PharmaPendium

The risk assessment tool for translational safety, drug efficacy and DMPK

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Improve the speed and success of drug approvals

For success in regulatory submissions, you need up-to-date evidence that your drug is safe and effective. With PharmaPendium, easily find and analyze precedent data from regulatory documents throughout the drug development life cycle.

Drug approvals stall or fail when evidence is lacking. PharmaPendium helps you answer critical questions on the path to drug approval and avoid regulatory delays:

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Is my drug candidate competitive?

  • Benchmark against approved drugs
  • Identify and avert safety concerns
  • Anticipate key parameters to demonstrate clinical readiness
  • Cite previous studies and submissions
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What is the clinical value of my drug?

  • Inform your regulatory strategies
  • Strengthen clinical trial designs
  • Define trial exclusion criteria based on predicted drug interactions
  • Avoid unnecessary animal experiments

Sanofi and DNDi drug approval

Discover how Sanofi and DNDi used PharmaPendium’s Drug-Drug Interaction Risk Calculator to support successful EMA and FDA submissions for fexinidazole, the first all-oral treatment for sleeping sickness.

Read the story

What makes PharmaPendium unique?

PharmaPendium is the most comprehensive source of preclinical and clinical pharmaceutical data and intelligence from regulatory documents.

Deep and broad translational coverage

Integration of decades of FDA and EMA information on marketed and withdrawn drugs across the life cycle: preclinical to clinical to post-market

Knowledgeable curation. Powerful taxonomies

High-quality data manually excerpted from FDA drug packages and EMA EPARs, organized, linked, and accessed via expert taxonomies

Insights from decision support tools

Intuitive decision support tools like the Drug-Drug Interaction (DDI) Risk Calculator provide fast and reliable translational insights

Visibility of relevant content beyond keywords

An intuitive user interface with browse, suggest and filter functions to easily find and review the right data, regardless of how it was reported

How PharmaPendium helps you focus on best-in-class drugs

We extract data from:

Organize, index and connect:

You leverage the right data and tools to:

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  • FDA drug approval documents back to 1938 and EMA drug approval documents back to 1995
  • FAERS
  • FDA Advisory Committee meeting reports
  • Meyler’s Side Effects of Drugs
  • Journal articles
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Pharmacokinetic data

 

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  • Determine first-in-human dosing with toxicity parameters like NOAEL
  • Assemble DDI modeling sets to identify problems early
  • Save time assessing interactions among multiple drugs at once
  • Guide study designs and anticipate translatability
  • Train predictive models with curated, machine-readable data
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Metabolizing enzymes and transporters data

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Drug safety data

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FAERS data

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Chemistry search

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Clinical trial data

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Pharmacology data

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Drug-drug interaction data

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Toxicity data

PharmaPendium supports the team throughout the drug development process

Top global pharmaceutical companies use PharmaPendium because:

  1. PharmaPendium provides access to regulatory information that would otherwise take weeks to find. This critical intelligence helps de-risk and streamline drug development.
  2. PharmaPendium helps you address key decisions points all along the drug development life cycle from preclinical R&D to post-market surveillance.

PharmaPendium supports the team throughout the drug development process

Toxicologists and safety pharmacologists

Assess drug safety risk early to fail drugs fact and optimize IND submission

DMPK specialist

Determine ADME properties of drugs to optimize first in human dosage and reduce drug-drug interaction risk

Clinical researcher

Optimize clinical trial design to maximize chances of success and avoid unnecessary costs and delays

Regulatory affairs expert

Optimize regulatory submissions and communication to reduce cycling and maximize drug market potential

Global patient safety expert

Monitor risk-benefit profile of approved drugs to eliminate risks to patients and business

Data scientist

Feed off-platform data into federated search dashboards, business intelligence analyses, and predictive models

What PharmaPendium customers say

Instead of spending weeks gathering data from scientific articles which would then have to be standardized, we now spend a half day working with PharmaPendium; the hard work is all done for us.

Scientific information manager, leading dermatology company

… with PharmaPendium, I get information about how it was measured, and a click will show what source document it came from — all very important for building robust, well-founded models.

Senior expert modeler, Novartis

PharmaPendium’s new Drug-Drug Interaction Risk Calculator is quicker and more comprehensive than other tools in our toolbox that we can easily utilize ourselves.

Senior research investigator, global pharmaceutical company