Plenary Lecture

Niki Patel, Ph.D.

Associate Principal Scientist, Process Research & DevelopmentMerck Research Laboratories
Niki Patel grew up in Philadelphia, PA. She conducted her undergraduate studies at Temple University, earning a B.S. in Chemistry in 2010. Following graduation, she went on to perform her doctoral studies under the supervision of Professor Robert Flowers at Lehigh University. In 2015, Niki moved to the University of Pennsylvania as a postdoctoral researcher in the laboratory of Professor Gary Molander. In 2017, Niki began working at Merck as a Senior Scientist within Process Research & Development in the Process Chemistry group at Rahway, NJ, working on route scouting and manufacturing process development of islatravir. In 2020, she moved into the Discovery Process Chemistry (DPC) group in Kenilworth, NJ, supporting and enabling Structure Activity Relationship studies for several early programs. In addition to her scientific efforts, Niki is also involved in Merck’s chemistry recruiting efforts, and is a strong advocate for diversity and inclusion, both internally and externally.

Innovative Strategies toward Complex Molecule Synthesis: Development of a Fully Biocatalytic Manufacturing Route for Islatravir

A staggering 37 million people are currently living with HIV worldwide, with more than 2 million individuals newly infected every year. There is, therefore, an urgent need for a simplified treatment for this highly infectious disease to improve the overall quality of patient lives. Islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI) is a uniquely suited compound due to its high efficacy and potency, which has the potential to improve the overall quality of life for patients. On the road to developing a highly sustainable and green commercial manufacturing route, the process chemistry team has employed biocatalysis to facilitate the synthesis of this nucleoside. In a novel transformation, an enzymatic cascade sequence is utilized for the preparation of the 4’-ethynyl-2’-deoxyribose sugar fragment of the molecule. In addition, a highly selective glycosylation reaction involving another enzymatic system is used to fuse the 2-fluoroadenine base to the sugar component. This talk will focus on the progress surrounding the development of this unparalleled manufacturing route.