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Time Topic Speaker Company 1:00 – 1:15 Welcome and Introductions Mark Tartaglia & Dave Eherts The Pharma Forum 1:15 – 1:45 Why Potent Compound Containment is so Valuable to Business David Eherts, PhD CIH Actavis - Allergan 1:45 – 2:15 Selecting a Cleanroom Garment – It’s not all Apples to Apples: Make Sure the Data Fits the Use Jennifer Galvin, Ph.D. DuPont Protection Technologies 2:15 – 2:45 Merck’s Journey to Control Workplace Exposures Terry Lane, CIH Merck 2:45 – 3:15 Break 3:15 – 3:45 A Good Example of Occ Tox, IH and Containment Challenges George Petroka, MS CIH CSP IES Engineering 3:45 – 4:15 Early Stage API Categorization James Lieberman, CIH Environmental Information Services Inc. 4:15 – 4:45 Banding Gone Wrong Brent Altemose, CIH CSP PhD SafeBridge 4:45 – 5:00 Q&A and Recap Mark and Dave 5:00 – 7:00 Networking Reception Olympus Ballroom A Courtesy of DuPont and Allergan

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Time Topic Speaker Company 1:00 – 1:15 Welcome and Introductions Mark Tartaglia & Dave Eherts The Pharma Forum

1:15 – 1:45 Why Potent Compound Containment is so Valuable to Business David Eherts, PhD CIH Actavis - Allergan

1:45 – 2:15 Selecting a Cleanroom Garment – It’s not all Apples to Apples: Make Sure the Data Fits the Use

Jennifer Galvin, Ph.D. DuPont Protection Technologies

2:15 – 2:45 Merck’s Journey to Control Workplace Exposures Terry Lane, CIH Merck

2:45 – 3:15 Break

3:15 – 3:45 A Good Example of Occ Tox, IH and Containment Challenges George Petroka, MS CIH CSP IES Engineering

3:45 – 4:15 Early Stage API Categorization James Lieberman, CIH Environmental Information Services Inc.

4:15 – 4:45 Banding Gone Wrong Brent Altemose, CIH CSP PhD SafeBridge

4:45 – 5:00 Q&A and Recap Mark and Dave

5:00 – 7:00 Networking Reception Olympus Ballroom A Courtesy of DuPont and Allergan

Why Potent Compound Containment is so Valuable to Business

The Pharma Forum June 2015

David Eherts PhD CIH Vice President Global EHS cell: +1 862 579 7765 email: [email protected]

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Forbes ranked Actavis #1 in its list of top 17 global large cap ($50+ billion) pharma companies.

GLOBAL SUPPLY CHAIN

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Strategic Value The macro business case

Strategic Value The macro business case

Strategic Value The macro business case

As a strong proxy for management quality, environmental performance consistently correlates well with stock price performance.

Investors obviously seek out companies with superior leadership who maximize operating profitability. Our analysis suggests that climate change leadership is another strong reflection of superior management quality; thus, we observe strong correlations with our financial measures.

Strategic Value The macro business case

Sikorsky Revenues ($ billions)

Paul Simpson Chief Executive Officer, CDP

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Safety “At the end of the day, the two most important things in this company are that our products are safe and that our employees are safe.”

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Safety There are two things that really matter . The first is that our products are of the highest quality and at the same time, affordable, so that they are available to do the most good for the greatest amount of patients. The second is that every employee goes home at the end of their workday, the same as when their families sent them to us in the morning. Or better. If we commit to these two most important things, Quality and Safety, business success will surely follow.

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Safety There are two things that really matter . The first is that our products are of the highest quality and at the same time, affordable, so that they are available to do the most good for the greatest amount of patients. The second is that every employee goes home at the end of their workday, the same as when their families sent them to us in the morning. Or better. If we commit to these two most important things, Quality and Safety, business success will surely follow.

INFLUENCING LEADERSHIP CULTURE Etiology doesn’t matter

Understanding Value The business case Regulations Organizational Behavior The Galvanizing Event Recognition, Persistence, Repetition

The Tactical Business Case

Safety

Accident rates

Property loss

Insurance premiums

Fines and citations

No. of people trained

Exposure Assessments

Near misses

Behavioral Observations

Audit findings

Finance/Operations

Earnings/EPS

ROI

Payback

PVRR

Internal Rate of Return

Production rates

Earnings/employee

Net Present Value

Cost Benefit

Issue Potent compounds are being handled utilizing various levels of engineering controls and PPE

Controls have been implemented on a product-by-product and site-by-site basis

Approach

An enterprise wide review of all potent compound unit operations to identify and address potential gaps The impact and benefits summary provided to management for prioritization

Result

Significant commitment to address gaps at strategic sites

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The Value of Containment

The Control banding concept has simplified the selection and implementation of appropriate engineering controls while speeding up the competitive process of bringing innovative new medicines to market quickly, efficiently and safely. Managing exposures at the source provides significant business benefits in addition to reduced operator exposures .

Control Banding Concept

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Exposure Control Strategy Goal

The goal is not just to prevent overexposures, it’s about increasing our capacity to develop and market new products quickly and efficiently.

Benefits

Reduced employee exposures

Reduced chance of cross contamination Reduced variability Reduced Costs

- Reduced PPE requirements - Reduced need for IH Sampling - Reduced facility control requirements - Higher yields

Increased Productivity

- Reduced gowning/de-gowning - Quicker change overs

OSHA’s Hierarchy of Controls

Saves Money Quantitative Financial Analysis completed utilizing ROHSEI©

BIG RULE Safety Culture comes from changed behaviors first, which can become habits and eventually become strongly held beliefs. Once you have this Culture established, it can yield tactical and strategic advantage with a demonstrable reduction in risk and real financial return.

And ensure full funding for EHS programs and full employment for EHS professionals.

Feel free to call or email: David Eherts PhD CIH Vice President Global EHS cell: +1 862 579 7765 email: [email protected]

Time Topic Speaker Company 1:00 – 1:15 Welcome and Introductions Mark Tartaglia & Dave Eherts The Pharma Forum

1:15 – 1:45 Why Potent Compound Containment is so Valuable to Business David Eherts, PhD CIH Actavis - Allergan

1:45 – 2:15 Selecting a Cleanroom Garment – It’s not all Apples to Apples: Make Sure the Data Fits the Use

Jennifer Galvin, Ph.D. DuPont Protection Technologies

2:15 – 2:45 Merck’s Journey to Control Workplace Exposures Terry Lane, CIH Merck

2:45 – 3:15 Break

3:15 – 3:45 A Good Example of Occ Tox, IH and Containment Challenges George Petroka, MS CIH CSP IES Engineering

3:45 – 4:15 Early Stage API Categorization James Lieberman, CIH Environmental Information Services Inc.

4:15 – 4:45 Banding Gone Wrong Brent Altemose, CIH CSP PhD SafeBridge

4:45 – 5:00 Q&A and Recap Mark and Dave

5:00 – 7:00 Networking Reception Olympus Ballroom A Courtesy of DuPont and Allergan