Business Continuity Planning: Ensure Your Life Science Organization is Prepared for a Crisis

10 Minute Read

 

Disasters can strike at any time, and no organization is immune to disruption. For life science organizations, a robust business continuity plan (BCP) is essential to safeguard assets, protect scientific progress, and minimize financial and operational damage should a disaster or disruption hit. The Business Continuity Institute’s Horizon Scan Report¹ states that some of the greatest threats include:

• Cyber-attacks, data breaches, or financial fraud
• IT and telecom outages
• Economic conditions and their impact on financial stability
• Supply chain disruption
• Adverse weather or natural disasters
• Critical infrastructure failure, such as power disruptions
• Reputation incident, such as product-quality problems or recalls
• Staff shortages and regulatory changes

While all institutions are at risk, life science facilities face unique challenges. With millions invested in specialized equipment, research animals and materials, and carefully controlled environments, even brief disruptions such as a power outage or flood, can result in catastrophic loss of samples and critical data. Life science organizations must have an effective business continuity plan that protects assets and minimizes disruption and potential financial loss.

What is Business Continuity Planning and Why it’s Essential

Business continuity planning is an organization-wide strategy that ensures critical operations can continue during and after an unexpected disaster or disruption. A documented framework, the BCP identifies essential functions, assesses risks, and outlines step-by-step recovery procedures—protecting people, assets, data, and compliance obligations. Business continuity plans are broader in scope than OSHA-mandated Emergency Action Plans. BCPs focus on an integrated or “all hazards” approach and use flexible planning to address any type of emergency, rather than specific planning for each individual threat. A business continuity plan focuses on critical capacities such as communication, training, incident response, and recovery, making the organization better prepared for a wide range of potential disasters.

Life sciences organizations undergo audits and, more frequently, these audits include a review of the BCP or evidence of BCP implementation. Agencies that conduct these audits include: The Food and Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), the European Medicines Agency (EMA), third-party auditors for Good Manufacturing Practices (GMP) or International Organization for Standardization (ISO), insurance organizations, customers and collaborators.

Life Science Environments Present Unique Challenges

Few environments test resiliency planning like research and commercial laboratories. These facilities often house large, specialized equipment such as bioreactors, robotic or automated filling systems, vivariums, or spaces requiring continuous environmental control and monitoring. It is impractical—or impossible—to move operations to an alternate site during a prolonged disaster. Laboratories with regulatory licenses or accreditations may also be legally required to operate only in the licensed facility, making rapid restoration the top priority.

Specialized equipment may depend on vendor-specific consumables, and certain reagents or rare products may have long lead times or a single supplier. Qualifying backup vendors and off-site warehousing can offset these risks. Preserving temperature-sensitive materials is another priority, as power disruptions are common and emergency generators may not suffice in large-scale or extended outages. Banking or relocating critical biological materials to a cold storage biorepository can assure these assets are protected and can be readily retrieved once operations are restored.

Staffing critical functions may require specialized skills and certifications. These roles cannot be easily filled during shortages caused by epidemics, weather events, or transportation disruptions. Organizations can mitigate these risks through cross-training programs or by temporarily relocating qualified staff to alternate sites within the organization, with logistical plans for transportation and lodging.

Finally, laboratory-centered organizations require complex information technology services and support including systems to ensure data security, availability, processing integrity, confidentiality and privacy. Management systems should be developed to provide data backup, cloud storage, virtual desktop infrastructure and redundancies for internet access and other vital system components.

Key Steps in Business Continuity Planning

Risk Assessment and Business Impact Analysis

The first step, and foundation, to a comprehensive BCP is to conduct a risk assessment and business impact analysis. This involves identifying the types of threats that may impact the organization, such as hurricanes, cyber-attacks, supply-chain disruptions, and estimating the probability of an occurrence and the severity of the impact. It will help to prioritize resources and develop strategies for preventing serious incidents that could compromise the facility and its operations, as well as develop mitigation measures to minimize the consequences and severity of unpreventable incidents.

Questions a life science organization must address include:

• What are our critical functions and operations?
• What are our essential assets? For example, transgenic animals, recombinant cell lines, primary tissue, genetically engineered vectors, compound libraries, scientific and/or clinical data.
• Who are the key personnel and vendors?
• Where are our vulnerabilities? This could include single-source suppliers, facility location in a flood zone, or undersized emergency generator, etc.
• What resources are needed for recovery? For example, staff, supplies, equipment, facility, utility systems, technology, finances and vital records.

Next, estimate the consequences or impact resulting from recovery delays such as loss of revenue, customers, company reputation, products or investments. Develop and implement prevention and mitigation measures to offset the vulnerabilities.

Involve Key Stakeholders

Important to a successful BCP is including all relevant stakeholders in the planning process and in developing the written BCP. This helps ensure that all research, development, manufacturing and essential administrative support operations are considered.

BCP Recovery Objectives, Strategies, Tasks and Timeframes

Once the risk assessment and business impact analysis are complete, you can establish and prioritize response and recovery objectives, strategies, tasks and timeframes. This may include relocating critical biological materials to a temperature-controlled biorepository, temporarily using a reference laboratory, relocating some operations to an academic core facility, switching production to another company site or to contract research and contract manufacturing organizations (CROs/CMOs), using back-up vendors or having staff work remotely.

In some situations, it may not be possible, or safe, for staff to enter the facility. There may also be circumstances where staff may be unable or unwilling to come to the work site, such as employees who were injured, emotionally affected by the disaster, or need to care for family members. If it is possible for staff to work remotely or at temporary alternate locations, it is important to ensure that technology support is available such as VPN access or remote logon capabilities.

Communications

An essential component of a BCP is specific procedures for internal and external communications. Employees must be notified of the emergency and instructed whether to come to work or stay home. These notifications can be accomplished using mass-electronic notification software systems, telephone call trees, group texts and other media platforms. Keeping employees well informed regarding situation developments and providing instructions and expectations is essential to maintain a calm and organized response to disruptions.

Communication with external organizations such as fire departments, police, public health and emergency response units is necessary to obtain critical information regarding the emergency and request assistance. Other stakeholders may need to be notified, such as regulatory agencies, vendors, collaborators, and customers. It is advisable to prepare pre-scripted information bulletins, press releases or communication templates in advance and obtain internal approvals with your organization’s legal and public relations departments. Communication within your organization and with external stakeholders is critical to maintain confidence in the organization and to preserve the company’s reputation.

Document and Organize

Many laboratories depend on specialized equipment and supplies. It is important to develop and maintain lists of equipment, supplies, and vendors so the information is readily available during a crisis. Work out specific steps and procedures such as when to activate the BCP, who will conduct the tasks and in what order; and when to return to normal operations. A recovery checklist is a useful tool to ensure that all systems are re-established and calibrated.

A Response and Recovery Management System

Determine in advance of an incident, the roles and responsibilities for those who will participate in the continuity and recovery processes and how the activities will be organized. An example is the Federal Emergency Management Agency (FEMA) National Incident Management System (NIMS) Incident Command (ICS) – a nationally recognized framework used to designate responsibilities and reporting relationships during a crisis. Adoption of such a system can ensure an organized and efficient response and recovery.

Education, Training and Testing of the Plan

Employees involved in the BCP program should receive education and training to implement, support and maintain the program relative to their level of involvement. BCPs are not complete until you can demonstrate that they work. A critical part of the process is conducting tabletop exercises, which are discussion-based simulations to test the BCP.

Stakeholders walk through a hypothetical disruption scenario to confirm strategies, identify gaps, and ensure everyone understands their roles before a real incident occurs. In these sessions, a facilitator presents a realistic scenario, such as a cyberattack, power outage, or supply chain failure, and participants discuss their step-by-step responses using the BCP. These rehearsals help validate compliance, expose weaknesses, and fine-tune recovery strategies so responses are swift and effective when disruptions occur.

All exercises should end with a debrief meeting to discuss strengths and weaknesses in BCP implementation, including gaps in the plan. This should be followed by an update or modification to the BCP based on the findings of the exercises.

Program Maintenance and Process Improvement

The BCP should be reviewed by all relevant stakeholders and updated at least annually to keep pace with the growth and evolution of your organization and the continually changing threat environment. For example, emergency call lists must be updated as personnel responsibilities change in the organization. Drivers to update or modify your BCP include changes to any of the following conditions:

• Regulations
• Hazards and potential impacts
• Resource availability, including critical vendors and suppliers
• Your organization (relocation, merger, expansion) or its operations
• Funding
• Infrastructure, including the technology environment
• Economic and geographic stability
• Personnel

Turning a Crisis into an Opportunity

Every crisis presents an opportunity to review the BCP’s effectiveness and determine if modifications are necessary. Once the crisis has passed, the Crisis Management Team (usually comprised of key leadership position holders within an organization) should convene to assess its performance and identify ways the institution’s response could be improved. For example, did the planned measures appropriately address the situation and help alleviate disruption to operations? Did personnel understand their role in implementing the measures? Is additional training needed?

Process documentation is key to evaluating the response post-incident, including a narrative of events, emergency response actions, communication efforts, receipts for costs, etc. This documentation should be maintained by an appropriate member of senior management.

Building Resilience

No institution is immune to the losses a crisis can bring. Life science organizations must take precautions to protect their operations, workers and assets, many of which are unique and irreplaceable. A BCP is not a one-time effort—it must be regularly reviewed and tested to remain effective in an evolving laboratory environment.

Because every plan must be tailored to the organization, BCP development is an investment in resources, not a template exercise. A well-implemented program builds resilience and enables a smoother, faster response to—and recovery from—disruptions.

Effective business continuity planning is a crucial investment. EH&E provides comprehensive services, from development and review to tabletop exercises, to help you protect your organization. Contact us today!

Reference:

1. The Business Continuity Institute. BCI Horizon Scan Report. Published November 13, 2024. Accessed: August 22, 2025. https://www.thebci.org/news/what-lies-ahead-for-the-resilience-industry-in-2025-and-beyond.html#:~:text=Cyber%2Dattacks%20and%20severe%20weather,threats%20posed%20by%20extreme%20weather.

---

---