Mesothelin-ADC - Molecular Diagnostics for Cancer Drug ...
Mesothelin-ADC - Molecular Diagnostics for Cancer Drug ...
Mesothelin-ADC - Molecular Diagnostics for Cancer Drug ...
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Companion <strong>Diagnostics</strong> –<br />
Some Practical Considerations<br />
• Consult with FDA, EMA early in development process<br />
• CDRH pre-IDE and CDER pre-IND processes aid study design and execution<br />
• Parallel consultation with HTAs helpful <strong>for</strong> discussion on reimbursment<br />
• Does the study trigger IDE Requirements?<br />
• Is invasive sampling (biopsy) being done <strong>for</strong> the study?<br />
• Do results from study influence patient management?<br />
• IRB oversight (approval/exemption) is needed <strong>for</strong> diagnostic testing sites<br />
• If archived specimens are used, In<strong>for</strong>med Consent must allow <strong>for</strong> storage and<br />
future use of samples: renewal of consent may be required<br />
• Bridging studies needed in case change is made to any part of the system<br />
(antibody, detection kit, instrument, scoring)<br />
• Ideally, test reagents and protocols finalized be<strong>for</strong>e starting first clinical trial<br />
• Analytical validation of the test procedure should include the target tissue type<br />
and include finalized scoring algorithm/cut-off<br />
14 • <strong>Mesothelin</strong> <strong>ADC</strong> • Boston, June 2012 • David Henderson
Change language