PumasAI - Strategic & Scientific Consulting Services

It has never been more important to consider utilizing model-based strategies as part of your drug development program.

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Model Informed Drug Development (MIDD) Services

MIDD Services

Dose Translation, Rationale, and Justification

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Establishing the appropriate dosing regimens is critical to maximizing safety and efficacy for patients and clinical trial participants. Our pharmacologists and pharmacometricians are experts in dose translation, selection, and justification across all therapeutic areas, modalities, and stages of development.

Utilizing Modeling & Simulation, including the Bayesian approach, proves invaluable in guiding dose selection. Our prowess in this arena is exemplified by the impressive capabilities of Project Optimus.

Bridging & Extrapolation Approaches 505(B)(2) Pathway

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When planning your pediatric development or 505(b)(2) development program, you must determine how to support the efficacy and safety. You can leverage existing knowledge to bridge efficacy and safety to the new population or new product or new dosing regimen.

We specialize in the nuanced science of extrapolating pediatric efficacy.

Modeling and Simulation

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Using modeling and simulation, existing data can be leveraged to provide critical insights on product safety and effectiveness as related to drug concentration. They can guide trial design, provide evidence of effectiveness and support labeling.

Let us partner with your team on bringing new therapies to light.

Testimonials

PumasAI worked with us with incredible flexibility and agility despite tight timelines and sometimes the need for re-work or additional evaluation, as often is the case with data driven exercises.

Samira Merali, PharmD, MS

SR. Director & Cardiovascular Therapeutic Head, Clinical Pharmacology and Pharmacometrics

We are impressed by the quality and breadth of the experience of PumasAI scientists in collaborating with us on modeling and simulation projects across our pipeline spanning investigational therapeutics and vaccines at various stages of clinical development.

Husain A. PhD

Director, Head of Clinical Pharmacology and Pharmacometrics

...The collaboration spans across the continuum of the drug development cycle, Clinical Development, Clinical Pharmacology, Pharmacometrics, Regulatory, and Strategy. One of these collaborations for a cardio-renal asset, has resulted in a precedent-setting registration pathway where the conventional approach was not viable...

Arash Raoufinia, MS, PharmD

VP Head of Early Phase Development and Translational Medicine at Otsuka Pharmaceutical Companies (U.S.)

We have a high priority oncology drug development portfolio at our company. PumasAI provided us with high quality MIDD work product which supported regulatory submissions in a timely manner. It is a pleasure to work with PumasAI scientists, and we highly recommend them!

Balaji Agoram, PhD

VP & Head of Clinical Pharmacology, Arcus BioSciences