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Boston QSP January event announcement: Fit-for-purpose M&S in drug development

Happy New Year Everyone! The New Year edition of Boston QSP event will be held at Cambridge Innovation Center on Wednesday, January 25th. We will kick off the event with presentations in the Havana Room followed by a reception in Venture Cafe. Food and drinks courtesy of Novartis.

(Photo: Past Boston QSP event)

Brian P. Smith, PhD, global group head in biostatistical sciences supporting the Novartis Institute of BioMedical Research will be the first speaker of the night. The title of his talk is “Impact of the choice of endpoint and analysis on the ability to discern treatment effects: Why does the underlying statistical distribution used matter?” Brian’s talk will showcase two separate analyses: 1. explore the impact of data transformation and adjustment for baseline on the fit of the model and 2. explore the value of using statistical distributions which are consistent with data to be analyzed and the value of conditioning on a baseline observation.

Second speaker is Nikolaos Tsamandouras, PhD, research associate at MIT, Biological Engineering, where his work focuses on Translational Systems Pharmacology approaches in the context of microphysiological systems (also known as organs-on-chips). The title of his talk is “A tale of model simplicity versus model complexity with the case example of simvastatin pharmacokinetics." Nikolaos will use a case-example of simvastatin to illustrate that the complexity of a developed model should be conditional on the modeling purpose and the amount and quality of the available data. We will learn about modeling methodology aspects and the employment of statistical approaches that can facilitate the use of complex mechanistic PK/PD models for clinical population data analyses.

We invite you to engage and become a part of Boston QSP community! Seats are limited. RSPV is required.

Event Detail:

  1. 5:00-5:40PM - Brian P. Smith, PhD, followed by Q&A (Havana Room)

  2. 5:40PM - 6:20PM - Nikolaos Tsamandouras, PhD, followed by Q&A (Havana Room)

  3. 6:20 pm-7:30 pm -Reception @ Venture Cafe (a few steps down the hallway from Havana Room).

* We will be serving some local craft beer and food from a local business.

* RSVP here.

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