Our Faculty

  • Tali Azulay is a graduate of a B.A degree in Psychology, Ludwig-Maximilians University, Munich, Germany and a M.A. degree of Experimental Psychology, Bar Ilan University, Ramat Gan, Israel.
    Tali has a 7-year experience in clinical trials data management, with a specialty in medical device trials. Within the framework of her work she has managed trials of different phases in Israel, United Europe and USA, from planning the trial till database closure. Tali has a profound acquaintanceship with the regulatory requirements and the relevant standards.
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  • Mr. Clay Anselmo (CEO of Reglera LLC.) is a Senior Executive Manager with more than 19 years of experience in all areas of Quality, ISO, FDA Regulatory Compliance and Operations Management in the Medical Device & Human Cellular Products Industries.
    Clay has expertise in Developing Strategic Regulatory Approaches for Products that include Class II &Class III Medical Devices, Drug & Device Combination Products, Human Tissue Products & In-Vitro Diagnostic Products.
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  • Mr. Daniel B. Floyd, B.S. RM(NRM) is the Sterilization Section Leader at Nelson Laboratories, Inc.  For the last 16+ years Dan has specialized in all aspects of EO validations including cycle development, D-value determinations, bioburden resistance studies, biological indicator sterility testing, BI incubation reduction studies, comparative resistance testing, PCD development, and temperature and humidity distribution studies.  Dan has performed onsite validations of sterilizers domestically and abroad both at contract sterilization facilities as well as for customers sterilizing product in house.  Recently Dan has become involved with vaporized hydrogen peroxide sterilization validations and has had experience with EO, steam, dry heat, vaporized hydrogen peroxide, liquid chemical sterilants, and ozone sterilization.
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  • Karen Ginsbury, B.Pharm. M.Sc. MRPharmS.
    With strong experience of more than 20 years both working in pharmaceutical and biotechnology companies, and as a consultant, Karen Ginsbury has assisted numerous corporations with their Quality needs. As President and CEO of her own consultancy firm, PCI Ltd. Karen has accompanied companies from pure R&D through clinical trials to pre-approval inspections and subsequent ongoing compliance inspections by European and FDA auditors as well as other regulators.
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  • Prof. Nelu Grinberg is a Distinguished Scientist in the Chemical Development Department at Boehringer Ingelheim Pharmaceuticals in Ridgefield, CT. Prior to this, he worked for sixteen years in the Analytical Department at Merck Research Laboratories in Rahway, NJ, where he was a Senior Research Fellow. He has authored and coauthored over 80 publications, including articles and book chapters.
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  • Dr. Barbara Jentges is founder and Managing Director of PhACT (Pharmaceutical Advice, Compliance & Training specialised in Drug Regulatory Affairs) GmbH, Switzerland.
    Dr. Jentges is a pharmacist with more than 19 years experience in the Regulatory Affairs field, who worked for many years as an external assessor of the Federal Institute for Drugs and Medical Devices (BfArM), Germany. Dr. Jentges is co-author and co-editor of the Guide to Drug Regulatory Affairs, published by Editio Cantor Verlag, Aulendorf, Germany. 
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  • Ana T. Menendez, Ph.D., is Senior Director of Bioassays and Biosafety Testing at Catalent. She is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Dr. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers.
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  • Dr. Malcolm Ross is the Managing Director of Generapharm-Consulting specialising in training, project management and research and development in the Generics industry.

    Malcolm holds a B.Pharm and Ph.D from London University, was a lecturer in Pharmacognosy at the Welsh School of Pharmacy and a Senior Lecturer in the Dept. of Chemistry at Bar-Ilan University.
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  • Mr.Stephen Schwartz - founder of Solaris Research Corporation, Steve has a background in basic virology research, progressing into 10 years clinical research program administration in the pharmaceutical industry.  Entering the CRO industry, he performed clinical monitoring and clinical quality assurance field service using that expertise to achieve a management position at the director level. 10 years of CRO experience culminated in the formation of his full service CRO in 1989, under the initial name of Commonwealth Clinical Research Corporation- now Solaris Research Corp. Steve has also served as the investigator of several phase IV clinical trials and a member of an Institutional Review Board.
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  • Dr. Edward J. Smith, Ph.D. is Principal at Packaging Science Resources which provides consulting and training in packaging for the pharmaceutical, biotechnology, and medical device industries.  Ed retired from Wyeth Pharmaceuticals in 2008, where he headed a team responsible for the development and qualification of cold chain packaging systems for transporting temperature-sensitive drug products.
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  • Dr. Monica Tocchi serves as the Executive Medical Director of an international contract research organization, Meditrial, and works with leading medical industry companies in developing and managing their clinical studies. She is a physician with a specialization in cardiology and a Ph.D. in Cardiovascular Pathophysiology. She has served as a clinical investigator at prestigious medical centers in Europe and the US. Dr. Tocchi has authored landmark studies published in peer-reviewed US scientific journals.
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  • Mr. Martell Winters has been at Nelson Laboratories for 13 years where he specialized in bioburden testing, sterility testing, bacteriostasis/fungistasis (B/F) testing and assisting customers in evaluating and interpreting validation and dose audit data.  He is currently a Study Director and External Consultant for Nelson Laboratories where he spends most of his time assisting customers with validation issues, test of sterility failures, adjusting and/or revalidating sterilization doses, investigating bioburden problems, assisting in implementing microbiological corrective action and writing procedures/rationales for customer’s validation files.
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