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The confluence of several factors, including: the growing recognition of the value of quantitative approaches to decision-making in drug development, advancements in numerical methods and analytics, and democratization of modern software engineering, has led to the emergence of multiple pharmacometrics-related software tools, both commercially and publicly licensed. A rigorously managed, high-quality, software development practice is central to reliable and reproducible scientific application and regulatory compliance for these tools. Professional software development best practices should typically be outlined in a Software Development Life Cycle (SDLC) policy or procedure, but the extent of guidance, consistency of methods, adherence to procedures, completeness of quality documentation, and execution rigor vary greatly across software development organizations or teams.

Metrum Research Group scientists participated in the first International Society of Pharmacometrics (ISoP) Regional Quantitative Systems Pharmacology (QSP) Day on July 16, 2019. 

The meeting, which included podium presentations, a poster session, and opportunities for discussion and networking, highlighted several examples of the application of QSP methods in drug development. Particularly notable topics included: the integration of transcriptomics and systems pharmacology models, challenges with calibration of virtual patients in QSP models, and the use of QSP as a scaffold for bridging from well studied therapeutic indications to related but somewhat less understood indications.

Madeleine Gastonguay, of MetrumRG and University of Connecticut, presented the poster "Development of an open-source physiologically-based pharmacokinetic model to predict maternal-fetal exposures of CYP450-metabolized drugs". The open science philosophy, exemplified in this work, resonated with attendees and was also highlighted by several of the conference speakers.

Special thanks goes to the meeting organizers, the ISoP QSP Special Interest Group (ISoP QSP SIG), and hosts, Bristol-Myers Squibb (BMS), for a well organized event and an energizing, thought-provoking day.

Pictures from the event below.

The following is a transcription of Dr. Gastonguay's acceptance speech when presented with the 2018 Bristol-Myers Squibb Mentorship in Clinical Pharmacology Award at the American College of Clinical Pharmacology on September 24, 2018.

Open Science: A Key to the Future Growth of Clinical Pharmacology.

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

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

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.