Speaker/Facilitator Biographies
2010 Open Conference on Compendial
Harmonization
"Participating in Change"
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 Susan
de Mars, J.D.
Chief Documentary Standards Officer and General Counsel, USP
Susan de Mars is Chief Documentary Standards Officer and General
Counsel for the United States Pharmacopeia (USP). She also
serves as secretary to the USP Board of Trustees and the USP
Convention. She is responsible for all legal, regulatory, and
governance issues affecting USP. As Chief Documentary Standards
Officer, Ms. de Mars oversees development of the documentary
standards that comprise USP's publications, including the United
States Pharmacopeia – National Formulary (USP–NF), the Food
Chemicals Codex (FCC), the Pharmacists Pharmacopeia, and the
Dietary Supplements Compendium (DSC).
Before coming to USP, Ms. de Mars was a partner at the law firm
of Reed Smith LLP in Washington, D.C., where her practice
included regulatory and legislative counseling and advocacy,
fraud and abuse issues, compliance, and other healthcare
matters.
Prior to joining Reed Smith, Ms. de Mars spent nearly 10 years
in the pharmacy benefit management (PBM) industry, where she
held various management and legal positions. She most recently
served as senior vice president of Government Affairs, and
general counsel of AdvancePCS, where she was responsible for all
legal, regulatory, and compliance matters, as well as the
government relations activities of the company. Previously, she
was senior vice president and general counsel of PCS Health
Systems.
Before working in the PBM industry, she was a partner at the law
firm of Sacks Tierney, P.A. in Phoenix, Arizona, where she
practiced in a variety of areas including corporate law,
partnerships and joint ventures, employment law, bankruptcy,
real estate, and healthcare regulatory issues and transactions.
Ms. de Mars is a cum laude graduate of Harvard Law School and
received her B.A. degree from Claremont McKenna College, summa
cum laude.
 David Hussong, Ph.D.
Associate
Director, FDA/CDER
Dr. David Hussong is the Associate Director for New Drug
Microbiology in the Office of Pharmaceutical Science in FDA's
Center for Drug Evaluation and Research. He directs the staff
that reviews microbiological quality aspects described in the
Chemistry, Manufacturing and Controls technical section of new
drug applications. He is also a member of USP’s 2005 – 2010
Microbiology and Sterility Assurance committee.
David earned his M.S. and Ph.D. in microbiology from the
University of Maryland and has served as a laboratory researcher
at the US Department of Agriculture, and the Office of Naval
Research. He has published several papers on microbial
populations in the natural environment, and published focused
studies of Salmonella and Legionella that included new methods
for their detection. He also performed research at FDA’s Center
for Biologics, studying antigens in Pertussis and Mycobacteria
spp. He has 25 years of FDA experience and is a Commissioned
Officer in the US Public Health Service. Bio
Leonard Mestrandrea, Ph.D.
Consultant
Dr. Leonard Mestrandrea has more than thirty five years of QA/QC experience in
the Pharmaceutical Industry. He was the Senior Science Advisor
for Pfizer’s Global Quality Technical Services Group; the
Director Worldwide Microbiology Support at Schering-Plough;
Associate Director of QA at Sandoz and the Chief Microbiologist
at the Brooklyn District Office of the FDA. He is also an
Adjunct Professor at Morris County Community College and a
member of the USP Microbiology and Sterility Assurance Expert
Committee. He holds a Doctorate in Microbiology from Pacific
Western University, a Master of Science degree in Clinical
Microbiology from Wagner College and a Bachelor of Science
degree from St. John’s University.
Dr. Mestrandrea is the principal of Mestrandrea Consulting,
LLC.
 David Porter, Ph.D.
Director of Training, Vectech Consultants
Dr. 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.
American Society for Quality
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.
 T.C.
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 been consulting for 13
years, serving the pharmaceutical, biological, and medical
device industries with training and troubleshooting expertise
covering water systems, sterilization, aseptic processing,
microbiological and beta-lactam contamination control, and
microbiological laboratory operations. He has 30 years of
diverse pharmaceutical operating company experience beginning
with Pfizer and ending with DSM Pharmaceuticals (formerly
Catalytica, Glaxo Wellcome, and Burroughs Wellcome) before
moving into full time consulting. That experience spanned the
disciplines of Chemical and Microbiological Development, Quality
Operations, Aseptic Process and Sterilization Validation,
Regulatory Affairs, and Project Management.
His career-long involvement with pharmaceutical microbiology
and participation with pivotal industry water committees,
coupled with his extensive consulting experience afford him
valuable practical knowledge of all aspects of contamination
control, validation, quality operations, microbiological
testing, and high purity water systems with an ability to
troubleshoot complex microbiological issues and communicate the
results and recommendations.
He has lectured extensively and authored numerous papers and
several book chapters for PDA and ISPE publications, and is
Vice-Chair of the USP Pharmaceutical Waters Expert Committee
through which he has authored or co-authored several USP
Monographs, and Chapter revisions, including his complete
rewrite of USP’s “pharmaceutical water bible”, Chapter <1231>.
Prior to this, he served on the PhRMA Water Quality Committee
that derived the now globally used USP Water Conductivity and
TOC tests and specifications. He holds B.S. and M.S. degrees in
Microbiology from Texas A&M University and a Ph.D. in
Microbiology and Immunology from the University of Arizona.
 Scott Sutton,
Ph.D.
President, Microbiology Network, Inc.
Dr. Scott 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 Microbiology
Network, 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
Dr. Radhakrishna Tirumalai 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.
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