Program Management at a Biotech Startup
 

"instrumental to planning and preparation"

The client, a clinical-stage gene therapy company, was in the process of submitting their biologics license application (BLA) to the FDA – the last step before being granted permission to sell manufactured drug products.

This BLA is hinged on successfully passing an FDA inspection of the company’s manufacturing facility. A Consulting Consortium Associate was tasked with reviewing the current state of operations and developing a plan to ensure that the manufacturing facility successfully passed through the inspection. To do so, they required an additional project management resource and leveraged another Associate to fill this gap.

Midway through the project, the client underwent a high-profile acquisition drawing additional attention to the outcome of the inspection as a pivotal milestone in getting to the market as quickly as possible.

Approach

The Consulting Consortium team leveraged the software tool Smartsheets to define priorities and implement project plans across the organization, working with the leads from each major workstream and regularly presenting status updates to VP & SVP-level executives. Once project plans had been established, the team managed the program and interfaced on behalf of manufacturing with other facets of the business including clinical and finance teams.

Intent on bringing an additional level of professionalism and strategic planning to the entrepreneurial company, the Consulting Consortium team developed maturity models for each functional area. Defining a 3-year roadmap gave leadership a path out of the current startup modus operandi toward an integrated and automated operation. Furthermore, the Consortium team designed global reporting dashboards for sites across the organization. These dashboards and maturity models provided a newfound level of professionalism and control over the organization, and were presented to the CEO as well as executives from the acquiring organization.

With the combined expertise of Consulting Consortium Associates, the team made a name for themselves as the go-to-team to get things done regardless of the challenge. They were instrumental in the planning and preparation for the company to be successfully granted approval to license life-saving drug products.

 

Results

Project still ongoing, pending FDA approval of groundbreaking drug technology.

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