New format tracks drug manufacturing from development to market The organizers and Advisory Board of INTERPHEX have reengineered the 2012 conference program, to be held at New York's Javits Center on May 1-3, 2012. This year's conference and technical sessions will mark a new level of content, including new session criteria and formats, growth in the number of senior-level speakers, and a third day of programming.
"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.
- Guidance for Industry Process Validation: General Principles and Practices - A CMO's Approach: Sandra Lueken, Director of Quality, Baxter Pharmaceutical Solutions.
- Is Your CMO Committed to Your Success?: Raul Soikes, Sr. Director Program Management R&D, Baxter Healthcare Corporation.
- Case Study: How to Benefit from Pharmaceutical Distribution Outsourcing: Michael Trocchia, P.E. CPIM, Director Project Management, US Supply Chain Management, Novartis Pharmaceuticals Corporation.
- Why Deploying Lean Six Sigma is Important for Global Manufacturing Networks: Robert Lechich, Director Operational Excellence, Pfizer, Inc.
- Why Supply Chain Security is so Important in Today's Marketplace: Thomas Dale, Director, Supply Chain Marketing and Vertical Marketing Development, FedEx.
- Applying a Knowledge-Based Approach to Supply Chain Pharmaceutical Temperature Control Management: Arminda O. Montero, Global Distribution QA Program Manager, Global Pharmaceutical Operations, Abbott Laboratories.
- Regulatory Strategies and Considerations for Successful Site Transfers: Sema Z. Ariman, Regulatory Affairs Manager, CMC Regulatory Affairs PPG, Abbott Laboratories.
The Thursday schedule will include special presentations, including:
- Practical Applications of Statistical Methods Under 2011 FDA Process Validation Guidance: Abe Germansderfer, Associate Director, Gilead Sciences, Inc.
- Making it in Massachusetts –A Small Company's Road to the CMO Market: Glenn Alto, President and CEO, Pharmalucence, Inc. and Edward J. Connolly, Chief Operating Officer, Pharmalucence, Inc.
- Development of Novel CR Formulation Mitigating Dose Dumping & Misuse: Shams Rustom, M.Pharm, RPh., Senior Director, Product Development & Manufacturing, Labopharm.
The conference will also feature keynote presentations, including:
- What the New Bio/Pharma Business Model Means for CMOs and CROs, by Jim Miller, President of PharmSource.
- Control, Capability, and Capacity: Elements Assuring a Reliable Drug Supply, by Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products, Center for Drug Evaluation & Research, FDA.
- Creating Innovative Cold Chain Solutions for your Pharmaceutical and Biopharmaceutical Products, by Richard Smith, Director, Life Sciences & Specialty Services, FedEx.
Complementing the 2012 Conference agenda will be eight 45-minute Technical Workshops to be led by Bosch, EMD Millipore Corporation, Fette Compacting America, GE Healthcare, Glatt Air Techniques, Pall Life Sciences, STERIS, and Thermo Fisher Scientific. The workshops will complement the conference agenda with industry leaders presenting technical and educational content. The third-day programs, keynote presentations, Floor Tours, and Technical Workshops will be open to all badge holders, welcoming both conference and exhibits-only attendees.
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:
- The Role of CMOs in Supporting Global Vaccine Production Needs: A Case Study on Brazil Fill Finish. This will cover a greenfield vaccine manufacturing plant in Brazil, followed by a floor tour of advanced aseptic providers.
- Next Gen Biomanufacturing: Developing the Manufacturing Facility of the Future. High-performing biopharmaceutical manufacturing facilities capable of simultaneously manufacturing products from late stage development through commercial manufacturing, followed by a floor tour of biologics suppliers.
- Should it be Scale-Up or Scale Out…Bigger is not Always Better or Faster. A discussion designed to provide insight regarding the 'what scale' question, including the risk in scale-up vs. scale-out using a batch process more aligned with a pilot scale. The presentation will be followed by an Oral Single Dose floor tour.
Floor Tours are open to all badge holders, however pre-registration is required..
"We've designed the conference to be even more practical and case-study driven than before," said R.J. Palermo, Vice President of Strategic Initiatives. "The programming is becoming an ever-stronger complement to the exhibit, which remains unique in the industry for its scope."
"The genesis of this new programming was to provide an enhanced value proposition for our attendees," noted Somma. "During our advisory board sessions, the group focused on the pragmatic aspects industry professionals associate with INTERPHEX: 'How do I accomplish my product goals quickly, identify the goods and services needed, assure a seamless regulatory review, and achieve a rapid commercial transition and maximize market uptake."
Details on registration, conference packages, group and ISPE member discounts can be found at www.INTERPHEX.com/press and event news is available via Facebook, Twitter and LinkedIn.
For any further information please contact:
Nadine Wright Marketing Manager