Scott Van Wagenen Sutton 150 Parkway Dr. North Chili, NY 14514 USA

[email protected] +1(585) 594-8273

http://www.microbiologynetwork.com http://www.linkedin.com/in/scottvwsutton http://www.twitter.com/MicrobiologyNet

Degrees: Ph.D. (microbiology) 1987 University of Rochester Advisor: Dr. Robert E. Marquis Thesis: Proton-translocating, Fluoride-sensitive ATPases of Streptococcus mutans, Streptococcus sanguis, and Lactobacillus casei. M.S. (microbiology) 1984 University of Rochester B.S. (genetics) 1978 University of California at Davis

Experience: The Microbiology Network (http://www.microbiologynetwork.com) 2/95 – Present: Owner and Principal  Active Consultant and Trainer o QC Microbiology of Personal Care Products o GMP o Investigations o Contamination control o Environmental Monitoring/Control o Objectionable Organisms/Non-sterile production control o QC microbiology  Operate and maintain Internet information service for microbiologists. This service provides information, links, mail lists, and web pages for individuals and user's groups in microbiology.  Own and Moderate the PMFList since 7/95 – an Email list devoted to pharmaceutical microbiology  Own and Moderate the PSDGList since 9/05 – an Email list devoted to pharmaceutical stability: study designs, regulatory and technical issues, etc. List has a 25 year history in the stability community.  Own and Moderate the RxList since 2013 – an Email list devoted to compliance and contamination control in the compounding pharmacy. Vectech Pharmaceutical Consultants 3/04 – 11/09 Assignments have included manufacturing process redesign, aseptic manufacturing qualification, non-sterile manufacturing, laboratory design and development of quality systems for microbiology, in-house training on contamination control, QC testing and rapid microbiological methods.

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The Pharmaceutical Microbiology Forum (http://www.microbiologyforum.org) 5/05 – Present: President; Editor - PMF Newsletter (http://www.microbiologyforum.org/news.htm) Rapid Micro BioSystems (formerly Genomic Profiling Systems) 4/02 – 1/12: Industrial Microbiology Advisory Board Serve as advisor to management in the development of a novel rapid microbiological method for microbial enumeration. American Pharmaceutical Review 1/12 - Present: Editorial Board Pharmaceutical Technology Magazine 6/10 - Present: Editorial Board J Validation Technology & Journal of GxP Compliance 6/09 – Present: Editorial Board; Columnist: Microbiology Topics (to 12/13) Controlled Environments Magazine 10/05 – Present: Editorial Board PDA Newsletter Magazine 12/05 – 12/09: Editorial Board MODA Technology Partners 12/06 – 1/12: Scientific Advisory Board Serve as advisor to management on application of a wireless data collection system and dedicated database for Environmental Monitoring data in the pharmaceutical, medical device and personal products industries. Alcon Laboratories, Inc., Fort Worth, TX 3/01 – 3/04: Director, R&D Microbiology 1/98 – 3/01: Associate Director of R&D Microbiology 6/94 – 12/97: Assistant Director of R&D Microbiology Bausch & Lomb Research Center, Rochester, NY 9/92 - 6/94: R&D Manager, Product Development Microbiology 10/91 – 9/92: R&D Manager, Healthcare Products 9/88 - 10/91: Senior Research Specialist; Lab Leader, Microbiology Research Monroe Community College, Rochester, NY 1992 - 6/94: Adjunct Faculty, Dept. of Biology Taught course (lecture and lab) "Medical Microbiology for Nurses" for four semesters. Medical College of Virginia, Richmond, VA NIH Postdoctoral Fellowship under Dr. Francis Macrina in the Department of Microbiology, 1/86 - 7/88.

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University of Rochester, Rochester, NY. Teaching assistant in introductory microbiology, 1981; in medical school microbiology, 1984; lectured in microbial physiology, 1986. University of Rochester, Rochester, NY Laboratory Technician III, 1978; Technical Associate I, 1980. University of California at Davis, Davis, CA Teaching assistant in introductory biology class 1976 and 1977.

Expert Testimony in the Last 4 Years: Deposed and testified at trial in the case of Astrazeneca LP v. Breath Ltd., 1:08-cv-01512 (D.N.J.) for the defendants. Deposed and testified at trial in case of Fresenius Kabi USA, Inc v. Dr. Reddy's Labs (Delaware 13-925-SLR) for the defendants.

Memberships: United States Pharmacopeia (USP) - Elected to serve on the Committee of Experts, Microbiology for the 19952000, 2000-2005, 2005-2010 and 2010-2015 revision cycles - Elected Vice-chairman of the USP Committee of Experts, Analytical Microbiology, for the 2000-2005 and 2005 – 2010 revision cycles. - Instructor in the USP Pharmacopeial Education group - Member Project Team 18 (PAT); Working Group 6 (Rapid Microbiology Methods) from 2003 to present - 1993 - Named to advisory panel (Preservation Efficacy and Aseptic Processing) to Microbiology Subcommittee of USP Pharmacists Society of the State of New York (2013 – present) Personal Care Products Council (PCPC, previously CTFA) 2012 - present - Member of the Microbiology Subcommittee Royal Society of Medicine (London) - Elected Fellow 2012 Association for the Advancement of Medical Instrumentation (AAMI) - USP representative to the Association for the Advancement of Medical Instrumentation (AAMI) 1995-2000. - Alcon representative to WG 8-Microbiological Methods; and WG 4-Biological Indicators, from 1999 to 2004. Parenteral Drug Association (PDA) (1991 – present) - Editorial Board of PDA Newsletter 2007-2010 - Faculty for TRI (Training Research Institute) 2004 to 2009 - Member of several Task Forces - Served on many conference planning boards

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American Society for Microbiology (ASM) - Board of Education and Training - Auditor/Reviewer for Workshops - Faculty and convener in national workshops 1990, 1992, 1994, and 2004. - Vice President of Central NY chapter 1991-1993 - President of Central New York Chapter 1993-1994 - Planning Committee, Texas Branch Fall Meeting, 1999

Publications Correlation of the Genetic Map and the Endonuclease Site Map of Bacillus subtilis Bacteriophage SPO2; with S. Graham, Y. Yoneda, and F.E. Young. Journal of Virology 42:131-134 1982. Acid Tolerance, Proton Permeabilities, and Membrane ATPases of Oral Streptococci; with G.R. Bender and R.E. Marquis. Infection and Immunity 53:331-338 1986. Membrane-associated and Solubilized ATPases of Streptococcus mutans and Streptococcus sanguis; with R.E. Marquis. Journal of Dental Research 66:1095-1098 1987. Fluoride Inhibition of Proton-Translocating ATPases of Oral Bacteria; with Gary R. Bender and Robert E. Marquis. Infection and Immunity 55:2597-2603 1987. A Spreadsheet for the Quantitative Validation of Direct Transfer Sterility Testing. Binary: Computers in Microbiology. 2:191-194. 1990. Neutralization Efficacy of Dey-Engley Media in Testing of Contact Lens Disinfecting Solutions; with Thomas Wrzosek and David W. Proud. Journal of Applied Bacteriology 70:351-354. 1991. D-value Determinations Are an Inappropriate Measure of Disinfecting Activity of Common Contact Lens Disinfecting Solutions; with R.J. Franco, M.F. Mowrey-McKee, S.C. Busschaert, J. Hamberger, and D.W. Proud. Applied and Environmental Microbiology 57:2021-2026. 1991. Ophthalmological Preparations; with T.M. Dolak, O.W. Lever, D. Marsh, and I. Moran. IN Ullman's Encyclopedia of Industrial Chemistry vol. A 18 VCH Publ, Germany. pp. 127-151 1991. A Universal Diluting Fluid for Use with Membrane Filtration Testing of Preservatives and Disinfecting Solutions; with David W. Proud. Applied and Environmental Microbiology. 58:1035-1038. 1992. A Critical Evaluation of the Multi-item Microbial Challenge Test in Ophthalmic Disinfectant Testing; with D.W. Proud, H. Proskin and D.A. Keister. The CLAO Journal. 18:155-160. 1992. The Importance of Neutralizer Evaluations in the Microbicidal Testing of Preservatives and Disinfecting Solutions. International Contact Lens Clinics. 19:167-173. 1992. The Relation Between Oral Pain and Ethanol Concentration in Mouthrinses; with S.J. Bolanowski and G.A. Gerscheider. Journal of Periodontal Research 30:192-197. 1995.

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Neutralizer Evaluations as Control Experiments for Biocidal Efficacy Tests IN Handbook of Disinfectants and Antiseptics, J.M. Ascenzi (ed.) Marcel Dekker, Inc., NY. pp. 43 - 62. 1996. Antimicrobial Effects of Hydrogen Peroxide as an Antiseptic and Disinfectant; with Andrea Lance, IN Handbook of Disinfectants and Antiseptics, J.M. Ascenzi (ed.) Marcel Dekker, Inc., NY. pp159 - 176. 1996. USP Open Conference on Compendial Microbiology. DIFCO Culture Club News v6 Spring 1996 p.1. Preservative Efficacy, Microbial Content, and Disinfectant Testing; with Mary Anne Magee and Daniel K. Brannan, IN Cosmetic Microbiology, D.K. Brannan (ed.) Marcel Dekker, Inc., NY. 1997. p.95. In-use Shelf-Life Testing – What Data are Required and When?; with Brian Matthews and Danny Dunn. Regulatory Affairs Journal 9:728-733. 1998. Activities of the USP Microbiology Subcommittee of Revision During the 1995 – 2000 Revision Cycle; with Joseph E. Knapp and Roger Dabbah PDA Journal of Science and Technology 55(1):33-48. 2001 The Role of USP in the Assessment of Microbiological Quality of Pharmaceuticals: A Five-Year Retrospective Leading to the Future; with Roger Dabbah and Joseph E. Knapp Pharmaceutical Technology North America 25(7):54-61 2001 Invited Paper Review of Standard for Evaluating the Effectiveness of Contact Lens Disinfectants with Ruth A. Rosenthal and Barry A. Schlech. PDA Journal of Science and Technology 56(1):37-52. 2002 Developing an Information Chapter in the USP to Demonstrate Equivalency in Microbiological Methods with Joseph Knapp, Roger Dabbah and David Porter American Pharmaceutical Review 5(2):14-19 2002 Invited Paper Validation of Microbial Recovery from Disinfectants; with David W. Proud, Stephen Rachui, and Daniel K. Brannan PDA J of Science and Technology 56(5):255-266. 2002 Development of the Antimicrobial Effectiveness Test as USP Chapter ; with David Porter. PDA J of Science and Technology. 56(6):300-311. 2002 The USP Perspective to Minimize the Potential Risk of TSE-infectivity in Bovine-derived Articles Used in the Manufacture of Medical Products; with Ian DeVeau and Roger Dabbah. Pharmacopeial Forum. 30(5):1911-1921. 2004 Microbial Identification in the Pharmaceutical Industry; with Anthony Cundell. Pharmacopeial Forum. 30(5):1884-1894. 2004 Towards an Improved Sterility Test; with Jeanne Moldenhauer. PDA J of Science and Technology 58(6):284-286. 2004 Validation of Alternate Microbiology Methods for Product Testing - Quantitative and Qualitative Assays. Pharmaceutical Technology. 29(4):118-122. 2005

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Activities of the USP Analytical Microbiology Committee of Experts During the 2000 - 2005 Revision Cycle; with Joseph E. Knapp and David Porter PDA J Pharm Sci Tech. 59(3):157176 2005. Disinfectant Rotation – A Microbiologist’s View; Controlled Environments. 8(7):9-14. 2005 Cleanroom Microbiology; IN Environmental Monitoring in the Pharmaceutical Industry Volume 1, J. Moldenhauer (ed.) DHI Publications, Washington, DC. pp 97-118. 2005. Opportunities for the Pharmaceutical Industry; IN Encyclopedia of Rapid Microbiological Methods Volume 1, M Miller (ed). DHI Publications, Washington, DC. pp. 123-156. 2005. Microbial Identification Systems; with J. Moldenhauer. IN Environmental Monitoring in the Pharmaceutical Industry, J. Moldenhauer (ed.) DHI Publications, Washington, DC. 2006 Preservative Efficacy Testing; IN Cosmetic Microbiology 2nd Ed, P. Geiss (ed.) Marcel Dekker, Inc., NY. 2006 Automated Microbiological Method Validation and the Role of USP Chapter Automated Methods of Analysis and the Proposed Chapter Analytical Instrument Qualification; with David Jones. PDA Newsletter June, 2006. Microbial Surface Monitoring; IN Environmental Monitoring for Cleanrooms and Other Controlled Environments, Anne Marie Dixon (ed), Informa Healthcare. 2006 The Harmonization of the Microbial Limits Tests; Pharmaceutical Technology 30(12):66-73. 2006 Is Real-Time-Release Through PAT Compatible with the Ideal of ”Science-Based Regulation?” Pharmaceutical Technology 31(2):97-98. 2007 Compounding of Sterile Medications in the Pharmacy - USP Chapter Provides Guidance with David Porter Controlled Environments 10(6):11-13. 2007 Is Real-Time-Release Through PAT Compatible with the Ideal of "Science-Based Regulation?” Pharmaceutical Technology 31(2):97-98. 2007 Articles of Interest to the Microbiologist; PDA Letter 18(2):7-10. 2007 Disinfectant Rotation in a Cleaning/Disinfection Program for Clean Rooms and Controlled Environments; IN Disinfection and Decontamination: Principles, Applications and Related Issues Gurusamy Manivannan (ed). Taylor and Francis. 2007. Pharmaceutical Quality Control Microbiology: A Guidebook to the Basics DHI Publishers, Inc. 2007 Awarded PDA's "Distinguished Author" for 2008 Microbiology and the Internet IN Microbiology in Pharmaceutical Manufacturing 2nd Ed Richard Prince (ed) DHI Publ 2008 Global Harmonization of Microbiology-Related Compendial Chapters IN Microbiology in Pharmaceutical Manufacturing 2nd Ed Richard Prince (ed) DHI Publ 2008

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Trending in the Environmental Monitoring Program: The Role of a Good Database Program; IN Environmental Monitoring Jeanne Moldenhauer (ed) DHI Publ 2009 USP ‫ۦ‬1211ۧ: The Compendial Informational Chapter on Sterility Assurance - Origins and Future Direction Pharm Technol Sterile Manufact 2009 Suppl:s16-s21 2009 Does the International Harmonization of the USP Microbial Limits Tests Require Revalidation of Finished Product Tests? Journal of Validation Technology 15(3):10-16. 2009 Hand Washing—A Critical Aspect of Personal Hygiene in Pharma Journal of Validation Technology 15(4):50-55. 2009. The International Harmonization of the Compendial Microbial Limits Tests - A Cautionary Tale of Compendial Participation. Journal of GXP Compliance 13(4):8-15. 2009. Handwashing, Hygiene, CGMP and Science. Journal of GXP Compliance 14(1):62-69 2010. Limiting Avoidable Microbiological Variability. Journal of Validation Technology 16(1):50-56 2010. The Importance of a Strong SOP System in the QC Microbiology Lab. Journal of GXP Compliance 14(2):44-52 2010. Qualification of an Environmental Monitoring Program. Journal of Validation Technology 16(2):78-82. 2010. The Environmental Monitoring Program in a GMP Environment Journal of GXP Compliance 14(3):22-30 2010. Microbiology Laboratory Design: Establishing the Facility and Management Structure (editor) for DHI Publ. 2010. The Most Probable Number Method and Its Uses in Enumeration, Qualification and Validation. J Val Technol 16(3):35-38. 2010. Qualification of a Contract Microbiology Laboratory. Journal of Validation Technology 16(4):5259. 2010. "The Compendial Sterility Tests" IN Pharmaceutical Dosage Forms: Parenteral Medications, Third Edition Sandeep Nema and John D. Ludwig, (ed) pp. 187 – 194. 2010. The Most Probable Number Method and Its Use in QC Microbiology. Journal of GXP Compliance 14(4):28-33. 2010. Laboratory Design: Establishing the Facility and Management Structure. DHI Publishers. Editor. 2010. Successful Use of a Contract Microbiology Laboratory. Journal of GXP Compliance 15(1):54-64. 2011. Measurement of Microbial Cells by Optical Density. Journal of Validation Technology 16(4):4649. 2011.

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Successful Microbiological Investigations. American Pharmaceutical Review 14(2):34-42. 2011. Microbiological Best Laboratory Practices, USP : Value and Recent Changes to a Guidance of Quality Laboratory Practices with Don Singer. American Pharmaceutical Review 14(4):41-47 Determination of Inoculum for Microbiological Testing. Journal of GXP Compliance 15(3):49-53 2011 Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005– 2010 Revision Cycle with Radhakrishna Tirumalai. American Pharmaceutical Review 14(5):12-30 2011 Measurement of Microbial Cells by Optical Density. Journal of Validation Technology 17(1):4649 2011 “Sterility Tests” IN Rapid Sterility Testing J. Moldenhauer (ed) PDA/DHI Publ. pp. 7-28 2011 Accuracy of Plate Counts Journal of Validation Technology 17(3):46-49 2011 Contamination Control in the Compliance Program Journal of GXP Compliance 15(4):58-64 2011 Qualification of a Microbial Identification System Journal of Validation Technology 17(4):50-53 2011 A Review of Reported Recalls Involving Microbiological Control 2004-2011: With Emphasis on FDA Considerations of “Objectionable Organisms” with Luis Jimenez. American Pharmaceutical Review 15(1):42-57 2012 Letter to the Editor in Response to “Burkholderia cepacia: This Decision is Overdue” PDA Journal of Science and Technology 66(2):91-95 2012 The Limitations of CFU – Compliance to CGMP Requires Good Science Journal of GXP Compliance 16(1) 2012 Microbial Identification in a GXP Environment – Which System is Best? Journal of GXP Compliance 16(2):55-59 2012 The Contamination Control Plan in Facility Validation Journal of Validation Technology 18(2):4247 2012 Aspects, Advantages and Disadvantages of Current Microbial Identification Systems: A Multicomponent Approach to Identifications in the QC Microbiology Lab IN: Aspects, Advantages and Disadvantages of Current Phenotypic and Genotypic Systems. Reber, D and M Griffin (ed). DHI Publications. 2012 USP and Contamination Recovery Rates Journal of Validation Technology 18(4)79-83. 2012 What is an “Objectionable Organism”? American Pharmaceutical Review 15(6):36-48 2012

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Environmental Monitoring Data Trending in the Aseptic Core – USP and “Contamination Recovery Rates” Journal of GXP Compliance 16(4):59-63. 2012 GMP and Compounding Pharmacies American Pharmaceutical Review 16(3):48-59. 2013 “The Contamination Control Plan in Facility Validation” IN: Contamination Control in Healthcare Product Manufacturing RE Madsen and J Moldenhauer (ed) PDA/DHI Publications pp. 730 2013. Method Suitability Control Studies for Microbial Testing: 1. Quantitative Comparisons Journal of Validation Technology Journal of Validation Technology 17(2) 2013 Implications of the Human Microbiome on Pharmaceutical Microbiology with Cara Wilder and Tim Sandle American Pharmaceutical Review. 2013 QC Microbiology, GMP and Social Media: Results of an Industry Survey Journal Validation Technology September, 2013 Implications of the Human Microbiome on Pharmaceutical Microbiology. American Pharmaceutical Review 16(5):17-21 with Cara Wilder and Tim Sandle 2013 The Antimicrobial Efficacy Test, GMP and Investigations American Pharmaceutical Review 16(5):40-48 2013 Understanding the Role of Sterility Testing in Good Compounding Practice. Pharmacy Purchasing and Products 11(3)28-29 2014 Recovery of Stressed (Acclimated) Burkholderia cepacia Complex Organisms, with Julie Barlasov and Richard Jakober American Pharmaceutical Review 17(3):16-24. 2014 FDA, USP and Compounding Manufacturers (Outsourcing Facilities) Journal of GXP Compliance 18(2) 2014 What are the Risks of Reusing Metered-Dose Inhalers? Pharmacy Purchasing & Products 11(5):26 2014 FDA Expectations for 503B Outsourcing Facilities Pharmacy Purchasing & Products 11(10):1821 2014 Media fill simulations. with Anne Connors Manufacturing Chemist Nov 2014 Suppl pp. IX-XI 2014. How to Choose a 503B Outsourcing Facility Pharmacy Purchasing & Products in press Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy – Science and Compliance. with Anthony Grilli, International Journal of Pharmaceutical Compounding in press Cross-Functional Considerations & Health System Economics: A Review and Critical Analysis of Common Canister Programs with Trent Larson, Ravindra Gudavalli, Dean Prater and Ramie L. Quiroz submitted for publication

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Abstracts and Oral Presentations Hundreds of presentations and webinars have been made at international conferences, courses workshops and webinars. Recent invited presentations dealt with topics in Quality Control Microbiology, GMP, Aseptic Processing, Investigations of MDD (OOS), Environmental Monitoring, Manufacturing Contamination Control, Compendial Topics, Objectionable Organisms and alternate microbiological methods.

Training Courses Webinars have been actively developed, promoted and delivered. More than 3,000 separate registrations (an individual registration may have 1-100 attendees at that site) have attended these webinar sessions since 2011. Dozens of in-house courses presented since 2005 dealing with microbiological topics in pharmaceutical, medical device and personal product manufacture and testing. More than 1,500 students have attended these in-house courses.