Kathy Lee

Accomplished Chemistry Manufacturing and Controls Regulatory Professional with solid experience in leadership roles. Adept at implementing novel strategic and global regulatory strategies. Influences global regulatory strategy through relationships and committee participation. Skilled in stakeholder relations. Collaborative and dedicated to building and leading talented and motivated individuals

• CASSS Member of Board of Directors, 2018-2022
• CASSS WCBP Committee Member, 2017-2019
• CMC Strategy Forum Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry, Industry Co-Chair, 01/23/17
• Committee Member for the Parental Drug Association; The Universe of Pre-filled Syringes and Injection Devices, 2014 and 2016
• Charter Committee Member for the CASSS Mid-West Discussion Group, 2015 and 2016
• Committee member for Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (WCBP), 2016
• Regulatory Considerations for Drug/Device Combination and Companion Diagnostics; CMC Pre-Market Considerations for Combination Products Device/Biologics., 11/07/13-11/08/13
• The Universe of Pre-filled Syringes and Injection Devices, Parenteral Drug Association (PDA), Plenary talk; “Prefilled Syringes: A CMC Regulatory Perspective.”, 10/2012
• FDA Small Business Regulatory Education for Industry Fall Conference, Plenary talk; “Combination Products: An FDA Discussion on Regulating Combination Drugs, Devices, and Biologics.”, 09/2012
• CMC Strategy Forum; Drug Product for Biological Medicines Novel Delivery Systems, Challenging Formulations and Combination Products; “Regulatory Expectations for the Characterization of Biotechnology Products in Combination Products.”, 07/2012
• FDA Small Business Regulatory Education for Industry Spring Conference, Plenary talk; “Combination Products: An FDA Discussion on Regulating Combination Drugs, Devices, and Biologics.”, 06/2012
• PDA Washington DC Local Chapter Meeting; “Combination Products: A Regulatory Perspective.”, 04/2012
• Well Characterized Biotechnology Products Annual Meeting Plenary talk “Prefilled Syringes: A Regulatory Perspective.”, 01/2012
• 2011 American College of Toxicology Annual Meeting; “Combination Products: CMC Perspective.”, 11/2011
• Bioassay 2011: Scientific Approaches and Regulatory Strategies, A CASSS Meeting; “Implementing and Reporting Changes to Potency Assays.”, 10/2011
• 2011 Food and Drug Administration-Orange County Regulatory Affairs Educational Conference; Key Note Address “FDA Today” and Plenary talk “Risk Assessment.”, 05/2011
• 2011 Annual Meeting and Exposition for the Society for Biomaterials; “Combination Products: CMC Perspective.”, 04/2011
• Well Characterized Biotechnology Products, Workshop Session “Small Company Key Issues – It’s a Risky Business…Or Is it? Managing Risk Associated with Early Product Development.”, 01/2011
• Institute for Collaborative Biotechnologies 2010 Well Characterized Biologicals “Combination Products: An Overview.”, 10/2010
• FDA/Industry Statistics Workshop “QbD for Biotechnology Products, Where are We Now.”, 09/2010
• CMC Strategy Forum Open Forum Panel Discussion “Critical Quality Attributes.”, 07/2010
• PDA Combination Products Workshop, “Regulatory Challenges of Manufacturing Changes for Combination Products.”, 09/2009
• CMC Strategy Forum Europe 2009; Open Forum Panel Discussion “Stability Requirements for Products in Clinical Development.”, 04/2009
• Well Characterized Biotechnology Products; Workshop Session “Quality by Design for Analytical Methods.”, 01/2009
• Well Characterized Biotechnology Products; “Combination Products: An Overview.”, 01/2009
• American Association of Orthopedic Surgeons, Orthopedic Device Forum, “Combination Products Device/Biologic: CMC Perspective.”, 11/2008
• PDA/FDA Joint Regulatory Conference, “Improving Application Quality: Content, Format and Process.”, 09/2008
• American Association of Pharmaceutical Science, National Biotechnology Conference, “Comparability Protocols.”, 06/2008
• Well Characterized Biotechnology Products, Workshop Session “Combination Products.”, 01/2008
• 2007 FDA/Industry Statistics Workshop, “Analytical Method Transfer.”, 09/2007
• PhRMA B & B Annual Meeting Dialogue Session with CDER OBP, “Good Review Management Principles” and “Improving Application Quality: Content, Format and Process.”, 10/2006
• Regulation of Biologics and Biotechnology Products in the United States and Europe, “Know Your Product, Control Your Process.”, 05/2006
• Well Characterized Biotechnology Products, “Overview of Extractables and Leachables in Protein Therapeutics: Sources Methods and Case Studies.”, 01/2006

• Halle Germany, 09/06/12-09/12/12
• Biberach Germany, 04/21/10-04/27/10
• Horsham PA, 08/17/09-08/21/09
• Billingham United Kingdom, 01/05/09-01/09/09
• North Carolina, 09/11/08
• Vacaville, CA, 07/22/08-07/31/08
• Rockville, MD, 09/25/07-09/28/07
• Netherlands Antilles, 07/2006
• Cambridge, MA, 03/20/06-03/24/06

• Statistical Assessment of Analytical Method Transfer, Zhong, Jinglin, Lee, Kathy and Tsong, Yi, Journal of Biopharmaceutical Statistics, 18, 5, 1005 - 1012, 2008
• Regulatory Aspects of Chemistry Manufacturing and Controls for Investigational New Drug applications and Biologic License Applications to the United States Food and Drug Administration, Lee, Kathy, Comprehensive Biotechnology, 2nd Edition, Volume 3 Industrial Biotechnology and Commodity Products, Elsevier, July, 2011
• Comprehensive Biotechnology, 2nd Edition, Volume 3 Industrial Biotechnology and Commodity Products, Bai, Fengwu; Cordoba-Rodriguez, Ruth; Lee, Kathy; and Antonio, Moreira, Elsevier, July, 2011
• Technical Report No. 54 Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, Emabelle Ramnarine, Jeffery L. Hartman, Thomas Genova, Laura Huffman, Kathy Lee, Michael A. Long, Kevin O'Donnell, Jayesh Patel, Siegfried Schmitt, Rebecca Spohn, Edward C. Tidswell, Robert P. Thomaselli, Anthony C. Warchut, Parenteral Drug Association, 2012
• Methods on the Move: Addressing Method Transfer Challenges for Biopharmaceutical Industry, Mary Beth Pelletier, Jeffery Stacker and Kathy Lee, BioProcess International, June, 2018