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Strategic Advice

Horizontal 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.

Nuventra approaches strategic advice 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 FDA/EMA.

Our pharmacokinetic consultants and clinical pharmacology consultants apply their experience from prior drug programs as well as current interactions with regulatory agencies to determine logical next steps in rational drug development.

Strategic Planning Services

  • Complete NDA/BLA/ANDA due diligence
  • Full-service NDA/BLA/ANDA support
  • Interpretation of preclinical or early human data as a guide for next steps in clinical pharmacology programs
  • DDI waiver justifications
  • Pediatric study and PREA guidance
  • 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
  • International trial advice and due diligence in support of expanding studies internationally

 

Explore Our Blog

3 Pathways to Approval

Abbreviated New Drug Application vs. 505(b)(2) NDA: Choosing the Right Path

by Scientific Writing Team  Media attention and investor fanfare in drug development tend to focus on novel therapies. But did you…

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Questions for the FDA

Former FDA Reviewers Provide Answers to Key Questions

Nuventra’s consultants Gene Williams and Brian Furmanski spent a combined 23 years working for the FDA. In this new blog…

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What is Model-Based Drug Development?

by Scientific Writing Team  Model-Based Drug Development (MBDD), sometimes referred to as Model-Informed Drug Development (MIDD), is a process whereby key…

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