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.
Ready to take the next step? Register today and join us at the EuroPotent Therapeutics Summit to be part of this transformative journey at https://veridonglobal.com/events/europotent-therapeutics-summit/register-europotent/