Anil Tarachandani

Company: Verge Genomics

Job title: Vice President & Head of Translational Medicine

Seminars:

Novel, Sensitive, Digital Endpoints that Detect ALS Progression for Clinical Studies: Early Data from Pretreatment Run-In Period in Proof-of-Concept ALS Study VGCS-50635-002 1:00 pm

The ALS-FRS-R is the primary efficacy endpoint for proof of concept and registrational ALS trials It is challenging to perform early efficacy (Proof of Concept) and dose ranging studies in ALS with the ALS-FRS-R as large sample size and long study duration is needed Digital clinical biomarkers could provide a better option for Proof of…Read more

day: Conference Day One Track B PM

Panel Discussion: Given Recent Failures, How Can we Tailor ALS Clinical Trials to Successfully Meet Regulatory Expectations 1:30 pm

Outlining the approval path for sporadic and familial ALS: is it the same for different modalities? What is the regulatory bar for approving this? Harnessing innovative trial design Cross comparing diverging requirements for different regulatory agencies including the FDA, EMA and more Establishing clear, patient-relevant endpoints and leveraging biomarkers to demonstrate efficacy Critically identifying stumbling…Read more

day: Conference Day One Track B PM