Please join us for a virtual lecture this Sunday afternoon 3/14/21, pi day, at 3:14 PM for a lecture about navigating Federal Drug Administration regulations during the pandemic.
Dr. Alexei Mlodinow will provide an overview of FDA medical device regulation using topical and specific experiences as examples. Alexei’s first company, SIA, currently has one FDA-cleared, CE-marked, bioabsorbable implant, for which it also has an NIH grant for a pivotal study of breast reconstruction under FDA oversight. He will review the commonly-misunderstood US FDA Class II and Class III device pathways that applied to SIA’s first clearance and ongoing clinical trial, respectively. He will also touch upon the basic elements of biocompatibility that need to be proven to get a device approved, and the difference between leveraging pre-existing vs novel polymers in device development. Alexei’s second company, RapidRona, took advantage of excess capacity in US CLIA labs and attaining an Emergency Use Authorization (EUA) to deliver the first at-home sample collection kit for COVID testing with a guaranteed 48-hour turnaround. They are one of the only companies offering the gold standard RT-PCR entirely from the comfort of your home, and have quicky scaled daily capacity to levels amongst those of well-established companies. He will review the different types of COVID tests and how they work, as well as describe the FDA EUA regulatory pathway.
Please use the form below to register for the event. On the evening of Saturday the 13th and just prior to the presentation, you will receive an email with the Zoom link for this event at the email address you provide below. We look forward to your attendance and to your questions.
This is a virtual event that will be conducted via Zoom. Please visit https://www.zoom.us to make sure you have installed the Zoom application prior to the event.
Date and Time: Sunday March 14, 2021 at 3:14 PM
Location: Zoom
Cost: Free
Dr. Alexei Mlodinow co-founded SIA (Surgical Innovation Associates), an academic spin-out focusing on bioabsorbable devices for plastic/reconstructive surgery, whilst studying in the joint MD/MBA program at Northwestern. SIA currently has one FDA-cleared, CE-marked, commercial implant, for which it also has a $2M NIH grant for a pivotal study of breast reconstruction under FDA oversight. The company has raised ~$8.5M in equity capital, and has multiple pipeline products
in development. In 2020, Alexei co-founded RapidRona, taking advantage of excess capacity in US CLIA labs and attaining an EUA to deliver the first at-home sample collection kit for PCR testing with a guaranteed 48-hour turnaround. In addition to his entrepreneurial work, he has authored over 20 peer-reviewed publications and book chapters, and he regularly lectures on both science and entrepreneurship at national and international meetings. He is listed as inventor on over 10 issued and pending patents for both SIA products and other technology; and he serves as board advisor to several start-ups focused on nanotechnology, medical robotics, tissue engineering, and structural heart disease. Alexei was named one of Forbes’ “30 under 30” in 2018 and Crain’s “20 in their 20s” in 2019.