ACT

February 18/2020

news roundup

Latest People Moves and Business News

This month’s update includes news from Advanced Clinical, AG Mednet, CTI Clinical Trial and Consulting Services, Ergomed, Novotech, PHASTAR, and many more.


IQVIA Global Compliance Releases New Tools

IQVIA Global Compliance has released three new tools aimed at improving regulatory publishing cycle times and productivity: Regulatory Templates, Regulatory PDF Tools, and the eSubmission Validator.


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Advances in RBM Drive the Clinical Trial of the Future
Access an online resource with useful tools and practical information about advances in RBM. The site provides useful white papers, articles, webcasts, and more.
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Parexel Acquires PK/PD Company

Parexel has acquired Model Answers, a consultancy firm based in Brisbane, Queensland, Australia, that provides pharmacokinetic (PK) and pharmacodynamic (PD) modeling, simulation and analysis services to the life sciences industry.

In this edition

COVID-19: Drug Shortages, Clinical Research, and Inspection Impacts
Addressing the Immunogenicity Challenge


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Events

11th Proactive GCP Compliance Conference
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DIA 2020 Global Annual Meeting
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COVID-19: Drug Shortages, Clinical Research, and Inspection Impacts

U.S. and European regulatory officials continue to anticipate drug supply shortages in multiple areas, as are generic drug producers in India, which also obtain APIs from China. FDA also has postponed planned inspections of medical product manufacturers in China due to a State Department travel warning.


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Virtual, Decentralized, Site-less Trials… What Does it All Mean?
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Articles

Addressing the Immunogenicity Challenge

This article discusses how a quantitative systems pharmacology (QSP)-based approach can be used to predict and better manage immunogencity, taking advantage of bioinformatics data as an input to the model.


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AI in Action: Clinical Development AI Use Cases
Access an online resource with useful tools and practical information about advances in RBM. The site provides useful white papers, articles, webcasts, and more.
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Blog Posts

Teen Cancer Patients Should Be Able to Participate

The Fostering Age Inclusive Research Trials Initiative maintains that teenagers with cancer are routinely prevented from trying out potentially lifesaving treatments because of a bureaucratic impediments that keep those 18 and under from participating in many trials for new cancer drugs.


Data Resolutions for 2020

All the interesting things we can use our operational data for relies squarely on its quality. While analyzing data is exciting, unfortunately, cleaning it takes a great deal of time investment. The author shares some data resolutions that will make data more usable.

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Lisa Henderson
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Todd Baker
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TBaker@mmhgroup.com