BIO International Convention 2023

On Thursday, June 8, 2023, Morrison Foerster partner Stacy Amin will participate in two panels at the BIO International Convention, including "PDUFA VII and Beyond: Building Confidence in AI Tools as New "Gold Standards" for Drug Development" and "In Vitro Diagnostics Regulation in the US and Beyond: Trends and Strategies to Navigate Change."

PDUFA VII and Beyond: Building Confidence in AI Tools as New "Gold Standards" for Drug Development

Thursday, June 8, 2023

9:00 AM - 10:00 AM (EDT) - Session Room 254B

Companies and regulators are turning to artificial intelligence and machine learning models across the entire life-cycle of product development, from drug discovery and clinical research to post-market safety surveillance, to help make drug development more efficient and optimize real world patient outcomes. In early May 2023, FDA issued a discussion paper on Using Artificial Intelligence and Machine Learning in the Development of Drug and Biologic Products requesting stakeholder feedback on how to best develop “standards for trustworthy AI that address specific performance in areas such as explainability, reliability, privacy, safety, security, and bias mitigation.” Please join us as our panel takes up the question of AL/ML standards in drug development and how we can move from high level principles to engineering standards by creating a collaborative test bed for AI/ML tools that allows for agile and effective regulation without deterring innovation in a rapidly evolving field.

Moderator:

• Paul Howard, Senior Director of Public Policy, Amicus Therapeutics, Inc.

Panelists:

• Stacy Amin, Partner, Morrison Foerster
• Maria Pineda, Co-founder and CEO, Envisagenics, Inc.
• Joseph Lehar, SVP R&D Strategy, Owkin
• Blanca Rosales Baez, Founder and CEO, DBounce

In Vitro Diagnostics Regulation in the US and Beyond: Trends and Strategies to Navigate Change

Thursday, June 8, 2023

1:00 PM - 2:00 PM (EDT) - Session Room 209

In vitro diagnostics have seen incredible innovation during the COVID-19 pandemic, and advances in real world evidence, precision medicine, genetic sequencing, and AI/ML driven software have made this one of the fastest developing industries. However, the regulatory landscape for in vitro diagnostics is in a state of change and uncertainty. Europe's new IVDR law has brought new regulatory challenges for test developers. Meanwhile, FDA has hinted at its intention to regulate laboratory developed tests, and has taken an enforcement posture toward direct-to-consumer, pharmacogenetic, and certain genetic screening tests. This panel will discuss the most important trends in the industry, the VALID Act and Congressional efforts to bring about regulatory clarity, the latest actions from FDA, and how industry should navigate these shifting sands in the U.S. and internationally.

Moderator:

• Stacy Amin, Partner, Morrison Foerster

Panelists:

• Elizabeth Hillebrenner, Associate Director for Scientific and Regulatory Programs, FDA Center for Devices and Radiological Health
• Shilpa Prem, Corporate Counsel, Amazon Lab126
• Lauren Silvis, Senior Vice President of External Affairs, Tempus
• Elizabeth Mansfield, Vice President of Regulatory Policy, Foundation Medicine

Register or learn more.