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BAPM-CTSL-Workbook-and-prereading-m1.04

Business Acumen for

Business Acumen for Project Management Simulation Project B Challenge: Xorra Biotech Process Monitoring You will be involved with Project B on the second day of the Business Acumen Program. Please familiarize yourself with the background now, but it will be suggested that you re-read it the evening after the first day of the course. Client Background • Xorra is a small biotech company with several products in Stage 3 clinical trials and close to approval for sale in the domestic market. The company has been growing quickly because of a proprietary production capability and is expected to launch a steady stream of new products in the next 1-3 years. • The Xorra Tech Ops organization is responsible for manufacturing and is stretched thin as the business is building new production facilities, as well as integrating several bench production labs from recent acquisitions. • This project is to monitor the by-product waste media and fluids from an innovative new biologic production process. At the lab level, the production waste is completely environmentally neutral, but regulatory agencies are concerned that this may not be the case as the production process scales. The EPA and FDA have each required environmental monitoring as Xorra scales production of their next compound. This project will help Xorra reassure the regulators, design full scale by-product treatment facility for a new plant, and develop a documented baseline for the waste output levels. • Xorra has a diverse portfolio of compounds in the pipeline that will use the same new production process if it is approved by the regulators. Ongoing monitoring could represent a significant opportunity for EnviroAid, and accurate monitoring of this initial scale-up is strategically very important to Xorra. • This is the first project Xorra has hired EnviroAid to complete, but they have been discussing creating a partnership with EnviroAid longer term. Contract History This project was originally bid as a larger project in 3 stages but was split into three discreet parts when Xorra’s venture capitalists were unready to fund scaling of production end to end prior to regulatory approval. As a result, this project is Phase 1 with the additional phases to possibly follow. EnviroAid Business Development offered a volume discount if Xorra awards EA Phases #2 and #3 and starts them within 18 months of beginning this current project (Phase 1). This price discount was offered based on the margin forecasts for the overall work that were developed during the proposal phase. The project has proceeded intermittently: it was slow to kick off because of problems with the production process at the lab level. Once the scaling of the process began, the data collection took longer than expected because the process was run in batches and production machinery has often broken down. When it is operational, the monitoring demands have been intense. Progress on the project is heavily dependent on the production volume and timing from Xorra. © 2018 Insight Experience, Inc. 14 Developed for PAREXEL.

Project B Challenge: Xorra Biotech Process Monitoring Timeline Budgeted Timeline Project Timeline Weeks Months Note: 1 month = 4.3333 weeks Protocol and Regulatory 4.0 0.9 15-Jan-01 to 12-Feb-01 Project Initiation 4.0 0.9 13-Feb-01 to 13-Mar-01 Monitoring Visits 18.0 4.2 14-Mar-01 to 18-Jul-01 Data Evaluation 8.0 1.8 19-Jul-01 to 13-Sep-01 Project Close and Documentation 4.0 0.9 14-Sep-01 to 12-Oct-01 Total Timeline (weeks/months) 38.0 8.8 15-Jan-01 to 12-Oct-01 Current Timelines (Based on discussions with client) Add comments Project Timeline Weeks Months Note: 1 month = 4.3333 weeks For what has changed Protocol and Regulatory 6.0 1.4 15-Jan-01 to 26-Feb-01 unclear scope and problems getting decisions finalized Project Initiation 6.0 1.4 27-Feb-01 to 10-Apr-01 staffing issues Monitoring Visits 25.0 5.5 11-Apr-01 to 10-Oct-01 Production breakdowns, and client approval process causing delays Data Lock 15-Sep-01 Data Evaluation 8.0 1.8 15-Sep-01 to 22-Nov-01 slight increase due to local holidays Project Close and Documentation 3.0 0.9 23-Nov-01 to 21-Dec-01 Total Timeline (weeks/months) 48.0 11.1 15-Jan-01 to 21-Dec-01 Recent Events The project is now in the 7 th month of the project of what was projected to be a 9 month project and has only completed 50% of the project scope. The prior Project Leader just resigned from EnviroAid to join a small biotech competitor of Xorra. Xorra’s Senior Client on the project, the VP of Technical Operations, and Xorra’s President have asked for a full project review with Sandra Williams. You have been asked to take on this project and “get it back on track.” The EnviroAid receivables system is about to be merged into the GRI Enterprise Resource Planning (ERP) system with cutover happening within the next two months: some of the project reports may be affected. © 2018 Insight Experience, Inc. 15 Developed for PAREXEL.

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