“The sessions have been arranged in a cross-functional team matrix that aligns with the business process used by firms in the industry,” said Russ Somma, Ph.D., INTERPHEX 2012 advisory board member and conference consultant. “In this way, we’re confident the ensuing conversations between conference attendees and suppliers present will be based on the latest industry trends, tempered by insights gained from industry leaders providing the educational content. The conference attendees will hear it, see it and procure it in one comprehensive venue – INTERPHEX 2012.”
The 2012 conference topics will be grouped into Product Development, Facility & Process Design, Manufacturing & Packaging and Supply Chain tracks, designed to deliver the latest achievements in each stage of manufacturing as a drug moves to market, plus a track highlighting Regulatory Quality Assurance/Quality Control. The three-day program of comprehensive technical education will offer thirty-five sessions, plus eight technical workshops, keynote presentations, and case studies coupled with show floor tours. The conference topics include:
Regulatory Quality Assurance/Quality Control:
• Case Study: Regulatory Consequences from Poor Microbiological Manufacturing and Laboratory GMPs: Dennis E. Guilfoyle, Ph.D., Pharmaceutical Microbiologist, U.S. Food & Drug Administration
• Seven Things You Should Do Before Facing an Inspection: Rosario Quintero-Vives, Sr. Regulatory & Compliance Specialist, RQV Consulting.
• Case Study: An Enterprise-Wide Approach to Global Change Management: K.R. Karu, Pharmaceutical Industry Principal, Sparta Systems.
• Learn Why Export Control on Processing Equipment is Important: Betty Lee, Ph.D., Microbiologist, U.S. Department of Commerce.
• Streamlining Risk Management Evaluations for New Manufacturing Processes: Mike Porter, Consultant, Commissioning Agents, Inc.; Ivan Toponarski, Project Engineer, Allergan Medical.
• Proven Cost-Savings Using Manufacturing Execution Systems (MES) for BioPharm Manufacturers: Marco Lederle, Director Consulting / Partner, i+o Industry Planning + Organization.
• Proven Processes and Metrics to Optimize Operational Excellence: Shane Yount, Principal / Author, Competitive Solution, Inc.; Ed Dubeau, Director and Team Leader of Manufacturing for Consumer Healthcare Operations, Pfizer, Inc.
• Panel Discussion: Best Practices and Regulatory Expectations in Continuous Processing: Elaine Morefield, Ph.D., Deputy Director, Office of New Drug Quality Assessment (ONDQA), CDER, FDA; Fernando J. Muzzio, Ph.D., Director, NSF ERC Structured Organic Particulate Systems, Professor II, Dept. of Chemical and Biochemical Engineering, Rutgers; Moheb Nasr, Ph.D., Vice President, CMC Regulatory Strategy, Global Regulatory Affairs, GlaxoSmithKline, Former Director FDA CDER ONDQA. Presented and moderated by: Angie Drakulich, Editorial Director, Pharmaceutical Technology.
• Learn the Technical Challenges in the Development of Biosimilars: E. Morrey Atkinson, Ph.D., Chief Scientific Officer, V.P. of Research and Development, V.P. of Drug Substance Manufacturing, Cook Pharmica, LLC.
• Making Risk Assessment Part of Technology Transfer: J. Richard Creekmore, Ph.D, R.Ph., US Technology Manager, AstraZeneca Pharmaceuticals LP.
• Case Study: Designing Critical Cleaning Processes to Mitigate Microbial Risk in Multiproduct Facilities: Mary Ellen Clark, Validation Scientist I, MedImmune; Brian Goss, Associate Director, Validation Technical Services, Imclone Systems; Paul Lopolito, Technical Services Manager, STERIS Corporation.
• Case Study: Why is Product and Process Understanding in Supporting Post-approval Change Important?: Yihong Qiu, Ph.D., Research Fellow, Oral Drug Products, Manufacturing Science and Technology, Global Pharmaceutical Operations, Abbott Laboratories.
• How to Use Online Analytics as a PAT Tool to Enable QbD in Upstream Cell Culture: Stefan Steigmiller, Ph.D., Head of PAT-Biotech Projects, Bayer Technology Services GmbH.
• Bioburden Control for Sterile Filtration for Injectable Biotechnological and Pharmaceutical Drug Product Manufacturing: Dilip Ashketar, Sr. Director Quality Control, Gilead Sciences, Inc..
Facility & Process Design
• Case Study: You Need a Small Clean Room For... So Where Do I Start?: Susan Morrison, Principal Construction Engineer, Parsons Engineers @ Goddard Spaceflight Center, NASA.
• Case Study: Optimizing Execution with Modular Construction: John Gilroy, P.E., Sr. Vice President and Principal, Integrated Project Services.
• Case Study: Greener Manufacturing with Reduce, Reuse, Recycle & Reclaim of Water: Johann Bonnet, Strategic Account Manager, Veolia Water Solutions & Technologies.
• Case Study: Meeting Sustainability Challenges with the Revamping of Your Wastewater Plant: Ajit Ghorpade, Ph.D., Technical Director for Biological Processes, Veolia Water Solutions & Technologies.
• Case Study: Asset Optimization & Flexible Multi-Product Facility Concepts: Jim Robertson, Sr. Technical Director of Facilities Integration, Fluor Enterprise Inc. and Craig Sandstrom, Ph.D., Director of Process Engineering, Fluor Enterprise Inc.
• Case Study: Why Logistics Modeling and Architectural Layouts is Important: Philip R. Lyman, Ph.D., Director, Process Simulation, CRB Consulting Engineer, Inc. and Robert K. Orgera, AIA, LEED, AP, Sr. Architect, CRB Architects & Engineers, Inc.
• Implementing Commissioning and Qualification In Line with the FDA’s Recent Process Validation Guidance: Aaron Weinstein, Northeast Regional Director - Commissioning & Qualification,
• IPS - Integrated Project Services and Jason D’Orlando, Associate Director - Project Controls, Shire HGT.
Manufacturing & Packaging
• Case Study: Implementing Single-Use Technologies in a GMP Facility: Peter Watler, Ph.D., Principal Consultant and Chief Technology Officer, Hyde Engineering+ Consulting, Inc..
• Single Use Technology Enabling Biosimilar Manufacturing: Todd Bucciarelli, Business Development, IIT Research Institute; Bill Whitford, Market Manager, Cell Culture, Thermo Fisher Scientific.
• Case Study: Use of Pre-Sterilized Single Use Disposable Fluid Paths in Sterile Manufacturing: Matthew P. von Esch, Manager Manufacturing Fill/Finish, United Therapeutics and Wenzel Novak, Ph.D., Director Pharmaceutical Research and Development, Groninger & Co. GmbH.
• Case Study: Aspects of a Sustainable Maintenance for a Lifecycle Cleaning Validation Program: Igor Gorsky, Associate Director, Validation, Global Pharmaceutical Technology, Shire Pharmaceuticals, Inc..
• Case Study: Translating the New Process Validation Paradigm to Cleaning Processes: Keith Bader, Sr. Consultant, Hyde Engineering+ Consulting, Inc. and Jeff Slutsky, Director of Design for Six Sigma, Bausch and Lomb.
• Introduction to the New ISPE Guide: Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment: Steven Wisniewski, Principal Compliance Consultant, Commissioning Agents, Inc.
• Case Study: Path to Reduce Operational Expenses and Improve Operational Efficiency: Niranjan Kulkarni, Ph.D., Operations Specialist, CRB Consulting Engineers, Inc.; Philip R. Lyman, Ph.D., Director, Process Simulation, CRB Consulting Engineer, Inc.; Amit Srivastava, Project Manager, Novartis Institute of Biomedical Research.