Meet the USP 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.

Daniel Bempong

Senior Scientist, Department of Standards Development
M.Sc. in Pharmaceutical Analysis and Quality Control, Kings College, University of London
Ph.D. in 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.

Peter Bippus

Director, USP Sales, Europe, Middle East, and Africa
B.S. in Business, Huber Widemann Business School, Basel

Peter came to USP in 2005 to direct our Basel office operations. He brings 16 years of experience in European and Middle Eastern pharmaceutical and healthcare marketing and sales, which included key management and executive positions with the SOTAX group. Peter's impressive international business development track record is an asset to strategic planning and relationship building with USP customers worldwide.

Kristie Bowman

Scientific Liaison for the Food Chemical Codex
Bachelor's degree in chemistry and a Master's degree in analytical chemistry

Kristie came to USP in September 2007 after working in the food industry for ten years as a chemist, laboratory manager, and technical/regulatory director for a supplier of food and dietary supplement ingredients.

William E. Brown

Senior Scientist, Department of Standards Development
B.S. in 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.

Sandra Cai

USP Consultant
BS/MS Pharmaceutical Chemistry, Beijing Medical University
MS Bio–Organic Chemistry, Baylor University
PhD Analytical Chemistry, Purdue University

Before returning to China for consulting activities, Sandra applied her expertise in various analytical techniques, HPLC, TLC, GC, flash chromatography, GPC, Ion–exchange, etc. for 10 years at the Schering–Plough Research Institute. While at Schering–Plough, Sandra led a group of analytical chemists to conduct method development and validation tests for a wide range of products. Sandra has 20 publications/presentations to her credit, as well as a patent on the use of membrane binding constants in drug discovery.

Kevin H.X. Cao

Customer Relationship Manager, USP–China
B.S. in Economics, Shenyang Pharmaceutical University, China
M.B.A. East China University of Science and Technology

Kevin joined USP–China in March 2007 as Customer Relationship Manager. Prior to USP, he spent more than 9 years in China's pharmaceutical industry, most recently acting as Country Operation Manager for SOTAX International Trading Co., Ltd., in Shanghai. Kevin's well–rounded experience in strategic planning, new product and market development, and QA is a great asset to providing comprehensive standards solutions for customers in the USP–China region.

Todd L. Cecil, Ph.D.

Vice President, Compendial Science Department, USP
B.S. degree in Chemistry, University of Iowa
Ph.D. in 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.

Thomas E. Chapman

Director Pharmaceutical Services, BioScreen Testing Services, Inc.

Thomas E. Chapman, Ph.D., is Director of Pharmaceutical Services of BioScreen Testing Services, Inc, a contract–testing laboratory to the Pharmaceutical, OTC and Cosmetics Industries. He has worked in the Pediatric Departments of the University Hospital Groningen, The Netherlands and Shriner's Burns Institute, and Massachusetts General Hospital where he studied metabolism. At MIT, he was laboratory manager of the Laboratory of Human Nutrition where he studied the iv–vivo kinetics of amino acid metabolism in adults. At the UCLA Olympic Analytical Laboratory, he was involved in the screening of athletes for doping.

He has worked in the pharmaceutical industry for fifteen years. Currently, he is the head of BioScreen Testing Services Chemistry Department, which offers all types of analytical services such as wet chemistry, HPLC, GC and LC/MS used to assay drug actives, impurities and breakdown products in drug substances, formulations, and bioanalytical samples. He has designed and taught a course, "Analytical Chemistry in the Pharmaceutical Industry" at University of San Diego Extension. He also teaches an ACS one–day course "Validation of Laboratory Instruments". He has published over 50 papers in peer–reviewed literature using analytical techniques to assay natural and drug.

Keith E. Conerly, MBA, CQA, CQM

Director, Quality Assurance, USP
BS degree in Chemistry from Jackson State University
MBA in Management/Quality, Central Michigan University
Executive Certificate in International Management, Garvin School of International Management,
Thunderbird University

As USP's Director of Quality Assurance, Mr. Conerly is responsible for setting the direction and maintaining quality assurance related to all issues affecting USP globally. Before coming to USP, Conerly was at the Dow Chemical Company for over sixteen years. At Dow, he had assignments in research and manufacturing, spanning various businesses within Dow. Keith also led the successful transition to ISO 9001:2000 standard globally across one of Dow's businesses. Most recently, he was a Business Quality and Analytical Leader for numerous businesses, where he was charged with leveraging quality and analytical best practices globally. Mr. Conerly is an ASQ Certified Quality Manager and Auditor, and a Six Sigma Green Belt. Additionally, Mr. Conerly currently sits on the Board of Directors of the ANSI–ASQ National Accreditation Board (ANAB).

Antonio Hernandez–Cardoso

Scientist, Latin American Specialist, USP
M.Sc. (Clinical and Epidemiological Research) by the Autonomous National University of Mexico from 1994 to 1995
B.Sc. (Chemist Pharmacist Biologist) by the Autonomous National University of Mexico from 1986 to 1990

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.

Paul J. Cowan

Senior National Account Manager, Sales and Marketing, USP
B.S. in 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) in Chemistry, Panjab University, Chandigarh M.B.A. in 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. He holds graduate degrees in both chemistry and business administration.

Behnam Davani, Ph.D., MBA

Senior Scientist and Liaison to the USP Expert Committee M.S. in Analytical Chemistry, University of Iowa
Ph.D. in 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. in Pharmacy, Drake University
M.S. in Pharmacy Continuing Education, University of Madison, Wisconsin
Ph.D. in 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.

Joseph Eaton

Senior Chemist II, Dosage Form Performance Laboratory, USP
B.S. in 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. in Chemical Engineering, Polytechnic Institute, Bucharest, Romania
Ph.D. in 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 7 years as a pharmaceutical quality control chemist and 8 years with the SOTAX group–4 years as a sales representative, and 4 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.

Gabriel I. Giancaspro

Director, Dietary Supplements Group, Department of Standards Development, USP
Degree of Pharmacy, Buenos Aires University
Ph.D. in 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.

Barbara B. Hubert

Director, USP Sales, Sales and Marketing
B.S. in Chemistry, Virginia Commonwealth University
M.B.A in 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.

Vivek Josh

Senior Scientist, Millipore Corp
PhD, in Pharmaceutical Science, Mumbai University, India

Vivek is involved in studies in sample preparation and its impact on various analytical techniques such as dissolution testing and UHPLC. He has presented his work at various conferences and has done multiple presentations around the world highlighting the importance of sample preparation and its effects on analyte binding, extractable impurities in down stream analysis in dissolution testing. Prior to joining Millipore, Vivek worked at ArQule Inc. and was involved in HPLC–MS methods development for high throughput purification of library compounds.

Johannes Krämer

Phast Gmbh
Degree in Pharmacy from Frankfurt University
Ph.D. in Pharmaceutical Technology and Biopharmacy from 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.

Mark Liddell

Chemist III, USP
B.S. in Chemistry, Westminster College of Salt Lake City

Mark joined USP in May 2005 and is involved in investigating the impact of mechanical tolerance variability on dissolution results, and the development and evaluation of additional in vitro testing methods. Prior to joining USP, Mark conducted research in electrically–assisted transdermal drug delivery in the laboratory of Dr. William Higuchi at the University of Utah.

Margareth R.C. Marques

Senior Scientist, Department of Standards Development, USP
M. Sc. in Pharmacy, University of Sao Paulo
Ph.D. in 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. in Chemistry, Drexel University
M.Sc. in 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. in Chemistry, State University of New York, Albany
M.S. in Analytical Chemistry, State University of New York, Binghamton

Laura has over eleven 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.

Ren Min

Manager, Verification and Testing, USP China
BS Biochemical Engineering, East China University of Science and Technology

Prior to his employment with USP China, Ren held QA/QC positions at: Shanghai Wyeth Nutrition, Boehringer Ingelheim Pharmaceutical Co., Roche Vitamin Co., RAAS Blood Product Co., and Shanghai New Asiatic Pharmaceutical Co. Ren is well versed in cGMP requirements, production process and quality systems, and various analytical techniques such as HPLC, GC, UV, AAS, and IR.

Jeffrey Moore

Senior Scientific Associate in the Department of Standards Development, USP
B.S. Food Science/Food Chemistry, Michigan State University
Doctor of Philosophy from the University of Maryland in Nutraceutical and Functional Food Chemistry

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.

Pallavi Nithyanandan

Chemist III, USP
B.S. Pharm., Mumbai University, India;
PhD, Pharmaceutical Science, University of Maryland Baltimore

As a research scientist at USP, Pallavi has been involved in developing performance tests and reference standards, as well as identifying and reducing sources of variability in compendial test methods used in the performance testing. She has published several research articles in this area. Her previous research experience includes particle size reduction and analysis, development of inhaler testing methods, and metered dose inhaler formulation.

Horacio N. Pappa

Senior Scientist, Department of Standards Development, USP
Degree of Pharmacy, Buenos Aires University
Ph.D. in 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

National Account Manager, Sales and Marketing, USP
B.S. in Chemistry, Northern Illinois University
M.S. in Analytical Chemistry, Northern Illinois University

Steven joined the USP Sales and Marketing team in November 2004. 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. in Biology, Beloit College
M.S. in Biology, University of North Dakota
Ph.D. in 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
PhD Analytical Chemistry from 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.

Eike Reich

Head of Laboratory, CAMAG
PHD, Natural Producsts Chemistry, Humboldt University Berlin

From 1990 to 1998 he was Associate Professor of Chemistry at Longwood College, Farmville (VA) and taught courses in organic chemistry, analytical chemistry and chromatography. In 1998 he moved to Switzerland to join CAMAG as Head of Laboratory. His research is focused on applications of modern Thin–Layer Chromatography, particularly in the field of botanicals. Dr. Reich has published numerous papers on the subject and contributed chapters to text books and encyclopedias. He is a member of the Swiss and the European Pharmacopoeia, the USP–expert committee on dietary supplements – general chapters, AOAC, the American Botanical Council, the Utah Natural Products Alliance and the American Herbal Products Association. He is a technical advisor to the Chinese Pharmacopoeia TLC Atlas, contributor to the American Herbal Pharmacopoeia monographs and an editor of the Journal of Planar Chromatography.

Benoît Rime

Senior International Account Manager, France, Belgium, The Netherlands, and North Africa
B.S. in Chemistry, University of Bordeaux, France
B.A. in 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. in Chemistry and Biology, Murray State University
Ph.D. in 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.

John Santell

Director, Educational Program Initiatives, USP
B.S. in Pharmacy – Duquesne University, Pittsburg, PA (1981)
M.S. in Hospital Pharmacy Administration – The Ohio State University, Columbus, OH (1989)
Leadership in Healthcare Administration – Thunderbird International Management, Graduate School; Glendale, AZ (2000)
Pharmacy Leadership Institute – Boston University; Boston, MA (2000)

John joined USP in 2001 and has been developing educational programs, publications, and services to help healthcare practitioners improve the quality and safety of medication management both domestically and internationally. 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.

Leon Shargel

Affiliate Associate Professor, School of Pharmacy
Ph.D. Major: Pharmacology, Minors: Physiology, Biochemistry, Drug Metabolism
The George Washington University, Medical Center, Washington, DC
B.S. (Cum laude) Pharmacy, University of Maryland, Baltimore, Maryland

Leon has over thirty years of experience in the pharmaceutical industry, with a wealth on 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.

Susan J. Schniepp

Manager, Specifications and Test Methods, Hospira, Inc.
B.S. in Microbiology, Northern Illinois University

Susan Schniepp has over 24 years of experience in quality assurance for both the food and pharmaceutical industries. She began her career in 1980 as a microbiologist in the food industry working for both Quaker Oats and M&M/Mars where she first used the USP. In 1984 she transitioned to the pharmaceutical industry as an R&D Microbiologist. During her career she has had responsibilities for complaints, labeling, test method validation and other quality systems but her primary focus has been establishing communications with compendial authorities. She was founder and chairman of the Midwest Compendial Discussion Group from 1995 until 2004 when she relocated to San Diego and founded and co–chaired the Western Compendial Discussion Group. She has presented on USP Issues in many venues including at the PDA/FDA joint Regulatory Conferences from 2001–2004. She has authored several articles on compendial matters including a book titled "Understanding the United States Pharmacopeia–National Formulary: Demystifying the Standards–setting Process". Ms Schniepp currently resides in the Boston area.

Robert Shimahara

National Account Manager, Sales and Marketing, USP
B.S. in Chemistry, University of Redlands, California

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.

Erika Stippler

Director Dosage Form Performance Laboratory, USP
Ph.D. in Pharmacy at the 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

Robert Tyler

Sales Manager, Reference Standards, Sales and Marketing, USP
B.A. in Chemistry, North Carolina State University

Rob joined USP Sales and Marketing in 2002 as a senior national account manager. His current role as Sales Manager is to visit USP customers, educate them on collaborative opportunities and encourage their active involvement in USP's standards–setting processes. Rob serves as a customer liason, apprising USP of customer issues and needs in order to deliver the best solutions. Prior to USP, Rob worked in technical sales for the specialty chemical industry and spent time in the lab as an analytical chemist.

Doris Y. Wang

Customer Relationship Executive, USP–China
B.S. in Chemistry and International Business, Shanghai University, China

Prior to joining USP–China in December 2007, Doris gained nearly 5 years' experience in sales, business development management, and import and export operations with Sinopharm Chemical Reagent Co., Ltd. Her work with different end–users in the chemical and pharmaceutical industries is beneficial in interacting closely with our customers in the USP–China region.

Terry Way

Senior International Account Manager, UK, Ireland, and Scandinavia, USP
BSc. in Pharmacy, Portsmouth School of Pharmacy, UK

Terry joined USP in 2006, bringing with him more than 30 years' experience in the European pharmaceutical industry. Over the years, his focus shifted from analytical chemistry for QC operations to specialized instrumentation and automation for dissolution testing. Previously a scientific instrument product specialist, Terry has lectured and trained professionals throughout Europe. He provides support for USP customers in the expanding European market.

Doris Weisman

USP Consultant
Bachelor of Science, Mathematics, Summa Cum Laude, Elizabethtown College, 1975
Master of Science, Statistics, Virginia Polytechnic Institute and State University, 1977
PhD, Statistics, Virginia Polytechnic Institute and State University, 1980

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
BS Zoology-Physics, University of Wisconsin
MS Chemistry, University of Idaho
PhD 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.