Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

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Shouldn’t pharmacovigilance be less painful?

Posted on May 26th, 2017 by

Pharmacovigilance

PV white board

Even with advanced information technologies, too many companies and pharmacovigilance practitioners are still living with the pain of having to rely on ineffective and outdated systems and processes. Continue reading “Shouldn’t pharmacovigilance be less painful?” »

Compliant Monitoring of Adverse Events

Posted on May 24th, 2017 by

Pharmacovigilance

Professional services case study

Developing and maintaining a solid strategy for screening for adverse events is critical for every pharmaceutical company. Without one, an adverse event could be reported in scientific literature without the company knowing — and failure to report it to the regulatory authorities could result in a serious warning. Continue reading “Compliant Monitoring of Adverse Events” »

Re-Inventing R&D for Precision Medicine

Posted on May 22nd, 2017 by

Pharma R&D

Pills white paper

Precision medicine first emerged in the late ‘90s. But it was the completion of the Human Genome Project in 2003 that really opened up a world of opportunity in this area because it became possible to test patients for certain biomarkers Continue reading “Re-Inventing R&D for Precision Medicine” »

Protocol Deviations and Serious Breach Expedited Reporting

Posted on May 19th, 2017 by

Pharmacovigilance

Breach

Protocol deviations will occur even with the best designed clinical trial protocols and investigator training. Although minimizing such protocol breaches is an absolute mandate for Clinical Trial Sponsors, there are specific deviations (usually qualified as “major”) which require expedited reporting if they impact patient safety. Continue reading “Protocol Deviations and Serious Breach Expedited Reporting” »

Predicting Adverse Event Risks and Gaining Insights from Disparate Data

Posted on May 17th, 2017 by

Pharma R&D

bioIT world

The upcoming Bio IT World Conference and Expo will feature two talks from Elsevier Life Sciences consultants, focusing on predicting adverse events in clinical trials and extracting knowledge from multiple data sets. Continue reading “Predicting Adverse Event Risks and Gaining Insights from Disparate Data” »

Building a Team That Transforms Lives

Posted on May 15th, 2017 by

Pharma R&D

telescope

The Rubius Therapeutics team grew by over 300% in 2016, as we brought in talented individuals from industry and academia. Managing a team that keeps expanding is always challenging, but having a thoughtful growth strategy ensures cultural coherence and operational progress Continue reading “Building a Team That Transforms Lives” »

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About this Blog

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The Elsevier Pharma R&D blog provides insight and opinion on topics related to pharmaceutical research and development, namely: big data, target identification, new drug discovery, drug safety monitoring, risk mitigation and regulatory compliance. We serve the community of chemists, scientists, drug safety specialists, educators and students interested in pharmaceutical R&D.

Editor’s note: The views and opinions expressed are those of the author and do not necessarily reflect the views of Elsevier,  its affiliates and sponsors or its parent company, Reed Elsevier.