Challenge

To conduct clinical trials with their stimulant abuse deterrent (a drug that induces undesirable side effects such as headaches only when stimulants are abused), 4P-Pharma must provide regulatory agencies documentation of all the adverse events that have occurred as a result of stimulant misuse and abuse. Performing a clinical trial with a fixed-dose combination stimulant/abuse deterrent both with different potential side effects is a daunting task requiring the clinical trial staff to be able to distinguish the drug responsible for the observed side effect. Knowledge of these adverse events is essential for keeping a clinical trial safe and interpreting drug safety and efficacy.

Solution

4P-Pharma staff use the PV Wizard tool of Elsevier’s Embase to search for literature that reports on stimulant abuse and misuse. This new application enables 4P-Pharma to build an optimized search query designed to filter and find all relevant adverse events for a medicinal substance. They also utilize Emtree in these queries to refine their search results to the most pertinent articles. “Embase is more powerful than PubMed to access relevant safety data” says 4P-Pharma Scientific and Clinical Operations Manager Keren Bismuth. Embase enables staff to use their time more efficiently so that they are not searching through articles for pharmacovigilance data only to later find them irrelevant. 4P-Pharma also values the email alert option to stay up to date on these pharmacovigilance reports.

Impact

The ease of collecting pharmacovigilance data through Embase has helped 4P-Pharma establish — and continuously enrich — a table on stimulant abuse they created. It tabulates not only the associated adverse events, but also other valuable information, such as which populations are abusing stimulants, what doses are being used and how the drug is being administered.

With this table, 4P-Pharma has been better able to communicate the extent of the medical emergency attributable to drug abuse. “The numbers that we extract from our Embase searches are helping us convince potential partners or investors that the need for a solution [such as a stimulant abuse deterrent] is real and urgent,” Keren says.

Nicki Catchpole

Sr. Manager, Pharma and Biotech Segment

As a professional with over 14 years of experience in strategy development and partnership management across a variety of industries, Nicki’s latest role as a Senior Manager, Segment Marketing at Elsevier applies her skills to the area of drug discovery and development in the Pharma and Biotech industry.
In this capacity she is focused on understanding biopharmaceutical R&D challenges and turning them into opportunity to further Elsevier’s ability to serve industry executives and the professionals who innovate in the drug discovery and development space. Prior to joining Elsevier, Nicki held senior alliance and strategy roles in the Legal, Tax & Accounting, Life Sciences and Cyber Security industries.
Nicki resides in New York City and holds a BA in English Literature and Mandarin Chinese from Carleton College in Northfield, MN.