Barbara F. Taylor, CIH3/17/06

Barbara F. Taylor, CIH3/17/06

The Evolving Role of the EHS ManagerThe Evolving Role of the EHS Manager

March 17, 2006 2

OutlineOutline

• Overview of Biogen Idec

• Global EHS Policy and Mission Statements

• Core Competencies– Strategy

– Organizational Effectiveness

– EHS Functionality

• EHS Management Program

• Technology

• Challenges – Success Stories

March 17, 2006 3

Transforming Discovery Into CareTransforming Discovery Into Care

March 17, 2006 4

• BIIB in S&P 500

•• 3,4003,400 employees in 2121 countries

• We create new standards of care in oncology, neurology and immunology through our pioneering research, strategic alliances and our global development, manufacturing and commercial capabilities

• 2005 revenues exceeded $2.4 B

• Commercial Products: RITUXAN®, AVONEX®, ZEVALIN®, AMEVIVE®

Biogen Idec (Nasdaq: BIIB)Biogen Idec (Nasdaq: BIIB)

March 17, 2006 5

Biogen Idec Operates WorldwideBiogen Idec Operates WorldwideAn Integrated Biopharmaceutical CompanyAn Integrated Biopharmaceutical Company

Direct Commercial Capabilities in 21 Countries (yellow)

Distribution partners extend commercial reach to over 70 additional markets (blue)

Manufacturing in RTP and Denmark (expected 2008)

North Carolina:Manufacturing

SwitzerlandInternational Headquarters

Cambridge, MAWorld Headquarters,R&D, Marketing, &

Corporate AdminJapanDeveloping Commercial

Capabilities

NetherlandsPackaging & Quality

Australia / NZDirect Sales Force

San Diego R&D,

Oncology

Marketing,

DenmarkManufacturing

(2008)

UKClinical &

RegulatoryCanada

North Carolina:Manufacturing

SwitzerlandInternational Headquarters

Cambridge, MAWorld Headquarters,R&D, Marketing, &

Corporate Admin

JapanDeveloping Commercial

Capabilities

NetherlandsPackaging & Quality

Australia / NZDirect Sales Force

San Diego R&D, Oncology

Marketing

DenmarkManufacturing (2008)

UKClinical &

RegulatoryCanada

Affiliates

Austria Italy

Australia Japan

Belgium The Netherlands

Canada Norway

Denmark Portugal

Finland Spain

France Sweden

Germany Switzerland

UK

March 17, 2006 6

Biogen IdecBiogen Idec’’s Global Portfolios Global PortfolioFour Products, Approved Around the WorldFour Products, Approved Around the World

67 Countries 83 CountriesMabTheraMabThera

®®

29 Countries 6 Countries

March 17, 2006 7

BIIB PartnershipsBIIB Partnerships““small enough to care, big enough to mattersmall enough to care, big enough to matter””

BG-12

BIIB014 (V2006)

Product / Program Company

Daclizumab in MS M200 (volociximab)

HuZAF (fontolizumab)

Hu anti-cd20 mAbBAFF-R/BR3

Small Molecule

March 17, 2006 8

World Class R & DWorld Class R & D

Nobel San Diego California

March 17, 2006 9

Biogen Idec Community LabBiogen Idec Community LabCambridge, MA Established 2002 San Diego, Cambridge, MA Established 2002 San Diego, CACA

Two dedicated teaching labs

at Biogen Idec host more than

2,000 students each year.

Biogen Idec Community Lab is a state-of-the-art

teaching program designed to help transform

today's young students into the discoverers of

tomorrow.

“Working in the community lab made me realize how

much I enjoyed science. I have decided to pursue

Biology based on the experience at Biogen. It helped

me become more aware of how a scientist works and I

can see myself doing this type of work.” – Laura, student

Free to local middle and high school students

For more information e-mail us at:Communitylab@biogenidec.com

March 17, 2006 10

World Class ManufacturingWorld Class Manufacturing

March 17, 2006 11

A Leader in Biologic ManufacturingA Leader in Biologic Manufacturing

Present RTP, NC 6 x 15k L

Cambridge, MA 5 x 2k L

2008 Denmark 6 x 15k L

North Carolina Denmark

Multiple Clinical Supply Manufacturing Sites

+

March 17, 2006 12

Jim Mullen, CEO, has signed the Global EHS Policy that is consistent with our vision, mission and values.

We believe that good values are fundamental to good business. An effective EHS program reduces or eliminates occupational safety and environmental risks. Holding fast to our five Core Values, one of which is “Quality, Integrity, Honesty,” we strive to conduct ourselves with honesty and integrity in all our business dealings, including our commitment to employee safety and environmental integrity.

– Unequivocal commitment to the safety and health of its employees and to communities in which we work and live.

– Our responsibility is fostered at all levels of our business. • Corporate Policy - to provide a safe work environment for its employees and to

be a "good corporate citizen" in the community

• Operating Departments - responsible for daily implementation of the safety and environmental programs and for the safety of their employees

• Individuals - each employee is ultimately responsible to work safely and not place him or herself, a co-worker, or the community at significant risk of harm

• EHS provides the infrastructure and the expertise to develop and implement proactive, hazard-prevention EHS programs that are integrated into all aspects of our business.

Biogen Idec Global EHS Policy Biogen Idec Global EHS Policy

March 17, 2006 13

Global EHS Mission Global EHS Mission

• Provide EHS leadership for Biogen Idec.

• Integrate EHS accountability and hazard prevention practices into all business activities.

• Strive for best practices, while ensuring EHS compliance.

• Provide responsive and supportive customer service to all stakeholders.

• Develop sustainable and integrated EHS infrastructure and aligned programs.

• Embrace available and future technology.

March 17, 2006 14

Core Competencies:Core Competencies:StrategyStrategy

1. Provide strategic worldwide EHS Management Program – (hazard prevention)

2. Organizational effectiveness

• Consistent and clearly defined roles and responsibilities

3. Overall functional capabilities –

• 100 % Customer service

• Continuous improvement, innovation, passion

• Coordination of efforts

March 17, 2006 15

Core Competencies:Core Competencies:StrategyStrategy

• EHS plans that clearly define Global EHS requirements.

• EHS documentation that is user friendly, defensible, and meets regulatory requirements.

• Hazard prevention activities to ensure employee safety - anticipate, recognize, evaluate and recommend / implement controls.

• Continued EHS compliance - anticipate and maintain regulatory and permit requirements.

• Customer service.

March 17, 2006 16

Core Competencies:Core Competencies:Organizational EffectivenessOrganizational Effectiveness

• Global staffing:

• Technical experts and EHS generalists

• Dedicated liaison to EVP organization

• EHS project management

• EHS program management

• EHS Global team leader

• Site staffing:

• Technical experts and EHS generalists

• Site EHS program implementation

• EHS project management

• EHS program management

• EHS Global team member

March 17, 2006 17

Core Competencies:Core Competencies:Organizational EffectivenessOrganizational Effectiveness

Technical expertise, specialized:• Biosafety

• EHS Program Management

• Environmental

• Industrial Hygiene (advanced)

• Occupational Health

• Process Safety / Hazops

• Radiation Safety

• Risk Assessment

• Toxicology

• Ventilation

• Wastewater

• Workers Compensation

• Other

March 17, 2006 18

Core Competencies:Core Competencies:Organizational EffectivenessOrganizational Effectiveness

• Chemical safety

• Gas Safety

• Lab Safety

• Industrial Safety

• Construction, Maintenance and Repair Safety

• Emergency Preparedness/response/ crisis management

• Hazardous materials management

• Hazardous waste

• DEA, BATF Permits

• Toxic Use Reduction

• Life Safety

• Training

• Inspections/audits

• Accident reporting

• Ergonomics/material handling

• EHS Management Program

• Technology

General Expertise General Expertise -- Short ListShort List

March 17, 2006 19

Sr Sec

Global/Camb

Coordinator, EHS

Assoc II, EHS

Global/Camb

Sr Assoc II, EHS

CA

Contractor

Sr Assoc I, Occ Health

CA

Mgr, EHS

CA

Global OSHA

Sr Assoc I, EHS

RTP

Assoc III, Occ Health

RTP

Mgr, EHS

RTP

Global Env

Sr Assoc I, EHS

Camb

Staff Associate, EHS

Camb

Global Biosafety

Open FTE

Sr Assoc II, EHS

Camb

Global Special Projects

Assoc III, EHS

Camb

Env

Assoc I, EHS

Camb

Tech III, EHS

Camb

Tech III, EHS

Camb

Sr. Assoc III, , EHS

Camb

Global Radiation

Sr Assoc I, Occ Health

CA

Assoc III, Occ Health

RTP

Mgr, Occ Health

Global/Camb

Sr Mgr, EHS

Denmark/Europe

Barbara Taylor

Dir, EHS

Global

Yellow – Global/site staffWhite – site staffGrey = contractor or internPink = dotted line

EHS 2006EHS 2006

March 17, 2006 20

EHS Functionality EHS Functionality

StrategyPhilosophyAlignment

Global Accountability

LogisticsImplementation

Make sure it gets doneSite Accountability

Global(enterprise-wide)

LocalSite-based

PrioritiesDecision-making

March 17, 2006 21

Global EHS StaffGlobal EHS Staff

• Functional global leadership, strategy, responsibility, and accountability for area(s) of expertise and/or site management.

• Ensures best practices & consistency of programs and legal interpretations across sites.

• NO SURPRISES.

• 100% customer satisfaction.

• Tap into strengths of different sites.

• Share expert resources.

• Provide infrastructure for consistent but flexible development of site specific programs (Consistent does not equal identical).

• Set company-wide standards for performance.

• Develop strategies for 100% customer satisfaction.

• Develop preferred vendor lists, if applicable.

• Share tools for work processes, data management, and training.

• Optimize technology to support programs.

• Track industry and EHS regulatory changes.

March 17, 2006 22

Globally Driven ProgramsGlobally Driven Programs

• IT applications

• Pandemic Flu Planning

• Construction

• LOTO

• Training matrixes

• Emergency Planning

• Metrics

• Chubb

• Workers Comp

• Fall

• Electrical Safety

• Product MSDSs/toxicology

• Tech Transfer

• Global Engineering Standards

• Global contracts

• Resolution of EHS issues identified through projects, incidents, engineering, etc.

Other Tasks Driven by Global EHS Staff or Ad Hoc Task Group

March 17, 2006 23

EHS Management Program: EHS Management Program: Biogen Idec Global EHS Strategy Biogen Idec Global EHS Strategy –– Hazard PreventionHazard Prevention

1. Management commitment and worker involvement

2. Worksite analysis - Hazard prevention and control

3. Self-inspection & internal audits

4. Education

5. Communication

6. Performance metrics

Hazard Prevention Activities= Hazard Prevention Activities=

Accomplishments= Safety=ComplianceAccomplishments= Safety=Compliance

March 17, 2006 24

Technology:Technology:Biogen Idec iNetBiogen Idec iNet

• Complete EHS Manual– EHS Policy

– EHS Management Program

– OSHA

– Biosafety

– Radiation Protection

– Environmental Programs

– Construction

– Occupational Health

– Ergonomics

– Training matrix

– Inspection forms

• Resources– Technical documents

– Inspection forms

– MSDSs

– BI Product MSDSs

– Work permits

– Links back to resources:• Lotus Notes

• Traincaster

• Other department sites

• EHS iNet linked to other department sites

• Spotlights

March 17, 2006 25

Technology:Technology:iNet SpotlightiNet Spotlight

March 17, 2006 26

Technology:Technology:iNet SpotlightiNet Spotlight

March 17, 2006 27

Technology:Technology:Lotus NotesLotus Notes

• Incident Report System

• Needlestick tracking

• Blood donor system

• Announcements

• Training calendar sign-up

• Flu clinics

• MSDS template for BI products

• Waste pickup forms

• Work order system

– Identify safety hazards

– Ergonomic evaluation request

• EHS Knowledgebase

March 17, 2006 28

Technology:Technology:Misc.Misc.

• Traincaster

• SafeTec

• CisPro

• iProcurement

• IT Global Initiatives

• Travel Advisory – SOS

• Event Reporting

March 17, 2006 29

Changing Business ClimateChanging Business ClimateFall 2005 Fall 2005 -- Strategic InitiativeStrategic Initiative……

to Drive Longto Drive Long--Term GrowthTerm Growth

Re-Sizing for the TYSABRI Overbuild

StrategicChoices

RationalizingSupporting & Enabling Functions

Repositioning

$200 – 300 MMannual savings

• In-licensing

• Collaborations

• M&A

External Growth

~$200 MM per yearearmarked

beginning 2006

March 17, 2006 30

Challenges: Challenges: Changing Business DriversChanging Business Drivers

• Major Business Drivers– Cost savings opportunities

– Metrics

• Mergers

– Integration of EHS groups

– Refocusing EHS philosophy and hazard prevention strategy in new business entity.

– Changing the culture

• Downsizing / Hiring– Developing new internal relationships

– Adjusting resource allocation

• In-Licensing

– Developing cross-functional procedures to ensure EHS timely involvement

March 17, 2006 31

ChallengesChallengesSuccess storiesSuccess stories

• Assets– Sales of assets

• Expedited EHS related issues (transfer or closure of permits, decontamination, negotiation with regulators) to ensure timely final closure of transaction. EHS brought savings of close to $3Million.

– Integration of assets• Integrated EHS, Global Engineering, and Facilities systems to

deliver outcomes.

• Expedited radiation license approval and site approval for transfer of process from CA to RTP.

– New assets• Due diligence

• Project involvement – drive consistent best practices

• Cogeneration Plant (EHS provided concept)

March 17, 2006 32

ChallengesChallengesSuccess storiesSuccess stories

• Construction– Capital projects valued to $460 Million.

– From conception, design, construction and project closeout

– Projects that stop and start and stop and start……………..

– Major capital projects:

• 3 LSM pharmaceutical mfg plants (NC, CA, Denmark)

• Clinical mfg plant expansions (bioreactor trains, wastewater treatment systems, water systems, building utilities, etc.)

• 4 R&D buildings (MA, NC, CA).

• Closeout and decommissioning of R&D and Preclinical Mfg campus in CA.

– Smaller capital projects:

• Small animal facilities to meet AAALAC certification and research needs for BL2 and radiation safety.

• Conceptual design, feasibility studies and permitting for Cogeneration plant.

• Wastewater neutralization conceptual design.

• Hazops and general advocacy for EHS best practices for all capital projects

March 17, 2006 33

ChallengesChallengesSuccess storiesSuccess stories

• Product Development and Technology Transfers– Integrated hazard prevention and best practices

– Facility design (BL1-LS)

– Reduction in ethanol use

– Occupational risk assessments

• Wastewater and stormwater– Contaminated groundwater

• Denmark

• Cambridge – under slab water infiltration

– Wastewater Model - Wastewater management to meet production requirements

– Site specific expectations• Auto detailing

March 17, 2006 34

Newest ChallengeNewest Challenge

March 17, 2006 35

TogetherTogether……we make a difference!we make a difference!

We are Biogen Idec.