ParagonRx® | Minimize Risk and Optimize Use

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

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

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
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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