CASE STUDY: EFFECTIVE GOVERNANCE PROCESSES FOR A SUCCESSFUL BIOREPOSITORY PARTNERSHIP As a non-core activity to many research organizations, biorepository managers are increasingly partnering with outsourced service providers to manage their ever-growing sample inventory. Given the scientific and financial value gained from properly preserved samples, it has become paramount that all aspects of sample management processes are outlined, evaluated and measured to ensure a successful long-term partnership. STATEMENT OF ISSUE SITUATION BioStorage Technologies entered into a strategic partnership with one of the leading biotech companies in the world. That company has an internal biorepository which was facing the common industry issue of rising costs. In addition, the company needed to ensure that vital discovery and drug development research samples were efficiently managed to and from the bench. As such, BioStorage Technologies provided on-site biorepository operations support as well as long-term storage services for the research samples. SOLUTION BioStorage Technologies used a disciplined three-phase approach to establish the biorepository operations and track services in the current, desired and future states. • Disciplined governance reporting of operational, financial and quality markers were defined and published monthly. • A proven evaluation method was used, which included a variety of process-mapping and gap-analysis tools, Six Sigma quality calculations, process streamlining, SOP adherence and governance oversights. • Governance tools were used to assess sample management quality, performance and efficiencies, and validated operational and financial KPIs. • Financial tools for budget tracking were assessed monthly using purchase orders vs. invoice details. • Process improvement initiatives and their progress status were reported via a dashboard. Kai-Alexander Wiemer BioStorage Technologies GmbH EVALUATING YOUR SAMPLE MANAGEMENT FRAMEWORK PHASE I: CURRENT STATE ASSESS THE CURRENT SAMPLE MANAGEMENT MODEL. • Conduct a needs assessment • Map and document lab/ sample workflow • Generate gap analysis • Identify opportunities for improving and optimizing the sample lifecycle management operation PHASE II: DESIRED STATE SELECT THE PREFERRED SAMPLE MANAGEMENT MODEL. IDENTIFY LONG-TERM & SHORT-TERM RESEARCH GOALS. • Validate research needs and goals • Validate IT and customer data management requirements • Develop a transition plan PHASE III: FUTURE STATE DeVelop a CoMprehensIVe SAMPLE MANAGEMENT PLAN ThaT aChIeVes researCh Goals. • Improve sample quality and access • Increase research efficiencies • optimize sample value RESULTS: COST SAVINGS AND COST AVOIDANCE The governance process increased quality, operational efficiencies and reduced costs, which enabled the company to support future research. Expected Cost $10M Actual Cost $6M 40% Savings 55% Cost Savings 45% Cost Avoidance STRATEGIC PARTNERSHIP SAVED ≥ 40% 2012 Cost Savings and Cost Avoidance Breakdown IMPROVED SAMPLE MANAGEMENT EFFICIENCIES TREND & FORECAST Trending toward Future State The foundation of an effective biorepository partnership is the integration of an appropriate governance structure with an experienced team, standard operating procedures and smart technology tools that enable the success of the relationship to be measured. From an operational perspective, planning and creating the appropriate governance structure and tools are critical for effective communication, decision-making and the achievement of research goals. Governance processes and tools allow key stakeholders to quickly identify and evaluate process improvements for critical management tasks. RECOMMENDATION BT13018_ESBBPoster.indd 1 9/26/13 9:16 AM