KBI Biopharma is a contract development and manufacturing organization (CDMO). They offer a plethora of services for external clients, including cell line, cell therapy development, and clinical and commercial manufacturing. A key step in their manufacturing process includes downstream bioprocessing to purify and obtain final products. The downstream processes are resource intensive and require the use of various buffer solutions.

Previously, KBI imported most of their buffers from vendors. In recent years, they decided to move away from complete reliance on outsourcing, and began in-house buffer production. Currently, 80% of the buffers KBI is utilizing are made on-site. The general process involves utilizing a single-use mixer and transferring completed buffer into plastic drums or stainless steel totes for storage. While their buffer preparation process has been underway for some time, current practices are only producing neutral cost outcomes. KBI is interested in evaluating other modalities of buffer production to ensure they are optimizing buffer preparation. Their hope is to determine the most cost effective and efficient system of buffer management for their unique site.

The overarching goal of this practicum project was to examine two approaches for large-scale buffer preparation for pharmaceutical production: the traditional stainless steel approach and innovative buffer concentrate approach. The MMB team was tasked with evaluating potential scenarios for each approach and building a business case to determine which approach the KBI team should employ in their manufacturing facility in the future. To achieve the project objective, the team identified three primary areas of focus: background research, (voice of customer and vendor outreach) , analysis, and project deliverables.

The U.S. Food and Drug Administration (FDA) requires pharmaceutical companies to conduct pre-clinical and clinical trials to ensure safety, determine dosage, prove efficacy, and identify adverse effects of a new therapeutic. Approximately 7% of the starting patient population identified for a clinical trial makes it through the pre-screening process and consent process . The pre-screening process determines if patients meet the eligibility criteria defined in the clinical trial protocol. Sponsor companies often choose to issue expensive protocol amendments to widen the criteria and expedite the patient recruitment process. By improving the initial eligibility criteria selection, recruitment times would increase and protocol amendments would decrease, as well as their associated costs.

In response to this unmet market need, Optimized Trial Screening (OTS) was founded by Jaron Ballentine. Optimized Trial Screening empowers sponsors to make data-driven adjustments to a protocol’s eligibility criteria before the protocol publication. The service helps maximize patient recruitment success while maintaining high-quality results for study validation. The service aggregates physician-reported, de-identified patient data to determine the impact of inclusion and exclusion criteria on trial feasibility. Using this service prior to protocol publication would increase recruitment rate, prevent costly amendments, and expedite product commercialization.

The objective of the practicum project was to develop a sales and marketing strategy for OTS by elucidating its niche in the clinical trial ecosystem, identifying target clients, determining a pricing strategy, and designing a promotional flyer. To achieve the project objectives, the team identified three primary areas of focus: background research, primary voice of customer (VOC) market research, and project deliverables. The scope expanded over the course of the semester to include a market analysis and competitive analysis based on background research findings.