Speaker Biographies

• Rabia Ballica, PhD
  Rabia Ballica, PhD, CMC/Product Reviewer, CBER, FDA
  
  
• Dennis M. Bensley, Jr., PhD
  Dennis M. Bensley, Jr., PhD, Director, Division of Manufacturing Technologies, Office of New Animal Drug Evaluation, CVM, FDA
  
  
• Eric Berg
  Eric Berg, Director of Supplier Quality, Amgen, Inc.
  
  
• Michael W. Bonney
  Michael W. Bonney, President and CEO, Cubist Pharmaceuticals, Inc.
  
  
• Jon Clark
  Jon Clark, Associate Director For Policy, CDER, FDA
  
  
• Howard Drake
  Howard Drake, Vice President, Ompi of America
  
  
• Katherine Eban
  Katherine Eban Investigative Journalist and Author
  
  
• John Eltermann
  John Eltermann, Director, Division of manufacturing and Product Quality, CBER, FDA
  
  
• Joseph C. Famulare
  Joseph C. Famulare, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, FDA
  
  
• Thomas Friedli, PhD
  Thomas Friedli, Managing Director Tectem, University of St. Gallen, Switzerland
  
  
• Rick Friedman
  Rick Friedman, Director, Division of Manufacturing and Product Quality, CDER, FDA
  
  
• Betsy Fritschel
  Betsy Fritschel, Director, Corporate Quality and Compliance Worldwide, Johnson & Johnson
  
  
• Nigel Hamilton
  Nigel Hamilton, Quality Director, Sanofi Aventis
  
  
• Lothar Hartmann, PhD
  Lothar Hartmann, PhD Head of External Relations - Global Quality, Hoffmann-La Roche
  
  
• Brian Hasselbalch
  Brian Hasselbalch,Team Leader, Guidance and Policy Team, FDA/CDER/Office of Compliance
  
  
• Christian Helbig
  Christian Helbig, Manager Business Development, SCHOTT North America Inc.
  
  
• Malcolm Holmes
  Malcolm Holmes Retired [previously director Quality Assurance GSK (Glaxosmithkline)]
  
  
• Kirk Huber
  Kirk Huber Executive Director and Global Head of Laboratory and Preclinical Quality Assurance, Novartis Pharmaceutical Corporation
  
  
• Brian Johnson
  Brian Johnson, Director/Team Leader of Contract Operations Quality Assurance, Pfizer Global Manufacturing
  
  
• Christopher Joneckis, PhD
  Christopher Joneckis, PhD, Senior Advisor for CMC Issues, Office of the Center Director CBER, FDA
  
  
• Shane D. Killian, M.S.
  Shane D. Killian, M.S., Manager, Johnson & Johnson Pharmaceutical Supply
  
  
• Duncan Low, PhD
  Duncan Low, PhD, Scientific Executive Director, Amgen, Inc.
  
  
• Anthony Luttrell
  Anthony Luttrell, President, Raland Technologies, LLC
  
  
• Mary Anne Malarkey
  Mary Anne Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA
  
  
• Sei-ichi Manabe
  Sei-ichi Manabe President, Sepa-Sigma, Inc.
  
  
• Daniel G. McChesney, M.S., PhD
  Daniel G. McChesney, M.S., PhD Director, Office of Surveillance & Compliance Center for Veterinary Medicine, FDA
  
  
• Edwin Melendez
  Edwin Melendez, Consumer Safety Officer, CDER, FDA
  
  
• Karen Migliaccio
  Karen Migliaccio, President, migliaccio Consulting, LLC
  
  
• Charles Mignosa
  Charles Mignosa, President, Business systems Architects, LLC
  
  
• Paolomi Mukherji
  Paolomi Mukherji, Manager, Clarkston Consulting
  
  
• Richard Norgard
  Richard Norgard Executive Director, Global Manufacturing Compliance, Pfizer
  
  
• Stephen Notarnicola, PhD
  Stephen Notarnicola, PhD, Principal Investigator,Biogen Idec
  
  
• Ulku Oktem, PhD
  Ulku Oktem, PhD, Adjunct Professor, Operations and Information Management Department, Wharton School of the University of Pennsylvania
  
  
• Gerard Pearce
  Gerard Pearce, Executive Vice President, SQA Services Inc.
  
  
• Michael J. Popek, M.S.
  Michael J. Popek, M.S., Supervisory Microbiologist, Center for Veterinary Medicine, FDA
  
  
• Anurag S. Rathore, PhD
  Anurag S. Rathore, PhD, Process Development, Amgen, Inc.
  
  
• Edwin Rivera-Martinez
  Edwin Rivera-Martinez, Chief, Manufacturing Assessment and Preapproval Complaince Branch Division of Manufacturing and Product Quality, Office of Compliance,CDER, FDA
  
  
• Stephan Roenninger, PhD
  Stephan Roenninger, PhD Global Quality Manager, F. Hoffmann-La Roche, Ltd.
  
  
• Barbara A. Ryan
  Barbara A. Ryan, Analyst, Deutsche Bank
  
  
• Swroop Sahota, PhD
  Swroop Sahota, PhD Vice-president of Global Quality Services, Schering-Plough
  
  
• Robert Sausville
  Robert Sausville, Supervisor, Consumer Safety,CBER, FDA
  
  
• David R. Schoneker
  David R. Schoneker, Director of Global Regulatory Affairs, Colorcon
  
  
• Jacqueline Scott, J.D., M.L.
  Jacqueline Scott, J.D., M.L., Professor, Harrison Institute for Public Law, Georgetown University
  
  
• Joshua M. Sharfstein, MD
  Joshua M. Sharfstein, MD, Principal Deputy Commissioner, FDA
  
  
• James Shirey
  James Shirey, Director/Team Leader, Pfizer, Inc.
  
  
• Jeffrey Shuren, MD, J.D.
  Jeffrey Shuren, MD, J.D. ,Associate Commissioner for Policy and Planning, FDA
  
  
• Steven Silverman
  Steven SilvermanAssistant Director, Office of Compliance, FDA
  
  
• James Skrine
  James Skrine, Executive Director / Site Head, Quality, Amgen, Inc.
  
  
• Janeen Skutnik
  Janeen Skutnik, Director/Team Leader of Quality & Regulatory Policy, Pfizer
  
  
• Douglas Stearn
  Douglas Stearn, Director, Division of Compliance Policy, Office of Regulatory Affairs, FDA
  
  
• Wayne Taylor, PhD
  Wayne Taylor, PhD, Chairman, Taylor Enterprises
  
  
• Lynn Torbeck
  Lynn Torbeck, Principal Statistician, Torbeck and Assoc., Inc.
  
  
• Wallace Torres
  Wallace Torres, QuaSaR Program Leader, Hoffman-La Roche Inc.
  
  
• Kimberly Trautman
  Kimberly Trautman Medical Device GMP/Quality Systems Expert, FDA
  
  
• Timothy Ulatowski
  Timothy Ulatowski, Director, Office of Compliance, CDRH, FDA
  
  
• David Ulrich
  David Ulrich, Distribution and Logistics QA Manager, Abbott Laboratories
  
  
• Martin VanTrieste
  Martin VanTrieste Vice President Commercial Quality, Amgen, Inc.
  
  
• Greg Walker
  Greg Walker, Director, Wyeth Pharmaceuticals
  
  
• Steven Wolfgang, PhD
  Steven Wolfgang, PhD, Consumer Safety Officer, CDER, FDA
  
  
• Janet Woodcock, M.D.
  Janet Woodcock, M.D., Director, CDER, FDA
  
  
• Klaus Wuttke
  Klaus Wuttke, DirectorGerresheimer Bunde GmbH
  
  
• Victor Yamauchi
  Victor Yamauchi, Director of Supplier Quality, Amgen, Inc.
  
  
• Barbara Zinck
  Barbara Zinck Senior Director, Corporate Compliance, Cambrex Corporation