Challenge

4P-Pharma cannot select every promising drug candidate they review for co-development. To make prompt, well-informed decisions on which drugs to license, 4P first needs to thoroughly understand the drug and drug development environment for the particular indication. With this information, the company can assess a candidate’s true potential to progress forward through the drug development pipeline. 4P-Pharma needs to quickly determine the suitability of drugs they are considering for licensing, so staff can focus their time and energy on the candidates with the most promise.

Solution

4P-Pharma uses the Elsevier R&D Solution PharmaPendium to efficiently review information about a drug molecule’s characteristics and pharmacokinetics and evaluate its upstream potential. This platform is particularly valuable for 4P-Pharma because of the company’s focus on repurposing drugs for new indications. Company staff could search the U.S. Food and Drug Administration and European Medicines Agency websites to acquire this information, but doing so takes days, and pertinent information could get missed.

With PharmaPendium, 4P can extract and organize all the preclinical and clinical data instantaneously. 4P-Pharma Project Manager Luigi Formicola emphasizes that “what is most valuable is the integration of all the data, and the way they are presented. It’s fast, it’s clear. The table is easily searchable … and it saves us a lot of time.”

4P-Pharma also utilizes this platform to determine the key experiments necessary to perform with the drugs they choose to co-develop. The research team uses PharmaPendium almost daily to review previously performed experiments by other drug developers and decide on the parameters of their own experiments.

“It saves us resources. We won’t lose time performing experiments with dosage or route of administration that have been tested before and were shown to be toxic… PharmaPendium provides us with a quality assurance for our results, as we know that we have performed our experiments within the expected standards set [for] approved drugs,” Luigi says. With this ready access to information through PharmaPendium, “we were able to confirm the efficacy and safety of our [stimulant] abuse deterrent” that 4P is bringing forward into early-stage clinical trials.

“With the thoroughness of the drug development plan we conduct,” crafted with the help of PharmaPendium, we have “enforce[d] our credibility as a small biotech with the capability of going forward with preclinical development of a drug candidate.” Luigi also indicated that because of its extensive value, “PharmaPendium is now part of our process for decision-making.”

Impact

The time the company would have spent searching for information is time 4P-Pharma staff can spend designing experiments and analyzing results. “We are very happy with PharmaPendium. All the time savings, and the confidence in the data that we got from PharmaPendium, helps us to go faster through our preclinical program. People say ‘you cannot buy time’, however, PharmaPendium is doing exactly that: It is buying us time and that is great for us.”

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.
Nicki resides in New York City and holds a BA in English Literature and Mandarin Chinese from Carleton College in Northfield, MN.

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.

zebrafish

Research using the tiny tropical fish has shown how key brain cells that are damaged in people with Parkinson’s can be regenerated.

The findings offer clues that could one day lead to treatments for the neurological condition, which causes movement problems and tremors.

Parkinson’s occurs when specialised nerve cells in the brain are destroyed. These cells are responsible for producing an important chemical called dopamine.

When these cells die, or become damaged, the loss of dopamine causes body movements to become impaired. Once these cells are lost from the human brain, they cannot be repaired or replaced.

In zebrafish, however, dopamine-producing nerve cells are constantly replaced by dedicated stem cells in the brain, the researchers found.

The team, led by the University of Edinburgh, found the immune system plays a key role in this process. In some regions of a zebrafish’s brain, the process does not work, however.

Researchers say understanding the immune signals that facilitate replacement of these nerve cells could hold vital clues to developing treatments for people.

The study, published in the Journal of Neuroscience, was funded by UK Research and Innovation through the Biotechnology and Biological Sciences Research Council and Medical Research Council.

Dr Thomas Becker, of the University of Edinburgh’s Centre for Discovery Brain Sciences, said: “We were excited to find that zebrafish have a much higher regenerative capacity for dopamine neurons than humans. Understanding the signals that underpin regeneration of these nerve cells could be important for identifying future treatments for Parkinson’s disease.”