Pinnacle helps a major Vaccine Company get ready for an Integrated Baseline Review
Our Biotech client, the prime contractor for a $400 million military vaccine development program for the Department of Defense called upon Pinnacle to assist with getting program baselines in place and preparing for Integrated Baseline Reviews. The programs were for 7 vaccine development efforts.
Pinnacle worked with the Biotech clients’ Product Development Teams comprised of the Senior Scientist, Product Manager, Control Account Manager and other key individuals in crucial roles including regulatory affairs, facilities, quality control, contracts to focus on preparing the needed program documentation. Within the time agreed, Pinnacle made sure that all of the needed program documentation was prepared, this included:
- Statement of Scope and Deliverables
- Technical Approach
- Organization of Resources
- Work Breakdown Structure and Dictionary
- Integrated Master Plan (IMP)
- Integrated Master Schedule(IMS)
- Program Budget
- Quantified Risk Assessment that included a Risk Budget
- Management Controls (to meet cost, performance, and schedule requirements throughout the contract)
The purpose of the Biotech clients’ contract was to develop licensed vaccines and other medical biological defense products to protect U.S. Forces against biological warfare agents. The client served as the prime systems contractor, creating and executing an integrated approach leading to Food and Drug Administration (FDA) licensure and long-term production and stockpiling of each vaccine (life-cycle management to the point of product release to the DoD distribution chain).
Subsequent to the creation of these Program Baselines, The Biotech client established and maintained an Earned Value Management System (EVMS) to combine elements of cost, schedule, and technical performance into an information management system. This system was successfully validated by the DCMA.
The software components of the EVMS were:
- Microsoft Project for project planning and scheduling
- MPM (now Deltek MPM) for Earned Value data management
- wInsight (now Deltek wInsight) for EVM data analysis and reporting
The Pinnacle team worked with the Biotech client team to implement, configure and integrate these tools with the newly developed processes. We provided customized training that was tailored to the Biotech client processes, roles, tools and deliverables.
The Biotech client managed product development programs for U.S. government agencies, and provides technical, consulting and project management services to companies in the biotechnology and pharmaceutical industries.
The company's portfolio includes vaccines and therapeutics to protect against emerging infectious diseases, including biological and chemical warfare threat agents and seasonal and pandemic influenza.