Strategic Planning

Nuventra provides horizontal strategic planning across a drug development program.  Instead of focusing on a single study, Nuventra determines how that study complements prior data and influences future decisions in a program.  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.

Examples of strategic clinical pharmacology/regulatory planning:

  • Evaluation if a standalone impaired renal study or impaired hepatic study be avoided because the patient population being studied is enriched for varying degrees of renal or hepatic function such that population PK analyses in late phase studies would satisfy regulatory requirements.
  • Using modeling and simulation techniques to extrapolate the expected exposure of a drug in adults to pediatrics to enable proper dose selection that provides sufficient and safe blood drug concentrations in a pediatric study.
  • Conducting clinical drug-drug interaction evaluations all potential drugs that a patient may take concomitantly with an investigational drug is not feasible.  Nuventra can help determining which drug-drug interaction studies are needed in a poly-pharmacy patient population, including those drugs that may interact with metabolizing enzymes (CYP P450) or transporters or for drugs that are commonly used in the target population.  Many times drug-drug interaction pharmacokinetic evaluation can be done in Phase 2 and Phase 3 studies using population pharmacokinetics modeling.
  • Appropriate presentation of different clinical pharmacology/PK/PD analyses within a regulatory submissions such as NDA/BLA/ANDA (small molecules, biologics, and biosimilars)

 

Clinical Pharmacology Plan

The Clinical Pharmacology Plan is the backbone of a drug development strategy for a given drug.  This document establishes the group of clinical trials to be completed during the development process, and includes initial synopses for each trial.  The plan includes built-in contingencies for unexpected developments in the drug program.  Click here for your clinical pharmacology plan.

Other Strategic Activities

  • 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.