ParagonRx® builds appropriate use programs for medications and medical devices to mitigate risks and optimize use

What's New

Blog Post:
  • Ethnographic Research and REMS
    -Guest Blog by Andrea J. Simon, PhD.- In the past year, pressures to integrate observational or ethnographic research (which really are one and the same) in pharmaceutical and biotech industries are increasing as the value of this research is becoming better understood. In particular, Phase IV research involving the management and use of a drug protocol [...]
News: Sep 1, 2010
FDA Panel Looks at CNS Depressant for Fibromyalgia
A joint FDA advisory committee wіƖƖ meet here Friday tο consider whether tһе narcolepsy drug sodium oxybate (Xyrem) ѕһουƖԁ receive аח additional indication tο treat fibromyalgia. Sodium oxybate, currently approved аt a 500 mg/ml dose fοr narcolepsy-associated cataplexy аחԁ excessive daytime sleepiness, іѕ a central nervous system depressant аחԁ carries a boxed warning against іtѕ υѕе іח amalgamation wіtһ additional similar drugs.
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inVentiv Health Acquires ParagonRx

inVentiv Health

inVentiv Health, Inc., a leading provider of commercialization services to the global healthcare industries, announced it has acquired ParagonRx, a leading consulting company specializing in pharmaceutical risk management and optimizing medication use. The addition of ParagonRx will position inVentiv as the leading provider of comprehensive, fully-integrated REMS (Risk Evaluation & Mitigation Strategy) and risk management solutions, ranging from strategic consulting and program design to implementation coordination, project tracking and assessment. The acquisition was completed on December 31, 2009.

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Five Possible Barriers to Product Adoption

  1. The drug does not fit well into an existing patient care process resulting in increased work load.
  2. Severe known risks of an existing drug are easier to manage than unknown risks of a new drug.
  3. The definition of an “appropriate” patient may be different from one physician to another.
  4. Actual barriers to adoption may be different than the ones verbalized by physicians.
  5. The physician is not always the one making the treatment decision.  The nurse and/or other allied health professionals play a major influential role.

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Five Reasons to Consider Risk Mitigation in Early Development

  1. Forecasts will have more accurate “top box”
  2. Survey design can factor in appropriate patient groups
  3. Avoid regulatory approval delays
  4. Sales reps can overcome potential objections at launch
  5. Product can reach peak sooner
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PDUFA Date Coming Up?

Be prepared and avoid approval delays with:

  • A robust evidence base for risk assessment and mitigation
  • Contingency plans to meet regulatory requirements
  • A  fully-documented risk mitigation program that will also increase comfort with prescribing
  • The infrastructure for program implementation at launch and ongoing assessment
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Ten Things to Consider When Developing a REMS

Ten of the most important considerations to take into account when developing a REMS:

  1. Patient Safety First
  2. Create Options
  3. Co-design with Stakeholders
  4. Use Science-Based Approaches
    5. more...

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Will the FDA require a REMS for your new compound?

Check this qualitative index of the likelihood that FDA may require a REMS for a specific development compound as part of the NDA submission.  The presence of any attribute increases the probability of a REMS requirement...

  • New mechanism of action
  • Theoretical risk based on new MOA
  • Small clinical study population
  • more...

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