Sam Maldonado, M.D., M.P.H., FAAP is Vice President of Child Health Innovation and Leadership Department (CHILD) at Johnson & Johnson.
Dr. Maldonado graduated with an MD degree from the National University of Honduras and completed his pediatric residency training at Henry Ford Hospital in Detroit. He completed a 3-year fellowship in Pediatric Infectious Diseases at Children’s National Medical Center in Washington, DC. and a Regulatory Medicine Fellowship in the Center of Drug Evaluation and Research of the FDA. He has a Master’s in Public Health from George Washington University.
Dr. Maldonado was a Medical Officer at the FDA from 1990 to 1998. He participated in the policy, scientific, and regulatory processes leading to the Pediatric Exclusivity Initiative that was signed into law as the Best Pharmaceutical for Children Act (BPCA) under the FDA Modernization Act (FDAMA) in 1997.
He joined J&J in February 2000 as Director of Pediatric Drug Development. In 2007, he represented J&J and the pharmaceutical industry in the negotiations for the renewal of the US pediatric laws and testified before the Health, Education, Labor and Pensions committee of the US Senate. Dr. Maldonado remained involved in the policy work that culminated with the signing into law of BPCA and the Pediatric Research Equity Act (PREA) in July 2012.
Dr. Maldonado has participated in the planning and execution of multiple global pediatric programs. He also represented the industry at the FDA Pediatric Advisory Committee and at the International Conference of Harmonization (ICH). Dr. Maldonado was instrumental in bringing together pediatric stakeholders and advocates in the US and Europe to further the improvement of pediatric product development. He worked in bringing together a diverse group of child advocates to form the International Neonatal Consortium, the Institute of Advance Clinical Trials (I-ACT) for children, and conect-4-children (c4c) in Europe under IMI sponsorship.