Development and Regulatory Strategy

Strategic planning across a drug development program can determine logical next steps and rational decision making. Instead of focusing on a single study, it is critical to consider how that study complements prior data and influences future decisions in a program. Each drug program has unique challenges and special circumstances. Allucent approaches regulatory strategy for your program based on therapeutic class characteristics, individual aspects of the asset (formulation, route of administration, etc.), current FDA expectations, target patient population, and disease indication.

We build in steps to increase the valuation of your asset, de-risk certain characteristics of the asset based on your exit strategy, or address known therapeutic class or indication-specific issues to enhance your negotiation position with investors, partners, board members, and regulatory authorities. Whether your program is just emerging from discovery or is completing clinical studies, our clinical pharmacology experts can help guide you in the right direction.

Allucent has former FDA reviewers on staff who can provide essential “behind the curtain” regulatory insights into your development program. Our Clinical Pharmacology Modeling and Simulation group is in close collaboration with other business units across Allucent to ensure a successful strategy for your drug development program.

Development and Regulatory Strategy Services:

  • Regulatory strategy and integrated drug development
    • across all phases, therapeutic areas, and patient populations (including pediatrics)
  • Regulatory strategy for multiple therapeutic modalities
    • small molecules, biologics, oligonucleotides, cell and gene therapy
  • Dose justification, candidate selection, first-in-human, proof of concept, dose-ranging safety and efficacy studies, registration, and lifecycle management
  • Due diligence (asset evaluation) and gap analysis
  • Full-service Pre-IND, IND, NDA, BLA, and ANDA support
  • Interpretation of pre-clinical data as a guide for next steps in clinical pharmacology programs
  • Drug-drug interaction (DDI) waiver justifications
  • In vitro/in vivo transporter and DDI study guidance
  • Proactive risk management planning to identify and minimize development challenges
  • Review of clinical pharmacology data/decisions that impact late phase studies
  • Strategic planning for regulatory interactions associated with and without clinical pharmacology data
  • Interpretation of industry guidance documents for individual clinical pharmacology development programs