1st Annual Endotoxin Forum

Veronika Wills

Director, Global Technical Services

Associates of Cape Cod, Inc. (ACC)

Technical Forum Chair

Veronika is a globally recognized subject matter expert and speaker on endotoxin and glucan detection in pharmaceuticals and medical devices. Since joining ACC in 2007, she has specialized in complex-sample testing, method validation, troubleshooting, audits, and the regulatory aspects of bacterial endotoxin testing.

More recently, she has led the assessment, implementation, and automation of recombinant reagent technologies (rCR). She holds a Master's degree in Biochemical Engineering from the University of Chemistry and Technology in Prague, Czech Republic.

Jay Bolden

Senior Director, Global Quality Laboratories

Eli Lilly and Company

Keynote Speaker

A bacterial endotoxins subject matter expert, Jay leads a team with global quality-control oversight for endotoxin, microbiology, and virology test methods, and serves on the U.S. Pharmacopeia (USP) Microbiology Expert Committee.

With more than 26 years at Eli Lilly, he pioneered the company's move to non-animal recombinant endotoxin testing and has authored a book chapter and numerous peer-reviewed articles on endotoxins and recombinant reagents. He holds a B.S. in Biology from Indiana University.

Tim Sandle, PhD

Pharmaceutical Microbiologist, Consultant, Science Writer

University of Manchester / University College London 

Moderator

Professor Tim Sandle, PhD is a chartered biologist and holds a first-class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University.

Professor Sandle has over thirty years experience of microbiological research, quality assurance, and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing. In addition, Professor Sandle is experienced in contamination control, sterility assurance, quality risk assessment, GxP compliance, root cause analysis, and investigation.

Professor Sandle is an honorary staff member at University College London (Associate Professor); and was tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university’s pharmaceutical microbiology MSc course; and Head of QA Compliance / Sterility Assurance at Kedrion Elstree. He is also a pharmaceutical and healthcare sector consultant.

In addition, Professor Sandle has served on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and the National Blood Service advisory cleaning and disinfection committee). He is a long-standing committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for a range of scientific journals.

Professor Sandle acts as a consultant, expert witness and technical adviser to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken many technical writing and review projects.

Jason Rogers

Senior Manager, Sterility Assurance & Microbiology

Steris

Speaker

Jason Rogers is Senior Manager of Sterility Assurance & Microbiology for STERIS Applied Sterilization Technologies TechTeam. He represents STERIS on several AAMI standard Committees including Microbial Methods, Ethylene oxide Sterilization, Biocompatibility and Sterility Assurance. He received a bachelor’s degree in biology from the University of Minnesota Twin Cities and a master’s degree in microbiology from Colorado State University. Mr. Rogers has 20 years of experience in the medical device, industrial sterilization and contract laboratory testing industry. He has also given global educational webinars and seminars for laboratory testing related to sterilization validation and routine release of medical devices.

Jason has supported Customers in development of test methods for a wide range of challenging devices He has assisted in root cause investigations regarding cleanroom environmental excursions, elevated results for bioburden and endotoxin testing, and sterility test failures.

Poppy Cliffe

Senior Scientist, Global Product Development, Pharmaceutical Technology and Development

Astra Zeneca

Speaker

Poppy is a Senior Scientist in Microbiology within Global Product Development at AstraZeneca, where she supports the development and assurance of microbiological control strategies for pharmaceutical products. Her current work focuses on the validation and implementation of product endotoxin testing using synthetic reagents across AstraZeneca’s product portfolio, contributing to the adoption of innovative and sustainable approaches in microbiological testing. She has also contributed to the scientific field through her previous published work on the assessment of synthetic reagents for pharmaceutical water testing, reflecting her ongoing interest in advancing alternative methods in microbiology. Poppy holds a BSc in Biomedical Science from the University of Birmingham and is currently completing a Master’s degree in Drug Discovery and Development. She also has previous experience working in infectious disease drug discovery prior to joining AstraZeneca.

Shady Kamal, PhD

Principal Scientist, Manufacturing Science & Technology

Galderma

Speaker

Shady Kamal, PhD, is Principal Scientist in Microbiology Development at Galderma, Uppsala, Sweden, and an Affiliate Researcher at Karolinska Institutet, Stockholm. He specializes in microbiological method development and validation, contamination control, aseptic manufacturing, and bacterial endotoxin testing, supporting the development and manufacture of injectable biopharmaceuticals. He serves as an Expert Committee Member on the EDQM Bacterial Endotoxin Testing Working Party (2026–2028), contributing to the development and revision of European Pharmacopoeia standards, and is involved in the ongoing revision of PDA Technical Report 82. His career includes research appointments at MIT, Heidelberg University, and the University of Basel, with publications on microbial resistance and stress adaptation, bridging academic research and industrial application.

Alice Kenwright

Laboratory Manager

Associates of Cape Cod, Inc. (ACC)

Speaker

As the CTS Laboratory subject matter expert, Alice has led the implementation of recombinant cascade reagent (rCR) testing using PyroSmart NextGen^® (PSNG) within the CTS Laboratory. This has included validating PSNG on CTS tube and plate-reader instruments, qualifying technicians, and authoring standard operating procedures for the routine use of PSNG. Alice is currently developing a product validation procedure that can be adapted to meet individual CTS customer, and current Ph. Eur. requirements.

Alice holds a BSc (Hons) in Biomedical Science and an MSc in Oncology from the University of Chester.

Brett Hoffmeister

Manager, Sustainability Initiatives

Associates of Cape Cod, Inc. (ACC)

Speaker

Brett leads the development of the company's sustainability program and initiatives supporting responsible resource management and the transition to sustainable bacterial endotoxin testing solutions. With more than 22 years of experience in Limulus Amebocyte Lysate (LAL) manufacturing, Brett is ACC's subject matter expert on horseshoe crab conservation and helped develop the company's patented Horseshoe Crab Sustainability Project, which has released more than 1.4 million juvenile horseshoe crabs into Massachusetts coastal waters. Brett also serves as Chair of the Atlantic States Marine Fisheries Commission Horseshoe Crab Advisory Panel.

Learn from Industry Leaders

Hear directly from pharmaceutical companies and subject matter experts who have successfully implemented recombinant BET methods.

Understand Global Regulatory Progress

Gain insights into evolving pharmacopeial expectations from Europe, the United States, and other global markets.

Explore Real-World Case Studies

See practical examples covering:

• Water systems
• Drug products
• APIs
• Medical devices
• Global implementation strategies

Participate in Interactive Discussions

Exchange experiences during roundtable sessions designed to encourage collaboration and problem-solving with peers facing similar challenges.

Schedule private consultations for an opportunity to discuss project-related challenges, consider decision-making approaches, and develop strategies with ACC's technical experts, to strengthen laboratory operations and support the transition to non-animal-based testing.

• Validation Strategy
• Method Implementation
• Troubleshooting
• Regulatory Considerations

• Laboratory Transition Planning

  Schedule a Session

• QC Microbiologists
• QC Supervisors and Managers
• QA Professionals
• Regulatory Affairs Specialists
• Pharmaceutical Manufacturing Scientists
• Validation Specialists
• Laboratory Managers
• Technical Consultants
• Decision-makers Leading Recombinant BET Implementation

The Why & What

Vision, Trends & Industry Direction

Morning

• Opening Remarks
• Keynote: The Future of Bacterial Endotoxin Testing
• Sustainability, Supply Chain Security & Industry Drivers
• Global Pharmacopeial Updates

Afternoon

• Industry Survey & Market Trends
• Customer Case Studies
• Technical Breakout Sessions
• Live Demonstrations & Expert Discussions

Evening

• Networking Reception

The How

Implementation, Validation & Action

Morning

• Validation & Equivalency Case Studies
• Implementation Strategies
• Practical Lessons From Industry Leaders

Afternoon

• Global rBET Conversion Strategies
• Interactive Roundtable Discussions
• Expert Panel & Lightning Talks
• Closing Remarks

Andaz Prague, Czech Republic

Set in the beautifully restored historic Sugar Palace in the heart of Prague, Andaz Prague combines modern luxury with the city's rich architectural heritage. Just steps from Old Town, the venue provides an inspiring environment for scientific collaboration, executive discussions, and professional networking, while offering convenient access to Prague's renowned cultural and historical landmarks.

Attendees are welcome to stay at the Andaz or there are a range of local accommodation options available close to the venue. 

• INNSiDE Prague Old Town
• Prague Marriott Hotel
• Hilton Prague Old Town

Business casual attire is recommended throughout the Forum, including the networking event.

Registration​

€599 (both days)​

Registration Includes:​

• Full access to scientific program​
• Networking reception​
• Breakfast and lunch​
• Refreshments and breaks
• Exclusive technical consultation session

Register Today!

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• Speaker Updates
• Program Releases
• Venue Information