· including aerospace, textiles, and pharmaceuticals. At Biogen since 2013, he is responsible for...
Transcript of · including aerospace, textiles, and pharmaceuticals. At Biogen since 2013, he is responsible for...
www.websitename.com1www.websitename.comee
One Disaster a Week How Biogen Stabilized Supply During August-Septem ber 20 17
Janeen has over 223 years of pharmaceutical quality,
cGMP experience. At Biogen since 2015, she is
responsible for Biogen’s cGMP Regulatory
Intelligence and Pharmacopoeial Affairs Activities,
influencing and ensuring the implementation of
global cGMP regulations, guidance and
pharmacopoeial standards. She is actively involved
in leadership roles within various trade associations
and professional organisations such as IPEC, PDA,
EFPIA and BPOG, spending much of her career
participating in the development of ICH standards.
As part of her career she has been actively involved
in excipient quality, cGMP, supplier qualification and
compendial standards. She holds a Bachelor’s of
Science in Chemistry from the University of
Connecticut, Storrs.
Janeen Skutnik-WilkinsonHead Regulatory Intelligence & Pharmacopoeial Affairs, Biogen
Quality/ cGMP Regulations, Guidance Expert
Worked in the areas of cGMP compliance, External Advocacy,
Quality Strategy and Pharmacopoeial Advocacy &
Compliance
INTRODUCTION
Lee has over 115 years of manufacturing and supply
chain operations experience in various industries
including aerospace, textiles, and pharmaceuticals. At
Biogen since 2013, he is responsible for Biogen’s
Global Product and Supply Chain security team
leading all the aspects of end to end supply chain
prevention, detection, and response to potential
supply chain disruptions and threats.
As part of his supply chain career he has worked
diligently in the areas of improving supply chain
resiliency, robustness, and security. Lee holds an
Aerospace degree from Embry-Riddle Aeronautical
University.LEE SPACH
Director, Global Product and Supply Chain Security, Biogen
Manufacturing and supply chain operations expert
Worked in the areas of improving supply chain resiliency,
robustness, and security
INTRODUCTION
Resilinc® - Information and Analytics Driven Approach Tool
• Part-Site Mapping• Sub-Tier Dependencies• Recovery Time/Alternate Sites• Supplier/Site Risk Assessments
Quantify/ Prioritize
Risks
Mitigate Proactively
Monitor/ Assess Events
Respond Effectively
PPROTECT Brand
PREDICT R iskCO N N EC T t o Re s i l i n c D a t a N e t w o r k
Visibility/Recovery
CyberSecurity
Mitigation of natural disaster impact by proactively planning res ilience in the s upply chain
Value of proactive mapping and vis ibility to events and links to s upply chain
Organizational s tructure for efficient and effective event res pons e
ONE DISASTER A WEEKHow Biogen Stabil ized Supply during August -September 2017
Integrate data and technology to bus ines s proces s es to drive res ults
IRMAMexico CityEarthquake
HARVEY
MARIA
VP-Global Security
Director Global Security, North American
Operations, Business Continuity & Crisis
Management
Assoc Director, Business Continuity & Crisis Management
Assoc Director, Global Security MA, Canada, and
US Sales Force Operations
Assoc Director, Global Security North Carolina &
DC Operations
GSOC Manager
GSOC Specialist
Director Global Security, Product & Supply Chain
Security
Sr Manager Supply Chain Security
Program Manager, Product and Supply Chain Security
Sr. Supervisor, Product and Supply Chain Security
Assoc Director, Global Security Systems and
Technology
Manager, Security Systems & Technology
Director, International Security Operations
Assoc Director, Denmark & Nordic Security
Operations
Sr Manager DACH Security
Sr Manager, LATAM Security
Sr Manager, Global Event Security
Manager, APAC Security(PO&T Security Partner)
Global Security Department Coordinator
Chief Informat ion Security Of f icer
BIOGEN’SGLOBAL SECURITY ORG
44 Consecut ive Natural DisastersIm pacting RegionsCritical to Life Sciences Industry
TRIGGERS FOR ACTIVATION
Through August and September 2017,
supply chain anticipated impact from
numerous high profile natural disaster
disruptions, including:
• Hurricane HHarvey (Texas)
• Hurricane IIrma (Puerto Rico/Caribbean/Florida)
• Hurricane MMaria (Puerto Rico/Caribbean Islands)
• Mexico City EEarthquake
Ut il izing Resilinc Intell igence and Tools, Biogen Proact ivelyMit igated Disrupt ion Risk From These Events
RRISK MANAGEMENT SYNERGYBiogen GSOC + Resil inc Tool
responsible for real-time monitoring global employee locations and safety, Travel Safety, Major Disaster Events – security of Biogen assets, Physical Sites (Self-owned manufacturing sites, offices, physical security), Overall security of Biogen employees, locations – not inherently supply-chain oriented
Monitoring of supply chain network, supplier and manufacturing sites, real-time intelligence of events analyzed from supply chain perspective, Utilization of Impact Notifications, What-If: Proactive risk mitigation and scenario planning
Resilinc Event WarRoom, What-If Scenario Planner
Biogen “GSOC”Global Security Operations CenterExtensive monitoring center in Cambridge MA
BBIOGEN EVENT RESPONSE PROCEDURE WITH RESILINC
Senior Leadership
Resiliency Team (SC Security Lead)Cross Departmental Line Functions
Procurement, Logistics, Manufacturing (Int./Ext.), SC Quality, Regulatory, Finance, Network Strategy,
Site Leadership, Process Engineering, etc
Natural Disaster
War Room
Top-Down DirectivesBased onWar Room
Output
Post-Event Evaluation & Playbooks
Formalization
• Pull Forward Purchasing• Secondary Sourcing • Alt. Sites – Level Loading• Inventory Relocation
GSOC
Other IntelligenceServices
Resilinc Supply Chain Intelligence
Resilinc What-If Scenario Planning
Corp Crisis Mgmt
Supply Chain Security
Analysis of impact to Biogen facilities; employees,
travelers
Mitigation Recommendation
s
HHURRICANE MARIA RISK AVOIDANCE
Team assisted in the successful interception of “lost” shipments from USA to PR.
Avoided potential stock out of certain drug substance bags across multiple products
Team identified several bags that are made to Biogen only specs; initiated dual sourcing project
Limited product flow out of US to PR to ensure delivery
002Decisions to Ensure CapacityMade purchasing decisions to ensure capacity from region which is currently rebuilding and at-risk of future disruption
03Risk IntelligenceHurricane Maria (& Crisis Mgmt SOP gleaned): Risk intelligence from Resilinc ultimately pushed to Executive Management; Executive Management pushed directives to active line functions responsible for mitigating specific disruptions.
01Proactive AssessmentProactively identified
vulnerabilities
04Streamlined Communication
Greatly streamlined cross-departmental communication and
collaboration to mitigate and identify supply chain vulnerabilities
HURRICANE MARIA TAKEAWAYS
MEXICO CITY EARTHQUAKEIDENTIFYING QUALIFIED ALTERNATES
Event WarRoom and What-If tool › Identified vials used in US manufacturing ops› Distributor and 3PL warehouses that sell to Mexican market› Clinical sites and supply movement in surrounding Mexico City areas
Qualified alternate site outside impact region› Worked with suppliers to evaluate impact and viability of secondary
inventory warehouses.
001Pre-Incident PhasePreparation for forecasted weather event or other predicted event.
02Assessment phaseGather and review data and assess impact.
04Transition Phase
Monitor results and adjust actions. Transitions to
business-as-usual
03Execution Phase
Determine planned actions and execute
SUPPLYCHAIN CRISIS PHASES – PLAYBOOK
Incident Occurs
SSUPPLYCHAIN EXPANSIONClinical Sites and Studies
Map Biogen clinical trial sites and study #’s globally
Leverage natural disaster, macroeconomic, geopolitical risk scores per site location
Monitor clinical sites disruptive events – real time intelligence for supply chain disruptions
Plan future clinical studies in less risky regions of the world
Utilize risk scoring to vet locations and select vendors based on locations
One Disaster a Week
RISK MANAGEMENT SYNERGY Biogen GSOC + Res ilinc Tool
Lee Spach, Director Global Product and Supply Chain Security, Biogen