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Impurities Profile Management in the Pharmaceutical Product Life Cycle
September 20, 2017 | Toronto, Canada
October 18, 2017 | Montreal, Canada
Distinguished Presenters:
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  • Conference Chair
    Natasha Demberg, BSc, MSc
    Vice President of Pharmaceutical Solutions
    Neopharm Labs
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    Natasha Demberg is a Pharmaceutical Executive with 20+ years expertise in the development and application of Quality Management Systems throughout product life-cycle. She is skilled in leadership and management and has lead international multi-functional groups to address challenging global regulatory compliance issues. She has both hands-on expertise and a strategic view of all aspects of the pharmaceutical manufacturing process.

    Natasha is presently the Vice President of Pharmaceutical Solutions at Neopharm Labs, a full service GMP analytical testing laboratory serving the Life Science industry where she is responsible for Business Development, and Customer Experience.

    She is known for her dynamic leadership style and her ability to think strategically. She brings with her the tremendous mix of both technical expertise and regulatory knowledge.

    Natasha’s career has included a wide range of successful leadership positions in Quality Organisations of several large companies in the pharmaceutical field. Initially as a chemist at Plantex Teva and Abbott Laboratory and later as Senior GMP Compliance Associate at Merck Frosst Canada, responsible for Quality aspect of Clinical manufacturing, and Head of Quality at Valeant Canada and Confab Laboratory responsible of entire Quality Operations.



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  • Diego A. Zurbriggen
    Supervisor, Analytical Laboratory
    West Pharmaceutical Services, Inc.

    With more than 13 years of laboratory experience, Diego Zurbriggen brings a wealth of knowledge to his position as Supervisor of the Leachables/Stability group in the Analytical Labs division of West Pharmaceutical Services, Inc., in Exton, PA. Mr. Zurbriggen began work at West in 2003 as a Project Leader in the Raw Materials and Product Testing group, rising quickly to Supervisor of the GxP Support team. As a Senior Chemist, he conducted a variety of analytical investigations supporting internal and external customers, and developed and validated methods using a range of analytical techniques. In his current role, he supervises a team of eight scientists and serves as the West subject matter expert on elemental impurities. A published author, Mr. Zurbriggen holds a Bachelor of Science/Chemistry degree from the Gewerbliche Berufsschule Visp – Visp, Valais, Switzerland.


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  • Steven Baertschi, Ph.D.
    President
    Baertschi Consulting, LLC

    Dr. Steven Baertschi is President of Baertschi Consulting, LLC, an Indianapolis, IN based firm specializing in providing solutions to the most difficult stability, impurity, and formulation issues. Retiring from Eli Lilly and Company in early 2015, he brings more than 27 years of experience in the pharmaceutical industry to his consulting firm, with a demonstrated track record of innovation and problem-solving. He received his B.S. degree in Chemistry from Lipscomb University (Nashville, TN) in 1980. From 1980 to 1985 he worked in the environmental analytical area focusing on priority pollutant analysis. He obtained his PhD in Organic Chemistry in 1989 from Vanderbilt University (Nashville, TN) joining Eli Lilly and Co. (Indianapolis, IN) that same year. While at Lilly he was responsible for developing the areas of degradation chemistry, including stress testing, photostability testing, and degradation product identification for small molecule drug candidates. Research interests impurity isolation / structure elucidation, photostability and photochemistry of drugs, mechanisms of drug degradation, reactive intermediates, mass balance investigations, degradation-derived genotoxic (mutagenic) impurities…, and drug-excipient interactions.

    Dr. Baertschi is internationally renowned, organizing / chairing numerous scientific conferences and symposia on stress testing, photostability, and impurities; he has published more than 50 scientific articles in refereed journals, more than 25 book chapters, and has edited two editions of a book focused on the topic of pharmaceutical stress testing. Dr. Baertschi has been a member of the American Chemical Society since 1980, the American Association of Pharmaceutical Scientists (AAPS) since 1993, and was named a Fellow of the AAPS in 2007.


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  • Jeffrey P. Kiplinger, Ph.D.
    Founder and General Manager,
    Averica & VP Science and Innovation,
    Neopharm Labs
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    Dr. Kiplinger has over 25 years of experience in the pharmaceutical industry, initially as a mass spectrometrist and analytical chemist at Pfizer and later as a strategic consultant to startup discovery organizations. He is founder and CEO of Averica Discovery Services, an analytics Contract Research Organization (CRO) in Boston. Averica was acquired by Neopharm Labs (Blainville, QC) in 2016, and Dr. Kiplinger serves as Neopharm’s Vice President of Science and Innovation as well as General Manager of Averica.

    Dr. Kiplinger received his PhD in Organic Chemistry at Indiana University, and carried out postdoctoral research at the University of North Carolina and Ohio State University. In 1988 he joined Pfizer in Groton Connecticut, leaving in 1998 to found the Gilson CIDT technical center. After consulting with a number of pharmaceutical companies and entrepreneurs, he founded Averica in 2007. Dr. Kiplinger has published over 30 research papers, in addition to several articles on high-throughput technologies and laboratory form and function. He has a strong interest in science and entrepreneurship.


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  • Kenneth C. Waterman, Ph.D.
    President
    FreeThink Technologies, Inc.
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    Dr. Ken Waterman received his B.S. degree with honors in Chemistry from UCLA, his Ph.D. in Physical Organic Chemistry from UC Berkeley and conducted post-doctoral studies in physical and photo-chemistry as an NIH research fellow at Columbia University. Dr. Waterman worked 12 years at Polaroid (as a distinguished scientist) developing imaging products, then 13 years at Pfizer (as a Research Fellow) working on drug stability, drug delivery, biopharmaceutics and prodrugs. He is the author of over 70 publications and was made an AAPS Fellow in 2011. In 2011, he started FreeThink Technologies which both produces and licenses the accelerated stability software package ASAPprime® and is a CRO that has Connecticut-based laboratories specializing in stability for pharmaceuticals, generics, OTCs, nutraceuticals and consumer products.


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  • Mathieu Fournier, MSc
    Supervisor, Analytical R&D
    Neopharm Labs
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    Mathieu Fournier has over 10 years of experience in applied analytical research & development within the pharmaceutical industry. Over the course of his career, he has managed new method development projects for oral dosage forms, ophthalmic solutions and injectable products. These projects have enabled him to develop a solid expertise in method development and validation, as well as in forced degradation and dissolution studies, reverse engineering and process automation. He is also experienced in providing answers to health authorities as a subject matter expert.

    Mathieu also worked in analytical troubleshooting, product investigations (ex. unknown peak identifications), source & site changes and monograph updates for commercialized products. His expertise in mass spectrometry (GC/MS and LC/MS) brought him to develop methods for genotoxic impurities analysis. He has acquired in-depth knowledge of extractables & leachables by conducting complete studies for various packaging systems. More recently, he extended his knowledge to ICP-MS by leading projects for the method development of elemental impurities determination as per ICH/USP new guidelines.

    Mathieu is currently the Supervisor of the Analytical R&D department of Neopharm Labs. This challenging role allows him to apply his global knowledge and expertise of analytical chemistry in the pharmaceutical industry to meet the evolving business demands of various customers from the life sciences industry.

    Mathieu holds a Master of Science degree in Analytical Chemistry, specializing in small molecule analysis by LC/MS from the Université du Québec à Montréal (UQAM).