MY MISSION

I will help you saving time, money, and efforts during your drug development program by turning data into faster and better decisions and decreasing the possibility of regulatory rejection.

Mario Gonzalez Sales, PhD

Manager

MY WORK

High Quality

I use state-of-art pharmacometrics techniques to deliver to you high-quality “fit-for-purpose” work to the agreed timelines

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Compliance

I have robust policies and procedures in place to ensure that I am fully compliant to the appropriate regulatory guidance

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Secure Data Handling

I ensure data integrity and data confidentiality by working with the appropriate security standards

Reproducibility

I work in a scriptable environment to facilitate traceability and reproducibility. As simple as clicking a button

SOME TESTIMONIALS

“It is a pleasure for me to strongly recommend you, Mario. First of all, Mario has an impressive CV with experience at the FDA. He worked for me on the development of PK/PD model. We only have few data from the literature but Mario could develop with a short and agreed timeframe a model for PK prediction. Based on the model, I could validate a clinical protocol. On short notice, I invited Mario to a clinical study committee. He did a really great presentation. People (not familiar with PK/PD modeling) were enthusiastic to see the model that Mario developed. Last but not least, the committee had questions and Mario answered with live simulation… “What if we would give it twice a day? What if we would give it once a day?”. The model delivered immediately the answers. The committee was really impressed and could take important decisions on the study design.
I have no conflict of interest with Mario or Mario’s company.”

Dr. Vincent Grek

Global Clinical Development Lead - Acute Care and Muscle related conditions, Nestlé Health Science

“What an exciting experience it was to work with Mario on the entrectinib PopPK Filing! Mario is an experienced PopPK modeler and an excellent programmer. He is always available to efficiently and quickly address the requests coming both from the project team and from Health Authorities.”

Nassim Djebli, PhD

Senior Principal Pharmacometrician, Hoffmann-La Roche

“Mario came to us at a critical juncture during the development of our lead clinical candidate therapy. We had to conduct a detailed PK analysis under an extremely tight deadline. He was able to review our PK data, analyze, conduct and explore various relationships with the dose, identify the critical parameters as well as covariates. He also built a model, at our request, that strategically informed our approach to dosing. Mario is very responsive and rises to the challenge even when he is working with seemingly impossible deadlines. His work is meticulous and he typically delivers ahead of schedule. He has a crisp grasp of pharmaceutical regulation especially as it pertains to pharmacometrics principles. His reports are very thorough and clear. I highly recommend Mario as a PK Consultant.”

Victor Moyo, MD

Executive Vice President, Head of Research and Development and Chief Medical Officer, LEAF4Life Inc

“‘It has been my pleasure collaborating with Mario on a large exposure-response PopPK modeling effort. Mario is a hard worker, always available and dedicated, he was able to quickly adapt to our working environment and bring valuable insights into the project.”

Benjamin Guiastrennec, PhD

Associate Director Consulting, IntiQuan GmbH

MY VALUES

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Flexibility

I will adapt to your needs to ensure you have the best experience from a stand-alone project to long term support

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Commitment

My word and hard work over everything else. I am committed to achieving your full satisfaction as my client

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Transparency

You know who is in charge of your project at all times. I work directly with you

Over Deliver

Deliver more value than you expect. Every day, over every project

SOME RECOGNITION

Did you know I am a former FDA pharmacometrics reviewer awarded for addressing challenging regulatory questions and for excellent team collaborations?

Modeling Great Solutions Regulatory Science Excellence Mario Gonzalez Sales
team excellence mario gonzalez sales

More than 10 years of experience in solving drug development problems are a guarantee!

STAGES WHERE I CAN SUPPORT YOU

In any phase of drug discovery and development, from pre-clinical to post-marketing approval

Pre-Clinical

If you have pre-clinical data, I can help you to select the first dose in humans

Clinical

If you have clinical data, I can help you to select the dose with the best trade-off between safety and efficacy

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Late Phase

I can also help you to design more efficient and informative clinical trials and make Go/No-Go decisions

Regulatory

I can help you to interact with regulatory authorities in matters related to PK, PKPD, modeling and simulation

I can support you with much more!

+971 50 270 41 99

mario@modelinggreatsolutions.com