Currently, Rachel is also President of Rachel Sherman Partners LLC. She is assisting national and international clients in medical product development and regulation. Rachel is applying her expert knowledge of regulatory science and extensive experience in medical product evaluation and approval to address regulatory challenges at all stages of product development.
Rachel is an accomplished executive and is well known for her innovative, patient-centered approaches to solving complex policy questions. She served until January 2019 as Principal Deputy Commissioner at the U.S. Food and Drug Administration (FDA), where she spent the last 30 years in medical product development and regulation, honing her proficiency at managing the complex dynamics of small- and large-scale organizations in both public and private sectors.
Rachel’s medical and regulatory experience spans a broad range of subject matters, including biosimilars, expedited drug development, infectious diseases, good clinical practice, prescription drug promotion, and active postmarket surveillance. She fostered multiple FDA efforts to modernize and expedite traditional drug development programs, enabling the FDA to respond to public health needs in a nimble, patient-centric, and scientifically rigorous manner. The FDA’s entire process for licensing biosimilar biological products, an extensive effort following statutory changes in 2010, was designed, developed, and implemented under her leadership.
In addition to Sema4, Rachel currently serves as a member of the Board of Directors for Aptinyx and is a part-time lecturer at the Department of Population Health, Harvard Pilgrim Health Care Institute.
Among Rachel’s many FDA awards are the FDA Distinguished Career Service Award, the Commissioner’s Special Citation (2006 and 2008), the FDA Award of Merit, and multiple Center for Drug Evaluation and Research (CDER) Center Director’s Special Citations. Rachel earned her MD at Mount Sinai School of Medicine and her MPH at Johns Hopkins University. She is the author or co-author of approximately 30 articles in peer-reviewed journals.
Being a doctor and fostering the success of others, especially in what was initially a male dominated field. There are projects, programs, and pathways that I conceived of or led that have helped accelerate the delivery of safe and effective products to patients. This was possible because of my commitment to creating and nurturing high-performing teams, making mentoring a priority, and keeping a careful eye on my staff’s professional development and workplace satisfaction (which often meant helping others achieve their potential and breaking barriers and stereotypes). A colleague once wrote that I “make everyone around me better than they would otherwise have been.” I am very touched by and proud of that.
My four children (and their dad) are my heroes, and my favorite team is my family. The children have taught us what pure joy means and they’ve also taught us to be mindful of attempts to divide and conquer.
I would love to meet Jane Austen – she understood that we are all flawed but (mostly) decent and she approached her characters with affection, kindness, and courage. She too chose the “road not taken.”
I have always been fiercely and actively supportive of social justice and civil rights probably because I grew up in New York City when it was quite diverse and because at Passover a central point was that none of us is free unless all are free. As a federal manager much of my professional life, I have been able to apply these principles and values to the workplace.
I am a cancer survivor and have had to adjust to certain physical limitations as a result of the surgery. As a regulator, when diagnosed I had access to data others did not, an inequity that must be addressed. Sema4 is spearheading an effort to “liberate data,” one of the many reasons I was genuinely thrilled when I was asked to join this incredible team.