Highlights from ExL Pharma's 4th Clinial Supply Forecasting Summit


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  • Highlights from ExL Pharma's 4th Clinial Supply Forecasting Summit

    1. 1. ExLPharma’s4th Clinical Supply Forecasting Summit Highlights<br />April 13-14, 2010<br />Philadelphia, PA<br />
    2. 2. Drug Supply and Use<br />Optimal Techniques for Clinical Supply Forecasting and Making Better Use of Drug Supplies<br />2<br />
    3. 3. Supply Plans<br />Program vs. Study Level<br />Various Factors Incorporated<br /><ul><li>Clinical Program
    4. 4. Drug Properties (e.g., shelf life, dosage form)
    5. 5. Supply Chain
    6. 6. Supplies Forecast
    7. 7. Packaging
    8. 8. Labeling
    9. 9. Distribution</li></ul>Should be comprehensive so that the clinical supply team has one place to access information<br />3<br />
    10. 10. Clinical Supply Forecasting<br />Program Level: Set of studies planned for drug development<br />When forecasting for a clinical program<br /><ul><li>Often planning for the manufacturing of the API
    11. 11. Lengthy Plans; years out (typically 3-4)
    12. 12. Studies will only have the most basic of details
    13. 13. Flexible – program will change over time
    14. 14. Due to the vagueness, may not be a good candidate for forecasting tools</li></ul>4<br />
    15. 15. Clinical Supply Forecasting<br />Study Level: Individual study or set of studies<br />When forecasting for a study:<br /><ul><li>More details are available
    16. 16. Usually packing against a planned manufacture
    17. 17. Future oriented; but not quite as far into the future as a program
    18. 18. Still a need to be flexible; study events will change the course of supplies over time
    19. 19. Usually good candidates for forecasting tools</li></ul>5<br />
    20. 20. Translating Clinical Requirements<br />Factors Affecting Forecast<br />Basics<br />Number of Patients, Visits, Centers, Countries<br />Drug / Packaging Properties<br />Dosing / Component Restrictions<br />Predictability <br />Recruitment<br />Patient Need<br /><ul><li>Randomization Type</li></ul>6<br />
    21. 21. Basics<br />Number of Patients<br />Obvious core of demand; a few items to look for <br /><ul><li>Length of time taking drug product
    22. 22. Patient Compliance
    23. 23. Recruitment
    24. 24. Drop out rate</li></ul>Number of Visits<br /> Another obvious core of demand; visit windows can impact the packaging amounts needed in a study<br />Number of Centers<br /> Each center that needs an initial shipment adds to the forecasted demand<br />Number of Countries<br /> Every country with a local distribution depot adds to the demand due to loss in flexibility in supplies<br />7<br />
    25. 25. Drug / Packaging Properties<br />Component Restrictions<br />Humidity conditions<br />Availability / Limited Distributors of components (e.g., foil envelopes, blister pack plastic)<br />Cold Chain<br />Out of temperature shipments; need to pack more<br />Dosing Restrictions<br />Limits in available strengths to make up the dose can also add to the forecast – use of multple unit kits<br />8<br />
    26. 26. Efficient and Fit for Purpose<br />To lessen the amount forecasted, when possible<br />Simple packaging<br />Multi-protocol packaging<br />Multi-language booklet labels<br />Avoid expiration dates on the labels<br />Ease ‘switch-out’ when replacing expiring stocks<br />Bar-coding <br />Ease fulfilment (pick and pack) of orders<br />The more flexible supplies are, the less overage is needed in the forecast<br />9<br />
    27. 27. Why isn’t this always possible?<br />Available strengths don’t match the dosing needed<br /><ul><li>Creates kits with multiple strengths used to create the dose – adds to the overall forecast</li></ul>e.g., if dose is determined by Body Surface Area (BSA), assumptions will need to include amounts for various types of patients thus adding to the forecast<br />Stability program does not support packaging that would faciliate the distribution, compliance, etc.<br /><ul><li>Blisters/wallets are packages that can facilitate multiple strength studies but the stability data or lack of stability testing may not support this packaging type</li></ul>10<br />
    28. 28. Why isn’t this always possible?<br />Components can limit the use of labels<br /><ul><li>Some drug components can be so small (e.g., vials) that booklet labels are not possible resulting in a country-specific supply</li></ul>Clinical system may not support the use of multiple-protocol packaging<br /><ul><li>Some IWRS’s may not support the use of protocol pooling without additional programming / development costs</li></ul>11<br />
    29. 29. Why isn’t this always possible?<br />Regulatory concerns<br /><ul><li>Some agencies don’t support IWRS as a method to control expiry, can increase supplies if manual switch-outs occur</li></ul>Legal Restrictions<br /><ul><li>Child resistance packaging is required within the US when a patient is provided drug to take home
    30. 30. Components used to handle a drug’s stability conditions (e.g., humidity) may not be capable of supporting the legal requirements (foil envelopes)</li></ul>12<br />
    31. 31. Predictability<br />Recruitment Predictability<br /><ul><li>The more uncertain the number of patients to be recruited, the more supplies needed
    32. 32. Screen failues, drop-outs and lengthy study times all affect the amount of drug needed
    33. 33. Country recruitment levels need to be accurate to support the forecast
    34. 34. Competitive recruitment impacts need as demand will fluctuate among participating markets
    35. 35. Faster enrolling countries lessen the demand need for those that are slower in recruiting
    36. 36. Late starts impact supply needs/plans</li></ul>13<br />
    37. 37. Predictability<br /><ul><li>Patient Need Predictability</li></ul>The more uncertainty there is of what type and how many kits patients need, more clinical supplies are needed and have to be added to the forecast<br /><ul><li>Variable Titration Studies
    38. 38. Adaptive Randomizations
    39. 39. Center vs. Centralized Balancing</li></ul>14<br />
    40. 40. Have you used Pooled Supplies?<br />
    41. 41. What Does Pooling of Clinical Supplies Mean?<br />Supplies that are primary packaged so that they can be used across multiple protocols<br />Supplies that are primary packaged and labeled for multiple protocols and distributed for predetermined study<br />Supplies that are primary packaged and labeled and distributed to allow for use across multiple protocols<br />All of the Above<br />
    42. 42. Pooling Definition<br />All of the above –<br />Pooling Definition- use of an allocated pool of supplies that are uniquely labeled such that they can be used across sites within a protocol and across protocols within a program. <br />
    43. 43. Agenda<br />What is Program Pooling<br />Key Considerations in Executing an Effective Pooling Plan<br />Uncovering what the Potential Cost Savings are to Clinical Supplies<br />Working with Regulators to Ensure Complaint Pooling Activities<br />Key Take Home Messages<br />
    44. 44. All pools are not created equal…<br />
    45. 45. What Does Pooling of Clinical Supplies Mean?<br />Supplies that are primary packaged so that they can be used across multiple protocols<br />Supplies that are primary packaged and labeled for multiple protocols and distributed for predetermined study<br />Supplies that are primary packaged and labeled and distributed to allow for use across multiple protocols<br />
    46. 46. Pooling until Shipment<br />Subject 1001<br />Protocol A, Site 1<br />Shipment<br />Dispensing<br />Protocol 1252<br />Protocol 1253<br />Protocol 1254<br />Container is commutable until shipment<br />Labeling Options<br />Protocol ID added to label when shipping (via ancillary label)<br />All Protocol IDs associated with the pool on label, specify protocol when shipping (via circle or highlight)<br />Container is “married” to the protocol and site at Shipment, <br />System must be designed to capture protocol specificity for container at shipping<br />Re-supply algorithm is protocol-specific<br />IVRS system is not needed<br />Protocol: 1253<br />
    47. 47. Pooling until Dispensing<br />Pool-A050_ _ _ _<br />Pool-A050<br />-or-<br />Protocol A, Subject 1001<br />Site 1<br />Shipment<br />Dispensing<br />Protocol 1252<br />Protocol 1253<br />Protocol 1254<br /><ul><li>Container is commutable until dispensed to a subject
    48. 48. Labeling Options:
    49. 49. Umbrella Pool ID on Label
    50. 50. If needed, Protocol ID added when Dispensing
    51. 51. All Protocol IDs on Label, specify protocol when dispensing (via circle or highlight)
    52. 52. Container is “married” to the site at shipment
    53. 53. container is “married” to the protocol at dispensing
    54. 54. Re-supply algorithm considers needs of all protocols running at site in pool</li></ul>Advantageous when same sites are running multiple protocols in the pool<br />
    55. 55. Overview of Program Level Supplies<br />A500 Pooled Supply <br />A500_____________<br />(Program # on Label)<br />Upon protocol approval IVR adds it to its list of “approved protocols for shipping studies”<br />Study 1<br />Study n<br />Study 2<br />Study 4<br />Study 5<br />Study 3<br />Site 1<br />Upon site approval IVR adds site to its list of “approved sites for dispensing” to the POOLED supplies<br />Site 2<br />Site 3<br />Protocol number added manually to label at study sites AFTER IVR links container # and protocol # at the time of drug assignment<br />Bottle Labels<br />Labeled supplies ready <br />to use in study<br />
    56. 56. Theory to Practice<br />
    57. 57. What controls do we have with using Pooled supplies?<br /><ul><li>IVR knows which container types are suitable for which protocols, subjects, and visits
    58. 58. Investigator specifies Protocol, Subject and Visit and system selects suitable container (i.e., container ID is “married” to Protocol ID at dispensing)
    59. 59. Label can provide space to record or apply ancillary label with specific protocol ID upon dispensing, if deemed important
    60. 60. Confirmation memo sent to investigator includes subject container and protocol IDs</li></li></ul><li> Key Considerations<br />When will the supplies be allocated to a protocol (distribution vs. dispensing)?<br />Are the protocols being conducted at many of the same sites?<br />Can one pool of supplies be used across all 3 protocols for all countries?<br />If not, how should the supplies be grouped?<br />By distribution center / depot<br />By labeling requirements<br />
    61. 61. Key Considerations<br />Distribution / Labeling<br />From which depot will the supplies for each country originate?<br />What are the label requirements for each country?<br />Are there additional unique labeling requirements?<br />
    62. 62. Common Logistical Concerns<br />Alignment of invoices with shipping documents and import license.<br />Multiple investigators at a single site without central pharmacy<br />Proper interpretation of shipping documentation<br />Clinical supply reconciliation <br />Contractors seeking verification of any dossier updates prior to shipment.<br />
    63. 63. Other Pooling Challenges<br />Regulatory Acceptability (pooling not well understood)<br />Annex 13 (section 26) <br />Local Laws<br />Labeling options must be agreed to by each country in advance.<br />May need to have separate pools due to differences in expiry dating or other labeling variations.<br />IVR/IWR must be designed to support pooling approach<br />
    64. 64. Potential Savings<br />
    65. 65. Pooling Benefits<br />Supply commutability translates to flexibility and responsiveness.<br />Protocols can be ramp up rapidly using a pre-exiting pool<br />New Protocols can be added to pool downstream (dependent on labeling approach)<br />Fewer packaging & labeling campaigns to prepare and release.<br />Generally will achieve some supply savings (reduction of waste) <br />
    66. 66. Where will you see a reduction in cost<br />API<br />Directly correlated with overall drug product savings<br />Drug Product <br />Demand quantities <br />Packaging/labeling<br />Campaigns<br />Container types<br />Containers<br />Label Prints<br />
    67. 67. Where will you see a reduction in cost<br />QA<br />Decrease number of releases<br />Distribution <br />Number of shipments if multiple protocols at same site<br /> Value Added Tax (VAT)<br />Time = money <br />Takes Supply Chain off of critical path when clinical plan changes<br />
    68. 68. 4 protocols in pool, 2 dosage forms,35 countries, over 350 sites<br />
    69. 69. Partnering with Regulators<br />
    70. 70. Partnering with Regulators<br />Know your facts<br />Regulation or interpretation<br />Many countries look to Europe <br />What have other companies done<br />Ensure regulators understand and are comfortable with IVR technology<br />Provide information on concept and controls associated with system<br />High light benefits not in terms of cost but in terms of patient safety<br />Present solutions to challenges <br />Small steps can bring you to your goal<br />Pilot one program<br />Company specific waiver<br />Resources ISPE<br />
    71. 71. Key Take Home Messages<br />Pooling can be done many different ways<br />There can be logistical and Importation Challenges but they can be overcome<br />Pooling adds greater flexibility in your program <br />Many benefits NOT just cost<br />
    72. 72. Still have any questions? For additional information on ExLPharma’s Clinical Supply Forecasting Summits, please visit www.exlpharma.com<br />