Clinical Risk Assessments

“Show me a drug with no side effects and I will show you a drug with no effect.”

- Eli Lilly -

This quotation, attributed to Eli Lilly, then CEO of the company that bore his (and his grandfather’s) name was reportedly made after Mr. Lilly received a dose of the “miracle drug” penicillin in the early 1940’s. The product’s formulation—required at the time—resulted in an extremely painful injection. Mr. Lilly’s quote speaks to the essence of the benefit/risk assessment:

Does the medication’s benefit outweigh the risk to the patient to a degree sufficient to justify its use?

Today is no different. And with more therapeutic options available for the treatment of similar conditions it is critical that the benefit/risk profile accurately reflects the incremental value that product provides.

The benefit-risk calculus is not static. The assessment should be conducted at key milestones throughout the product lifecycle.

Pharmaceutical Product Risk Assessments

  • Product Quality Attributes

  • Deviations or Excursions

  • Foreign Material & Particles

  • Acceptance Criteria

Medical Device Risk Assessments

  • FMEA Severity Ratings

  • Residual Risk Assessments

  • Product Integrated Benefit-Risk Assessments

Biologic Product Risk Assessments

  • Critical Quality Attributes

  • Clinical Impact of Common Cause Variability

  • CQA Heterogeneity

  • Clinically Relevant Specifications