Steven A. Silber, MD
Steven joined NGT Biopharma Consultants after his retirement from Janssen Research and Development (a JNJ company) and he is an expert on our Pediatric Center of Excellence team.
From 2007 until his retirement in 2018, Steven led Janssen Research and Development (a JNJ company) as VP and Head of Established Products. In addition to other drug development projects, Steven led the program to obtain Pediatric Exclusivity for AcipHex (a proton pump inhibitor). This 10-year program involved multiple trials, some conducted in NICUs, and was ultimately successful.
While at J&J in 2012, he began working with the Gates Foundation to drive J&J’s participation in its global project to stimulate drug development efforts for Neglected Tropical Diseases. Shortly after this, J&J established its Global Public Health organization, which Steven joined as Medical Advisor. In this role he led the development of a pediatric formulation of an existing drug (Vermox) which is used to treat intestinal worms, one of the most prevalent infectious diseases in the world. The program culminated in an NDA in 2016 and was later approved by WHO.
Steven also led the development of a drug to treat Niemann-Pick Disease (Type C, NPC), a rare genetic disease of childhood that results in physical and mental deterioration, has no currently approved treatment, and is ultimately fatal. He also developed and managed JNJ’s Expanded Access Program, and the collaboration with NIH’s clinical development program. The drug has shown great promise and is still in development. Because of his involvement in this effort, Steven was asked to become Chairman of Together Strong-NPC, a non-profit foundation dedicated to funding research efforts for NPC. (https://ts-npc.org/)
Additionally, because of his expertise in rare genetic diseases, he was recruited to serve as the scientific consultant and Board member of the Beyond Batten Foundation which is developing a drug for the CLN3 form of this rare genetic disease.
Previously in 2003, Steven was the VP of Research and Development at McNeil Consumer and Specialty Pharmaceuticals (a subsidiary of Johnson & Johnson). In this role, he worked to develop various pediatric and adult formulation of Tylenol and supervised the execution of trials in multiple pediatric indications including enzyme replacement for Cystic Fibrosis, an NME for Sickle Cell Anemia, an NASAID patch for children with JRA, and a pediatric formulation for Ultram.
Earlier in his career, in 1998, Steven was recruited for a leadership role at Premier Research Worldwide, a Pennsylvania based CRO, of which he became president when PRW was acquired by SCP Communications.