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.

Roberto Santucci

Team Leader, QC Micro Validation

Thermo Fisher Scientific / Pharma Services

Speaker

Roberto leads a team responsible for the design, execution, and scientific oversight of microbiological validation projects supporting pharmaceutical manufacturing in GMP-regulated environments. 

Roberto has extensive experience in pharmaceutical microbiology, with particular expertise in Bacterial Endotoxin Testing (BET), Low Endotoxin Recovery (LER), method suitability, Holding Time studies, sterility testing, bioburden, and microbiological risk assessment. Throughout his career, he has supported the validation of microbiological methods for a broad range of pharmaceutical products, working closely with customers on technical troubleshooting, regulatory expectations, and implementation of compliant testing strategies. 

In addition to leading validation activities, Roberto serves as a subject matter expert during customer and regulatory inspections and contributes to the evaluation and adoption of innovative microbiological technologies within quality control laboratories.

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.

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

• 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.

Early Registration​

Register by 31 August 2026 €399 (both days)​

Standard Registration​

From 1 September 2026 €599 (both days)​

Registration Includes:​

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

Register Today!

We'll keep you informed with:

• Speaker Updates
• Program Releases
• Venue Information