Committee & Presenter Biographies

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, facilities 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 towards her PhD degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel.

She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive 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.

Fred was a student-athlete at Franklin College of Indiana and participated in the college’s Leadership Program while graduating in 1999 with a Bachelor of Arts (BA) in Biology.  After graduating, he spent time in the contract manufacturing industries, prior to joining Eli Lilly in 2001. 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 of the development, implementation, and continuous improvement for the site's sterility assurance programs. As an Advisor for the Global Quality Standards organization, Fred is responsible for ensuring the Lilly Quality Standards for the 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 local and national PDA events including being a PDA Midwest Chapter Board Member since 2014, serving as the President from 2020-2021, and is a current PDA Science Advisory Board member.

Peter E. Baker, President - Live Oak Quality Assurance, is a consultant specializing in Data Governance and Quality Risk Management. He spent 11 years as an FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity, and has performed more than 100 foreign drug inspections around the world on behalf of the FDA.

Elisabeth Bik, PhD is a Dutch-American microbiologist who has worked for 15 years at Stanford University, working on the microbiome of humans and dolphins, and another 2 years in industry. Since 2019, she is a science integrity volunteer and consultant who scans the biomedical literature for images or other data of concern and has reported over 6,000 scientific papers. Her work has resulted in over 900 retracted and another 900 corrected papers. For her work on exposing threats to research integrity, she received the 2021 John Maddox Prize.

Crystal M. Booth, M.M., ASQ-CQE, PMI-PMP is a Senior Technical Director at PSC Biotech and has over 20 years of experience in pharmaceutical microbiology, environmental monitoring, and quality assurance. She obtained her master’s degree in microbiology from North Carolina State University. Crystal is a seasoned award-winning technical writer and author of Method Development and Validation for the Pharmaceutical Microbiologist.  During her career, Crystal has worked in microbiology, consulting, quality assurance, CDMOs, R&D, and quality control laboratories. Crystal has developed and validated numerous microbial methods and has worked with many different product types. She also performs cGMP audits, cGLP audits, risk assessments, and gap assessments.

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 MS in Biomedical Sciences from Auburn University College of Veterinary Medicine in 2001 and BS 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.

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 Pharma Quality Control 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 PhD 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.

Dr. Lynne Ensor is a Senior Vice President and the Head of Global Compliance Consulting for Parexel. She has been a consultant to the biopharmaceutical industry for over 3 years, with expertise in sterile product manufacturing, contamination control, and testing methods for both large and small molecule products. Lynne is currently a member of the U.S. Pharmacopeia Microbiology Expert Committee, part of the USP 2020-2025 Council of Experts. She was previously employed by the FDA for 21 years, having most recently served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/OPQ/CDER. Her prior experience includes Roche Biomedical Laboratories, the Discovery Channel, and the University of Maryland (UMD) at Baltimore’s School of Medicine. She earned her BS in Biology and PhD in Microbiology from UMD, College Park. Her professional activities include serving as a chairperson for 3 international pharmaceutical microbiology conferences, serving as a planning committee member for 11 scientific conferences, presenting 46 oral presentations to technical audiences (including frequently representing the FDA), and authoring 24 scientific publications.

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.

Marc Glogovsky is currently managing the microbiology consulting division at ValSource, Inc. His career spans more than 25 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 also co-chairing the Microbial Data Deviation Investigations conference and participating on the planning committee for PDA/FDA and Global Microbiology conferences. Additionally, Marc has 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, and the 2023 Michael Korczynski Award for his work with PDA’s international chapters.

Marc earned his BS in Biology from Monmouth University and his MS in Microbiology & Molecular Genetics from Rutgers University.

Jaime Kaho’ohanohano has 15 years of direct work experience in quality control testing and microbial contamination control ranging from clinical to commercial facilities. She began her career in the lab and field of collecting and testing microbial samples. Her attention to detail and inquisitiveness led her to lead high-level microbial investigations, trending of data, client audits, risk assessments, and regulatory audit SME.  Later in her career as a manager, she worked to improve the overall contamination control of a facility that assessed all aspects of microbial risk to the product from gowning, cleaning and disinfection, to a risk-based Environmental Monitoring program. She now rounds out her career as a Senior Microbiology Consultant for Microrite Inc., for the last 7 years. She applies her hands-on knowledge and experience to help clients from many different disciplines. She has a bachelor’s degree in Microbiology from Arizona State University. She is passionate about sharing her love for science to inspire young students to pursue careers in STEM.

CAPT Simleen Kaur has a Masters in Biotechnology from Johns Hopkins University and Bachelors in Biology from the University of Delhi (India). She is currently stationed in Food and Drug Administration, under Center for Biologics and Evaluation and Research, Office of Compliance and Biologics Quality. She serves as a Team Leader for Laboratory of Microbiology In-vivo Testing and Standards where she reviews microbiological test methods used in the release of biological products as submitted in Biological License Applications and Supplements to ensure they are validated in accordance with Code of Federal Regulations and different pharmacopeia requirements. In addition, she manages production and distribution of CBER Reference materials used in potency testing of biological products such as vaccines prior to release to public.

Dr. Heike Merget-Millitzer is Microbiology CoE Lead within Janssen and is leading and coordination strategic Global Microbiology related projects including implementation of Advanced and Rapid Microbiology Methods. She has more than 25 years of work-experience in aseptic manufacturing and testing of cell therapeutics and large molecules as well as in environmental monitoring in pharmaceutical industry.

She joined J&J in 2005 where she was managing manufacturing of clinical supplies, commercial products and new product introduction of sterile drug products before she managed the QC Microbiology & Hygiene Department at Janssen Schaffhausen. In her current role one of the focus areas is to develop the JSC QC Technology Roadmap and to implement Advanced Technologies in the Microbiology Labs. She is member of PDA and is co-author of the recently revised PDA Technical Report #13 on Environmental Monitoring. Heike holds a PhD in Biochemistry from the University of Frankfurt, Germany and a MSC degree in Biology and Microbiology from the Technical University of Darmstadt, Germany.

Dr. John Metcalfe holds a BA in biology from Merrimack College in Andover, MA, and a PhD in microbiology from the University of Rhode Island. John spent 14 years teaching college microbiology courses prior to beginning a career in CDER in 2003. At FDA, John is a Senior Pharmaceutical Quality Assessor (SPQA) where he performs a microbiological quality assessment of both sterile and non-sterile drug products. He is an FDA Liaison to the USP Expert Committee on Pharmacy Compounding and is a published author in the area of drug product microbiological quality.

Vineeta Pradhan joined the Food and Drug Administration (FDA) in 2016 and is currently working as a Microbiologist in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at the Center for Veterinary Medicine (CVM). She reviews the pre- and post-approval CMC information of generic sterile injectable drugs for the entirety of the drug application lifecycle. She has experience in moist steam sterilization, aseptic processing, media fills and microbiological testing.

Prior to joining the FDA, Vineeta worked as an Assistant Professor at the Northern Virginia Community College, Loudoun Campus in Sterling, Virginia.

Vineeta received her PhD in Microbiology from The Ohio State University.

Abby Roth, founder of Pure Microbiology, has over 18 years of experience in supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring. Abby served as a USP Compounding EC member during the 2015-2020 cycle. She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.

Dr. Schweitzer has held senior positions in analytical development, quality control and quality over the past 38+ years with Novartis, AbbVie, Searle/Pharmacia/Pfiizer, Battelle Memorial Institute and Rohm & Haas developing experience in the analysis of impurities in a wide variety of matrixes. He was active in ICH as the rapporteur for ICH Q3D: Elemental Impurities Expert Working group and was the PhRMA topic lead in the EWG until his retirement from industry. He is currently the Chair of the USP General Chapters Microbiology Expert Committee and served previously as a member and Vice-Chair of the USP General Chapters Chemical Analysis Expert Committee. While volunteering at USP, he has been involved in sub-committees defining the standards for elemental impurities and chaired the USP Joint Subcommittee for Nitrosamine Impurities in Pharmaceuticals. Dr. Schweitzer earned his PhD from The Ohio State University Department of Chemistry. His career has been focused on analytical method development, validation and transfer of chromatographic analyses and complex hybrid methods. Additional areas of experience include:  assurance of data integrity, development and validation of IT applications (e.g. LIMS), elemental impurity product assessments, and development of analytical strategies to improve compliance with new and evolving regulations, quality and efficiency improvement.

Don Singer is Senior Microbiology Technical Consultant, North America, for Ecolab, and a Fellow in the American Society for Quality.  He was formerly a GSK Senior Fellow.  Don has been Chair of the USP General Chapters - Microbiology Committee of Experts and a member since 2000.  He is a Certified GMP Professional, a Certified Specialist Microbiologist and is a member of the European Pharmacopeia Group 1 Microbiology Committee. Don is also an adjunct professor in the Biopharmaceutical Quality graduate program at the University of Maryland Baltimore County.  He was an author of the PDA Technical Report for “Contamination Control Strategy” along with two other technical reports, one for Pharmaceutical Package Integrity and one for Objectionable Microorganisms.  Don’s career spans over 40 years of research and quality control.

Jessica Stolzenberger is leading a Late Stage Downstream laboratory at Boehringer Ingelheim, Germany, with more than 20 years of experience in Downstream process development for commercial facilities. For the past 6 years, she starts developing the impact of Endotoxin removal during downstream processing. She published the first endotoxin removal study by considering the impact of endotoxin masking.

Dawn is a Global Quality Assurance Director at Merck & Co., Inc., Rahway, NJ, USA. She works in Microbial Quality & Sterility Assurance managing a team that leads and executes global initiatives targeted to proactively address quality and compliance risks in the sterile and low bioburden network while driving continuous improvement. Additionally, her team provides microbial contamination control and sterile manufacturing expertise to resolve critical production issues, develop innovative solutions, and ensure network alignment with industry and regulatory expectations. She is an active member in the Parenteral Drug Association and BioPhorum Operations Group. She has 28 years of experience in the pharmaceutical industry, specifically focused on sterile and low bioburden products including vaccines, therapeutic proteins and small molecules. She is trained and certified in Six Sigma and Change Management. She has held positions in validation, manufacturing, technical operations and research and development throughout her career with Merck.

Rob Weker is a thirty-year healthcare executive. He is a three-time cancer survivor including pancreatic cancer and is focused on improving patient engagement throughout the development and delivery of healthcare.

As the Principal at Weker Advisors, Rob provides a unique perspective based on his industry, patient, and continuous improvement experience. Rob serves on patient boards at two pharmaceutical companies - GSK’s Oncology Patient Council and Incyte’s Patient Council. Additionally, Rob is a charter member of Medifind's Patient Advisory Board, a website for patients to find medical care for serious health conditions, and is part of the Acellus Health Patient Think Tank Initiative, refining AceCancer, a patient-centric digital health app for oncology patients and clinicians to manage their care.

Rob holds a degree in Chemistry from Cornell University and an MBA from the Ross School of Business at the University of Michigan. He publishes a blog on the patient journey – “Through the Patient Lens” and frequently authors articles and presents at conferences. Rob serves on the national patient advisory committee at the Canopy Cancer Collective and is a member of the Hospital of the University of Pennsylvania Patient & Family Advisory Council.

Rob and his wife reside in Philadelphia, PA.

Jason Willett is currently the Midwest Manager for Veltek Associates Inc., providing contamination control products and services to the pharmaceutical, biotech, and healthcare industries. In this position, Jason regularly consults with pharmaceutical manufacturers in the areas of cleaning, disinfection, aseptic practices, environmental monitoring and regulatory expectations. With over 20 years of relevant experience, Jason is able to help customers develop compliant and cost effective contamination control programs. In addition to his responsibilities at Veltek, Jason is a volunteer on the PDA’s Exhibit Committee and Treasurer for the PDA Midwest Chapter.

Jason graduated from the University of Cincinnati with a bachelor’s degree in Chemistry and lives near Cincinnati, OH with his wife, Leslie, and three children, Ella, Laney and Matthew.