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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