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QUALITY&GMP DEVELOPMENT&OPERATIONS DUE DILIGENCE MANUFACTURING OUTSOURCING CASE STUDIES


Luana R. C. Pesco Koplowitz
MD, PhD, FCP, FFPM
President & Chief Medical
and Scientific Officer
of DUCK FLATS Pharma, LLC

Johnson & Johnson, Janssen Research Foundation - Global Group Director of Clinical Pharmacology and US Nonclinical Development

Research Assist, Inc, Chief Medical & Scientific Officer

Knoll, Fujisawa, Key Pharmaceutical Companies and Squibb Institute for Medical Research

Responsible for numerous successful INDs and NDAs

Expertise in multiple therapeutic areas

PK/PD modeling, drug-drug interactions, receptor-binding modeling

Special population clinical trials, including pediatric, elderly and critical-care patients

Author or co-author on over 30 publications.

Adjunct faculty - Medical Center of Delaware, University of Miami Medical School

Academic Achievements

MD, Rutgers Medical School

PhD, Rutgers College of Pharmacy, Columbia Pacific University.

Clinical Pharmacology Training - University of Miami School of Medicine