The objective of Milad Pharmaceutical Consulting is to provide effective and efficient drug development clinical pharmacology programs.

Objective Driven:

  • Streamline drug development by improving the efficiency of the Pre-IND phase to the Proof-of-Concept study by applying 15 years of drug development and pharmacokinetic and pharmacodynamic (PK/PD) analysis and experience.


Effective:

  • Provide development plans, study designs and analysis based on the body of drug and disease state literature integrated with the understanding of PK, dose-response, time course of drug effect and disease progression.


Efficient:

  • Maximize information - the right data at the right time to make timely data driven decisions.
  • Minimize waste - plans and studies are designed to target specific program, business and regulatory goals while avoiding superfluous studies or assessments.


Skillful:

  • Standard non-compartment PK analysis for non-clinical and human PK/PD studies
  • Strategic drug development planning especially clinical pharmacology plans
  • Phase 1 study designs and dose selection for first-in-human, multiple dose tolerance, drug-drug interaction studies, dose response and proof of concept studies
  • PK/PD and dose-response analysis
  • Phase 2/3 population PK and PK/PD study design and analysis
  • In-licensing opportunities preparation and evaluation - experience in first-pass review and full due diligence of the pharmacokinetic and clinical pharmacology aspects of drug candidates


Deliberate:

  • IND option selection for streamlining development and decision making
  • Phase 1 study design option selection to maximize information and minimizing cost
  • Proof of concept study design optimization to enhance learning and decision making
  • Develop quantitative decision making criteria based on comparison to marketing profile and market place competition


Resourceful:

  • Partners with experts from other disciplines with a broad range of experiences to optimize strategies, study designs, study conduct and meet project goals and development objectives.