Marc Gastonguay

Recent Posts

Slides available:  Neighbor’s Envy Owner’s Pride – Comparator Analysis for Drug Development and Market Access

Posted by Marc Gastonguay on Oct 25, 2017 9:45:43 AM

Slides presented by Dr. Marc Gastonguay at ACoP8 can be found here

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Slides available: Points to Consider when Making Inferences about Covariates

Posted by Marc Gastonguay on Oct 16, 2017 11:45:00 AM
Click here to access the slides from " Points to Consider when Making Inferences about Covariates" presented by Marc Gastonguay, Ph.D. at ACoP8 Session Quantification of Covariate Effects for Labeling. 
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Topics: Open Science

Theory, Empiricism, and a Vision for the Continued Growth of Pharmacometrics

Posted by Marc Gastonguay on Oct 15, 2017 11:17:16 PM

Slides Available: Dr. Marc Gastonguay's Sheiner Award lecture presented at ACoP8 on October 15, 2017. GastonguayISoPSheinerLecture2017final

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Topics: Open Science

Rare Disease Day 2014: Orphan Drug Trial Design and Analysis

Posted by Marc Gastonguay on May 31, 2017 11:45:27 AM

In recognition and support of Rare Disease Day, 2014, the scientists and staff at Metrum Research Group have focused the weekly journal club on articles related to this topic, for the month of February…

Though deemed “rare”, approximately 25—30 million Americans, and 300 million people worldwide, have been diagnosed with one of >6,800 known rare diseases. An estimated 50% of those affected are children. The prevalence of individual rare diseases can range from dozens in the US (progeria, hypophosphatasia, Niemann-Pick, for example), to thousands globally (such as, Crohn’s disease and cystic fibrosis). Although traditionally considered impractical for big pharma development, innovation and development of therapeutics for rare diseases have led to promising treatments for some diseases in recent decades. In the period of time from the passage of the Orphan Drug Act of 1983 until May 2010, the FDA approved 353 orphan drugs and granted orphan designations to 2,116 compounds. As of 2010, at 200 orphan diseases have become treatable (Armstrong). Still, rare diseases pose a critical unmet medical need.

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Topics: Rare Disorders

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