Rasika Kalamegham

Rasika Kalamegham, Ph.D, is 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. She leads personalized medicine regulatory policy development. Rasika has recently been focused on influencing FDA’s regulation of digital health – from SaMDs to development of novel digital endpoints to decentralized clinical trials.

A geneticist by training, she studied cell-fate specification during her post-doctoral work at the NIH. She then worked in increasingly senior regulatory policy positions at Friends of Cancer Research (FoCR), The Pew Charitable Trusts and The American Association for Cancer Research (AACR) before joining Genentech.
She plays an active role in many trade groups including BIO, PhRMA, Transcelerate and ARM and serves in leadership positions on taskforces.

Her work has led to several important regulatory policy outcomes including FDA guidances (Codevelopment of Two or More New Investigational Drugs for Use in Combination, Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics etc.), passage of the Generating Antibiotics Incentives Now or GAIN Act (signed into law by President Barack Obama), Vice President Biden’s Cancer Moonshot Initiative and others.

Rasika and her husband Jim reside in Washington, D.C with their recently adopted retired racing greyhound Fynn and her sourdough starter Ffyeasty.