Year: 2014-15

Company: Gilead Sciences

Liaison(s): Tracy Hsu

Gilead Sciences is a biopharmaceutical company that
researches, develops and markets innovative treatments
for life-threatening diseases. Gilead’s therapeutic
areas of focus include HIV/AIDS, hepatitis, serious
respiratory, cardiovascular, and metabolic conditions,
cancer and inflammation. Since their founding 27
years ago, Gilead Sciences has grown rapidly, with
a portfolio of 19 marketed products and a growing
pipeline of investigational drugs and more than 7,000
employees across six continents.
The administration device of a therapeutic is a critical
aspect in ensuring safety and patient compliance in
addition to ensuring therapeutic efficacy through
controlled dosage delivery. The device selection is
dependent on many input parameters such as dosing
frequency, dosing volume, and cost of goods. A
growing trend in the biologics landscape is the use
of self-administration for delivery of the therapeutic
which allows the patient more flexibility and
convenience. The move towards self-administration
places a stronger emphasis on designing a delivery
system that can be used by the patient and results
in additional inputs to consider such as patient
capabilities and preferences which can impact overall
market success.
This semester the team assessed the current state
of auto-injectors, a group of delivery devices used
in the delivery of biologics therapeutics. The team
established the basic process engineering principles to
identify critical parameters and specifications of drug
delivery devices for high viscosity formulations. The
team identified vendors with auto-injector platforms
available to meet these specifications. The team
then systematically interviewed each vendor using a
risk-based approach and generated a comprehensive
list of recommendations for Gilead. The team also
evaluated patient preferences for a given subset of
disease indications to understand the utility of an
auto-injector as a key delivery device for Gilead’s
current pipeline. In addition, the team analyzed the
auto-injector drug delivery landscape and made
appropriate recommendations to guide Gilead’s drug
device development team on their selection of an autoinjection
device platform for their products.