Rasika Kalamegham, Ph.D, is Executive Director and Head of U.S. Regulatory Policy at Genentech, a member of the Roche Group. She joined Genentech in 2015 bringing considerable, scientific, regulatory and policy experience to her role. Rasika’s focus has been advancing regulatory frameworks to keep pace with emerging scientific knowledge. She has recently focused on influencing FDA’s regulation of digital health – using AI/ML, digital, decentralized clinical trials (DCTs) and other technology enabled approaches to improve drug developement. A geneticist by training, she studied cell-fate specification during her post-doctoral work at the NIH. She then worked in increasingly senior positions at Friends of Cancer Research (FoCR), The Pew Charitable Trusts and The American Association for Cancer Research (AACR) before joining Genentech. Her work has led to important policy outcomes via passage of several laws and FDA guidances. She is a sought-after expert speaker, widely published in peer-reviewed journals and author of several text book chapters.Based in Washington, DC, she is always willing to chat about policy, dogs or baking.