SEE THE LATEST INDUSTRY TOPICS AND TRENDS ......Back by popular demand, the Exhibit Hall Technology Floor Tours presented by IPS–Integrated Project Services offer a series of presentations

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APRIL 23-25, 2013JAVITS CENTER | NEW YORK, NY

BRINGING TOGETHER KEY PHARMA AND BIOTECH PROFESSIONALS WITH SUPPLIERS TO CREATE INNOVATIVE SOLUTIONS.

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CONFERENCE PROGRAMSEE THE LATEST INDUSTRY TOPICS AND TRENDS

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TABLE OF CONTENTSINDUSTRY KEYNOTES............................3

CONFERENCE AT-A-GLANCE..................4

SESSION DESCRIPTIONS........................6

FREE SESSIONS...................................14

ADVISORY BOARD................................19

FACILITY OF THE YEAR AWARDS...........20

SPECIAL EVENTS AND FEATURES.........21

SHOW PACKAGES.................................22

PLAN YOUR SHOW................................23

SHOW FLOOR OVERVIEW......................24

EXHIBITOR LIST.....................................25

TRAVEL.................................................27

SHOW & CONFERENCE HOURS

A NEW AND IMPROVED EXPERIENCE INDUSTRY KEYNOTES

LEARN FROM THE MOST SUCCESSFUL AND INNOVATIVE INDUSTRY AUTHORITIES AT OUR 2013 KEYNOTE SESSIONS. Keynote Sessions are open to all badge holders.

CONFERENCE HOURSTuesday, April 23 9:00am – 5:00pmWednesday, April 24 9:00am – 5:00pmThursday, April 25 9:30am – 12:00pm

EXHIBIT HALL HOURSTuesday, April 23 10:00am – 5:00pmWednesday, April 24 10:00am – 5:00pmThursday, April 25 10:00am – 3:00pm

DR. RAJESH NAIRPresident, IndegeneReorganizing For the Future: Succeeding In The New Pharmaceutical Industry Tuesday, April 23, 1:30pm-2:30pmRoom: 1E15

The global pharma industry is currently restructuring to solve fundamental challenges with regard to shrinking pipelines, increased regulatory requirements, changing customer profi les, new technologies and commercial models. These themes are playing against a backdrop of robust growth of emerging world economies, and decreased growth from developed markets including US and EU. Understanding the key trends that are driving this transformation, the structure of the emerging business and commercial models, the role of new technologies and customer behaviors and the challenges brought by the growth of emerging markets are all crucial for succeeding in the new pharmaceutical industry. How do these trends impact you? What are the new business models and new opportunities opening up? How can you proactively build capabilities, expertise and skills to take advantage of this emerging model?

JIM MILLERPresident, PharmSource Information Services, Inc.Recalibrating The Pharmaceutical Services Opportunity Wednesday, April 24, 9:00am-10:00amRoom: 1E15

Global bio/pharmaceutical companies are replacing their low-percentage strategy of “maximizing shots on goal” with more rigorous criteria for graduating candidates into the development pipeline. While they have become more selective, early stage companies have faced more challenges gaining fi nancing. The combined effect of these two trends has been to reduce the number of candidates coming through the pipeline and tilt the game more in favor of larger bio/pharma companies. The new industry dynamics has serious implications for contract service providers. Only a relative handful will qualify to work with the largest bio/pharma companies and those that don’t win preferred provider status will be fi ghting over a smaller market. This presentation will discuss the implications of the changing bio/pharma R&D model for the contract service providers.

CONFERENCE ACCREDITATIONWe are pleased to announce that this year’s conference program is accredited by CIAPR and IACET. CEUs will be calculated as 10 contact hours = 1.0 CEU, that means you can earn up to 0.5 CEU per day on Tuesday and Wednesday. A

representative will be available onsite to assist you with your CEUs.

PRODUCT SOURCINGTouch the latest new products from 650+ exhibitors on the show fl oor. Visit our website’s “Featured Products” section to get a sneak peek of the new and featured products exhibitors will be displaying on the Show Floor. See a complete exhibitor list on pages 25-27.

NETWORKING OPPORTUNITIESINTERPHEX offers you the opportunity to relax, take a break and network with industry colleagues. You never know when a chance meeting with a colleague will turn into a spontaneous solution. See a complete list of featured areas on page 21.

EXHIBIT HALL TECHNOLOGY FLOOR TOURSBack by popular demand, the Exhibit Hall Technology Floor Tours presented by IPS–Integrated Project Services offer a series of presentations and interactive case-studies, including walking tours on the Show Floor to select technology vendors. See more details on page 15, pre-registration is required.

STUDENTS AND YOUNG PROFESSIONALS PROGRAMINTERPHEX is pleased to partner with the ISPE New Jersey chapter and host a Students and Young Professionals Program. This special program has been designed to facilitate high quality education and career development, offering focused course content for students and young professionals. See the complete program overview on page 16.

Need help obtaining approval from your manager to attend INTERPHEX? Download and use our

“justifi cation letter” template at www.INTERPHEX.com.

Need help obtaining approval from your manager to attend INTERPHEX? Download and use our

“justifi cation letter” template at

CONGRESSMAN BILL CASSIDY M.D.Congressman (R-LA) Policy Recommendations for Improving Patient Access to Drugs in ShortageTuesday, April 23, 9:00am-10:00amRoom: 1E15

Current government policy has contributed to the shortage of vital pharmaceuticals by disturbing market forces that drive production. Artifi cial price caps have forced some manufacturers to cease production, denying patients access to affordable drugs. This presentation will discuss potential improvements to the current reimbursement system to avoid future drug shortages.

The Authority on Drug Development & Manufacturing

PharmTech.com

Sponsored by:


8:45am-9:00am Welcome and Introduction Welcome and Introduction

9:00am-10:00am Keynote: Policy Recommendations for Improving Patient Access to Drugs in Shortage

REGULATORY QA/QC PRODUCT DEVELOPMENT FACILITY & PROCESS DESIGN MANUFACTURING & PACKAGING SUPPLY CHAIN

10:15am-11:15am Current Development Best Practices for IR & MR Dosage Forms

Process Robustness: From Development to Life Cycle Management

Effective Cleaning Procedure for Medical Devices Using Laboratory Studies

Risk Management of Contaminationand Cross Contamination in

Pharmaceutical Manufacturing

How Commercial Payers Restrict the Specialty Supply Chain

11:30am-12:30pm Become a Better CAPA Sleuth The Role of Process Analytical Technologies in the Current Quality by Design Framework

Establishing a Design Space Cleaning Process Development

and Validation

Highly Potent, Poorly Soluble Product Manufacturing Contract,

with 100% OTIF

Business Continuity for Biopharmaceutical Companies:

Real Implementation of Operational Excellence

12:30pm-1:30pm Lunch Lunch

1:30pm-2:30pm Keynote: Reorganizing for the Future: Succeeding In The New Pharmaceutical Industry

2:45pm-3:45pm Panel: Understanding GDUFA (2:45pm-4:15pm) Regulatory Strategy for Implementation of QbD and

PAT in a Pharmaceutical Manufacturing Environment

Implementing Single-Use Biomanufacturing Systems into Traditional Stainless Steel-

Based Facilities

Mechanical Characterization, Testing and Defect Monitoring of Tablets

Commercialization Outside the US: What are the Challenges

4:00pm-4:45pm Technical Workshops: Belimed, Bosch, Fette

CONFERENCE AT-A-GLANCE CONFERENCE AT-A-GLANCE

REGULATORY QA/QC PRODUCT DEVELOPMENT FACILITY & PROCESS DESIGN MANUFACTURING & PACKAGING SUPPLY CHAIN MINI COURSE - SERIALIZATION

9:00am-10:00am Keynote: Recalibrating the Pharmaceutical Services Opportunity

10:15am-11:15am

Panel: Lessons Learned: Successes and

Challenges in Implementing Quality by Design

Combination Product Development: Drug Products

for Device Companies

Design Aspects for a Bio Fill and Finish Facility Biopharma’s Flexible Imperative

Establishing Quality Agreements with a Unifi ed Approach

for All Suppliers

Manufacturing Intelligence: Serialization to Improve Processes

11:30am-12:30pmApplication of Quality by Design in API Process

Development

Pharmaceutical Technology Transfer Practices into

Design Control for Convergent Products

Purpose-Driven Design: Savings for Pharmaceutical Facilities

OEE Master Class: How to Increase Production Time by 20%

Supply Agreements: Strengthening the Linchpin of Your Outsourcing Partnership

Implementing Unit-Level Serialization on a New Packaging Line

12:30pm-1:30pm Lunch Lunch

1:30pm-2:30pm New Product Assessment in a Multiproduct Environment –

A Risk-Based Approach

Current Continuous Process Validation Program (CCVP)

Following FDA Current Guidelines

Panel: Getting Excited about the Modular Experience!

(1:30pm-3:00pm)

Panel: Road Map to Implementing EBR Managing Your Suppliers with Scorecard Metrics

Economic Impact of Implementing a National Serialization and Traceability System

2:45pm-3:45pmProcess Validation (PV): Designing an Effective

PV Program

Warehouse Management Systems (WMS): How to Achieve a Warehouse of the Future

Securing Information as Part of the Global Supply Chain

Wrap Up Panel: Understanding the Complexities of Serialization

4:00pm-4:45pm Technical Workshops: EMD Millipore Corp, GEA Process Engineering, Glatt Air Techniques, Inc, Thermo Fisher Scientifi c

9:30am-10:30am Case Study and Framework for Implementing the New Process Validation Guidance

10:45am-11:45am Pushing the Limits: Questioning the Methodology

12:00pm-1:00pm Conference Ends

TUESDAY, APRIL 23, 2013

WEDNESDAY, APRIL 24, 2013

THURSDAY, APRIL 25, 2013


CONFERENCE SESSION DESCRIPTIONS CONFERENCE SESSION DESCRIPTIONS

REGULATORY QA/QCCurrent Development Best Practices for IR & MR Dosage Forms Glenn Van Buskirk, Managing Partner, Nonclinical Drug Development Consulting Services, LLC Tuesday, April 23, 10:15am-11:15amRoom: 1E07

Gain valuable knowledge on the Product Quality Research Institute’s efforts in updating the Scale-up and Post Approval Changes (SUPAC) guidance documents on IR and MR dosage forms including current best practices. Such current development best practices include the use of ICH Q8, Q9 & Q10 principles as well as the application of Quality by Design (QbD), during development. Also included will be a discussion of the role of Analytical Technologies (PAT) in facilitating release of batches and the use of in vitro in vivo correlation (IVIVC) and improved statistical tools in setting fi nished product specifi cations and allowable ranges.

Become a Better CAPA Sleuth Walt Murray, Director of Quality and Compliance Services, MasterControl Inc. Tuesday, April 23, 11:30am-12:30pm Room: 1E07

Do you tiptoe through non-conformance investigations, hoping that a safety or product quality issue will just go away? If you suspect your investigatory skills are not up to par, there’s hope for you. You can become a better CAPA sleuth. Attend this interactive session for examining CAPA and learning critical skills to kick-start your CAPA system. Learn how to ask better questions for investigating and getting to the root cause using a new deductive thinking method. Valuable for anyone involved in the quality and CAPA processes.

Panel: Understanding GDUFA Moderator: Christopher Verbicky, Ph.D., MBA, Director of Business Development and Marketing, Coldstream Laboratories, Inc.Panel: Padam Bansal Ph.D., Vice President, Research & Development, Amneal Pharmaceuticals; Jason R. Money, Senior Director for Federal Government Affairs, Generic Pharmaceutical Association (GPhA); Edward Price, President and CEO, PCI SynthesisTuesday, April 23, 2:45pm-4:15pm Room: 1E07

Gain a better understanding of the GDUFA laws/regulations, the reasons they are necessary and the related challenges facing the generic pharmaceutical industry. Having participation from various industries will ensure a well-rounded perspective as we discuss

how to navigate the new GDUFA rules and the steps companies can take to ensure compliance.

Panel: Lessons Learned: Successes and Challenges in Implementing Quality By Design Moderator: Jennifer Markarian, Manufacturing Editor, Pharmaceutical Technology Panel: Chris Moreton, Vice President Pharmaceutical Sciences, FinnBrit Consulting; Jonathon Thompson, Technical Sales Consulting Supervisor, Invensys Wednesday, April 24, 10:15am-11:15am Room: 1E07

Quality by Design (QbD) requires a good understanding of statistical, analytical and risk-assessment methods that historically have not been systematically used by the pharmaceutical industry or regulators. In adopting this new model for pharmaceutical manufacturing, what benefi ts has the industry realized to date and what challenges exist and lie ahead? Manufacturing and regulatory experts share their insight and practical experience in implementing QbD, including strategies for defi ning a design space, adaption of manufacturing processes, the feasibility for real-time release testing, and the keys to continuous process verifi cation.

Application of Quality by Design in API Process Development Erik Johnson, Senior Application Specialist and Nirav Shah, Senior Application Specialist, Umetrics - An MKS Company Wednesday, April 24, 11:30am-12:30pm Room: 1E07

QbD should by defi nition involve DoE to identify critical interactions and noise. Hear how calculations are used in the determination of a Design Space with many factors. Using a case study we will demonstrate how the design space can be calculated for fi ve factors and illustrate the fundamental difference between a design space approach and a process set-point with a maximum process window. The process set-point with fi ve factors gives a high and low value for each factor corresponding with ICH Q8. The Monte Carlo derived design space approach is more in accordance with ICH Q11 where the design space is given by an equation. The advantage is the possibility for control - the best value for one factor is changed on the basis of set point of another factor.

New Product Assessment in a Multiproduct Environment – A Risk-Based ApproachVeda Walcott, Vice President of Quality, Cook Pharmica LLCWednesday, April 24, 1:30pm-2:30pm Room: 1E07

In order to manage the risks associated with cross-contamination, multiproduct facilities must review both Quality (CGMP) and personnel health and safety risks for each new product and process prior to manufacture. Cook Pharmica, LLC will share its experience in implementing the ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) in its New Product Assessment (NPA) process. Cook Pharmica’s NPA process provides for review of facility capabilities, regulatory considerations, industrial hygiene assessment, and client requirements. Additionally, the outputs of the assessment include acceptability determination, control plan and appropriate communications.

PRODUCT DEVELOPMENT Process Robustness: From Development to Life Cycle Management Richard Creekmore, US Technology Manager, AstraZeneca Pharmaceuticals Tuesday, April 23, 10:15am-11:15am Room: 1E08

Process robustness is an important attribute for any product. Manufacturing processes that are fair or poor in nature are more expensive to manufacture, more likely to be out of stock and have a higher probability for a recall. The robust manufacturing starts with the proper formulation and manufacturing processes and continues with the proper experiments during development and monitoring during routine manufacture. Current guidances, e.g., ICH Q9 and best practices can lead to the development and maintenance of a product with a robust manufacturing process.

The Role of Process Analytical Technologies in the Current Quality by Design Framework Benoit Igne, Research Coordinator, Duquesne University, Center for Pharmaceutical Technology Tuesday, April 23, 11:30am-12:30pm Room: 1E08 Since the adoption of the Quality by Design (QbD) framework by FDA, the role of process analytical technologies (PAT) had been discussed extensively; specifi cally, the need to monitor and control of pharmaceutical processes to support a QbD paradigm. This presentation will focus on describing the relationship between PAT and QbD. Using practical examples, the role of PAT will be described as a method to facilitate and implement QbD strategies. Additionally, the common misconception that PAT methods ensure that processes are of adequate quality will be challenged.

Regulatory Strategy for Implementation of QbD and PAT in a Pharmaceutical Manufacturing EnvironmentCarl Anderson, Associate Professor and James K. Drennen III, Associate Professor, Duquesne University, Center for Pharmaceutical TechnologyPanel: TBD Tuesday, April 23, 2:45pm-4:45pm Room: 1E08

The practical implementation of process analytical technologies (PAT) and Quality by Design (QbD) will be discussed by industry leaders and regulators. Invited panelists from leading pharmaceutical companies will share their experience and the approach taken by their company in implementing PAT and QbD submissions. These case studies will be complemented by the inputs from prominent academic and FDA personnel. Following the presentations, a panel discussion will take place, allowing the audience to interact with the speakers.

Combination Product Development: Drug Products for Device Companies David Armbruster, Global Program Manager, DePuy Synthes Wednesday, April 24, 10:15am-11:15am Room: 1E08

Drug-device combination product development is a complex undertaking, whether approached from the drug company or device company perspective. For a device company developing a product regulated as a drug, the learning curve is steep. Lessons learned will be shared by a device company along with the process of submitting an Investigational New Drug (IND) application. The basics of drug-device combination product regulation by FDA and the EU will be reviewed, and the key differences between drug product development and medical device development discussed and contrasted. A focus will be on key ingredients of successful combination product development, as illustrated by the development of a local antibiotic delivery implant.

Pharmaceutical Technology Transfer Practices into Design Control for Convergent Products Roy R. Fennimore Jr., Research Fellow, Product & Process Scienti� c Solutions (P2S2) - Johnson & Johnson Wednesday, April 24, 11:30am-12:30pm Room: 1E08

A high level view of where Pharmaceutical Technology Transfer (TT) integration aligns with Design Control (DC) and the New Product Development (NPD) Process for Combination/Convergent Medical Products.


CONFERENCE SESSION DESCRIPTIONS

Provide an overview of how Technology Transfer (TT) Pharmaceutical Development (PD) deliverables and best practices can be integrated into a Design Control (DC) System and the New Product Development (NPD) Process for Combination/Convergent Medical Products. Explore key aspects in: Adapting Pharmaceutical Development Technology Transfer Practices into a Design Control System; Integration Strategy & Translation from Pharmaceutical to Design Control Deliverables. Also discussed will be Technology Transfer Guidelines: Key Concepts for Integration; Linking Pharmaceutical Development to the Design Control System; New Product Development Process; Roadmap and Internal Guides; Key Take-Aways from the Technology Transfer Guidelines.

Current Continuous Process Validation Program (CCVP) Following FDA Current Guidelines Victor Hernandez, Project Engineer III, EMD Millipore CorporationWednesday, April 24, 1:30pm-2:30pm Room: 1E08

Knowledge of FDA related regulations and guidelines, GxP, GAMP, ASTM, ICH, ISPE Guidelines, PDA and 21 CFR 820/210/211 etc. will help participants to rapidly understand the scope of this presentation. Gain a better understanding of design, development, brainstorming, review, and implementation of a Continuous Validation Program from a corporate level down to corporate sites and supply chain. An advanced level of technical information pertaining to all the disciplines involved will be disseminated along with the requirements to develop and implement a CVP following current trends. Learn about the impact on the industry and how CVP will help to maintain a cost effective “validated state” involving the support manufacturing, technical services, engineering, quality assurance, suppliers, customers, and corporate sites.

Process Validation (PV): Designing an Effective PV ProgramMike Porter, Consultant, Commissioning Agents, Inc.Wednesday, April 23, 2:45pm-3:45pmRoom:1E08 Process Validation has been a key element of the overall validation program for a signifi cant period of time. However, new guidance, including the 2011 Process Validation guidance from the FDA and the EMA Draft Guideline on Process Validation issued in 2012 are having an impact on the traditional PV approach. Expectations for a successful PV program are changing, and long held views, including the number of batches required in a PV, need to be revisited.

This session will present the principles from the guidance documents, discuss critical elements to consider when designing a PV program and discuss

practical approaches for a program from process design through fi nal report. Also covered will be the heightened impact of risk assessment in PV, critical considerations when designing a PV program and a discussion on integrating the PV program with the quality system to support maintaining the validated state.

FACILITY & PROCESS DESIGN Effective Cleaning Procedure for Medical Devices Using Laboratory Studies Elizabeth Rivera, Technical Service Specialist, STERIS Tuesday, April 23, 10:15am-11:15am Room: 1E09

Designing an effective cleaning procedure is a critical part of a medical device site operation. Gain insight regarding laboratory studies that lead to the design of a successful cleaning procedure to be incorporated in the medical device manufacturing process. Review critical parameters, cleanliness acceptance criteria and quality attributes to ensure that medical devices are successfully cleaned. Actual case studies will be used throughout to demonstrate critical points. In addition, the following topics will also be covered: residues typically associated with the manufacturing of medical devices and laboratory evaluation: why and how.

Establishing a Design Space Cleaning Process Development and Validation Keith Bader, Sr. Director of Technology, Hyde Engineering + Consulting, Inc. Tuesday, April 23, 11:30am-12:30pm Room: 1E09

Approaches to the development and validation of cleaning processes are changing to achieve greater effi cacy and effi ciency. In the past, cleaning processes have typically been developed at commercial scale concurrent with production, resulting in cleaning cycles often lacking a strong basis in science. Recent FDA and ICH Q8 guidance describes the application of front-loaded quality by design concepts for pharmaceutical development. Developmental work provides a scientifi c basis for the cleaning process based on the idiosyncratic behavior of post-production residues. These concepts can be applied for the selection of cleaning agents, the development of a cleaning process design space and initial parameter discovery tests, thus providing a basis for strategic and tactical decision making, as well as the reduction of cost of goods. The information gathered from this developmental work can be employed in conjunction with ICH Q9 risk management approaches to provide a basis for the extent and scope of cleaning validation requirements at lab, pilot and manufacturing scales.

Implementing Single-Use Biomanufacturing Systems into Traditional Stainless Steel-Based Facilities Tom Piombino, PE, Project Director/Process Architect and Principal, IPS – Integrated Project ServicesTuesday, April 23, 2:45pm-3:45pm Room: 1E09

Many organizations that are investigating the implementation of SU systems have current manufacturing operations that are based on the traditional stainless steel (SS) manufacturing components found in both upstream and downstream operations. Being rooted in SS manufacturing platforms does not mean that the implementation of SU systems should be viewed as a risk or ineffi cient cost alternative.However, to implement SU systems within an existing SS manufacturing operation does come with some unique attributes and challenges. Discussions will include some of the aspects of SU implementation and identify areas of focus to ensure that there is synergy between the different manufacturing platforms and operational philosophies.

Design Aspects for a Bio Fill and Finish Facility Josef Trapl, Technology Manager Pharma/Medical Devices, M+W Group Wednesday, April 24, 10:15am-11:15am Room: 1E09

Based on the design experience of an F&F (Fill and Finish) multi-use facility for bio products, the basic engineering and design aspects for a lean facility design will be demonstrated. The project shows a new way for fi lling product in a BSL2 environment by using blow fi ll seal (BFS) technology for the primary packaging step. Based on a real case study the process integration, clean room aspects and operational requirements are discussed. Finally the methodology for the applied risk assessment to reduce potential contamination and operational risk will be explained. Based on view risk assessment examples, primary and secondary actions will be highlighted and the related activities which have to be considered during the design, construction and start-up.

Purpose-Driven Design: Savings for Pharmaceutical Facilities John Cunningham, Design Partner, ACi; Hank Jibaja, Project Manager, Nephron Pharmaceuticals Wednesday, April 24, 11:30am-12:30pm Room: 1E09

Leading drug manufacturer Nephron Pharmaceuticals sought to expand production capabilities with the addition of two major facilities: one that would incorporate an advanced robotic packaging system

and another that would include R&D, manufacturing and administration space with an eye toward future expansion. With the help of an architect fi rm, Nephron developed design elements to revolutionize the company’s production processes using advanced automated technology and a “visual corridor” layout for laboratory design that few laboratories around the globe feature. Nephron’s new facility not only incorporates cutting-edge features into the design, but also anticipates fl exible space for pharmaceutical manufacturing capabilities that Nephron has yet to employ. A building design was created that anticipates future technologies while keeping the functionality of the space fl exible and saving costs in the long term.

Panel: Getting Excited about the Modular Experience!Moderator: Sandra Lueken, MedimmunePanel: Par Almhem, President, ModularPartners; Detlef Kehm, Vice President - Maintenance and Engineering Services, Grifols; Craig Sandstrom, Director, Process Engineering, Fluor, Inc. Wednesday, April 24, 1:30pm-3:00pm Room: 1E09

Subject Matter Experts integrate different aspects of the modular experience into an exciting and lively panel discussion. Review a recent case study of a project execution approach by utilizing large scale process modules to implement fi rst of a kind technology for the Plasma Fractionation Industry. Discuss the rationale and benefi ts behind modular construction for the biopharmaceutical industry along with case studies on their implementation on several recent projects. Gain insight to how modularization and standardization can help reduce risk, time and cost in projects, domestically and internationally.

MANUFACTURING & PACKAGING Risk Management of Contamination and Cross Contamination in Pharmaceutical Manufacturing Alan Fisher, Business Development Manager/Contamination Control Specialist, Dycem USA Limited Tuesday, April 23, 10:15am-11:15am Room: 1E10

What is contamination? Explore the latest insights about the sources and vectors of contamination and cross contamination along with particles, particle technology and particle movement. Discussions will also center around all the stages of risk, such as: risk management, identifi cation, analysis, evaluation, control, reduction, review, and communication. An emphasis will be placed on the application of risk management policies in multi-product contract manufacturing pharmaceutical operations, particularly the impact upon all the stakeholders of Pharmaceutical Manufacturing Facilities.




Highly Potent, Poorly Soluble Product Manufacturing Contract, with 100% OTIF Fidelma Callanan, Sr. Director, Contract Pharma Services, Alkermes Tuesday, April 23, 11:30am-12:30pm Room: 1E10

Alkermes Contract Pharma Services was approached by a Large Pharmaceutical company to provide development, scale-up and commercial manufacturing services for a Highly Potent product. This compound required formulation optimization due to inherent solubility diffi culties associated with the original liquid dosage form. Through the application of our nano-technology, the product was optimized to allow for improved dissolution and increased oral bioavailability and was developed into a solid oral tablet. The optimized tablet was subsequently scaled-up to commercial levels in a specially commissioned high potency suite. The product is now commercially available in over 100 major markets worldwide with 5 year On-Time In-Full of 100%.

Mechanical Characterization, Testing and Defect Monitoring of TabletsCetin Cetinkaya, Professor, Clarkson University Tuesday, April 23, 2:45pm-3:45pm Room: 1E10

The effects of mechanical properties of drug tablets on their therapeutic and structural functions have been reported by various researchers and practitioners. With the advent of new solid dosage types such as push-and-pull and multi-layered tablets, the structures of some tablet forms have become quite complex, and, consequently, their testing and monitoring requirements are often more demanding and critical than those for traditional compacts. Recent developments on the test and characterization approaches based on online and wireless monitoring techniques will also be provided. Gain a better understanding of mechanical characterization, testing and defect monitoring of drug tablets.

Biopharma’s Flexible Imperative Robert Dream, Principal, HDR Company LLC Wednesday, April 24, 10:15am-11:15am Room: 1E10

Recently, a number of different trends have converged to demand a new type of biopharmaceutical facility, one that emphasizes fl exibility and agility. When drawing this new blueprint, business needs to: minimize timelines and fi nancial risks, and conside; understand “biotech on demand” and the ability to shore up local manufacturing capacity to quickly meet market demand; identify national security needs for systems that can easily and rapidly respond to biological attacks and be aware of urgent national health care

necessary to protect the public from large-scale, fast moving epidemics and pandemics. With today’s biopharmaceutical manufacturing facilities being smaller, more fl exible, effi cient and more cost-effective than those of the 1990s, and they are able to adapt quickly to market changes.

OEE Master Class: How to Increase Production Time by 20% Adrian Pask, OEE Expert, Vorne Industries Wednesday, April 24, 11:30am-12:30pm Room: 1E10

Overall Equipment Effectiveness (OEE) came from the Toyota Management System and is a standardized way of measuring the productive time of your equipment. Most plants measure OEE, few get really great sustained improvement. This session will give you practical guidance on how to measure and improve production by over 20% through the use of OEE with your operators, supervisors and managers working on bottling, blister, compression, encapsulation, forming, injection moulding, and fl uid bed equipment.

Panel: Road Map to Implementing EBR Moderator: Michelle J. Alleman Adkins, Manager, Life Science Industry Consulting, EmersonPanel: David Gleeson, Assistant Director, Manufacturing Systems, Bristol Myers Squibb; Chuck Krumwiede, Vice President/Managing Partner, Malcom Associates Wednesday, April 24, 1:30pm-2:30pm Room: 1E10

EBR/MES benefi ts will not be fully realized until you “lean the existing paper Batch Record documentation FIRST”. Companies continue to underestimate their value of addressing the documentation and work fl ow in order to implement EBR effectively. Documentation often becomes the “step child” when a project schedule is developed with the focus on user requirements planning, sandbox testing and training. The leaning or redesign process eliminates redundant information, identifi es what data to integrate to EBR, develops a strategy for interface with other systems, validates and/or invalidates user and functional requirement specifi cations, and identifi es what SOPs need to be revised and created to support and comply with system functionality and interfaces and provides the true ‘road map’ to implementing EBR effectively.

Warehouse Management Systems (WMS): How to Achieve a Warehouse of the FutureJoe Scioscia, Vice President, VAI (Vormittag Associates, Inc.)Wednesday, April 24, 2:45pm-3:45pmRoom: 1E10

Warehouse Management Systems (WMS) rely on myriad technologies to ensure inventory accuracy and product service organization—e.g. receiving, inventory management, product/service layout, staffi ng and purchasing. Effi cient WMS is integral to organizations’ supply chains and critical to overall business process success. However, controlling movement, storage and technologies can present signifi cant challenges. This session will outline best practices organizations must consider to achieve a warehouse of the future. Key factors for ensuring effi cient WMS, including a proper warehouse layout, the importance of knowing your product and training your staff will be identifi ed. It will also discuss advanced technologies, including: RF, Voice, A Frame, conveyors, and carousels—examining biggest mistakes, and providing real-world examples of organizations enhancing productivity, streamlining processes, improving inventory accuracies, and reducing costs by implementing effective WMS.

SUPPLY CHAIN How Commercial Payers Restrict the Specialty Supply Chain Lee Goldberg, Director, Syndicated Research, The Zitter Group Tuesday, April 23, 10:15am-11:15am Room: 1E11

You’re well aware of the pieces and processes that must be integrated to securely, safely and effi ciently manufacture life-saving specialty therapies. But you might have less knowledge of the supply chain hurdles your product faces once it leaves the facility. Commercial payers restrict the specialty supply chain in numerous ways, all with an eye toward encouraging appropriate utilization. Learn the various methods of control directed at the manufacturer, the doctor and the patient. Plus, how manufacturers work to minimize these controls to make sure as many patients get your drug as need it. No technical background is required, only an interest in understanding the barriers your colleagues must overcome to let you fi nish your job-getting specialty therapies to patients.

Business Continuity for Biopharmaceutical Companies: Real Implementation of Operational Excellence Dave Goswami, CEO/Managing Director, IPS – Integrated Project ServicesTuesday, April 23, 11:30am-12:30pm Room: 1E11

In any industry, unplanned stoppages in business proceedings usually mean loss of income from an existing asset. In Biopharmaceuticals, the risk of disruption in the business goes beyond immediate loss of income and could be extremely costly. Examples are loss of space condition invalidating preclinical test results and possibly delaying drug approval or extended disruption in production resulting in a shortage of a particular drug affecting the patient community. As companies operate under strict regulatory requirements in the Biopharmaceutical industry, manufacturing and R&D facilities are vulnerable to external as well as internal infl uences. Discussions will focus on Business Continuity Planning to ensure effective continuation and reliability of critical business functions and mitigate risks to business focus such as continuous drug supply in the event of disruption or adverse conditions.

Commercialization Outside the US: What arethe Challenges Stephen J. Fadden, P.E., Sr. Director, Process Engineering, Johnson & Johnson Tuesday, April 23, 2:45pm-3:45pm Room: 1E11

This presentation will highlight the technical, quality/regulatory and staffi ng challenges associated with bringing commercial capacity on-line outside the US. It will include technical and regulatory considerations for the design and operation of equipment and facilities, as well as strategies to ensure appropriate technical staff are available and attracted to your organization.

Establishing Quality Agreements with a Unifi ed Approach for All Suppliers Morgan Palmer, Chief Technology Of� cer, EtQ, Inc. Wednesday, April 24, 10:15am-11:15am Room: 1E11

This session will explain the various elements that can result from poor supply chain quality, and how organizations are taking steps to extend their quality system to the supply chain. It will discuss the benefi ts of extending the quality system to suppliers, including real-time risk management in the supply chain. Part of the challenge is getting suppliers to “buy-in” to the contracting organization’s quality system. The key to harmonization is crafting a Quality Agreement with suppliers that not only promotes a culture of Quality down the supply chain, but also enables the suppliers the fl exibility to operate in their own capacity. Being able to extend business systems to the supply chain and have suppliers participate in your Quality Management System becomes a key focus in this respect.




Supply Agreements: Strengthening the Linchpin of Your Outsourcing Partnership Curtis Gingles, Vice President, Business Development, Jubilant HollisterStier Contract Manufacturing & Services Wednesday, April 24, 11:30am-12:30pm Room: 1E11

The Supply Agreement is a vital component in helping determine the successes, or failures, of your outsourcing partnership. Learn about the key elements to consider when negotiating a Supply Agreement, with highlights on specifi c lessons learned and contract negotiations. Discussions will also include key considerations of the Supply Agreement and will illustrate how the Supply Agreement should be used as a tool to provide innovative solutions and to anticipate and solve problems before they occur, thereby ensuring that the terms of the partnership are clearly defi ned and remain collegial, rather than punitive, to either party.

Managing Your Suppliers with Scorecard Metrics Shane Yount, Principal/Author, Competitive Solutions, Inc. Wednesday, April 24, 1:30pm-2:30pm Room: 1E11

One of the greatest challenges organizations face is maintaining a common business focus on improving results across all functional areas and levels, as well as communicating these said results to all involved. This interactive session outlines the process for developing, tracking, communicating and presenting workgroup business goals and objectives. Attendees will learn the importance of a common business focus to organizational success through the development of a mission statement and specifi c, measurable business goals.

Securing Information as Part of the GlobalSupply Chain Bikash Chatterjee, President and CTO, Pharmtech Associates, Inc.Wednesday, April 24, 2:45pm-3:45pm Room: 1E11

A comprehensive review followed by discussions regarding methodologies and technologies for addressing security threat assessment and risk management across the Supply Chain, including clinical trials data management, IP management and regulatory submissions. Learn more about the methodologies for analyzing and mitigating process risks as well as discuss the strengths and weaknesses of best in class technologies (e.g RFID, bar coding, fi rewalls, monitoring systems) for minimizing information breaches.

MINI-COURSE: SERIALIZATIONManufacturing Intelligence: Serialization to Improve Processes Jean-Pierre Allard, Serialization Product Manager, Optel Vision Wednesday, April 24, 10:15am-11:15am Room: 1E14

Tracking and Tracing for pharmaceutical companies can be very simple and effi cient if done properly. One of the most important aspects to understand is what’s really required to be done in terms of regulations and the related applied solutions. Companies also need to know the various changes involved in order to realize their serialization project(s) effi ciently.

Learn from our experience in worldwide implementation and gain a clearer understanding of how serialization can affect your business and how it must be handled. Review simple and precise aggregation solutions while becoming more familiar with current and evolving worldwide serialization requirements. In addition, extensive coverage of the different perspectives possible regarding IT implementation will be covered.

Implementing Unit-Level Serialization on a New Packaging Line Mike Salinas, Director of Manufacturing Technology, M+W U.S., Inc. Wednesday, April 24, 11:30am-12:30pm Room: 1E14

Packaging equipment suppliers and life science manufacturers alike are playing “Beat the Clock” to comply with California’s e-pedigree requirements for prescription drugs. Highlighted are some of the not so obvious strategies and nuances for successful implementation of serialization track and trace at the saleable unit level for a new packaging line from a project management perspective. Successful implementation takes a combination of teamwork, some foresight, constant communications, and attention to details. It’s a continuous process to an end game initially targeted for enforcement starting January 1, 2015.

For more details regarding badge pricing on these conference sessions, go to page 22 or

visit www.INTERPHEX.com/Conference.

Economic Impact of Implementing a National Serialization and Traceability System Gabrielle Cosel, Project Manager, Drug Safety Project, Pew Charitable Trusts Joel Grosser, Associate, Booz Allen HamiltonWednesday, April 24, 1:30pm-2:30pm Room: 1E14

There is currently a lack of public analysis on the costs and benefi ts of implementing a national serialization and traceability system for pharmaceuticals in the US Lawmakers are considering a federal standard to reduce the risk of counterfeit and diverted medicines entering the legitimate pharmaceutical supply, but they are doing so in the absence of a system-wide, data-driven analysis of costs or effi ciencies.

Research collaboration between Booz Allen Hamilton and The Pew Health Group has resulted in a model of the economic dimensions of a national serialization and traceability system for stakeholders in US pharmaceutical supply chain. Several elements will be examined including a discussion on barriers to implementation and exploring the potential economic and patient safety benefi ts generated by investment in such a system.

Wrap Up Panel: Understanding the Complexities of Serialization Moderator: H. Steven Kennedy, Director, Life Sciences + Chemicals, M+W U.S., Inc.Panelist: Jean-Pierre Allard, Serialization Product Manager, Optel Vision; Mike Salinas, Director of Manufacturing Technology, M+W U.S., Inc.; Joel Grosser, Associate, Booz Allen HamiltonWednesday, April 24, 2:45pm-3:45pm Room: 1E14

Now that you’ve listened to the individual presentations, it’s time to bring it all together. During this lively panel discussion, our industry experts will further enhance your understanding of the complex world of serialization. Review “Lessons Learned” and practical solutions to diffi cult challenges. Evaluate the costs and benefi ts resulting from various traceability system options. Come ready to ask your serialization questions and get the answers needed to make more informed decisions!

Separate conference badge required for Mini-Course Serialization sessions.

For more details regarding badge pricing for this special track, go to page 22 or visit www.INTERPHEX.com/Conference.


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INTERPHEX 2013April 23-25, 2013Javits Center | New York, New Yorkwww.INTERPHEX.com

INTERPHEX 2013April 23-25, 2013Javits Center | New York, New Yorkwww.INTERPHEX.com INTERPHEX 2013

April 23-25, 2013Javits Center | New York, New Yorkwww.INTERPHEX.com

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FREE CONFERENCE SESSIONSTECHNICAL WORKSHOPS

FREE CONFERENCE SESSIONSTECHNICAL WORKSHOPS / EXHIBIT HALL TECHNOLOGY FLOOR TOURS

TECHNICAL WORKSHOPSAutomating a Manual Cleaning Program in a Biopharmaceutical Manufacturing OperationGordon Leichter, Sales Manager, BelimedTuesday, April 23, 4:00pm-4:45pmRoom: 1E09

This informative presentation will serve as a guide for those considering implementing automatic washing in facilities where manual washing is conducted and to provide valuable insight into lessons learned and key considerations in the planning for their future-state process.

Single Use TechnologyDavid Cousins, Sales Director and Dena Flamm, Project Manager, BoschTuesday, April 23, 4:00pm-4:45pmRoom: 1E10

Single Use Technology has been greatly accepted in many steps in the manufacture of injectable pharmaceuticals. This presentation will discuss the design, assembly and validation of SUD for the fi nal fi ll stage of production.

A Compressed View of Modern Tableting TechnologyMatt Bundenthal, Senior Regional Sales Manager, Fette Compacting America, Inc. Tuesday, April 23, 4:00pm-4:45pmRoom: 1E11

Modern high-speed tablet presses must contribute to the overall maximization of manufacturing effi ciencies; they must offer maximum versatility across an ever-widening scope of dosage forms and, in an increasing number of applications, must help to ensure the safety of operators compressing potent compounds. A brief overview of these topics, and others, will be discussed.

Development, Qualifi cation and Application of Single-Use Technologies for BioprocessingMillie Ullah, Senior Product Manager, SUS, Thermo Fischer Scienti� cWednesday, April 24, 4:00pm-4:45pmRoom: 1E07

As the application of single-use technologies has grown, so have the number of assays, risk-based approaches and quality principals (such as QbD) by which the component fi lms and systems can be assessed. Gain a better understanding of new approaches to validating the quality and performance of fi lm used in single-use technologies.

Insight, Foresight, and Oversight - Using PAT for Continuous Manufacturing Andrew Birkmire, Process Development Manager, GEA Process EngineeringWednesday, April 24, 4:00pm-4:45pmRoom: 1E08

Insight is how you mine historical data generated from experimental design to develop process understanding. Foresight is how you use process understanding to develop your predictive models and design space. Oversight is how you use your process knowledge and modeling to generate continuous process quality.

Conversion of Stainless Steel Facility to Hybrid or Single-Use FacilityRoman Rodriguez, Mobius Group Global Manager, EMD Millipore CorporationWednesday, April 24, 4:00pm-4:45pmRoom: 1E09

Converting all or part of an existing facility to single use technologies can be dictated by a diverse yet intertwinedset of parameters that are technical, strategic and administrative. Additional parameters will impact the decision including personnel, schedule, current facility design, existing equipments, product comparability, and inventory control management. This presentation will assist with the decision making process by highlighting the key considerations for each of these parameters.

Comparing Drug Pellets Made via Wurster and Direct Pelletization ProcessesEd Godek, Manager, Process Technology, Glatt Air Techniques, Inc.Wednesday, April 24, 4:00pm-4:45pmRoom: 1E11

Explore the differences between drug loaded pellets made by both Wurster and direct pelletization techniques. A study comparing the physical properties and dissolution of controlled release coated pellets made by each technology will be discussed.

Technical Workshops are open to all badge holders.

EXHIBIT HALL TECHNOLOGY FLOOR TOURS PRE-REGISTRATION IS REQUIRED - TOUR SPACE IS LIMITED! Wednesday, April 24, 10:00am and repeated at 1:00pm

OSD Technologies Tour – “Multi-Product Facilities…There is More to Them Then Cleaning”Tour Leaders: Sam Halaby; Russ Somma, Ph.D.; Mike Vileikis

The continued success of a Multi-Product Facility depends on operational areas designed with multi-functionality. Multi-functionality design allows for the fl exibility to change out unit operations for various drug products, as well as the capability to “scale-out” to accommodate the dynamics of capacity, market demand and product changes.Tour attendees will gain insight on designing successful fl exible operational areas that can accommodate numerous types of process equipment, execute various functional operations and allow for an equipment change-out and functional overhaul. Additionally, attendees will fi nd out how take advantage of the latest modular equipment that are offered by selected tour vendors.

Advanced Aseptic Technologies Tour – “The Latest Innovations in Aseptic Barrier Filling Technology”Tour Leaders: Sterling Kline, RA; Jason Collins, RA, NCARB; Rob Roy, PE; Jerrod Shook

Innovation in Aseptic barrier fi lling technology continues to improve. This Tour offers the opportunity to see the evolving 4th generation of barrier technology which continues to simplify and shorten manufacturing processes. Leading industry vendors offer new introductions and current trends in aseptic processing along with meeting current regulatory expectations. Tour attendees will gain insight into the latest innovations in fully integrated process of aseptic manufacturing and how to take advantage of the latest equipment that is offered by vendors and internationally recognized experts.

Biomanufacturing Technologies Tour – “Biomanufacturing”Tour Leaders: Jeff Odum, CPIP; Chuck Stock, CxA

With increasing insights into product requirements and product characterization, the critical path for the development of new products is shifting to process development and manufacturing timelines where speed and fl exibility are critical. Future manufacturing systems must be agile enough to deliver more types of products in a shorter timeframe. Tour attendees will gain insight on identifying new enabling technologies and innovative solutions that provide a platform to support biomanufacturing operational excellence, including effi ciency, fl exibility and reducing overall costs.

Modular Construction Technologies Tour – “Optimizing Execution with Modular Construction”Tour Leaders: John Gilroy, PE; Gene Martini, PE

This Tour offers a different way to think about modular facilities and achieving fl exible environments. Today modular is much more than a completed facility organized in shipping container sized units. For smaller expansion and upgrade projects within existing facilities, plant owners can take advantage of customized modular product delivery to reduce overall project schedules, increase quality with minimal disruption to site operations, and potentially realize cost benefi ts. Tour attendees will learn how to take advantage of modular options and employ custom modularization options in order to accelerate commercial construction and achieve a fl exible manufacturing environment.

Presented by:


FREE CONFERENCE SESSIONSSTUDENTS AND YOUNG PROFESSIONALS PROGRAM

STUDENTS AND YOUNG PROFESSIONALS PROGRAM

INTERPHEX is pleased to partner with the ISPE New Jersey chapter and host the Students and Young Professionals Program.

A special program has been designed to facilitate high quality education and career development. With networking opportunities and focused course content, Students and Young Professionals will gain valuable insight into the pharmaceutical industry.

TRACK 1 - YOUNG PROFESSIONALS TRACKAn Introduction to Pharmaceutical Engineering for Young ProfessionalsRoom: 1E12

A review of important background information necessary for a clear understanding of the Pharmaceutical Engineering fi eld. Sessions will include a historical overview of pharmaceuticals, discussion of Pharmaceutical Discovery, Research & Development and clinical trials culminating in an introduction to Lean Six-Sigma manufacturing.

SESSION 1: Overview of Drug Discovery, Development and Clinical TrialsJoseph Manfredi, President & CEO, GMP Systems, Inc.Wednesday, April 24, 9:00am-11:00am

Mankind has been seeking relief from various affl ictions for thousands of years with the quest for safe, high quality remedies dating to prehistoric times. This session will offer a brief overview of drug history including a review of drug discovery methods, drug formulation and development and testing required, including multi-phase human clinical trials, necessary for FDA approval to market these drugs within the US. This session is tailored to Young Professionals recently entering the health sciences industry.

SESSION 2: Overview of Pharmaceutical Manufacturing Using Process Analytical Technology and Lean Six-Sigma Concepts and MethodologiesRobert Lechich, Director, P� zer, Inc.Wednesday, April 24, 1:30pm-3:30pm

Pharmaceutical manufacturing, for many decades, has

used fi nal product testing to ensure safe and effective products are delivered to patients. This process is often costly, time consuming and ineffi cient resulting in rejection of entire batches and lots of fi nished goods. Lean Six-Sigma manufacturing and PAT (Process Analytical Technology) seek to assure each step in the process is correct, suitable, ensures product quality, and minimizes waste. This session will provide an overview of these concepts targeted to young professionals in the health sciences industry.

TRACK 2 - STUDENTS TRACKPlanning for Your Career in the Health Sciences Industry – A Student PerspectiveRoom: 1E13

A full day workshop suitable for both undergraduate and graduate students to increase their knowledge of the Pharmaceutical Industry, network with industry executives, meet and learn from industry HR personnel, and hone their interviewing and resume skills. Presentations will be informative and interactive with time allotted for resume critiquing.

SESSION 1: Making a Positive “First Impression”Dave Novak, Northeast Area Manager, ProPharma GroupWednesday, April 24, 9:00am-11:00am

This session will provide students with the needed tools to assure they are empowered. Sessions will focus on mastering the skills necessary to make a positive fi rst impression. Learn interactively about preparing and making an “elevator speech”. Gain insight into the best methods for cross generational interaction, networking with industry executives, HR personnel and peers, and learning the best techniques for interviewing. This session will assist students at all stages with the critically important task of assuring they are perceived positively.

SESSION 2: Creating a Career PlanNancy Tomoney, Vice President, PSC BiotechWednesday, April 24, 1:30pm-3:30pm

This session will begin with a discussion of the best practices for developing a career plan followed by career insights from a number of industry executives describing their specifi c career path into the health sciences industry with highlights of their experiences and accomplishments. Additional subject matter will include tips for: applying for a job, use of social networking and resume preparation and submission. Time will be provided to allow industry professionals to critique the resumes of individual students who wish to have this feedback.

Wednesday, April 24: 8:00am-9:00am Registration & Networking

9:00am-11:00am Track 1 and 2: Session 1

11:00am-1:30pm Activity on Show Floor

1:30pm-3:30pm Track 1 and 2: Session 2

3:30pm-4:30pm Show Floor/Tracks Close

To register for this complimentary program, please select the “Students and Young

Professionals Program” category.

THE HEALTHCARE BUSINESSWOMEN’S ASSOCIATION WORKSHOP SERIESThe Healthcare Businesswomen’s Association is the premier catalyst for the leadership development of women in healthcare worldwide. Learn from the experts, who are also HBA members, to give you actionable strategies you can take to Build your Personal Brand and Advance Your Leadership by Focusing on the Patient. (www.hbanet.org)

Wednesday, April 24Room: 1E21

AGENDA: TOPIC I

Arrival and Networking9:30am-10:00am

AGENDA: TOPIC II

Arrival and Networking2:00pm-2:30pm

The Healthcare Businesswomen’s Association Workshop series is open to all badge holders.

FREE CONFERENCE SESSIONSTHE HEALTHCARE BUSINESSWOMEN’S ASSOCIATION WORKSHOP SERIES

1-2-3 Success: Three Steps to a Winning Personal BrandWendy L. Mantel, A Personal Brand and Career Strategist, Mantel Coaching, Inc.10:00am-12:00pm · Branding, Personal Branding and the REACH 1-2-3 Process

· Three Actions to Successful Personal Branding

· The 1-2-3 Success Process and Its Use

· Building Your Personal Brand Identity System

Marketing Leadership by Focusing on the PatientDyan Bryson, Managing Director, Inspired Health Strategies, LLC2:30pm-4:30pm · Understand the concepts “user experience” and “patient centricity”

· Understand the business opportunity in becoming more patient centric

· Understand how to put patient centricity into action and manage the real business challenges of putting the patient at the center


M.J. KIMMELPrincipalMJK Solutions

CHAD WACHTERSr. CMC Manager BTG International

ALBERT MANIGO-BEY JR.Sourcing ManagerTeva Pharmaceutical

MICHAEL A. ZUPON, PH.D.Vice President,Pharmaceutical and Manufacturing Technology MannKind Corporation

TIMOTHY P. HOWARD, CPIP, P.E.Vice President & Company Offi cerCommissioning Agents, Inc.

ROBERT TIMKO, RPH, PH.D.Director CMC Group,Global Regulatory AffairsAstraZeneca Pharmaceuticals LP

MICHELLE M. GONZALEZ, P.E.Engineering ConsultantBioPharm

RUSS SOMMA, PH.D.PresidentSomma Tech, LLC

JASPREET SIDHU, PH.D. Vice President, Business Development & Pharmaceutical MicrobiologyMolecular Epidemiology

EJ BRANDRETHVP, Quality &Regulatory AffairsAlthea Technologies, Inc.

E. MORREY ATKINSON,PH.D.Vice President, Biologics Process SciencesBristol Myers Squibb Company

RICHARD POSKA, R.PH.D.Director, Regulatory AffairsAbbott Laboratories

DILIP ASHTEKAR, PH.D.Sr. Director Quality ControlGilead Sciences, Inc.

SANJAY PATELSr. Director, Global Materials ManagementShire Pharmaceuticals, Inc.

CONFERENCE ADVISORY BOARD

MICHALLE J. ALLEMAN ADKINSManager, Life ScienceIndustry ConsultingEmerson

ÇETIN ÇETINKAYAProfessorClarkson University

BOWMAN COXManaging Editor, “The Gold Sheet”Reed Elsevier

JOHN GILROY, P.E.Sr. VP and PrincipalIPS - IntergratedProject Services

GEORGIA KERESTY,PH.D.Chief Quality Offi cer &VP, Quality & ComplianceJohnson & Johnson Family of Consumer Companies

SANDRA LUEKEN Medimmune

CHRIS VERBICKY, PH.D. MBADirector of Business Development & MarketingColdstream Laboratories Inc.

INTERPHEX would like to thank the 2013 CONFERENCE ADVISORY BOARD MEMBERS, a volunteer panel of industry experts whose valuable insights played a strong role in determining this year’s conference program and direction.

SCOTT RUDGE, PH.D.Chief Operating Offi cerRMC Pharmaceutical Solutions, Inc.

FREE CONFERENCE SESSIONSTHURSDAY PRESENTATIONS

THURSDAY PRESENTATIONSCase Study and Framework for Implementing the New Process Validation GuidanceBikash Chatteriee, President and CTO, Pharmatech AssociatesThursday, April 25, 9:30am-10:30amRoom: 1E07

The new 2011 Process Validation guidance has dramatically changed the previous understanding of the scope and content of Process Validation. Many of the key concepts of ICH QS and Q9, along with those of PAT, have been embraced in the new guidance. Discussions will center around the components of each of the three stages of Process Validation along with the clarifi cation of the content within each stage. An actual case study will be presented on an application conducted for a pharmaceutical company using the framework. Come ready to participate in a discussion on the application of practical approaches for satisfying lifecycle Process Validation expectations.

Pushing the Limits: Questioning the MethodologyJaspreet S. Sidhu Ph.D., Vice President, Business Development & Pharmaceutical Microbiology, Molecular EpidemiologyWith contributions by: Greg Ma, Director General of Microbiology; Connor Tyler, Staff Scientist; Mansour Samadpour, Ph.D. Principal and President, Molecular EpidemiologyThursday, April 25, 10:45am-11:45amRoom: 1E07

USP Methods for Microbial Limits are a consensus of opinions which defi ne an averaged approach, or in other words, minimum acceptable practices. The various case studies presented will discuss: methodological approaches consistent with USP procedures which failed to provide clear indications of problems, leading to misinformed evaluations and/or costly rejection of product; actual quantitative limits and the concept of “culture purity” especially with regards to Master and Working Cell Banks; evaluations of the variable approaches (rapid methods) towards the identifi cation of microorganisms and the subsequent interpretations as “objectionable” or non-signifi cant; genetic fi delity in platform and production strains and will the minimum methodological approach adequately provide the assurance needed for peace of mind as well as economic security.

Thursday Presentations are open to all badge holders.


Meet the Category Award Winners at the FACILITY OF THE YEAR AWARDS (FOYA) Display Area located in Booth #1483. Team members from the winning companies will be on-hand to discuss the success stories associated with these pharmaceutical manufacturing facilities.

Connecting a World of Pharmaceutical Knowledge

SPONSORED BY:

BIOGEN IDECWinner of the Facility of the Year Award for Facility Integration for its Flexible Volume Manufacturing (FVM) Project in Research Triangle Park, North Carolina USA.

F. HOFFMANN – LA ROCHEWinner of the Facility of the Year Award for Project Execution for its TR&D – Building 98 Facility in Basel Switzerland.

MEDIMMUNEWinner of the Facility of the Year Award for Equipment Innovation for its UK Automation Upgrade Project in Speke, Liverpool UK

MERCK & CO., INC.Winner of the Facility of the Year Award for Operational Excellence for its Vaccine and Biologics Sterile Facility (VBSF) Project in Carlow, Ireland

MORPHOTEK, INC.Winner of the Facility of the Year Award for Sustainability for its Morphotek Pilot Plant in Exton, Pennsylvania USA

NOVARTIS VACCINES AND DIAGNOSTICSWinner of the Facility of the Year Award for Process Innovation for its US Flu Cell Culture Facility in Holly Springs, North Carolina USA

2013 WINNERS:

FACILITY OF THE YEAR AWARDS (FOYA)

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 high-quality medicines. We’re proud to recognize this year’s winners.

SPECIAL EVENTS AND FEATURES

The industry’s largest event, bringing together over 12,000 industry professionals to be inspired with fresh ideas, share experiences and build new relationships.

Keynotes1E15Leading industry experts: Congressman Bill Cassidy M.D., Rajesh Nair and Jim Miller, share their insights and opinions on today’s hottest topics. Strategies discussed will benefi t and enrich the thought process of those attending. See full session descriptions on page 3.

INTERPHEX ConnectsINTERPHEX Connects will serve as your networking hub. Relax, take a break, use a computer, grab a refreshment, get a massage and share insights and ideas with industry colleagues.

Facility of the Year Awards (FOYA) Show Floor, Booth #1483Meet the winners, ask questions and learn best practices from these award-winning pharmaceutical manufacturing facilities. Find out more and see a complete list of category winners on page 20.

ISPE Member Lounge Crystal Palace, LobbyISPE members can relax and unwind at the ISPE member lounge. Enjoy light refreshments, check in at the offi ce and discuss business with colleagues away from the show fl oor.

Cyber Café Crystal Palace, LobbyStay connected, stop by the cyber café to access your internet and check your email.

Exhibit Hall Technology Floor ToursWednesday, April 24, 10:00am and repeated at 1:00pmSeries of presentations and Exhibit Hall Technology Floor Tours presented by IPS – Integrated Project Services. Pre-registration is required, see a complete list of tours on page 15.

Students and Young Professionals ProgramINTERPHEX is pleased to partner with the ISPE New Jersey chapter and host a Students and Young Professionals Program. This special program has been designed to facilitate high quality education and career development. See the complete program overview on page 16.

Technical WorkshopsTuesday, April 23 and Wednesday, April 244:00pm-4:45pm1E08 - 1E11Presentations will be technical in nature and complement the conference agenda. Sessions have been developed to bring real-world experiences directly to you. See the complete line up on pages 14-15.

Healthcare Businesswomen’s Association Workshop SeriesWednesday, April 249:30am-12:00pm & 2:00pm-4:30pm1E21The Healthcare Businesswomen’s Association is the premier catalyst for the leadership development of women in healthcare worldwide. Learn from the experts, who are also HBA members, to give you actionable strategies you can take to build your personal brand and advance your leadership by focusing on the patient. See more details on page 17.

Excellence UnitedShow Floor, In front of 2500 AisleExcellence United is a strategic alliance of independent, privately owned companies, each representing the recognized leader in their specifi c area of expertise. As a unifi ed whole, the alliance offers an unprecedented network of technology, equipment and resources, thereby providing turnkey solutions to global clients representing the pharmaceutical, medical technology, and process industries. Exhibitors include: Bausch + Stroebel, Fette Compacting, Glatt, and Harro Hofl iger.

INTERPHEX Global EventsINTERPHEX Sales & Marketing BoothDid you know that INTERPHEX has events in Puerto Rico, Japan, China, Singapore and the United Kingdom? Find out more information about attending or exhibiting at these events by visiting with their country representative.

Puerto Rico Pharmaceutical OpportunitiesCrystal Palace, LobbyRepresentatives from key industry groups including the Puerto Rico Industrial Development Corporation (PRIDCO), the Puerto Rico Manufacturers Association (PRMA) and INDUNIV (government, academic, industry consortium) will be available to discuss the island’s pharmaceutical and life sciences industries. The Puerto Rico Convention Bureau will also be represented to present the island’s capabilities as a venue for both company and industry meetings.


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INTERPHEX 2013April 23-25, 2013Javits Center | New York, New Yorkwww.INTERPHEX.com

INTERPHEX 2013April 23-25, 2013Javits Center | New York, New Yorkwww.INTERPHEX.com INTERPHEX 2013

April 23-25, 2013Javits Center | New York, New Yorkwww.INTERPHEX.com

INTERPHEX MOBILE 2013Your FREE and personal guide to INTERPHEX on your web-enabled phone!

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ACCESS THE MOBILE APP AT WWW.INTERPHEXMOBILE.COM.

MY INTERPHEX SHOW PLANNERYou’re just one step away from a personalized INTERPHEX experience!

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

This online planning tool gives you the opportunity to: • Preview the fl oor plan.• Search exhibitors by company name and

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SHOW PACKAGES

Conference Passes Early Date(Before 4/1)

Advance/Onsite(After 4/1)

TWO DAY CONFERENCE(Includes access to all INTERPHEX Conference Sessions, Exhibit Show Floor, Keynotes, Thursday Presentations, and Technical Workshops plus lunch each day. Does not include Mini-Course: Serialization.)

$995 $1,095

ONE DAY CONFERENCE(Includes access to all INTERPHEX Conference Sessions for one day, Exhibit Show Floor, Keynotes, Thursday Presentations, and Technical Workshops plus lunch on chosen day. Does not include Mini-Course: Serialization.)

$695 $795

SINGLE SESSION PASS(Includes access to one (1) INTERPHEX Conference or Serialization Session of your choice, Exhibit Show Floor, Keynotes, Thursday Presentations, and Technical Workshops.)

$185 $195

EXHIBIT HALL PASS(Includes access to Exhibit Show Floor, Keynotes, Thursday Presentations, and Technical Workshops.)

FREE FREE($75 onsite)

MINI COURSE – SERIALIZATION(Includes access to Serialization Conference Sessions, Exhibit Show Floor, Keynotes, Thursday Presentations, and Technical Workshops plus lunch. Does not include INTERPHEX Conference Sessions.)

$395 $495

GOVT/ACADEMIA TWO DAY CONFERENCE(Includes access to all Conference Sessions, Exhibit Show Floor, Keynotes, Thursday Presentations, and Technical Workshops plus lunch each day. Must show Govt/Academic ID when picking up badge. Does not include Mini-Course: Serialization.)

$495 $595

STUDENTS AND YOUNG PROFESSIONAL PROGRAM(Includes access to either Student or Young Professional courses, lunch voucher, Exhibit Show Floor, Keynotes, Thursday Presentations, and Technical Workshops.)

FREE FREE

STUDENT TWO DAY CONFERENCE(Includes access to all INTERPHEX Conference Sessions, Exhibit Show Floor, Keynotes, Thursday Presentations, and Technical Workshops. Must show Student ID when picking up badge. Does not include Mini-Course: Serialization.)

$50 $50

THE HEALTHCARE BUSINESSWOMEN’S ASSOCIATION WORKSHOP SERIES(Includes access to the Healthcare Businesswomen’s Association Workshop Series, Exhibit Show Floor, Keynotes, Thursday Presentations, and Technical Workshops.)

FREE FREE

ISPE TWO DAY CONFERENCE(ISPE Members with valid membership are eligible for a discounted Two Day Conference Pass. ISPE Membership number needed when registering to activate discount.)

$875 $875

.GROUP RATE INFOGroups of four (4) or more people from the same company, who register at the same time, will save 15% on Two Day Conference packages. Not applicable to One Day Pass or Single Session Pass packages. To take advantage of the Group Discount, please contact Alycia Grenesko at 203-840-5897 or [email protected].

SHOW PACKAGES


3M FiltrationA&B Process Systems Corp.AAF InternationalAAIPharmaAaron Equipment CompanyAbbVieABC ActiniAbec IncABMACG North America LLCAcro Associates, Inc.Acsis, IncADCO ManufacturingAdvanced Microdevices Pvt.

Ltd.AdvanceTEC LLCAdvantaPureAdvantest CorporationAdvantix SystemsAES Clean Technology Inc.Aesica Pharmaceuticals Ltd.Afl ex Hose USA, LLCAir Products and Chemicals

IncAIV SolutionsAlconox IncAlfa Wassermann IncAlkermes Contract Pharma

ServicesAllegheny Bradford Corp.Allegheny Surface TechnologyAlliance Medical Products IncAlloy Products CorpALLpaQ Packaging GroupAlmac Pharma ServicesAlpVisionAlthea TechnologiesAmerican Pharmaceutical

Review/Pharmaceutical Outsourcing

AMRIANDRITZ Separation Inc.

(formerly) KMPTAnritsu Industrial Solutions

USAAnton Paar, USAAphena Pharma Solutions Inc.Applied Chemical TechnologyApplied Control Engineering,

Inc.Applikon Biotechnology IncAPPS IncAptar PharmaAquafi ne CorpAQUASYN LLCAramarkArchon Industries, IncArcoplast IncArizona Instrument LLCArkema Inc.ArkPlas®Asahi Kasei BioprocessAsco NumaticsASEPCOAseptic TechnologiesAshcroft IncASIAssociates of Cape Cod IncAstro Pak Corporation

ATC, Inc. - Advanced Test Concepts, Inc.

ATEC Pharmatechnik GmbHAtlantic Scale IncAtlantium Technologies, Ltd.ATMI LifeSciencesAWH GmbH/RiegerAWS Bio-Pharma

Technologies LLCAzbil Biovigilant Systems IncAZO IncAzzur GroupB & D Products LLCB&W Tek Inc.Bahnson Environmental

Specialties, LLC.Baldor Electric CompanyBanner Engineering CorpBausch & Stroebel Machine

CompanyBausch Advanced

Technologies IncBaxterBEE International Corp.Behringer CorpBeijing Gylongli Science &

Technology Co., Ltd.Belimed Infection ControlBelimo AmericasBellatrx Inc.BellwyckBenchmark Products IncBioengineering Inc.Biologics ModularBiopro International IncBioProcess InternationalBioSurplusBishamon Industries CorpBlack Forest Container

Systems LLCBlue Ribbon Group Co. Ltd.Blue Thunder TechnologiesBlueSens gas sensor GmbHBlue-White IndustriesBMT USA LLCBONFIGLIOLI ENGINEERING, A

TASI Group CompanyBormioli Rocco SpABOSCH Packaging TechnologyBrandenburg Industrial

Service CoBREVETTI CEA S.p.A.Broadley-James CorpBS&B Safety Systems LLCBudzar IndustriesBuffalo Air Handling CoBullardBurkert Fluid Control SystemsBurns Automation LLCBurns Engineering IncBustin, a Division of R-O-M

CorporationCadmach Machinery Co

Pvt LtdCangene bioPharmaCanty IncCapmaticCapsugel/Pfi zerCarltex IncCAS

Cashco IncCatalent Pharma SolutionsCCL Label Inc.CD-adapcoCE&IC IncCEIA USA, Ltd.Central Research

LaboratoriesCentral States IndustrialCESGROUPChallenge Printing CompanyChargePoint TechnologyCharter Medical Ltd, A Lydall

CompanyChartwell PharmaceuticalsChase-Logeman CorpChemic Laboratories IncChemical Engineering

MagazineChemical ProcessingChemoMetec A/SChesapeake Pharmaceutical

and Healthcare PackagingChris Hillseth EnterprisesChrist Aqua Pharma and

BiotechCincinnati Sub-Zero ProductsCintas CorpClariant Healthcare

PackagingClean HarborsCleanseal Doors an ASI

Technologies CompanyClinical Systems IncCMIC CMO USA CorporationCOLANARColder Products CompanyColdstream Laboratories IncCole-Parmer Instrument

CompanyComar IncCOMAS S.R.L.Commissioning Agents Inc.Competitive Solutions, Inc.Complete Inspection Systems

Inc.Compli LLCConfab Laboratories IncCONSTANTIA FLEXIBLESContact, CanadaContec Inc.Continental Disc CorpContract Pharma (Rodman

Publishing Corp, )Control MagazineControl Micro Systems IncControlled EnvironmentsCook Pharmica LLCCornerStone FlooringCotter Brothers CorporationCozzoli Machine CompanyCRBCreative Design & Machine

Inc.CropharmCSP TechnologiesCustom Powder SystemsCustom Sensors &

TechnologyCustomVault

Dabrico IncDagard Clean RoomDaiichi Jitsugyo Inc, AmericaDaisy Data Displays, Inc.DCI IncDec USA IncDecagon Devices, Inc.Desiccare IncDFE pharmaDicksonDistek, Inc.DME AllianceDomino North AmericaDPSS Lasers Inc.Dr PharmDriam Inc, U.S.A.DSM Pharmaceutical

ProductsDSSDustcontrol Inc.Dycem LtdDynamic AutomationE Packaging & Fulfi llment,

LLCEagle Stainless ContainerEast Montgomery County

Improvement DistrictEdwards VacuumEHS SolutionsElectrol Specialties CompanyElizabeth Carbide Die Co. Inc.Ellab IncElpro ServicesEMD Millipore CorpEmerson Process

ManagementEm-Tec Flow Technology LPEnerquip LLCEntegris Inc.Eppendorf North AmericaEquipNetERIEZErtelAlsopESS Technologies Inc.EtQ Inc.Evolution Scientifi cExergy LLCF.P.S. Food and Pharma

Systems SrlFabOhio, Inc.FarevaFarrar Scientifi c LLCFDA.comFederal Equipment CoFeldmeier Equipment IncFenwal Protection SystemsFette AmericaFikeFilamaticFinesse Solutions, Inc.Flad ArchitectsFlow Sciences IncFlow Smart IncFluid Metering IncFluke CorpFluorFOSS NIRSystems, Inc.Foster Wheeler Biokinetics

IncFP Developments Inc

EXHIBITOR LIST (as of 2/19/13)

SHOW FLOOR OVERVIEWAccess the best selection all under one roof. Build and sustain relationships with your favorite vendors and make time to visit new ones. Over 650 of the industry’s best suppliers, representing 1,000+ products, smartly organized by product zones on the Show Floor:

• Manufacturing & Packaging• Facilities

JAVITS CONSTRUCTION

JAVITS CONSTRUCTION

• Sourcing & Services• Automation: System & Controls

Be sure to check out our new year-round INTERPHEX Webinar Series which complements the quality education program you’ll see at the show. View the latest schedule and archived sessions online at www.INTERPHEX.com/Webinars.

NEW! WEBINAR SERIES

SHOW FLOOR AND WEBINAR SERIES


Fresenius Kabi Product Partnering

Freund-Vector CorpFrewitt SAFristam Pumps, USAFujimori Kogyo Co., Ltd.G Bopp USA Inc.G&K - Vijuk Intern Corp.GamajetGardner Denver Industrial

Products GroupGarmen LaboratoryGarvey CorpGE Analytical InstrumentsGE HealthcareGE Inspection TechnologiesGE Sensing & Inspection

Technologies GmbHGEA Niro Soavi NAGEA Process Engineering IncGEA Tuchenhagen North

AmericaGECITECH, LLC.Gemu Valves Inc.General Econopak IncGenesis Packaging

TechnologiesGeorg Utz, Inc.Gerteis Maschinen +

Processengineering AGGetinge USA Inc.Gibraltar Laboratories Inc.Girton Mfg. Company,

Pharmaceutical DivisionGlatt Air Techniques IncGlobepharma Inc.Grand River Aseptic

Manufacturing, Inc.Grand View Media Groupgroninger USA L.L.C.GSFCC-Global Society for

Contamination ControlHach - Particle Counting

DivisionHaitima CorporationHalo Pharmaceutical, Inc.Hamilton CompanyHamo-Amsonic AGHangzhou Cobetter Filtration

Equipment Co. Ltd.Harrington Industrial Plastics

IncHarrison Electropolishing LPHarro Hofl iger Packaging

Systems IncHaupt Pharma Inc.HealthStar, Inc.Heat and Control, Inc.Helix Medical LLCHepa CorpHETIRISKHiwin CorporationHolloway AmericaHosokawa Micron Powder

SystemsHospira One 2 One™Howell PackagingHoworth Air TechnologyHP Services IncHuttlin GmbH

Hyla SoftI Holland LimitedICOS Impianti Group S.p.A.IGI Laboratories Inc.ILC Dover, LPILS LimitedIMA Life North America IncImportfab IncINDCO Inc.Industrial Info Resources IncInformetricIngersoll Paper Box Co.

LimitedInmark North AmericaINOX Industries IncInteractive Safety Products

Inc.interpack 2014 / Messe

Dusseldorf North AmericaIntevac PhotonicsIPS-Integrated Project

ServicesIron Mountain Fulfi llment

ServicesIsolation Systems IncISPEITT CorporationIvek CorpJamco Products, Inc.JEC PumpJennison Quality ComponentsJHP Pharmaceuticals LLCJRS PHARMA LPJubilant HollisterStier

Contract MfgJung Gummitechnik GmbHJVNW IncKaiser Optical Systems IncKanomax USA Inc.Kavon Filter ProductsKeith Machinery CorpKemwell BiopharmaKey International IncKey Resin CompanyKikusui USA IncKNS MediaKorber MedipakKorsch America IncKoslow Scientifi c CompanyKraemer US, LLCK-TronLAGARDE AUTOCLAVESLaminar Flow IncLancaster Laboratories IncLaporte ConsultantsLavallab Inc.LB Bohle LLCLCI CorporationLESER LLCLevel One Construction

Services, Ltd.LEWA-Nikkiso America, Inc.Life Science ConnectLighthouse InstrumentsLighthouse Worldwide

SolutionsLiquidity Services, Inc.Littleford Day IncLives International

Corporation

LJ Star IncLock Inspection Systems Inc.Longford International LtdLSNE Contract ManufacturingLuminer Converting GroupLymtech Scientifi cLyne PharmaceuticalsM&O Perry Industries IncM.A.R. S.p.A.M+W GroupMalema SensorsMarchesini Packaging

Machinery Inc.MasterControl Inc.Masy Systems Inc.MatconMcBrady Engineering IncMedline Industries, Inc.Meissner Filtration ProductsMesa Laboratories IncMetenova Inc, AmericaMeto CorpMetrics IncMettler-ToledoMettler-Toledo IngoldMG America IncMicro-Clean IncMicrofl uidicsMicromeritics Instrument

CorpMicromeritics Pharmaceutical

ServicesMiddough Inc.Mini Graphics IncMitsubishi Gas Chemical

America, Inc.MKS Instruments IncMO Industries IncMonitoring Technology

CorporationMoorfi elds PharmaceuticalsMorse Watchmans IncMuller Group GmbHMultisorb Technologies IncNCA Technologies/Neoceram

SANeolpharmaNeopharm LabsNEPA RBINergeco, USANetpakNEUMO GmbH + Co. KGNewark Wire ClothNewman Sanitary Gasket

CompanyNextPharma Technologies Inc.Nicos Group IncNikka Densok USA IncNilfi sk-Advance, Inc.Nipro Glass AmericasNJM PackagingNon-Metallic Solutions IncNora Systems IncNOR-Lake IncNorwich Pharmaceuticals Inc.Nova BiomedicalNovasepNU-Star IncOCS Checkweighers IncO’Hara Technologies

Ompi of AmericaOncode Inc, A Div of Gem

GravureOpen Date Systems Inc.Optek-Danulat IncOptel VisionOptima PharmaOrthos Liquid Systems IncOSO Biopharmaceuticals

Mfg LLCOverlook Industries IncPace Analytical Life SciencesPalbam Class - Cleanroom

FurniturePall Life SciencesPallayPack Inc.PALPharma Handling

SolutionsParker | Parker domnick

hunter | SciLogParticle Measuring Systems

IncPatheon Pharmaceutical

Services Inc.Patterson-Kelley Process

Equipment, A Division of Bufl ovak

Paul Mueller CompanyPawling Engineered Products,

Inc.PBM IncPBS BiotechPendoTechPenn Pharmaceutical

Services LtdPennTech Machinery Corp.Pepperl+Fuchs Inc.Perritt LaboratoriesPharma Packaging SolutionsPharma Technology Inc.Pharmaceutical & Medical

Packaging News & Packaging Digest,

Pharmaceutical Equipment Services, LLC

Pharmaceutical Manufacturing

Pharmaceutical ProcessingPharmaceutical TechnologyPharmalucence, Inc.PharmaPack Asia LimitedPharmasys IncPharmaSystems IncPharmatron, IncPiercan, USAPIERRE FABRE MEDICAMENT

PRODUCTIONPii-Pharmaceutics

International IncPlascore IncPlastikon IndustriesPlatinum Press IncPLUMAT Maschinenbau

Vertrieb GmbHPMT USAPorta-FabPowder Systems LtdPPI Technologies LLCPraxair IncPreSens Precision Sensing

EXHIBITOR LIST (as of 2/19/13)

Prime Environmental IncPrimus Sterilizer Company IncProditec Inc.ProPharma Group IncPrudential Cleanroom

ServicesPTI Packaging Technologies &

InspectionQ Laboratories Inc.QS Pharma LLCQuadro Engineering Corp.Qualicaps IncQuality Chemical LaboratoriesR on IRathGibsonRecipharm IncReed-Lane IncRemcon Plastics IncResodyn Acoustic Mixers IncResolution Development

ServicesRieger + Co. KGRigaku Raman Technologies,

Inc.RMB Products IncRobatel IncRomaco IncRommelag Inc, USARopack IncRotronic Instrument CorpRottendorf Pharma GmbHRovi Contract Manufacturing,

SLRovisys CompanyRubber Fab Technologies

GroupRussell Finex IncRutten Engineering LtdRychiger AGSafebridge Consultants IncSaint-Gobain Performance

PlasticsSaint-Gobain Performance

PlasticsSani-Matic IncSanisure IncSanofi USSartoriusSaundersSchenck AccuRateSchlick Spray NozzlesSCHOTT North America, Inc.Schreiner MediPharmScilog IncSefar IncSensorinSentinel Process Systems IncServolift LLCSGS Life Science ServicesShaffer Products IncSharp CorporationSherwin-Williams CompanySiemens Healthcare

Diagnostics Inc.Sika CorporationSilikal AmericaSKAN US, Inc.SMI (Specialty Measurements

Inc, )Sonaer Inc.

SOTAX Corp.South Carolina Power TeamSP Scientifi cSpectrum Laboratories IncSPI PharmaSpraying Systems Co.SPX Flow TechnologyStainless Fabrication IncStamixco LLCSteridose Sales Inc.Sterifl ow ValveSteris CorpSterivalves SrlStevanato Group SPAStilmas, USAStonhardStrongarm DesignsSturtevant IncSurplus SolutionsSussman Electric BoilersSuzhou Pharma ServicesSwagelok CompanySWAN Analytical USA, Inc.SymexSympatec IncTapemarkTECHNIlab DevelopmentTechnofl ex SATelstar Life SciencesTesto IncThe David Round Co.The Fitzpatrick CompanyThe Ritedose CorpTherapex, Div of E-Z-EM Inc,

CanadaTherapure BioPharma IncThermo Scientifi cThomas Engineering IncTiger-VAC IncTMF CorporationTMI-USA IncToffl onTop Line Process Equipment

Co.Transcat Inc.Tri-Mer CorporationTri-Star TechnologiesTroemner LLCTSI IncTuthill Vacuum & Blower

SystemsUFP Technologies IncUhlmann VisioTecUnibloc-Pump, Inc / Flowtech

DivUniclean Cleanroom ServicesUnited Industries IncVac-U-MaxVAI/Vormittag Associates Inc.Vaisala IncValidation Technologies IncValue Plastics Inc.Valumax Disposable Apparel

IncVan London-PhoenixVanteVeltek Associates IncVenairVideojet Technologies Inc.Vileda Professional-FHP

Vindon Scientifi cVNE Corp.Volkmann IncVorne Industries IncVorti, SIV DivisionWalker Barrier SystemsWaters CorpWatson-Marlow Pumps GroupWeiler Engineering IncWEKO Industrial Component

Corp.WellSpring PharmaceuticalWestern States Machine CoWILCO AGWilden Pump & Engineering

CompanyWinpak Heat Seal Packaging

IncWipotec North AmericaWirecrafters LLCWisconsin Oven Distributors,

LLCWL Gore & Associates IncXcelienceXcellerex Inc , a GE Healthcare

Life Sciences CompanyYonkers Industries IncYula CorpZenpureZPI Inc.

EXHIBITOR LIST / TRAVEL

See the most current exhibitor list at www.INTERPHEX.com/exhibitors.

TRAVEL TO NYC FOR LESS • 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 couponsfor Central Parking.

HOTEL & TRAVEL INFORMATION Through our offi cial housing partner, onPeak, we provide reduced hotel rates and travel discounts for your trip to New York. Visit

www.INTERPHEX.com/NYC for low rates and travel discounts.Hotel Reservation Deadline: March 29, 2012.

VIEW ALL DISCOUNTS AT WWW.INTERPHEX.COM/NYC.

REGISTER TODAY AT: WWW.INTERPHEX.COM/CONFERENCE

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Documents

SEE THE LATEST INDUSTRY TOPICS AND TRENDS ......Back by popular demand, the Exhibit Hall Technology Floor Tours presented by IPS–Integrated Project Services offer a series of presentations