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.