USP Pharmacopeial Education Faculty
D. Scott Aldrich
President, Ultramikro, LLC
B.S. Biology, Western Michigan University, Kalamazoo, MI
McCrone Research Institute micro–analytical training
Scott, who is a member of the 2005–2010 USP Parenteral Products—Industry Expert Committee, has extensive skills and deep experience in contamination analyses for a broad array of pharmaceutical products with a rich history of success in many aspects of pharmaceutical product development. He is a recognized expert in pharmaceutical particulate matter control using solid-state analytical approaches. He has demonstrated problem-solving capability in industrial domestic and foreign project assignments, often chairing multi-disciplinary scientific teams to bring a unified conclusion to particulate matter issues. Scott is an experienced teacher and lecturer in microanalytical disciplines, primarily optical microscopy, electron microscopy, and infrared spectroscopy. He is also knowledgeable in optical crystallography, particle size, physical character determination, X-ray diffraction, and thermal analysis.
Fouad Atouf
Scentific Liaison, Cell, Gene, and Tissue Therapies Expert Committee, USP
Ph.D., Cell Biology, Pierre & Marie Curie University, Paris, France
Dr. Atouf Joined the United States Pharmacopeial Convention (USP) in 2006, to serve as a scientific liaison to the Cell, Gene, and Tissue Therapies Expert Committee. He possesses a strong background in Cell and Molecular Biology with considerable research experience in cell and tissue culture applications as well as in the development of cell-based assays and methodologies for analysis of protein, nucleic acids, and enzymatic assays. Dr. Atouf is responsible for the development of compendial standards for cellular and tissue-based products to be included in the USP–NF book of standards. He is also involved with standards setting activities for other biologics, i.e. blood and blood products, biotechnology derived articles, and ancillary materials used in cell manufacturing. In addition to his work on monographs and chapters development, Dr. Atouf supports the International Activities Group at USP with the coordination of USP activities in the Middle East and North Africa Region. Before joining USP, he worked at the National Institutes of Health, his research focused on the development of methods for the in vitro generation of pancreatic islets cells, as potential strategies of cell-based therapies for diabetes. Prior to that, he was a fellow of the Howard Hughes Medical Institute, at the State University of New York, where he studied mechanisms involved in the development of neuronal cells. Dr. Atouf is the author of original scientific articles published in peer-reviewed journals; he is also an experienced speaker at national and international seminars, meetings and conferences.
Daniel Bempong
Senior Scientist, Department of Standards Development
M.Sc., Pharmaceutical Analysis and Quality Control, Kings College, University of London
Ph.D., Pharmaceutical Analysis, University of Georgia
Having joined USP as a laboratory chemist in 1997, Daniel transferred to the Department of Standards Development where he now serves as liaison to the Monograph Development—Pulmonary and Steroids Expert Committee. He began his career at the NCI Laboratory at the University of Kansas developing analytical methods and performing preformulation studies and stability studies. Over the years, he has developed dissolution methods for several drugs and used compendial dissolution methods to screen pharmaceutical products and assess shipping and storage conditions. Daniel has co-authored several articles and presented papers internationally on a variety of subjects, including the identification of labile preparations, dissolution testing, and analytical method development.
Anthony C. Bevilacqua
Director of Research and Development, Mettler–Toledo Thornton
Ph.D., Analytical and Physical Chemistry, Tufts University
Anthony Bevilacqua has been leading Thornton in the development of sensors and instrumentation, specializing in measurements that monitor the purity and physical attributes of ultrapure water systems. Since 1994, Anthony has been supporting the USP to be a center of expertise for the quality, control, and standards for Pharmaceutical Water quality and water systems. Anthony was the Chair of the USP Pharmaceutical Water Expert Committee from 2000–2005, and has been re-elected to another 5-year term. He has been cooperating with EP, JP and other Pharmacopeias on international harmonization of pharmaceutical water quality standards.
William E. Brown
Senior Scientist, Department of Standards Development
B.S., Chemistry, University of Maryland
Will joined USP's Drug Research and Testing Laboratory as a chemist in 1981. In the lab, he participated in an FIP evaluation of the use of the USP prednisone and salicylic acid calibrator tablets in the flow-through cell and was involved in the design and evaluation of dissolution and drug release tests for a variety of dosage forms. In 1997, Will moved to the Department of Standards Development where he currently serves as liaison to USP's Expert Committee on Biopharmaceutics and to the Expert Committee on Pharmaceutical Dosage Forms. Here, he has been instrumental in developing and organizing the first USP-controlled collaborative study to determine ranges for calibrator tablets. Will has also been active in harmonization efforts directed at General Chapters on dissolution and disintegration.
Kevin H.X. Cao
Senior Customer Relationship Manager, USP–China
B.S., Economics, Shenyang Pharmaceutical University
M.B.A., East China University of Science and Technology, China
Kevin Cao is Senior Customer Relationship Manager of USP–China. He joined USP–China in March 2007. He works for the customers in mainland China, Taiwan, Hong Kong, Macau, and Singapore, to provide technical support and USP comprehensive standards solutions.
Kevin is a USP Professional Education faculty member qualified by USP HQ. He has delivered several courses in mainland China and Taiwan and has received a wide range of positive feedback. His course topics have included “Effectively Using USP–NF,” “Effectively Using Reference Standards,” “Dissolution: Theory and Best Practices,” and others.
Prior to USP, Kevin spent more than 9 years in China’s pharmaceutical industry and had well-rounded experience in strategic planning, new product and market development, and quality assurance.
Antonio Hernandez-Cardoso
Scientist, Latin American Specialist, USP
M.Sc., Clinical and Epidemiological Research, Autonomous National University of Mexico
B.Sc., Chemist Pharmacist Biologist, Autonomous National University of Mexico
Since July 2005, Antonio has worked at USP providing general scientific support within the Department of Standards Development (DSD), assisting in the development and revision of general chapters and responding to internal and external queries related to USP–NF. Antonio brings fourteen years’ experience in pharmacopeial issues working for the Mexican Pharmacopeia developing the Allopathic, Homeopathic, and Herbal Pharmacopeias, and special publications for medical devices and drugstores. He has taught compendial topics to the pharmaceutical industry and general pharmaceutical topics at the National Autonomous University of Mexico.
Todd L. Cecil
Vice President, Compendial Science Department, USP
B.S., Chemistry, University of Iowa
Ph.D., Analytical Chemistry, Virginia Commonwealth University
Dr. Cecil has worked at USP since 1991 in a number of increasingly responsible positions. He started in the USP Drug Research and Testing Laboratory, working on dissolution studies for Conjugated estrogens and vitamins and minerals. In 1993, he moved to the Division of Standards Development as Scientific Liaison for several monograph committees. In 2000, he moved into USP management, initially with monographs, later with General Chapter development. In 2005, Dr. Cecil was promoted to Vice President in the Documentary Standards Division. In addition, Dr. Cecil has been active in the Analysis and Pharmaceutical Quality Section of the American Association of Pharmaceutical Scientists.
Before joining USP, Dr. Cecil was a consultant, testing rocket fuels with NASA at the Naval Research Laboratory.
Holly Chang
Senior National Account Manager
B.S., Chemistry, West Virginia University, Morgantown, WV
Holly joined USP in 1999 and became part of the USP Account Management Team in December 2007. Previously, she worked in the USP Reference Standards Laboratory characterizing and analyzing USP Reference Standards. As a National Account Manager, Holly uses her laboratory experience to assist customers in understanding and using USP resources efficiently and effectively.
Paul J. Cowan
Senior National Account Manager, Sales and Marketing, USP
B.S., Industrial Administration and Marketing, Iowa State University
Paul joined the USP Sales and Marketing team in 2002. For over 18 years, he has served in high-level national sales positions providing analytical instrumentation and supplies to the pharmaceutical, biotech, and medical diagnostic industries. Having worked with both start-up and established companies, Paul's well-rounded knowledge of industry sales management and product development is a great asset in relating to the needs of USP educational program participants.
Ashok Dang
Customer Relationship Manager, USP–India M.Sc. (Hons), Chemistry, Panjab University, Chandigarh
M.B.A., Marketing, MD University, Rohtak
Ashok joined USP–India in April 2006. Previously, he spent more than 8 years in marketing for the pharmaceutical industry, most recently serving as a senior product specialist at a leading international analytical instrumentation manufacturer. At USP, Ashok helps cultivate, expand, and manage USP customer relationships in the India region.
Behnam Davani
Senior Scientist and Liaison to the USP Expert Committee
M.S., Analytical Chemistry, University of Iowa
Ph.D., Analytical Chemistry, New Mexico State University
Postdoctoral Fellow, U.S. Department of Energy, West Virginia
M.B.A.., Webster University, St. Louis, Missouri
Dr. Davani joined USP in 1999 as the Scientific Program Manager for the USP Industry Outreach. He has presented compendial topics related to monograph development and revision process, USP Reference Standards, and other USP initiatives. In 2002, he accepted his present responsibility in the Department of Standard Development as the Liaison to the USP Expert Committee for Monograph Development—Antiviral and Antimicrobials. He works with the USP Expert Committee, industry, FDA, and other scientific organizations to develop and revise monographs for drug substances and products.
Prior to joining USP, Dr. Davani worked in industry for twelve years in various technical management positions in quality control/quality assurance, analytical method validation, technology transfer, and stability studies. He is a member of the American Chemical Society and the American Association of Pharmaceutical Scientist.
James E. DeMuth
Professor, School of Pharmacy, University of Madison–Wisconsin
B.S., Pharmacy, Drake University
M.S., Pharmacy Continuing Education, University of Madison, Wisconsin
Ph.D., Pharmacy Continuing Education, University of Madison, Wisconsin
In his professorship at the University of Wisconsin–Madison's School of Pharmacy, Jim is responsible for the development, implementation, and evaluation (relying heavily on statistical methodology) of continuing education offerings for pharmacists and pharmaceutical industry professionals in the U.S. Jim has authored more than 35 research articles and Basic Statistics and Pharmaceutical Statistical Applications (currently in the second edition). He has taught more than 120 statistical short courses in the U.S., Canada, Puerto Rico, Western Europe, and the Middle East. Jim received the Rufus A. Lyman Award for most notable original research and/or scholarly work published in the American Journal of Pharmaceutical Education and the American Association of Colleges of Pharmacy's William A. Blockstein Award for contributions to the field of continuing pharmaceutical education. He serves as current (2005–2010) chair of the USP General Chapters Expert Committee.
Anthony DeStefano
Vice President of General Chapters, USP
B.S., Chemistry, Villanova University
M.S., Physical Chemistry, Cornell University
Ph.D., Physical Chemistry, Cornell University
Tony DeStefano began his career at Procter & Gamble’s Miami Valley Laboratories in mass spectrometry Cincinnati, OH. After P&G acquired Norwich Eaton Pharmaceuticals, he moved to Norwich NY and managed Physical Measurement and Method Development Sections as well as the pharmaceuticals reference standard program for several years. In 1991, he established Norwich’s first Bioanalytical Section. In 2002, he returned to Cincinnati to manage the bioanalysis programs for several large clinical studies. He has spoken and written extensively in the areas of regulated bioanalysis and analytical and bioanalytical outsourcing. He retired from P&G in January of 2008 and joined the US Pharmacopeia as its Vice President of General Chapters. At USP, he is leading initiatives to maintain, update and redesign the General Chapters. Major efforts include the replacement of USP’s Heavy Metals General Chapter <231> and the development of new product quality and product performance chapters. He is a member of the ICH Q3D Expert Working Group on metal impurities, a member of the American Chemical Society (ACS), on the Board and Technical Steering Committee Chair-Elect of the Product Quality Research Institute (PQRI), and actively involved in the American Association of Pharmaceutical Scientists (AAPS), holding leadership positions in the Bioanalytical Focus Group, the APQ Section and Annual Meeting programming committees for 2009–2011.
Nelson dos Santos
Biography to come
Shawn Dressman
Biography to come
Michael N. Eakins
Vice-Chair, USP Packaging and Storage Expert Committee
Principal Consultant, Eakins & Associates
Ph.D., London University
Dr. Michael N. Eakins is the Founder and Principal Consultant of Eakins & Associates with over 25 years’ experience in pharmaceutical research and development. At Eakins and Associates, Michael provides experience and advice on parenteral drug development especially in the use of plastic primary packaging, pre-filled syringes and in the application of anti-counterfeiting technologies and strategies and regularly lectures on these topics worldwide. Michael has presented on global drug counterfeiting, anti-counterfeiting technologies and pharmaceutical containers to the USP’s Annual Scientific meetings in 2007, 2008 and 2009, respectively, chaired PharmaEd Resources conferences on pre-filled syringes in 2008 and 2009 and the Parenteral Drug Association’s 2006 and 2007 Pharmaceutical Anti-Counterfeiting Forums.
Michael joined the Squibb Research Institute in the USA in 1980 becoming Director of Diagnostics Development with Bristol–Myers Squibb before moving to Bracco Research USA, where he was Senior Director responsible for the strategic development of new packaging within R&D and then Senior Director of the International Packaging Center for Bracco’s Corporate Worldwide Sales and Marketing Group. Michael obtained his Ph.D. from London University and has contributed to 56 publications and holds eight USA patents.
Joseph Eaton
Senior Chemist II, Dosage Form Performance Laboratory, USP
B.S., Chemistry, Virginia Polytechnic Institute and State University
Joe joined USP in 2002 as a chemist in the Research and Development Laboratory and currently works in the Dosage Form Performance Laboratory. His primary focus has been in the area of dissolution testing using Apparatus 1 and 2. He also has experience in dissolution methods using Apparatus 3 and Apparatus 4.
L. Valentin Feyns
Consultant to U.S. Pharmacopeia
B.S., Chemical Engineering, Polytechnic Institute, Bucharest, Romania
Ph.D., Organic Chemistry, Polytechnic Institute, Timishoara, Romania
Dr. Feyns served as a Scientific Fellow of the Monograph and Reference Standards Development Department at the United States Pharmacopeia in Rockville, Maryland. After a post-doctoral Fogarty International Visiting Fellowship at the National Cancer Institute of the National Institutes of Health in Bethesda, Maryland, Dr. Feyns joined the Drug Research and Testing Laboratory of the United States Pharmacopeia in 1978 where he was the Supervisor of the Methods Development Group at its inception in 1981. In this position he was responsible for developing and validating official analytical methods, investigating complaints regarding compendial procedures, and evaluating candidates for USP Reference Standards. In 1992 he transferred to the Reference Standards Operation at USP, where he was Associate Director for Scientific Operations, Acting Director of the Reference Standards Operation, and Director of the Reference Standards Evaluation Group, the group that initiates, monitors and reviews the evaluation of candidates for the entire collection of USP Reference Standards. He was also liaison with the USP Reference Standards Committee and in charge of USP Scientific Outreach Programs.
Dr. Feyns made major contributions to the publication by USP of the "Structure Index for USP–NF" and to the "Chromatographic Reagents Used in USP–NF." He is author or co–author of over 70 papers, podium and poster presentations, of two monographs in the "Analytical Profiles of Drug Substances", and of two patents. He was on the faculty of the "Analytical Biotechnology" seminar organized by Professors Karger and Reigner. He is a member of the American Chemical Society and a "founding member" (1986) of the Association of the American Pharmaceutical Scientists. Dr. Feyns retired from USP in November 2006, but continues to work as a consultant.
Alex Fiechter
Senior International Account Manager, Switzerland, Germany, and Eastern Europe, USP
Alex joined USP in 2005. His work experience includes seven years as a pharmaceutical quality control chemist and eight years with the SOTAX group—four years as a sales representative, and four years as sales manager for the Europe/Asia distributor markets business unit. Alex's work with different pharmaceutical markets is beneficial in meeting the varied needs of our customers.
Mary G. Foster
Vice-President of Quality Programs, Catalent Pharma Solutions
PharmD, University of Kentucky
B.S., Pharmacy, University of Kentucky
B.F.A., Western Kentucky University
Teaching Certificate, Western Kentucky University
Dr. Foster is a senior level Regulatory/Quality professional with 25+ years’ experience in human pharmaceutical /biotechnology, veterinary, and OTC monograph products; dietary supplements/neutraceuticals/foods; medical devices and cosmetics all in one or a combination of regulatory compliance, regulatory affairs, quality control and quality assurance capacities for manufacturing, packaging, holding and transportation of product encompassing global operations. She is currently the Vice-President of Quality Programs at Catalent Pharma Solutions. She has expertise in USA FDA drug current good manufacturing practices (cGMP) and device Quality System development and implementation; in-depth experience with Canadian, South American countries and EU cGMP; and, interface with Australia and Japan in development of compliance programs. Dr. Foster is a member of the USP 2005–2010 Expert Committee on Packaging, Storage and Distribution of Drug Product. She is a subject matter expert in global transportation practices, as well as, in creating and maintaining compliant regulatory USA Drug Enforcement Administration environment.
Gabriel I. Giancaspro
Director, Dietary Supplements Group, Department of Standards Development, USP
Degree of Pharmacy, Buenos Aires University
Ph.D., Medicinal Chemistry, Buenos Aires University
Gabriel joined USP in 1997 as a scientific liaison for Latin American countries and chemistry Expert Committees. Two years later, he moved to the Dietary Supplements Division to serve as a liaison for dietary supplements with an emphasis on botanicals, non-botanicals, and bioavailability. Today, he is director of the Dietary Supplement Group. Prior to working at USP, Gabriel spent seventeen years as professor of drug stability and drug quality control in the pharmacy school at Buenos Aires University. In addition to academia, he has worked in private industry as a technical director for Schwabe Argentina and as a director of research and development for Laboratorio Kampel Martian SA.
Wanderson Guimaraes
Biography to come
Barbara B. Hubert
Director, USP Sales, Sales and Marketing
B.S., Chemistry, Virginia Commonwealth University
M.B.A, Management of Science, Technology and Innovation, George Washington University
For the past 25 plus years, Barbara has lent her scientific expertise and industry acumen to various aspects of USP operations. Before joining the Sales and Marketing department, she served as a USP scientific liaison in the areas of pharmaceutical analysis, dissolution, bioavailability, and General Chapters; was the Assistant Director of the Department of Standards Development; and acted as Director of the Executive Secretariat. Prior to USP, Barbara spent seven years honing her analytical research and development skills at Philip Morris Research and A.H. Robins Company. Barbara's research experience and interests include analytical method development; development of dissolution and drug release compendial standards for conventional and modified-release dosage forms; and establishment of purity standards for USP monographs. She has published papers and lectured internationally on drug purity and quality, dissolution and bioavailability of drugs, and USP and the standards development process. A charter member of the American Association of Pharmaceutical Sciences (AAPS), Barbara has served as chair of its Analysis and Pharmaceutical Quality section, on the Executive Council, and on numerous other AAPS committees. She is also a member of the American Chemical Society.
Desmond G. Hunt
Scientific Liaison, Department of Standards Development (DSD), USP
M.S., University of Texas at Austin, Austin, TX
Ph.D., University of Texas at Austin, Austin, TX
Dr. Desmond G. Hunt is a Scientific Liaison in the Department of Standards Development (DSD) at the United States Pharmacopoeia. For the 2005–2010 revision cycle, he was responsible for assisting USP Expert Committees, Packaging, Storage and Distribution and Parenteral Products—Industrial, in the development and revision of USP General Chapters. Dr. Hunt has over 15 years of research experience and prior to joining USP, in 2005, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA.
Dr. Hunt has conducted a number of studies relating to the development and establishment of public standards for materials used for pharmaceutical packaging systems and helped develop Pharmacopeial Education Courses on pharmaceutical packaging and the determination of particulate matter in parenterals and ophthalmic products. He is a member of the American Association of Tissue Banks Container & Packaging Qualification Task Force and the Product Quality Research Institute Container–Closure and Extractable and Leachable Working Groups.
R. Karthik Iyer
Customer Relationship Manager, USP–India
B.Sc. (Honors), Bio-Sciences, Sri Sathya Sai Institute of Higher Learning, Prasanthi Nilayam
M.Sc., Microbiology, University of Mumbai, India
Before becoming part of the USP–India team in November 2008, Karthik gained more than six years of experience in the marketing and sales of high-end life science products throughout India, serving most recently as a regional sales manager for a large, international laboratory instrument distributor. Karthik’s familiarity with India’s diverse markets, along with his scientific acumen, enhances his ability to establish and maintain strong relationships with USP customers.
Johannes Krämer
Phast Gmbh
Degree in Pharmacy, Frankfurt University
Ph.D., Pharmaceutical Technology and Biopharmacy, Heidelberg University
Johannes is an elected member of the USP Biopharmaceutics Expert Committee and Chair of the Ad Hoc Advisory Panel Proficiency Tests—Mucosa, as well as member of the Ad Hoc Advisory Panel Proficiency Testing. With the International Pharmaceutical Federation's he is a member of the Special Interest Group on Dissolution/In Vitro Release Performance Testing. He is also a member of the American Association of Pharmaceutical Scientists, the Biopharmaceutics Group within APV (International Association for Pharmaceutical Technology), and the Deutsche Pharmazeutische Gesellschaft (DPhG).
In addition to lecturing and teaching worldwide on dissolution and IVIVC curses, he has published several books on the same topics. Johannes is also the founder and managing director of PHAST laboratories and Flexible4science.
Jim Lu
Quality Assurance Manager, USP–China
Jim Lu is the QA Manager of USP–China, responsible for managing the quality system of the lab and other operations in USP–China. Under his leadership, USP–China has successfully received ISO17025 Accreditation and ISO9001 Certification. Before joining USP, he has worked for Bristol–Myers Squibb (BMS) for more than 10 years in charge of quality control department.
Edward G. Malawer
President, Malawer & Associates Consulting, LLC
B.S., Chemistry, City College of New York
M.S., Physical Chemistry, New York University
Ph.D., Physical Chemistry, New York University
Dr. Malawer is presently consulting with both the USP's Pharmaceutical Education and Verification Departments. He is currently developing a short course for the USP on excipient quality and supply chain integrity. He had previously taught for the USP at a workshop on the <467> Residual Solventsgeneral chapter. Dr. Malawer is a member of the advisory panel developing a new general chapter, <1197> Good Distribution Practices for Bulk Pharmaceutical Excipients. Additionally, Dr. Malawer serves on the USP's newly formed Pharmaceutical Education Programming Committee. Until 2007, Dr. Malawer had been a VP at International Specialty Products responsible for analytical R&D, quality assurance, product stewardship and the technical library. He holds a Certified Quality Auditor credential from the American Society for Quality. His consulting practice specializes in cGMP pharmaceutical supplier auditing as well as process analytical chemistry problem solving. He also teaches a course for the American Chemical Society entitled "Introduction to Process Analytical Technology". He holds ten
granted U.S. patents and has authored 35 peer-reviewed publications including several textbook chapters.
Margareth R.C. Marques
Senior Scientist, Department of Standards Development, USP
M. Sc., Pharmacy, University of São Paulo
Ph.D., Analytical Chemistry, State University of Campinas, Brazil
Margareth joined USP's Department of Standards Development in 1999 and presently serves as a liaison for the Expert Committee on Biopharmaceutics and the Expert Committee on Pharmaceutical Dosage Forms. In addition, she is the primary liaison for reagents and Chromatographic Reagents and serves as a liaison to Latin America. Before coming to USP, Margareth was a laboratory manager in active pharmaceuticals for Ciba–Geigy and Sandoz and was the quality control manager at Astra Brazil.
Gregory P. Martin
Vice-Chair, USP General Chapters Expert Committee
B.S., Chemistry, Drexel University
M.Sc., Analytical Chemistry, Villanova University
Greg is a Director in Pharmaceutical Analysis and Control, Pharmaceutical R&D at Merck Research Laboratories in West Point, Pennsylvania. Supporting new product development, his primary responsibilities include release and stability testing of products under development during early phases. He has related responsibilities for excipients and comparators. His interests include dissolution and harmonization of excipient requirements and the specifications process.
Laura McCurry
Senior National Account Manager, Inside Sales, Sales and Marketing, USP
B.S., Chemistry, State University of New York, Albany
M.S., Analytical Chemistry, State University of New York, Binghamton
Laura has over 11 years of experience in the testing and characterization of USP Reference Standards. She joined USP in 1989 as a chemist, served as Group Leader in the Drug Research and Testing Laboratory, then transferred to USP's Reference Standards Laboratory in 1998. Laura's experience includes providing laboratory support for compounding; harmonization; packaging, storage, and distribution; and dietary supplements. In addition to laboratory experience, she has served as USP's Manager of Pharmacopeial Education and recently worked in the pharmaceutical industry as a quality engineer and quality control laboratory manager of raw materials, training, and instrumentation groups.
Doreen McDonald
Senior National Account Manager, Inside Sales, Sales and Marketing, USP
B.A., Chemistry, State University of New York, Cortland
Doreen joined USP in 1999 and has worked in and closely with the Reference Standards and monograph development groups throughout her tenure. As a Senior National Account Manager, Doreen applies her understanding of customers’ needs to help them work efficiently and effectively with USP. Prior to joining USP, she worked as an analytical method development chemist at WR Grace. She also taught high school chemistry for two years.
Jeffrey Moore
Chemist III, USP
Senior Scientific Associate in the Department of Standards Development, USP
B.S., Food Science/Food Chemistry, Michigan State University
Ph.D., Nutraceutical and Functional Food Chemistry, University of Maryland
Jeffrey comes to USP after completing his dissertation. His dissertation involved analytical method development for in-vitro antioxidant capacity estimation and development and evaluation of new techniques to improve the bioavailability of antioxidant compounds found in wheat. Prior to his Ph.D. program, Jeff worked as a Food Technologist for Nestlé in Solon, OH. Jeff has published 11 peer reviewed manuscripts and authored two book chapters.
Horacio N. Pappa
Senior Scientist, Department of Standards Development, USP
Degree of Pharmacy, Buenos Aires University
Ph.D., Pharmaceutical Chemistry, Buenos Aires University
Horacio has been with USP since 2003. He is the scientific liaison to both the Expert Committee on General Chapters and the Expert Committee on Statistics. Prior to joining USP, he worked in the pharmaceutical industry for six years in QA/QC. Horacio also served as the assistant professor of quality control in the Faculty of Pharmacy at Buenos Aires University and was the Executive Secretary of the Argentine Pharmacopeia from 1997–2001. He is a Quality Engineer certified by the American Society for Quality.
Steven Paul
Marketing Director, Pharmaceuticals, USP
B.S., Chemistry, Northern Illinois University
M.S., Analytical Chemistry, Northern Illinois University
Steven joined the USP Sales and Marketing team in 2004 and, in 2010, became USP’s Marketing Director for Pharmaceuticals. Before coming to USP, Steven acquired over thirteen years of analytical instrument industry experience with Perkin–Elmer and Thermo Electron in sales, marketing, and product management roles. Steven's marketing expertise is complemented by previous scientific experience gained in laboratory management and bench–level chemistry work with G. D. Searle & Company and Abbott Labs.
David A. Porter
Pharma Consultant, Vectech Pharmaceutical Consultants, Inc.
B.S., Biology, Beloit College
M.S., Biology, University of North Dakota
Ph.D., Zoology, University of California at Berkeley
David joined the Department of Standards Development in 2000 where he currently supervises a broad range of activities regarding General Chapters. David previously acted as a scientific liaison to the USP Council of Experts, industry, government and academia in the areas of biologicals, biotechnology, gene therapy, cell engineering, microbiology, devices and diagnostics, toxicity testing, biocompatibility, and alternatives to animal testing. In 2004, he was named Director of the General Policies and Requirements division (now the General Chapters Group) that oversees the development and revision of the majority of USP–NF General Chapters. David began his industrial career managing the areas of microbiology and toxicology at Bausch & Lomb where his activities included R&D, QA, developing and performing in vitro toxicology methods, and monitoring animal toxicology studies. He also managed biostatistics for their clinical affairs group, which developed statistical protocols and performed statistical analyses of both clinical and laboratory data. After leaving Bausch & Lomb, David developed numerous new analytical methods as the leader of the biological science section of Advanced Concepts at Revlon.
Ravi Ravichandran
Senior Scientist, USP
Ph.D., Analytical Chemistry, University of Louisville in Kentucky
Ravi has over 20 years of experience in both industry and government. His industrial experience includes several years in diagnostics and pharmaceutical industry where he gained experience in analytical methods development for both raw materials and finished product characterization, methods-technology transfer to manufacturing sites, and QC laboratory management. He has worked in Indian Atomic Energy research program, studying the applications of nuclear gamma resonance spectroscopy for the study of corrosion products in nuclear power reactors.
Ravi is published in over 20 publications and has been very active in the American Chemical Society—Indiana, Minnesota and Washington, DC sections. In addition, he has served as the President of the Minnesota Chromatography Forum. He serves on the Board of Washington Chromatography Discussion Group.
Min Ren
Verification and Testing Services Manager, USP–China
ASQ Certified Auditor
Min Ren joined USP–China in Oct 2007. In his current role as Verification & Testing Services Manager, Min is responsible for providing technical support of local verification participants including manufacturers of active pharmaceutical ingredients, excipients, dietary supplement ingredients and dietary supplements. He is ASO certified auditor, and he also support the customers’ needs for testing services in Greater China region. Min has more than 10 years of experience in pharmaceutical quality control and quality assurance. Prior to USP, he worked in various multinational pharmaceutical companies including Roche Vitamin, Boehringer–Ingelheim and Wyeth Nutrition.
Benoît Rime
Senior International Account Manager, France, Belgium, The Netherlands, and North Africa
B.S., Chemistry, University of Bordeaux, France
B.A., Business Administration, University of Paris–Sorbonne, France
Benóit joined USP in 2006. He has more than 15 years' experience in specialty chemicals and engineering thermoplastics. He previously held positions in technical sales, global account management, and application development at several major global companies, including General Electric. Benoît's wealth of experience helps him forge strong relationships and anticipate customer needs.
Karen A. Russo
Director, Small Molecules and Monograph Acquisition—Department of Standards Development, USP
B.S., Chemistry and Biology, Murray State University
Ph.D., Pharmacology, University of Missouri—Kansas City
Karen joined USP in 2002 and has developed public standards for various drug substances and dosages forms. She serves USP in a coordinating role with the pharmaceutical industry for monograph development and acquisition efforts. Karen oversees a staff of scientific liaisons working with the USP Council of Experts to provide the scientific content for monographs. She is also responsible for oversight of databases and applications that manage the monograph acquisition and revision workflow.
Karen worked at Midwest Research Institute (Kansas City, MO) for 12 years and gained experience in project management involving method development and validation of drugs from various therapeutic categories. She also managed projects involving chemical characterization of drug substances and stability studies for dosage forms. Karen also worked at Regulatory and Clinical Consultants, Inc. as a clinical research associate responsible for monitoring human Phase II and Phase III clinical trials. She is a member of the American Association of Pharmaceutical Scientists.
Nancy C. Sajjadi
Quality Consultant, Sajjadi Consulting
M.Sc., Microbiology, University of British Columbia
B.Sc. (Honours), Microbiology, University of British Columbia
Nancy Sajjadi is an independent consultant with over 20 years’ experience in biopharmaceutical product development. She has provided consulting services to more than 25 clients, ranging from venture capital backed start-up companies to major pharmaceutical manufacturers.
Operating from a firm belief that well documented, good science is the foundation for development of any successful product, she works effectively with scientists, engineers and non-technical staff and interfaces with quality control, quality assurance and regulatory affairs departments to develop effective regulatory strategies and meet compliance requirements. She encourages clients to develop programs designed to meet their business needs by taking into account such factors as the stage of product development, critical path timelines, and available personnel and budget constraints.
With extensive experience in gene therapy product development, she understands that application of regulations for some types of products and services may not be able to follow an “off-the-shelf” approach. She encourages clients to take a leadership role in establishing high quality standards for their products.
John Santell
Director of Quality and Safety, Meds by Mail–CHAMPVA, Department of Veterans Affairs
B.S., Pharmacy, Duquesne University
M.S., Hospital Pharmacy Administration, The Ohio State University
Leadership in Healthcare Administration, Thunderbird International Management, Graduate School
Pharmacy Leadership Institute, Boston University
As the Director of Quality and Safety, Mr. Santell is responsible for providing oversight, coordination, and leadership in developing and managing all quality and patient safety initiatives for the national Meds by Mail program which is part of the Veterans’ Pharmacy Benefits Services. John is the program’s recognized subject matter expert and formulates policies relating to quality and safety programs and exercises independent authority to ensure organizational and individual compliance. John is a former Director of Pharmacopeial Education at USP. Prior to USP John was Director, Center on Pharmacy Practice Management at the American Society of Health-System Pharmacists and previous to that was Manager of Quality Assurance/Central Operations, Grant Medical Center, Columbus, OH.
Timothy Schofield
Director, U.S. Regulatory Affairs, GlaxoSmithKline
USP Bioassay Validation ad hoc Panel
B.S., Mathematics, Lafayette College
M.A., Statistics & Operations Research, University of Pennsylvania
Timothy Schofield is a Director in the U.S. Regulatory Affairs department of GlaxoSmithKline, where he provides regulatory support to vaccines. Prior to joining GSK Tim worked at the Merck Research Laboratories heading the Nonclinical Statistics unit, supporting development and manufacture of Merck pharmaceuticals, biologics, and vaccines. In addition to his service to GSK, Tim has held several positions on industry and regulatory committees. He was elected to the PhRMA Biostatistics and Data Management Technical Group in 2002 where he represented nonclinical statistics for 3-years, and is an active member of the PhRMA CMC Statistics Expert Team since 2004. Tim also served as liaison to the PhRMA Biologicals and Biotechnology Subcommittee, where he was co-chair of the Specifications and Formulation Working Group. In that role he led efforts to publish a PhRMA white paper on A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology–Derived Products. He is also a coauthor on a white paper on Quality by Design for Biotech Products. Tim is a member of the USP Bioassay Validation ad hoc Panel, and lead author of Chapter <1033> Bioassay Validation.
Leon Shargel
Affiliate Associate Professor, School of Pharmacy
Ph.D., Pharmacology (Minors: Physiology, Biochemistry, Drug Metabolism), The George Washington University, Medical Center, Washington, DC
B.S. (Cum laude), Pharmacy, University of Maryland, Baltimore, MD
Leon has over thirty years of experience in the pharmaceutical industry, with a wealth of knowledge in Applied Biopharmaceutics and Pharmacokinetics. He has published dozens of research papers on topics ranging from Bioavailability to covering the cost of prescriptions under Medicare. Additionally, Dr. Shargel has held several high-level teaching positions at various universities, as well as a number of positions within industry. Leon's combination of extensive industry knowledge and his ability to teach make him a valuable addition to the PE faculty.
Catherine M. Sheehan
B.Sc., National University of Ireland, University College Cork
M.S., Bioscience Regulatory Affairs, Johns Hopkins University
M.S., Biotechnology, Johns Hopkins University (currently pursuing)
Ms. Sheehan is Director of Excipients in the Foods, Dietary Supplements and Excipients, Documentary Standards Division, at USP. In her current role, she is responsible for development and modernization of excipient monographs and related chapters, and participates in the Pharmacopeial Discussion Group’s compendial harmonization of excipient monographs and related chapters. In her current position, she shared responsibility for the successful launch of the Food Chemicals Codex (FCC) Sixth Edition on February 29, 2008, that also included the launch of the June 2007 FCC Forum that included revisions appearing in FCC Sixth Edition.
Ms. Sheehan is active in many professional organizations such as RAPS and IFT. She was a working member on the PQRI Excipient Working Group from 2006-2007. She has brought to USP more than 15 years’ experience in organic chemistry [GC (gas chromatography), UV/VIS (ultraviolet/visible) and IR (infrared) spectroscopy], biochemical, microbiological, and biotech tissue culture techniques.
Timothy L. Shelbourn
M.S., Roosevelt University
M.B.A., Webster University
B.S., University of Nebraska
Tim Shelbourn has 25 years of experience as an analytical chemist in healthcare and pharmaceutical industries using AA, ICP, ICP–MS, HPLC, GC–MS, NMR, FT–IR, SEM/EDS, AFM, and NIR. Tim is a member of the USP General Chapters Expert Committee and is vice chair of the Metal Impurities Advisory Panel. Mr. Shelbourn is currently employed by Eli Lilly and Company, Pharmaceutical Research and Development in Indianapolis.
Robert Shimahara
National Account Manager, Sales and Marketing, USP
B.S., Chemistry, University of Redlands, CA
Robert provides sales account management support for domestic reference standards and education accounts. He is responsible for serving as a sales and marketing liaison for domestic customer needs, including coordination of relevant sales and marketing projects with other USP departments. Before joining USP in March 2004, Robert spent more than ten years in the pharmaceutical industry as a quality control chemist, in management, and as a sales representative. He previously worked for Bayer Pharmaceutical and Watson Laboratories.
Henrique Araujo R. Silva
Customer Relationship Manager, USP–Brazil
B.Sc., Pharmacy and Biochemistry, University of São Paulo, Brazil
M.B.A., Getúlio Vargas Foundation, Brazil
Henrique joined USP–Brazil in 2010 after successfully assembling a commercial office and sales team for a laboratory products distributor in Brazil. He brings with him more than 6 years of experience as sales and product manager at Millipore, where he dealt directly with customers and supported distributors from Brazil, Argentina, and Chile. Henrique knows how to answer customers’ technical issues and help distributors reach their sales targets. Also, he has worked inside the lab for the pharmaceutical industry.
Robert Singer
Principal Consultant, Biometry Associates LLC
B.A., Psychology, B.A. Chemistry, Florida Atlantic University
M.S., Statistics, CSU East Bay
Bob joined Protein Design Labs (now PDL BioPharma) in 1991 to use his flow cytometry expertise in the evaluation of humanized monoclonal antibodies. Bob went on to establish and manage the bioassay development and service groups. After completing the M.S. in Statistics, Bob also worked in Clinical Biometry at PDL, doing exploratory data analysis of clinical trial data in areas including pharmacokinetics, pharmacodynamics, and immunogenicity. Bob joined the USP volunteer corps in 2001, as a member of an ad hoc panel of the Statistics Expert Committee charged with revising General Chapter <111>, Design and Analysis of Biological Assays. Bob is Vice-Chair of the Statistics Expert Committee, 2005-2010 cycle, and chairs the panels working on Chapters <111>; <1032>, Design and Development of Biological Assays; and <1033>, Validation of Biological Assays. Bob is a founding member and Principal Consultant of Biometry Associates LLC, a consulting firm that provides statistical analysis of biological data.
Terri C. Soli
Principal Consultant, Soli Pharma Solutions
Ph.D., Microbiology & Immunology, University of Arizona
M.S., Microbiology, Texas A&M University
B.S., Microbiology, Texas A&M University
Dr. Soli is currently vice-chair of the USP Pharmaceutical Waters Expert Committee through which he authored the complete rewrite of USP's Chapter <1231>, Water for Pharmaceutical Purposes (which many consider to be USP's "pharmaceutical water bible"). Dr. Soli is President of Soli Pharma Solutions, Inc., and since becoming a full time consultant, has served consumer products and U.S. Food and Drug Administration-regulated industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, and microbiological laboratory operations. He has also served as a pharmaceutical expert witness in several "contamination" litigations. Prior to full time consulting, Dr. Soli had 25 years of diverse "Big Pharma" operating company experience. Throughout his 30-year career he has lectured extensively at conferences, authored numerous papers, and recently written several book chapters related to water system microbiology for the Parenteral Drug Association and the International Society for Pharmaceutical Engineering.
Erika Stippler
Director Dosage Form Performance Laboratory, USP
Ph.D., Pharmacy, J. W. Goethe University, Frankfurt, Germany
Erika has been at USP since August 2007 where she brings expertise on the field of development and validation in vitro dissolution testing for various dosage forms. She gained her experience working as a Senior Project Manager at Solvias AG, Basel, Switzerland and as a Technical Director at PHAST GmbH, Homburg/Saar, Germany.
Scott V. W. Sutton
Pharma Consultant, Vectech Pharmaceutical Consultants, Inc.
Ph.D. in Microbiology and Immunology, University of Rochester Medical School
Scott is a PhRMA consultant with more than 20 years experience in microbiology, rapid microbiology, validation, and PAT. His expertise lies in microbiology testing, microbiology data for pharmaceutical and medical device regulatory submissions for domestic and global markets, and validation of rapid microbiology instrumentation. Over his extensive career, Scott has led microbiology laboratories in the pharmaceutical, medical device and personal products industries, serving in roles from scientist to director. He operates the PMFList email discussion list. He is a member of the Parenteral Drug Association, the American Society for Microbiology, and serves as Vice–Chairman for the USP Expert Committee on Analytical Microbiology. Scott's credentials include more than 28 publications and 100 presentations to international audiences.
Radhakrishna Tirumalai
Senior Scientist, USP
Dr. Tirumalai has been at USP since 2003 and is currently a Senior Scientist in the Documentary Standards/General Chapters Division. He is the Staff Liaison to the USP Expert Committees on Microbiology and Sterility Assurance, and General Toxicology and Medical Device Biocompatibility. He works with industry, academia, and government as the USP Expert Committee liaison in the development and revision of General Chapters and Monographs in these areas.
Dr. Tirumalai's prior industry experience encompasses process and product research and development, transfer, and product manufacturing. His postdoctoral work included studies on HIV and MuLV reverse transcriptase and bacteriophage lambda integrase. He has authored several publications and review articles.
Doris Weisman
USP Consultant
B.S., Mathematics (Summa Cum Laude), Elizabethtown College
M.S., Statistics, Virginia Polytechnic Institute and State University
Ph.D., Statistics, Virginia Polytechnic Institute and State University
Dr. Weisman has more than 25 years of experience in applying Statistical Process Control and Statistical Design of Experiments to a broad range of pharmaceutical applications. She retired while working at Eli Lilly and Company as a Research Advisor at the end of 2006. She has developed and taught practical, down-to-earth training courses explaining the statistical concepts underlying these powerful methods to scientists from various disciplines.
Terry D. Wilson
USP Consultant
B.S., Zoology–Physics, University of Wisconsin
M.S., Chemistry, University of Idaho
Ph.D., Pharmaceutics–Medicinal Chemistry
Terry has nearly 40 years of experience in the Pharmaceutical industry working for a wide range of firms, from Upjohn, through Bristol–Myers Squibb and on to Pathogenesis/Chiron/Novartis. He has demonstrated expertise in commercial product support, clinical development, regulatory support, and inspections and audits. Terry has prepared 60 topics for publication over his career on a wide range of analytical techniques that support pharmaceutical development and quality control.
Jiong Yu
USP Consultant
Lab Director, USP–China
Ph.D., Analytical Chemistry, University of Nebraska, Lincoln, NE
Dr. Jiong Yu joined USP in January 2007 and currently is the Lab Director of USP–China. He worked as a Laboratory Manager in the same university after graduation and later did a post doctoral research at Harvard Medical School. Before Joining USP, Dr.Yu worked in Wuxi Pharmatechs (Currently know as Wuxi AppTec) as Principal Scientist/Assistant Director and as Group Leader in China Technology Center of FMC. Dr.Yu has published more than 10 bio-analytical papers in international journals.
Kahkashan Zaidi
USP Consultant
Senior Scientist, General Chapters, USP
M.Sc, Physical Chemistry, Quaid–Azam University, Pakistan
M.Phil, Physical Chemistry, Quaid–Azam University, Pakistan
Ph.D., Analytical Chemistry, University of Missouri, Kansas City, MO
Kahkashan Zaidi is a Senior Scientist in the General Chapters group of the Drug Standards Development at the United States Pharmacopeia. She is a liaison to the USP Expert Committee on dosage Forms, Chemical analysis, and Expert Committee on Physical Analysis.
Kahkashan Joined USP in May 1999. Prior to that, she worked in the Pharmaceutical industry for five years as a Research Scientist.
Diana Zhang
USP Consultant
Marketing Manager, USP–China
B.S., China Pharmaceutical University
M.B.A., Fudan University, China
Diana Zhang is Marketing Manager of USP–China. In her current role of Marketing Manager, Diana provides product support, organizes customer outreach activities and helps USP build strong customer relationships in the Great China region. Prior to USP, she worked in a European API sourcing company based in China, where she gained rich knowledge about the market and the industry.
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