Advancing Drug Development with Model-Informed Strategies

Connect with Our Experts

 

As FDA support for model-informed drug development grows, integrating PK/PD modeling into your development plan is no longer optional—it’s a competitive advantage. MIDD approaches are transforming how drug developers design studies, optimize dosing, and support regulatory decision-making.

 

Our experts will guide you toward success. We can help you:

 

  • Use PK/PD Modeling to Reduce Trial Risk: Apply quantitative methods to improve dose selection and streamline study design.
  • Optimize Drug Development across pathways: See how MIDD accelerates both 505(b)(1) and 505(b)(2) programs.
  • Translate complex data into action: Get support analyzing and integrating preclinical and clinical data into regulatory-ready models.
  • Implement MIDD From End to End: Align pharmacokinetics, bioanalysis, and regulatory strategy into a seamless, model-informed plan.

Meet our Experts

Agnieszka Marcinowicz, PhD, Director, Clinical Pharmacology

 

Isaac Asante, PhD, Principal Scientist, Pharmacology

 

Jayesh Patel, Principal Scientist Pharmacokinetics

 

Ready to get started?

 

Complete the form to schedule an informational session with our expert

Schedule A Meeting

By submitting your information to us through this webform, your business details will be added to our database. In accordance with our Privacy Notice, we may then contact you with marketing information about Premier Research that might be of interest to you. We will never sell your details to third parties. You can unsubscribe from marketing communications at any time.