Overview:

This consumer healthcare organization is seeking novel modeling solutions to better simulate how the body interacts with a drug over time, i.e., PK (Pharmacokinetics) profiles and efficacy end points, to strengthen confidence in targets and improve the translation of in-vitro into clinical development.

 

Background:

Developing new or modifying existing Over-the-Counter (OTC) formulations can be a time consuming and costly process, requiring extensive PK studies. This organization is interested in exploring various simulation models that enable PK performance prediction & clinical de-risking such as PBPK (physiologically based pharmacokinetic) modeling platforms, PKPD (Pharmacokinetics Pharmacodynamics), MPS (micro-physiological systems) and other novel modeling  approaches that leverage novel AI/ML techniques, thereby enabling higher confidence of success prior to investment in clinical studies.

Models must correlate in vitro data with clinical meaningfulness and clinical efficacy, (IVIVC) and have the ability to simulate/predict drug PK in various populations (e.g., pediatric, elderly, pregnant women, organ impairment or other altered physiological factors). Modelling in healthy patients would also be beneficial.

 

Key Criteria

Must have

• Demonstrated ability to predict PK profiles with accuracy meeting regulatory expectations (e.g., FDA, MHRA)
• Established IVIVC with demonstrated regulatory acceptability (e.g., FDA Level A/B correlation standards)

Nice to have

• Consumer healthcare experience
• PBPK modeling supporting oral sustained release and delayed release formulations
• Nasal and topical delivery modeling
• Regulatory acceptance by MHRA, FDA and other equivalent regulatory bodies.
• Cost-effective

 

Possible Solution Areas:

This client is open to a range of solutions including but not limited to:

• Physiologically Based Pharmacokinetics (PBPK) modeling
• Pharmacokinetic pharmacodynamic (PK/PD) Modeling
• Physiologically Based Biopharmaceutics (PBBM) Modeling
• Model-Informed Drug Development (MIDD) which combines PBPK and PKPD
• AL/ML approaches
• PopPK – Population PK
• Organ on a chip
• Hybrid wet-dry approaches

 

Desired outcome of the solution:

Looking for contract research organizations to undertake modeling efforts and/or software licensing if strong customer support is available.  

 

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