Bioanalytical Community

The meeting will take place at 12:30-1:30 p.m. ET, April 25th,2025

Microsoft Teams meeting

Join on your computer or mobile app

Click here to join the meeting

Or call in (audio only)

+1 860-785-9696,,877368932#   United States, Hartford

Phone Conference ID: 877 368 932#

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Mark Ma Ph.D.
VP. Head of Translational Sciences and Early Development
Rallybio
Madison CT
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Thanks for the great conversation today. Per request, attached a PK course information below:

 https://pharm.ucsf.edu/pkcourse

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Mark Ma Ph.D.
VP. Head of Translational Sciences and Early Development
Rallybio
Madison CT
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 04-17-2025 12:51
From: Mark Ma
Subject: Bridging Bioanalysis and PK Assessment in the AI Era

The PK method group will hold a discussion on the following topic:

Bridging Bioanalysis and PK Assessment in the AI era - a new role of bioanalytical scientists?

• Advancements in AI are indeed lowering the drawbridge between the world of bioanalysis and the realm of PK assessment. Bioanalytical scientists, once primarily tasked with producing data, now have an unprecedented opportunity also to interpret and model that data, driving decisions in drug development. AI tools and platforms are acting as force multipliers – handling tedious aspects of PK analysis and guiding less-experienced users, which enables scientists without formal pharmacometrics training to contribute in meaningful ways to PK/PD modeling and simulation.

• However, making this transition is not effortless-it requires upskilling in areas like pharmacokinetics theory, computational tools, and data science. AI can greatly assist, but it works best in the hands of someone who is continuously learning and curious. Experts repeatedly emphasize the need for a growth mindset and resilience when expanding one's skill set.

• By embracing new technologies and education, the BA scientists can potentially broaden their impact from the bench to the computational modeling arena. We are entering an era where the traditional silos in drug development are breaking down: the BA scientist can be a PK scientist, and the modeler can value hands-on data knowledge. Artificial intelligence, combined with human intelligence and experience, is enabling a more fluid and interdisciplinary approach in PK assessments.

The meeting will take place at 12:30-1:30 p.m. ET, April 25th,2025

Microsoft Teams meeting

Join on your computer or mobile app

Click here to join the meeting

Or call in (audio only)

+1 860-785-9696,,877368932#   United States, Hartford

Phone Conference ID: 877 368 932#

------------------------------
Mark Ma Ph.D.
VP. Head of Translational Sciences and Early Development
Rallybio
Madison CT
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

Thanks Dr. Mark Ma's wonderful presentation for our April AAPS PK methodology discussion group meeting. The title is Bridging Bioanalysis and PK assessment in the AI Era -New Role for Bioanalytical Scientist? Below is the summary of his presentation and please see the enclosed slide deck for detailed information.

• Traditionally, bioanalytical (BA) scientists generate drug concentration data, while pharmacokinetic (PK) scientists analyze that data to assess drug absorption, distribution, metabolism, and excretion.

• AI and machine learning are disrupting traditional PK modeling by automating tasks, interpreting results, and even debugging code (e.g., in NONMEM or R), reducing the complexity barrier. AI tools make PK analysis more accessible to BA scientists by lowering the technical threshold and acting as virtual mentors or decision-support systems. While AI assists with technical execution, a solid understanding of PK/PD concepts and model structures remains essential to avoid misinterpretations or flawed extrapolations.

• Successful transition from BA to PK roles depends on a growth mindset, willingness to learn, and stepping outside of one's comfort zone.

• Challenges include gaps in knowledge, lack of training opportunities, organizational separation of roles, and limited cross-functional pathways.

• Recommended approaches include building a foundation in PK/PD, learning software tools like WinNonlin, NONMEM, Monolix, GastroPlus, and using AI-driven learning platforms.

• AI encourages integration between lab and modeling scientists, breaking down traditional silos in drug development. Scientists who combine lab expertise with computational skills will play key roles in future pharmaceutical innovation. The fusion of lab science and AI-powered modeling is just beginning. Adaptable scientists who embrace AI and new skills will lead the next wave of drug development.

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Xiaohui Xu Ph.D.
Director
Daiichi Sankyo
Basking Ridge NJ
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

Original Message:
Sent: 04-17-2025 12:51
From: Mark Ma
Subject: Bridging Bioanalysis and PK Assessment in the AI Era

The PK method group will hold a discussion on the following topic:

Bridging Bioanalysis and PK Assessment in the AI era - a new role of bioanalytical scientists?

• Advancements in AI are indeed lowering the drawbridge between the world of bioanalysis and the realm of PK assessment. Bioanalytical scientists, once primarily tasked with producing data, now have an unprecedented opportunity also to interpret and model that data, driving decisions in drug development. AI tools and platforms are acting as force multipliers – handling tedious aspects of PK analysis and guiding less-experienced users, which enables scientists without formal pharmacometrics training to contribute in meaningful ways to PK/PD modeling and simulation.

• However, making this transition is not effortless-it requires upskilling in areas like pharmacokinetics theory, computational tools, and data science. AI can greatly assist, but it works best in the hands of someone who is continuously learning and curious. Experts repeatedly emphasize the need for a growth mindset and resilience when expanding one's skill set.

• By embracing new technologies and education, the BA scientists can potentially broaden their impact from the bench to the computational modeling arena. We are entering an era where the traditional silos in drug development are breaking down: the BA scientist can be a PK scientist, and the modeler can value hands-on data knowledge. Artificial intelligence, combined with human intelligence and experience, is enabling a more fluid and interdisciplinary approach in PK assessments.

The meeting will take place at 12:30-1:30 p.m. ET, April 25th,2025

Microsoft Teams meeting

Join on your computer or mobile app

Click here to join the meeting

Or call in (audio only)

+1 860-785-9696,,877368932#   United States, Hartford

Phone Conference ID: 877 368 932#

------------------------------
Mark Ma Ph.D.
VP. Head of Translational Sciences and Early Development
Rallybio
Madison CT
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------