« DCAT WEEK 2015
Quality Metrics: Te FDA’s Initiative and Its Impact on Pharma Manufacturers and Suppliers Tuesday, March 17, 2015, 9:00 AM - 11:30 AM
As announced in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the US Food and Drug Administration is moving toward a risk-based inspection schedule. In support of and to strengthen this risk-based approach, the agency started developing quality metrics as objective measures of the overall quality of pharmaceutical manufacturing sites and their products, processes, and systems. This program will provide the latest on FDA’s Quality Metrics Initiative, its impact on pharmaceutical manufacturers and inspection models, and evolving expectations between pharma companies and suppliers. Speakers are: Russell Wesdyk, Scientific Coordinator, Office of Pharmaceutical Science, U.S. Food and Drug Administration; Frances Zipp, President, Lachman Consultants; Mary Oates, Vice President, Global Quality Operations and EHS, Pfizer Inc.; and Robin Jones, Vice President, Quality Compliance, Teva Pharmaceuticals.
Excipient GMPs: Risk Assessment, Supplier Selection, and the Global Supply Chain Tuesday, March 17, 2015, 1:30 PM - 3:30 PM
A new wave of excipient regulations and industry programs focused on quality, risk management, supply-chain security, and supplier integrity are creating both opportunities and challenges for the industry. This program will examine the latest US and EU provisions and industry initiatives relating to excipient GMPs and the impact on the excipient supply chain, including the implications for supplier selection, qualification, and evaluation. Speakers are: David B. Klug, Senior Manager, GMP Audit, Sanofi US (Immediate Past Chair of IPEC- Americas); William Dale Carter, Global Director Quality, J.M. Huber Engineered Materials, Silica Business Unit (Past Chair of IPEC Americas); and Dr. Frank Milek, Head of GMP and SHEQ Operations, Aug. Hedinger GmbH & Co. KG (Chair of IPEC-Europe).
DCAT’s 2015 BioPharmaceutical Forum:Te Latest Market Opportunities/Trends and How to Establish & Ensure the Supply Chain Tuesday, March 17, 2015, 1:30 PM - 3:30 PM
Biologic-based drugs are an increasingly important part of the pharmaceutical industry’s pipeline and commercial product portfolios. This session will provide an in-depth view of the global biopharmaceutical market and its key segments (monoclonal antibodies, recombinant proteins, vaccines, antibody drug conjugates, and other specialty products) and case studies from leading biopharmaceutical companies on how to establish and ensure a reliable and robust biologics supply chain. Speakers are: David A. Dunn, PhD, Practice Consultant, Life Sciences Professional Services, IP & Science, Thomson Reuters; Maria Nieradka, Senior Vice President Global Supply Chain, Biogen Idec; and Fred Jacobson, PhD, Staff Scientist, Genentech Inc., a member of the Roche Group.
Value Creation Trough Strategic and Collaborative Sourcing March 18, 2015, 9:00 AM - 11:30 AM
Sourcing, procurement, and supply management leaders face
the challenge of delivering value in an environment marked by increasingly complex global supply chains, greater cost pressures, and dynamic business conditions. This program will provide insight on the organizational structures, operational and risk-mitigation approaches, and metrics for building successful collaborative supplier partnerships. Speakers are: Marielle Beyer, Head Technical Operations, Procurement, Roche Pharma; Peter Lyford, Commodity Director, Custom Manufacturing, Production Procurement, GlaxoSmithKline; Craig Michael, Director, API External Manufacturing, Eli Lilly and Company; Bill Rich, Vice President, External Supply, Amgen; and Patricia Turney, Executive Director, External Supply Chain, Amgen.
Cutting-Edge Technologies: Te Future of the Pharmaceutical Value Chain Wednesday, March 18, 2015, 9:30 AM - 11:30 AM
What are the next game-changers in the pharmaceutical industry? This program will examine the emerging technologies, tools, and processes that will impact the landscape of the pharmaceutical value chain. Topics and speakers are: smart and mobile technologies’ impact on drug delivery, Nick Bonny, Director, Pharmaceuticals and Life Sciences Operations, PwC; integrated continuous manufacturing of both drug substances and drug products, Timothy Jamison, PhD, Principal Investigator, Novartis-MIT Center for Continuous Manufacturing, and Professor of Chemistry, Massachusetts Institute of Technology (MIT); crowdsourcing, the new technology for external innovation, David Thomson, Director of Organizational Engagement, Boehringer Ingelheim Pharmaceuticals, Inc.; and cloud computing, a tool for pharmaceutical manufacturing and its impact on the interface between internal and external manufacturing, Jerry Megaro, Director of Manufacturing Analytics and Innovation, Merck & Co., Inc.
Registration and further information may be found at
www.dcat.org. About DCAT
As a not-for-profit, member-supported business development association for the global pharmaceutical manufacturing industry, the Drug, Chemical & Associated Technologies Association (DCAT) is committed to providing programs, events, and services that help its members expand their network of customers, suppliers, and colleagues in the industry. Founded in 1890, DCAT is the industry’s premier business development association whose membership is comprised of companies that manufacture, distribute, or provide services to the pharmaceutical, chemical, and related industries. With over 375 corporate members, DCAT is headquartered in Robbinsville, New Jersey.
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