MAY 1-3, 2012 JAVITS CENTER l NEW YORK, NY BRINGING TOGETHER KEY PHARMA AND BIOTECH PROFESSIONALS WITH SUPPLIERS TO CREATE INNOVATIVE SOLUTIONS. INSIGHT • INNOVATION • INTERACTION IT HAPPENS AT ARE YOU IN? INTRODUCING THE NEW, RESTRUCTURED CONFERENCE PROGRAM
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MAY 1-3, 2012 JAVITS CENTER l NEW YORK, NY
BRINGING TOGETHER KEY PHARMA AND BIOTECH PROFESSIONALS WITH SUPPLIERS TO CREATE INNOVATIVE SOLUTIONS.
INSIGHT • INNOVATION • INTERACTION
IT HAPPENS AT
ARE YOU IN?
I NTRODUC ING THE NEW, RESTRUCTURED
CONFERENCE PROGRAM
2 REGISTER TODAY AT: WWW.INTERPHEX.COM/CONFERENCE CONNECT WITH US: @INTERPHEX 3
RESTRUCTURED CONFERENCE PROGRAM This year’s conference has been re-engineered to align with the way companies bring products to successful market realization. Tracks and sessions have been developed to bring real-world experiences directly to you.• Regulatory QA/QC • Product Development • Facility & Process Design
CONFERENCE ADVISORY BOARDWe’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 SESSIONSThree Keynote Sessions to inspire you with new ideas, led by: •JeffBaker,FDA•JimMiller,PharmsourceInformationServices,Inc.•RichardSmith,FedEx
SPEAKERS Featuring the industry’s best and brightest highlighting current trends in product development/process introduction.• International Speakers/Companies• Microbiologist from Dept. of Commerce
TECHNICAL WORKSHOPSFeaturing eight, 45 minute Technical Workshops, led by:• Bosch• EMD Millipore Corporation• Fette Compacting America• GE Healthcare
EXPERIENCE WHAT’S NEW AT INTERPHEX INDUSTRY KEYNOTES
JIM MILLER President, PharmSource Information Services, Inc. WHAT THE NEW BIO/PHARMA BUSINESS MODEL MEANS FOR CMOS AND CROS Tuesday, May 1, 9:15am - 10:15amThe 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 - 11:15amThe 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.
Learn from the most successful and innovative industry authorities at our 2012 Keynote Sessions. Keynote Sessions are open to all badge holders.
• Manufacturing & Packaging• Supply Chain
• Principle Engineer from NASA• Speakers from the FDA
• Glatt Air Techniques• Pall Life Sciences• STERIS• Thermo Fisher Scientific
CONFERENCE HOURS Tuesday, May 1 9:00 am – 5:00 pmWednesday, May 2 9:00 am – 5:00 pm Thursday, May 3 9:30 am – 1:00 pm
EXHIBIT HALL HOURSTuesday, May 1 10:00 am – 5:00 pmWednesday, May 2 10:00 am – 5:00 pmThursday, May 3 10:00 am – 3:00 pm
4 REGISTER TODAY AT: WWW.INTERPHEX.COM/CONFERENCE CONNECT WITH US: @INTERPHEX 5
CONFERENCE AT-A-GLANCE CONFERENCE AT-A-GLANCE
REGULATORY QA/QC
PRODUCT DEVELOPMENT
FACILITY & DESIGN PROCESS
MANUFACTURING & PACKAGING SUPPLY CHAIN
9:00 AM– 9:15 AM
Welcome and Introduction
9:15 AM– 10:15 AM
Keynote: What the New Bio/Pharma Business Model Means for CMOs and CROs *
10:30 AM– 11:30 AM
Case Study: Regulatory Consequences from Poor Microbiological Manufacturing andLaboratory GMPs
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 *
2:45 PM– 3:45 PM
Seven Things You Should Do Before Facing an Inspection
Learn the Technical Challenges in the Development of Biosimilars
Case Study: Optimizing Execution with Modular Construction
Streamlining Risk Management Evaluations for New Manufacturing Processes
Case Study: Why is Product and Process Understanding in Supporting Post-approval Change Important?
Case Study: Asset Optimization & Flexible Multi-Product 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 Cost-Savings 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 Risk-Based 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 ProductManufacturing
Implementing Commissioning and Qualification in Line with the FDA’s Recent Process Validation Guidance
Case Study: Path to Reduce Operational Expenses and Improve OperationalEfficiency
Regulatory Strategies and Considerationsfor Successful Site Transfers
WEDNESDAY, MAY 2, 2012
THURSDAY, MAY 3, 2012
* = Open to all badge holders
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 *
1:00 PMConference Ends
6 REGISTER TODAY AT: WWW.INTERPHEX.COM/CONFERENCE CONNECT WITH US: @INTERPHEX 7
Case Study: Regulatory Consequences from Poor Microbiological Manufacturing and Laboratory GMPsTuesday, May 1, 10:30am – 11:30amDennis 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.
Seven Things You Should Do Before Facing an InspectionTuesday, May 1, 2:45pm – 3:45pmRosario Quintero-Vives, Sr. Regulatory & Compliance Specialist, RQV ConsultingDiscover 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 ManagementTuesday, May 1, 4:00pm – 5:00pmKR Karu, Pharmaceutical Industry Principal, Sparta SystemsTo 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 ImportantWednesday, May 2, 9:00am – 10:00amBetty Lee, Ph.D., Microbiologist, U.S. Department of CommerceFocus 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 ProcessesWednesday, May 2, 1:30pm – 2:30pmMike Porter, Consultant, Commissioning Agents, Inc.Ivan Toponarski, Project Engineer, Allergan MedicalWhen 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:
Proven Cost-Savings Using Manufacturing Execution Systems (MES) for BioPharm Manufacturers Wednesday, May 2, 2:45pm – 3:45pmMarco Lederle, Director Consulting / Partner, i+o Industry Planning + OrganizationThis 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.
Proven Processes and Metrics to Optimize Operational Excellence Wednesday, May 2, 4:00pm – 5:00pmShane 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. Panel Discussion: Best Practices and Regulatory Expectations in Continuous ProcessingTuesday, May 1, 10:30am – 11:30amPresented and moderated by Pharmaceutical TechnologyModerator: Angie Drakulich, Editorial Director, Pharmaceutical TechnologyPanelist: Moheb Nasr, Ph.D., Vice President, CMC Regulatory Strategy, Global Regulatory Affairs, GlaxoSmithKline, Former Director of the FDA Office of New Drug Quality Assessment, CDERFernando J. Muzzio, Ph.D., Director, NSF ERC on Structured Organic Particulate Systems, Professor II, Department of Chemical and Biochemical Engineering, Rutgers UniversityElaine Morefield, Ph.D., Deputy Director, Office of New Drug Quality Assessment, CDER, U.S. Food & Drug AdministrationThis 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 BiosimilarsTuesday, May 1, 2:45pm – 3:45pmE. Morrey Atkinson, Ph.D., Chief Scientific Officer, V.P. of Research and Development, V.P. of Drug Substance Manufacturing, Cook Pharmica, LLCLearn 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.
REGULATORY QA/QC TRACK REGULATORY QA/QC TRACK
PRODUCT DEVELOPMENT
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Making Risk Assessment Part of Technology TransferTuesday, May 1, 4:00pm – 5:00pmJ. Richard Creekmore, Ph.D, R.Ph., US Technology Manager, AstraZeneca Pharmaceuticals LPTechnology 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 FacilitiesWednesday, May 2, 9:00am – 10:00amMary Ellen Clark, Validation Scientist I, MedImmuneBrian Goss, Associate Director, Validation Technical Services, Imclone SystemsPaul Lopolito, Technical Services Manager, STERIS CorporationMicrobial 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 – 2:30pmYihong Qiu, Ph.D., Research Fellow, Oral Drug Products, Manufacturing Science and Technology, Global Pharmaceutical Operations, Abbott LaboratoriesThis 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 CultureWednesday, May 2, 2:45pm – 3:45pmStefan Steigmiller, Ph.D., Head of PAT-Biotech Projects, Bayer Technology Services GmbHCurrently FDA and other regulatory agencies encouraging pharmaceutical industry to a paradigm change and the use of process analytical technologies (PAT) in pharmaceutical production. The biggest challenges for Process Development in Cell Culture Upstream will be discussed. Latest data will be presented, as well as our setup of a closed-loop control for glucose including an integrated PAT data management.
Bioburden Control for Sterile Filtration for Injectable Biotechnological and Pharmaceutical Drug Product Manufacturing Wednesday, May 2, 4:00pm – 5:00pmDilip 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.
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 ConstructionTuesday, May 1, 2:45pm – 3:45pmJohn Gilroy, P.E., Sr. Vice President and Principal, Integrated Project ServicesCompanies 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 WaterTuesday, May 1, 4:00pm – 5:00pmJohann Bonnet, Strategic Account Manager, Veolia Water Solutions & TechnologiesManufacturing 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.
FACILITY & DESIGN PROCESS
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CONFERENCE SESSION DESCRIPTIONS
Case Study: Meeting Sustainability Challenges with the Revamping of Your Wastewater PlantWednesday, May 2, 9:00am – 10:00amAjit Ghorpade, Ph.D., Technical Director for Biological Processes, Veolia Water Solutions & TechnologiesThe 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 ConceptsWednesday, May 2, 1:30pm – 2:30pmJim 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 ImportantWednesday, May 2, 2:45pm – 3:45pmPhilip 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 decision-making 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 GuidanceWednesday, May 2, 4:00pm – 5:00pmAaron Weinstein, Northeast Regional Director - Commissioning & Qualification, IPS - Integrated Project ServicesJason D’Orlando, Associate Director - Project Controls, Shire HGTWith 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.
Case Study: Implementing Single-Use Technologies in a GMP FacilityTuesday, May 1, 10:30am – 11:30amPeter 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.
CONFERENCE SESSION DESCRIPTIONS
Single Use Technology Enabling Biosimilar ManufacturingTuesday, May 1, 2:45pm – 3:45pmTodd Bucciarelli, Business Development, IIT Research InstituteBill Whitford, Market Manager, Cell Culture, Thermo Fisher ScientificBiosimilars 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 ManufacturingTuesday, May 1, 4:00pm – 5:00pmMatthew P. von Esch, Manager Manufacturing Fill/Finish, United TherapeuticsWenzel Novak, Ph.D., Director Pharmaceutical Research and Development, Groninger & Co. GmbHRecent 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 ProgramWednesday, May 2, 9:00am – 10:00amIgor 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 ProcessesWednesday, May 2, 1:30pm – 2:30pmKeith Bader, Sr. Consultant, Hyde Engineering+ Consulting, Inc.Jeff Slutsky, Director of Design for Six Sigma, Bausch and LombToo 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.
FACILITY & DESIGN PROCESS
MANUFACTURING & PACKAGING
MANUFACTURING & PACKAGING
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Introduction to the New ISPE Guide: Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and EquipmentWednesday, May 2, 2:45pm – 3:45pmSteven 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 EfficiencyWednesday, May 2, 4:00pm – 5:00pmNiranjan 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 ResearchIt 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?
Guidance for Industry Process Validation: General Principles and Practices - A CMO’s ApproachTuesday, May 1, 10:30am – 11:30amSandra Lueken, Director of Quality, Baxter Pharmaceutical SolutionsThe 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 – 3:45pmRaul Soikes, Sr. Director Program Management R&D, Baxter Healthcare CorporationA 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.
Case Study: How to Benefit from Pharmaceutical Distribution OutsourcingTuesday, May 1, 4:00pm – 5:00pmMichael Trocchia, P.E. CPIM, Director Project Management, US Supply Chain Management, Novartis Pharmaceuticals CorporationNovartis had to decide whether to outsource the nerve center of its U.S. supply chain - the New Jersey-based 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.
Why Deploying Lean Six Sigma is Important for Global Manufacturing Networks Wednesday, May 2, 9:00am – 10:00amRobert 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 MarketplaceWednesday, May 2, 1:30pm – 2:30pmThomas Dale, Director, Supply Chain Marketing and Vertical Marketing Development, FedExListen 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 ManagementWednesday, May 2, 2:45pm – 3:45pmArminda O. Montero, Global Distribution QA Program Manager, Global Pharmaceutical Operations, Abbott Laboratories
• Applyingknowledge-basedapproachtoproductstabilitytooptimizetemperature-sensitiveproduct distribution
Regulatory Strategies and Considerations for Successful Site TransfersWednesday, May 2, 4:00pm – 5:00pmSema Z. Ariman, Regulatory Affairs Manager, CMC Regulatory Affairs PPG, Abbott LaboratoriesIn 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.
SUPPLY CHAIN
MANUFACTURING & PACKAGING SUPPLY CHAIN
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FREE CONFERENCE SESSIONS FREE CONFERENCE SESSIONS
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 - 2:30PMADVANCED ASEPTIC TOUR: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.
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.
Participating Companies: Abec, Inc., EMD Millipore, GE Healthcare, GEA Process, Pall Life Sciences, Sartorius-Stedim, Thermo Fisher/Hyclone, Xcellerex.
ORAL SOLID DOSAGE TECHNOLOGIES TOUR: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.
Practical Applications of Statistical Methods Under 2011 FDA Process Validation Guidance Thursday, May 3, 9:30am - 10:30amAbe 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, LabopharmLearn 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.
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 James Mossop, New Business / Project Manager, Fette Compacting America, Inc
Innovative Technique for the Production of Drug Loaded Pellets 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
Pragmatic Implementation of Single-Use Technologies Richard Pierce, Ph.D., Director, Strategy and Business Development, EMD Millipore Corporation
Facility Operation Intensification: In-Line Conditioning Buffer Preparation versus In-Line Dilution Enrique Carredano, Scientist, GE Healthcare
On-line TOC Monitoring in GMP Parts Washers 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
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.
TECHNICAL WORKSHOPS
KEYNOTES
FLOOR TOURS
SPECIAL PRESENTATIONS
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FACILITY OF THE YEAR AWARDS (FOYA)
Meet the Category Award Winners at the Facility of the Year Awards (FOYA) Display Area. Team members from the winning companies will be on-hand 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 high-quality medicines. We’re proud to recognize this year’s winners.
Connecting a World of Pharmaceutical Knowledge
SPONSORED BY:
CHIESI FARMACEUTICI S.P.A. 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.
WINNERS:
CONFERENCE ADVISORY BOARD
M.J. Kimmel PrincipalMJK Solutions
Chad Wachter Manager, Business OperationsGlaxoSmithKline
Albert Manigo-Bey Jr. Manager, ProcurementWatson Pharmaceuticals
Michael A. Zupon, Ph.D. Vice PresidentPharmaceutical and Manufacturing TechnologyMannKind Corporation
Timothy P. Howard, CPIP, P.E. Vice President & Company OfficerCommissioning Agents, Inc.
Robert Timko, RPH, Ph.D. Director CMC Group, Global Regulatory AffairsAstraZeneca Pharmaceuticals LP
Michelle M. Gonzalez, P.E.BioPharm Engineering Consultant
Russ Somma, Ph.D. PresidentSomma Tech, LLC
John Gilroy, P.E. Sr. Vice President and PrincipalIPS - Integrated Project Services
Jaspreet Sidhu, Ph.D. Vice President, Business Development & Pharmaceutical MicrobiologyMolecular Epidemiology
EJ Brandreth VP, Quality & Regulatory AffairsAlthea Technologies, Inc.
Scott Rudge, Ph.D. Chief Operating OfficerRMC Pharmaceutical Solutions, Inc.
E. Morrey Atkinson, Ph.D. Chief Scientific Officer, VP of Research & Development, VP of Drug Substance ManufacturingCook Pharmica LLC
Richard Poska, R.Ph.D. Director, Regulatory AffairsAbbott Laboratories
Dilip Ashtekar, Ph.D. Sr. Director Quality ControlGilead Sciences, Inc.
Sanjay Patel Sr. Director, Global Materials ManagementShire Pharmaceuticals, Inc.
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.
18 REGISTER TODAY AT: WWW.INTERPHEX.COM/CONFERENCE CONNECT WITH US: @INTERPHEX 19
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:
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:
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. Sponsored by:
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. Sponsored by:
CYBER CAFE 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. Sponsored by:
A 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. Hosted by:
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.
20 REGISTER TODAY AT: WWW.INTERPHEX.COM/CONFERENCE CONNECT WITH US: @INTERPHEX 21
Systems LLCBlueCielo ECM SolutionsBMT USA LLCBoehringer Ingelheim Pharma
GmbH & Co KGBormioli Rocco e Figlio SpABosch Packaging TechnologyBrandenburg Industrial
Service Co.BREVETTI CEA S.p.A.Broadley-James Corp.BS&B Safety Systems LLCBUCHI Corp.Budzar IndustriesBuffalo Air Handling Co.BullardBurkert Fluid Control SystemsBurkhead-DeVane Label
SpecialistsBurns Engineering Inc.Busch LLCBushu Pharmaceuticals Ltd.Bustin, a Division of R-O-M Corp.Cadmach Machinery Co Pvt LtdCangene BioPharma
Systems Inc.Haupt Pharma AGHaz-Safe LLCHCT Co., Ltd.Heat and Control, Inc.Heat Pipe Technology, Inc.Heateflex Corp.Helix MedicalHelvoet Pharma, USAHibar Systems LimitedHolloway AmericaHosokawa Micron Technology
Powder SystemsHospira One 2 One®Howell PackagingHoworth Air TechnologyI Holland LimitedI+o Industry Planning +
Organization LP Inc.ICOS Impianti Group S.p.A.IGI Laboratories Inc.iGPSIKA Works Inc.ILC DoverIMA Life North America Inc.Importfab Inc.INDCO Inc.Industrial Info Resources Inc.InformetricInmark North AmericaINOX Industries Inc.Interactive Safety Products Inc.International Products CorpIPS-Integrated Project Services
Contract ManufacturingJVNW Inc.Kanomax USA Inc.Kavon Filter ProductsKeith Machinery CorpKemwell BiopharmaKeofitt a/sKey Resin Co.Kikusui USA Inc.Kleen Test ProductsKorber MedipakKorsch America Inc.Koslow Scientific Co.K-Patents, Inc.Kraemer US LLCKrieger AGkSep Systems LLCK-TronLabel Vision Systems Inc.Laminar Flow Inc.Lancaster Laboratories Inc.Laporte ConsultantsLB Bohle LLCLCI Corp.LESER LLCLighthouse InstrumentsLighthouse Worldwide
SolutionsLittleford Day Inc.Lives International Corp.LJ Star Inc.Lock Inspection Systems Inc.Longford International Ltd.LSNE Contract ManufacturingLuce, Schwab & Kase, Inc.Lymtech ScientificLyne LaboratoriesM&O Perry Industries, Inc.M.A.R. S.p.A.M+W US Inc., A Company of
the M+W Groupm2p-labs GmbHMadgetech Inc.Malvern Instruments Inc.Mar COR, PurificationMarchesini PackagingMarken LtdMasterControl Inc.Masy Systems Inc.McBrady Engineering Inc.Meissner Filtration ProductsMENNEKES Electrical ProductsMesa Laboratories Inc.Metenova Inc., AmericaMeto CorpMetrics Inc.Mettler-Toledo Hi-SpeedMettler-Toledo IngoldMettler-Toledo SafelineMettler-Toledo ThorntonMettler-Toledo, Inc.MG America Inc.Microbac Laboratories Inc.Micro-Clean Inc.MicrofluidicsMicromeritics Instrument CorpMidas Pharmaceuticals Inc.
Middough Inc.Mini Graphics Inc.Mission PharmacalMiura North America Inc.MKS Instruments Inc.MO Industries Inc.Moorfields PharmaceuticalsMultisorb Technologies Inc.Munters CorpNCA Technologies/Neoceram SANetzsch Premier Technologies
LLCNewark Wire ClothNewman Sanitary Gasket Co.NextPharma GmbHNicos Group Inc.Nilfisk-Advance America Inc.NJM Packagingnora systems, Inc.NOR-Lake Inc.Norwich Pharmaceuticals Inc.NOTTER GmbH
TablettierwerkzeugeNova BiomedicalNovasepNU-Star Inc.OBK Technology Ltd.OCS Checkweighers Inc.O’Hara TechnologiesOlympus Innov-XOncode Inc., A Div of Gem
GravureOptek-Danulat, Inc.Optel VisionOptima pharmaOregon Freeze Dry Inc.Orthos Liquid Systems Inc.Overlook Industries Inc.Pace Analytical Life SciencesPall Life SciencesPALPharma Handling SolutionsParker-Hannifin Corp.Parsec Automation CorpParsonsParticle Measuring Systems Inc.Patheon Pharmaceutical
PlasticsSani-Matic Inc.Sanisure Inc.Sanner of America Inc.Sartorius Stedim North
America Inc.Schenck AccuRateSchlick Spray NozzlesSchott North America, Inc.Schreiner MediPharmSciLog Inc.SciLog Inc.SCM PharmaSefar Inc.SensorinSentinel Process Systems Inc.Service Engineering Inc.Servolift LLCSGS Life Science ServicesShaffer Products Inc.Shanghai Haishun New
22 REGISTER TODAY AT: WWW.INTERPHEX.COM/CONFERENCE CONNECT WITH US: @INTERPHEX 23
We’ve made it easy to get organized before you arrive at INTERPHEX.
MY INTERPHEX SHOW PLANNERThis online planning tool gives you the opportunity to:
• Preview the floorplan
• Search Exhibitors by company name and product category
• View each exhibitor’s online showroom
• 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
• Find booth-to-booth directions to the exhibitors you want to see
• See the complete list of conference sessions and special events
• Access the latest announcements and breaking show news
• Now available for Android, as well as iPhone and all web-enabled phones
ACCESS THE MOBILE APP AT WWW.INTERPHEXMOBILE.COM Log into the app with your registration ID before May 1, 2012 to be automatically entered to win an iPad!
PLAN YOUR SHOW 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.
SHOW PACKAGES
Travel to NYC for Less
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.
Conference Passes Early Date(Before 4/1)
Advance/Onsite(After 4/1)
FULL CONFERENCE PASS(Includes access to all INTERPHEX sessions, lunch both days, exhibit show floor, keynotes, technical workshops, and opening night reception)
$995 $1,095
ONE DAY PASS(Includes access to One-Day of INTERPHEX sessions and lunch that day, exhibit show floor, keynotes, technical workshops, and opening night reception)
$695 $795
EXHIBITS PLUS PASS(Includes choice of one INTERPHEX session, access to exhibit show floor, keynotes, technical workshops, and opening night reception)
$185 $185
EXHIBIT HALL PASS(Includes access to exhibit show floor, keynotes, technical workshops, and opening night reception)
FREE FREE ($75 onsite
Processing Fee
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