Facilities of the FutureMark A. ButlerSr. Vice President Integrated Project Services - IPS10 March 2015

Agenda

1. Background2. Recent Trends3. Todays Program:

• Appling Pharma Facility Design Standards and Practices to Other Areas of Healthcare

• The Paradigm Shift in Bio manufacturing

FOF Cohort

• Jim Breen – J&J• Gert Molgaard – NNE• Simon Shelley– GSK• Mark Butler – IPS • Nandita Kamdar – J&J

Background1. In 2012 the ILF issued the GPS document that

discussed challenges facinging pharmaceutical companies with respect to operation and design & construction of dedicated plants for ”blockbuster drugs”

2. Higher titers, smaller batches, higher potency products, complex delivery forms all challenge the traditional paradims in the way we design and operate manufacturing facilities.

3. Agility, Facility Design, Enabiling Technologies, # of Products, Flexibility, Continuious Processing and Batch Sizes

4. Several Companies and organizations are all looking at FOF inititiaves

5. The goals of this cohort is to educate and identify how new and existing facilities can adapt to change and to see how standards can drive cycle time reduction, reduce risks and costs

1. Cohort will works with ISPE on an initiative called Facilities of the Future supported by ILF• Obtain input from owners, suppliers and regulators

2. The plan is to make it a global initiative• Annual conferences 3 regions – US, EMEA and AP

3. Aim at close cooperation with ISPE’s PQLI and preferably make joint events with separate tracks to address ”the implementation of QbD on the plant floor”

4. Continue to work with educational partners (STEM) and update white papers on specific tech topics (Aseptics, OSD and Biologics)

What are we doingEvents Year Q1 Q2 Q3 Q4

Forums 2014 ISPE Europe

Seminars / Forums

2015 ISPE NC ISPE India ISPE NJ ISPE Asia

Seminars / Forums

2016 In Planning Stages

Some Industry Pressures• Margins under pressure• Business Models Challenged (out sourced

R&D)• Commoditization is taking hold• Product Shortages• Product Recalls• High cost to bring a product to market• Attrition rates during long trials

1. >56% of respondents say the factory of the future will be measured according to its production capability and flexibility.

2. Over the next five years about 10% of Western enterprises will give up to make-to-stock (MTS) heading toward make-to-order.

3. In five years, 47% of manufacturers will produce modular platforms centrally while using local small factories, suppliers, and distributors to tailor final products for local demand.

4) Manufacturers will have to achieve the global plant floor, harmonizing, supervising, and coordinating execution activities across the company's and suppliers' network .

5) Despite growing plant automation, people — and flexibility / decision-making capabilities they provide will be at the center.

6) 63.6% of respondents expect their production processes to be largely or completely digitized in the next five years.

7) 26% of manufacturers will invest over 25% of their total ICT budget for plant-floor IT

More than 43% of Manufacturers are Designing Factories of the Future Today, According to new IDC Manufacturing Insights Survey

Recent Trends

Back to the Future

March 1020 15 1 7 32

March 1 020 20 1 7 32

March 1 02050 1 7 22

What will the Future look like?

What will the FOF Look like?

1. One size will not fit all. 2. What does the FOF look like to a

Biologics Manufacturere with high volume Block Buster Drugs?

3. What does the FOF look like to a start up Biologics Company with no products?

4. What does it look like to Contract Manufacture?

5. What does it look like to a Contract Research Company?

6. What does it look like to a small molecue API company?

7. What does it look like to a Generic Drug Manufacturer?

Current Disruptors

• Internet of Things• Big Data• Enchanted Objects• Modularity• Single Use• Shared Commons • 3D Printing

1111

“Things” connected to the internet

Image Courtesy: : CISCO

Change is Happening

What Can we expect?

• Innovate the adjacent possible

“The adjacent possible is a kind of shadow future, hovering on the edges of the present state of things, a map of all the ways in which the present can reinvent itself.” Steve Johnson

Disruptive Technologies in R&D

Organ on a Chip

Stem Cell Organs

3D Printed Organs

Big Data Analytics

Creative Commons License by Alfresco Software

Collaboration Enterprise Management

Predictive Maintenance

Yellow Line Concept

Why Different ?Other

industries

1. Simplify & Standardize2. Increase Speed to Market3. Sustainable4. Reduce Risk Exposure5. Service Improvement6. Free up resources activities

Summary

• Look at your plant for areas to standardize

• Look for opportunities to Innovate the Adjacent Possible

• Look to other industries for ideas to improve efficiency

Based on our history of predicting the Future we will likely over estimate the amount of change in the next two years and underestimate the change in the next ten…

Thank You

Mark A. ButlerSr. Vice PresidentIPS 721 Arbor Way Blue Bell, PA 19422mbutler@ipsdb.com