keep an organization humming.  Based on her pivotal role managing the H1N1 pandemic and the BP Oil Spill, as well as her experience with the National Commission on Terrorism (among her many other formative career highlights), Professor Kayyem highlighted Five Key Elements to Building Resilient Systems, which I see as directly translatable into the life science industry.

1. Redundancies: Identify your system’s “points of failure” and determine how you can protect them or back them up.
2. Flexibility: Design flexibility into background systems to facilitate quick response and deep recovery.
3. Fail-safe: Assume there will be another disaster and build processes with an eye toward minimizing the harm of the response and stopping cascading losses.
4. Ability to rapidly rebound: Develop systems that can help you return to regular operations as quickly as possible after downtime or interruption.
5. Commitment to learning: Assume there will be another disaster, learn in real time, and have the discipline to iterate on the rebuilding process to continue to improve response.

Infectious disease and epidemiological insights indicate the unfortunate reality that the novel coronavirus will continue to challenge the life science industry for the foreseeable future.  Thus, our call to action is to build resilience into our processes, systems, and infrastructure to enable our response to inevitable “spikes” in case load.  It’s only once we design this agility into the fabric of our organizations that we’ll be able to continue doing the work of developing life-saving therapies for patients in need.  The table below translates the 5 Elements of Resilient Systems from a Homeland Security context to a life science company context.

Elements of Resilient Systems
Life Science Organization-Level Applications vs. Clinical Trial-Level Applications

1. RedundanciesLife Science Org:

• Ensure adequate staffing and resources to support duplicative or “shift” style work. Engage with an external source to bring interim management in as backup. Define and document roles for clarity in an unexpected transition.
• Invest in / maintain systems and tools to support remote or alternative work. Liberally “centralize technology” in terms of files, project documentation, and status updates to ensure cross-coverage is possible with little notice.Clinical Trial:
• Include diverse geography of sites and vendors in case of geographical limitations on trial activities, patient mobility, site activity, etc.
• Hire and train personnel to be able to support across multiple areas beyond their sole responsibility on the trial in case certain studies or roles are incapacitated by a crisis event. Document/record the training to avoid the need to recreate/repeat it in a crisis.
• Perform a thorough risk assessment to identify, mitigate, and control for potential key points of failure.

2. FlexibilityLife Science Org:

• Invest in remote work technology and systems and develop associated agile policies and procedures. Ensure access to data and files so they reside internally.
• Build flexibility into the corporate budget to adjust for unanticipated risks.
• Develop a flexible vendor management and oversight plan with feasible alternatives for when “Plan A” is not an option.Clinical Trial:
• Design a protocol with some flexible options for remote and alternative treatment windows, sites, etc.
• Engage local clinics and partners to make decentralized visits feasible.
• Choose endpoints that can provide meaningful data in abnormal circumstances, and ideally be collected either on-site or remotely.
• Design data collection procedures to allow data collection in various remote / onsite / combination settings and allow secure database access to various stakeholders.
• Consider a dosing regimen that can withstand wider treatment windows and a more variable schedule.
• Ensure trial-related activities can be executed remotely without compromising data integrity or patient safety.
• Collaborate with vendors / partners to optimize flexibility and get an understanding of existing solutions.
• Implement risk-based monitoring to optimize budget flexibility and to facilitate more flexible data analysis approaches.

3. Fail-safeLife Science Org:

• Invest in and maintain cloud-based technology that can be securely accessed when conventional systems would normally be threatened.
• Build a resourcing plan that will ensure enough quick-to-identify resources should a crisis impact the organization.
• Build stop-gaps into the organization’s budget in the form of accurate, crisis-specific cost options for flexible on-demand resources.  This could include external interim senior level development resources who are available on short notice and can engaged with a small retainer.Clinical Trial:

• Utilize a diverse variety of sites to minimize chances that one crisis could impact all sites in a trial.
• Pressure-test the study design to enable the right agile virtual solutions.
• Build in data analytics and strategies to ensure data visibility, control, and integrity even when disaster strikes.
• Ensure data collection methods can endure crisis-related threats to normal systems.
• Build crisis-specific stop-gaps into the study-specific budget.
• Consider direct-to-patient shipping of clinical trial material.
• Implement risk-based monitoring.

4. Ability to rapidly reboundLife Science Org:

• Create a business continuity plan to leverage after the crisis hits and recovery can begin.
• Maintain standard procedures with the right balance of detail and flexibility for business interruption so that they’re up to date when crisis strikes.
• Build in and maintain organizational governance structure to plan for crisis and practice response.
• Identify and build training for flexible resources who can be trusted to take the lead during crisis.Clinical Trial:
• Train all trial staff and vendors on crisis and business continuity procedures and plans so they can act quickly when necessary.
• Engage in regular practice executing the disaster plan so that it’s familiar and relevant if crisis strikes.
• Be flexible and encourage innovation among trial staff.
• Maintain active communication with investigators and site personnel.

5. Commitment to learningLife Science Org:

• Ensure the Executive Level and C-Suite understand the importance of building resilience and quality into regular organizational culture and operations.
• Commit to improving and iterating on crisis management planning even outside times of actively managing a disaster.
• Resources to do the workClinical Trial:

• Ensure staff is open to continued learning and improvement.
• Emphasize reflection and iteration.
• Include all levels and roles in crisis planning.
• Focus on training study teams, site staff, vendors, and patients on new virtual options.

Furthermore, what makes the life science industry unique is the monumental importance of empathy.  Our “customers” are patients managing illnesses or conditions that are, or could ultimately be life-threatening, which has brought patient-centric care to the forefront of clinical operations.  Industry has faced challenges incorporating the patient perspective into our decision-making process, but our environment during the pandemic has demanded an even more heightened sensitivity to patient needs and experiences.  I’m hopeful that an up-side to COVID-19 will be the ability to truly join the mechanics of business process with the humanity of empathic understanding.  For that reason, I’ve added empathy as a 6th pillar to Professor Kayyem’s Elements of Resilient Systems.

6. EmpathyLife Science Org:

• Commit to patient-centric solutions by listening to patients and bringing their voices to the forefront of all disaster planning conversations.
• Commit to proactive dialogue with investigative site personnel as they can provide more relevant context around site and patient challenges/barriers.Clinical Trial:

• Be constantly present and listening to patient and site perspectives; bring patient concerns and feedback back to relevant stakeholders to further develop and document patient-centric concepts should they be required to secure virtualization.

One of the most valuable lessons that’s come out of the COVID-19 era is the importance of recognizing that seemingly unrelated disciplines can be united by crisis.  We can choose to see this as a sad reality, or we can choose to be inspired by the innovation and collaboration that the pandemic environment has fostered.  Translating the Key Elements of Resilient Systems from a Homeland Security context to the life sciences highlights the importance of identifying opportunities to look outside our own industry for innovative solutions to challenges we sometimes mistakenly view as uniquely ours.  Let’s just say I’m glad I paid attention in class.