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Symposium #1: Biosimilars: Defining Successful Development Strategies in an Evolving Regulatory Environment The global biosimilars sector continues to gain momentum with the emergence of significant new commercial partnerships and the continued evolution of the global regulatory environment over the past year. Recent advances in the global regulatory framework for biosimilar products include the publication of the first three draft guidance documents related to biosimilars by the US FDA in February and an update to the overarching guideline for biosimilar medicinal products and new product-specific guidelines by the European Medicines Agency. Both originator and biosimilar companies are refining their strategies to enter and compete in this dynamic new market. This symposium will discuss overall business trends and biosimilar development and manufacturing strategies. Agenda to include: • What is the emerging competitive landscape and what will be the keys to success in this space? • What technical and regulatory challenges are presented by alternative development and manufacturing strategies? • What are the opportunities for innovation in this area? Co-Chairpersons: Thomas Stangler, Ph.D., Development Strategy and Technology Manager, Biopharmaceuticals, Sandoz, Austria Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics R&D, Hospira, Inc. 1:00 Co-Chairperson’s Remarks Thomas Stangler, Ph.D., Development Strategy and Technology Manager, Biopharmaceuticals, Sandoz Biopharmaceuticals, Austria Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics R&D, Hospira, Inc. 1:15 A Global Update on the State of Biosimilars in the Highly Regulated Markets: A Regulatory and Policy Perspective Gillian Woollett, D. Phil, Vice President, Avalere Health 1:45 Update on US Regulation of Biosimilars John M. Pakulski, R.Ph., Head US Biopharmaceutical Regulatory Affairs, Sandoz Inc. a Novartis company 2:15 How to Leverage Resources for Biosimilar CMC Activities: Hindsight is 20/20 Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group 2:45 Networking Refreshment Break 3:15 Biosimilar Development – An Emerging Market Perspective Cyrus Karkaria, Ph.D., President, Biotech Division, Lupin Ltd., India 3:45 The Potential Role of Network Strategies in the Emerging Biosimilars Space Thomas J. Nikolai, Senior Director, Global Biologics R&D, Hospira Corp. 4:15 Audience Interactive Panel Discussion with all presenters 5:00 Close of Pre-Conference Symposium Pre-Conference Symposia • Monday, October 8, 2012 • 1:00 pm - 5:00 pm Symposium #2: Best Practices for Implementation Challenges with Single Use Systems This session will focus on addressing challenges when implementing single use systems. Single use systems have become critical components of many processes, so an understanding of potential risks and challenges is critical to developing successful control strategies when implementing processes which utilize single use systems. This session will discuss the challenges, risks and potential control strategies that can be implemented throughout the supply chain. 1:00 Chairperson’s Remarks Robert Repetto, M.S., MBA., Research Fellow, External Affairs, Pfizer BioTherapeutics Pharmaceutical Sciences; Chair, PDA Single-Use System Task Force 1:15 Evolution and Sustainability of Single Use Systems Robert Repetto, M.S., MBA., Research Fellow, External Affairs, Pfizer BioTherapeutics Pharmaceutical Sciences; Chair, PDA Single-Use System Task Force 1:45 Economics of Single Use Operations and Loss Risk Andrew Sinclair, Managing Director, BioPharm Services Ltd., United Kingdom 2:15 Material Understanding and Supplier Partnerships Duncan Low, Ph.D., Scientific Executive Director, Amgen Inc. 2:45 Networking Refreshment Break 3:15 Using Single-Use Technologies to Improve Speed to Clinic: A Case Study Looking at Scalability as Well as Leachables and Extractables in a Fully Disposable Downstream Process Joshua Hayes, Field Marketing Manager – Single Use Processing Systems, Biopharm Process Solutions, EMD Millipore 3:45 Global Adoption of Single Use Technologies: Perspectives from an End User Jeffrey C. Johnson, New Technology Lead, Sterile Technology and Commercialization, Merck & Co., Inc. 4:15 Audience Interactive Panel Discussion with all presenters 5:00 Close of Pre-Conference Symposium 12:00 pm Registration Symposium #3: Best Practices in Managing Variability of Raw Materials Managing raw material variability is becoming an increasingly important topic within the biopharmaceutical industry. This symposium will discuss best practices within process development, clinical and commercial manufacturing, supply chain and quality to ensure that the impact from raw material variability to process performance and product quality is minimized. 1:00 Symposium Introduction and Overview: Current Challenges in Managing Raw Material Variability – From Development to Commercial CASE STUDY UNPUBLISHED DATA The impact of lot-to-lot variability of raw materials on process performance and product quality has gained increased attention. This talk will provide an overview of the strategies one can incorporate to effectively manage the impact of raw material variability. Examples will include development approaches to minimize variability, as well as data analysis and supply chain tools to manage variability. Niall Carolan, Ph.D., Director of Manufacturing Sciences, Human Genome Sciences, Inc. 1:30 Amgen’s Supplier Excellence Program Ran Zheng, Ph.D., Executive Director, Plant Manager, Amgen Inc. 2:00 Development of a Novel Chemically- Defined Growth Media for CHO Cell Applications: Coupling Raw Material Quality and a Design of Experiments Approach to Optimize Cell Culture Media Performance Michael A. Cunningham, Ph.D., Senior Research Scientist, EMD Millipore 2:30 Networking Refreshment Break 3:00 Single Use Systems and the Challenges They Present Regarding Raw Material Quality and Management Melissa Morandi, Vice President Quality, Acceleron Pharma Inc. 3:30 Joint Presentation: How Can Industry and Suppliers Work Together to Identify Critical Raw Material Attributes to Ensure More Consistent and Reliable Performance? David Radspinner, Ph.D., Director of Global Marketing and Customer Applications, Thermo Fisher Scientific and end-user to be announced 4:00 Audience Interactive Panel Discussion sponsored by How Can Industry and Suppliers Work Together to Identify Critical Raw Material Attributes to Ensure More Consistent and Reliable Performance? Panelists will discuss the potential for integration of suppliers’ and end-users’ quality systems including product safety data, change control and change control notification and related topics. Moderator: Niall Carolan, Ph.D., Director of Manufacturing Sciences, Human Genome Sciences, Inc. Panelists: Industry End-User to be named Melissa Morandi, Vice President Quality, Acceleron Pharma Inc. David Radspinner, Ph.D., Director of Global Marketing and Customer Applications, Thermo Fisher Scientific Ran Zheng, Ph.D., Executive Director, Plant Manager, Amgen Inc. Additional End-users and providers to be identified 5:00 Close of Symposium Symposium #4: Regulatory Requirements in Preclinical CMC Development This symposium provides a comprehensive overview of the FDA regulatory requirements applicable to pharmaceutical research organizations during the preclinical stages of drug development and the preparation of an IND (Investigational New Drug) application. The CMC (Chemistry, Manufacturing and Controls) section of the IND application will be reviewed in detail, and a short preview will be provided of the regulatory process during clinical development. The course is intended to provide participants from all facets of the pharmaceutical and biotech industry with a broad understanding of what is required from a regulatory standpoint in early drug development. Agenda to include: • FDA structure and function • The product development timeline from R&D to IND • Good Laboratory Practice (GLP) • Preclinical studies required throughout drug development • Good Manufacturing Practice • GMP compliance throughout drug development • The CMC section of the initial IND • Regulatory compliance in CMO relationships Instructor: Bruce K. Burnett, Ph.D., RAC, Director of Regulatory Affairs, Duke Translational Medicine Institute, Duke University School of Medicine Early Registration and Group Discounts are Available (see page 27) 6
Symposium #5: Best Practices in Cleaning and Cleaning Validation A Science-based and Integrated Approach for Biopharmaceuticals Room ??? In this symposium we will identify the elements of a robust cleaning program for biopharmaceuticals. we will then see how each element is systematically developed and integrated to ensure successful implementation. The symposium will cover current regulatory expectations, science-based methodologies for cleaning characterization, and the lifecycle approach to cleaning validation and monitoring. In addition to the fundamentals of cleaning, this symposium will also cover the following advanced topics: Agenda to include: • Unique cleaning challenges for multiproduct bioprocesses equipment. • Effective strategies for addressing these challenges through planned small-scale studies. • Degradation/inactivation studies and how they can be used to eliminate product-specific assays and the traditional MAC approach. • Acceptance limits for degraded/inactivated product. • Cleaning tenacious residues in bioreactors and media tanks. • The use of master soils to streamline and provide flexibility for scheduling cleaning validation activities. Instructor: Rizwan Sharnez Ph.D., Principal Engineer, Process Engineering, Amgen Inc. Pre-Conference Symposia • Monday, October 8, 2012 • 1:00 pm - 5:00 pm 12:00 pm Registration Symposium #7: CMC Project Management throughout the Product Development Life Cycle Room ??? The session will provide a comprehensive overview of phase-dependent CMC activities and the role of CMC teams in integrating development plans and facilitating progress. Talks will cover different models for managing CMC projects that are tied to company’s resources, number of products, and phase of development. Best practices in CMC PM be discussed in detail. The symposium is intended to provide participants with a broad understanding of the drug development process from discovery to commercialization and how CMC- PM can help integrate the strategic vision with tactical implementation. • Overview of Integrated Phase Dependent CMC Development • Best Practices in CMC Project Management • CMC structure: One Size Does Not Fit All • Bridging Discovery to Human Proof of Concept and Commercialization • CMC PM as a Career Path Talks will be followed by a panel discussion which will cover topics of interest to the audience and the speakers. Agenda to include: • Understand Product Development Life Cycle from a CMC perspective • Models for managing CMC activities throughout development life cycle • CMC PM organizational structures and functional roles • Risk Management processes to maneuver through development hurdles • CMC PM business processes, tools and templates • Managing in-licensed products, partnerships, and CROs • Interactive discussions with peers and experts in managing CMC development Co-Chairpersons: Seshu Tyagarajan, Ph.D., Associate Director, CMC Project Management, ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company Zahra Shahrokh, Ph.D., Biotech Product Development Consultant, ZDev Consulting Symposium #8: Microbial Protein Production Systems Room ??? Microbial systems are being used to express a growing number of early stage protein products, circumventing issues such as viral clearance associated with CHO and other mammalian platforms, offering lower media costs and much shorter bioreactor run times. Virtually every new “antibody-like” scaffold is selected for efficient microbial expression, thereby facilitating discovery and manufacture. While almost all approved antibodies and most of those in clinical development rely on mammalian cell culture for production, a rapidly growing number of smaller antibody fragments, scaffold-based therapeutics and other proteins are produced in microbial systems. These production platforms include various bacterial hosts, several species of yeasts, and other small eukaryotes. This session focuses on recent advances and improvements to microbial systems and case studies of protein production and manufacture. Agenda to include: • Gain an overview of microbial production systems. • Understand key advantages and challenges of bacterial and eukaryotic microbial hosts. • Insights into the latest improvements to established and novel microbial expression platforms. • Learn from case studies of current protein products manufactured by microbial process. • Be prepared for increasing applications of microbial systems for new products. Chairperson: David Bramhill, Ph.D., Research Corporation Technologies and Bramhill Biological Consulting, LLC. 7 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI
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