QbD Updates from ISPE 2013 (Washington, DC) Conference

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I will be attending ISPE 2013 (Nov. 3-6) starting this Sunday.

Although I won’t be presenting this time, I will share with the QbDWorks Community,

Quality-by-Design related updates from the conference.

Some key players of QbD in Biotech are attending:

Janet Woodcock (Director of CDER, FDA )
Steven Kozlowski (Director, Office of Biotechnology Products, FDA)
Lynne Kruemmen (VP, Genentech, QbD head)
Christine Moore (Director, ONDQA, FDA)

Overall, I will try to share:

Latest QbD Benchmark of other BioPharma companies
QbD Suggestions, Challenges, Opportunities from FDA
Industry and Regulatory Network of QbD pioneers

Please take a look at the agenda below.

If you have any person that you’d want to meet or session that you’d want to attend, but cannot in person,

please let me know by sending an email sun_at_qbdworks.com or leaving a comment.

If I happen to be available at the time, I’ll try to cover it.

Also From Nov. 7~16, I will be traveling to Korea to teach “Design for Excellence” workshop at Siemens Healthcare.

ISPE 2013 Program Schedule (Source: http://www.ispe.org/2013annualmeeting)

Sunday, 3 November
13:30 – 17:00	Biomanufacturing Leader: Jeffery Odum, CPIP, Director Ops, Biotech Lead, IPS, USA Ali Afnan, PhD, President, Step Change Pharma Inc, USA Peter Bigelow, President, XCell Strategic Consulting, LLC., USA If Single use is the answer, why isn’t everyone using it? Parrish Galliher, Chief Technology Officer, Upstream, Xcellerex LLC, USA The future of Biomanufacturing: Faster, Better, Cheaper Joshua Hays, Associate Director of Upstream Business Development, EMD Millipore, USA If single use is the answer, why isn’t everyone using it? Paul Smock, Sr. Director, Technical Quality, MedImmune LLC, USA Biomanufacturing: Challenges for Controlled Non-Classified (CNC) Multi-Product Drug Substance Facility Design and Operation Andre Walker, CPIP, Director, Mfg Sciences, Biogen Idec, USA Bombs, Batteries or Baby Carriages: We can Learn from Other Industries Thomas Warf, Chief, Infrastructure Branch, HHS/BARDA, USA HHS Centers for Innovation in Advanced Development and Manufacturing
13:30 – 17:00	New EU GMPs, Risk-MaPP and You • Are You Ready? Leader: Stephanie Wilkins, PE, President, PharmaConsult US Inc, USA Setting Limits – EMA/Risk-MaPP Approaches Applying Health-Based Limits to determine if shared facilities can be used Nuah Al-Hafez, TEVA Canada, Canada Teva Global Quality Risk Management Program – Cross Contamination Pamela Kelberer, EHS Officer, PII, USA Joseph Payne, TEVA USA, USA Teva Global Quality Risk Management Program – Cross Contamination George Petroka, CIH, CSP, Principal, IES Engineers, USA QUANTIFYING CROSS-CONTAMINATION IN A MULTI-PURPOSE FACILITY: EXPERIMENTAL DESIGN AND INTERPRETATION
13:30 – 17:00	Best Practices for Single Use Technologies Leader: Pietro Perrone, PE, Mobius Single-Use Sys Eng, EMD Millipore Corporation, USA Ross Acucena, Regulatory Consultant, EMD Millipore, USA Best Practices in Qualification and Validation of Single-use Systems for Aseptic Final Filling Jean-Marc Cappia, Group VP Mktg Product Mgmt, Sartorius Stedim Biotech, France Validation of Single-use Systems: Extractables and Leachables Niels Guldager, CPIP, Senior Technology partner, NNE Pharmaplan A/S, Denmark Christian Matz, Global Project Manager, F. Hoffmann-La Roche Ltd, Switzerland Best Practices in Qualification and Validation of Single-use Systems for Aseptic Final Filling Robert Munday, VP Technical Operations, CMC Icos Biologics, Inc., USA Implementation of Single Use Technologies David Wolton, Biopharma Consultant, PM Group, Ireland Standardization of Disposables Design
13:30 – 17:00	Asset Reduction Leader: Terry Jacobs, AIA, Partner, Jacobs/Wyper Architects, LLP, USA Sara Gates, Senior Interior Designer, Jacobs/Wyper Architects, LLP, USA Gualberto Medina, Executive VP Brokerage Svcs, CBRE Group, USA Repostioning of Life Sciences Office and Laboratory Spaces William Wiederseim, President/CEO, PharmaBioSource, USA The State of the Industry-Too Much Space
13:30 – 17:00	The Use of Metrics in the Pharmaceutical Industry: A Practical Approach for Computerized System Compliance and Validation Due to unforeseen circumstances, this session is CANCELLED. Handouts of presentations will be available after the conference.
13:30 – 17:00	Clinical Data and Systems Leader: Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany How to combine 21 CFR Part 11, EU-GMP Annex 11 requirements and how to apply these to local and global GCP systems Leader: Eric Staib, Sr. Director IT Quality, RPS – ReSearch Pharma Services, USA How to combine 21 CFR Part 11, EU-GMP Annex 11 requirements and how to apply these to local and global GCP systems Jonathan Helfgott, Acting Associate Director for Risk, Science, Intelligence & Prioritization, FDA/CDER/Office of Scientific Investigations, USA Today’s FDA perspective on the role of electronic source data used in eClinical Systems Frank Henrichmann, Technical Quality Manager, PAREXEL International, Germany Agile Project Management for Implementation of Regulated (GCP and GMP) Systems Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany How to combine 21 CFR Part 11, EU-GMP Annex 11 requirements and how to apply these to local and global GCP systems Marina Mangold, Head of EClinical Solutions & Data Management, Alcedis GmbH, Germany Agile Project Management for Implementation of Regulated (GCP and GMP) Systems Maximilian Stroebe, QA eCompliance Manager, Novartis Vaccines & Diagnostics GmbH, Netherlands Audit Trail Review in GCP and GMP Systems – A Regulatory Requirement? Dieter Wachtmann, Sr Mgr Regulatory Intelligence, Parexel International, Germany Today’s FDA perspective on the role of electronic source data used in eClinical Systems
13:30 – 17:00	Project Execution in Emerging Markets Leader: James Hamilton, Business Development, Fluor Corporation, USA Thomas Hendricks, Vice President of Operations, Fluor Engineering & Construction Ltd, China Project Execution in Emerging Markets John Hyde, Chairman & Founder, Hyde Engineering + Consulting Inc, USA State of the Art Biopharmaceutical Manufacturing in the Developing World Niranjan Kulkarni, PhD, Operations Specialist, CRB Consulting Engineers, USA Designing a Lean Facility Kristina Pumphrey, PE, Ops Improvement Specialist, CRB Consulting Engineers, Inc., USA Designing a Lean Facility Josef Trapl, Tech Mgr Pharma-Medical Devices, M+W Group, Germany Advanced Facility Design in Emerging Markets
13:30 – 17:00	Institutionalizing the Process Improvement Mindset by Utilizing Operational Excellence Leader: Elizabeth Zybczynski, Sr. Manager, Baxter Healthcare Corp, USA Prabir Basu, PhD, Consultant, USA What is Operational Excellence? Richard Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA/CDER, USA, FDA/CDER, USA Regulatory Findings of Variability in Industry Theodora Kourti, PhD, Senior Technical Director, GlaxoSmithKline, United Kingdom Leveraging PAT to enhance OpEx Grace McNally, Consumer Safety Officer, FDA/CDER/Office of Compliance, USA Chris Stevenson, Sr Mgr Quality Inno. & Lifecycle Mgmt, Baxter Healthcare Corp, USA Implementation of Quality by Design (QbD) Concepts for a Legacy Immunoglobulin Product
13:30 – 17:00	Science-Engineering-Compliance: Essentials of GMP Manufacturing – A Young Professionals Track – Understanding Your Industry Leader: Brody Stara, Process Engineer, CRB Consulting Engineers, USA Timothy Fields, Vice President, Quality, Protein Sciences Corporation, USA Regulatory Concepts of Pharma, Medical Device and Biotech Alice Redmond, Ph.D., Vice President, Commissioning Agents Inc, Ireland Manufacturing Techniques in Traditional and Biotech Facilities Jonathan Romero, Associate Director Global Eng, Biogen Idec, USA Engineering Scale-up Challenges for Manufacturing Mammalian Cell System for producing Biologics Andre Walker, CPIP, Director, Mfg Sciences, Biogen Idec, USA Manufacturing Techniques in Traditional and Biotech Facilities
13:30 – 17:00	We the People: Managing People to assure Quality throughout the Project Management Lifecycle Leader: Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA Leader: James McGlade, Senior Project Manager, Clark Nexsen, USA
15:00 – 15:45	Networking Break in Exhibit Hall
17:00 – 19:00	Sunday Welcome Reception in Exhibit Hall
Monday, 4 November
09:00 – 12:00	Plenary Session 2013 FOYA – Introduction of Category Winners and Announcement of the Overall Winner Nancy Berg, President and CEO, ISPE, USA Strategic Direction for ISPE Damian Greene, Global Network Strategy Leader, Zoetis, Belgium The Role of ISPE as a Global Organization Julie Kim, General Mgr-BioTherapeutics, Baxter Healthcare Corporation, USA Importance of the Baxter Covington Facility to the Industry and Patients Janet Woodcock, Director, FDA/DHHS/Accounting Operations, USA Update on “Office of Pharmaceutical Quality,” What’s new in CDER and how it affects your process.
10:00 – 10:30	Networking Break
12:00 – 14:00	Lunch in Exhibit Hall
14:00 – 17:30	QbD and CPV for Biotech: How To Advance Implementation Leader: Ranjit Deshmukh, PhD, Sr. Director, AstraZeneca, USA Industrial Case Study: Continued Process Verification (CPV) for Biotech Product (BPOG Collaboration) Leader: David Dolgin, Senior Quality Program Mgr, AbbVie Inc., USA Process Validation for Biotech Products Ranjit Deshmukh, PhD, Sr. Director, AstraZeneca, USA Industrial Case Study: Continued Process Verification (CPV) for Biotech Product (BPOG Collaboration) David Dolgin, Senior Quality Program Mgr, AbbVie Inc., USA Process Validation for Biotech Products Richard Gunderlock, Dir, Corp Validation Services, Astra Zeneca Global Ops Supply, USA Stephen Tyler, Director Quality Assurance, AbbVie, USA Points to Consider for Process Validation for non-US regions
14:00 – 17:30	Individual Technical Presentations I – Cost-Saving Facilities Projects Moderator: John Gilroy, PE, General Manager-CM, IPS, USA Integrated Project Delivery: Minimizing Risk and Reducing Overall Delivery Schedule and Costs Vincent Cebular, Senior Vice President, IPS, USA John Gilroy, PE, General Manager-CM, IPS, USA Integrated Project Delivery: Minimizing Risk and Reducing Overall Delivery Schedule and Costs Klaus Hermansen, Senior Technology Partner, NNE Pharmaplan A/S, Denmark Case study: Design of Vaccine Multiproduct facility – Challenges and Benefits! Kiu Leung, Life Science Consultant, ProcessArc, Vito Pirrera, Vice President of Operations, Vantage Consulting Group, USA Keys to Implementing a Successful Serialization Project Shahbaz Shahbazi, Prinicpal, Process ARC, USA Product Complaint Investigations – The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries Steve Shank, Senior Process Engineer, Process Plus, USA John Wentz, P.E., Dir., Water/Wastewater Svcs, ProcessPlus, Wastewater Cost Savings by Design
14:00 – 17:30	Individual Technical Presentations II – Validation Trends Moderator: Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany Validation of Computerized Systems in a Global GCP Cloud: What can manufacturing and the GMPs learn? John Fisher, President, Unidec, USA Extending the Life-Cycle of GMP Validated Legacy Systems Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany Validation of Computerized Systems in a Global GCP Cloud: What can manufacturing and the GMPs learn? Martin Preis, Director, Tech Quality Mgmt, Parexel International, Germany Validation of Computerized Systems in a Global GCP Cloud: What can manufacturing and the GMPs learn? James Schweitzer, Director, Commercial Technology Services, Vision Point Systems Inc., USA Lessons Learned from Validating a Cloud-based IRT system using the GAMP 5 Risk-based Approach Luciano Tavares, Commercial Director, NNE Pharmaplan, Brazil Biotechnology Scenario on Brazilian Market Connor White, Engineer I, Hyde Engineering + Consulting Inc, USA Development of TOC Analytical Methods
14:00 – 17:30	Individual Technical Presentations III – Lifecycle Processes and Production Moderator: Klaus Fritsch, Manager Compliance, Mettler Toledo AG, Switzerland GWP – The Scientific Global Standard for Risk-based Lifecycle Management of Weighing Equipment GWP® – The scientific global standard for risk-based lifecycle management of weighing instruments Michael Anderson, Executive VP – COO, Total Facility Solutions, Inc, USA Collaborative Contracting for Project Success Steve Buckingham, Engineer II, Hyde Engineering + Consulting Inc, USA Visual Image Processing for Bench Scale Cleanability Studies Albert Dyrness, Vice President, ADVENT Engineering Services, Inc., USA Leveraging the ASME-BPE Standard for Compliance and Continuous Improvement Klaus Fritsch, Manager Compliance, Mettler Toledo AG, Switzerland GWP – The Scientific Global Standard for Risk-based Lifecycle Management of Weighing Equipment GWP® – The scientific global standard for risk-based lifecycle management of weighing instruments Frank Henrichmann, Technical Quality Manager, PAREXEL International, Germany Agile Project Management for Implementation of Regulated Systems David Marks, P.E., Principal, DME Alliance Engineering Consultants, USA Kelly Scalva, Engineer II/CORE Lab Lead, Hyde Engineering + Consulting Inc, USA Visual Image Processing for Bench Scale Cleanability Studies
14:00 – 17:30	“In Order to Form a More Perfect Project” – Managing Risk To Assure Quality throughout the Project Management Lifecycle Leader: Brian Beck, Manager / TL – Project Eng, Zoetis Global Mfg and Supply, USA Leader: Patricia Melton, BSc, PhD, MBA, Managing Director, MIME Solutions Ltd, United Kingdom PM Track: Sesseion 802 Exercise Handout Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA James McGlade, Senior Project Manager, Clark Nexsen, USA Alfred Penfold, Director, Global Engineering, Pfizer, United Kingdom
14:00 – 17:30	Executive Series – ISPE Research Initiatives Leader: Michael Arnold, RPh, Sr. Dir., Strategic Partnerships, Invest. Prods, Pfizer Global Clinical Supplies, USA John Berridge, PhD, CChem, FRSC, Pharma Quality & Reg., -, United Kingdom Overview: ISPE’s Drug Shortage Initiative Ken Getz, Senior Fellow, Tufts University Medical School Center for the Study of Drug Development, USA Patient Survey – A read out on the ISPE IP COP Survey on Patient Experience related to Investigational Medicinal Products (IMPs) Karleen Kos, Vice President of Member and Industry Services, ISPE, USA ISPE’s 2014 Research Priorities Stephen Mahoney, Sr Dir, Head, Compl. Ext. Collaboration, Genentech Inc, USA CMC Authorization Christine Milligan, Global Director, Catalent Pharma Solutions, United Kingdom Patient Survey – A read out on the ISPE IP COP Survey on Patient Experience related to Investigational Medicinal Products (IMPs) Sam Venugopal, Director, PricewaterhouseCoopers LLP, USA Operations Team Update Bryan Wright, ISPE Regulatory Advisor, United Kingdom Outcomes from EMA Workshop on Drug Shortages
14:00 – 17:30	Executive Series – Baxter Facility Case Study Leader: Brien Johnson, Vice President, Program Mgmt, Baxter Healthcare Corp., USA Saving and Sustaining Lives Worldwide Leader: Jerald Polly, Principal, Flad Architects, USA Creating Solutions and Building the A/E Team Samuel Kitchell, VP Engineering, Baxter Healthcare Corporation, USA Team Development Ken Meschke, PE, Principal, Affiliated Engineers Inc., USA Creating Solutions and Building the A/E Team Jerald Polly, Principal, Flad Architects, USA Creating Solutions and Building the A/E Team Eric Schnake, Engineering Director, Baxter Healthcare Corp, USA Implementation: The Covington Site Ryan Schroeder, Regional Leader, CRB Consulting Engineers Inc, USA Process Design & Innovation Steven Shelden, Vice President of Operations, Yonkers Industries Inc, USA Construction Scot Thomas, Program Director, Baxter Healthcare Corp, USA Implementation: The Covington Site
14:00 – 17:30	Executive Series – Facilities of the Future: Innovation, Standardization and Modularization Leader: Pär Almhem, President, ModWave and ModularPartners, USA Competing in a Global Market – Innovation, Standardization and Modularization Mark Bell, Vice President of Operations, Gallus BioPharmaceuticals, LLC, USA The Future of Biologics Contract Manufacturing Douglas Hausner, Assoc Dir. Business Dev Ind. Relations, Rutgers University, USA Continuous Solid Oral Dose Manufacturing Detlef Kehm, PhD, VP, Maintenance and Engineering Services, Grifols Therapeutics Inc., USA Case Study: An Innovative Approach to Facilities Delivery Robert Snow, CPIP, Senior Engineer Biologics Dev, Genzyme Corp a Sanofi Company, USA The Integrated Continuous Biomanufacturing Platform
14:00 – 17:30	Executive Series – Quality Metrics Outcomes: Conversations with FDA Leader: Cynthia Salamon, VP, Global Quality Services, Bristol-Myers Squibb, USA Out of Specification / Laboratory Failure Investigation Rates Lorraine McClain, Sr Dir. Quality Compliance, Teva Pharmaceuticals, USA Quality Metrics Proposal: Batch Rejection Rate Quality Metrics a PQLI Initiative – Leading Indicators Lorraine McClain, Sr Dir. Quality Compliance, Teva Pharmaceuticals, USA Quality Metrics Proposal: Batch Rejection Rate Quality Metrics a PQLI Initiative – Leading Indicators Cynthia Salamon, VP, Global Quality Services, Bristol-Myers Squibb, USA Out of Specification / Laboratory Failure Investigation Rates Lorraine Thompson, Quality Sys Implementation Dir, Novartis, USA Russell Wesdyk, Science Coordinator, US FDA, USA
14:00 – 17:30	Science-Engineering-Compliance: Essentials of GMP Manufacturing – A Young Professionals Track – Integrating Quality Into Your Project Leader: Brody Stara, Process Engineer, CRB Consulting Engineers, USA Nikolas Burlew, VP Quality Systems, Clinipace, Inc., USA Essential Elements of a Quality Management System John Hannon, Vice President, SE Region, Commissioning Agents Inc, USA Effective Deployment of Information Management Systems Michael Kimball, Executive Dir, Transdermal Dev, Actavis plc, USA Quality by Design James Lambert, Baxter, The Structure of Risk Management Dawn Tavalsky, Director, Genzyme Corp., USA Essentials of Process Validation including Case Studies
14:00 – 17:30	Investigational Products – Defining the New Landscape of Clinical Supplies: Share Industry Findings – Patient Survey Leader: Michelle Foust, PharmD, Director New Product Dev, Almac Clinical Services, USA Ken Getz, Senior Fellow, Tufts University Medical School Center for the Study of Drug Development, USA Patient Survey and Case Study Discussion: Findings and Implications Michael Ku, PharmD, MBA, VP, Global Clinical Supply, Pfizer Inc, USA Patient-Focused Clinical Supply Supply Study Christine Milligan, Global Director, Catalent Pharma Solutions, United Kingdom Patient Survey – A read out on the ISPE IP COP Survey on Patient Experience related to Investigational Medicinal Products (IMPs) Robert Pizzie, PhD, Associate Vice President, Merck, USA
14:00 – 17:30	Maintenance and Reliability Programs and the Evolution into World Class Best Practices Leader: Marie Getsug, CMRP, Engineer, Commissioning Agents, Inc., USA FDA’s Perspective on Maintenance & Reliability Programs and the Evolution into World Class Best Practice Matthew Sparks, Merck, Transitioning from Craft Based to Procedure Based Maintenance & a Silver Bullet for Results
15:00 – 15:45	Networking Break in Exhibit Hall
19:30 – 22:00	YPREC-Young Professional’s Event
Tuesday, 5 November
07:00 – 08:00	Quality Metrics Breakfast
08:00 – 11:30	Executive Series-The FDASIA Transition Point for Pharmaceutical Quality Systems (PQS) and cGMP Leader: Joseph Famulare, VP Global Compliance, Genentech Inc, USA Benefits of Implementation for an Industry Standpoint of PQS, how quality systems informed the ISPE drug survey Leader: Richard Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA/CDER, USA, FDA/CDER, USA FDA’s Next Steps for Quality Systems for Pharmaceuticals following FDASIA Barbara Allen, PhD, Sr Director, Global Quality Sys, Eli Lilly SA, Ireland How management uses PQS to ensure consistent operations and reliable supply, and as a risk Mitigation strategy Zena Kaufman, Sr. VP Global Quality, Hospira, Inc., USA Robert Sausville, Director, Division of Case Management, Office of Compliance and Biologics Quality, CBER, USA How FDA Communicates expectations for the Implementation of Quality Systems via its cGMP Inspection Compliance programs and via Regulatory Communications with Firms
08:00 – 11:30	“Establish plans to assure Project Tranquility” – Managing Project Initiation and Delivery Planning to assure Quality throughout the Project Management Lifecycle Leader: John Honey, Head of Technical Site Services, Roche, China Leader: Alfred Penfold, Director, Global Engineering, Pfizer, United Kingdom
08:00 – 11:30	Managing and Assuring Quality Leader: Alex Brindle, Ph.D., Managing Partner, NNE Pharmaplan, USA Ferdinando Aspesi, VP, Sr Advisor To Group, Novartis, USA Managing and Assuring Quality: From Development through Manufacture Jean-Marie Geoffroy, Ph.D., VP Quality, Hospira, USA Duncan Low, PhD, Scientific Executive Director, Amgen Inc, USA Eye of Newt and Toe of Frog – Understanding the Witches Brew of Raw Materials Kelly Swinney, Associate Director, Vertex Pharmaceuticals, Inc., USA
08:00 – 11:30	Advanced Aseptic Processing I Leader: Ryan Hawkins, VP of Operations & COO, Cook Pharmica, USA Leader: Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA 2012 Global Barrier Isolator Survey-Results and Trends Hite Baker, Principal Process Engineer, DME Alliance Engineering Consultants, USA Isolator-Based Sterile Manufacturing Facilities: A Comparison of Conventional Stainless-Steel versus Single-Use-Disposable Technology Implementation Sterling Kline, R.A., Vice President, IPS, USA
08:00 – 11:30	FOYA I Leader: Kelly Keen, Senior Project Manager, Genentech Inc., USA Marcus Habluetzel, Senior Project Manager, F. Hoffmann-LaRoche Ltd, Switzerland FOYA Category Winner: Project Execution Brent Hill, Director of Automation, AstraZeneca, USA Redesigning Egg-based Bulk Vaccine Manufacturing Jack Kane, Associate Director, Project Eng, Biogen Idec, USA Flexible Volume Manufacturing Project, Biogen Idec Mark Proctor, Director, MS&T, AstraZeneca, United Kingdom Redesigning Egg-based Bulk Vaccine Manufacturing
08:00 – 11:30	Data Integrity I: Ensuring Data Integrity throughout the Pharmaceutical Lifecycle Leader: Monica Cahilly, President, Green Mountain Quality Assurance, LLC, USA Leader: Michael Rutherford, Consultant, Lab Systems, Eli Lilly & Co, USA The Importance of Data Integrity When Performing Data Reviews and Investigations Jonathan Helfgott, Acting Associate Director for Risk, Science, Intelligence & Prioritization, FDA/CDER/Office of Scientific Investigations, USA E-Source Data Guidance and GCP Data Integrity Karen Takahashi, Compliance Officer, FDA, USA Assuring Data Integrity and Current FDA Enforcement Related to Data Integrity Problems
08:00 – 11:30	Lean Principles: QC Labs Leader: Javier Garay, Principal-Architectural Designer, Flad Architects, USA Lean From a Design Perspective Leader: James Gazvoda, Principal, Flad Architects, USA Lean From a Space Planning Perspective Emilio Moia, Engineering Manager, Jacobs Italia S.p.A., Italy Lean From an Energy / Systems Perspective Tom Reynolds, BSM, Ireland Lean in a Lab Environment Pamela Thurtle, Div. Continuous Improvement Manager, Novartis, United Kingdom
08:00 – 11:30	Securing the Global Drug Supply Chain – Protecting Patients and Your Business Leader: Brian Johnson, Sr Dir Supply Chain Security, Pfizer, USA Introdcution to Rx360 and the Supply Chain Security Challenge Leader: Raymond Scherzer, PE, PM SET, LLC, USA Thomas Christl, Acting Director, ODSIR, FDA, USA Brian Johnson, Sr Dir Supply Chain Security, Pfizer, USA Introdcution to Rx360 and the Supply Chain Security Challenge Peggy Staver, Director, Product Integrity, Pfizer Inc, USA Tara Steketee, Assoc Dir, Product Integrity, Merck & Co Inc, USA Timothy Valko, Executive Director, Operations Risk Management, Amgen Inc, USA Comprehensive Pharmaceutical Supply Chain Security Programs
08:00 – 11:30	PAT Based Process Control for Batch and Continuous Process – Ultimate Step in Real Time Release Leader: Sharmista Chatterjee, PhD., QbD CMC Lead, FDA, USA Leader: Theodora Kourti, PhD, Senior Technical Director, GlaxoSmithKline, United Kingdom Bryan Looze, Senior Engineer, Amgen, USA PAT-based Control on BioPharma John Mack, Principal Engineer, Perceptive Engineering Ltd, United Kingdom PAT based Advanced Process Control and Monitoring applications for batch and continuous crystallization. Robert Perks, MSc CEng, Engineering Specialist, Baxter Healthcare Corp, USA Manufacturing Tracking and Control Systems – State of the Art Practice for Parametric Release Sterilization Programs Martin Warman, Senior Manager/Team Leader, Vertex Pharmaceuticals, USA Process Control in Continuous Processes
08:00 – 11:30	Regulatory Harmonization in Asia Pacific Countries – Challenges to Multi-National companies Leader: Chi-wan Chen, PhD, Executive Director, Pfizer Inc., USA Session 209 Introduction Min Gui, Assoc Director, Regulatory, Bristol-Myers Squibb Co., USA Challenges in New Drug Application (NDA) Rebecca Komas, Dir CMC Advocacy-Strategy, GlaxoSmithKline, USA What’s New with the Pharmacopeias? Maurice Parlane, Principal/Director, New Wayz Consulting Ltd, New Zealand Update on Good Manufacturing Practice (GMP) and PIC/S in the Asia Pacific Region Xiling Song, Associate Regulatory Program Director, Genentech, A Member of Roche Grp, USA Recent Trends in Investigational Drug Application (IND) in Asia Pacific Countries Susan Stolz, Principle Reg. Consultant, Eli Lilly & Co, USA Comparison of Asia Markets – Case Study for the Landscape in Post-Approval Changes/Variations Robert Tribe, AP Reg. Affairs Advisor, ISPE, Australia Update on Good Manufacturing Practice (GMP) and PIC/S in the Asia Pacific Region
08:00 – 11:30	Process Validation: Bringing the Lifecycle Apporach to Practical Global Reality and Beyond Leader: Joanne Barrick, Advisor, Global Validation, Eli Lilly & Co, USA Grace McNally, Consumer Safety Officer, FDA/CDER/Office of Compliance, USA Jenn Walsh, Associate Director Mfg Tech, Bristol-Myers Squibb, USA
08:00 – 11:30	Investigational Products – Defining the New Landscape of Clinical Supplies: Risk Management and the Supply Chai – Part I Leader: Neal Gordon, Ph.D., Director, Project Management, Merck, USA Leader: Lorann Morse, SVP, Clinigen CTS, Clinigen, USA Richard Gaeto, VP Corporate Operations, Dendreon Corp, USA From Autologous Cell Collection To Personalized Immunotherapy in 4 Days: Dendreon’s Supply Chain, A Case Study Catherine Hall, Assoc Dir Clinical Operations, Biogen Idec, USA Driving the Last Mile toward Customer Focus in Clinical Trials John Holland, Sr. VP-Research-Business Dev, AMC Health, USA Crowd Sourcing and Telemonitoing: “Better Data at Lower cost” Darlette Luke, RPh, IDS Pharmacy Manager, University of Minnesota Medical Center Fairview, David Northrup, Accenture Inc., United Kingdom Strategies in Controlling Risk in the Clinical Supply Chain
08:00 – 11:30	Science-Engineering-Compliance: Essentials of GMP Manufacturing – A Young Professionals Track – Critical Components To Successful Manufacturing Leader: Joseph Manfredi, President, GMP Systems Inc, USA Facilities Daniel Deese, PE, Mechanical Engineer, CRB Consulting Engineers Inc., USA Utilities – Energy saving options, case studies Marcel Dion, Director of Marketing, STERIS Corp, Canada Principles of Steam Sterilization and Common Mistakes Kevin Rawls, Auto System Integrator II, Avid Solutions Inc, USA Automation Applications in the Pharmaceutical Industry
09:15 – 10:00	Networking Break in Exhibit Hall
11:45 – 13:15	Membership Lunch
12:00 – 13:00	Exhibitor Lunch with Speaker
13:30 – 15:00	PHARMA CAFE-Cutting Edge Technologies Leader: Nicholas Haycocks, Senior QA Specialist, Amgen Inc., USA Leader: Randolph Leinhauser, Associate Director, Engineering, Merck, USA Bikash Chatterjee, President & CTO, Pharmatech Associates, USA Oliver Stauffer, COO-VP Inspection Technologies, Packaging Tech & Inspection LLC, The Path to Package Integrity Non-Destructive Package Inspection Technologies Carmine Stropoli, PE, Pharma Technology Director, Middough Inc, USA Non-Contact Measurement for Filled Weight Control Randy Turner, Technical Director, Swan Analytical USA, USA TOC Innovations for Direct UV Oxidation in Pharma
13:30 – 17:15	Risk Based C&Q Leader: Frank Van Der Steen, Owner/Principal Consultant, FVCS, Netherlands Leader: Steven Wisniewski, Principal Consultant, Commissioning Agents, Inc., USA Joerg Block, PS-TS-KM-Technical Compliance, Bayer HealthCare AG, Germany Risk Based C&Q for Standard Equipment Qualification in a Global 2-D Matrix Program Machteld Deconinck, Principal Engineer, Johnson and Johnson, Belgium Lessons Learned about Planning David Dolgin, Senior Quality Program Mgr, AbbVie Inc., USA Science and Risked Based C&Q Nicholas Haycocks, Senior QA Specialist, Amgen Inc., USA Practical Application of a Risk Based Approach, and Lessons Learned Brian Pochini, CPIP, Principal Engineer, Genzyme, A Sanofi Company, USA Ghenet Simpson, Senior Central Engineer, Novartis Consumer Health Inc, USA Lessons Learned About Risk Assessment and Critical Aspects
13:30 – 17:15	Flexible API Manufacturing Leader: Sarah Mancini, Senior Mgr, API Tech Group, Pfizer, USA Frank Gupton, PhD, Technical Director, Virginia Commonwealth University, USA Streamlining Pharmaceutical Processes into Continuous Operations Patrick Kelleher, Sr Mgr-Team Leader Tech Lab, Pfizer, Ireland Flexible Scale Up in Pfizer One Approach Technology of the Future Michael O’Brien, Head Innovation-Tech Strategy, Pfizer Inc, USA Bernhardt Trout, Ph.D., Professor-Chemical Eng Dept, MIT, USA Transforming Pharmaceutical Manufacturing to Continuous
13:30 – 17:15	FOYA II Leader: Kelly Keen, Senior Project Manager, Genentech Inc., USA Scott Billman, Director, Engineering, Novartis Vaccines & Diagnostics Inc., USA Advancing Vaccine Production for Pandemic Readiness Robert Dick, PE, Principal, Precis Engineering, Inc., USA Sustainability: Winning Commitment to Sustainable Design Sarah Fitzgerald, Associate Director, Global Eng Svcs, Merck, Ireland Operational Execellence: Building a Lean Structure for High Performance – Vaccine & Biologics Sterile Facility (VBSF)Carlow Ireland Philip Sass, Ph.D., Executive Vice President/COO, Morphotek Inc, USA
13:30 – 17:15	Data Integrity II: Cloud Controls Leader: Kathleen Gniecko, IT Quality Management Services Head, Hoffmann-La Roche, Switzerland Cloud Computing in GxP Environment – The Promise and Road to Clarity Leader: Michael Rutherford, Consultant, Lab Systems, Eli Lilly & Co, USA Monica Cahilly, President, Green Mountain Quality Assurance, LLC, USA Krishnakali Ghosh, CDER Compliance Officer, CDER/OC/OMPQ/DGMPA, USA Data Integrity in the Cloud – The Regulatory Perspective Robert Streit, Sr Mgr Quality & Compliance, Johnson & Johnson, USA Data Integrity in the Cloud: The Promise, Reality and Road to Clarity Anders Vidstrup, Senior IT Quality SME, NNIT A/S, Denmark Data Integrity in the Cloud: The Promise, Reality and Road to Quality
13:30 – 17:15	Master Planning Within the Pharmaceutical Industry Leader: Dennis Romak, VP Food/Pharma Markets, Process Plus, USA Steven Duckro, Senior Engineering Manager, Aptalis Pharmatech, USA Utilization of a Master Plan: Perspectives from Management & Engineering Timothy Grinstead, Sr Director Mfg Ops-NA, Aptalis Pharma, USA Utilization of a Master Plan: Perspectives from Management & Engineering Kenneth Popham, Senior Architect, Process Plus, USA Master Planning Processes John Schlagetter, Senior Architect, ProcessPlus, USA Facility Master Planning – How To Look Forward
13:30 – 17:15	Quality Systems and the Cost of Non-Compliance Leader: Rose Mary Dollard, Director, Johnson & Johnson, USA Eric Good, Vice President, Quality, KV Pharmaceutical, USA Quality Systems and the Cost of Non-Compliance Tara Gooen, LCDR, PHS, Branch Chief (acting), FDA/CDER/OMPQ, USA Lisa Ray, Advisor-DCOE Exter. Sourcing, Eli Lilly and Company, USA Third Party Organization Management and Oversight: Evolution Requires Focus
13:30 – 17:15	Advanced Aseptic Processing II Leader: Joerg Zimmermann, Dir Process Dev Implementation, Vetter Pharma Fertigung GmbH Co KG, Germany Aarti Gidh, Investigator, GlaxoSmithKline, USA Product Impact study to Support Technology Transfer to a Commercial Isolator Enclosed Filling Line Aaron Mertens, US Technical Manager, Atec Pharmatechnik, USA Equipment Replacement with a Stopper Processing System James Thompson, Senior Engineer, Amgen Inc, USA Technology Transfer of a Viscous, High-Concentration Protein Product: Case study in Filling Pump Technology Selection Philipp Trojan, Mgr Compliance & CAPA, AbbVie GmbH & Co., Germany Applying Quality Risk Management into Aseptic Manufacturing
13:30 – 17:15	Latin America Regulatory Compliance Forum Leader: Gregory Gallegos, Sr Program Dir, Tech Regulatory, Genentech, USA Leader: Marta Vidal, Consultant, Angostura Salud, Argentina Stephen Colgan, Ph.D., Senior Director in Global CMC, Pfizer Global Research and Dev, USA Opportunities for Lean Stability Strategies Eugenia Gotsis, Assoc Director, Reg. Affairs, Abbott Pharmaceuticals, USA Import Testing Requirements and Opportunities for Waivers Rebecca Komas, Dir CMC Advocacy-Strategy, GlaxoSmithKline, USA Alternatives for Faster Approvals in Latin America Birgit Unterladstaetter, Global Quality Manager, F. Hoffmann La Roche Ltd, Switzerland Challenges and Opportunities with Multi-Product Facilities for High Potent Drugs
13:30 – 17:15	Breakthrough Therapy—Are You Ready for Approval? Leader: Eric Thostesen, Sr Dir-Strategic Bus. Support, Janssen Pharmaceutical Company Inc., USA Tara Gooen, LCDR, PHS, Branch Chief (acting), FDA/CDER/OMPQ, USA John Groskoph, Sr Dir., New Products CMC, Pfizer, USA Risk Management Poitns to Consider CMC Planning for Small Molecule Product Launch Small Molecule Brian Kelley, VP Bioprocess Development, Genentech Inc, USA Risk Managment in CMC Planning for BT Applications Impact of Accelerated Launch in the Development Pathway, Large Molecule Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA, USA Christine Moore, Ph.D., Acting Office Director, FDA, USA Sarah Pope Miksinski, PhD, Director (Acting), FDA/ONDQA/DNDQA 2, USA Kelly Swinney, Associate Director, Vertex Pharmaceuticals, Inc., USA
13:30 – 17:15	Science-Engineering-Compliance: Essentials of GMP Manufacturing – A Young Professionals Track – Effective Project Leadership Leader: Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA Kenneth Ewan, Principal, KME Leadership LLC, USA Effective Project Leadership – Are you managing or are you leading – Understanding the distinction Richard Gunderlock, Dir, Corp Validation Services, Astra Zeneca Global Ops Supply, USA Example of a worthy mission for a Biotech Project, The Merck-China hepatitis B Technology Transfer Project Jerald Polly, Principal, Flad Architects, USA Baxter Case Study Daniel Rouse, PE, Assoc. Director Project Eng, Novartis Vaccines & Diagnostics Inc, USA
13:30 – 17:15	Investigational Products – Defining the new Landscape of Clinical Supplies: Risk Management and the Supply Chain – Part II Leader: Neal Gordon, Ph.D., Director, Project Management, Merck, USA Leader: Lorann Morse, SVP, Clinigen CTS, Clinigen, USA Nicola Barnes, Director, Pfizer Ltd, United Kingdom An evolution – a patient and site focused approach to booklet label designs Robert Scarth, VP and General Manager, Clintrak Clinical Labeling Services, USA Clinical Labeling Technology and Innovation Paul Thomas, Chief Technical Officer, Clinigen Group, United Kingdom EU GDP – links to Clinical Trials Terrence Walsh, Head, Comparator Network, TransCelerate BioPharma Inc, USA TransCelerate Introduction and The Comparator Network
13:30 – 17:15	“Provide for and promote a Project’s General Welfare” – Managing Project Implementation to assure Quality throughout the Project Management Lifecycle Leader: Brian Beck, Manager / TL – Project Eng, Zoetis Global Mfg and Supply, USA Leader: Shannon Chesterfield Yonker, Senior Consultant, Exemplar Compliance, USA Leader: Dave Koncak, Director of Eng & Logistics, Zoetis Inc., USA
15:00 – 16:00	Networking Break in Exhibit Hall
19:00 – 22:00	Tuesday Party
Wednesday, 6 November
08:00 – 13:00	“Ensure the Blessings of Project Success” – Managing Project Closeout to Assure Quality throughout the Project Management Lifecycle Leader: Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA Leader: Jeffery Odum, CPIP, Director Ops, Biotech Lead, IPS, USA
08:00 – 13:00	Investigational Products – Defining the New Landscape of Clinical Supplies: Labeling and Industry Updates Leader: Neal Gordon, Ph.D., Director, Project Management, Merck, USA Leader: Lorann Morse, SVP, Clinigen CTS, Clinigen, USA Nicola Barnes, Director, Pfizer Ltd, United Kingdom Labeling Panel Discussion Timothy Brewer, President, Yourway Transport, USA Sandra Cook, PhD, President, Cook Consulting, USA The Blinding of Materials in Clinical Trials: Essential Processes for Ensuring the Integrity of Clinical Study Data Matthew Gilson, Director Computer Systems QA, GlaxoSmithKline, USA David Glynn, Sr Mgr New Prod. Planning, Sunovion Pharmaceuticals Inc, USA ISPE Update Robert Scarth, VP and General Manager, Clintrak Clinical Labeling Services, USA The Future of Clinical Labeling
08:00 – 13:00	Current Regulatory Issues: QbD, Q7 Leader: Tara Gooen, LCDR, PHS, Branch Chief (acting), FDA/CDER/OMPQ, USA Challenges to Inspection Readiness for QbD Applications Leader: Roger Nosal, VP CGMC, Pfizer Inc, USA Industry Perspective of Evolution of Quality by Design In NCE Implementation Betsy Fritschel, Director Quality & Compliance, Johnson & Johnson, USA Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q&A Development & Status Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA, USA FDA Perspective of Improving Quality of Biopharmaceuticals Lynne Krummen, Vice President, Genentech Inc, USA Biotech Lessons Learned from the Genentech and Roche QbD Journey Christine Moore, Ph.D., Acting Office Director, FDA, USA ONDQA View on Implementation of QbD: Successes and Remaining Challenges Alicia Mozzachio, RPh, MPH, Director Regulatory, FDA Interface Management Branch, USA ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q&A Development and Status
08:00 – 13:00	Integrating Risk Management as part of Process Development Leader: Bikash Chatterjee, President & CTO, Pharmatech Associates, USA Integrating Risk Management as Part of Product, Process, and Quality System Development Leader: Wai Wong, VP Gen. Mgr Worldwide Ops, Pharmatech Associates, Inc, USA Introduction: Integrating Risk Management as Part of Product, Process, and Quality System Development Brett Duersch, Associate Director, Chemistry, Merck & Co Inc, USA ICH Q9 Applied to Small Molecule Process Development, Scale-up and Implementation Ian Leader, PhD, Product Dev Director, Shire Pharmaceuticals, United Kingdom Practical Risk Assessment for Process Design in a Virtual Development Environment Vincent McCurdy, Ph.D., Head Operational Excellence, Pfizer Inc, USA Introduction to a Holistic Approach to Quality Risk Management of Product and Process Development
08:00 – 13:00	Stratefied Sampling Plans Leader: Thomas Garcia, Research Fellow, Pfizer Inc, USA Introduction and the basis for the withdrawal of the draft guidance for industry “Powder Blends and Finished Dosage Units – Stratified In-Process Dosage James Bergum, President, BergumSTATS, LLC, USA Karthik Iyer, Senior Policy Analyst, FDA, USA Innovative Approaches to Assure Adequacy of Mixing James Prescott, Senior Consultant, Jenike & Johanson Inc, USA CU/BU Variations – How Far is Too Far? (By way of examples) Ravi Tejwani, Senior Principal Research Scientist, Bristol-Myers Squibb, USA Relating blend uniformity specification to finished product Alex Viehmann, Operations Research Analyst, FDA, USA FDA Recommendations Regarding In-process Sampling of Finished Dosage Units Huiquan Wu, CDER/OPS/OTR/DPQR, USA Recommended Innovative Approaches to Ensuring Adequacy of Mixing of Powder Blends
10:15 – 10:30	Networking Break
13:00 – 14:00	Lunch
13:00 – 18:00	Manufacturing Facility Tour
14:00 – 15:30	Global Regulatory Summit Richard Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA/CDER, USA, FDA/CDER, USA Tara Gooen, LCDR, PHS, Branch Chief (acting), FDA/CDER/OMPQ, USA Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA, USA Christine Moore, Ph.D., Acting Office Director, FDA, USA Ian Rees, Expert GMP Inspector, MHRA, United Kingdom Robert Sausville, Director, Division of Case Management, Office of Compliance and Biologics Quality, CBER, USA

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ISPE 2013 Program Schedule (Source: http://www.ispe.org/2013annualmeeting)

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