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Webinar

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Date: Tuesday, December 2, 2025

Time: 11am EST - 12pm EST

Services: Pharmacometrics, Regulatory Submissions

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Summary

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) increasingly expect pharmacometric evidence to play a pivotal role in New Drug Application (NDA) and Biologics License Application (BLA) submissions. Initiatives such as the FDA’s Model-Informed Drug Development (MIDD) pilot underscore how analyses like population pharmacokinetics (PopPK) and exposure–response modeling have become essential for dose justification, variability assessment, and labeling decisions.

However, meeting these expectations can be challenging—especially when submissions are expedited. Smaller and mid-sized biopharma companies often face limited resources and compressed timelines, while larger organizations must manage cross-functional coordination, evolving regulatory guidance, and global submission alignment. Sponsors are increasingly seeking strategies that balance scientific rigor with the practical realities of meeting regulatory deadlines.

This webinar will bring together regulatory and pharmacometric experts to share practical insights into how sponsors can navigate these challenges. From understanding agency expectations to applying fit-for-purpose modeling approaches, attendees will gain actionable strategies to strengthen submission readiness, streamline workflows, and accelerate review timelines—whether operating in a lean biotech environment or across large, global R&D teams.

Key learning objectives:

  • Regulatory Readiness: Understand FDA, EMA, and global expectations for pharmacometric evidence through early engagement and clear justification strategies.
  • Core Analyses: Leverage population PK and exposure–response models to support dose selection, labeling, and benefit–risk decisions.
  • Operational Challenges: Tackle evolving guidance, data complexity, and resource constraints with practical, proven solutions.
  • Expedited Strategies: Manage compressed timelines with efficient, scientifically sound, and compliant modeling approaches.
  • Future Outlook: Adopt integrated modeling, adaptive workflows, and clear visualization to strengthen next-generation submissions.

Speakers:

Felix Boakye-Agyeman MD PhD

Vice President, Consulting, Certara

Dr. Felix Boakye-Agyeman is Vice President of Pharmacometrics within the Integrated Drug Development (IDD) group at Certara, a global leader in model-informed drug development. Certara partners with more than 2,300 organizations worldwide and has contributed over 99% of all new drug approvals in the past decade.

At Certara, Dr. Boakye-Agyeman leads a multidisciplinary team of scientists who integrate quantitative modeling and clinical pharmacology, and to optimize drug development across therapeutic areas. His work has directly supported the development and approval of multiple therapies, particularly in oncology, immunology, and pediatric indications.

With a background spanning medicine, clinical pharmacology, and quantitative sciences, Dr. Boakye-Agyeman is recognized for advancing model-informed strategies for special and vulnerable populations, ensuring that data-driven innovation translates into safer and more effective therapies.

Prior to joining Certara, he held leadership roles at Synteract, where he oversaw pharmacometric consulting for adult and pediatric programs, and at the Duke Clinical Research Institute (DCRI), supporting early-phase and pediatric trials through the NIH-funded Pediatric Trials Network. His contributions have informed pediatric dosing strategies and labeling updates by major regulatory agencies, including the FDA, EMA, PMDA, NMPA, and Health Canada.

Beyond his role at Certara, Dr. Boakye-Agyeman serves on the Board of Africa Partners Medical (APM), where for over 15 years he has contributed to health system strengthening, medical training, and quality improvement initiatives across Ghana and West Africa.

Functional Expertise

  • Population PK
  • Exposure Response Analysis
  • PK/PD analysis
  • Non-compartmental analysis
  • Concentration QTc analysis
  • Clinical pharmacology

Specialty Areas

  • Oncology
  • Autoimmune
  • Infectious diseases
  • Antibody drug conjugates (ADC)
  • Special Populations (Pediatrics, Maternal Health)
Huub Jan Kleijn

Sr Director, Consulting, Certara

Huub is a senior pharmacometrician with an in-depth knowledge of pharma R&D, with 20+ years of pharmaceutical industry / consulting experience. He has a broad regulatory experience reflected by contributions to multiple new drug applications across therapeutic areas. He has proficient modeling skills in population PK, PKPD and exposure-response analysis. Huub has demonstrated ability to successfully lead pharmacometric project teams covering the full chain from scoping, pricing, setting up M&S analysis plans, execution of analysis and authoring regulatory quality reports.

Functional Expertise

  • Clinical pharmacology
  • DMPK
  • Drug development strategy
  • Non-compartmental analysis
  • PK/PD analysis
  • Population PK

Specialty Areas

  • Antibody drug conjugates (ADC)
  • Central nervous system (CNS)
  • Oncology
  • Orphan diseases
  • Pediatrics
  • Psychiatric

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