A 101 in Potency Assays

Time: 8:30 am - 10:30 am
day: Pre-Conference Workshop Day


  • Establishing potency assays relevant for your therapeutic activity
  • Developing potency measurements that reflect the product’s mechanism of action
  • How early should potency assay development begin?
  • How should you adapt your matrix approach through early- to late-stage development?
  • Recommendations for assay design and validation, including the importance of using reference materials and standards
  • Dissecting the new FDA guidance on potency assurance: how should these be interpreted and implemented to guide strategy?
  • Discussing real-life case studies of potency strategies used to support IND filings