8th HPAPI: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (APIs)
Premier gathering of experts in the development and manufacturing of highly potent active pharmaceutical ingredients (HPAPIs)
H10 Berlin Ku'damm
Joachimsthaler Str. 31-32, 10719 Berlin, Germany
17 – 18 September 2025
Speakers
BETTERISE
Founder
Christophe Dehondt, FR
Advanced Cyclone Systems
Project Manager
Marta Loureiro, PT
Pharmascience Inc.
Manager, Industrial Hygiene & Toxicology
Rich Arnett, CA
CRB
Associate, Process Engineer
Ashley Harp, US
ValSource Inc.
Principal Consultant
Igor Gorsky, US
Minapharm
Quality Senior Manager Biologics F&F and New Projects
Morcos Loka, EG
Howorth Air Tech
Regional Business Development Manager
Pietro Virgilio, IT
Eliquent Life Sciences
Associate Director of Cleaning Validation
Fred Ohsiek, US
Indépendant
Independent Senior Policy Advisor on Health
Dr. Adela Maghear, BE
CSV Life Science
Containment Expert & Co Founder
Luca Vietri, IT
Quality Hill
Director of Quality
Dr. Ildiko Ziegler, HU
CRB
Sr. Fellow - Aseptic and Sterile Products
Christa Myers, US
Skan AG
Senior Consultant, Aseptic Processing & Containment
Richard Denk, CH
Affygility Solutions
President and CEO
Dean Calhoun, US
HPAPI Project Services Limited
Owner/Director
Justin Mason-Home, UK
Bayer AG
Senior Biotech Program Lead
Dr. Ulrich Rümenapp, DE
The 8th #Ehpapi Summit in Berlin is a premier gathering of experts in the development and manufacturing of highly potent active pharmaceutical ingredients (HPAPIs). As demand for HPAPIs in oncology and targeted therapies continues to grow, this summit provides a vital platform for exploring the latest innovations, regulatory insights, and safety protocols shaping the future of HPAPI production.
Join us for two days of expert-led sessions on cutting-edge drug delivery systems, AI-driven manufacturing advances, and the evolving regulatory landscape. Network with industry leaders to navigate the complexities and drive advancements in #Ehpapi manufacturing.
Partners & Sponsors
Advanced Cyclone Systems (ACS)
Advanced Cyclone Systems (ACS) specializes in high-efficiency cyclone technology for the pharmaceutical industry, with a focus on API and HPAPI containment, product recovery, and emission control. Leveraging proprietary numerical models like PACyc and patented technologies such as Hurricane and ReCyclone®, ACS designs tailored, filter-free solutions that ensure high performance even with submicron particles.
Their systems are ideal for handling potent compounds, minimizing product loss, reducing cleaning needs, and complying with ATEX and GMP standards. Trusted by global pharmaceutical leaders, ACS partners closely with clients to optimize critical processes where efficiency, containment, and compliance are non-negotiable.
Their systems are ideal for handling potent compounds, minimizing product loss, reducing cleaning needs, and complying with ATEX and GMP standards. Trusted by global pharmaceutical leaders, ACS partners closely with clients to optimize critical processes where efficiency, containment, and compliance are non-negotiable.
ChargePoint Technology
ChargePoint Technology is the trusted market leader in powder and fluid containment and aseptic transfer technology for pharmaceutical and biopharmaceutical drug manufacturers. Our Powder Transfer, Flexible Packaging, and Fluid Management technology connect our customers’ manufacturing processes, enabling safe, reliable powder and fluid handling while providing operator safety and sterility assurance, protecting people, products, and the environment.
As a trusted partner to the top 50 global pharma brands, we are committed to delivering beyond expectations. Together we reach beyond.
As a trusted partner to the top 50 global pharma brands, we are committed to delivering beyond expectations. Together we reach beyond.
Bausch+Ströbel
Bausch+Ströbel is the partner for pharmaceutical production worldwide. Since 1967, the family owned company has been developing innovative, forward-looking solutions for the reliable, flexible and aseptic filling of pharmaceutical products. Together with its customers, Bausch+Ströbel develops solutions that best meet their needs. With a strong focus on quality, innovation and customer proximity, Bausch+Ströbel ensures the highest level of reliability and safety in pharmaceutical production for its customers.
Through these efforts, the company makes a significant contribution to ensuring that essential medicines and vaccines are safely, reliably and affordably available worldwide.
Bausch+Ströbel is continually expanding its global presence, providing the best possible support to its customers worldwide.
Through these efforts, the company makes a significant contribution to ensuring that essential medicines and vaccines are safely, reliably and affordably available worldwide.
Bausch+Ströbel is continually expanding its global presence, providing the best possible support to its customers worldwide.
As the global demand for highly potent active pharmaceutical ingredients (HPAPIs) continues to rise, driven by their crucial role in oncology and targeted therapies, the 8th Annual HPAPI Summit serves as a pivotal gathering for industry leaders, innovators, and regulatory experts. This summit provides a comprehensive platform for exploring the latest advancements, challenges, and strategies surrounding the development and manufacturing of HPAPIs.
With the landscape for highly potent drugs evolving rapidly, industry players are navigating an era of unprecedented technological and regulatory shifts. Key advancements include:
However, these exciting developments also bring significant challenges:
Join us in Berlin as we gather to address these complexities and share forward-looking insights. Over two days, industry experts will delve into regulatory updates, novel technological applications, risk mitigation strategies, and advancements in HPAPI manufacturing. The 8th HPAPI Summit promises to be an invaluable opportunity to network, collaborate, and explore the future of HPAPI development and its potential to transform targeted therapies and personalized medicine.
Prepare to shape the future of HPAPIs—where cutting-edge science meets robust safety practices, leading to the next generation of highly potent therapeutics.
With the landscape for highly potent drugs evolving rapidly, industry players are navigating an era of unprecedented technological and regulatory shifts. Key advancements include:
- Sophisticated Drug Delivery Systems: Technologies such as nanoparticles, liposomes, and micelles enable precise targeting of potent therapies, significantly enhancing treatment outcomes and minimizing side effects.
- Biological HPAPIs: Antibody-drug conjugates (ADCs) are creating new pathways for targeted therapies, using antibody specificity to deliver therapeutics directly to cancer cells and other targeted sites.
- Technological Innovations in Manufacturing: Artificial intelligence and machine learning are now integral to HPAPI production, driving efficiencies and raising the bar for quality control and product safety.
However, these exciting developments also bring significant challenges:
- Stringent Safety Protocols: HPAPI production requires rigorous safety standards to protect workers and ensure product integrity.
- Specialized Containment Facilities: Advanced containment systems and facilities are essential for handling high-potency substances safely.
- Skilled Workforce: Managing HPAPIs demands a workforce trained specifically in handling and processing potent compounds.
- Evolving Regulatory Landscape: Companies must stay updated on emerging regulatory frameworks that balance innovation with strict safety and compliance requirements.
Join us in Berlin as we gather to address these complexities and share forward-looking insights. Over two days, industry experts will delve into regulatory updates, novel technological applications, risk mitigation strategies, and advancements in HPAPI manufacturing. The 8th HPAPI Summit promises to be an invaluable opportunity to network, collaborate, and explore the future of HPAPI development and its potential to transform targeted therapies and personalized medicine.
Prepare to shape the future of HPAPIs—where cutting-edge science meets robust safety practices, leading to the next generation of highly potent therapeutics.
About the 8th HPAPI Summit: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (HPAPIs)
Gallery
Health & Safety
Research & Development
- Industrial Hygiene
- API and HPAPI Development
- Occupational Toxicology
- Research & Development (R&D)
- Corporate Toxicology
Key Specializations
- Analytical Development Laboratories
- Health, Safety & Environment
- Chemistry
Manufacturing & Processing
- Cleaning Validation
- Aseptic Processing
- Continuous Processing
- Manufacturing Science & Technology
Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, and Managers specialising in:
Who should attend
Research & Development
- API and HPAPI Development
- Research & Development (R&D)
- CMC (Chemistry, Manufacturing, and Controls)
- Formulation Development
- Chemistry
- Analytical Development Laboratories
Specialized Roles
Key Specializations
Product & Process Quality
- Product Quality
- Drug Safety Evaluation
Operational & Plant Management
- Operations
- Plant Management
- Engineering
Additional Key Areas
- ADC (Antibody Drug Conjugates)
- CMO/CDMO Coordination
- Technology Transfer
- New Products
Facility & Equipment Management
- Equipment Selection
- Facility Design
- Containment & Isolation
- Cleanrooms
- Contract Manufacturing & Development (CMOs/CDMOs)
- Occupational Health Advisors
- Pharmaceutical & Biotechnology Companies
- Chemical Manufacturing
- Containment Solution Providers
- Equipment Suppliers
Industry Sectors
- Production
- Scale-up Operations
- Process Development
Manufacturing & Processing
- Cleaning Validation
- Aseptic Processing
- Continuous Processing
- Manufacturing Science & Technology
- Environmental, Health & Safety (EHS)
Health & Safety
- Occupational Toxicology
- Corporate Toxicology
- Hazard Assessments
- Health, Safety & Environment (HSE)
- Industrial Hygiene
Business Strategy & Commercialization
- Parenteral Drugs
- Outsourcing
- Licensing
- Commercialization
- Strategic Development
- Business Development
Quality & Compliance
- Risk Management
- Internal & External Audit of Regulatory Affairs
- Validation of Process Monitoring & Control
- Compliance
- Quality Assurance/Control (QA/QC)
Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, and Managers specialising in:
Who should attend
Key practical learning points
- Staying updated on FDA, EMA, and international standards for HPAPI handling and compliance.
Global Compliance
- Strategies for secure, compliant transport and storage of HPAPIs, with regulatory alignment.
Supply Chain Safety
- Effective waste disposal and containment practices to minimize environmental impact.
Waste & Environmental Control
- Building a proactive safety culture through training in HPAPI handling, risk reduction, and incident response.
Training & Safety Culture
- Insights on layout, airflow, and modular upgrades for safe, efficient HPAPI production.
Cleaning & Decontamination
- Insights on layout, airflow, and modular upgrades for safe, efficient HPAPI production.
Facility Optimization
- Setting and maintaining strict occupational exposure limits to protect personnel and ensure compliance.
- Expert guidance on selecting, training, and using PPE tailored for safe HPAPI handling.
PPE Excellence
OEL Standards
- Cutting-edge isolator designs, engineering controls, and tech solutions to safeguard workers and maintain product quality.
- Identifying HPAPI hazards, toxicity, and exposure risks to establish robust containment measures.
Risk & Hazard Analysis
Containment Innovations
Key practical learning points
- Staying updated on FDA, EMA, and international standards for HPAPI handling and compliance.
Global Compliance
- Strategies for secure, compliant transport and storage of HPAPIs, with regulatory alignment.
Supply Chain Safety
- Effective waste disposal and containment practices to minimize environmental impact.
Waste & Environmental Control
- Building a proactive safety culture through training in HPAPI handling, risk reduction, and incident response.
Training & Safety Culture
- Insights on layout, airflow, and modular upgrades for safe, efficient HPAPI production.
Cleaning & Decontamination
- Insights on layout, airflow, and modular upgrades for safe, efficient HPAPI production.
Facility Optimization
- Setting and maintaining strict occupational exposure limits to protect personnel and ensure compliance.
- Expert guidance on selecting, training, and using PPE tailored for safe HPAPI handling.
PPE Excellence
OEL Standards
- Cutting-edge isolator designs, engineering controls, and tech solutions to safeguard workers and maintain product quality.
- Identifying HPAPI hazards, toxicity, and exposure risks to establish robust containment measures.
Risk & Hazard Analysis
Containment Innovations
Past sponsors
Join us in Berlin as we gather to share forward-looking insights. Over two days, industry experts will delve into regulatory updates, novel technological applications, risk mitigation strategies, and advancements in HPAPI manufacturing.
The 8th HPAPI Summit promises to be an invaluable opportunity to network, collaborate, and explore the future of HPAPI development and its potential to transform targeted therapies and personalized medicine.
The 8th HPAPI Summit promises to be an invaluable opportunity to network, collaborate, and explore the future of HPAPI development and its potential to transform targeted therapies and personalized medicine.
This event is a must for professionals in
the HPAPI sector. The discussions on
safety protocols, regulatory compliance, and risk management were incredibly
thorough, and it was reassuring to see so many leaders committed to advancing standards in high-potency API production.
It's an excellent opportunity to gain insights, share experiences, and build relationships that drive real
progress.
the HPAPI sector. The discussions on
safety protocols, regulatory compliance, and risk management were incredibly
thorough, and it was reassuring to see so many leaders committed to advancing standards in high-potency API production.
It's an excellent opportunity to gain insights, share experiences, and build relationships that drive real
progress.
Head of Compliance
Raj P.
The #Ehpapi Summit is hands-down the best event for anvone involved in high-potency API manufacturing and development. The speakers were knowledgeable, and the case studies presented real-world challenges and solutions that resonated with our work. What impressed me most was the focus on innovation-learning about Al applications and new delivery technologies really opened my eyes to the future of HPAPI.
Director of R&D
Sarah M.
Attending the #Ehpapi Summit was an invaluable experience. The sessions covered a wide range of highly relevant topics, from regulatory updates to the latest advancements in containment
technologies. I left with a deeper
understanding of the industry's direction and practical strategies that I could implement immediately in our processes.
The networking opportunities were fantastic-I connected with experts who have since become key collaborators.
technologies. I left with a deeper
understanding of the industry's direction and practical strategies that I could implement immediately in our processes.
The networking opportunities were fantastic-I connected with experts who have since become key collaborators.
VP of Manufacturing
James L.
What our participants are saying
What our participants are saying
Attending the #Ehpapi Summit was an invaluable experience. The sessions covered a wide range of highly relevant topics, from regulatory updates to the latest advancements in containment
technologies. I left with a deeper
understanding of the industry's direction and practical strategies that I could implement immediately in our processes.
The networking opportunities were fantastic-I connected with experts who have since become key collaborators.
technologies. I left with a deeper
understanding of the industry's direction and practical strategies that I could implement immediately in our processes.
The networking opportunities were fantastic-I connected with experts who have since become key collaborators.
Sarah M.
Director of R&D
The #Ehpapi Summit is hands-down the best event for anvone involved in high-potency API manufacturing and development. The speakers were knowledgeable, and the case studies presented real-world challenges and solutions that resonated with our work. What impressed me most was the focus on innovation-learning about Al applications and new delivery technologies really opened my eyes to the future of HPAPI.
Raj P.
Head of Compliance
This event is a must for professionals in
the HPAPI sector. The discussions on
safety protocols, regulatory compliance, and risk management were incredibly
thorough, and it was reassuring to see so many leaders committed to advancing standards in high-potency API production.
It's an excellent opportunity to gain insights, share experiences, and build relationships that drive real
progress.
the HPAPI sector. The discussions on
safety protocols, regulatory compliance, and risk management were incredibly
thorough, and it was reassuring to see so many leaders committed to advancing standards in high-potency API production.
It's an excellent opportunity to gain insights, share experiences, and build relationships that drive real
progress.
VP of Manufacturing
James L.
our contacts
made by dreamfish
hello@etapahub.com
+420 777 717 488
For booking assistance please contact
gabriela@etapahub.com
Gabriela Vladimirova
Dr. Ulrich Rümenapp, DE
Senior Biotech Program Lead
Bayer AG
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.
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, UK
Owner/Director
HPAPI Project Services Limited
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 R&D, 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 and a board level position in a biotechnology company. Mr. Mason-Home has been involved in and worked on potent and highly potent API projects over more than 25 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.
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 R&D, 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 and a board level position in a biotechnology company. Mr. Mason-Home has been involved in and worked on potent and highly potent API projects over more than 25 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.
Dean Calhoun, US
President and CEO
Affygility Solutions
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.
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, CH
Senior Consultant, Aseptic Processing & Containment
Skan AG
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
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, US
Sr. Fellow - Aseptic and Sterile Products
CRB
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.
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, HU
Director of Quality
Quality Hill
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.
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.
Christophe Dehondt, FR
Founder
BETTERISE
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.
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.
Luca Vietri, IT
Containment Expert & Co Founder
CSV Life Science
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.
Dr. Adela Maghear, BE
Independent Senior Policy Advisor on Health
Indépendant
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.
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, US
Associate Director of Cleaning Validation
Eliquent Life Sciences
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.
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.
Pietro Virgilio, IT
Regional Business Development Manager
Howorth Air Tech
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, EG
Quality Senior Manager Biologics F&F and New Projects
Minapharm
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.
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, US
Principal Consultant
ValSource Inc.
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.
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.
Ashley Harp, US
Associate, Process Engineer
CRB
Rich Arnett, CA
Manager, Industrial Hygiene & Toxicology
Pharmascience Inc.
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.
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, PT
Project Manager
Advanced Cyclone Systems
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.
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