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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.
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Regulatory QA/QC
Product Development
Facility & Process Design
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•
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.
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International Speakers/Companies
Microbiologist from Dept. of Commerce
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Principle Engineer from NASA
Speakers from the FDA
TECHNICAL WORKSHOPS
Featuring eight, 45 minute Technical Workshops, led by:
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Bosch
EMD Millipore Corporation
Fette Compacting America
GE Healthcare
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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
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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
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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
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
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CONFERENCE SESSION DESCRIPTIONS
CONFERENCE SESSION DESCRIPTIONS
REGULATORY QA/QC TRACK
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
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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.
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CONFERENCE SESSION DESCRIPTIONS
CONFERENCE SESSION DESCRIPTIONS
PRODUCT DEVELOPMENT
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.
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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
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
REGISTER TODAY AT: WWW.INTERPHEX.COM/CONFERENCE
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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15
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.
SPONSORED BY:
Manager, Business Operations
GlaxoSmithKline
Connecting a World of
Pharmaceutical Knowledge
Albert Manigo-Bey Jr.
Manager, Procurement
Watson Pharmaceuticals
16
Michael A. Zupon, Ph.D.
Vice President
Pharmaceutical and
Manufacturing Technology
MannKind Corporation
REGISTER TODAY AT: WWW.INTERPHEX.COM/CONFERENCE
CONNECT WITH US:
@INTERPHEX
17
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.
OPENING NIGHT RECEPTION
Tuesday, May 1, 4:30pm - 6:30pm - Special Events Hall (Level 1)
Join us on opening night to network and celebrate the industry. Open to all badge holders.
OUTSOURCING ONE-ON-ONE
Tuesday, May 1 - Thursday, May 3 - Meeting Rooms (Level 1)
Opportunity for you and your team to meet one-on-one with sourcing and service providers during
INTERPHEX. This match-making program is a free service to attendees and exclusive to companies
in the Sourcing & Services Zone on the show floor. As you register for INTERPHEX you will be able to
sign-up to participate.
Sponsored by:
SHOW FLOOR OVERVIEW
Access 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
Sourcing & Services
Automation: System & Controls
O
AUT
LEVEL
3
ISPE LOUNGE
Tuesday, May 1 - Thursday, May 3 - South Concourse (Level 2)
ISPE members can relax and unwind in the ISPE member lounge. Enjoy light refreshments, check in
at the office, and discuss business with colleagues away from the show floor.
I
FAC
Sponsored by:
34
Connecting a World of
Pharmaceutical Knowledge
FACILITY OF THE YEAR AWARDS (FOYA) DISPLAY AREA
Tuesday, May 1 - Thursday, May 3 - ISPE Booth, Crystal Palace (Level 3)
Meet the winners, ask questions and learn best practices from these award-winning pharmaceutical
manufacturing facilities. See the list of winners on page 17.
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Pharmaceutical Knowledge
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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.
OM
LEVEL
RO
CYBER CAFE
BRAND
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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1A05
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1A02
1B01
1B02
1B03
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1B05
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1C01
1C03
Hosted by:
1C04
1C05
HA
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.
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1A03
REGISTER TODAY AT: WWW.INTERPHEX.COM/CONFERENCE
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1E02
1E03
1E04
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CONNECT WITH US:
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@INTERPHEX
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19
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.
20
20
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.
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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!
REGISTER TODAY AT: WWW.INTERPHEX.COM/CONFERENCE
$995
$1,095
$695
$795
$185
$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
22
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:
@INTERPHEX
23
MEDIA PARTNERS:
Connecting a World of
Pharmaceutical Knowledge
SPONSORED BY:
A
CORPORATE PARTNERS:
BRAND
JOIN THE CONVERSATION AND
KEEP UP-TO-DATE WITH INTERPHEX
WWW.INTERPHEX.COM/CONFERENCE
Start planning your INTERPHEX 2012
Conference Experience Today!
The Authority on Drug Development & Manufacturing
PharmTech.com
Scan here to register!
DON’T MISS OUT ON EARLY BIRD PRICING! REGISTER BEFORE APRIL 1
REGISTER TODAY!
MAY 1-3, 2012 | JAVITS CENTER l NEW YORK, NY
Customer ID:
Priority Code:
Reed Exhibitions
INTERPHEX
383 Main Ave., Norwalk, CT 06851