Sydney Stern, PhD

Medical Writing, Publications, Global Publications & Scientific Communications Global Medical Affairs

I lead the strategy and execution of programs for TGCT Support, under The Life Raft Group, with a mission to enhance treatment options and quality of life for patients with tenosynovial giant cell tumor (TGCT) through patient-powered research, education, empowerment, and global advocacy efforts. I focus on improving outcomes and treatment challenges for patients with TGCT worldwide. My work spans KOL engagement, generation of real-world evidence (RWE) and natural history research, patient outreach, healthcare navigation, public policy advocacy, medical communications, and education for both patients and healthcare professionals. I oversee the development of educational content (including webinars and CME programs), create patient-centered resources and global initiatives to harmonize global TGCT management, and serve as the Principal Investigator for the TGCT Support Registry, an effort I designed, manage, and analyze to generate actionable insights shared regularly with the community.

• Served as a subject matter expert for Olignucleotide-based therapeutics, both commercial and N-of-1 development across Office of Clinical Pharmacology review divisions • Reviewed a wide range of drug and oligonucleotide-based therapeutic applications to determine the adequacy of the bioavailability, safety, and efficacy protocols and resultant data • Interpreted complex biochemical, pharmacological, and toxicology aspects of drug protocols as part of clinical trial studies • Applied expert knowledge of the design and analysis of human pharmacokinetic and pharmacodynamic studies to review and evaluates the approvability of regulatory submissions in all stages (e.g., NDA, BLA, IND, PIND) • Ensured that rapid advances in translational science such as quantitative systems pharmacology, clinical pharmacology, and pharmacogenomics are incorporated into regulatory reviews • Independently reviewed clinical studies/protocols and provided scientific expertise as a member of a multi-disciplinary scientific and medical teams engaged in the review, evaluation, and decision-making regarding the approvability of submissions • Led, planned, scheduled, and carried out major studies and projects with the analysis and evaluation of drugs and clinical trials • Conducted regulatory research in the Rare Disease therapeutic area and Antisense Oligonucleotide Therapeutics using internal datasets and disseminates results in academic publications • Provided special scientific expertise on translational science components of complex surrogate endpoints as part of a CDER-level cross-disciplinary subject matter expert team

I worked in the lab of Dr. Hongbing Wang and we focused on the regulation of hepatic metabolism and its implications in chemotherapeutic agents for rare and prevalent cancers. The constitutive androstane receptor (CAR) is a master regulator of hepatic metabolism. Cyclophosphamide, a prodrug, requires hepatic metabolism for its cytotoxic target effects. We focus on understanding the mechanism and regulation of CAR and Nrf2 pathways in hopes of creating potential drug candidates for improving the efficacy of commonly used chemotherapeutics.

The TL1 training program is part of the National Institutes of Health (NIH) Ruth L. Kirschstein National Research Service Award (NRSA) program. Funding for this TL1 pre-doctoral training program is provided through the NIH National Center for Advancing Translational Sciences (NCATS) Clinical and Translational Science Award (CTSA) and is a joint CTSA partnership between University of Maryland Baltimore and Johns Hopkins University.

I taught 150 student review sessions for general chemistry and introductory psychology as well as group/one-on-one sessions (Spring 2014-2016)