1. “PBBM and PBPK modeling is expected and often suggested by regulatory agencies.” -Neil Miller.

A Simulations Plus survey reveals that PBBM is highly utilized not only for formulation selection but also in regulatory submissions supporting biowaivers and certain clinically relevant specifications.

2. “PBBM offers the possibility of building an expanded safe space and increases the likelihood of gaining regulatory flexibility.” – Sandra Suarez- Sharp.

PBBM is a modeling approach that goes beyond PBPK modeling, and it is centered around building an in vitro/in vivo link between the drug product failure modes (e.g., via dissolution) and Cp time profiles.

3. “There’s more usage of MIDD in the clinical trial definition.” – Jonathan Chauvin.

There’s a need for MIDD to increase clinical trials efficiency and interdisciplinarity between the various types of modeling to make globally better decisions.

4. “New PBPK models to be built for new modalities on their various routes to address the broader definition of the word ‘drug’.”– Joel Owen

New pharmacometrics models will be developed and employed to address dosing of novel modalities such cells, viral genomes, vaccines, siRNA, mRNA and others.

5. “Modeling science will expand to address further combination drug treatments, multi-drug targets, and drug-device products.” – Joel Owen.

As we refine the tools, regulatory agencies are more confident in utilizing them as an alternative approach to approval decisions.

In conclusion, modeling is exciting, efficient, and there’s plenty of passion behind its increasing use. Re-watch the 2021 MIDD+ talk here.

Learn how Simulations Plus’ modeling experts can take your drug development projects to the next level, contact us at info@simulations-plus.com.