Designing your supply chain as accurately as possible based on thorough product testing

Transcription

1 Designing your supply chain as accurately as possible based on thorough product testing Virginie ROUX Sanofi R&D Clinical Supplies Scientific Core Platform

2 Agenda I. Our organization II. Adaptability to new regulations III.Protective measures against temperature excursions IV.Overcoming temperature monitoring issues 2

3 Our organization 3

4 Sanofi R&D Investigational Medicinal Products (IMPs) Distribution network 4

5 Facilities equipment A few examples of sanofi s distribution facilities (1/2) GREAT-VALLEY Automatic systems (VLM*) *VLM: Vertical Level Montage 5

6 Facilities equipment A few examples of sanofi s distribution facilities (2/2) Harbor Park Strong partnership between Sanofi Units 6

7 Adaptability to new regulations 7

8 Official Journal of the European Union Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) CHAPTER 9 TRANSPORTATION 9.2. 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. If a deviation such as temperature excursion or product damage has occurred during transportation, this should be reported to the distributor and recipient of the affected medicinal products. A procedure should also be in place for investigating and handling temperature excursions. It is the responsibility of the wholesale distributor to ensure that vehicles and equipment used to distribute, store or handle medicinal products are suitable for their use and appropriately equipped to prevent exposure of the products to conditions that could affect their quality and packaging integrity. Equipment used for temperature monitoring during transport within vehicles and/or containers should be maintained and calibrated at regular intervals. 8

9 New regulations: Implementation within sanofi R&D Clinical Supplies Scientific Core Platform (1/2) Concrete Impacts = For each shipment Appropriate transport Qualified boxes Temperature Monitoring Device The use of qualified boxes and temperature recorders is mandatory for all IMP* shipments (ambient and cold products) from and to European countries. *IMP: Investigational Medicinal Product 9

10 New regulations: Implementation within sanofi R&D Clinical Supplies Scientific Core Platform (2/2) The EU GDP states: The required storage conditions for medicinal products should be maintained during transportation ISSUE Numerous storage conditions depending on the products (15-25 C / C.) EXAMPLE Extract from USP* General Notices and Requirements (section 10): *USP: U.S. Pharmacopeial Convention 10

11 What s going on outside Europe? What are the local regulations? 1. Local regulations on ambient IMP transportation Following a survey done end of 2013 through our local contacts all around the world (IP Managers Network), we got 29 answers and the results are as followed. Canada Yes No 3 26 Israel Turkey 11

12 What s going on outside Europe? What are the local regulations? 2. Local practice for ambient IMP transportation Standard boxes only Argentina Australia Canada Chile China Guatemala Hong-Kong Indonesia Malaysia Mexico Panama Paraguay Philippines Singapore Uruguay Vietnam Standard boxes + Temperature Monitoring Devices Turkey UAE/Kuwait Qualified boxes only Egypt Qualified boxes + Temperature Monitoring Devices Colombia India & Sri Lanka Japan South Africa Several solutions* Belarus (b) Brazil (a) Georgia (b) Israel (c) Russia (b) Ukraine (b) * Several solutions depending on: (a) For some studies we use TMD and qualified boxes. (b) Depending on the temperature of the delivery address. If the temperature is between +2 C and +30 C, standard boxes only. If it is higher than +30 C, qualified boxes. And if it is lower than -30 C qualified boxes + Temp Recorder. (c) Decision taken by the shipper. 12

13 What s going on outside Europe? What are the local regulations? 3. Expected changes in local regulations? Yes No 4 25 China (a) Mexico (b) South Africa (c) Ukraine (d) (a) Anytime. (b) It may be a possibility due to the fact that our MoH is now certificate by the USA, so they can request the temperature control for ambient medication. (c) Expected but have no idea when to expect this. (d) From 01/01/

14 Protective measures against temperature excursions Stability programs 14

15 Time Out of Refrigeration (TOR*) Management TOR* Monitoring within each activity Process implementation to Monitor the TOR* during all supply chain activities (until dispensation to the patient) TOR* Consolidation along supply chain *Time out of refrigeration (TOR): Time during which the product is outside 2-8 C. 15

16 Temperature Management Time Out of Refrigeration Statement (used for 2-8 C products / applicable for manufacturing, packaging and storage before shipment from warehouse to depot/site) Temperature Excursion Stability Statement (used for all storage conditions / applicable for shipments from warehouse to depot/site and local storage) Common issue: For comparators/marketed products, the TOR and Stability statements are not always available or provided. Eg.: Embrel *TOR: Time during which the product is outside 2-8 C 16

17 Adaptability with appropriate equipments & devices to ensure IMPs distribution in the best conditions (1/2) 17

18 Adaptability with appropriate equipments & devices to ensure IMPs distribution in the best conditions (2/2) LAST MILE IMP Kits transportation from site to patient s home A cool bag with gel packs delivered on investigational site for patients To ensure the integrity of IMPs during transportation from site to patient s home EXEMPLE OF THE INSULATED BAGS PROVIDED TO PATIENTS FOR SPECIFIC STUDIES QR Code: Instructions for use 18

19 Distribution strategy evolution (1/2) CONTEXT Clinical distribution is used at different stages of Sanofi value chain Evolution of Sanofi molecules portfolio Sensible products: More controlled temper. products Less TOR Data available Expensive products: Comparator (HUMIRA : ~1400 per kit) Human monoclonal antibody (Sarilumab) Rare products: Sourcing of comparator is being harder Less stock of products More complex regions e.g.: Dengue study Reduced budget compared to the past IPs Distribution network evolution since

20 Distribution strategy evolution (2/2) STRATEGY & BENEFITS Sensible products Expensive products Rare products Multiple suppliers More complex regions Reduced budget No control on budget spent One supplier Belgium Netherland Belgium Netherland Germany Italy Spain UK USA Argentina Germany Italy Spain UK USA Argentina Czech republic Estonia Finland Hungary Norway Poland Romania Russia Harbor Park Israel MP Mexico Brazil Colombia Czech republic Estonia Finland Hungary Norway Poland Romania Russia Harbor Park Israel MP Mexico Brazil Colombia Sweden Sweden 20

21 Shipping material evolution (1/2) Reusable boxes 21

22 Shipping material evolution (2/2) Monoconfiguration boxes We are currently working with our commercial partners on new type of equipment which does not require any programming before use. That means that the boxes are under a mono configuration wherever the products have to be sent, whatever the season and whatever the local temperature. 22

23 Overcoming temperature monitoring issues 23

24 Overcoming temperature monitoring issues Current situation & issues More and more products in the pipeline are sensible to temperature environment throughout the Clinical Supply Chain Secondary packaging Shipping Investigators Primary packaging Packing As of today, the ways of temperature tracking are: T O D A Y Manual TOR tracking sheet (packaging and packing steps) TempTale data loggers (shipping/distribution) The whole pallet is unusable! 24

25 Overcoming temperature monitoring issues Next Step: Innovation Objective Develop wireless low cost temperature recorders Automatize temperature recording 1st phase: Autonomous smart label recorders applied during packaging and readable with RFID readers in warehouses Technology RFID (Radio Frequency Identification) chip Temperature Sensor RFID reader T O M O R R O W 2 nd phase: Autonomous smart labels recorders and smart 3G, 4G emitting reader for remote live temperature monitoring Only the identified kits will be unusable! 25

26 MoniTOR Sanofi Wireless Temperature Recording Solution Y Mobile Device with Moni-TOR application Bluetooth RFID Reader RF 868 MHz Shipment Treatments Kits 26

27 Questions? Thank you! 27