Aron Stein

Company: Intellia Therapeutics

Job title: Senior Vice President - Global Regulatory Affairs

Bio:

Aron is the Sr VP of Global Regulatory Affairs at Intellia Therapeutics. He has over 35 years of product development experience in pharmaceutical and biotechnology having responsibility for multiple drug approvals in both large and small companies.  He is a toxicologist by training receiving his PhD from Texas A&M and a NIEHS postdoctoral fellow at the University of Kansas Medical Center.

Seminars:

MANAGING COMPLEX MULTINATIONAL SUBMISSIONS 1:00 pm

Differentiating key strategic approaches between collaborating with the FDA, EMA and other health authorities Assessing how expedited program criteria and benefits differ between the two bodies Addressing key regulatory CMC differences Utilizing these differences to help inform clinical and manufacturing strategies Top tips for drug sponsors working across these different regionsRead more

day: Workshop Day - track c PM

Panel Discussion: A 101 in Expedited Programs for Gene Therapy 2:00 pm

Outlining the practicalities of gaining FDA expedited designations Criteria for designation and best practices with regulatory touchpoints Considerations for successful interactions with CBER reviewers  Common reasons for denial of RMAT applicationsRead more

day: Regulatory - PM