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Volume 04
Journal of Neonatal & Pediatric Medicine
Neonatal Nursing Congress 2018
May 14-15, 2018
Page 14
Notes:
conference
series
.com
May 14-15, 2018 Singapore
30
th
Global Experts Meeting on
Neonatal Nursing &
Maternal Healthcare
Drug-induced cardiac abnormalities in premature infants and neonates
T
he Cardiac Safety Research Consortium (CSRC) is a transparent, public-private partnership that was established in 2005 as
a Critical Path Program and formalized in 2006 under a Memorandum of Understanding between the United States Food
and Drug Administration and Duke University. Our continuing goal is to advance paradigms for more efficient regulatory
science related to the cardiovascular safety of new therapeutics, both in the United States and globally, particularly where
such safety questions add burden to innovative research and development. This presentation is a summary of a White Paper
that provided a summary of discussions by a cardiovascular committee cosponsored by the CSRC and the US Food and
Drug Administration (FDA) that initially met in December 2014 and periodically convened at FDA’s White Oak headquarters
from March 2015 to September 2016. The committee focused on the lack of information concerning the cardiac effects of
medications in the premature infant and neonate population compared with that of the older pediatric and adult populations.
Key objectives of this presentation are as follows: Provide an overview of human developmental cardiac electrophysiology, as
well as the electrophysiology of premature infants and neonates; summarize all published juvenile animal models relevant to
drug-induced cardiac toxicity; provide a consolidated source for all reported drug-induced cardiac toxicities by therapeutic
area as a resource for neonatologists; present drugs that have a known cardiac effect in an adult population, but no reported
toxicity in the premature infant and neonate populations and summarize what is not currently known about drug-induced
cardiac toxicity in premature infants and neonates and what could be done to address this lack of knowledge. This presentation
presents the views of the authors and should not be construed to represent the views or policies of the FDA or Health Canada.
Biography
Luana Pesco Koplowitz is a Chief Medical and Scientific Officer, received her MD from Rutgers Medical School and her PhD from Rutgers College of Pharmacy and
Columbia Pacific University. She has completed her training in Clinical Pharmacology at the University of Miami, School of Medicine. She is an Adjunct Professor
of Medicine, Department of Internal Medicine at the Medical Center of Delaware and is also Adjunct Faculty at the University of Miami, USA. She is a Fellow of
the American College of Clinical Pharmacology and the Faculty of Pharmaceutical Medicine in UK. She is the President and Chief Medical and Scientific Officer
of Duck Flats Pharma, LLC, USA. Previously, she was Chief Medical and Scientific Officer of Research Assist, Inc. She also held the position of Global Group
Director of Clinical Pharmacology and US Nonclinical Development for the Janssen Research Foundation of Johnson & Johnson. She has been responsible for
numerous successful INDs and NDAs during her 22-year career and holds several use patents in the treatment of various diseases. She has personal interests
in the areas of overall drug development, PK/PD modeling and drug-drug interactions, receptor-binding modeling and special population clinical trials, especially
pediatric, elderly and critical-care patients.
lpk@dfpharma.comLuana Pesco Koplowitz
Duck Flats Pharma LLC, USA
Luana Pesco Koplowitz, Neonat Pediatr Med 2018, Volume 4
DOI: 10.4172/2572-4983-C1-001