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September 18-20, 2017 | Montreal, Canada
Distinguished Presenters:
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  • Evald Muraj
    Stability Manager
    Ironwood Pharmaceuticals

    Biography will be available soon.

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  • Peter I. Tattersall, Ph.D.
    Principal Scientist, Chemical & Synthetic Development
    Bristol-Myers Squibb Company
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    Dr. Peter Tattersall received a BS in Chemistry and a PhD in Organic Synthesis from the University of Manchester in the UK. He is currently an R&D analytical scientist in the Chemical & Synthetic Development group within Pharmaceutical Development at the Bristol-Myers Squibb Company in New Brunswick, NJ. He is an analytical project lead providing support for early stage to NDA approval development projects for small molecules.

    He joined the pharmaceutical industry in 2001 as an organic chemist in Analytical Development at AstraZeneca, Wilmington before joining Bristol-Myers Squibb in 2003.

    For the last 16 years his areas of focus include analytical method development in support of drug substance and drug product, project leadership and leading analytical investigations. He has interests in Quality by Design for method development and has experience with analytical method transfers around the world together with late stage filings.

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  • Anthony Rainosek
    Senior Manager of Global Stability
    Baxter Healthcare
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    Anthony Rainosek is Senior Manager of Global Stability at Baxter Healthcare, leading teams in Europe, China, and the United States. His global team develops stability strategies and study designs, and performs subsequent data assessments supporting the development and maintenance of premixed drug, IV, nutrition, and renal solution products. Anthony received his bachelor’s degree in Chemistry from the University of Texas at Austin, and has 29 years of experience in the pharmaceutical industry, including leadership roles in analytical method development/validation and stability testing.

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  • Patrick Forenzo
    Senior Fellow / Stability Expert
    Novartis Pharmaceuticals Corporation
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    Pat Forenzo is a senior fellow at Novartis Pharmaceuticals and has been in the Pharmaceutical Industry for thirty years starting as a bench chemist and has been serving as Novartis Global Stability Expert for the last 16 years. He is a past co-chair and currently a member of the PQRI ‘Stability Shelf Life Working Group’. Pat was a co-author of ‘On the Shelf Life of Pharmaceutical Products’, AAPS PharmSciTech, Vol 13, No. 3, September 2012 which was the initial offering from the PQRI ‘Stability Shelf Life Working Group’.

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  • Zahra Shahrokh, Ph.D.
    CMC Consultant, ZDev Consulting
    Chief Development Officer, STC Biologics, Inc.

    With 30 years experience in biotechnology product development, Dr. Shahrokh has a track record in global regulatory approvals of several biological products, authoring 8 BLAs and dozens of INDs. As a CMC Consultant, she provides technical and strategic guidance to advance biotech products through development life cycle. As Chief Development Officer for STC Biologics, Dr. Shahrokh provides Development, Quality, and Regulatory strategy to advance STC’s products and Bioservices programs. She was Senior VP of Development at Aurabiosciences, responsible for regulatory, nonclinical and CMC development of protein nanoparticle delivery systems. She led Pharmaceutical and Analytical Development at Shire for ten years, and was Head of CMC & PD Operations. She had technical and leadership roles at Genentech's Pharmaceutical R&D department for ten years, where she drove pharmaceutical development of several classes of biologics and small molecules.

    Dr. Shahrokh has a PhD in Biophysics from UC Berkeley, BA in Chemistry and in Physics from University of Pennsylvania, and post-doctoral fellowship at UCSF. She holds several pharmaceutical patents and over 60 papers & invited presentations.

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  • Nila Das, Ph.D.
    Senior Research Investigator
    Bristol-Myers Squibb
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    Nila Das is a Senior Research Investigator at Bristol-Myers Squibb, based at New Brunswick NJ. Her research interests include product development, stability and CMC filings of therapeutic monoclonal antibodies, antibody-drug conjugates, and gene therapy. Most recently she had led the product development activities of parenteral products at Boehringer Ingelheim. She is a member of USP expert panels on biologics and analytical methods. She is also an assistant editor of mAbs journal, scientific advisor for Journal of Pharmaceutical Sciences and editorial board member of American Pharmaceutical Review Magazine. She has her Ph.D. in Industrial Pharmacy from St. John’s University.

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  • Geoff Carr, Ph.D.
    Director, Analytical Development
    Patheon Inc.
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    Geoff Carr was appointed as Manager, Analytical Development at Patheon Inc, Canada in 2000 and is now Director, Analytical Development, Ontario. Prior to that, he held positions of Manager, Analytical Sciences at Celltech-Chiroscience, UK, Head of Analytical Development at Medgenix, Belgium and before that at Wyeth Research, UK. He originally started his career in pharmaceutical analysis at The British Pharmacopoeia Laboratory where he held several posts and was finally appointed Head of the Laboratory. He has been a Member of various British Pharmacopoeia Committees, a UK representative to Committees of the European Pharmacopoeia and Member of USP Committees and is currently a Member of the 2015-2020 Cycle USP General Chapters – Physical Methods Expert Committee. He is the author of numerous papers and presentations at international conferences on various topics related to Pharmaceutical Analysis.

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  • Wayland Rushing, Ph.D.
    Director, Scientific Affairs
    EAG Laboratories
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    Dr. Wayland Rushing is a technical expert in Chemistry Manufacturing and Controls (CMC) program design, analytical development and regulatory submissions. Over his career, he has led CMC development programs for a wide array of pharmaceutical products, including parenteral and inhalation drugs, drug/device combinations and other therapies with complex delivery systems. Dr. Rushing is a subject matter expert in HPLC and GC method development and validation, extractables and leachables program design and regulatory submission requirements; has drafted multiple IND and NDA submissions. Dr. Rushing currently serves on Parenteral Drug Association (PDA) advisory committees for Technology Transfer and Elastomeric Closures and Seals Defects.

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  • Krista Coventry, M.Sc.
    Director of Regulatory Services, East
    Source Nutraceutical, Inc.
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    Ms. Krista Coventry is the Director of Regulatory Affairs (Eastern Canada) for Source Nutraceutical, Inc., a Canadian contract research organization. She is a regulatory affairs specialist in the North American health products sector with 15 years of experience providing project management, regulatory strategies and market compliance solutions to industry clients, globally. Krista has expert knowledge of acts, regulations, policies and guidelines relating to natural health products (NHPs) and foods. She has worked extensively within the Canadian regulations to communicate the health benefits of various health products through regulatory efforts, and has vast experience critically evaluating evidence in support of health claims. Krista has also advised numerous clients with products at the interface of the NHP, food, cosmetic and drug regulations navigate the Canadian requirements for pre-market approval.

    Krista has extensive experience lecturing on regulatory topics impacting the NHP and food sectors at various industry conferences, workshops and seminars, and also regularly authors articles for several health product industry publications. She has numerous distinguished volunteer affiliations with regulatory-based professional and scientific societies. Krista is the Vice-President of the Natural Health Product Research Society (NHPRS) of Canada; an active member of Health Canada’s Food Expert Advisory Committee (FEAC); an active member of the Board of Directors for CAPRA (Canadian Association for Professionals in Regulatory Affairs); Chair of the Canadian Health Food Association’s Food Regulatory Advisory Committee (CHFA-FRAC); and an active member of Seneca College’s Ad Hoc Program Advisory Committee for the Fundamentals of NHPs program. Krista is also a past member of the International Regulatory Affairs Committees for the Council for Responsible Nutrition (CRN) and GOED (Global Organization for EPA+DHA).

    Krista is also completing a Ph.D. at the University of Guelph, with a research focus on clinical research involving natural health products and functional foods.

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  • Karl F. Popp, R. Ph.
    KPopp Consulting, LLC.

    Karl Popp founded KPopp Consulting, LLC in 2010 as a consulting firm providing services to pharmaceutical, cosmetic and allied industries. He also is a practicing retail pharmacist.

    From 1989 to 2008 he was associated with Stiefel Laboratories as Director of Product Development, and later as Senior Director of Special Projects coordinating external manufacturing, global research activities, and managing the corporation’s intellectual property estate. Prior to joining Stiefel in 1989, he was a Scientist and Project Manager for the Sterling-Winthrop Research Group. During his career he has been responsible for the development of products that have generated over $2 billion in sales.

    He earned his B. S. in Pharmacy from the Albany College of Pharmacy, an M.B.A. from Rensselaer Polytechnic Institute and is licensed to practice pharmacy in NY.

    He has been active in the SCC in coordinating local educational seminars, served on the National Committee on Scientific Affairs and as the Society’s President in 1999. Karl was elected a Fellow of the Society in 2002. Served as a Past Chair of the New England Chapter, and more recently elected an Emeritus Member.

    He is an inventor, an author and a scientist. His interests encompass topical, oral, inhalation, and parenteral dosage forms in addition to various therapeutic categories. During his over 40 years in the industry, Karl Popp has lectured around the globe on new product development activities including GMPs, regulatory strategies, product pipeline efforts, process validation, product life cycle management, and management of intellectual property. He has also served as an expert witness in matters before the U.S. federal courts.

    He is an inventor, an author and a scientist. His interests encompass topical, oral, inhalation, and parenteral dosage forms in addition to various therapeutic categories. During his over 40 years in the industry, Karl Popp has lectured around the globe on new product development activities including GMPs, regulatory strategies, product pipeline efforts, process validation, product life cycle management, and management of intellectual property. He has also served as an expert witness in matters before the U.S. federal courts.

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  • Kenneth C. Waterman, Ph.D.
    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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  • Glen McCarthy, P.Eng.
    Founder and President
    Labworks International Inc.
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    Glen McCarthy, P.Eng., is the founder and President of Labworks International Inc. Graduating from Ryerson Polytechnical University, Glen has over 25 years of experience designing and building temperature and humidity controlled environments for critical applications. Glen is a member of Professional Engineers Ontario; ASHRAE and ISPE. Glenn started Labworks International Inc. in 1996 and it has now grown to a team of 6 professional engineers.

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  • Jacques-Marcoux
    Viking Technical Services inc.
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    With 29+ years experience working for the Canadian Pharmaceutical manufacturing industry, Jacques has extensive knowledge with respect to maintenance, calibration and validation activities with processing equipment and clean utilities both from an operational and a regulatory perspective.

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  • Sean D. Benedik, , B.Sc. Biochemistry
    Director of Pharmaceutical Business Development
    WSP Group
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    SINCE 1998, Mr. Benedik has been a cGMP thought leader and change agent for numerous large and small pharmaceutical, biotech, and medical device firms worldwide. His substantial expertise as an analytical chemistry and quality systems professional as well as his laser-focus on solutions innovation has been employed in various roles across Canada, the Unites States, Mexico, and Europe. In his current role at WSP in Montreal, Sean leverages his experience to offer civil, structural, mechanical, electrical, process, validation, and quality systems engineering services to cGMP clients anywhere in the world. Mr. Benedik speaks fluently in English and French.

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  • Parsa Famili
    President & CEO
    Novatek International
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    Parsa Famili, MSc. is the President and CEO of Novatek International. Prior to joining Novatek,he held senior management positions in quality departments of several North American pharmaceuticalcompanies. He has participated and successfully completed several FDA, EMEA, TGA, and Health Canada audits. He was also an instructor of Chemistry and Bio-Chemistry at Vanier College in Montreal. Mr. Famili has published several chapters and articles in various journals and books. His latest chapter was “Chapter 16 Automation of Environmental Monitoring: Achieving Efficiency and Control” in Environmental Monitoring (Vol. 6, edited by Jeanne Moldenhauer, 2012). He is an International speaker at ISPE, IVT, PDA, IPA, CBI among others.


  • Intertek

  • SGS
  • Neopharm

  • Labworks
  • Sotax
  • Novatek

  • WSP Group
  • Branal Scientific
  • AAPS