Ziva Abraham, PhD
Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation. Ziva has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel.
She uses her extensive clinical microbiology experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.
Frederic B. Ayers
Eli Lilly and Company
Fred, a 1999, graduate of Franklin College of Indiana with a Bachelor of Arts (B.A.) in Biology. While at Franklin College he was a 4-year student-athlete and participated in the institution's Leadership Program. After graduating, Fred spent time in the contract manufacturing industries, then joined Eli Lilly and Company in 2001. During his 20+ year career at Eli Lilly and Company, Mr. Ayers has held various roles within the Quality and Technical Services organizations. In each position Fred has helped advance Lilly's state of regulatory compliance and is regarded as a Sterility Assurance Subject Matter Expert. For Lilly's Indianapolis Parenteral Manufacturing site, he had the responsibility to develop, implement, and continuously improve the site's sterility assurance programs. As a Global Advisor, Fred was responsible for ensuring Lilly Quality Standards and associated Sterility Assurance Programs evolve with global regulatory expectations. He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations. Fred has been a strong supporter and contributor to PDA. He has been a PDA Midwest Chapter Board Member since 2014, serving as Chapter President from 2020-2021, and was recently nominated and selected to join the PDA Scientific Advisory Board.
Yemi Babatola, MS
Yemi Babatola is a Principal Engineer in Amgen, Process Development, with several year experience in aseptic manufacturing, technology transfer, device and primary container development, and method development. He has led a number of projects to introduce next generation aseptic technologies into the manufacturing network, including isolator technologies and enzyme indicators. Currently, as part of Process Development, he leads a team of engineers and scientists responsible for tech transfer and new product introductions into Amgen commercial drug product manufacturing sites. Yemi holds a BS in Mechanical Engineering from Illinois Institute of Technology and a MS in Mechanical Engineering from Carnegie Mellon University.
Martin Blaser, MD
Center for Advanced Biotechnology and Medicine/RWJMS/Rutgers University
Martin J. Blaser holds the Henry Rutgers Chair of the Human Microbiome at Rutgers University, and serves as Director of the Center for Advanced Biotechnology and Medicine. Previously, he served as Chair of the Department of Medicine at New York University. A physician and microbiologist, Dr. Blaser has been studying the relationships we have with the human microbiome, the bacteria that live in us. Over the last 20 years, he has also been actively studying the relationship of the human microbiome with both health and important diseases including asthma, obesity, diabetes, and cancer. Dr. Blaser has been the advisor to many students, post-doctoral fellows, and faculty. He has served as President of the Infectious Diseases Society of America, Chair of the Board of Scientific Counselors of the National Cancer Institute, and Chair of the Advisory Board for Clinical Research of the NIH. He currently serves as Chair of the Presidential Advisory Council for Combatting Antibiotic Resistant Bacteria (PACCARB). He was elected to the National Academy of Medicine and the American Academy for Arts and Sciences. He has authored over 600 original scientific articles, holds 24 U.S. patents, and he also wrote Missing Microbes, a book targeted to general audiences.
Renée S. Blosser, MS
Renée Blosser joined the FDA in 2004 and is currently a Master Microbiology Reviewer in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at CVM. She has extensive experience in aseptic processing for finished drug products and review of media fill and sterility failure investigations. She also serves as a Quality Assessment Lead for review of pioneer and generic injectable drug products. Prior to joining the FDA, Renée worked in the field of antimicrobial drug development and surveillance of antimicrobial resistance.
Renée received a Bachelor of Science in Biology from Florida State University and a Master of Science in Microbiology from the University of South Florida.
Angie L. Bragdon, MS
Eli Lilly and Company
Angie Bragdon is a Senior Principal Scientist at Lilly's Indianapolis Parenteral Manufacturing site. Within the Technical Services organization, she serves as a Sterility Assurance Subject Matter Expert providing contamination control technical stewardship. Angie's background in microbiology includes supporting sterile and non-sterile manufacturing facilities representing various production platforms and technologies. Additionally, she is experienced leading highly complex microbiological investigations.
Angie received her M.S. in Biomedical Sciences from Auburn University College of Veterinary Medicine in 2001 and B.S. in Laboratory Technology from Auburn University College of Science and Mathematics in 1999. Before joining Lilly in 2012, she held positions in academic research, pharmaceutical product development and micro quality control labs.
Ellen Brunbech, MSc
Novo Nordisk A/S
Ellen Brunbech graduated year 2000 from the University of Copenhagen with a master degree in biology. Since 2001 Ellen Brunbech has worked in the field of microbiological quality control of pharmaceuticals for Novo Nordisk A/S, a global healthcare company with headquarters in Denmark. Through her more than 20 years of work in the pharmaceutical industry she has gained an in depth understanding of testing methodology, analytical requirements and current Good Manufacturing Practices in the field of pharmaceutical microbiology.
Erica Carpenter, MBA, PhD
University of Pennsylvania School of Medicine
Erica L. Carpenter, MBA, PhD, is the director of the Liquid Biopsy Laboratory and a Research Assistant Professor in the Department of Medicine, Division of Hematology/Oncology at the University of Pennsylvania.
She completed her doctoral studies in the Biomedical Graduate Studies immunology program at the University of Pennsylvania School of Medicine. She subsequently completed post-doctoral training in the field of cancer genetics at the Oncology Division of the Children’s Hospital of Philadelphia.
Prior to joining Penn, Dr. Carpenter obtained a Masters in Business Administration at the Tuck School at Dartmouth College, and worked as a business executive for a Fortune 50 manufacturer. Over the course of her business career, she had profit and loss responsibility for divisions with >$2 billion revenue, and participated in the management of both domestic and overseas business units.
Dr. Carpenter’s NCI-funded research programs focus on the identification, capture, and analysis of circulating tumor cells, exosomes, and cell-free circulating tumor DNA from cancer patients. The overarching goal is to utilize molecular profiling of circulating tumor material to improve the delivery of precision medicine by informing individualized treatment decisions, and targeting the most aggressive cancer cells. For our patients, this means better care and less discomfort.
Harolyn M. Clow, MS, SM (NRM)
Harolyn Clow has over 35 years of industry experience in pharmaceutical microbiology in manufacturing, biotech and contract laboratory operations. Ms. Clow is currently a Manager of Quality Control Microbiology at Teva Pharmaceuticals in West Chester, PA. She is a subject matter expert in disinfectant efficacy studies and environmental monitoring programs. Ms. Clow holds a Bachelors of Science degree in Microbiology from Colorado State University and a Masters of Science in Quality Assurance and Regulatory Affairs from Temple University.
Lori Daane, PhD
Lori Daane is the Sr. Director of Scientific Affairs at bioMérieux and has over 30 years’ experience in clinical, environmental and industrial microbiology. She is a technical expert on rapid and alternative microbiological methods and provides scientific support to the Healthcare Business in North America. Prior to joining bioMérieux, Lori worked for 11 years at Celsis in a variety of technical roles including VP of Scientific Affairs and Reagent Development. Lori received her Ph.D. from the University of Minnesota in Microbial Ecology studying the influence of earthworm activity on microbial gene transfer in the environment. She performed postdoctoral research at Rutgers University focusing on phytoremediation of polyaromatic hydrocarbons and at the Los Alamos National Laboratory studying microbial communities associated with cryptobiotic soil crusts. She also holds a Master’s degree in Limnology and a Bachelor’s degree in Medical Technology.
Gilberto Dalmaso, PhD
Veltek Associates Inc.
Gilberto Dalmaso has over 35 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK). Over his last five years with GSK, Gilberto led a series of initiatives implementing Process Analytical Technologies (PAT) and Rapid Microbial Methods (RMM) that improve quality and process understanding while yielding significant cost savings.
In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today Gilberto is the Technical Science Director Europe & Asia for Veltek Associates Inc.
In this role, he collaborates with pharmaceutical companies and authorities to develop and implement science-based strategies and processes that utilize Quality by Design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes.
With his extensive experience in sterility assurance and microbiology, Gilberto has the capability of supporting pharmaceutical manufacturers in a wide variety of aseptic processes, machinery, and methods.
CDR Donald Ertel, MS, MT(ASCP)
Commander Donald Ertel received his B.S. Degree in Medical Technology from the University of Maryland and a master’s degree in Regulatory Affairs / Quality Assurance from Temple University School of Pharmacy. CDR Ertel currently serves in the role of Team Lead for DMPQ. For over 12 years, CDR Ertel’s primary duty has been scientific review (CMC) of BLAs and PMAs. As a CBER lead inspector, he performs, and trains new inspectors in, pre-license/approval inspections for BLAs and supplements; and has performed numerous facility inspections, domestically and internationally. CDR Ertel has over 30 years of experience working in quality assurance and compliance in and with regulated industries of blood banking & cell therapy (prior employment at Johns Hopkins Hospital), biotechnology, and pharmaceuticals (prior employment at Shire Pharmaceuticals). As an USPHS officer, CDR Ertel has participated in multiple deployments in support national crisis including twice to the COVID-19 global response.
Irving Ford, MSc
Irving Ford is currently the VP of Quality at Adaptimmune.
Irving has over 29 years of QA/QC experience in pharmaceutical/biotechnology and cell/gene therapies industries.
Prior to joining Adaptimmune, Irving was a significant contributor for activities supporting the regulatory filings and commercial approval of BMS’ CAR T products Abecma and Breyanzi as well as Novartis’ CAR T product Kymriah.
Irving is an active member of PDA and has served on several planning committees for various PDA Conferences. Irving is a co-author of PDA TR-13- EM of Low Bioburden Facilities, PDA Points to Consider for ATMPs, and for the published White Paper – Risk Assessment Approach to Microbiological Controls of Cellular Therapies.
Rick L. Friedman, MS
Richard L. Friedman is Deputy Director, Office of Manufacturing Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER). This position includes oversight of regulatory action decisions relating to manufacturing site acceptability, and promoting sound regulatory policy development. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems. Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.
Beth Fulton, MS
Beth Fulton is a Consultant at ValSource and a subject matter expert in design of quality systems and situational application of risk and investigation tools (e.g. FMEA, PHA, HACCP, RBIA, RRF, Process Mapping, 8D, 6M, Cause Mapping, etc.).
Microcoat Biotechnologie GmbH
My name is Maria Gajewi and I am Group Leader in the Endotoxin Services at Microcoat Biotechnologie GmbH.
I studied chemistry, focused on biochemistry and then got into endotoxins and pyrogens. Now I am taking care of BET, as well as MAT projects for development of special sample treatments (e.g. demasking of endotoxin or measurement of samples in the MAT), especially in the stage of method validation and release testing. If you have a product that is not easily measurable in the BET or shows an LER effect, we are the right to call.
Gurpreet Ganda, MS
Gurpreet Ganda, Senior Manager at Roche for 10 yrs and has experience of working with multiple pharmaceutical/biotechonology companies. I have Masters in Microbiology and has extensive experience with setting up qualification program for new facilities, leaning, applying risk assessment tools, setting up routine Environmental monitoring program for facilities and presenting to health authorities. The experience span to Drug substance, Drug product, Small molecules, new modalities, clinical and commercial facilties. I also have extensive experience with aspectic processing, qualification and validation of equipments.
I head the Roche network team of Environmental monitoring team and responsible for implementing any changes/addressing challenges and providing overall network support. I have presented previously two times for UPW seminars on the topic of Pharmaceutical Water. I am also a member of BPOG team that covers the EM part.
Tamara Garcia-Armisen, PhD
Tamara Garcia-Armisen is a senior scientist currently in charge of the Sterility Assurance and contamination control strategy for aseptic manufacturing of viral vaccines bulk (Biologicals) at GSK. She holds a Master in Microbiology and Molecular biology and a PhD in Microbiology from the ULB (Free University of Brussels). Tamara has over 20 year of academic and industrial experience in Microbiology and Quality Assurance. Previous roles included microbiology and sterility assurance expert for QC and QA in plasma-derivate products manufacturing; Research Scientist in Sterility assurance for medical devices in charge of development and Validation of sterilization and disinfection strategies and Academic researcher authoring more than 20 papers in peer reviewed journals in Environmental Microbiology and water contamination topics. This experience across different fields, different products and lifecycle steps and different companies allow her to have a complete vision of the main challenges of the industry for the next years in the Contamination control and sterility assurance topics.
Marc Glogovsky, MS, SM (NRCM)
Marc Glogovsky is currently managing the microbiology consulting division at ValSource, Inc. His career spans more than 20 years in the pharmaceutical industry, in various microbiology and management roles. In his current position, Marc focuses on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs.
He has been an active PDA member for over 20 years and is presently serving on the Board of Directors, both the Science and ATMP Advisory Boards and is the co-chair of the Microbiology/EM Interest Group. Marc is co-chairing the Microbial Data Deviation Investigations conference and participating on the planning committe for PDA/FDA and Global Microbiology conferences. Marc has also chaired several Technical Reports and Points to Consider publications and is currently supporting multiple PDA global chapters.
In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA’s Training and Research Institute, where he has been a faculty member for more than 10 years. He has also developed the EM training course for the FDA’s Compounding Quality Center of Excellence.
Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology & Molecular Genetics from Rutgers University.
Ruben A. Grosso, PhD
University of Southern Denmark
My name is Ruben Adrian Grosso, and I was born in Argentina. During my veterinary degree I started my research career as fellow at the Clinical Microbiology lab focusing on Escherichia coli O157:H7 epidemiology and surveillance of antimicrobial resistance in animal-infecting microbes. Afterwards, I completed my Ph. D. in Biological Sciences studying the molecular mechanisms involved in erythroid cells maturation and its relationship with erythroid leukemia disease. In 2019, I moved to Sweden for my first postdoc at the Clinical Immunology Department of Uppsala University where I focus on unraveling the role of lymph node endothelium in modulating the anti-tumoral and anti-inflammatory immune response. I have been always passionate about Public Health, and since beginning of 2021, I´ve been working as postdoc in a collaborative effort between the University of Southern Denmark and Novo Nordisk company. This project aims to detect microbial contamination in drug products using novel Raman spectroscopy methods.