Year: 2021-22

Company: Gilead

Liaison(s): Kathleen Lingo, Tina Torabi, Lane Yunghans

Gilead Sciences is a biopharmaceutical company that discovers, develops, and delivers medicines for life-threatening diseases mainly in immunology, cardiovascular, metabolic, and oncology therapeutic areas. Through bold and transformative science, the company is driving innovation that has the potential to become the next generation of life-changing medicines. This dedication to addressing the complexity of an ever-evolving drug landscape is evident in its Vision, Mission, and Core Values.

Gilead Oceanside is currently seeking to explore the use of Electronic Batch Records (EBRs) in a clinical GMP setting that enables increase flexibility, speed and compliance in a multi-product manufacturing environment.

By sponsoring this TMP, Gilead Oceanside hopes to leverage the expertise and research acumen of the KGI team to help identify an EBR software candidate that will provide the necessary platform to mimic its existing paper batch records, provide flexibility of use for all batch record stakeholders, and in real-time, generate an electronic report of batch records. By doing so, management seeks to accelerate the time required to review batches, identify non-conformities, and speed up approval time in a clinical setting while strictly adhering to safety and compliance regulations. In order to address this challenge, the project scope of the KGI team encompasses delivery of the following:

• Recommendation of vendor/software
• Surveys of internal stakeholders, vendors, and industry peers
• Comparison of paper Vs EBR vs hybrid
• Prioritization of user requirement specifications
• Recommendation with evaluation framework (what criteria to use to evaluate software choices)
• Project Report & Presentation