Year: 2015-16

Company: Gilead Sciences

Liaison(s): Chris Makely Jemelle Dizon-Maspat

Gilead Sciences, Inc. is a biopharmaceutical company
that discovers, develops and commercializes innovative
therapeutics for life-threatening diseases. Gilead was
founded in 1987, with operations in more than 30
countries worldwide, and is currently headquartered in
Foster City, California. Gilead’s portfolio and pipeline
includes treatments for HIV/AIDS, liver diseases,
hematology/oncology, cardiovascular, and respiratory
conditions. Its blockbuster hepatitis C drugs, Sovaldi®
and Harvoni® earned a combined record sales of
greater than $20 billion in 2014.
Maximizing production capacity while maintaining
agility and remaining compliant in a highly regulated
environment are major challenges for the commercial
manufacture of biopharmaceuticals. In a rapidly
changing environment, the need for CMC efficiency is
vital. Companies must incorporate new technologies
and novel processes to cut time and costs. This shifts
the balance between building and relying on traditional
in-house production versus streamlining capacity
management through new partnerships with state of
the art contract manufacturing organizations (CMOs).
The purpose of the Gilead Team Master’s Project
was to assess and evaluate the global CMO biologics
landscape. The intent was to identify and recommend
a mid-scale platform manufacturing process that could
give Gilead Sciences the flexibility and confidence
in scaling commercial processes with broad options
in selecting CMOs. The team identified established
and emerging CMOs of interest. In each case the
team performed a detailed evaluation of the CMO’s
technical capabilities, quality track record, regulatory
experience, and financial stability. Comparative
analysis of the data was performed quantitatively
using a pairwise decision-making tool. This approach
allowed the team to objectively rank each CMO based
on its alignment with Gilead’s current and future
manufacturing needs. The results of the work were
disseminated to Gilead management through regular
meetings, formal presentations and a final report which
included the team’s recommendations.