Global Clinical Supplies Regional Leads EPICS SEPTEMBER 20, 2010

Transcription

1 Global Clinical Supplies Regional Leads EPICS SEPTEMBER 20, 2010

2 Discussion Points Background on the Regional Leads Purpose of the Regional Leads Key Roles & Responsibilities Examples & Case Studies

3 Global Clinical Supply Regional Leads Clinical Supply Chain Clinical Research Planning Manufacturing Packaging Distribution Clinical Operation Countries Global Clinical Supply Project Managers Global Clinical Supply Regional Leads Clinical Supply Organizations often have Project Managers that work with Study Teams to Identify country demand, requirements and plans Clinical Supplies to support studies Coordinate preparation & delivery of supplies GCS Regional Leads are focused resources that work between GCS & the countries running the studies to Carry back to GCS key information about country requirements, environments and management of the supplies Facilitate resolution of issues & use data to drive improvements needed to support the GCS/countries interface.

4 Background on Organization The Global Clinical Supply (GCS) Regional Lead (RL) role in the Schering Plough clinical supply group was Established in early 2007, following 2006 process re-engineering efforts Greatly enhanced the connectivity and alignment of Clinical Teams and GCS. Leaders identified significant opportunities for additional improvements through better alignment between GCS and Clinical Country based teams. Since that time, legacy SP has been undergone two significant merger integration activities 2007 Merger with Organon Merger with Merck. Individuals were identified for 6 clinical operations regions across the globe. The RL role helped to prevent any potential supply issues during the integrations through proactive communications to the Country Operations (CO) RL role preserved through both mergers. Regional Leads have played key roles in supporting key Integration activities.

5 High Level Purpose Provide GCS leadership at the interface between Global Clinical Supply (GCS) and Global Clinical Operation (GCO) regions around the world to facilitate the efficient and effective delivery of clinical supplies in aid of the timely completion of trials. Regional Leads work to: Provide transparency between GCS & GCO through the development of strong communication channels Serve as a liaison for management of supplies from multiple supply chains Understand & communicate unique regional characteristics, opportunities, and challenges Lead & Support global implementation of process improvement intiatives based on best practices Serve as an Subject Matter Expert and trainer to support the regions

6 GCS Regional Leads are located regionally North America Montreal, Canada Eastern Europe, Middle East, and Africa (EEMEA) London, UK Latin America San Diego, CA, USA European Union I Milan, Italy European Union II Nice, France Asia Pacific Shanghai, China

7 Alignment of Clinical Supply Chain Regional Leads to GCS & Regions GCTO HEAD North America Latin America Europe I Europe II EEMEA Asia Pacific GCTO Lead GCTO LEAD 1 GCTO LEAD 2 GCTO LEAD 3 GCTO LEAD 4 GCTO LEAD 5 GCTO LEAD 6 GCS GCS Regional Lead GCS Regional Lead 1 GCS Regional Lead 2 GCS Regional Lead 3 GCS Regional Lead 4 GCS Regional Lead 5 GCS Regional Lead 6 Regional Leads current reporting relationships Reporting directly to head of Global Clinical Supply Reporting (dotted line) to head of Global Clinical Trial Operations (GCTO) Leads

8 Regional Leads As Key Interface Between the GCS & Clinical Operation Regional Teams The Regional Leads are responsible for: Facilitating the efficient and effective delivery of supplies to support timely completion of trials, with a particular focus on high priority programs Providing support for resolving clinical supply chain issues and/or directing regional and country-level clinical supply chain issues and questions to appropriate resources for resolution RLs report directly to GCS Leader to have full engagement of the GCS leadership with the partners GCTO and Global Logistics Providing transparency between GCS & GCTO through the development of strong communication channels Understanding and communicating unique regional characteristics, opportunities and challenges Supporting development of end to end clinical supply processes from planning stage through to sites, investigators and patients. Support for implementation of cross-functional process improvement initiatives based on best practices Providing education and setting expectations to GCTO on GCS processes and practices

9 Regional Leads Support GCS Project Managers by Extending Their Reach into the Region The Regional Leads support the Project Managers (PM) within GCS by: Providing support and expertise on country or regional practices & challenges Facilitating communication of issues between PMs & Regions Leading Resolution of regional issues affecting protocols Supporting Resolution of protocol specific issues impacting a country or region Understanding & communicating unique regional characteristics, opportunities and challenges to demand planning to aid in risk management. Helping to set expectation of GCS to GCTO and the Regions, including education and training on clinical supply processes where appropriate Supporting global implementation of GCS and cross functional process improvement initiatives based on best practices Supporting GCS PMs with mitigation strategies during integration Supporting development of effective distribution plans & strategies

10 Example: Chilean Earthquake (1 of 2) Background: We had many studies running in Chile at the time of the earthquake Clinical Supplies in various locations (depot, sites, customs, in transit) Our Chilean Depot, office and sites all suffered some level of damage Chilean team members were unable enter the offices, contact the depot regularly, were struggling with widespread power outages and intermittent network connectivity. (about 1 hour per day) Headquarter Clinical and Clinical Supplies teams eager to help, but not sure of the best way to help.

11 Example: Chilean Earthquake (2 of 2) Regional Lead Role: Made initial contact with the Chilean team and determined what support they needed Single point of contact for communications Needed support detailing inventory, status, etc Identification of resupply plans should we determine supplies were lost Single point of contact and expedited support for any temperature excursions on supplies in the country Immediately gathered PMs and kicked off a triage process PMs communicated with study teams on supplies PMs gathered status of inventories & contingency plans Compiled input from PMs and executed regular discussions with Chilean team as more and more details came clear. Results: Maintained availability of clinical supplies in the country without disruption to patients

12 Example: New Labeling Process for Latin America (1 of 3) Background: A regulatory change & an internal improvement project caused an urgent need to update our Labeling Process Colombian authorities held shipment due to new regulations on content for Clinical Label & Import Documentation. We had to comply immediately fro existing shipments and describe a plan for cutover. Two large studies added countries after supplies had been released with timelines not permitting new packaging campaigns. Required us to rerelease supplies for new countries. Two issues had very different timeline requirements but there was a connection and an opportunity to be efficient in our approach Colombian labeling requirement had to be remedied in a very short timeframe to release shipments from customs New labeling process required a little more time to update SOPs and business processes.

13 Example: New Labeling Process for Latin America (2 of 3) Regional Lead Role: Regional Lead was very involved in both issues to help assure alignment going forward: Colombian Issue: Regional Lead was notified of regulatory change from country, inventoried list of studies running in Colombia and then scheduled triage meeting with GCS Project Managers, Packaging & Vendor Relations PMs pulled schedule of upcoming shipments to Colombia and packaging location (internal or vendor). Also communicated to study teams Packaging & Vendor relations provided proposals/timing on Just In Time labels, new labeling schedules, and other New Labeling Process: We designed a new process to submit GMP orders for packaging and release of supplies to all Latin American countries anytime a single Latin American countries is involved in a study, avoiding the need to release.

14 Example: New Labeling Process for Latin America (2 of 3) Results: We had a single project, point of contact and initiative that provided Just in Time labels for shipments stuck in customs and all shipments due to Colombia in the short term. New label template designed with new Colombian regulation agreed upon by all Latin American countries such that we could continue using a single label for all Latin American countries. New label requirements were incorporated into the overall process redesign for the entire Latin American labeling process. Were able to do a single training and communication covering both initiatives.

15 Regional Lead Case Studies S. KOREA Issue Drug Supply Drug supply delayed for supporting S. Korea study, which resulted in unsatisfied key investigator of the study. CANADA/RUSSIA Depot to Site Distribution Many temperature excursions between local depot and site, due to long transit time & extreme temperatures RL Action Result a) Explored the reasons and the root cause of drug supply delay with GCSO. Communicated with GCTO lead in S. Korea and GCTO leader in AP to confirm the committed shipment date. b) Continued following up with GCSO and keeping in touch with S. Korea on drug shipment until the final shipment occurred. a) During the period of waiting IMP arrived to sites, GCTO colleagues in S. Korea had been provided confirmation on the progress of drug supply shipment, which could assist them to manage the expectation of local key principle. b) Through the root causes analysis, GCS could look for potential improvement in the process. Short Term Obtained approval to employ World Courier as freight provider Long Term Imported appropriate cold chain materials into Russia and Canada, including Elpro devices & insulated shippers Provided SME led training to depot staff in Russia and Canada RUSSIA /Reverted from World Courier to preferred, lower cost forwarder Elimination of temperature excursions in resupply shipments in Russia and Canada using a cost-effective delivery solution.

16 Regional Lead Case Studies ASIA PACIFIC Issue RL Action Result CAPA commitments Distribution-related observations from internal GCP audits. Example related to: Temperature monitoring of supply shipments from local depot to sites in Taiwan Qualification of depot in China for the storage and distribution of clinical supplies to sites Worked cross functionally to develop & implement solutions to satisfy CAPA. Facilitated resolutions between the local GCO personnel and appropriate HQ personnel (QA, cold chain subject matter experts) Performed the depot qualification visit Provided the training on cold chain shipments to the personnel of local depot CAPA commitments were completed on time while maintaining clinical supply chain continuity Successfully delivered supplies without temperature excursion RUSSIA Import Valuation - Remicade Delays in importing drug due to discrepancy between commercial and clinical value of product Brokered interfaces between Clinical & Clinical Supplies and Financial stakeholders to assess the financial models, understand the risks and develop a solution A commonly acceptable valuation solution was established without any delays to the study start.