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.
Real-World Evidence (RWE) Transforming Pricing and Reimbursement
RWE and Real-World Data (RWD) have become integral to clinical development and commercialization. According to Boxiong Tang , these data sources are not only vital for pricing and reimbursement decisions but also play a crucial role in regulatory submissions and clinical development. Historically, RWE was primarily utilized in post-market studies; however, a significant shift is now underway, with its application extending to earlier stages of clinical development and regulatory decision-making. This trend highlights the growing importance of RWE across the entire product lifecycle.
At the upcoming EVIDENCE 360: RWE, Pricing & Reimbursement Summit USA, Boxiong Tang will bring unique insights on the intersection of RWE, digital health, AI/ML technologies, and patient-centric approaches. His session will focus on Patient-Focused Drug Development (PFDD) and Clinical Outcomes Assessments (COA), particularly in light of recent FDA guidance. Key discussion points will include:
The role of COA and Patient-Reported Outcomes (PROs) in regulatory and reimbursement decisions.
Global PFDD guidance and its implications for drug development.
Strategies for integrating COA/PRO within clinical trials and real-world studies.
Case studies demonstrating COA/PRO in regulatory and reimbursement approvals.
The significance of a patient-centric market access strategy.
Digital Health Technologies Revolutionizing RWE Collection
The integration of digital health technologies is reshaping how RWE is collected and applied. Boxiong Tang identifies several ways in which digital tools such as wearable devices, electronic health records (EHRs), mobile health apps, and remote monitoring systems are enhancing RWE generation:
Expanding data sources for richer insights.
Enhancing data accuracy and timeliness.
Supporting decentralized and pragmatic clinical trials.
Enabling advanced analytics and AI applications.
Improving patient-centered outcomes research.
Strengthening regulatory and payer decision-making.
Facilitating interoperability and seamless data integration.
AI and Machine Learning: The Future of Evidence Generation
Artificial intelligence (AI) is expected to play a transformative role in evidence generation and decision-making. AI’s ability to analyze large datasets quickly and accurately presents new opportunities for:
Enhanced data analysis, reducing bias and improving accuracy.
Predictive modeling for better decision-making.
Personalized, real-time, and transparent insights.
Automating evidence generation.
Optimizing resource allocation in healthcare systems.
Global Regulatory Shifts and RWE Utilization
Regulatory frameworks worldwide are evolving to incorporate RWE in market access and reimbursement strategies. Boxiong Tang notes that regulatory bodies, including the US FDA and EU EMA, are increasingly emphasizing the importance of RWE throughout the product lifecycle. The Joint Clinical Assessment (JCA), launching in January 2025 for oncology products in Europe, is a significant step toward harmonizing regulatory and health technology assessment (HTA) requirements.
Overcoming Challenges in Data Quality and Interoperability
While digital health and AI/ML technologies offer immense potential, challenges remain. Key considerations include:
Data Privacy & Security: Ensuring compliance with HIPAA, GDPR, and other regulations.
Bias & Data Gaps: Addressing disparities in digital access to create more representative datasets.
Regulatory Uncertainty: Aligning RWE methodologies with evolving regulatory expectations.
Key Takeaway for EVIDENCE 360 Attendees
Boxiong Tang emphasizes that RWE, digital health technologies, AI/ML, and patient-centric approaches are transforming pharmaceutical development and commercialization, particularly in pricing and reimbursement. The growing sophistication of these tools is making RWE more robust, actionable, and patient-centered. Attendees will gain valuable insights into how these trends are shaping the future of healthcare decision-making and market access strategies.
About Boxiong Tang:
Dr. Boxiong Tang is the Associate Vice President, Head of HEOR and Value Access at Agenus, responsible for establishing HEOR strategies to support product launches and global reimbursement.
Previously, he served as the Head of HEOR at BeiGene and held senior leadership roles at Teva, Pfizer, Johnson & Johnson (JNJ), and GlaxoSmithKline (GSK).
Join Us at EVIDENCE 360: RWE, Pricing & Reimbursement Summit USA
We invite you to be part of this critical discussion at EVIDENCE 360: RWE, Pricing & Reimbursement Summit USA, taking place on 26th-27th June 2025 in Philadelphia, USA.
Highly Potent Active Pharmaceutical Ingredients (HPAPIs) are revolutionizing therapeutic development, particularly in oncology, neurology, and rare diseases. As the industry advances, regulatory requirements, technological innovations, and sustainability efforts are reshaping HPAPI manufacturing. Thomas Adam, Head of Global QA, Chemical APIs at Bayer | Pharmaceuticals , shares his expert insights on key trends, challenges, and opportunities driving development of HPAPI.
Significant Advancements in HPAPI Development
The growing demand for targeted therapies, such as antibody-drug conjugates (ADCs) and targeted radiotherapy (TRT), is increasing the need for HPAPIs. “These innovations allow for more precise drug delivery, minimizing off-target effects and improving patient outcomes,” says Adam. Additionally, advancements in API molecular engineering enhance potency and selectivity, further optimizing therapeutic efficacy.
Artificial intelligence and automation are playing a crucial role in accelerating HPAPI research. “Machine learning is now optimizing molecular discovery, reducing development timelines, and improving overall efficiency in drug development,” he adds.
Robotics in HPAPI Development & Manufacturing
The implementation of robotic technologies in HPAPI manufacturing is transforming safety, precision, and scalability:
Enhanced Safety: Robotics minimizes direct human interaction with hazardous materials, significantly reducing exposure risks.
Precision & Quality: Automated systems ensure accuracy in weighing, blending, and filling processes, maintaining consistency in product quality.
Scalability & Cost-Efficiency: “Robotic systems allow for rapid, safer production scale-up, which is critical for meeting growing market demands,” Adam explains. Additionally, reducing manual intervention lowers operational costs over time.
New Annex 1 Guidelines & Implications for HPAPI Manufacturing
The updated Annex 1 guidelines for sterile medicinal products introduce stricter control measures, significantly impacting HPAPI production. “The emphasis on contamination control, cleanroom design, and digital compliance tools is reshaping how manufacturers approach HPAPI handling,” notes Adam. Key updates include:
Contamination Control Strategy (CCS): Manufacturers must implement a robust CCS, integrating robotics and digital systems to mitigate contamination risks.
Advanced Cleanroom Design: Facilities must comply with higher air quality standards and adopt isolator-based technologies to prevent cross-contamination.
Closed-System Technologies & Automation: The guidelines encourage using closed systems and automated sterilization for improved safety.
Data Integrity: Digital solutions are essential for ensuring compliance by maintaining secure, tamper-proof records.
To meet growing regulatory and safety demands, the industry is adopting novel manufacturing approaches:
Containment Systems: Isolators and closed-loop technologies minimize worker exposure and environmental contamination.
Continuous Manufacturing: This method enhances consistency, reduces production waste, and improves efficiency.
Modular Facilities: These enable flexible production setups tailored to specific HPAPI needs, optimizing safety and resource utilization.
Strategies for Managing Regulatory Compliance
As global regulations continue to evolve, companies must adapt their compliance strategies. Adam highlights three critical approaches:
Integrated Compliance Teams: Establishing cross-functional teams ensures alignment with regulatory updates.
Digital Compliance Solutions: Real-time tracking and documentation management streamline adherence to global regulatory frameworks.
Risk Management Frameworks: Strong risk assessment models are essential for safe HPAPI handling, storage, and transport.
Sustainability in HPAPI Development & Production
Sustainability is becoming a core priority for pharmaceutical companies. “Adopting green chemistry principles, energy-efficient facility designs, and circular economy practices is key to minimizing environmental impact,” Thomas emphasizes. Efforts include:
Eco-friendly Solvents & Waste Reduction
Energy-Efficient Manufacturing Processes
Solvent Recycling & Circular Economy Practices
Emerging Therapeutic Areas Driving HPAPI Innovation
The demand for HPAPIs continues to grow, particularly in the following therapeutic areas:
Oncology: ADCs, TRT, and immunotherapies are leading HPAPI applications.
Neurology: Potent drugs targeting Alzheimer’s and neurodegenerative diseases are gaining traction.
Rare Diseases: Precision medicine is driving the need for highly potent, targeted molecules.
Key Takeaways for the Industry
Thomas concludes with an outlook on the future of HPAPI development:
Advanced technologies, regulatory strategies, and sustainability initiatives will define the future of HPAPI manufacturing.
Cross-industry collaboration is essential to drive innovation and ensure the safe, efficient production of potent therapeutics.
As the HPAPI sector evolves, companies must embrace automation, compliance modernization, and sustainability to stay ahead in this rapidly advancing field.
Thomas Adam is currently the head of global quality assurance chemical APIs in the chemical development of Bayer AG. He is responsible for the release of chemical APIs for clinical trials and the GMP-Quality system. Thomas holds a PhD in analytical chemistry from the University of Mainz in Germany. He has about 20 years of industrial experience at Bayer AG in different QC/QA-functions and a two years Post-Doc experience at Novartis, Switzerland. He is and was involved in many technical (transfer)-projects so as the planning and launching of the new GMP-kg lab for highly potent APIs and establishing a cleaning concept.
Join the Discussion at the EuroPotent Therapeutics Summit 2025
To explore these cutting-edge advancements and gain firsthand insights from industry leaders like Thomas Adam and many more!
📅 Event Date: 📍 Frankfurt, Germany: 22-23 May 2025
Network with top experts in development of HPAPI, regulatory compliance, and manufacturing.
Gain actionable strategies to enhance safety, efficiency, and sustainability in HPAPI production.
Discover innovative technologies shaping the future of potent pharmaceutical manufacturing.
