“driving innovation and technology in the bio-pharma ... · chain forecasting” jason dean....

TRACK 2“Increasing Demand Visibility in Clinical Supply

Chain Forecasting” Jason Dean

Director of Product ManagementBracket Global

“Driving Innovation and Technologyin the Bio-pharma Supply Chain”

Science. Technology. Service.

www.BracketGlobal.com

Increasing Demand Visibility in Clinical Supply Chain Forecasting.

Jason Dean - jason.dean@bracketglobal.com

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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.”

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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 2016

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The Companies We Serve

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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• Reduction in forecast errors by using a fully validated system• Reduction in obsolete/ excess stock• Standardization of process reduces forecast variability as a whole6

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Visibility to Demand and Supply Factors

DEM

AN

D

varia

bilit

ySU

PPLY 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

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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

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Clinical Trial Trends

10.923.4

41.058.0

75.493.2

112.7133.2

156.5180.6

208.5

240.1Registered Clinical Trialsin Thousands

Source: clincaltrials.gov *Annual Projected

25% compounded annual growth rate

• The number of registered clinical trials has grown consistently from 2006-2016• Drug development costs have significantly increased from approximately

$140 million in the 1970s to over $2.6 billion today.

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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

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Forecasting and Planning Enterprise Solution

- IRT Subjects- IRT Lots

- Item Master- Lots

- Variance details- Item Master- Lots

- ManufacturingRequests

‘Complete end-to-end visibility from demand creation to last subject out across

all bill of materials’

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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.

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Matching Demand and Supply

Study Planning Program Review and Allocation

Outcomes and Escalation

Monthly/Quarterly Demand Planning and Allocation Process

Weeks 1-3 Week 4

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

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PMD

LRA

Forecasting LDP EBR

Planning Bulk DrugManufacturing Label Creation Drug

AdministrationClinical Packaging

Distribution / Shipping

Drug Assignment

Reconciliation & Returns

RAR

EBR

CSM – SmartSuppliesVisibility to the entire Clinical Supply Chain

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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

CSM – SmartSupplies Benefits

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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.

About CSM - SmartSupplies

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Bracket CSM - SmartSupplies Professional Services

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Thank You

Jason Deanjason.dean@bracketglobal.com

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