Dr. Sandra Kweder is an internal medicine expert with more than 30 years of experience in U.S. and international medical products regulation and policy. At ELIQUENT, she offers broad expertise in drug development and regulatory strategy for clients as they navigate the lifecycle of drug and biologicals. The mature approach and keen insights she brings to Eliquent accrued through multiple senior leadership roles at the FDA, where she oversaw significant regulatory developments during periods of transformation in the landscape of science policy and public health.

Prior to her work at Eliquent served for six years as Deputy Director of the FDA’s Europe Office and Liaison to the European Medicines Agency (EMA), first in London and later in Amsterdam, working to strengthen international collaboration across all areas of FDA regulation, especially medical products. She launched new engagements with the EMA in areas including labeling and study of drugs in pregnancy, patient engagement strategy, rare disease product development, and an invigorated parallel scientific advice program.

As Deputy Director of the Office of New Drugs (OND) in the FDA’s Center for Drug Evaluation and Research (CDER), Sandy guided OND through a phase of substantial growth in staff and sophistication in regulatory science, driven by the prescription drug user fee program (PDUFA). Within OND she built consensus around strengthened review standards and practices to incorporate scientific innovation and emerging areas such as patient-reported outcomes in clinical trials. Among other initiatives, Sandy led the taskforce responsible for developing the 2014 Pregnancy and Lactation Labeling Rule that updated the regulations on labeling prescription drugs for use in pregnant and lactating patients and helped to modernize the FDA’s policies on conducting research in these populations.

Sandy joined the FDA in 1988 as a medical officer in the Division of Antiviral Drug Products, newly established to address the urgent need for treatments for HIV/AIDS. She became Acting Director of the Division of Epidemiology and Surveillance, then, after a two-year clinical fellowship, Deputy Director of the Office of Drug Evaluation IV, responsible for regulating antiviral and antimicrobial drug products. While at the FDA, she was a delegate to the American Board of Medical Examiners and a Fellow of the Drug Information Association (DIA). Sandy was often called upon to communicate complex medical and regulatory information to audiences ranging from patients and clinicians to intragovernmental and global partners. In 2022, Sandy was honored with an FDA Reward of Merit for her work to advance the Agency’s mission, particularly on the global front.

For 33 years Sandy served in the U.S. Public Health Service (PHS), rising to the rank of Rear Admiral and receiving numerous PHS awards before retiring from the service in 2013.