Speaker/Facilitator Biographies

2008 Open Conference on Compendial Harmonization
"New Methods for Old"

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Roger L. Williams, M.D.

Executive Vice President and Chief Executive Officer, USP

Keynote Speaker

Roger L. Williams, M.D., has been the executive vice president and chief executive officer of the United States Pharmacopeia (USP) since April 2000. Working with a staff of nearly 400, Dr. Williams provides strategic leadership for USP at the direction of USP's Board of Trustees. Dr. Williams also serves as chair of the Council of Experts, USP's scientific body, which continuously revises the United States Pharmacopeia and National Formulary.

Dr. Williams received his undergraduate degree at Oberlin College and his medical degree and training in internal medicine at the University of Chicago. He served in the United States Army, both in Korea and at Walter Reed Army Institute of Research, where he conducted antimalarial drug research. After completing a fellowship in clinical pharmacology at the University of California, San Francisco, in 1974, he continued as a faculty member until 1989. He joined the Food and Drug Administration in 1990 where he worked for ten years. Dr. Williams is a member of the medical honor societies Phi Beta Kappa and Alpha Omega Alpha. He is a fellow of the American Association of Pharmaceutical Scientists, a member of the International Pharmacy Federation (FIP) Board of Pharmaceutical Sciences, and has represented USP at the World Health Organization. He has authored or co-authored approximately 200 reports in the areas of clinical pharmacology, patient safety, biopharmaceutics, and pharmaceutical chemistry, and has published books on clinical pharmacology and regulatory science. He retains an adjunct appointment at UCSF, has served on the Board of Overseers for the University's School of Pharmacy, Pharmaceutical Foundation Advisory Council of the College of Pharmacy at the University of Texas at Austin, the Board of Directors for the American Society for Clinical Pharmacology and Therapeutics, and the Pharmacy Compounding Accreditation Board. Dr. Williams is a board-certified internist and clinical pharmacologist.  

James Agalloco

President, Agalloco & Associates

Jim is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry.  Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 100 health care firms in a wide range of validation, automation and compliance areas.  Jim has over 30 years of industry experience and has worked in organic synthesis, pharmaceutical formulation, pharmaceutical production, project and process engineering, validation and process automation during his career at Merck, Pfizer, Squibb and Bristol-Myers Squibb.  He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979.  He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983.  He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993.  He is a member of USP’s Microbiology and Sterility Assurance Expert Committee for 2005-2010.  He is a member of the editorial advisory board’s of Pharmaceutical Technology and Pharmaceutical Manufacturing.  He serves on the scientific advisory boards of Laureate, MEDInstill, MODA and IPS.  He is a frequent author and lecturer on the subject of sterilization, aseptic processing and process validation. 

Ron Berzofsky, Ph.D

Principal Consultant, GeneChoice

Dr. Berzofsky (Ron) is an independent consultant specializing in endotoxin detection and removal.  

Ron received his undergraduate degree from the University of Maryland, and his master and doctorate degrees from The Johns Hopkins University in Baltimore. During his 25+ years at Cambrex BioScience (a.k.a. BioWhittaker, he was instrumental in the development and commercialization of quantitative LAL methodologies.  He is an internationally recognized authority on the use of LAL and has participated in numerous conferences and workshops throughout the world. 

Dennis Guilfoyle, Ph.D.

Laboratory Head, FDA

DDr. Guilfoyle has been classified as a FDA international expert in pharmaceutical microbiology (Sterile and non-sterile products).  He serves as an instructor at both national and regional FDA training courses for Pharmaceutical, Medical Device and biotechnology issues.  He performs pre-approval inspections for NDAs\(A)NDAs, and has assisted on over 100 team inspections that include Team Biologic.  

He is also a member of the FDA Process Analytical Technology Review and inspectional cadres for microbiological applications.  Dr. Guilfoyle has testified and consulted as a government expert for the U.S. Attorney's Office on several FDA court cases (civil and criminal).He has co-authored 29 scientific publications and co-wrote/reviewed several FDA field guidelines for microbiological inspections as well as some industry technical baseline documents. He has been involved in the design, construction, and validation of three FDA bioclean rooms as well as a BSL level 3 containment laboratory for the testing of select agents. Dr Guilfoyle is an active member of the USP expert committee on Microbiology and Sterility Assurance and the FDA field Biologics committee. Dr. Guilfoyle is an adjunct associate professor for St. John’s University in their graduate Pharmacy program. He teaches cGMPs and Process Validation.

Karen McCullough

Principle, MMI Associates

Karen Zink McCullough is a veteran of LAL compliance and technology.  She has been working with the bacterial endotoxins test since 1973 and in 1975, she published the first paper on the use of BET in small volume parenterals.  She also was the driving force organizing the LAL Users Group.  Karen is a highly regarded GMP trainer and organizer of professional development programs.   Ms. McCullough holds a Bachelor’s degree in bacteriology from Douglass College (Rutgers University) and a Master’s degree in Molecular Biology from the University of Oregon.   

Terry Munson

Vice President, Parexel Consulting

Mr. Terry E Munson, Vice President, provides strategic compliance consulting services for bio/pharmaceutical companies and API manufacturing facilities, both domestic and international.

Mr. Munson’s areas of expertise include sterile and aseptic drug manufacturing technology, facility design, environmental monitoring, GMP Quality Systems and FDA regulatory issues. Mr. Munson joined KMI, which later became PAREXEL Consulting, in 1994. His background includes over 20 years with the FDA, including serving as Chief, Sterile Drug Branch, Division of Manufacturing and Product Office of Compliance at the Center for Drug Evaluation and Research (CDER). Since joining PAREXEL, Mr. Munson has provided expert consulting services to clients worldwide, with a primary focus on microbiological control and aseptic processing. He is widely recognized as one of the foremost experts in this field.

Mr. Munson has been a member of the United States Pharmacopoeia Committee for Revision since 1985, serving on the Analytical Microbiology Expert Group. He is involved with USP harmonization efforts for the Japanese and European Pharmacopoeias. Mr. Munson has also participated on various PDA taskforces and the FDA PQRI task group on aseptic processing of sterile drug products. He is currently a US Delegate to ISO Technical Committee 209, which is focused on cleanrooms and controlled environments. He holds a BS in Microbiology from Colorado State University.  

David Porter, Ph.D.

Director of Training, Vectech Consultants

David Porter has an industrial/compendial background in microbiology, in vitro toxicology, and the application of statistics to experimental design, data analysis, and validation. His experience includes microbiology laboratory management, cell biology laboratory management, and management of biostatistics in a clinical affairs group.  He also has extensive experience pertaining to compendial affairs and their relationship to the FDA. He has employed statistical analysis in the development of new products, for two of which he is a co-holder of new product patents.  He has validated numerous novel test procedures, and performed both prospective and retrospective analyses leading to new product claims. He has effectively developed matrix approaches for laboratory and compendial operations. David has effectively taken broken processes and through team leadership, repaired them. He is an effective developer and instructor of training materials for technical audiences. David believes that effective consultation involves at least in part an educational process whereby the clients learn how to better address problems in the future. He is experienced in the development of SOPs for quality systems, and has performed numerous external and internal audits to determine compliance. While at the United States Pharmacopeia (USP), he served as a Scientist, Senior Scientist, Associate Director and Director, all within the area of general chapters. He also led the a matrix team responsible for the development of a software package presenting an attractive graphical user interface with which to access the corporate revision-related database. His particular concentration while at USP pertained to general chapters pertaining to microbiology and biotechnology. His Ph.D. is in Zoology from the University of California at Berkeley .  He is a member of the USP Microbiology and Sterility Assurance Expert Committee.

Donald Singer, M.S.

Donald C. Singer is a Certified Specialist Microbiologist in consumer and industrial microbiology and a Malcolm Baldrige National Quality Award Examiner. He is a second term member of the USP Microbiology and Sterility Assurance Expert Committee and has participated on the advisory team for the ICH working group on harmonization of global microbiological methods. Singer has been a member of the Food Drug and Cosmetic Division of the American Society for Quality (ASQ) since 1982, was chair of the FDC Division in 2003-2004 and is presently a National Director of ASQ. He has 30 years of research, quality control, quality assurance, and laboratory management experience in the pharmaceutical, cosmetic, food, beverage, hospital products and medical device industries. He is a co-author of "Laboratory Auditing for Quality and Regulatory Compliance", and editor of "A Laboratory Quality Handbook of Best Practices", as well as author of various other journal publications dealing with microbiology laboratory practices, sanitation awareness in manufacturing, microbiological control of water systems, and sanitary engineering. He has developed and taught courses concerning microbiological control, cGMPs, personal hygiene and product safety, including an ongoing series of workshops for the American Society for Microbiology and is a visiting adjunct biopharmaceutical instructor at the University of Maryland. He has been a member of the AOAC Technical Laboratory Accreditation committee which developed the Criteria for Laboratories Performing Microbiological and Chemical Analyses in Foods, Feeds and Pharmaceutical Testing to complement ISO 17025, and most recently a member of the AOAC Laboratory Proficiency Testing Program Advisory Committee and the Presidential Task Force on Best Practices in Microbiological Methodology. Singer holds a Masters degree in microbiology from the University of Dayton.

TC Soli, Ph.D.

Principal Consultant and President of Soli Pharma Solutions, Inc.

Dr. T. C. Soli, Principal Consultant and President of Soli Pharma Solutions, Inc. (SPS), has acquired considerable knowledge of pharmaceutical water systems through his 25 years of involvement with 5 pharmaceutical operating companies and career-long memberships on numerous industry-wide working committees related to water, including his current participation in the USP Pharmaceutical Water Expert Committee. 

His expertise also extends into all aspects of sterilization, aseptic and contamination control processes and the disciplines related to their quality control and testing, validation, and regulatory compliance.  During his career with operating companies, he has managed personnel and processes in various departments including microbiology and chemistry development laboratories, QC laboratories, regulatory affairs, project management, business development, and QA departments ranging from validation to complaint investigation. 

Using vacation time from his operating company jobs, Dr. Soli has been consulting part-time since 1995 for small and large pharmaceutical companies and related instrument manufacturers, and has served as an expert witness in two litigations.  He has also conducted numerous informational and training sessions related to pharmaceutical water microbiology and chemistry and written numerous articles and USP chapters, including the famous USP Informational Chapter <1231> Water for Pharmaceutical Purposes.  His consulting endeavors are now full time with SPS.

Scott Sutton, Ph.D.

Senior Director of Microbiology Services, Vectech

Dr. Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). With over 20 years of laboratory leadership experience in the microbiology arena of the pharmaceutical and personal products industries, he now consults through Vectech Pharmaceutical Consultants, Inc.  Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses. Laboratory management, training, GMP, testing methodologies and microbiology-related project management are areas of special interest.  He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000.   He operates the Pharmaceutical Microbiology Forum with its monthly newsletter (http://www.microbiologyforum.org) and serves as a reviewer for several peer-reviewed journals.  Dr. Sutton also operates an information source on the internet – The Microbiology Network (http://www.microbiol.org) that provides services to microbiology related user’s groups.  This service also supports two Email lists, the first devoted to pharmaceutical microbiology (http://www.microbiol.org/pmflist.htm) and the second devoted to pharmaceutical stability (http://www.microbiol.org/psdglist.htm).

Radhakrishna Tirumalai, Ph.D.

Senior Scientist, USP

Radhakrishna Tirumalai, PhD, is a Senior Scientist in the USP, Division of Documentary Standards. 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 the industry/ academia/ government and the USP Expert Committee in the development and revision of general chapters and monographs in these areas. He has been with the USP since 2003. Prior industry experience encompasses process and product research &development, process and product transfer and product manufacturing. He holds a PhD degree in biochemistry. His postdoctoral work included studies on HIV and MuLV reverse transcriptases and bacteriophage lambda integrase. He has authored several publications, and, has been a speaker at many national and international scientific meetings.