“Head of the first-ever successful submission to the FDA ISTAND Program“
InnovApproach is a regulatory start-up focused on helping biotechnology and life science companies qualify cutting-edge New Approach Methodologies (NAMs). From AI-based diagnostics and Large Language Models to in vitro organoids and organs-on-a-chip, no technology is beyond our scope. With experience in successful submission to the FDA ISTAND NAM qualification program, we are uniquely positioned to guide business to qualify their technologies in this rapidly changing regulatory landscape.
InnovApproach Consulting is based in Melbourne, Australia and currently serves clients in America, Europe, and Australia.
Michael Phelan, PhD
Founder and Principal Consultant
Dr. Michael Phelan brings unparalleled expertise in FDA regulatory strategy and Drug Development Tool (DDT) qualification for New Approaches and Methodologies (NAMs). As the lead behind the first and most advanced ISTAND program submission to date, Dr. Phelan possesses unique, hands-on experience navigating the complex regulatory landscape.
During his tenure as Associate Director of MPA Quality and Manufacturing at Integral Molecular, Dr. Phelan spearheaded the company’s groundbreaking participation in the FDA’s ISTAND program. As the first applicants through the program, the Integral Molecular team gained key insights into the requirements of the ISTAND Program and worked closely with ISTAND program officers to help develop and define the submission process.
Dr. Phelan holds a PhD in Bioengineering completed as an Intramural Fellow at the National Institutes of Health and awarded through Temple University. His multi-faceted research advanced bioreactor, biomaterial, and bioinformatic approaches to optimize organoid and other in vitro methodologies for drug development applications. Dr. Phelan is a US-Australian dual-citizen. He relocated from Philadelphia to Melbourne in 2025 and regularly travels between Australia and the United States.
To work with Dr. Phelan, contact InnovApproach Consulting.