Dr. Hoffman has been a key opinion leader in neuromuscular disease since his identification of the dystrophin protein in the late 1980’s. Dr. Hoffman and the AGADA team can help facilitate your clinical programs by determining robust primary and secondary outcome measures, performing biomarker assay validation studies, delivering biopsy processing training, and aiding with regulatory writing.
With over 30 years experience in dystrophin assays in over 5,000 human biopsies, Dr. Hoffman is able to translate experience into well designed, vigorous, established standard operating procedures (SOP). AGADA has developed over 50 SOPs specific to dystrophin testing in patient biopsies, many of which have been reviewed by FDA. AGADA has also developed an extensive biopsy processing training program and are available for on site training and monitoring throughout your clinical trial.