TRACK 2 Increasing Demand Visibility in Clinical Supply Chain Forecasting

Transcription

1 Driving Innovation and Technology in the Bio-pharma Supply Chain TRACK 2 Increasing Demand Visibility in Clinical Supply Chain Forecasting Jason Dean Director of Product Management Bracket Global

2 Science. Technology. Service. Increasing Demand Visibility in Clinical Supply Chain Forecasting. Jason Dean - jason.dean@bracketglobal.com 2

3 Supply Chain Visibility According to Jeff Dobbs, Global Sector Chair, Diversified Industrials and a partner with KPMG, Obtaining real-time visibility across all tiers in the supply chain can significantly increase speed to market, reduce capital expenditures and manage risk. He went on to make this statement, moving toward a demand-driven supply chain is probably the single most important step a global manufacturer can take today. 3

4 About Bracket CSM - SmartSupplies Software suite was originally build in 2005 with the Forecasting module as the first commercially available system. SmartSupplies provides mission critical solutions for Pre-clinical and Clinical challenges Rapidly developing global partnerships and client list Preferred vendor for leading Pharmaceutical and Biotech companies SmartSupplies was acquired from CLINapps in October

5 The Companies We Serve 5

6 Forecasting Demand Variability VISIBILITY Everyone forecasting in the same easy to use, open and secure system Individual forecasts are aggregated (rolled up) into a corporate level for production planning VELOCITY Less time spent creating new spreadsheets as the study changes Duplication/ learning from other similar forecasts Faster transfer of knowledge to other people and projects VARIABILITY 6 Reduction in forecast errors by using a fully validated system Reduction in obsolete/ excess stock Standardization of process reduces forecast variability as a whole

7 Visibility to Demand and Supply Factors DEMAND variability Constant study design changes/unknown design Dose and/or stability undefined Changing development requirements Increased/decreased recruitment rates Increased/decreased project priority Batch failures Polymorph/impurity issues Poor robustness/yield decreases Lack of internal/external capacity Non-availability of raw materials SUPPLY variability 7

8 CSM - SmartSupplies Visibility Benefits Due to the variability in clinical demand, each study s drug requirements should be reviewed monthly to ensure optimal inventory levels For most companies due to the lack of systems and the manual nature of the activity, this cannot be done as frequently or accurately as required This is even true with a small number of studies, however as growth occurs it becomes nearly an impossible feat The lack of adequate visibility increases the risk of stock outs, expiry dating issues, expedited shipments and production orders For most of our clients even a 5% savings in drug costs can provide millions of dollars annual savings 8

9 Clinical Trial Trends The number of registered clinical trials has grown consistently from Drug development costs have significantly increased from approximately $140 million in the 1970s to over $2.6 billion today. Registered Clinical Trials in Thousands % compounded annual growth rate Source: clincaltrials.gov 9 *Annual Projected

10 Goal of Supply Chain Visibility Reduce business and supply chain risk Improve lead times and performance Identify shortage and quality problems along the supply chain Getting there by making processes more collaborative Information must be shared across processes Data collection and analysis software are now making supply chain control towers possible 10

11 Forecasting and Planning Enterprise Solution Complete end-to-end visibility from demand creation to last subject out across all bill of materials - IRT Subjects - IRT Lots - Variance details - Item Master - Lots - Item Master - Lots - Manufacturing Requests

12 SmartSupplies Forecasting offers the ability to aggregate the demand across multiple trials or even multiple clinical programs. Providing the manufacturing group with a unified demand plan that encompasses the total demand for all clinical materials. SmartSupplies Forecasting is also designed to allow the clinical manufacturing organization to develop and verify manufacturing scenarios. These lot based scenarios consider the common manufacturing factors such as expiry dating, expected yields, reserves and more. 12

13 Matching Demand and Supply Monthly/Quarterly Demand Planning and Allocation Process Study Planning Program Review and Allocation Weeks 1-3 Week 4 Outcomes and Escalation Study Managers Program + Lead Study Manager(s) Every study has a regularly maintained forecast and clear demand supply position established Standard program level view of inventory, flexibility and future supply vs demand at all item levels 13

14 CSM SmartSupplies Visibility to the entire Clinical Supply Chain RAR PMD LRA Forecasting EBR LDP EBR Planning Bulk Drug Manufacturing Label Creation Clinical Packaging Distribution / Shipping Drug Assignment Drug Administration Reconciliation & Returns 14

15 CSM SmartSupplies Benefits Increases visibility and traceability of clinical supplies Provides repository for API to Patient genealogy Produces supporting documentation through validated reporting Provides online ordering for non-irt studies or consumables Provides patient assignment capability for non-irt studies Simplifies the site and study close-out and destruction process Provides unified process for all reconciliation and return activities Improves compliance Reduces errors / costs Simplifies training / only train on single system 15

16 About CSM - SmartSupplies SmartSupplies is the most widely used software for investigational supplies with a track record of successful implementations. Our products will help our clients meet their business goals. Our products can be successfully integrated with their existing systems. Our products will provide clients with the visibility and accessibility they expect. The Bracket Clinical Supplies team works diligently with clients to determine the ideal business process using SmartSupplies and to determine the points of integration required to achieve that process. 16

17 Bracket CSM - SmartSupplies Professional Services 17

18 Thank You Science. Technology. Service. Jason Dean 18