Expert Insights

An industry-wide need to improve future REMS assessments

by Christine Tervo, MS, June 28, 2018
There are currently more than 70 approved Risk Evaluation and Mitigation Strategies (REMS) in the Food and Drug Administration (FDA) database. These structured programs are designed with specific goals to ensure that the benefits of drugs outweigh risks, while also striving to reduce risk. However, industry changes are needed to improve future REMS, especially by those involved in drug development.

11 traits to transition from a bench scientist to a medical writer

by Ingrid Hansen, June 21, 2018
Many Ph.D. graduate students are led to believe that there are only two routes to take after graduation: Research projects in academia or industry.  On the contrary, one thing that many do not see is that they have obtained a set of unique, invaluable skills that can apply to a broad array of career paths, such as a medical writer.

Society needs to change to embrace open discussions on suicide

by Uma Sharma, June 14, 2018
One person dies from suicide every 40 seconds across the globe according to the World Health Organization (WHO), and the world is currently mourning two, with the unfortunate circumstances surrounding Kate Spade and Anthony Bourdain. However, suicidality is not always apparent or has warning signs, especially in the drug development arena.

Building a robust clinical data science process

by Staff writer, June 7, 2018
During PhUSE US Connect 2018 – the clinical data science conference – in Raleigh, North Carolina, MMS data science experts presented a paper and corresponding poster, titled Big Data Paradox: Development of a Unique and Repeatable Analytical Process while Implementing a Robust Data Science Solution.

Ask the Expert: The Future of Drug Development

by Staff writer, May 31, 2018
The size of the global pharmaceutical market will reach $1.12 trillion by the year 2022, according to Pharmaceutical Commerce. Yet, many questions linger about what the future of drug development will look like, including technology that will impact the industry and the expense to develop new drugs and treatment options.

Why Should GDPR Matter to all Clinical Research Firms?

by Barbara Rusin, May 24, 2018
Since the beginning of 2018, there has been a growing interest from pharmaceutical and biotech firms in the United States regarding the basic tenets of the European Union’s (EU) new General Data Protections Regulation (GDPR) law. With more than 50 percent of all U.S.-based businesses affected, the pharmaceutical industry is not exempt. GDPR’s widespread effects touch almost every clinical research and pharmaceutical firm – no matter where they are based or what type of work they are doing.

Start plain language summaries early or get left behind

by Staff writer, May 10, 2018
In July 2019, the European Union (EU) Clinical Trial Regulation No. 536/2014 will go into effect, requiring all sponsors, including academia, conducting clinical trials to draft lay or plain language summaries for phase 2-4 clinical trials. These lay summaries need to be published to the new portal that will be hosted by the European Medicines Agency (EMA) within 12 months from the close of each clinical trial.

Perfecting the hand-off from programming and statistics to regulatory operations

by Staff writer, May 5, 2018
A room full of statisticians and clinical programmers were floored to hear that regulatory operations experts were working with nearly 500,000 pages of text in a recent New Drug Application (NDA). This is how Mary Anne Potok, Technical Manager, Regulatory Operations, MMS, described the weight of one NDA submission to a full house during the PhUSE single day event at Vertex Pharmaceuticals in Boston, Mass. on April 26, 2018.

The Benefits and Risks of Expedited Drug Development and Review Pathways

by Amanda Beaster, Ph.D. and Janiel Shields, May 3, 2018
The Food and Drug Administration’s (FDA) drug approval process puts patient health at the forefront and subjects each new drug candidate to several stages of testing in both preclinical and clinical settings. This rigorous process typically requires 10 years or more in the drug development process to take a drug from the laboratory, through testing, and onto the market.

FDA Furthers Transparency Push with CSR Release Pilot

by Zach Weingarden, Guest Contributor, January 30, 2018
The FDA provided insight into their overall vision for clinical trial transparency last week, announcing a new program to publicly release clinical study reports (CSRs) that accompany drug approval submissions. They plan to pilot nine recently-approved drugs (yet to be determined) from volunteer sponsors, with CSRs to be posted to the FDA’s drug approval database, Drugs@FDA.


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