Thomas N. Feinberg, Ph.D.
`
`129 Colfax Drive
`Clhapel Hill, NC 27516
`919-360-3189
`www.Linkedin.com/in/tomfeinberg/
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`Results-oriented Research and Development Executive with particular
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`emphasis on Analytical Development and recognized expertise in
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`Extractables and Leachables
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`SUMMARY
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`CAPABILITIES
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`CMC Documentation Review
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`Analytical Development Program Management
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`Analytical Method Remediation J Gap Analyses
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`Extractables and Leachables Project Design / Project Management
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`005 Investigation Documentation/ Root Cause Analyses
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`Form 483 Response Preparation / Project Management
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`Pharmaceutical Technology Assessments
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`Technical Data Audit Support/ Data Integrity Evaluations
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`Contract Analytical Service Vendor Management/ RFP Development
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`Standard Operating Procedures/ 21CFR 211 Compliance
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`Computer System Validation/ 21CFR Part 11 Compliance
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`Breakthrough Lean Program Development
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`Lean Sigma Project Sponsorship
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`Laboratory and Quality Process Mapping
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`Technical Staff Training Module Development/ Deployment
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`Technical Staff Organizational Design / Implementation
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`PROFESSIONAL
`EXPERIENCE
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`2014-present President
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`SCIO Analytical, LLC
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`Provides expert consultation services to pharmaceutical manufacturers and
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`prospective vendors into this regulated industry. Specialty in Extractables
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`and Leachables testing program design/remediation, CMC documentation
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`review, Data Integrity Audits and strategies for compliance with future
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`world-wide regulatory initiatives.
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`2012-2014
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`Senior Director -Scientific Affairs
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`Development and Analytical Solutions
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`Catalent Pharma Solutions, LLC
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`Conducted primary market research for contract analytical services, vendor
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`alliances and strategic acquisitions. PM for successful validation and
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`installation of proof-of-concept global LIMS (SQL *LIMS P4) and site's first
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`MHRA audit response. Designed and presented directly at FDA the analytical
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`platform strategy for the Advasept® sterile packaging format.
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`2006-2012
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`Director -Structural Chemistry
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`Development and Clinical Services
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`Catalent Pharma Solutions, LLC
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`Directed Laboratory, Metrology, EH&S, and OpEx groups consisting of 50
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`technical Sponsored first successful OpEx projects for facility including
`staff.
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`Breakthrough LEAN deployment to over 200 employees which doubled OTO
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`and FPA in 6 months. PM for closure of San Diego facility which minimized
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`cost and regulatory risk (including environmental assessments) to Catalent
`and clients.
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`Bass and Spangenberg
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`V.
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`Fresenius Kabi USA, LLC
`U.S. Patent No. 8,476,010
`Exhibit 1003
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`Exh. 1003
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`

`
`919-360-3189
`Thomas N. Feinberg, Ph.D.
`2004-2006
`Director- Ana lytical Services
`Respiratory, Analytical and Biotechnology Services
`Cardinal Health, Pharmaceuticals and Technology Services
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`page 2 of 4
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`Site leader for all non-pulmonary CMC services including QC, stability, and
`stability storage. Developed and deployed career ladder and performance
`management process to 120 technical employees. Implemented metrics
`focus to improve report quality (First Pass Acceptance, FPA) and on-time
`delivery (OTD). PM for closure of Stockport, UK facility and transfer of all
`methods and materials to US sites ..
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`2001-2004
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`Associate Director - Structural Chemistrv
`Cardinal Health, Pharmaceuticals and Technology Services
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`Organized and hired team leaders for mass spectrometry, trace inorganic
`analysis (atomic spectroscopy), NMR, and degradation chemistry. Designed
`protocols for stability analysis per ICH and FDA requirements. Active
`member of PQRI Extractables and Leachables in Orally Inhaled and Nasal
`Drug Products (OINDP) WG. Doubled both revenue and operating income in
`3 years.
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`1999-2001
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`Section Head - Mass Soectrometry and Trace Organic Analysis
`Magellan Laboratories, Inc.
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`Developed container-closure ext ractables and leachables control strategies
`for MDis, DPis, Inhalation Solutions, Parent erals, Injectables and Topicals.
`Study Director for over SO GLP/GMP and ICH-compliant method
`development, method validation and investigational projects. Established
`and managed both efficiency metrics and cost-containment strategies to
`t u rnaround profitability.
`Scientist I - Scientist II - Mass Spectrometry
`Magellan Laboratories, Inc.
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`Conducted LC/MS and GC/MS studies for structural elucidation of drug
`product and drug substance impurities/degradants in a GLP/cGMP
`environment. Wrote SOPs and instrument calibration procedures per cGMPs.
`Developed bioanalytical methods for in vitro and in vivo screening for
`discovery support. Wrote over 30 submission-quality reports.
`Postdoctoral Research Assistant I Associate
`Departments of Chemistry and Environmental Sciences and Engineering
`University of North Carolina at Chapel Hill
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`Developed derivatization methodology for trace detection of multi-functional
`carbonyls using CZE/UV /ESI mass spectrometry and
`ion t rap GC/ MS.
`Designed new laser-based experiment to obtain accurate ionization
`potentials of molecules and compared results to ab initio quantum
`mechanical calculations.
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`Ph.D. in Physical Chemistry
`Dissertation: "Infrared and Mass Analyzed Ion Kinetic Energy Spectroscopy
`of Cluster I ons"
`University of North Carolina at Chapel Hill, Chapel Hill, NC
`A.B. in Chemistry
`Cornell University, Ithaca, NY
`PQRI, IPAC-RS, PDA, AAPS, ACS, ASMS, USP Expert Committee
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`1995-1999
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`1991-1995
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`EDUCATION
`1991
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`1985
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`AFFILIATIONS
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`Exh. 1003
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`

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`page 3 of 4
`919-360-3189
`Thomas N. Feinberg, Ph.D.
`SELECTED
`Feinberg, T. "Extractables and Leachables: Best Practices to Ensure Patient
`PUBLICATIONS
`Safety/' Pharmaceutical Technology, July 2013
`Jenke, D.; Castner, J.; Egert, T.; Feinberg, T.; Hendricker, A.; Houston, C.;
`Hunt, D.G.; Lynch, M.; Shaw, A.; Nicholas, K.; Norwood, D.L.; Paskiet, D.;
`Ruberto, M. ; Smith, E.J.; Holcomb, F. "Extractables Characterization for Five
`Materials of Const ruction Represent ative of Packaging Systems Used for
`Parenteral and Ophthalmic Drug Products/ PDA Journal of Pharmaceutical
`Science and Technology 2013, Volume 67
`Feinberg, T. "Critical Design Strategies for Extractables and Leachables
`Control: Methods for Avoiding Contamination/' Contract Pharma, April 2013
`Feinberg, T.N.; Norwood, D.N.; Granger, A.T.; Jenke, D. "Extractables - The
`Controlled Extraction Study" in Leachables and Extractables Handbook:
`Safety Evaluation, Qualification, and Best Practices Applied to Inhalation
`Drug Products (D.J. Ball, D.L. Norwood, C.L.M. Stults, and L.M. Nagao, Eds),
`Chapter 14, January 2012
`Norwood, D.N.; Feinberg, T.N.; Mullis, J.O.; Pennino, S. "Analytical
`Techniques for Identification of Extractables and Leachables" in Leachables
`and Extractables Handbook: Safety Evaluation, Qualification, and Best
`Practices Applied to Inhalation Drug Products (D.J. Ball, D.L. Norwood,
`C.L.M. Stults, and L.M. Nagao, EdsL Chapter 13, January 2012
`Norwood, D.N.; Mullis, J.O.; Feinberg, T.N.; Davis, L.K. "N-Nitrosamines as
`"Special Case" Leachables in a Metered Dose Inhaler Drug Product, " PDA
`Journal of Pharmaceutical Science and Technology 2009, Volume 63
`Norwood, D.L.; Paskiet, D.; Ruberto, M.; Feinberg, T.; Schroeder, A.;
`Poochikian, G.; Wang, Q.; Deng, T.J.; DeGrazia, F.; Munos, M.K.; Nagao,
`L.M. "Best Practices for Extract ables and Leachables in Orally Inhaled and
`Nasal Drug Products: An Overview of the PQRI Recommendations/
`Pharmaceutical Research 2008, Volume 25
`"Extractables and Leachables Studies for Biological and Other 'High Risk'
`Dosage Forms," delivered at the Eastern Analytical Symposium, Somerset,
`NJ, November 2012
`''Best Practices for OINDP Pharmaceutical Development Programs Leachables
`and Extractables," delivered at the Product Quality Training Course Program,
`San Diego, CA, November 2007
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`WORKSHOPS
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`SELECTED
`PRESENTATIONS
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`"Best Practices for OINDP Pharmaceutical Development Programs Leachables
`and Extractables," delivered at the Product Quality Training Course Program,
`Basel, Switzerland, September 2007
`"Best Practices for OINDP Pharmaceutical Development Programs Leachables
`and Extractables," delivered at the Product Quality Training Course Program,
`Chicago, IL, April 2007
`Feinberg, T.N. "Bridging t he Divide: Use of Simu lation Studies to Resolve the
`Parenteral and Ophthalmic Drug Products (PODP) Analytical Challenge,"
`presented at the USP/PQRI Joint Workshop on Suitability and Compatibility
`for Packaging and Delivery Systems Workshop Co-Sponsored by USP and
`PQRI, Rockville, MD, April 27-28, 2014
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`Feinberg, T.N. "What's good for OINDP (Orally Inhaled and Nasal Drug
`Products) may not be good for PODP/ presented at the E&L USA
`Conference, Rockville, MD, May 16, 2012
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`Exh. 1003
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`

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`page 4 of 4
`919-360-3189
`Thomas N. Feinberg, Ph.D.
`SELECTED
`Feinberg, T . N. "Characterization of Trace Impurities Leaching from
`PRESENTATIONS
`Pharmaceutical Packaging Syst ems" presented at 2011 Conference on Small
`(continued)
`Molecule Science, Chapel Hill, North Carolina, August 2-4 2011
`Feinberg, T.N. 'The Parenteral Ophthalmic Drug Product Leachables and
`Extractables Working Group: Status and Outlook" presented at International
`Pharmaceutical Aerosol Consortium-Regulatory Science 2011 Conference,
`Washington, D.C., March 29-31 2011
`Feinberg, T.N. "Challenges and Best Practices in Extractable and Leachables"
`presented at 2009 Professional Dinner Meeting Series Parenteral Drug
`Association (PDA) West Coast Chapter, San Francisco, California, January 19
`2009
`SELECTED POSTERS Feinberg, T.N.; Hendricker, A.D.; Cvetich, P.; Tonkiha, N.; Covington, L.;
`Cree, M.; Lennon, III, J.D.; Carico, L.; Jenke, D.; Maniak, P.; Egert, T.
`"Controlled Extraction and Simulation Study Results, " presented at the
`USP/PQRI Joint Workshop on Suitability and Compatibility for Packaging and
`Delivery Systems Workshop Co-Sponsored by USP and PQRI, Rockville, MD,
`April 27-28, 2014
`Hendricker, A.D.; Feinberg, T.N.; Tonkiha, N.; Covington, L.; Cree, M.;
`Cvetich, P.; Carico, L.; Lennon, III, J.D.; Castner, J.; Maniak, P.; Jenke, D.
`"Migration Study Test Results," presented at the USP/PQRI Joint Workshop
`on Suitability and Compatibility for Packagi ng and Delivery Systems
`Workshop Co-Sponsored by USP and PQRI, Rockville, MD, April 27-28, 2014
`Carroll, C.A.; Kolbert, A.C.; Feinberg, T.N. "Detection of Residual Solvents in
`a Large-Molecule API by 1H NMR Spectroscopy" presented at 2009 American
`Association of Pharmaceutical Scientists Meeting and Exposition, Los
`Angeles, California, November 7-12 2009
`Carroll, C.A.; DeRider, M.D.; Feinberg, T.N. "Detection of Adulterants in Raw
`Materials, Drug Substances, and Products by NMR Spectroscopy" presented
`at 2009 American Associat ion of Pharmaceutical Scientists Meeting and
`Exposition, Los Angeles, California, November 7-12 2009
`Carroll, C. A.; Kolbert, A.C.; Feinberg, T.N. "Determination of API:Counter
`Ion Ratio in Soft-Gelatin Capsules by Quantitative 13C Nuclear Magnetic
`Resonance (NMR) Spectroscopy" presented at 2008 American Association of
`Pharmaceutical Scientists Meeting and Exposit ion, Atlanta, Georgia,
`November 16-20 2008
`Hendricker, A. D.; Deal, A. L.; Feinberg, T. N. "Case Study: Method
`Optimization and Extractables Characterization of Peroxide Cured Rubber"
`presented at the PQRI Leachables & Extractables Workshop, Bethesda, MD,
`December 5-6 2005
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`Exh. 1003