Biotechnology and EVMS: What Do You Need to Respond to a BARDA BAA?

With the United States' increasing emphasis on defending our citizens against bioterrorism, the traditionally commercially minded pharmaceutical and biotechnology industries are finding themselves competing in the government arena more and more. Navigating the rules and regulations of government contracting is foreign territory to most companies, and the idea of using Earned Value Management (EVM) to manage their programs typically is one of the least familiar. While defense contractors have been using EVM for years, since the DoD mandates EVM on contracts valued at $20M or over, agencies like the Department of Health and Human Services (HHS) are turning to Earned Value Management Systems (EVMS) to provide them with the same level of program visibility the DoD requires. For pharmaceutical manufacturers and clinical trial companies competing for Federal business, this means structuring and monitoring programs in a whole new way.

One office within HHS, the Biomedical Advanced Research and Development Authority (BARDA), which is charged with dealing with public health emergencies, is driving the need for EVMS. Though BARDA's compliance requirements aren't nearly as rigid as the DoD's (yet), they explicitly ask for the solid program management principles of EVM to plan, manage, and report progress/variances in their RFPs. For drug manufacturers and affiliated industries, new lingo such as "Integrated Master Schedule (IMS)," "Performance Measurement Baseline (PMB)," and "Variance Analysis Report (VAR)" has to enter their vocabulary and become part of their program management plan.

One of the biggest challenges biotechnology companies face is setting a program up for success from the start; that is, integrating EVM techniques during the earliest stages of responding to a BARDA BAA (i.e., Broad Area Announcement) or RFP. Crafting an integrated plan for project management that includes Earned Value, and then following through on that plan, can be complex. Enlisting the services of an experienced EVM professional can save you time, resources, and money. How? By identifying processes and tools you already have in place that will meet EVM requirements and recommending necessary improvements that will make you compliant.

TriVariant is not only adept at EVM, we're experienced at EVMS implementations for the biotechnology industry and have supported BARDA programs for almost 10 years. Our consultants can help you review RFPs, identify the program management areas that point to EVM compliance, and draft the appropriate proposal language. Then, in preparation for and after contract/grant award, we can assist you with the actual EVM implementation, which will set the stage for managing and reporting on program progress in a manner that meets BARDA's expectations.

For help responding to a BARDA BAA, setting up your EVMS to meet the BARDA EVM requirements, or training your staff to manage your BARDA project to meet EVM analysis and reporting requirements, click here. You can also e‑mail us at info@trivariant.com and type "BARDA BAA" in the subject line.