You can use the search box below to locate specific speakers or sessions.
View Date: Thursday, March 27, 2008
Thursday, March 27, 2008
Meals & Special Events
Keynotes, General Sessions, Meals
SE-2: Innovation to Commercialization: Executive Life Science Panel Discussion 11:30AM - 12:30PM (Thursday, March 27, 2008)
Attend this high level panel discussion featuring CEOs from the three life science industries – medical device, pharma and bio - addressing current trends in innovation, global market challenges and collaborations across the industries as they impact future generations of product development and commercialization. Don’t miss out on the opportunity to connect with industry leaders as they share their insight and experiences!
SE-6: Lunch - Thursday, March 27 12:30PM - 1:45PM (Thursday, March 27, 2008)
Conference Luncheon, Thursday, March 27, 12:30 pm - 1:45 pm. Included in Full Conference Pass or the Wednesday One Day Pass price. Available for purchase to all other badgeholders for $45.00.
Technology Enablers
T-8: The Next Generation of Process Automation - The User's Requirements 9:00AM - 10:00AM (Thursday, March 27, 2008)
In the 1970's, the Programmable Logic Controller revolutionized the machine control industry. In the early 1980's, proprietary Distributed Process Control systems and microprocessor-based sensors and actuators facilitated large-scale digital plant automation for the first time. Later that decade, the personal computer made application-based automation and control inexpensive and scaleable. The S88 and S95 standards, in conjunction with GAMP4 guidelines, has given a framework for developing, documenting, and maintaining automation and process control systems for the pharmaceutical industry. Over the past ten years, however, while the industry has seen the introduction of new applications and smarter sensors and actuators, the author feels, as do a large percentage of end users, that a new paradigm in automation and process control is needed. The recent “advances” in automation have mostly come from vendors who have created different flavors of existing technologies in order to maintain market share and sales targets. In the process, application spaces have become crowded, “data” has been generated by the terabyte without much focus on “information”, and there has been a slow, but noticeable shift back to proprietary hardware platforms and software applications. It is time that end users voice their User Requirements for this next generation of automation and process control. This session will highlight the requirements of end users specifically, independent of any vendor or automation platform. The author has developed a survey and will conduct interviews which will target hundreds of end users in the pharmaceutical industry asking for input as to what this new generation of automation and process control system should look like. This session will reflect the results of this industry-wide interviews and survey, not those of the author. This session will focus on the user's perspective for the next generation of I/O subsystems, automation controllers, information processors, data historians, batch execution engines, and manufacturing execution systems.
T-12: The Price of Excellence: Examining the Value of Investments in PAT 9:00AM - 10:00AM (Thursday, March 27, 2008)
This presentation will discuss the synergistic aspects of combining process analytical technology (PAT) and Lean manufacturing for operational excellence (OpX). A method for estimating the value of achieving excellence in your operations will be described using published case studies and performance benchmark data. Additionally, the cost-benefit tradeoffs of different technology and project management strategies will be explored. Managers considering incorporating PAT, Quality by Design (QbD), or OpX initiative into their operations are encouraged to attend.
T-9: cGMP Informatics: IT Infrastructure Design for 21st Century Pharmaceutical QC Operations 10:15AM - 11:15AM (Thursday, March 27, 2008)
Pharmaceutical R&D and Manufacturing has not changed its fundamental paper-based infrastructure in decades. The principle reason is that science by nature and regulatory requirements resist change. Recently, industry and FDA have been more aligned with respect to utilizing innovation and technology to bring manufacturing processes into the 21st century. Leading companies are adopting a new approach to automating the non-value added tasks associated with paper processes in QC and batch record management. The dominate strategy is utilizing innovative technologies (such as Electronic Notebooks) and building quality into the research, quality and compliance infrastructure. The paper will discuss the current situation in cGMP lab and production floor operations relative to FDA initiatives in manufacturing and the broad opportunity for electronic notebook processes. The paper will profile an innovative “method and SOP-centric” software platform, designed to electronically execute and manage laboratory protocols, and production batch records, yielding significant reductions in overall method execution cycle times and electronically capture all data and metadata in a common repository. In addition the GMP Electronic Notebook System provides a Lab Execution System (LES) layer within the GMP IT infrastructure to provide seamless integration of the data capture steps in operating a lab or batch record process to LIMS and ERP systems.
John Helfrich - Director, GMP Lab Automation Programs, VelQuest Corporation
T-13: Application of PAT in Product Development 10:15AM - 11:15AM (Thursday, March 27, 2008)
The Process Analytical Technology, PAT, initiative encourages innovation in pharmaceutical development, manufacturing, and quality assurance to enhance understanding and control of the manufacturing process. The challenge for many manufactures is to identify how best to address the opportunities that PAT offers. Broadley James, Emerson Process Management, and the University of Texas are working together to examine and quantify the potential to reduce cycle time and out-of-spec product through the use of high fidelity, dynamic simulation and multivariate analytics. The objective of this work is to show that the impact of PAT can be maximized through the integration of these tools during product development (PD). Experiments are being run using a CHO cell line and 7 liter bio-reactors. In this presentation, information will be provided on the capability developed for fidelity process modeling of the mammalian cell cultures. A design of experiments (DOE) is described that minimizes the time and tests required to identify model parameters. Examples will be presented to illustrate how this simulation capability in a virtual plant is being used to find the best approach in stepping process inputs and operating conditions and how the improvements found through simulation are verified through experimental test. Also, information will be presented on innovations in PCA/PLS analytics for fault detection and end point prediction of quality parameters. Details will be provided on work that is being done to verify detection of faults and accuracy of end point prediction of quality parameter. Plans for future work will be presented that include applying this simulation and analytic capability during scale up from 7 liter to 50 liter disposable reactors.
Yang Zhang - Research Assistant, University of Texas, Austin
T-10: RFID on the Packaging Level - How to get the Chip on the Box! 2:00PM - 3:00PM (Thursday, March 27, 2008)
RFID is an emerging technology to be used in volume for the identification and tracking of goods. For contactless communication with pallets, boxes and individual items an RFID label is applied onto the goods. Due to an intended one-way use the cost target for a smart label currently is five US cents or less. To achieve this ambitious goal the development of novel manufacturing strategies for RFID products is of major importance. Several attempts are made to streamline the production process with the goal to create a smart label on the packaging level. The improvements in printing of conductive inks for antennae in combination with pre-packaged RFID chips (so called straps) open new opportunities to move from a relative costly slap-and-ship approach to an integrated smart label production process on the packaging level.
T-14: Achieving Manufacturing Process Excellence with Quality by Design, Design Space Development, Design for Manufacturing and PAT 2:00PM - 3:00PM (Thursday, March 27, 2008)
In the past, unacceptable product batches were prevented from entering the market only by laboratory testing of the finished product – posing risk to the public and wasting both time and money for pharmaceutical manufacturers. In the new regulatory environment, the challenge is to assure the appropriate quality outcome in “real time” by implementing appropriate systems into the process itself, assuring product quality while the batch is being manufactured versus relying on final product testing (RTQA). The increased emphasis on manufacturing process excellence through “Quality by Design” (QbD) requires manufacturers to make larger investments earlier in the product life cycle with the goal of developing a sound scientific basis for a “Control Space” that accommodates a range of defined variability in the commercial process materials and operations and still produces the right product quality outcomes. Manufacturers have the opportunity to develop a “Design Space” that takes into account the need for different Control Spaces to accommodate future changes in the scale, economics or other aspects of the commercial manufacturing process in the later stages of the product life cycle (ICH Q8). This, along with the adoption of QbD and a quality system as described in ICH Q10, will enable pharmaceutical manufacturers to achieve the “Desired State” of manufacturing. To realize the benefits of implementing QbD, it is critical that CPP and CQA be identified and understood during process development, so they can be measured and controlled in real-time during the manufacturing process. This requires a corporate culture of continuous improvement without the need for regulatory intervention to approve changes. It also calls for close collaboration between the process development and manufacturing teams to achieve a sufficient level of Process Understanding prior to regulatory approval of the commercial manufacturing process. And, of course, it requires the deployment of appropriate, enabling technologies. Such technologies provide a single point of on-demand access by multi-disciplinary users to all relevant data in multiple, disparate data sources (in the same environment with analytics) to identify and understand cause-and-effect relationships in process data and easily share results. Process improvement and QbD will become practical realities only when the barriers to easily accessing and working with all the process data together are removed, and the team can spend its time more productively on science-based collaboration. This is the best way to undertake the Design Space Development, Design for Manufacturing and PAT efforts needed to achieve manufacturing process excellence using the principles of QbD.
Speaker:
Justin Neway - Executive Vice President and Chief Science Officer, Aegis Analytical Corporation
T-15: Implementing Process Analytical Technology in a Regulatory-Friendly, Single-Use Biomanufacturing Process 3:15PM - 4:15PM (Thursday, March 27, 2008)
We report successful implementation of new technologies for on-line monitoring and control of cell culture in a disposable, animal origin-free process. Recombinant human antibody was produced by a well-characterized cell line using a chemically-defined, animal origin-free culture medium and disposable, stirred-tank bioreactors. Traditional methods of monitoring process variables were compared.
Cory Card - Regional Technical Support Manager, Thermo Fisher Scientific
T-11: Implementing a Service Oriented Organization in IT 3:15PM - 4:15PM (Thursday, March 27, 2008)
Merck's Global Application Engineering & Operations organization adopted a Service Oriented Organization model to become more lean and flexible. Specifically, this company wanted to improve its ability to manage and share global IT capabilities, to deliver quantifiable cost benefits to the business and to deliver higher-value strategic services to its clients. To this end, Merck adopted a new IT Operating Model that was built on three key elements: 1. Shared Services Delivery Structure 2. Professional Services Organization Model 3. Running IT as a business Throughout the transformation, Merck's efforts were informed by the IT Process Improvement frameworks, ITIL and CMM. Concepts of Relationship Management, Service Level Management and Financial Management served as key enablers for the Operating Model. Additionally, Process maturity was seen as fundamental to the new operating mode. To this end, an assessment was conducted of the group's processes compared to the ITIL and CMM frameworks. A custom transformation plan was developed to help achieve the business goals on an accelerated timeline. This included the development of a unique, quantitative Maturity Model to measure progress toward the fully operational state. Merck achieved powerful benefits as a result of this program including cost savings of greater than $ 20 Million in the first year of operating in the new model. Using Merck's project as a case study, the speakers will discuss the following topics: · Merck's Goals · The Service Oriented Organization · How Process Improvement Supported the Strategy · The Transformation Approach · Using a Maturity Model · Results To Date / Lessons Learned
Joseph Solfaro - Executive Director, Global Applications, Merck
Basics & Building Blocks
B-5: Beyond CAPA: Using Risk Assessment to Streamline your CAPA Process 9:00AM - 10:00AM (Thursday, March 27, 2008)
In this session, we will talk about how to reduce the number of CAPAs within a quality and compliance system using Risk Assessment Methods. Session covers the concept of how applying Risk Assessment can filter out the critical from non-critical issues, techniques for identifying and automating Risk, the concept of Risk mitigation as a measure of verification and effectiveness, and real-world examples of how this Risk-Based CAPA process is being used.
B-6: PAT: The Key to Successful FDA Regulated Manufacturing in the 21st Century 10:15AM - 11:15AM (Thursday, March 27, 2008)
There have been a great many changes in the FDA's guidance for manufacturing in the past 5 years. The publication of their “Pharmaceutical cGMPs for the 21st Century” in 2002 caused the greatest change in compliance guidance since the issuance of the original GMP documents in the late 1970s. Gone are the requirements for mounds and mounds of paperwork that were required to show the exhaustive testing needed to meet the “old” GMP guidance, replaced by the new “design quality in” concept. This concept is not new, but the new guidance documents from the FDA give direction and insight into how the agency expects manufacturers to design this quality into their processes. The need to understand the manufacturing process and provide that feedback into the control system is at the core of this new approach, and PAT is the methodology that gives manufacturers this understanding and control. This presentation describes how PAT supports the quality by design, continuous operation in a regulated industry and real time product release initiatives that are being driven by the new FDA guidance
Supply Chain excellence has become a core requirement in today’s global outsourced pharmaceutical industry. This course covers the basics and summarizes best practices.
• Pharmaceutical Supply Chains unique challenges • Supply Chain Visibility, Trace & track, E-Pedigree • Cold Chain and condition monitoring • RFID and sensors • Regulations and Standards
B-8: RFID in Pharma and Life Sciences: What You Need to Know 3:15PM - 4:15PM (Thursday, March 27, 2008)
This one hour session will give you a comprehensive overview of what RFID is and how it works. You will learn what are the essential components needed to make up an RFID system, such as tags, readers, antenna, printers and software and how they interoperate with each other. We will discuss why RFID is being talked about so much and how it can potentially change your business. Topics covered include how RIFD can be used for Improved Inventory Management (Including Product Life Cycle), Mass Serialization, Product Authentication and E-Pedigree, Chain of Custody, Anti-Counterfeiting, Contamination Control, Compliance with Government Regulations and Product Recall Management. This session will showcase all of the latest Case Studies on how and where RFID is being piloted and deployed by some of the biggest and most innovative pharmaceutical companies in the world. Come and see for yourself how pharmaceutical companies around the world are using this powerful technology to transform their businesses, save money and insure patient safety.
Speaker:
John Jordan - President, WW Field Operations, TAGSYS RFID
C-5: Pharmaceutical Manufacturing - The Challenge of Global Regulatory Compliance 9:00AM - 10:00AM (Thursday, March 27, 2008)
In the competitive pharmaceutical/ biotechnology industry, companies seeking to market products in new countries must strive to secure marketing authorization from government agencies in a smooth and timely fashion. A critical step to ensuring prompt approval is the need to demonstrate compliance with local regulatory agency manufacturing requirements. Inter-agency variations in regulatory demands can present significant challenges in navigating the approval process and assuring ongoing compliance. Prior knowledge or experience is essential to ensure the smooth implementation of processes and procedures that satisfy the needs of multiple international agencies and minimize the potential for costly production delays. First hand experience gained from multiple international submissions and manufacturing site inspections has established the need to: remain constantly apprised of regulatory changes; be mindful that differing interpretations of simple international guidelines that can hinder the approval process and beware the perils of taking compliance for granted. This presentation will provide an overview, discussing the challenges of simultaneously navigating both the demands of multiple international regulatory agencies with the differing and ever changing requirements across the pharmaceutical manufacturing continuum.
Speaker:
Kelly Davis - Manager of Regulatory Affairs, Baxter Healthcare Corporation
C-6: Utilizing Cpk to Understand Pharmaceutical Manufacturing Process Capability 10:15AM - 11:15AM (Thursday, March 27, 2008)
This session will be a discussion of data collection and application of statistical methods to help address the challenges of data starved first-time-quality projects. The foundation of the discussion will be the collection and aggregation of data from a variety of disparate sources including PLC, DCS, SCADA, Alarm & Event and manually entered data. Once the data has been acquired and consolidated a variety of statistical methods can be applied in order to drive enhanced online process visibility. Effectively, the statistical methods produce variables which reflect process capability that can be managed online and viewed like a traditional process variable. By applying analytical tools and product-based Cpk reporting to standard production data, greater process understanding is achieved.
Speaker:
Bart Reitter - Global Industry Manager - Life Sciences, GE Fanuc Intelligent Platforms
C-7: Case Studies in Laboratory Equipment Qualification 2:00PM - 3:00PM (Thursday, March 27, 2008)
This session will present three summaries of equipment qualification projects required by FDA regualtory action and discuss similarities and differences. It will also assess the overall level of compliance and overkill of each of the approaches and discuss how it related to the minimum level of validation expected.
Nancy Tomoney - Senior Validation Scientist, QPharma Corp/CSSC Inc.
Speaker:
Scott Collins - Senior Validation Manager, QPharma Corp/CSSC Inc.
C-8: Formulation and Process Design of Experiments: Quality by Design 3:15PM - 4:15PM (Thursday, March 27, 2008)
The session will provide an understanding of Design of Experiment (DOE) applications with respect to Formulation and Process Development during Drug Product Development. With an understanding of these applications and the data that is generated, companies can ensure predefined product qualtiy from the begining of drug development.
Ryan Doxey - Research Scientist II, Stiefel Research Institute
Biotechnology
Sponsored By:
BIO-8: WORKSHOP: Aseptic Processing and Manufacturing: From Compliance to Contamination to Control 9:00AM - 11:00AM (Thursday, March 27, 2008)
This session will cover a spectrum of issues related to aseptic processing and manufacturing. Dr. Vadheim will give an overview of regulatory and compliance guidelines as well as point to a scientific overview of critical issues pertaining to aseptic processing manufacturing. Dr. Ashtekar will focus primarily on success stories around the manufacturing of bacterial and viral derived vaccines as well as discuss potential microbial incursions into the manufacturing process. Dr. Sidhu will present case studies linking contamination issues to the aseptic environment as well as solutions for such. Mr. Guardino will focus on the latter as far as disinfectant challenge efficacy and case studies where manufacturing shutdowns have been resolved through the most effective disinfectant/sanitization challenge.
Moderator:
Jaspreet Sidhu, PhD - VP, Business Development and Pharmaceutical Microbiology, Molecular Epidemiology, Inc. (MEI)
Speaker:
Dilip Ashtekar, PhD - Chief Microbiologist for Operations and Director, Global Microbiology, Amgen
BIO-11: Drug Delivery of Biopharmaceuticals - What is Important for an Efficient Combination of Biologic, Pre-filled Syringe and Autoinjector? 10:15AM - 11:15AM (Thursday, March 27, 2008)
Injection is the most common route of administration for biopharmaceuticals. Product launches with pre-filled syringe systems facilitate life cycle strategies and improve patient convenience. As self-injection is increasing, biopharmaceutical companies go one step further and introduce their products with syringe-based autoinjectors. This means more components, more interfaces and higher complexity of the drug delivery system. How can these challenges be addressed in development projects? Key requirements are arising from the interfaces between biopharmaceutical, pre-filled syringe and autoinjector device. Highlighted in this presentation are - principles to select optimal syringe systems and autoinjector devices according to biopharmaceutical product and therapeutic class, - strategies to reduce interactions of biological molecules with leachables and silicone lubricant from pre-filled syringe systems (drug / device interface) and - technologies to establish syringe dimensions, break-out and gliding forces which are compatible with autoinjector specifications (device / device interface). The session points out which action items need to be agreed at an early stage of development between biopharmaceutical company, syringe supplier and autoinjector producer to lay out the road map for a successful product launch.
Speaker:
Arno Fries, PhD - Head of Sales North America, Gerresheimer Buende GmbH
BIO-12: Economics of Vaccine Production Using Virus-Like Particles 2:00PM - 3:00PM (Thursday, March 27, 2008)
Virus-like particles (VLPs) made by recombinant techniques using single use disposable equipment offer significant advantages over the traditional vaccine manufacturing approach. This manufacturing method results in lower capital and operating cost and greatly reduced time to market. This presentation provides an overview of the VLP manufacturing process and describes what a commercial facility might look like. Capital and operating costs are estimated and compared to conventional vaccine manufacturing processes. An update on the status of this developing technology is also provided.
Speaker:
Robert Bader - Sr Mgr Technology Pharmabio, Jacobs Engineering
James Robinson - Vice President of Preclinical and Quality Operations, Novavax, Inc.
BIO-9: The ASME-BPE Global Standard for the BioPharm Industry 2:00PM - 3:00PM (Thursday, March 27, 2008)
The session will provide an overview of the American Society of Mechanical Engineers - Bioprocess Equipment (ASME-BPE) standard and its implications for the biopharmaceutical industry. Mr. Zinkowski, who is Vice Chair of the BPE Standards Committee, will provide a brief overview of each part and structure of the BPE Standards committee, the inception & development of the standard, and the interface between the ISPE, P3A, 3A.
Speaker:
Rick Zinkowski - Vice Chair, BPE Standards Committee, American Society of Mechanical Engineers - Bioprocess Equipment
BIO-10: Shortening 'Time to Money' for BioPharma Facilities-Lessons from the Semiconductor Industry 3:15PM - 4:15PM (Thursday, March 27, 2008)
Shortening "time to money" is a critical factor for any new BioPharma facility. Important lessons can be learned from the Semiconductor Industry where the cost of new chip-making facilities range from $3.5B to $7B. Delays in production cost Chipmakers over $100M per week. Collaborative project management reduces or eliminates those delays. Shortening "Time to Money" for is a critical factor for BioPharma facilities.
BIO-13: Design Alternatives for Multi Product Vaccine Facilities 3:15PM - 4:15PM (Thursday, March 27, 2008)
Designing a multi product vaccine cell culture facility is a critical activity that must evaluate many factors in order to identify and meet all design objectives in a timely and cost efficient way. The design must ensure sufficient built in process capability and adaptability for the almost inevitable modifications that future processes will bring, while still keeping a limit on capital commitments. Then what are the design options to achieve requirements for product segregation, containment, work flows and GMPs and how have they been used in recent cell culture projects? Based on a series of large scale cell culture projects, the presentation uses case studies to illustrate design alternatives and discuss the pros and cons of these approaches. The case studies cover facility designs ranging from pilot plant to production scale and are selected to illustrate alternatives in modern vaccine facilities
F-7: WORKSHOP: Critical Utilities Case Studies: What Went Right, What Went Wrong! 9:00AM - 11:00AM (Thursday, March 27, 2008)
Various Operating companies, Consultants and Suppliers will present case studies on critical utilities. Each case study will examine a project and discuss lessons learned. Critical Utilities examined will include; WFI, Pure Steam, CIP/SIP.
Peter Vishton - Technology Engineer Pharma Water Systems, Wyeth
F-8: Key Considerations in Bioprocess Facility Fit 2:00PM - 3:00PM (Thursday, March 27, 2008)
A critical step in the development of a biopharmaceutical manufacturing process is the determination of process-facility fit. This involves evaluating whether a process may be economically carried out in a given facility. Some of the key considerations include the size and type of primary processing equipment, the availability and size of supporting equipment including media and buffer tanks and CIP skids, and utilities including especially purified water. Less tangible factors, such as worker productivity, may also play a role. This presentation will cover the key calculations that need to be made along with software that can speed the evaluation process. The calculations and techniques are illustrated by a case study in which two possible plants are compared for a monoclonal antibody process.
Charles Siletti - Director, Scheduling & Planning Applications, Intelligen, Inc.
F-9: Steps for Performing a Successful Facility Decontamination 3:15PM - 4:15PM (Thursday, March 27, 2008)
This presentation will start at the beginning of the process with general cleaning requirements to prepare the area for fumigation. It will then describe the three primary methods which are formaldehyde, hydrogen peroxide vapor, and gaseous chlorine dioxide. The room/area sealing requirements will be specified which includes doors, penetrations, and the HVAC system. The preparation of the area will include the ability of equipment and supplies to be decontaminated during the process. Fan locations, humidity requirements, generation points, decontaminant circulation and distribution, and air flows will be discussed. Aeration methods, time requirements, monitoring, and offgassing will be described as well as methods of determining when safe re-entry can occur. Pictures will be utilized to demonstrate activities and techniques to enhance the learning experience.
Mark Czarneski - Director of Technology, Clordisys Solutions, Inc
Manufacturing
M-7: Lean Enterprise: A Business Model that Drives Success 9:00AM - 10:00AM (Thursday, March 27, 2008)
In the 1990's Baxter began implementing Lean Manufacturing principles in its manufacturing plants. See how this organization benefited from its early Lean implementations and some of the lessons they have learned over the past decade. Learn about the benefits of transforming Lean from a tool to a business model. Discover the opportunities created by dropping the term Lean Manufacturing and creating a Lean Enterprise.
Speaker:
Tony Johnson - Plant Manager, Baxter Healthcare Company
M-11: The Change from Fixed to Disposable: Discover Process Improvement Opportunities through a LEAN Six Sigma Lens 9:00AM - 10:00AM (Thursday, March 27, 2008)
Formal operational excellence initiatives and processes such as Lean & Six Sigma are gaining more widespread acceptance and implementation in biopharmaceutical manufacturing. Likewise some vendors of enabling technologies and equipment are applying the same methodologies to improve the quality and efficiency of their product and service offerings. We will explore the multifunctional endeavor of LEAN Six Sigma at GE focusing on the mistakes made along the way, and the return to employee involvement in complement to technologies. We will discuss the fundamentals of LEAN in detail and walk through case studies on LEAN implementations in bio manufacturing environments. A special focus will be given analyzing how the implementation of increasingly available ready to use, single use or disposable technologies enable LEAN manufacturing strategies resulting in greater speed flexibility and overall process agility in bio manufacturing operations.
Speaker:
Victor Bornsztejn - Global Growth Director, GE Healthcare, Life Sciences Service
Gerard Gach - Global Product Platform Director , GE Healthcare
M-12: Syringe Processing, from Filling through Packaging 10:15AM - 11:15AM (Thursday, March 27, 2008)
All aspects of Syringe Processing will be discussed, from E-Beam sterilization through filling, laser marking, inspection, labeling and packaging. Recent case studies will be presented on different line and equipment options.
Nancy St Laurent - Sr. Supervisory Process Engineer, Parsons Corporation
M-8: Analysis of Particle Size and Distribution in a CFC-free Aerosol Based Pharmaceutical Preparation 10:15AM - 11:15AM (Thursday, March 27, 2008)
Several medications used to treat respiratory diseases are delivered in powdered form. Particle size and distribution are critical parameters for demonstrating the efficacy for these drugs. Robust analytical procedures and instrumentation are required to ensure reproducible and cost-effective particle size and distribution test results. IVAX Pharmaceuticals in Ireland has expanded its particle size and distribution analyses for its product, QVAR. (Medication details below.) Until recently, an outside laboratory in the U.K. had conducted drug particle size and distribution analyses for IVAX. Given the increased sample volume coupled with a need for more timely receipt of test results, IVAX chose to conduct this testing in-house. IVAX purchased a liquid particle counter to conduct their particle size and distribution analyses. This paper will focus on IVAX's evaluation to opt for in-house testing as a cost-effective, reproducible method for assessing drug quality via particle size and distribution. We will present the final methodology selected by IVAX to ensure quality and cost effective particle counting analyses. QVAR, is a maintenance medicine used to reduce the frequency and severity of asthma attacks. It is currently the only CFC-free (free of the chlorofluorocarbons) aerosol corticosteroid for the treatment of asthma in the U.S. QVAR delivers the smallest medication particle size, 1.1 microns, of any drug in its category. This smaller particle size allows for greater lung deposition in the smallest airways of the lung.
Joseph Gecsey, Jr. - Life Sciences Business Development Manager, Hach Ultra Analytics
M-13: New Development in Hydrogen Peroxide Vapor (HPV) Decontamination of Rooms, Facilities, Isolators, and Various Pharmaceutical/Bio-tech Applications 2:00PM - 3:00PM (Thursday, March 27, 2008)
This is a summary presentation highlighting the recent advantages in bio-decontamination using Hydrogen Peroxide Vapor (HPV) technology on rooms, isolators, facilities, and various pieces of laboratory equipment. The major advantages of this process, and why many people will be interested, are: 1) Residue Free and No Secondary wipe down 2) Ability to execute decontamination in ambient room conditions without affecting temperature/relative humidity 3) Minimal Material Compatibility Issues and very effective on computers, microscopes, and precise electronic equipment 4) Efficacy against a wide range of organisms such as bacillus spores, mold, parvo virus, anthrax, tuberculosis, etc. 5) Validation/Verification of process using biological indicators 6) Limited Environmental Health & Safety concerns
Adam Warner - East Coast Sales Manager, BIOQUELL,Inc.
Speaker:
Kevin Trottier - Associate Director, Facilities & Engineering, Avant Immunotherapeutics, Inc.
M-9: Blastoff: Best Practices & Lessons Learned for Successful Commercial Launch 2:00PM - 3:00PM (Thursday, March 27, 2008)
Launching a commercial product represents the penultimate event for a biotechnology or pharmaceutical company. However, there are considerable challenges in transitioning products from R&D to commercial excellence. Executing a successful launch program depends upon coordinating and bridging knowledge across virtually all corporate functions to effectively plan, organize, consider alternatives, reach consensus and ensure consistent communication and direction. This workshop will outline and discuss the commercial launch process and share insights and lessons learned from recent launches at companies including: LAUNCH TIMEFRAMES: Appropriate timing and critical time lines CROSS FUNCTIONAL APPROACH: How to engage the organization for launch and best organizational models for a launch team PARTNER SELECTION: Criteria to select effective manufacturing, packaging and distribution partners MULTI-YEAR BUDGETING: Cost to launch a new product and planning and budgeting for a multi-year launch effort CRITICAL NEW SKILLS & INFRASTRUCTURE: New people, processes and information systems needed to support a commercial launch.
Speaker:
Joan Bramer - Director, Commercial Launch Services, Maxiom Group
Andrew Komjathy - Vice President, Commercial Operations, North America, Shire Human Genetic Therapies
M-10: Enteric Coatings, Review and Advances 3:15PM - 4:15PM (Thursday, March 27, 2008)
There have been significant advances in enteric coatings over the past 10 years, from tablet core engineering to subcoat considerations, to ingredient selection, processing equipment and controls. Processes once cumbersome and trouble prone can now be completed with simplicity and high confidence of success. Required weight gains can now be greatly reduced. Color can be incorporated in one coating step. New techniques can be applied to both aqueous and solvent coating, on both tablets and capsules, and in using both coating pan and fluid bed applications.
Stephen Levine - Group Leader, Scientific Affairs, Emerson Resources, Inc.
Outsourcing
O-5: Outsourcing Utilities to Focus on Core Business 9:00AM - 10:00AM (Thursday, March 27, 2008)
Outsourcing utilities to focus on core business» Manufacturing drugs is a long and a complex process which involves many skills. Nowadays, a drug manufacturing site needs numerous utilities in order to produce pills, tablets, capsules, vaccines etc. For example: a site will need potable water for lavatories, electricity for running the machines, compressed air for component activation, clean steam for process sanitisation, industrial steam for heating buildings/processes, chilled water for cooling tanks, vacuum for packaging lines, water for injection for making parenteral products. All this utilities are part of a drug manufacturing facility but are not the core business of the pharmaceutical company. This course will examine existing possibilities in outsourcing for a pharmaceutical industrial site, outline goals and objectives of both parties and the service provider's guarantees needed in order to be compliant with regulatory issues. - What kind of utilities can be found in a typical pharma plant? - Why is it important to focus on core business? - What does ‘outsourcing utilities' mean? - What are the solutions for the industrial site (O&M, BOT, ROT, AOT, BOOT,…)? - Key decision factors for choosing outsourcing - How to implement outsourcing without disrupting the plant operation? - How to consider assets, staff, quality and cost control? - How can outsourcing help a site to grow? - Does regulatory compliance match with contract guarantees & performance? - Industry feed back experiences
Johann Bonnet - Market Manager, Veolia Water Solutions & Technologies
O-6: Performance Measurement Techniques for Outsource/Contract Manufacturing 10:15AM - 11:15AM (Thursday, March 27, 2008)
Measuring the performance of your contract manufacturer is difficult task, especially as you have little control over the contract organization. As well, as a contract manufacturer your ability to differentiate against your competition is also a difficult task as the last differentiator you want to use is price. Our presentation will discuss the real world techniques used to collect/present data in format to allow the outsourcing company to retrieve near real time supply chain data as well as present key performance indicators (KPIs) and dash boards for each contract manufacturer. For the contract manufacturer our presentation will provide a view into how you can proactively present data to your customers that provide visibility and these KPIs to provide greater value as a business partner and position yourself against the competition.
John Postle - Vice President - Life Sciences, Court Square Group
O-7: Finding and Delivering Value Through Collaboration: Recent Research, Case Studies, and Practical Advice on How to Increase Value from Key Supplier Relationships 2:00PM - 3:00PM (Thursday, March 27, 2008)
On the Boeing 777, the specification control document for suppliers to build the electrical distribution system was 2500 pages. The equivalent documentation for the 787 Dreamliner was 25 pages. Drawing on recent Vantage Partners research from both buy-side and sell-side executives and relationship managers at hundreds of companies, this presentation will provide important insights on barriers to collaboration, and how to enable breakthrough partnerships with CROs, external manufacturers, and other supply chain partners. Learn how to companies inside and outside the pharmaceutical industry have tapped into the power of partnering with key suppliers, and how your organization can take collaboration to the next level.
O-8: Operational CMO Strategies for Competitive Advantage 3:15PM - 4:15PM (Thursday, March 27, 2008)
The presentation would contain two main themes including operational excellence and network optimization as well as competitive advantage strategies. The content would be present in general terms along with examples of how Patheon has been implementing these concepts in our operations as a dedicated CMO.
Speaker:
Steve Liberty - Senior VP of Operations, Canada, Patheon, Inc.
Quick Search
You can use the search box below to locate specific speakers or sessions.
