Dr. Ulrich Rümenapp works within the biological development organisation of Bayer AG, where he is responsible for the transfer of Bayer’s pipeline candidates (antibodies and antibody drug conjugates) to external manufacturing partners and regulatory submission and launch preparations. Prior to working in development, Ulrich was head of biotech projects in product supply biotech at Bayer, where he was responsible for contract manu­facturing partnerships in the field of biotech¬nological drug substances, drug products and interdisciplinary project management with the goal to ensure market supply. Before it was acquired by Bayer, he held a similar position at Schering AG, and before that he worked in the production and logistics department of Schering. Ulrich studied chemistry and holds a PhD in biosciences. He has several years of experience in academic research in the field of signal transduction and as an assistant teacher in the field of general pharmacology. Currently, his area of expertise is the setup and management of external relationships for the development and supply of bio-pharmaceutical products.

Justin Mason-Home is an organic chemist with extensive health, safety, environmental, and chemical engineering experience in senior technical, legal, and commercial aspects of the pharmaceutical, biochemical, chemical, and other industries. He is a Fellow of the Royal Society of Chemistry in the United Kingdom.

Justin started as a research chemist in the flavour and fragrance sector, researching and discovering new chemical synthetic routes to produce nature-identical flavour and fragrance components. In the fine chemical sector, he worked through scale-up (Kilo Lab then Pilot Plant) to full-scale manufacture. After a move to corporate environmental management, Justin was head-hunted into environmental consulting, heading a technical environmental engineering function.

He has since held senior positions and worked globally in potent biopharmaceutical occupational health and safety global environmental consulting, he's held a board level position in a biotechnology company, and has worked in corporate environmental management. Justin has been involved in and worked on potent and highly-potent API projects for more than 22 years and specialises in technical complex and strategic projects, including unique experience in managing sensitive highly-potent and toxic biopharmaceutical compound matters. Justin has chaired, presented at, and attended many HPAPI events and is a recognised expert in this area.

With over 14 years of experience in the pharmaceutical industry, Lilia Lahouel Lefebvre has had the opportunity to define and implement cleaning validation strategies across various pharmaceutical environments. Her career began in France with a leading pharmaceutical company, where she specialized in cleaning validation and compliance within biologics drug substance manufacturing. Later, as a consultant in Switzerland, she supported multiple organizations with diverse technologies in developing robust cleaning validation strategies.

For the past 2 years, she has been leading cleaning and cleaning validation activities for internal and external projects, focusing on innovation and ensuring regulatory compliance to meet customer needs. Additionally, she is managing SMEPAC tests at SKAN, supporting customers on containment topics. She is also an active member of the A3P working group on Annex 1, contributing to the improvement of industry best practices in sterile manufacturing.

Richard Denk has studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, phar­maceutical engineering, and quality control at the University of Applied Sciences in Albstadt/Sigmaringen, Germany. Richard works at SKAN AG, headquartered in Allschwil, as the head of sales containment. He founded the expert con­tainment group of the ISPE DACH eight years ago. The containment group published the containment manual in September 2015. Richard has spent nearly 20 years working with highly active/highly hazardous substances and has developed the containment pyramid.

Dr. Ildiko Ziegler has been a professional for 20 years in the pharmaceutical industry, has extensive experience in Quality Assurance and supports various pharmaceutical companies to reach their business goals. Ildiko obtained her M. Sc. in chemical engineering at the Budapest University of Technology and Economics (BUTE). She earned a licentiate degree at the Lulea University of Technology (Sweden). She defended her Ph.D. at BUTE in 2000 and obtained the Géza Schay Award for the achievements in the field of physical and theoretical chemistry.

With nearly three decades of experience in EHS leadership, Christophe Dehondt has a proven track record in the pharmaceutical and chemical sectors, including key roles at Novartis and Kenvue. He has led critical HPAPI projects, ensuring regulatory compliance and safety excellence, and supported sustainable practices across global operations.

As a consultant, Christophe has advised on radiopharmaceutical safety, HPAPI risk assessments, and sustainability strategies, delivering actionable solutions for high-stakes environments. An engaging speaker, he shares insights on EHS risk mitigation, supply chain resilience, and sustainable innovation in pharma.

Almost 30 years spent in pharmaceutical industry. Starting as GMP consultant involved in start up and validation services and facilities conceptual design. Since 2008 involved in creating and built containment solutions either based on classic isolation and flexible technology.

Adela is a graduate in pharmacy studies and holds two PhD degrees; one in Medical Sciences (Field of Pharmacy) and another in Chemistry awarded by the University of Medicine and Pharmacy Cluj-Napoca (Romania) and University of Lorraine (France), respectively.

With a strong focus on health and environmental safety, her research work and scientific publications have dealt with a wide range of subjects. In 2015, she changed career paths when she received the Robert Schuman scholarship at the European Parliament Research Service in Brussels. Her career within the field of health policies continued as she became a member of the European Health Parliament, Antimicrobial Resistance Committee, that same year.

Since 2016, she has ushered her skills and expertise in the fields of health and environment working as Science and Policy Advisor in Brussels representing the interests of patients and healthcare professionals in relations with the EU Institutions and policy-makers.

Her work has been cited in international journals such as Financial Times, The Telegraph, POLITICO, ChemicalWatch UK, Pharmaceutical Technology, Market Business News, Pharma Technology Focus and Health Europa.

Fred Ohsiek, who earned his BS in Chemistry from University of South Florida, resides in the NC RDU area. He has 25 plus years of validation experience as an FTE and Consultant, while specializing in cleaning validation.

He has been fortunate to work for 7 major pharmaceuticals (Catalent, AstraZeneca, Boehringer Ingelheim, Teva, Astellas, Bayer, and Novo Nordisk) where he was considered the cleaning validation SME in most of his roles. Working with various routes of administration (OSD, parenteral, topical, and softgels) in green and brown field small and large molecule manufacturing projects has provided Fred with a very broad range of experience.

Fred also obtained “cleaning chemistry” experience while working as a Sr Global Technical Manager at Ecolab (Life Science division).

As Associate Director of Cleaning Validation at Eliquent Life Sciences, he and his team support industry by authoring tailored justifications, reducing the validation footprint via risk assessments, creating startup CV programs, remediating legacy processes, and increasing manufacturing capability.

He was one of the authors of the ISPE Cleaning Validation Lifecycle – Application, Methods, and Controls guidance, and he regularly presents at conferences nationally and globally.

Dr. Omid ZadakBar is a globally recognized expert in Process Safety and Risk Management with over 20 years of experience across the pharmaceutical, fine chemical, and energy sectors. He currently leads execution of EHS design integration and risk management for Amgen’s global capital portfolio, encompassing complex, large-scale manufacturing facilities and high-containment infrastructure projects. His focus is on embedding Risk-Based Process Safety (RBPS) principles across the lifecycle of facility design, commissioning, operations, and expansions, particularly in systems handling HPAPIs, flammable solvents, and biologics.

Dr. ZadakBar is widely known for translating advanced safety frameworks such as RBPS and RAGAGEP into pragmatic engineering applications that enhance system integrity, reduce risk exposure, and ensure regulatory alignment. A longstanding member of the AIChE Center for Chemical Process Safety (CCPS), he has contributed to industry-leading initiatives and technical publications that advance process safety performance in high-hazard environments.

Morcos Loka is a training manager and GMP advisor at Minapharm. Over 23 years, Morcos has played different production and quality roles in the pharmaceutical and biopharmaceutical industries. His experience includes the manufacture of sterile and non-sterile products, handling of regulatory and customer audits, conducting internal and supplier audits, GMP gap analysis, GMP training, GMP consultation, establishing quality management systems, management review, quality metrics, establishing quality risk management system, QRM studies including manufacturing of HPAPIs in shared facilities, and design of pharmaceutical and biopharmaceutical manufacturing facilities.
Morcos has an MBA, a BSc with honours in pharmaceutical sciences, two postgraduate diplomas in total quality management (TQM) and train of trainer (ToT), and four professional certificates: ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA), Certified Pharmaceutical GMP Professional (CPGP), and ISPE Certified Pharmaceutical Industry Professional (CPIP).

Morcos is an ASQ, ISPE, and PDA member. He participated in different ISPE and PDA publications and as a speaker in different IVT, ECA, PDA, and ISPE pharmaceutical industry conferences.

Jochen Weber holds a Bachelor of Engineering and has been leading customized isolator projects since 2019. As Project Manager and Engineering Lead, he has played a pivotal role in the design and development of complex containment isolator lines. Over the past three years, Jochen has overseen the engineering and successful execution of two major containment isolator systems, where he also implemented significant design and software enhancements in collaboration with his project teams.

In addition to project execution, Jochen has been closely involved in defining qualification strategies for advanced isolator solutions—ensuring technical robustness, regulatory compliance, and operational safety.

Starting in September 2025, Jochen will take on a new role as Strategic Product Manager, with a dedicated focus on containment isolators, continuing to drive innovation and excellence in high-containment technologies.

Currently Manager, Industrial Hygiene & Toxicology at Pharmascience Inc., Rich leads a team tasked with determining HBEL’s and collaborating with the various functional areas to ensure safe product manipulation. Prior to joining Pharmascience, Rich held different roles in IH and Production management for solid dose & injectable products at Uman Pharma.

Rich began his career at Merck Frosst Canada in 1998 supporting the formulation/process development, scale-up and tech-transfer of numerous dosage forms while executing the manufacture of worldwide clinical supplies for various Merck Research Laboratories programs. While at Merck, Rich held several positions of increasing responsibility, including leading the Canadian GMP Pilot Plant Operations.

Marta Loureiro is a Project Manager at Advanced Cyclone Systems, where she leads business development for customized cyclone solutions in the pharmaceutical, food, and fine chemicals industries. With a strong

background in engineering and a sharp focus on high-efficiency product recovery and ATEX compliance, Marta helps clients optimize clean air performance in highly regulated environments. She is passionate about bridging technical innovation with client success, especially in high-potency processing contexts where precision and safety are paramount.

Patrick Wieland is a senior professional with more than 10 years of working experience in the pharmaceutical industry. Patrick is leading the global Business Development Department to force technologies and innovations in the field of the pharmaceutical industry.

After successfully completing his master's degree in Leadership for Industrial Sales and Technology, he started in the Sales Engineering Department to implement high flexible filling machines for ready-to-use and bulk packaging materials.

For several years, Patrick was a Global Key Account Manager for the leading companies in Europe with production sites all over the world.

With his excellent experience in the field of aseptic fill-finish, Patrick has accompanied numerous projects from the first inquiry to the SAT (site acceptance test).

He graduated in Chemical Engineering at the Politecnico di Milano University in 1996, and has 28 years professional experience in the design of pharmaceutical facilities. His main focuses are isolator technology, containment processes, decontamination and sterilization technologies, pure fluids systems. He has been working on large multi-office biopharma projects in different European countries for many years. He has also an extensive knowledge of hydrogen peroxide decontamination processes, both for isolator applications and for clean room decontamination applications. He is a ISPE member since many years and has published papers with some Italian professional associations (ASCCA, AFI). He lives in Milan.