IPX 2012 Conference Brochure by Reed Exhibitions

IT HAPPENS AT ARE YOU IN?

I N T R O D U C I N G T H E N E W, R E S T R U C T U R E D

CONFERENCE PROGRAM

INSIGHT • INNOVATION • INTERACTION

MAY 1-3, 2012 JAVITS CENTER l NEW YORK, NY BRINGING TOGETHER KEY PHARMA AND BIOTECH PROFESSIONALS WITH SUPPLIERS TO CREATE INNOVATIVE SOLUTIONS.

EXPERIENCE WHAT’S NEW AT INTERPHEX RESTRUCTURED CONFERENCE PROGRAM

This year’s conference has been re-engineered to align with the way companies bring products to successful market realization. Tracks and sessions have been developed to bring real-world experiences directly to you. • • •

Regulatory QA/QC Product Development Facility & Process Design

• •

Manufacturing & Packaging Supply Chain

CONFERENCE ADVISORY BOARD

We’ve enlisted the help of the new INTERPHEX Conference Advisory Board, whose combined experience represents the spectrum of pharmaceutical and biopharmaceutical manufacturing. Their valuable insights played a key roll in determining the event’s conference program. Meet the Conference Advisory Board on page 16.

KEYNOTE SESSIONS

Three Keynote Sessions to inspire you with new ideas, led by: • Jeff Baker, FDA • Jim Miller, Pharmsource Information Services, Inc. • Richard Smith, FedEx

SPEAKERS

Featuring the industry’s best and brightest highlighting current trends in product development/ process introduction. • •

International Speakers/Companies Microbiologist from Dept. of Commerce

• •

Principle Engineer from NASA Speakers from the FDA

TECHNICAL WORKSHOPS

Featuring eight, 45 minute Technical Workshops, led by: • • • •

Bosch EMD Millipore Corporation Fette Compacting America GE Healthcare

• • • •

Glatt Air Techniques Pall Life Sciences STERIS Thermo Fisher Scientific

TABLE OF CONTENTS INDUSTRY KEYNOTES............................3 CONFERENCE AT-A-GLANCE..................4 SESSION DESCRIPTIONS........................6 FREE SESSIONS...................................14 ADVISORY BOARD................................16 FACILITY OF THE YEAR AWARDS...........17 SPECIAL EVENTS.................................18 SHOW FLOOR OVERVIEW......................19 EXHIBITOR LIST....................................20 PLAN YOUR SHOW...............................22 TRAVEL & SHOW PACKAGES................23 2

SHOW & CONFERENCE HOURS CONFERENCE HOURS Tuesday, May 1 9:00 am – 5:00 pm Wednesday, May 2 9:00 am – 5:00 pm Thursday, May 3 9:30 am – 1:00 pm

EXHIBIT HALL HOURS Tuesday, May 1 10:00 am – 5:00 pm Wednesday, May 2 10:00 am – 5:00 pm Thursday, May 3 10:00 am – 3:00 pm

INDUSTRY KEYNOTES Learn from the most successful and innovative industry authorities at our 2012 Keynote Sessions. Keynote Sessions are open to all badge holders.

JIM MILLER President, PharmSource Information Services, Inc.

WHAT THE NEW BIO/PHARMA BUSINESS MODEL MEANS FOR CMOS AND CROS Tuesday, May 1, 9:15am - 10:15am The radical transformation of the bio/pharma business model presents new opportunities and challenges to providers of development and manufacturing services.

JEFFERY C. BAKER Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. Food & Drug Administration

CONTROL, CAPABILITY, AND CAPACITY: ELEMENTS ASSURING A RELIABLE DRUG SUPPLY Tuesday, May 1, 1:30pm - 2:30pm This presentation will provide a technical/historical context for discussions that are currently underway in which the FDA is partnering with the industry to better understand and control factors that can compromise the ability to deliver high quality medicines in a reliable way.

RICHARD SMITH Director, Life Sciences & Specialty Services, FedEx

CREATING INNOVATIVE COLD CHAIN SOLUTIONS FOR YOUR PHARMACEUTICAL AND BIOPHARMACEUTICAL PRODUCTS Wednesday, May 2, 10:15am - 11:15am The international healthcare market is valued at more than $1 trillion in goods — and spending is expected to grow 5 percent annually through 2013. Given the huge growth within this industry, customers need a global distribution network they can trust.

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CONFERENCE AT-A-GLANCE

TUESDAY, MAY 1, 2012

WEDNESDAY, MAY 2, 2012

REGULATORY QA/QC

PRODUCT DEVELOPMENT

9:00 AM– 9:15 AM

FACILITY & DESIGN PROCESS

MANUFACTURING & PACKAGING

REGULATORY QA/QC

SUPPLY CHAIN

Welcome and Introduction

9:15 AM– 10:15 AM

Keynote: What the New Bio/Pharma Business Model Means for CMOs and CROs *

Case Study: Regulatory Consequences from Poor Microbiological Manufacturing and Laboratory GMPs

10:30 AM– 11:30 AM

Panel Discussion: Best Practices and Regulatory Expectations in Continuous Processing

Case Study: You Need a Small Clean Room For... So Where Do I Start?

Case Study: Implementing Single-Use Technologies in a GMP Facility

Guidance for Industry Process Validation: General Principles and Practices A CMO’s Approach

11:45 AM– 12:30 PM

Technical Workshop: Bosch; Fette Compacting America, Inc; Glatt Air Techniques; Pall Life Sciences *

12:30 PM– 1:30 PM

Lunch

1:30 PM– 2:30 PM

Keynote: Control, Capability, and Capacity: Elements Assuring a Reliable Drug Supply *

Learn the Seven Things You Technical Should Do Before Challenges in the Facing an Inspection Development of Biosimilars

2:45 PM– 3:45 PM

Case Study: An Enterprise-Wide Approach to Global Change Management

4:00 PM– 5:00 PM

Making Risk Assessment Part of Technology Transfer

Case Study: Optimizing Execution with Modular Construction

Case Study: Greener Manufacturing with Reduce, Reuse, Recycle & Reclaim of Water

Single-Use Technology Enabling Biosimilar Manufacturing

Case Study: Use of Pre-Sterilized SingleUse Disposable Fluid Paths in Sterile Manufacturing

9:00 AM– 10:00 AM

Learn Why Export Control on Processing Equipment is Important

PRODUCT DEVELOPMENT

FACILITY & DESIGN PROCESS

MANUFACTURING & PACKAGING

SUPPLY CHAIN

Case Study: Designing Critical Cleaning Processes to Mitigate Microbial Risk in Multi-Product Facilities

Case Study: Meeting Sustainability Challenges with the Revamping of Your Wastewater Plant

Case Study: Aspects of a Sustainable Maintenance for a Lifecycle Cleaning Validation Program

Why Deploying Lean Six Sigma is Important for Global Manufacturing Networks

10:00 AM– 12:00 PM

Floor Tours: Advanced Aseptic Tour, Biologics Tour, Oral Solid Dosage Technologies Tour *

10:15 AM– 11:15 AM

Keynote: Creating Innovative Cold Chain Solutions for your Pharmaceutical and Biopharmaceutical Products *

11:30 AM– 12:15 PM

Technical Workshop: EMD Millipore; GE Healthcare; STERIS; Thermo Fisher Scientific *

12:15 PM– 1:15 PM

Lunch

12:30 PM– 2:30 PM

Floor Tours: Advanced Aseptic Tour, Biologics Tour, Oral Solid Dosage Technologies Tour *

1:30 PM– 2:30 PM

Streamlining Risk Management Evaluations for New Manufacturing Processes

Case Study: Why is Product and Process Understanding in Supporting Postapproval Change Important?

Case Study: Asset Optimization & Flexible MultiProduct Facility Concepts: Abstract

Case Study: Translating the New Process Validation Paradigm to Cleaning Process

Why Supply Chain Security is So Important in Today’s Marketplace

2:45 PM– 3:45 PM

Proven CostSavings Using Manufacturing Execution Systems (MES) for BioPharm Manufacturers

How to Use Online Analytics as a PAT Tool to Enable QbD in Upstream Cell Culture

Case Study: Why Logistics Modeling and Architectural Layouts is Important

Introduction to the New ISPE Guide: Science- and RiskBased Approach for the Delivery of Facilities, Systems, and Equipment

Applying a Knowledge-Based Approach to Supply Chain Pharmaceutical Temperature Control Management

4:00 PM– 5:00 PM

Proven Processes and Metrics to Optimize Operational Excellence

Bioburden Control for Sterile Filtration for Injectable Biotechnological and Pharmaceutical Drug Product Manufacturing

Implementing Commissioning and Qualification in Line with the FDA’s Recent Process Validation Guidance

Case Study: Path to Reduce Operational Expenses and Improve Operational Efficiency

Regulatory Strategies and Considerations for Successful Site Transfers

Is Your CMO Committed to Your Success?

Case Study: How to Benefit from Pharmaceutical Distribution Outsourcing

THURSDAY, MAY 3, 2012 9:30 AM– 10:30 AM

Practical Applications of Statistical Methods Under 2011 FDA Process Validation Guidance *

10:45 AM– 11:45 AM

Making it in Massachusetts — A Small Company’s Road to the CMO Market *

12:00 PM– 1:00 PM

Development of Novel CR Formulation Mitigating Dose Dumping & Misuse * Conference Ends

1:00 PM

* = Open to all badge holders 4

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CONFERENCE SESSION DESCRIPTIONS

REGULATORY QA/QC TRACK

Case Study: Regulatory Consequences from Poor Microbiological Manufacturing and Laboratory GMPs

Proven Cost-Savings Using Manufacturing Execution Systems (MES) for BioPharm Manufacturers

Tuesday, May 1, 10:30am – 11:30am Dennis E. Guilfoyle, Ph.D., Pharmaceutical Microbiologist, U.S. Food & Drug Administration Learn about the microbiological problems documented during an on-site FDA inspection. The inspection resulted in the documentation of a variety of manufacturing practices and laboratory results that demonstrated the firm was out of compliance.

Wednesday, May 2, 2:45pm – 3:45pm Marco Lederle, Director Consulting / Partner, i+o Industry Planning + Organization This presentation discusses planning for MES from evaluating the benefits of MES, defining goals, positioning MES within the IT infrastructure and aligning stakeholder requirements through development of a coordinated user requirements document. These activities provide the basis for MES software selection and implementation resources. Examples of cost savings available through an MES implementation are included in the presentation.

Seven Things You Should Do Before Facing an Inspection Tuesday, May 1, 2:45pm – 3:45pm Rosario Quintero-Vives, Sr. Regulatory & Compliance Specialist, RQV Consulting Discover the short list of items which are usually overlooked in preparing for an inspection and how to improve the operation to pass. Not only will this make your inspection less stressful, but it may even end up improving your business plan and preventing observations in the future.

Case Study: An Enterprise-Wide Approach to Global Change Management Tuesday, May 1, 4:00pm – 5:00pm KR Karu, Pharmaceutical Industry Principal, Sparta Systems To ensure that product quality is not compromised as operations expand, companies have undertaken initiatives to implement controls throughout the organization and ensure that changes are recognized and enforced across boundaries. This presentation will provide organizations with a step-by-step approach to implementing and standardizing effective global change management across the enterprise.

Learn Why Export Control on Processing Equipment is Important Wednesday, May 2, 9:00am – 10:00am Betty Lee, Ph.D., Microbiologist, U.S. Department of Commerce Focus on US export regulations on dual use technology along with equipment for the biotechnology industries and microorganisms. It will cover the reasons for control of dual use technology in order to minimize the risks of bioterrorism. Additionally, it will also discuss the President’s export control reform initiative and the latest regulations that have been published in the Federal Register.

Streamlining Risk Management Evaluations for New Manufacturing Processes Wednesday, May 2, 1:30pm – 2:30pm Mike Porter, Consultant, Commissioning Agents, Inc. Ivan Toponarski, Project Engineer, Allergan Medical When performing a traditional FMEA approach to risk management, the process can require significant commitment in terms of number of people and time to execute. The presentation will utilize actual case studies to show how to: • Utilize a Fault Tree analysis to identify the critical areas that impact patient safety and product quality • Transfer this knowledge to a risk assessment tool • Document the final risk decisions

Proven Processes and Metrics to Optimize Operational Excellence Wednesday, May 2, 4:00pm – 5:00pm Shane Yount, Principal / Author, Competitive Solution, Inc. Ed Dubeau, Director and Team Leader of Manufacturing for Consumer Healthcare Operations, Pfizer, Inc. In this interactive presentation, participants will receive a lively overview of the four key elements necessary to create and sustain a high performance mentality and process throughout any organization. Additionally, it will look at the real-world business challenges facing organizations today, as well as give participants a specific implementation methodology to begin practicing upon immediate return to the workplace.

PRODUCT DEVELOPMENT Panel Discussion: Best Practices and Regulatory Expectations in Continuous Processing Tuesday, May 1, 10:30am – 11:30am Presented and moderated by Pharmaceutical Technology Moderator: Angie Drakulich, Editorial Director, Pharmaceutical Technology Panelist: Moheb Nasr, Ph.D., Vice President, CMC Regulatory Strategy, Global Regulatory Affairs, GlaxoSmithKline, Former Director of the FDA Office of New Drug Quality Assessment, CDER Fernando J. Muzzio, Ph.D., Director, NSF ERC on Structured Organic Particulate Systems, Professor II, Department of Chemical and Biochemical Engineering, Rutgers University Elaine Morefield, Ph.D., Deputy Director, Office of New Drug Quality Assessment, CDER, U.S. Food & Drug Administration This panel will include expert discussion of the most pressing questions, challenges, and best practices surrounding continuous processing and how industry and regulators can best move forward in this growing approach. Specific unit operations, full closed-loop automated control strategies, validation and cleaning requirements and more will be addressed.

Learn the Technical Challenges in the Development of Biosimilars Tuesday, May 1, 2:45pm – 3:45pm E. Morrey Atkinson, Ph.D., Chief Scientific Officer, V.P. of Research and Development, V.P. of Drug Substance Manufacturing, Cook Pharmica, LLC Learn more about the challenges and opportunities biosimilar manufacturers are facing, and how manufacturing processes and analytical techniques have changed since the launching of current branded biologics. The presenter will also discuss ways to achieve maximum manufacturing efficiency and in-depth understanding of the product and process, as well as the balance between demonstrating comparability to the innovator compound and best practices for today. CONNECT WITH US:

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CONFERENCE SESSION DESCRIPTIONS

PRODUCT DEVELOPMENT

Making Risk Assessment Part of Technology Transfer Tuesday, May 1, 4:00pm – 5:00pm J. Richard Creekmore, Ph.D, R.Ph., US Technology Manager, AstraZeneca Pharmaceuticals LP Technology transfer is an important stage in the life cycle of a project whether it is during development for clinical supplies or for transfer to the production site. This presentation will offer ideas on how to reduce the amount of time needed to complete the technology transfer risk assessment.

Case Study: Designing Critical Cleaning Processes to Mitigate Microbial Risk in Multiproduct Facilities Wednesday, May 2, 9:00am – 10:00am Mary Ellen Clark, Validation Scientist I, MedImmune Brian Goss, Associate Director, Validation Technical Services, Imclone Systems Paul Lopolito, Technical Services Manager, STERIS Corporation Microbial contamination of process equipment is a concern for pharmaceutical, biopharmaceutical, medical device, dietary ingredients and personal care industries. This presentation will focus on three critical elements and will also include numerous industry references and case examples to help assess risk of microbial cross-contamination from one batch or product to another.

Case Study: Why is Product and Process Understanding in Supporting Post-approval Change Important? Wednesday, May 2, 1:30pm – 2:30pm Yihong Qiu, Ph.D., Research Fellow, Oral Drug Products, Manufacturing Science and Technology, Global Pharmaceutical Operations, Abbott Laboratories This presentation will discuss opportunities of supporting various post-approval changes for solid oral products via understanding of the product, manufacturing process and test method, including examples of justifying specification revision, multiple related changes and biowaiver based on quantitative and non-quantitative in vitro-in vivo relationship (IVIVR).

How to Use Online Analytics as a PAT Tool to Enable QbD in Upstream Cell Culture Wednesday, May 2, 2:45pm – 3:45pm Stefan Steigmiller, Ph.D., Head of PAT-Biotech Projects, Bayer Technology Services GmbH Currently FDA and other regulatory agencies encouraging pharmaceutical industry to a paradigm change and the use of process analytical technologies (PAT) in pharmaceutical production. The biggest challenges for Process Development in Cell Culture Upstream will be discussed. Latest data will be presented, as well as our setup of a closed-loop control for glucose including an integrated PAT data management.

Bioburden Control for Sterile Filtration for Injectable Biotechnological and Pharmaceutical Drug Product Manufacturing Wednesday, May 2, 4:00pm – 5:00pm Dilip Ashketar, Sr. Director Quality Control, Gilead Sciences, Inc. Sterile filtration is critical for the manufacture of sterile injectable biotechnologically derived and small molecule drug products. Strategies to reduce bioburden, risks and benefits of multi-filter arrangements, filter selection and sizing characterization, critical filtration parameters and hold time validation strategies for the filtered materials will be presented. The presentation will also cover the regulatory and technical framework and strategies to assign meaningful bioburden limits prior to sterile filtration.

FACILITY & DESIGN PROCESS Case Study: You Need a Small Clean Room For... So Where Do I Start? Tuesday, May 1, 10:30am – 11:30am Susan Morrison, Principal Construction Engineer, Parsons Engineers @ Goddard Spaceflight Center, NASA Throughout the clean room industry there seems to be a lack of detailed design interest and knowledge in the small stick built direct expansion cooled clean room. This presentation will provide design thoughts and stimulate discussion of this over looked market segment and give the guidance in the “what do we need to know and consider” in design of these environments.

Case Study: Optimizing Execution with Modular Construction Tuesday, May 1, 2:45pm – 3:45pm John Gilroy, P.E., Sr. Vice President and Principal, Integrated Project Services Companies that embrace Modular Construction design and construction methodologies will realize a reduction in the overall project schedule and increased quality without minimal disruption to ongoing site operations while enjoying significant cost benefits. Successes will be showcased and real project examples presented.

Case Study: Greener Manufacturing with Reduce, Reuse, Recycle & Reclaim of Water Tuesday, May 1, 4:00pm – 5:00pm Johann Bonnet, Strategic Account Manager, Veolia Water Solutions & Technologies Manufacturing of API compound in some cases requires 1 ton of water for 800 kilos of active ingredient. Water in its many qualities (softened, deionized or purified) is a key utility fluid for the Active Pharmaceutical Ingredient processing and even more crucial for galenic (secondary) manufacturing which requires Purified Water and Water for Injectable quality.

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CONFERENCE SESSION DESCRIPTIONS FACILITY & DESIGN PROCESS Case Study: Meeting Sustainability Challenges with the Revamping of Your Wastewater Plant Wednesday, May 2, 9:00am – 10:00am Ajit Ghorpade, Ph.D., Technical Director for Biological Processes, Veolia Water Solutions & Technologies The pharmaceutical manufacturing industry is facing ever increasing environmental constraints. Wastewater management is definitely one of the key issues that need to be dealt with.

Case Study: Asset Optimization & Flexible Multi-Product Facility Concepts Wednesday, May 2, 1:30pm – 2:30pm Jim Robertson, Sr. Technical Director of Facilities Integration, Fluor Enterprise Inc. Craig Sandstrom, Ph.D., Director of Process Engineering, Fluor Enterprise Inc. This course presents two topics, often interconnected with a focus on realizing maximum output from existing facilities; flexible design concepts are then introduced, where additional facilities are required to replace or supplement existing operations.

Case Study: Why Logistics Modeling and Architectural Layouts is Important Wednesday, May 2, 2:45pm – 3:45pm Philip R. Lyman, Ph.D., Director, Process Simulation, CRB Consulting Engineer, Inc. Robert K. Orgera, AIA, LEED, AP, Sr. Architect, CRB Architects & Engineers, Inc. Decisions you make during design can have long term effects on the profitability of your biopharmaceutical manufacturing facility. Process simulation combined with analytical layout decisionmaking can mitigate this risk and give you a future cost advantage over your competition.

Implementing Commissioning and Qualification In Line with the FDA’s Recent Process Validation Guidance Wednesday, May 2, 4:00pm – 5:00pm Aaron Weinstein, Northeast Regional Director - Commissioning & Qualification, IPS - Integrated Project Services Jason D’Orlando, Associate Director - Project Controls, Shire HGT With the rise in the application of risk-based and science-based approaches and the industry-wide focus on Quality by Design, it is imperative that a good understanding of the C&Q effort be realized from the outset and the activities planned accordingly.

MANUFACTURING & PACKAGING Case Study: Implementing Single-Use Technologies in a GMP Facility

CONFERENCE SESSION DESCRIPTIONS MANUFACTURING & PACKAGING Single Use Technology Enabling Biosimilar Manufacturing Tuesday, May 1, 2:45pm – 3:45pm Todd Bucciarelli, Business Development, IIT Research Institute Bill Whitford, Market Manager, Cell Culture, Thermo Fisher Scientific Biosimilars differ from small molecule generics in a number of ways, resulting in distinct statutory, regulatory, clinical and business considerations. Single-use production technology provides a number of benefits from cost savings to process efficiency to heightened safety.

Case Study: Use of Pre-Sterilized Single Use Disposable Fluid Paths in Sterile Manufacturing Tuesday, May 1, 4:00pm – 5:00pm Matthew P. von Esch, Manager Manufacturing Fill/Finish, United Therapeutics Wenzel Novak, Ph.D., Director Pharmaceutical Research and Development, Groninger & Co. GmbH Recent advances in disposable technologies, along with greater understanding of regulatory expectations, have opened the door to incorporation of disposables in critical areas such as aseptic processing.

Case Study: Aspects of a Sustainable Maintenance for a Lifecycle Cleaning Validation Program Wednesday, May 2, 9:00am – 10:00am Igor Gorsky, Associate Director, Validation, Global Pharmaceutical Technology, Shire Pharmaceuticals, Inc. This session presents information in a pragmatic approach and includes case studies. It will assist pharmaceutical industry professionals in creating a robust cleaning validation maintenance program for their equipment and facilities.

Case Study: Translating the New Process Validation Paradigm to Cleaning Processes Wednesday, May 2, 1:30pm – 2:30pm Keith Bader, Sr. Consultant, Hyde Engineering+ Consulting, Inc. Jeff Slutsky, Director of Design for Six Sigma, Bausch and Lomb Too often, cleaning cycles are developed as an afterthought on full scale equipment without an initial science-based parameter set. Cleaning process development is a necessary and critical part of manufacturing process development activities and yet receives less attention than warranted. The information gleaned from this sort of study can then be further utilized when developing or modifying a site cleaning strategy.

Tuesday, May 1, 10:30am – 11:30am Peter Watler, Ph.D., Principal Consultant and Chief Technology Officer, Hyde Engineering+ Consulting, Inc. Implementing such leading-edge technologies brings new challenges, especially for change control, vendor selection and validation. This discussion will also focus on practical aspects of implementing disposable technologies.

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CONFERENCE SESSION DESCRIPTIONS

CONFERENCE SESSION DESCRIPTIONS SUPPLY CHAIN

MANUFACTURING & PACKAGING Introduction to the New ISPE Guide: Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment Wednesday, May 2, 2:45pm – 3:45pm Steven Wisniewski, Principal Compliance Consultant, Commissioning Agents, Inc. Hot off the Press! This session illustrates the application of Quality Risk Management to commissioning and qualification practices, presenting new terminology and approaches to the science- and risk-based specification and verification terminology and approaches applied in ICH Q8-10 and ASTM E2500.

Case Study: Path to Reduce Operational Expenses and Improve Operational Efficiency Wednesday, May 2, 4:00pm – 5:00pm Niranjan Kulkarni, Ph.D., Operations Specialist, CRB Consulting Engineers, Inc. Philip R. Lyman, Ph.D., Director, Process Simulation, CRB Consulting Engineer, Inc. Amit Srivastava, Project Manager, Novartis Institute of Biomedical Research It is common knowledge that reducing operational expenses and improving efficiencies help companies increase their profitability and market share. However, the million dollar question is how do we achieve this?

SUPPLY CHAIN Guidance for Industry Process Validation: General Principles and Practices A CMO’s Approach Tuesday, May 1, 10:30am – 11:30am Sandra Lueken, Director of Quality, Baxter Pharmaceutical Solutions The FDA’s new Process Validation Guidance outlines general principles and approaches appropriate for the manufacturing of human and animal drug and biological products. Replacing the 1987 guidance, this document aligns process validation with a product lifecycle concept, existing FDA guidance and the International Conference on Harmonisation (ICH) guidance.

Is Your CMO Committed to Your Success? Tuesday, May 1, 2:45pm – 3:45pm Raul Soikes, Sr. Director Program Management R&D, Baxter Healthcare Corporation A CMO needs to yield the best value to your organization and not just produce your product. They need to serve as an expert to help maximize your product’s potential and to treat your project with care and commitment. Presented here is a model leveraging best practices from project management, customer service, and Lean Six Sigma.

Why Deploying Lean Six Sigma is Important for Global Manufacturing Networks Wednesday, May 2, 9:00am – 10:00am Robert Lechich, Director Operational Excellence, Pfizer, Inc. In the pharmaceutical industry, future manufacturing strategies will require a balance of speed, cost and agility while maintaining high quality levels and regulatory compliance. This presentation will discuss experiences and lessons learned within the Pfizer’s manufacturing network.

Why Supply Chain Security is so Important in Today’s Marketplace Wednesday, May 2, 1:30pm – 2:30pm Thomas Dale, Director, Supply Chain Marketing and Vertical Marketing Development, FedEx Listen to some of the current challenges in securing a healthcare supply chain and how companies leverage various tools to improve the security of their supply chain. This presentation builds on the keynote presentation by Richard Smith and will delve into how to select the right network, 24x7 monitoring and sensor based innovations.

Applying a Knowledge-Based Approach to Supply Chain Pharmaceutical Temperature Control Management Wednesday, May 2, 2:45pm – 3:45pm Arminda O. Montero, Global Distribution QA Program Manager, Global Pharmaceutical Operations, Abbott Laboratories • Applying knowledge-based approach to product stability to optimize temperature-sensitive product distribution • Establishing product storage, shipping and excursion temperature ranges • Implementing compliant and cost-effective temperature control logistics solutions

Regulatory Strategies and Considerations for Successful Site Transfers Wednesday, May 2, 4:00pm – 5:00pm Sema Z. Ariman, Regulatory Affairs Manager, CMC Regulatory Affairs PPG, Abbott Laboratories In today’s current economic climate, it is critical more than ever to have flexibility in a pharmaceutical company’s Supply Chain for pharmaceuticals. The objectives of this presentation are to discuss the strategies applied for several site transfers and lessons learned. The knowledge gained from this presentation can serve as a guide for any future site transfers and development of best practices.

Case Study: How to Benefit from Pharmaceutical Distribution Outsourcing Tuesday, May 1, 4:00pm – 5:00pm Michael Trocchia, P.E. CPIM, Director Project Management, US Supply Chain Management, Novartis Pharmaceuticals Corporation Novartis had to decide whether to outsource the nerve center of its U.S. supply chain - the New Jerseybased warehouse and distribution operation responsible for receiving, packing and preparing for shipment the full range of Novartis pharmaceuticals to its U.S. customers. The case study will present the facts surrounding the decision and ask audience members to participate in the decision making process.

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FREE CONFERENCE SESSIONS

TECHNICAL WORKSHOPS

FLOOR TOURS

TUESDAY, MAY 1, 11:45AM – 12:30PM Flexible Aseptic Syringe and Vial Filling for CMO applications Klaus Ullherr, Production Manager, Bosch Milton Boyer, Vice President Product Development, OSO Biopharmaceuticals

New Technology in Tablet Compacting

Rounding out the educational component will be a series of presentations and exhibit technology floor tours on May 2 hosted by IPS-Integrated Project Services. (PRE-REGISTRATION IS REQUIRED - TOUR SPACE IS LIMITED!)

WEDNESDAY, MAY 2, 10:00AM - 12:00PM & repeated at 12:30PM - 2:30PM ADVANCED ASEPTIC TOUR:

James Mossop, New Business / Project Manager, Fette Compacting America, Inc

Visit leading aseptic technology suppliers to discuss new technologies, innovation and new strategies. Tours are preceded by a brief presentation, “The Role of CMO’s in Supporting Global Vaccine Production Needs: Case Study-Brazil Fill Finish” presented by Sterling Kline, RA. Tours will be led by Sterling Kline, RA; Rob Roy, PE or Jason Collins, RA, NCARB of IPS.

Innovative Technique for the Production of Drug Loaded Pellets

Participating Companies: AES, Bosch, Groninger, IMA Life, Rommelag, Sartoruis-Stedim, SKAN Stilmas

Ed Godek, Manager Process Technology, Glatt Air Techniques

Complex Single-Use Unit Operations: The Process and Economic Benefits Engin Ayturk, Principal R&D Engineer, Pall Life Sciences

WEDNESDAY, MAY 2, 11:30AM – 12:15PM

BIOLOGICS TOUR: Tour features a comprehensive view from leading suppliers of new developments and innovative technologies that can dramatically change the design, construction and operation of biopharmaceutical manufacturing facilities. Tours are preceded by a brief presentation, “Next Gen Biomanufacturing: Developing the Manufacturing Facility of the Future” presented by Jeff Odum and Actavis. Tours will be led by Jeff Odum, Edi Eliezer, Diana Karnas or Chuck Stock, CxA of IPS.

Pragmatic Implementation of Single-Use Technologies

Participating Companies: Abec, Inc., EMD Millipore, GE Healthcare, GEA Process, Pall Life Sciences, Sartorius-Stedim, Thermo Fisher/Hyclone, Xcellerex.

Richard Pierce, Ph.D., Director, Strategy and Business Development, EMD Millipore Corporation

ORAL SOLID DOSAGE TECHNOLOGIES TOUR:

Enrique Carredano, Scientist, GE Healthcare

On the Tour, view efficient processing options, innovation and recent developments in advanced oral solid dosage form technologies from leading suppliers. Tours are preceded by a brief presentation, “Should it be Scale-Up or Scale Out …Bigger is not Always Better or Faster” presented by Russ Somma, PhD and Rich Poska of Abbott Laboratories. Tours will be led by Russ Somma, PhD of SommaTech and Mike Vileikis; Felix Diaz or Sam Halaby of IPS.

On-line TOC Monitoring in GMP Parts Washers

Participating Companies: Biopharma Systems/ Telestar, Creative Design & Machine, Fette Compacting America, Inc., GEA Process, KORSCH America, L.B. Bohle, SKAN.

Facility Operation Intensification: In-Line Conditioning Buffer Preparation versus In-Line Dilution

Marcel Dion, Director of Marketing, Washing and Sterilization Systems, STERIS Corporation George Verghese, Director of Technical Services, STERIS Corporation

Single-Use Coming of Age - Next Generation Systems and Advantages Millie Ullah, Senior Product Manager, SUS, Thermo Fisher Scientific

KEYNOTES What the New Bio/Pharma Business Model Means for CMOs and CROs Tuesday, May 1, 9:15am - 10:15am Jim Miller, President, PharmSource Information Services, Inc.

Control, Capability, and Capacity: Elements Assuring a Reliable Drug Supply Tuesday, May 1, 1:30pm - 2:30pm Jeffery C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. Food & Drug Administration

Creating Innovative Cold Chain Solutions for your Pharmaceutical and Biopharmaceutical Products Wednesday, May 2, 10:15am - 11:15am Richard Smith, Director, Life Sciences & Specialty Services, FedEx

For full keynote session descriptions, see page 3. 14

SPECIAL PRESENTATIONS Practical Applications of Statistical Methods Under 2011 FDA Process Validation Guidance Thursday, May 3, 9:30am - 10:30am Abe Germansderfer, Associate Director, Gilead Sciences, Inc. This presentation will describe and demonstrate through examples, practical and simple data analyses that would directly support the new validation process. Tools for demonstration of process homogeneity and the use of the acceptance sampling plans for validation and continued process verification will also be presented.

Making it in Massachusetts –A Small Company’s Road to the CMO Market Thursday, May 3, 10:45am - 11:45am Glenn Alto, President and CEO, Pharmalucence, Inc. Edward J. Connolly, Chief Operating Officer, Pharmalucence, Inc. Pharmalucence owners will present the process which led them to the decision to construct a state-of-the-art aseptic drug production facility in Massachusetts at the height of the recent economic downturn and in contradiction to industry trends toward off-shore manufacturing. This is a story of the convergence of a business vision, public/private financial collaboration, industry partnerships and risk.

Development of Novel CR Formulation Mitigating Dose Dumping & Misuse Thursday, May 3, 12:00pm - 1:00pm Shams Rustom, M.Pharm, RPh., Senior Director, Product Development & Manufacturing, Labopharm Learn how a number of controlled release formulations have been withdrawn from the market because of medications error by patient or poor formulation robustness. This case study summarizes the design and development of a new dual active controlled release delivery platform.

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CONFERENCE ADVISORY BOARD INTERPHEX would like to thank the 2012 Advisory Board, a panel of industry experts whose valuable insights played a key role in developing this year’s program. Dilip Ashtekar, Ph.D. Sr. Director Quality Control Gilead Sciences, Inc.

Sanjay Patel Sr. Director, Global Materials Management Shire Pharmaceuticals, Inc.

E. Morrey Atkinson, Ph.D. Chief Scientific Officer, VP of Research & Development, VP of Drug Substance Manufacturing Cook Pharmica LLC

EJ Brandreth VP, Quality & Regulatory Affairs Althea Technologies, Inc.

John Gilroy, P.E. Sr. Vice President and Principal IPS - Integrated Project Services

Michelle M. Gonzalez, P.E. BioPharm Engineering Consultant

Timothy P. Howard, CPIP, P.E.

Richard Poska, R.Ph.D. Director, Regulatory Affairs Abbott Laboratories

Meet the Category Award Winners at the Facility of the Year Awards (FOYA) Display Area. Team members from the winning companies will be onhand to discuss the success stories associated with these pharmaceutical manufacturing facilities. The FOYA program is the pharmaceutical industry’s premier awards program dedicated to celebrating innovation and accomplishments in facility design, construction, and operation. The FOYA program recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing highquality medicines. We’re proud to recognize this year’s winners.

WINNERS: CHIESI FARMACEUTICI S.P.A.

Scott Rudge, Ph.D. Chief Operating Officer RMC Pharmaceutical Solutions, Inc.

Jaspreet Sidhu, Ph.D. Vice President, Business Development & Pharmaceutical Microbiology Molecular Epidemiology

Russ Somma, Ph.D. President Somma Tech, LLC

Robert Timko, RPH, Ph.D.

Vice President & Company Officer Commissioning Agents, Inc.

Director CMC Group, Global Regulatory Affairs AstraZeneca Pharmaceuticals LP

M.J. Kimmel

Chad Wachter

Principal MJK Solutions

FACILITY OF THE YEAR AWARDS (FOYA)

Winner of the Facility of the Year Award for Sustainability for its Chiesi Farmaceutici Research and Development Centre facility in Parma, Italy.

EISAI PHARMATECHNOLOGY & MANUFACTURING PVT. LTD. Winner of the Facility of the Year Award for Project Execution for its Eisai Knowledge Centre facility in Andhra Pradesh, India.

MERCK & CO., INC. Winner of the Facility of the Year Award for Facility Integration for its Merck Vaccine Bulk Manufacturing Facility (VBF) Program of Projects in Durham, North Carolina USA.

RENTSCHLER BIOTECHNOLOGIE GMBH Winner of the Facility of the Year Award for Equipment Innovation for its REX III manufacturing facility in Laupheim, Germany.

ROCHE DIAGNOSTICS GMBH Winner of the Facility of the Year Award for Operational Excellence for its TP Expand project in Penzberg, Germany.

NATIONAL INSTITUTE FOR BIOPROCESSING RESEARCH AND TRAINING (NIBRT) Winner of the Facility of the Year Award Special Recognition for Novel Collaboration for its New Greenfield facility in Dublin, Ireland.

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Tuesday, May 1 - Thursday, May 3 - Crystal Palace (Level 3) Stay connected, stop by the cyber cafe to access the internet and check your email.

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FLOOR TOURS Wednesday, May 2, 10:00am - 12:00pm & 12:30pm - 2:30pm Rounding out the educational component will be a series of presentations and exhibit technology floor tours hosted by IPS-Integrated Project Services (pre-registration is required). See full description on page 15.

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WOMEN’S NETWORKING RECEPTION Wednesday, May 2, 3:30pm - 4:30pm Calling all women in the industry, come together to network and share ideas with colleagues who share your passion. Open to all badge holders. 18

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EXHIBITOR LIST 3M Drug Delivery Systems 3M Purification A&B Process Systems A+ Secure Packaging AAIPharma Services Abec Inc. ABM Industries Inc. Acadeus Actlabs Ltd. Advance Engineering & Mfg Advance Fittings Corp. Advance TEC LLC Advanced Microdevices Pvt. Ltd. Advanced Scientifics Inc., Contract Services AdvantaPure/NewAge Industries Advantest Corp. AES Clean Technology, Inc. Aesica Pharmaceuticals Ltd. Aflex Hose USA, LLC AIV Solutions Alconox Inc. Alexanderwerk Inc. Alfa Wassermann Inc. Alkermes Contract Pharma Services Allegheny Bradford Corp. Allegheny Surface Technology Alliance Medical Products Inc. Alloy Products Corp ALLpaQ Packaging Limited Almac AlpVision SA Althea Technologies Amcor Amcor Glass Tubing Ampac AMRI Anton Paar, USA Aphena Pharma Solutions Inc. Apotex Fermentation Inc. Applied Control Engineering, Inc. Applikon Biotechnology Inc. Aptar Pharma Aqua-Chem Inc. Aquafine Corp. Aquionics Inc. Arizona Instrument LLC Arkema Inc. Asahi Kasei Bioprocess ASCO Numatics Ashcroft Inc. Asiatic Fiber Corp. Associates of Cape Cod Inc. Astro Pak, Pharmaceutical Division Atlantic Scale Inc. Atlas Copco Compressors Inc. ATMI LifeSciences AWH GmbH AWS Bio-Pharma Technologies LLC AZO Inc. B & D Products LLC B&W Tek, Inc. Baldor Electric Co. Banner Engineering Corp Barcharts Inc. Bausch & Lomb Pharmaceuticals-US Bausch & Stroebel Machine Co. Bausch Advanced Technologies Inc. Baxa Corp Baxter BD Medical-Pharmaceutical Systems Beamex Behringer Corp.

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Beijing Gylongli Sci. & Tech. Co., Ltd. Belimed Infection Control Belimo Aircontrols Inc., USA Bellatrx Inc. Bellcomb Technologies Bellwyck Packaging Solutions Benchmark Products Inc. Biopharmaceutical International Bio-Rad Laboratories Inc. Bishamon Industries Corp Black Forest Container Systems LLC BlueCielo ECM Solutions BMT USA LLC Boehringer Ingelheim Pharma GmbH & Co KG Bormioli Rocco e Figlio SpA Bosch Packaging Technology Brandenburg Industrial Service Co. BREVETTI CEA S.p.A. Broadley-James Corp. BS&B Safety Systems LLC BUCHI Corp. Budzar Industries Buffalo Air Handling Co. Bullard Burkert Fluid Control Systems Burkhead-DeVane Label Specialists Burns Engineering Inc. Busch LLC Bushu Pharmaceuticals Ltd. Bustin, a Division of R-O-M Corp. Cadmach Machinery Co Pvt Ltd Cangene BioPharma (Formerly Chesapeake Biological Laboratories) Canty Inc. Capmatic Capsugel Carltex Inc. Catalent Pharma Solutions CCL Label Inc. CCS Compression Components & Services CDI Engineering Solutions CE & IC Inc. CEIA USA Certolux ChargePoint Technology Charter Medical Ltd, A Lydall Co. Chartwell Pharmaceuticals Chase-Logeman Corp Christ Aqua Pharma and Biotech Cincinnati Sub-Zero Products Cintas Corp Cleanseal Doors, an ASI Co. Clinical Systems Inc. Cockram Construction Colder Products Co. Coldstream Laboratories Inc. Cole-Parmer Instrument Co. Comar Inc. Comecer SPA Commissioning Agents Inc. Competitive Solutions, Inc. Complete Inspection Systems Inc. Compli LLC Confab Laboratories Inc. Constantia Hueck Foils LLC Contained Technologies LLC Contec Inc. Continental Disc Corp. Contract Pharma Contract Pharmacal Corp. Contract Pharmaceuticals Ltd. Control Micro Systems Inc.

Cook Pharmica LLC Corden Pharma GmbH CornerStone Flooring Cortegra Cotter Brothers Corp Covaris Inc. Cozzoli Machine Co. CRANE ChemPharma Flow Solutions CRB Consulting Engineers Creative Design & Machine Inc. CSP Technologies Curti Costruzioni Meccaniche SPA CV Technology Inc. Dabrico Inc. Daiichi Jitsugyo Inc., America Daisy Data Displays DASGIP BioTools DCI Inc. Decagon Devices Inc. DeltaNu, Intevac Photonics DERMOLAB PHARMA LTD DE-STA-CO DIA Pharmaceutical Co., Ltd. Distek Inc. DME Alliance Engineering Consultants Dow Corning Corp Driam Inc., U.S.A. DSM DTI DuPont Co. Dycem Ltd EAG - LifeSciences Eagle Stainless Container East Montgomery County Improvement District Ecolab Inc. Edwards EHS Solutions Eisai Machinery Inc., U.S.A Electrol Specialties Co. Ellab Inc. Elpro Services EMD Millipore Emerson Process Management Enerquip LLC Entegris Inc. Environmental Specialties/A Bahnson Holdings Inc., Group Comp Eppendorf North America EquipNet Inc. ERIEZ ErtelAlsop ESS/ValSource, LLC Evolution Scientific, Inc. Exergy LLC F.P.S. Food and Pharma Systems Srl FabOhio Faubel Pharma Services Corp. Federal Equipment Co FedEx Healthcare Solutions Feldmeier Equipment Inc. Fenwal Protection Systems Fette Compacting America FHP Fike Corp Filamatic FILTROX North America Finesse LLC Fisher Scientific Flow Sciences Inc. Flow Smart Inc. Flowtech Inc., Div./Teknoflow Fluid Metering Inc. Fluke Corp Fluor

EXHIBITOR LIST FOSS NIRSystems, Inc. Foster Wheeler Biokinetics Inc. FP Developments Inc. Freeman Technology Ltd Fresenius Kabi Product Partnering Freund-Vector Corp. Frewitt SA Fristam Pumps, USA Fujifilm Diosynth Biotechnology Fujitsu Semiconductor Ltd. G Bopp USA Inc. Galbraith Laboratories Inc. Gamajet Cleaning Systems Inc. Garlock Sealing Technologies Garvey Corp GE Healthcare GE Sensing & Inspection Technologies GEA Process Engineering Inc. GECITECH, LLC. Gemu Valves Inc. General Econopak Inc. Genesis Packaging Technologies Gerteis Maschinen + Processengineering AG Getinge USA Inc. Gibraltar Laboratories Inc. Girton Mfg Co., Pharmaceutical Division Glatt Air Techniques Inc. GlobePharma Inc. Grand River Aseptic Manufacturing, Inc. Griffin-Rutgers Co. Inc. groninger USA Hach-Particle Counting Division Halo Pharmaceutical Inc. Hamilton Co. Harrington Industrial Plastics Inc. Harrison Electropolishing LP Harro Hofliger Packaging Systems Inc. Haupt Pharma AG Haz-Safe LLC HCT Co., Ltd. Heat and Control, Inc. Heat Pipe Technology, Inc. Heateflex Corp. Helix Medical Helvoet Pharma, USA Hibar Systems Limited Holloway America Hosokawa Micron Technology Powder Systems Hospira One 2 One® Howell Packaging Howorth Air Technology I Holland Limited I+o Industry Planning + Organization LP Inc. ICOS Impianti Group S.p.A. IGI Laboratories Inc. iGPS IKA Works Inc. ILC Dover IMA Life North America Inc. Importfab Inc. INDCO Inc. Industrial Info Resources Inc. Informetric Inmark North America INOX Industries Inc. Interactive Safety Products Inc. International Products Corp IPS-Integrated Project Services

Iron Mountain Fulfillment Services, Inc. Isolation Systems Inc. ITCM ITT Industries Corp IVEK Corp. Jamco Products, Inc. Jennison Quality Components JHP Pharmaceuticals LLC John Crane Inc. JRS Pharma LP Jubilant Hollisterstier Contract Manufacturing JVNW Inc. Kanomax USA Inc. Kavon Filter Products Keith Machinery Corp Kemwell Biopharma Keofitt a/s Key Resin Co. Kikusui USA Inc. Kleen Test Products Korber Medipak Korsch America Inc. Koslow Scientific Co. K-Patents, Inc. Kraemer US LLC Krieger AG kSep Systems LLC K-Tron Label Vision Systems Inc. Laminar Flow Inc. Lancaster Laboratories Inc. Laporte Consultants LB Bohle LLC LCI Corp. LESER LLC Lighthouse Instruments Lighthouse Worldwide Solutions Littleford Day Inc. Lives International Corp. LJ Star Inc. Lock Inspection Systems Inc. Longford International Ltd. LSNE Contract Manufacturing Luce, Schwab & Kase, Inc. Lymtech Scientific Lyne Laboratories M&O Perry Industries, Inc. M.A.R. S.p.A. M+W US Inc., A Company of the M+W Group m2p-labs GmbH Madgetech Inc. Malvern Instruments Inc. Mar COR, Purification Marchesini Packaging Marken Ltd MasterControl Inc. Masy Systems Inc. McBrady Engineering Inc. Meissner Filtration Products MENNEKES Electrical Products Mesa Laboratories Inc. Metenova Inc., America Meto Corp Metrics Inc. Mettler-Toledo Hi-Speed Mettler-Toledo Ingold Mettler-Toledo Safeline Mettler-Toledo Thornton Mettler-Toledo, Inc. MG America Inc. Microbac Laboratories Inc. Micro-Clean Inc. Microfluidics Micromeritics Instrument Corp Midas Pharmaceuticals Inc.

Middough Inc. Mini Graphics Inc. Mission Pharmacal Miura North America Inc. MKS Instruments Inc. MO Industries Inc. Moorfields Pharmaceuticals Multisorb Technologies Inc. Munters Corp NCA Technologies/Neoceram SA Netzsch Premier Technologies LLC Newark Wire Cloth Newman Sanitary Gasket Co. NextPharma GmbH Nicos Group Inc. Nilfisk-Advance America Inc. NJM Packaging nora systems, Inc. NOR-Lake Inc. Norwich Pharmaceuticals Inc. NOTTER GmbH Tablettierwerkzeuge Nova Biomedical Novasep NU-Star Inc. OBK Technology Ltd. OCS Checkweighers Inc. O’Hara Technologies Olympus Innov-X Oncode Inc., A Div of Gem Gravure Optek-Danulat, Inc. Optel Vision Optima pharma Oregon Freeze Dry Inc. Orthos Liquid Systems Inc. Overlook Industries Inc. Pace Analytical Life Sciences Pall Life Sciences PALPharma Handling Solutions Parker-Hannifin Corp. Parsec Automation Corp Parsons Particle Measuring Systems Inc. Patheon Pharmaceutical Services Inc. Paul Mueller Co. PBM Inc. PendoTech Penntech Machinery Corp Pentapack NA Corp PEP/Plastic Engineered Products Pepperl+Fuchs Perritt Laboratories Pharma Packaging Solutions Pharmaceutical Technology Pharmalucence, Inc. PharmaPack Asia Limited PharmaSys Inc. PharmaSystems Inc. Pharmatron Inc. Piercan, USA PII-Pharmaceutics International Inc. Plascore Inc. Plastikon Industries Platinum Press Inc. PLUMAT Maschinenbau Vertrieb GmbH Porta-Fab Porvair Filtration Group Ltd. Powder Systems Ltd. Precision Polymer Engineering PreSens Precision Sensing GmbH Prime Environmental Inc. Primus Sterilizer Co. Inc. ProPharma Group Inc.

ProSys Containment & Sampling Technology Prudential Cleanroom Services PTI Packaging Technologies & Inspection Pureflo Q Laboratories Inc. QS Pharma LLC Quadro Engineering Corp. Qualicaps Inc. Quality Chemical Laboratories R Baker & Son R on I Inc. RathGibson LLC Reed-Lane Inc. Remcon Plastics Inc. Rentschler Biotechnologie GmbH Resodyn Acoustic Mixers Resolution Development Services RMB Products Inc. Rommelag Inc., USA Ropack Inc. Rotonics Mfg Inc., Chicago Rotronic Instrument Corp Rottendorf Pharma GmbH ROVI Contract Manufacturing Rovisys Co. Rubberfab Technologies Group Russell Finex Inc. Rutten Engineering AG Rychiger AG Rytec High Performance Doors Safebridge Consultants Inc. Saint-Gobain Performance Plastics Sani-Matic Inc. Sanisure Inc. Sanner of America Inc. Sartorius Stedim North America Inc. Schenck AccuRate Schlick Spray Nozzles Schott North America, Inc. Schreiner MediPharm SciLog Inc. SciLog Inc. SCM Pharma Sefar Inc. Sensorin Sentinel Process Systems Inc. Service Engineering Inc. Servolift LLC SGS Life Science Services Shaffer Products Inc. Shanghai Haishun New Pharmaceutical Packaging Co., Ltd. Shanghai Morimatsu Pharmaceutical Equipment Engineering Co., Shanghai Ritai Medicine Equipment Project Co., Ltd. Sharp Corp. Sharpsville Container Corp Shenzhen Bona Medicinal Packaging Material Co., Ltd. Sika Corp Silikal America Skolnik Industries Inc. SMI (Specialty Measurements Inc.) Sotax Corp SP Scientific SPAMI - OPTREL SPI Pharma Spraying Systems Co SPX Flow Technology

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Stainless Fabrication Inc. Steriflow Valve STERIS Corp. Stevens Industries LLC Stilmas USA, LLC. Stratophase Ltd Strongarm Designs Sturtevant Inc. Sud-Chemie Performance Packaging Surplus Solutions, LLC Sussman Electric Boilers Suzhou Pharma Services SVF Flow Controls, Inc. Swagelok Co. SWAN Analytical USA Symetix Systec GmbH Talsico International Tapemark Co. TECHNIlab Development Technoflex SA Telstar Terracon Corp. Testo Inc. Texwipe, ITW The Challenge Printing Co. The David Round Co. The Fitzpatrick Co. The Hilliard Corp The Sherwin-Williams Co. Therapex, Div of E-Z-EM Inc., Canada Therapure BioPharma Inc. Thermo Scientific Thomas Engineering Inc. Tiger-Vac Inc. TMF Corp. TMI-USA Inc. Top Line Process Equip Co. Troemner LLC TSI Inc. Tuthill Vacuum & Blower Systems ULVAC, Inc. United Industries, Inc. UPM Pharmaceuticals Vaccon Co. Vac-U-Max Vaisala Inc. Validation Technologies, Inc. Value Plastics, a Nordson Co. ValuMax Disposable Apparel Inc. Van London - pHoenix Co. Vante Veltek Associates Inc. Venair Videojet Technologies Inc. Vijuk Equipment Inc. VNE Corp Vorti, SIV Division Walker Barrier Systems Waters Corporation Watson-Marlow Pumps Group Watson-Marlow Pumps Group Weiler Engineering Inc. WEKO Industrial Component Corp. WellSpring Pharmaceutical Western States Machine Co. Wilden Pump & Engineering Co. Winpak Heat Seal Packaging Inc. Wirecrafters LLC WS Tyler Wuxi AppTec Inc. Xcellerex Inc. Yula Corporation Zenpure ZPI Inc.

PLAN YOUR SHOW We’ve made it easy to get organized before you arrive at INTERPHEX.

MY INTERPHEX SHOW PLANNER This online planning tool gives you the opportunity to:

TRAVEL INFORMATION & SHOW PACKAGES HOTEL & TRAVEL INFORMATION

Book your hotel through our official housing partner, onPeak, and get reduced hotel rates and travel discounts for planning your stay in New York. Visit the INTERPHEX Travel Desk at www.INTERPHEX.com/NYC for low rates and discounts on hotels, car rentals, onsite parking, Amtrak and more! Reservation deadline: April 9, 2012.

• Preview the floorplan

Travel to NYC for Less

• Search Exhibitors by company name and product category

View all discounts at www.INTERPHEX.com/NYC • Flying? Book through American Airlines or Delta and save. • Driving? Book through Avis and save 5%. • Arriving by Train? Amtrak is offering a 5% discount for INTERPHEX. • Need Parking? Download our coupons for Central Parking.

• View each exhibitor’s online showroom

Look for these icons on our site!

• Request appointments with specific exhibitors • Create a personal agenda that maps out the locations of every exhibitor you want to see • Add the Conference Sessions that you plan on attending to your personal agenda

SET UP YOUR AGENDA TODAY AT WWW.INTERPHEX.COM/AGENDA

INTERPHEX MOBILE 2012 • Use your mobile phone to navigate INTERPHEX onsite • Take your personal agenda with you by signing in to the mobile app on your phone

Early Date Advance/Onsite (Before 4/1) (After 4/1)

Conference Passes

• Find booth-to-booth directions to the exhibitors you want to see

FULL CONFERENCE PASS

• See the complete list of conference sessions and special events

(Includes access to One-Day of INTERPHEX sessions and lunch that day, exhibit show floor, keynotes, technical workshops, and opening night reception)

ONE DAY PASS

EXHIBITS PLUS PASS

• Access the latest announcements and breaking show news • Now available for Android, as well as iPhone and all web-enabled phones

EXHIBIT HALL PASS

Log into the app with your registration ID before May 1, 2012 to be automatically entered to win an iPad!

$995

$1,095

$695

$795

$185

FREE

FREE ($75 onsite Processing Fee

(Includes access to all INTERPHEX sessions, lunch both days, exhibit show floor, keynotes, technical workshops, and opening night reception)

(Includes choice of one INTERPHEX session, access to exhibit show floor, keynotes, technical workshops, and opening night reception)

ACCESS THE MOBILE APP AT WWW.INTERPHEXMOBILE.COM

SHOW PACKAGES

(Includes access to exhibit show floor, keynotes, technical workshops, and opening night reception)

The following discounts are available: • Save $100 on the Full or One-Day Conference Pass when you register before April 1st. • Save $120 per person on the Full Conference price when you register 4 or more people from the same company at the same time. CONNECT WITH US:

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