Clinical Supplies Distribution January 2013

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2 Clinical Supplies Distribution Gino Vleugels January 2013 One Passionate Team Transforming Molecules into Medicines for Patients Worldwide

3 Janssen Clinical Supply Chain Supports all JRD compounds, more than 50 each year Provides medication for patients Delivers annually more than kits Supplied 915 API and Drug Product batches* Organized shipments to more than hospitals of which cold chain (2-8 C) and ambient shipments Started 130 new trials, managed 320 ongoing trials 2

4 Temperature Requirements Different temperature requirements exist for investigational medicinal products for transportation: o < -80 C o -30 to -50 C o -15 to -25 C o 2 to 8 C o 2 to 10 C o 15 to 30 C Robust transportation solutions are in place to maintain the right temperature conditions during transportation. 3

5 Transportation Solutions < -80 C: Supplies shipped on dry ice: 4

6 Transportation Solutions -30 to -50 C ; -15 C to -25 C ;2 to 8 C; controlled ambient C: Supllies shipped in validated shippers using gelpacks to maintain the requested temperature 5

7 Transportation Solutions - All shipments shipped in a temperature controlled way are temperature monitored by means of temperature monitors. - Evaluation of excursions beyond the requested temperature range by the QA department who will decide on the disposition of the drug. Disposition is based on stability information of the drug. - Procedures and agreements (MSA, SLA, QA) in place with transportation providers to maintain the requested temperature during transportation - Periodical audit of all transportation providers used for IMP transportation 6

8 Ambient Transportation 7

9 Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use It is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport. Regardless of the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity. A risk-based approach should be utilized when planning transportation. 8

10 Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use Transportation The required storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging. 9

11 Janssen Clinical Supply Chain Approach The sponsor of clinical trials is responsible for: -Determination of appropriate conditions for storage and transportation -Stability data needs to be established to demonstrate the integrity of the investigational product at the conditions to which it can be exposed to during transportation 10

12 Janssen Clinical Supply Chain Approach Temperature mapping study The results of the temperature mapping study recommends upper and lower temperature levels to be considered for investigational product stability testing in support of the Janssen transportation strategy for ambient investigational product. 11

13 Janssen Strategy - Distribution set-up: central depots versus local depots - Service Level Agreements with our logistics couriers -Temperature mapping studies of common shipping lanes: - Determination of the upper and lower temperatures that investigational product shipments could be exposed to. - These temperature mapping studies are conducted by shipping temperature monitored test shipments with the same service level as the investigational product shipments. - Design of Stability protocols To provide evidence that investigational product s quality is not impacted based on the potential temperature exposures that can occur during the transit in the distribution network. 12

14 Janssen Strategy Based on the deliverables, J&J takes a joined decision on which lanes, during which seasons and for which products if extra measures needs to be taken to guarantee a 100% safety to our patients. 13

15 Executive Summary Temp Map Project -Simulation of small parcel shipments throughout the global distribution network. -Central depots located in Belgium, US and Singapore -Local depots within 12 countries (India, Turkey, Ukraine, Russia, China, Japan, Argentina, Brazil, Mexico, Chile, Colombia and Peru) The data set is used to create Ambient Temperature profiles for each zone/country mapped. 14

16 Solutions The temperature mapping study: Analyzes the different distribution zones through Janssen s Clinical global supply chain. Examines the in country temperature profile for all countries where medication is shipped directly to depot instead of direct to site (12 countries) Exceeds the industry s minimum definition of an ambient temperature profile for each lane mapped. Provides documented temperature profiles that over time comprehensively identify and characterize conditions and variations across transportation channels Examines all aspects of temperatures that are the result of variations due to seasonal fluctuations in weather, shipment duration and packout. Each study is executed in Winter and Summer seasons to understand the worst case scenario for shipping in temperature extremes. 15

17 Distribution Network Clinical (Central Depots) US J&J Beerse UK Singapore 16

18 Local Depot Network Clinical Russia China Ukraine Turkey Mexico Peru Chile Colombia Argentina Brazil South Africa 17

19 g1 Approach The Temperature Mapping Study documents thermal conditions along the chosen transportation channels. The study achieves this goal by: Sending 30 shipments containing Temperature Monitors in a ventilated box along each of the regional shipping zones to record ambient temperatures during distribution. Sending 30 shipments containing Temperature Monitors in a ventilated box along each of the in-country domestic shipping lanes to record ambient temperatures during distribution. Creating a record of ambient temperature for each selected shipping lane Generate one ambient temperature profile (ATP) for all shipping lanes. Rationale behind using 30 shipments per zone: ISTA 5B recommends 25 records per zone / per transport method / per season. We use 30 to account for loss and to make sure we have a statistically significant sample. 18

20 Dia 19 g1 ISTA: international safe transit association gvleuge1; 26/01/2013

21 Example of Zones = depot 19

22 Methodology -Study to document ambient temperatures throughout their global distribution network. -Understand the extreme ambient temperatures that products may experience throughout the small parcel distribution network, to better gauge risk within individual lanes. -Analysis shipments from Janssen s global and local shipping hubs. - Simulation of small parcel shipments - The study is designed to record temperatures from the time the monitors leave the warehouse to the point of receipt at end destination. - Upon receipt of the monitor at the designated destination sites, the monitor is stopped, downloaded and the temperature data ed for analysis. 20

23 Equipment Ventilated Boxes: Ventilated cardboard boxes are used to allow for transmission and collection of ambient temperatures that occur during shipments. 21

24 Deliverables Janssen Clinical Supply Chain receives an electronic copy of a formal report containing data for each separate region mapped. These reports will be issued per each season of the mapping: Executive Summary The executive summary provides a high level view of the data collected by the study. It also highlights the key findings and recommendations. Key Findings Janssen wil have key statistics for every monitor included in the study. Key statistics include: maximum, minimum and mean temperatures as well as the standard deviation of that monitor. This information allows for areas of concern to be quickly investigated and resolved as needed Tabular Data Multiple tables that detail summary statistics for each monitor, as well as origin, destination and serial number- for traceabilty purposes. 22

25 Deliverables Ambient Temperature Profile An ambient profile for each lane mapped as well as an overal profile for the region (per season) Certificates of Validation NIST accuracy statement Envelope Graph representing the maximum, minimum and mean temperatures for each lane. Histogram: A graphical representation of all temperatures experienced in the selected lane AN overview of the ambient temperature profile creation process along with detailed information regarding each of the separate pieces can be Multi-Graph and Summary Statistics A graph of all shipments sent to the specified region or country. Statistics for each individual shipment 23

26 Example of an Envelope Graph The graph shows a compilation of the maximum, minimum and mean temperatures toall of the shipments. The mean temperatures at each point (or Moving Average) are the base line that the temperature profiles are derived from. The temperature data set from the lane (as depicted in the histogram) are curve fit to this line and the maximum and minimum temperatures are expanded to the upper and lower control limits. The mean temperature for the same point on each monitor is shown in yellow. The maximum temperature for the same point recorded across all Temperature recorders is shown in red. The minimum temperature for the same point recorded across all Temperature recorders is shown in blue. The graph shows temperatures for the entire conditioned data set. 24

27 Conclusion Janssen can conclude that the combination of a 5 day duration with the +60 C and -20 C temperature levels that are in excess of the temperature observed in the distribution network mapping provides for an appropriate safety margin between the stability data and actual exposure. 25

28 Cost Avoidance -Annually Janssen ships roughly +/ ambient boxes. -With an 80% success rate (meaning that 80% of our ambient products doesn t need extra packaging and monitoring) we anually will realize a cost avoidance of +/- 4.3 Million USD by avoiding the use of temperature monitors and protecting packaging materials. 26

29 Thank You CSC Clinical Supply Chain Beerse