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.

As Affygility Solutions’ founder and CEO, Dean does much more than wrestle industrial hygiene pumps, he leads people, teams, and companies in solving their toughest potent compound safety challenges.

With over 35 years of professional experience, Dean created and led the vision for OEL Fastrac+, Affygility’s newest award-winning digital health-based exposure limit (HBEL) database subscription designed so clients can gain access to previews of all OEL/ADE values in the online catalog. Dean also spearheaded OEL Fastrac, an industry-leading award-winning online platform for obtaining high-quality OEL/ADE reports. Additionally, Dean has performed numerous potent compound safety assignments throughout the world helping companies greatly improve their potent compound safety systems.

As an invited speaker, Dean has spoken at numerous events throughout the world including the HPAPI Summit, CPhI, AIHce, and many others.

Dean has a B.Sc. degree in Engineering from the University of Wyoming and dual M.Sc. degrees in Environmental Policy and Management, and Technology Management from the University of Denver. Dean is an American Board of Industrial Hygiene CIH, and is a member of AIHA, BOHS, ISPE, and SCHC. Dean is also a Fast Company executive board member.

In his spare time, Dean can be found outside running down a trail or skiing the mountains of Colorado.

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.

Christa Myers has been in the pharmaceutical industry for over 25 years and is a leader and subject matter expert. Christa is a well-recognized speaker at conferences and is frequently on-stage teaching others about regulatory requirements, operational issues and what to expect in the future of the in­dustry. Christa champions approaches that integrate strong project execution and technical solutions. Christa is on the steering committee for the ISPE community of practice for sterile products processing, a certified ISPE instructor of the sterile product processing baseline guide, the chair of ISPE’s women in pharma group, as well as an author of the most recent ISPE sterile processing baseline guide. Christa provides guidance and leadership to clients on how and when to utilise common or innovative solutions and continuously promotes the technical growth of people willing to learn more to advance the industry. She was recently awarded an honour as one of the 2019 Influential Women in Manufacturing.

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.

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.

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.

Igor Gorsky has been a pharmaceutical, biopharmaceutical, and medical device industry professional for over 39 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth, and Shire. He worked in production, quality assurance, technical services, and validation, including as an associate director of global pharmaceutical technology, at Shire, where he oversaw global validation efforts, including analytical methodology, equipment and facilities qualification, process, packaging, shipping, computer and cleaning validation, and environmental monitoring programs. He is currently a senior consultant at ValSource, LLC. Over the years, his accomplishments include validation of all the aspects of pharmaceutical, biotechnology, and medical device production and quality management, technical support of multi-billion-dollar drug product lines, and introduction of new products onto the market.

He developed analytical technology policies, procedures, and master plans for numerous biopharmaceutical firms based on latest global regulation. He also developed analytical technology qualification programs for many pharmaceutical and biopharmaceutical firms. He has published numerous articles and white papers in pharmaceutical professional magazines. He is an author of two books on pharmaceutical scale-up and process validation. In addition, he has been a presenter at PDA Annual Meetings, Interphex, UBM International Workshops, and other forums. He is also very active with PDA and ASTM participating in several task force groups authoring PDA technical reports 29 (Points to Consider for Cleaning Validation), 60 (Process Validation), and 60-2 (Process Validation Annex 1: OSD and SSD Dosage). He leads the PDA water interest group and is also a member of ASTM E55, G122).and participated in the ASTM E3106-18 Standard Guide for Science and Risk-based Approach to Cleaning Validation, and the ASTM E3219 and E3263. He holds a BS degree in mechanical/electrical engineering technology from Rochester Institute of Technology.