Minimize overspend by gaining visibility of total demand

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1 Minimize overspend by gaining visibility of total demand Patti Seymour 9th Annual Clinical Trials Supplies and Packaging October 10-12, 2011 BioProcess Technology Consultants

2 Supply and Demand Management Evaluating Your Supply Chain and Its Ability to Meet Demand 2 From Clone to Clinic

3 Integrate Demand and Supply Planning Demand Management Supply Management Develop demand management strategies / plans Develop demand forecast Develop feasible production plans Position materials for flexible response Execute demand plans; manage orders; service customers Align performance measures Use common data and formats Create formal product roadmap Produce and deploy product Create production schedule Procure materials Modify plans in real time as actual supply / demand and expectations dictate 3 From Clone to Clinic

4 Supply Chain is the Backbone of the Pharma Company Planning and Collaboration New Product Development & Innovation Active Pharmaceutical Ingredient Manufacturing Secondary Manufacturing and Packaging Distribution Direct to pharmacy Patient People and Skills Information Systems 4 Source: PWC Pharma 2020 Supplying the Future From Clone to Clinic

5 Supply Chain Issues Source: Pew Health Group; After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs July From Clone to Clinic

6 Investigational Medicinal Product Flow Source: Bearing Point Streamlining clinical trial supply management From Clone to Clinic

7 Clinical Trial Management Process Source: Bearing Point Streamlining clinical trial supply management From Clone to Clinic

8 Forecasting Improving Accuracy from API to the Patient 8 From Clone to Clinic

9 Accurate forecasts from bulk API to the patient Points to Consider when forecasting your IMP demand Trial Design Stage of development Phase 1 (SAD, MAD), Phase 2, Phase 3, etc. Size how many subjects/patients will be enrolled Cohorts how many cohorts/arm are included Dosing how many doses of drug per cycle or cohort of treatment; how many cycles can a subject/patient receive Placebo, Comparator or Combination drugs will a placebo be used; is a comparator drug necessary; will the IMP be dosed with a combination drug Randomization will subjects/patients be centrally randomized Trial Operations Duration over what period of time will the enrollment occur Geography what countries will enroll patients Sites how many primary investigator sites; will there be any subinvestigator sites 9 From Clone to Clinic

10 Accurate forecasts from bulk API to the patient Points to Consider when forecasting your IMP demand (cont.) IMP and Label / Package Considerations IMP strength how many IMP strengths are needed to meet the dosing requirements Dosage blinding is the IMP double blinded, is the IMP open label to pharmacist only, or is the IMP completely open label Dosage administration is the IMP administered in a clinical setting (e.g., iv infusion) or is it a take home medication Labeling will IMP be labeled for specific countries or for multiple countries; what about Just In Time labeling Packaging will the IMP be packaged per subject/patient or for bulk dispensing Packaging size will the packaging be based on a dose, a cycle or a full course of treatment Overage what percent overage is needed 10 From Clone to Clinic

11 Accurate forecasts from bulk API to the patient Points to Consider when forecasting your IMP demand (cont.) IMP Logistics Distribution plan how many and where should distribution depots be located based on the countries where patients will be enrolled Supply algorithms how should the depots be initially stocked; how should the clinical trial sites be initially stocked; how should the depot/clinical trial sites be re supplied Distribution readiness date by when does the IMP need to be ready for distribution 11 From Clone to Clinic

12 Accurate forecasts from bulk API to the patient Points to Consider when forecasting your IMP supply Batch size what is the current batch size for the finished goods; drug product; API Batch quantity how many batches will be needed to meet IMP demand for the clinic Non clinical demand what are other non clinical demands: release testing samples; stability study samples; retains; toxicology/pharmacology studies; CMC studies Batch cycle time how long will it take to procure all of the raw materials to manufacture a batch of API; a batch of drug product; a batch of finished goods How long will it take to procure labels and package IMP Is QP release required Compendial requirements are different compendial grades necessary for raw materials based on global nature of trial 12 From Clone to Clinic

13 Accurate forecasts from bulk API to the patient Points to Consider when forecasting your IMP supply (cont.) Batch yield what is the estimated batch yield for API, drug product, and finished goods Shipment cycle time how long does it take to ship bulk API to the drug product manufacture or to ship bulk drug product to the packaging manufacturer Expiry/retest period what is the current shelf life for the API; for the bulk drug product; for the packaged product Overage what percent overage is needed to meet all of the IMP demand 13 From Clone to Clinic

14 Technology suppliers vs. in-house solutions: pros and cons A recent benchmarking survey on the current state of clinical trial supply forecasting and supply chain management found that 69% of Clinical Supply Managers do not currently use software or methodologies for forecasting clinical trial supply 1 Technology suppliers include BioClinica Optimizer, ClinPhone MedSim, CLINapps SMART Supplies Forecasting, and N SIDE CT FAST In house solutions include Microsoft Excel, other spreadsheet based software Whether packaged software or an in house solution, planning and forecasting tools should calculate/forecast how much drug to manufacture, package and ship to countries, depots, and sites in a given clinical trial or group of trials over time without missing a dispensing visit due to lack of available IMP at the site while minimizing drug waste 1 Clinical Supplies Forecasting Survey Whitepaper. June Paragon Solutions 14 From Clone to Clinic

15 Technology suppliers vs. in-house solutions: pros and cons Packaged Technology Pros Can be very sophisticated Superior at planning multiple trials for a single product and for large product pipelines Can run scenarios to optimize clinical supply planning Have standardized processes More efficient through better allocation of planning resources Available for enterprise wide planning and viewing Cons More expensive (initially) Complicated to use Potential integration and compatibility issues In house Tool Pros Less expensive Platform readily available (i.e., Excel is standard at most companies) Users generally familiar with software Easily customizable Acceptable for small pipelines or limited number of trials Cons Not easily converted to enterprise use Not sophisticated Difficult to do simulation Generally a static form of planning 15 From Clone to Clinic

16 How to balance forecasting responsibilities: Sponsor versus Supplier Customer is always ultimately responsible, however One party may be in a better position to manage certain responsibilities Clearly set expectations with any supplier regarding the information expected as part of the forecasting process Sponsor must provide trial assumptions for forecasting Supplier can provide some or all of the supply forecasts to meet the trial demands Quantities of Supplies, e.g., x grams, x units, x kits Timing of Delivery, e.g., will be received on x date Presentation Format, e.g., will be bulk bright stock, or labeled, or kitted Expiry, e.g., when supply should be removed from available inventory Resupply of Depots / Site, e.g., determine who sets the resupply algorithms Mutually agree in writing to the division of responsibilities clear accountability is imperative! 16 From Clone to Clinic

17 Summary Proactive demand and supply planning will Enable comprehensive calculations of ALL potential demand for IMP, and Reduce costly overages and emergency packaging / shipping requirements Minimize study delays due to low inventory of IMP Eliminate stock outs, and Allow for efficient and transparent supply plans 17 From Clone to Clinic

18 Thank You! Patti Seymour BioProcess Technology Consultants, Inc. 12 Gill Street, Suite 5450 Woburn, MA 01801

19 Follow us bptcglobal

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