Year: 2014-15

Company: Coherus

Liaison(s): Vince Anicetti John McGinley

Coherus Biosciences, founded in 2010, is a late-stage
biologics company dedicated to providing biosimilar
products in response to urgent patient needs in the
global market. Coherus has a unique “virtual company”
business model in which a small, elite team of
experienced industry veterans leverage collaborations
and partnerships to outsource the majority of manufacturing
and development activities. This model allows
Coherus to best utilize their expert leadership team to
provide cutting-edge analytics, processes, and clinical
and regulatory guidance to move clinical candidates
rapidly through development. Coherus currently boasts
a robust pipeline led by two phase III ready candidates.
With recent expectations of entering the market, Coherus
has foreseen a need to scale its quality management
system (QMS) to sufficiently address compliance
requirements for a commercial company. A QMS can
be defined as a set of interrelated processes to establish
and maintain a state of control, ensure a quality
drug product, and facilitate continuous improvement
throughout the product life cycle. Coherus has identified
three key system needs for its operations. First, it
must remain lean and flexible to support a dynamic
virtual company model. Second, it must sufficiently
be capable of monitoring a number of contract service
providers. Lastly, the system must meet global regulatory
compliance requirements.
The KGI TMP team was tasked with assessing Coherus’
QMS to ensure it meets these needs. The project
was subdivided into to three phases: global compliance
research, QMS gap analysis, and a software market
analysis. Research was completed into industry best
practices, federal listings, and guidance documentation
to identify similarities and differences between regional
QMS compliance requirements, specifically in Japan,
EU, and USA. From this research, the team assessed
the Coherus system using gap analysis to provide
recommendations which would ensure that Coherus’
Standard Operating Procedures (SOPs) are robust and
globally compliant. Lastly, the TMP team evaluated
a number of SOP software platforms and provided
Coherus with a completed analysis which included
recommendations complementary to Coherus’ unique
business and compliance needs.