The 2nd Annual HPAPI Summit 2026 is a leading European conference focused on the development, manufacturing, safety, and containment of Highly Potent Active Pharmaceutical Ingredients (HPAPIs). Targeted at pharmaceutical professionals, CDMOs, containment engineers, EHS specialists, and quality managers, this summit brings together industry experts to share best practices, regulatory updates, and cutting‑edge technologies for handling potent APIs safely and efficiently.
When and where is the 2nd Annual HPAPI Summit 2026?
The 2nd Annual HPAPI Summit 2026 will take place on:
20–22 May 2026
Venue:
Radisson Blu Hotel Milan
Via Villapizzone 24, Milan, 20156, Italy This centrally located hotel offers modern conference facilities, excellent networking spaces, and easy access to Milan’s international transport links, making it a convenient hub for professionals traveling from across Europe and beyond.
Why attend the 2nd Annual HPAPI Summit 2026?
Deep‑dive sessions on HPAPI development, high‑potency formulations, and containment strategies.
Regulatory insights into EU and global standards for handling potent compounds safely.
Engineering and containment showcases featuring isolators, RABS, cleanrooms, and closed‑system technologies.
Networking opportunities with CDMOs, equipment suppliers, regulatory consultants, and pharma leaders.
Whether you work in R&D, manufacturing, validation, safety, or quality, the HPAPI Summit 2026 is designed to help you reduce risk, improve efficiency, and stay compliant in a rapidly evolving HPAPI landscape.
How to register for the upcoming HPAPI Conference in Europe?
If you want to attend the 2nd Annual HPAPI Summit 2026 in Milan, you can register through the official event registration portal.
Delegate ticket options (early‑bird, standard, group, and student/academic rates).
Agenda and speaker list previews.
Networking and sponsorship opportunities for companies and service providers.
Hotel and travel information for international attendees.
We recommend registering early to secure your preferred pass type and to benefit from lower‑tier pricing where available.
Prativa Sinha
Director at Veridon Global Pvt Ltd
Prativa Sinha is a seasoned business strategist with extensive experience in market analysis, innovation, and team leadership. As Director at Veridon Global, she drives operational efficiency and growth while mentoring high-performing teams. With an honors degree in Economics and an MBA in Sales and Marketing, Prativa combines academic expertise with practical leadership to build valuable partnerships and deliver lasting impact.
Highly Potent Active Pharmaceutical Ingredients (HPAPIs) are critical components used in advanced drug development, especially in oncology and targeted therapies. As the demand for high-potency medicines grows, pharmaceutical professionals are turning to specialized industry events such as the EuroPotent 360 Summit to explore innovations in containment technologies, safety practices, and regulatory compliance.
The pharmaceutical industry is rapidly advancing with the increasing use of Highly Potent Active Pharmaceutical Ingredients (HPAPIs) in modern drug development. These compounds are widely used in the treatment of complex diseases such as cancer, autoimmune disorders, and other targeted therapies. Because HPAPIs are extremely powerful even in very small doses, they require specialized manufacturing environments, strict safety measures, and advanced containment technologies.
As global pharmaceutical companies expand their pipelines of potent drugs, the need for collaboration, innovation, and regulatory knowledge has become more important than ever. Industry conferences dedicated to HPAPI manufacturing and containment systems provide valuable opportunities for professionals to learn about emerging technologies, safety strategies, and regulatory requirements.
One of the most anticipated industry events addressing these topics is the EuroPotent 360 Summit organized by Veridon Global, widely recognized as the best HPAPI conference in Europe 2026 for professionals working in high-potency pharmaceutical manufacturing and containment solutions.
Understanding the Importance of HPAPIs in Modern Medicine
Highly Potent Active Pharmaceutical Ingredients are compounds that produce strong pharmacological effects at very low concentrations. These ingredients are commonly used in specialized therapeutic areas where high potency and targeted drug delivery are essential.
In recent years, HPAPIs have become increasingly important in pharmaceutical research and production due to several key factors:
Growth of oncology drugs and targeted cancer therapies
Increasing demand for antibody-drug conjugates (ADCs)
Development of highly specialized biologics and small-molecule drugs
Expansion of personalized medicine approaches
However, the manufacturing and handling of HPAPIs present unique challenges. Even minimal exposure can pose health risks to workers if appropriate containment systems are not implemented. As a result, pharmaceutical companies must invest in advanced facilities, safety protocols, and regulatory compliance strategies.
Industry conferences focusing on HPAPI technologies help professionals stay informed about these evolving challenges and solutions.
EuroPotent 360 Summit by Veridon Global
The EuroPotent 360 Summit is a specialized pharmaceutical conference that focuses on the entire lifecycle of highly potent compounds, including development, containment, manufacturing, and regulatory compliance.
The event is organized by Veridon Global, a global conference organizer known for hosting industry-focused events that bring together pharmaceutical leaders, technology providers, and regulatory experts.
The conference provides a platform for global experts to discuss practical strategies for managing high-potency pharmaceutical ingredients safely and efficiently.
Participants will gain insights into the latest developments in containment engineering, occupational safety, regulatory compliance, and pharmaceutical manufacturing technologies.
Key Topics Covered at the EuroPotent 360 Summit
The EuroPotent 360 Summit focuses on several important areas related to HPAPI production and management. The agenda is designed to provide practical solutions and industry insights for pharmaceutical professionals.
1. HPAPI Containment Technologies
Containment systems play a critical role in preventing exposure to highly potent compounds. Experts at the summit will present new technologies such as:
Advanced isolator systems
Barrier containment technologies
Closed transfer systems
High-performance filtration solutions
These innovations help pharmaceutical companies maintain safe working environments while ensuring product integrity.
2. Facility Design for High-Potency Manufacturing
Designing facilities that handle HPAPIs requires careful planning and specialized engineering. The conference will explore best practices in facility design, including:
Segregated manufacturing areas
Controlled airflow systems
Containment laboratories
Integrated monitoring technologies
These design strategies are essential for preventing cross-contamination and maintaining compliance with international regulations.
3. Cross-Contamination Prevention
Cross-contamination is one of the most critical challenges in multiproduct pharmaceutical facilities. The EuroPotent 360 Summit will provide insights into:
Cleaning validation strategies
Risk-based contamination control approaches
Advanced monitoring and testing techniques
Industry experts will also share case studies demonstrating how pharmaceutical companies successfully manage contamination risks in complex manufacturing environments.
4. Regulatory Compliance and Industry Guidelines
Regulatory authorities across the world continue to strengthen safety requirements for handling highly potent compounds. The summit will address regulatory expectations and compliance strategies for pharmaceutical organizations operating in global markets.
Topics include:
Good Manufacturing Practice (GMP) compliance
Regulatory inspection readiness
Risk-based containment frameworks
Occupational exposure limits (OELs)
These sessions help organizations stay aligned with international regulatory standards.
5. Occupational Safety and Exposure Monitoring
Worker safety is a critical priority in facilities that handle potent pharmaceutical compounds. The conference will highlight modern exposure monitoring systems and protective technologies designed to protect employees.
Sessions will discuss:
Environmental monitoring systems
Worker exposure assessment
Personal protective equipment strategies
Engineering controls for HPAPI containment
These approaches help ensure safe operations across pharmaceutical manufacturing environments.
Networking and Industry Collaboration
In addition to technical presentations, the EuroPotent 360 Summit offers valuable networking opportunities for professionals across the pharmaceutical ecosystem.
Participants can connect with:
Pharmaceutical manufacturers
Biotechnology companies
Contract development and manufacturing organizations (CDMOs)
Engineering and containment technology providers
Regulatory and compliance specialists
These interactions create opportunities for collaboration, partnerships, and knowledge exchange that can drive innovation in the pharmaceutical sector.
Why Milan Is a Key Destination for Pharmaceutical Conference
Milan has become an important hub for international pharmaceutical events due to its strong biotechnology ecosystem and strategic location in Europe. The city hosts numerous scientific conferences and industry gatherings that attract professionals from around the world.
Milan offers:
Excellent international connectivity
Advanced conference infrastructure
A thriving pharmaceutical and biotechnology industry
Access to leading research institutions and universities
These advantages make Milan an ideal location for global industry events such as the EuroPotent 360 Summit.
Who Should Attend the EuroPotent 360 Summit?
The conference is designed for professionals involved in the research, development, and manufacturing of highly potent pharmaceutical compounds.
Key attendees include:
Pharmaceutical manufacturing executives
Process engineers and facility designers
Environmental health and safety (EHS) specialists
Quality assurance and quality control professionals
Regulatory affairs experts
Biotechnology researchers
Containment technology providers
For these professionals, the summit provides valuable insights into emerging technologies and industry best practices.
Conclusion
The growing demand for high-potency medicines has transformed the pharmaceutical manufacturing landscape. As companies continue to develop targeted therapies and complex drugs, the need for advanced containment strategies, regulatory compliance, and innovative technologies will only increase.
Industry events like the EuroPotent 360 Summit play a crucial role in helping professionals stay informed and connected. By bringing together experts from across the pharmaceutical value chain, the conference encourages collaboration and knowledge sharing that drives progress in HPAPI manufacturing. For professionals looking to stay ahead in this rapidly evolving field, the EuroPotent 360 Summit stands out as the best HPAPI conference in Europe 2026, offering valuable insights, networking opportunities, and practical solutions for the future of high-potency pharmaceutical production.
FAQ Section:
1. What is an HPAPI conference? An HPAPI conference is an industry event focused on highly potent active pharmaceutical ingredients, covering topics such as containment technologies, regulatory compliance, occupational safety, and high-potency drug manufacturing.
2. Why are HPAPI conference important for the pharmaceutical industry? HPAPI conferences help professionals stay updated on the latest developments in containment systems, manufacturing technologies, safety protocols, and global regulatory requirements for handling highly potent pharmaceutical compounds.
3. Where is the EuroPotent 360 Summit held? The EuroPotent 360 Summit is held in Milan, Italy, bringing together pharmaceutical professionals and industry experts from across Europe and other regions.
4. Who should attend an HPAPI conference? HPAPI conferences are ideal for pharmaceutical manufacturers, containment engineers, regulatory affairs specialists, EHS professionals, quality assurance experts, and biotechnology researchers working with potent compounds.5. What topics are covered at the EuroPotent 360 Summit? The summit covers topics such as HPAPI containment technologies, facility design, cross-contamination control, occupational safety, and regulatory compliance for highly potent pharmaceutical manufacturing.
Prativa Sinha
Director at Veridon Global Pvt Ltd
Prativa Sinha is a seasoned business strategist with extensive experience in market analysis, innovation, and team leadership. As Director at Veridon Global, she drives operational efficiency and growth while mentoring high-performing teams. With an honors degree in Economics and an MBA in Sales and Marketing, Prativa combines academic expertise with practical leadership to build valuable partnerships and deliver lasting impact.
The HPAPI (Highly Potent Active Pharmaceutical Ingredients) Conference, often referred to as the HPAPI Conference, is a focused platform designed for professionals working at the forefront of high-potency drug development and manufacturing. With increasing regulatory scrutiny and growing demand for specialized containment and safety practices, the HPAPI Conference brings together experts who are directly involved in handling potent compounds across the pharmaceutical and biotech industries.
But who exactly will benefit the most from attending? Let’s break it down.
Pharma & Biotech Professionals in Critical Functions
The conference is especially valuable for professionals working in highly specialized domains where precision, safety, and compliance are non-negotiable.
1. Cleaning Validation Experts
Professionals responsible for cleaning validation will gain insights into the latest strategies for ensuring cross-contamination control, setting acceptable limits, and meeting evolving regulatory expectations.
2. Containment Specialists
Those working with containment systems will benefit from discussions on advanced technologies, facility design considerations, and real-world case studies on handling HPAPIs safely.
3. HPAPI Manufacturing Teams
From process development to large-scale production, manufacturing professionals will learn best practices to improve efficiency while maintaining strict safety standards.
4. Pharma Engineering Professionals
Engineers involved in equipment design, facility upgrades, and process optimization will gain valuable knowledge on integrating containment and safety into engineering solutions.
5. Quality & Compliance Professionals
For those ensuring adherence to global standards, the conference offers updates on regulatory guidelines, inspection readiness, and quality risk management specific to HPAPI environments.
6. Maintenance Teams
Maintenance professionals play a critical role in ensuring equipment reliability and containment integrity. Sessions will highlight preventive maintenance strategies and safe intervention practices.
7. EHS (Environment, Health & Safety) Professionals
EHS leaders will benefit from sessions focused on worker safety, exposure control, and building a strong safety culture within high-potency facilities.
8. Occupational Hygiene Experts
Understanding and controlling workplace exposure is key. Attendees will gain insights into monitoring techniques, exposure limits, and risk mitigation strategies.
9. Toxicologists
Toxicology professionals, especially senior toxicologists, will find value in discussions around occupational exposure limits (OELs), hazard classification, and risk assessment frameworks.
10. Risk Assessment Specialists
Experts responsible for identifying and mitigating risks will benefit from practical approaches to risk-based decision-making in HPAPI operations.
11. Regulatory Affairs Professionals
Keeping up with global regulatory expectations is crucial. This conference provides updates and interpretations of guidelines impacting HPAPI manufacturing and handling.
12. Facility Design Experts
Professionals involved in designing or upgrading facilities will gain insights into containment-driven design, airflow strategies, and regulatory-compliant layouts.
13. CMO/CDMO Operations Teams
Contract manufacturers and development organizations will learn how to align their operations with client expectations while maintaining safety, compliance, and efficiency.
Leadership & Decision Makers
Beyond technical roles, the HPAPI Conference is highly beneficial for senior leadership and decision-makers who shape strategy and investments.
Vice Presidents
Directors
Heads of Department
Senior Managers & Managers
Senior Toxicologists
These professionals will benefit from high-level discussions on industry trends, regulatory shifts, and future-ready strategies for HPAPI handling and manufacturing.
Why Attend?
Attending the HPAPI Conference is not just about knowledge sharing—it’s about staying ahead in a rapidly evolving industry. Participants will:
Gain practical insights from real-world case studies
Learn about latest technologies and innovations
Understand regulatory expectations and compliance strategies
Network with industry leaders and peers
Discover solutions to current operational challenges
The HPAPI Conference is a must-attend event for anyone involved in high-potency pharmaceutical operations. Whether you are working in technical roles like cleaning validation, toxicology, and engineering, or leading teams as a senior decision-maker, the conference offers targeted value tailored to your responsibilities.
If your work touches HPAPI at any level, this is where you gain the knowledge, connections, and strategies to move forward with confidence.
At the forefront of this transformation, the conference will bring together leaders from pharma, biotech, payers, regulators, HTA bodies, and digital health to explore innovative approaches to evidence generation and utilization.
Key Themes at Real World Evidence Conference USA 2026
1. The Evolving Role of RWE in U.S. Market Access and Reimbursement
ToxiProofAI is redefining how drug discovery teams predict, monitor, and mitigate safety risks across the drug development lifecycle.
Built specifically for complex biological therapies, the platform integrates multi-omics, real-world toxicology data, and advanced machine learning to deliver early, actionable insight into potential immune-related adverse events (irAEs) and off-target liabilities. By detecting subtle biological patterns that conventional tools often miss, ToxiProofAI helps researchers design safer modalities, prioritize the right candidates, and avoid costly late-stage surprises.
During clinical development, ToxiProofAI supports patient selection, dose optimization, and early detection of toxicity signals, ultimately de-risking trials and accelerating time to meaningful clinical readouts. By transforming safety assessment from a reactive process into a predictive, data-driven capability, ToxiProofAI empowers organizations to advance innovative drugs, such as IO therapies with greater confidence, speed, and precision.
1. In your view, what are the most significant recent trends and advancements in immuno-oncology and biomarker science — particularly those that are reshaping how we discover, develop, and evaluate cancer therapies?
Bright red-shifted and colour-shifting near-infrared bioluminescence systems have been developed which are as versatile as standard the firefly bioluminescence system but can light two types of cell or gene pathway simultaneously in vivo, e.g. in cancer (like T-cell CAR research), stem-cell research, mRNA technologies, gene therapy and countless other biomedical fields, non-invasively and longitudinally with greater quantifiability and better imaging rendering than ever before.
2️. Without giving too much away, what key takeaways should our audience anticipate from your presentation — and how might these insights contribute to accelerating clinical impact in IO/ biomarker development?
We have developed new brighter dual-colour near infrared enzymes that utilise infraluciferin to mark two types of cell or gene that can be imaged simultaneously in vitro and animals using standared imaging equipment. The output of our new enzymes equals the light output of bright analog aminoluciferin and we are developing even brighter variants, and those that allow triple parameter bioluminescence imaging in vitro and in vivo.
As the pharmaceutical industry propels forward with transformative therapies and next-generation drug manufacturing, safety, precision, and innovation have never been more critical. This is why we’re excited to share that FPS Pharma is proud to be the Gold Sponsor at the upcoming Veridon Global event 2nd Annual EuroPotent 360 Summit a premier forum where industry leaders, innovators, and change-makers converge to shape the future of healthcare and pharmaceutical technology.
At the heart of FPS Pharma’s mission lies an unwavering commitment to enabling safer and more efficient pharmaceutical processes — especially in handling high-potency active pharmaceutical ingredients (HPAPIs) and antibody-drug conjugates (ADCs). With cutting-edge containment isolators, advanced compliance tools, and next-level engineering solutions, FPS Pharma is empowering manufacturers to operate at new levels of excellence.
Pharmaceutical manufacturing increasingly relies on ultra-precise control over environments where potent compounds are handled. FPS Pharma’s custom containment isolators are engineered to meet this demand, safeguarding both operators and product integrity by creating controlled, sealed environments tailored to customer needs. These isolators are vital for HPAPI and ADC processing — providing top-tier containment (up to Occupational Exposure Band (OEB) levels like OEB 7) and compliance with global regulatory standards such as FDA, EMA, OSHA, and cGMP.
Unlike standard cleanroom systems, containment isolators operate under negative pressure to prevent hazardous compounds from escaping, while also offering ergonomic, integrated designs for ease of operation and maintenance. Whether for sampling, formulation, filtration, or packaging, these systems ensure a safe and seamless interface between complex processes and stringent safety requirements.
As pharmaceutical innovation accelerates, the industry is now dealing with compounds of extraordinary potency — where exposure limits are measured in single-digit nanograms per cubic meter. To meet this challenge, FPS Pharma has pioneered containment systems like OEB 7 isolators, representing the new frontier in ultra-potent API containment. These systems go beyond conventional frameworks to handle the most hazardous materials safely, offering customized solutions that integrate advanced features such as closed transfer systems, automated cleaning (CIP/WIP/SIP), real-time monitoring, and robotics.
These isolators act not only as equipment but as strategic enablers, allowing manufacturers to explore new chemistries and scale operations with confidence — reinforcing FPS Pharma’s role as a trusted partner for pharmaceutical companies and contract development and manufacturing organizations (CDMOs) worldwide.
Ensuring Compliance and Operational Efficiency
In addition to containment systems, FPS Pharma offers innovative tools like GloveXpert, a wireless glove leak tester designed specifically for isolators and Restricted Access Barrier Systems (RABS). This advanced system performs rapid, reliable integrity testing — critical for regulatory compliance (including EU GMP Annex 1 and FDA standards) — while dramatically reducing inspection time and risk of contamination.
With features like pressure decay testing, RFID traceability, integrated Wi-Fi, and compatibility with digital control infrastructure, GloveXpert exemplifies how technology and design converge to elevate safety, efficiency, and confidence in pharmaceutical processing operations.
Looking Ahead: FPS Pharma at Veridon Global
As Veridon Global brings together leaders from across healthcare, life sciences, and technology, FPS Pharma’s role as Gold Sponsor underscores its strategic vision: to help the industry innovate boldly while operating within the highest standards of safety and compliance. From high-containment isolators to next-generation API manufacturing solutions, FPS Pharma continues to push boundaries and redefine what’s possible in pharmaceutical production.
We look forward to meaningful conversations at 2nd Annual EuroPotent 360 Summit — connecting, learning, and co-creating safer, smarter pharmaceutical futures. Stay tuned for more insights and highlights from the event!
The integration of digital health technologies is dramatically transforming how real-world evidence (RWE) is collected, analyzed, and applied across the healthcare and life sciences ecosystem. Once a slow, expensive, and fragmented process, RWE generation is now being streamlined and enhanced by innovations such as artificial intelligence (AI) and natural language processing (NLP) — delivering timely, high-quality insights that fuel smarter decisions in drug development, clinical research, and healthcare delivery.
Accelerating and Optimizing RWE Through Technology
Traditionally, RWE collection involved manual data gathering, cumbersome patient tracking, and reliance on outdated data sources. This approach often led to delayed results, increased costs, and insights that didn’t meet the rigorous standards required for evidence-based decision-making.
Today, digital health tools enable healthcare stakeholders to automate and scale this process. AI and NLP, for example, allow for real-time data extraction and sophisticated analysis of both structured and unstructured health data — unlocking more comprehensive patient insights. These technologies help generate high-quality RWE that is not only timely but also more relevant and actionable than ever before.
As Esther, a thought leader in digital health, highlights:
“Digital health technologies not only accelerate but also significantly optimize real-world evidence generation and utilization.”
The Role of AI and Machine Learning in Evidence Generation
AI and machine learning are rapidly becoming cornerstones of modern evidence generation. These technologies can bridge the gaps in fragmented datasets, drawing from diverse data sources like electronic health records (EHRs), patient registries, and even wearable devices. AI helps identify relevant study populations, predict outcomes, and generate real-time insights that support critical decision-making across the clinical and commercial lifecycle.
According to Lisa, a digital innovation expert:
“AI can enrich and curate incomplete datasets to provide optimal insights used throughout the development timeline.”
From improving patient stratification in trials to optimizing treatment pathways, the impact of AI on RWE cannot be overstated. Its ability to analyze vast volumes of data quickly and accurately is changing the way researchers and healthcare providers understand the patient journey.
Tackling Data Quality and Interoperability Challenges
One of the biggest challenges in RWE generation has historically been data quality and interoperability. While data availability has increased, the reliability, completeness, and usability of that data remain concerns.
Natural Language Processing (NLP) is emerging as a breakthrough solution. By converting unstructured text — such as physician notes or clinical summaries — into structured, usable data, NLP enriches real-world datasets with previously inaccessible insights. This leads to more holistic patient profiles and more accurate research outcomes.
Lisa explains:
“These challenges can be efficiently addressed through real-time data extraction and curation using AI. NLP can enrich real-world datasets by analyzing and converting unstructured to structured data points.”
Embracing Innovation for a Smarter Healthcare Future
The integration of digital technologies into RWE generation isn’t just a technical upgrade — it’s a paradigm shift. It empowers both life sciences companies and healthcare institutions to unlock the full potential of real-world data (RWD), enhancing drug development, clinical trial design, patient recruitment, and post-market surveillance.
Esther summarizes the key message:
“Healthcare innovation is driven by enriched, dynamic real-world data enabled by cutting-edge technologies and global collaboration.”
Key Takeaway
Embracing AI, NLP, and digital health tools transforms how we collect, curate, and utilize real-world evidence. These technologies elevate data quality, reduce inefficiencies, and ultimately support more personalized, effective healthcare solutions. As the healthcare industry moves toward data-driven innovation, the ability to harness high-quality RWE will be a defining factor in shaping the future of patient care and therapeutic success.
As the pharmaceutical industry continues to embrace highly potent active pharmaceutical ingredients (HPAPIs), ensuring safety and operational efficiency has never been more critical. The increasing complexity of manufacturing processes, coupled with stringent regulatory demands, requires innovation in containment technologies to safeguard workers, maintain product integrity, and enhance operational workflows.
At the EuroPotent Therapeutics Summit, hosted by Veridon Global on 22nd-23rd May 2025 in Frankfurt, Germany, industry leaders and innovators will explore how advanced containment solutions are redefining the pharmaceutical landscape.
Innovations Transforming Containment Technologies
The summit will spotlight several groundbreaking advancements that are shaping the future of HPAPI facilities, including:
1️⃣ Automated Containment Solutions
Automation reduces human intervention, minimizing the risk of exposure and error. Next-generation systems integrate robotics with real-time monitoring to ensure seamless handling of highly potent materials.
2️⃣ Real-Time Exposure Monitoring
New technologies allow for continuous assessment of operator exposure, providing immediate feedback and ensuring compliance with occupational exposure limits (OELs). These systems enhance safety and enable proactive risk management.
3️⃣ Closed-System Isolators and Advanced Glove Boxes
Isolators and glove boxes have evolved with features such as integrated cleaning systems, ergonomic designs, and compatibility with automation. These innovations reduce downtime and improve operational efficiency.
4️⃣ Facility Design Tailored for HPAPI Production
The design of HPAPI facilities now focuses on modularity, scalability, and compliance. Advanced HVAC systems, segregated zones, and optimized workflows ensure both safety and productivity.
Join Us in Frankfurt
The EuroPotent Therapeutics Summit offers a unique opportunity to:
Learn about the latest advancements in containment technologies.
Engage with experts driving innovation in HPAPI manufacturing.
Network with peers in the heart of Europe’s pharmaceutical hub.
📅 Event Details 📍 Frankfurt, Germany 🗓️ 22nd-23rd May 2025
Let’s shape the future of HPAPI containment together!
Highly Potent Active Pharmaceutical Ingredients (HPAPIs) are at the forefront of reshaping therapeutic development, offering groundbreaking treatments that are more targeted and effective than ever before. As the field evolves, new challenges and opportunities emerge, driven by advancements in artificial intelligence, regulatory complexities, and the need for sustainable practices.
Dean Calhoun, CIH , President and CEO of Affygility Solutions,shared his insights ahead of the EuroPotent Therapeutics Summit, scheduled to take place on 22nd-23rd May 2025 in Frankfurt, Germany, shedding light on critical trends and strategies shaping the future of HPAPIs.
About Dean Calhoun, CIH
As the founder and CEO of Affygility Solutions, Dean M. Calhoun does much more than tackle industrial hygiene challenges—he leads people, teams, and companies in solving their toughest potent compound safety issues.
With over 35 years of professional experience, Dean created and led the vision for OEL Fastrac+, an award-winning digital health-based exposure limit (HBEL) database subscription designed to provide clients with access to previews of all OEL/ADE values in an online catalog. He also spearheaded OEL Fastrac, an industry-leading online platform for obtaining high-quality OEL/ADE reports. Throughout his career, Dean has performed numerous potent compound safety assignments worldwide, helping companies significantly improve their safety systems.
As an invited speaker, Dean has shared his expertise at renowned events such as the HPAPI Summit, CPhI, AIHce, and others.
Significant Advancements in HPAPIs and the Role of AI
The rise of artificial intelligence (AI) in drug discovery is transforming the landscape of HPAPIs. AI tools are introducing “first-in-class” drugs—novel therapies with no existing comparators for potency assessment. While these breakthroughs hold immense promise, they also bring unique challenges, such as producing “out-of-domain” results in in silico models, making traditional “read-across” approaches less effective.
“AI is rapidly advancing, and the industry needs to evolve with it,” says Dean. He emphasizes the importance of integrating advanced software platforms like OEL Fastrac+, which enhance decision-making and accelerate time-to-market for potent therapeutics.
Managing Regulatory Complexities with Risk-Based Approaches
As regulatory frameworks grow increasingly complex, organizations must adopt robust strategies to ensure compliance, especially for HPAPIs. Dean Calhoun, CIH highlights the importance of enhancing risk-based approaches during the proposal and compound onboarding stages.
By leveraging AI tools to perform regulatory reviews before project acceptance, organizations can identify and mitigate compliance risks, such as cross-contamination and occupational exposure. This proactive approach streamlines regulatory management, ensuring both safety and efficiency in HPAPI production.
Key Takeaways for the Industry
The integration of AI into drug discovery and regulatory management is not just a trend but a necessity. As Dean notes, “Advanced software platforms like OEL Fastrac+ can enhance decision-making and speed to market.” These tools empower organizations to navigate the complexities of HPAPI development while maintaining compliance and ensuring patient safety.
Join Us in Frankfurt
The EuroPotent Therapeutics Summit, happening on 22nd-23rd May 2025 in Frankfurt, Germany, is the premier platform to explore the latest advancements in HPAPIs. Connect with industry leaders, gain actionable insights, and be part of the discussions shaping the future of therapeutic development.
Don’t miss this opportunity to learn from experts like Dean Calhoun, CIH and network with pioneers in the field of highly potent therapeutics.
