LEADERSHIP TEAM
Amar S Prashad, President & CSO
With more than 25 years of experience in the pharmaceutical industry Amar is a strong scientific leader with expertise in drug discovery through commercialization. His experience spans both medicinal chemistry in discovery (small molecules) & process development (biologics). He brings extensive biology training and experience encompassing various therapeutic areas such as infectious diseases, oncology, inflammation and vaccines. During his tenure at Lederle Laboratories, later acquired by Wyeth then Pfizer, Amar collaborated and worked with many departments across the larger legacy organizations, other biopharmaceutical companies (in-licensure, out- licensure) and Chemical Research/Manufacturing organizations with the goal of bringing quality medications to patients in the shortest possible time. Amar led a strong team of process development scientists to advance many early & late stage bioconjugate programs (Antibody Drug Conjugates, vaccines glycoconjugates, nucleic acid conjugates, etc.). Amar also engaged scientists across the larger Pfizer organization in the capacity of the Chair of the Bioconjugation Network (BCN; approximately 500 members). In addition, Amar pioneered & developed several innovative technology initiatives, most notably an optimized convergent calicheamicin process (used to manufacture the now commercial drugs Mylotarg & Besponsa) and Thio-Nitro-Benzoic acid (TNB) cysteine mutant technology (currently being used in a clinical program). These innovations lead to several patents and the TNB initiative earned him the prestigious Pfizer Worldwide R&D Achievement award in 2016. Amar holds degrees from University of Guyana (B.Sc. in Chemistry/Biology; Diploma in Education-Science), City University of NY (M.S. in Chemistry) and New York Medical College (M.S. in Microbiology/Immunology).
Lugene Maher, Head of Business Operations
Lugene brings a diverse background in the pharmaceutical, biologic and medical device industries, as well as academia. Her experience spans over 35 years of senior management in the life sciences. Focused on improving public health, she has held leadership roles in two Fortune 500 companies. Lugene was a Sr. Director in Business Operations and Strategy at a site and organizational level for the past 11 years at Pfizer. During this time, she also developed and led the site and organizational culture, colleague and civic engagement, diversity and inclusion initiatives and organizational leadership programs. She has also spent 10 years as a college-level instructor teaching courses in the biological, environmental and public health fields of study. Prior to joining Pfizer (Lederle Laboratories, later acquired by Wyeth), Lugene spent 8 years at Becton Dickinson and Company (BD), holding various advanced positions in the medical diagnostics division. Lugene has demonstrated in-depth career experience in the areas of Quality, Compliance, Regulatory Affairs, Clinical Operations, and Business Operations and Strategy. Lugene holds a Bachelor of Science degree in Social Science, a Bachelor of Science degree in the Biological/Life Sciences and Master of Science degree in Public Health Administration.
Michael Pastel, Quality Assurance Officer
Michael Pastel is an experienced pharmaceutical scientist with a strong background in analytical chemistry and GMP/GLP product development as an individual contributor, technical writer, manager, and team leader. Michael has held positions of increasing responsibilities from analyst to Director of Analytical & Quality Sciences. Compliance and quality assurance activities include extensive analytical support for production and release of clinical and process validation batches in commercial solid dosage, parenteral, and aseptic process facilities, directing and approving laboratory OOS investigations and manufacturing deviations with documentation and effective CAPAs, supporting customer complaint investigations, conducting internal audits and participation in US FDA pre-approval and other inspections, with direct interaction with Inspectors leading to successful product approvals and Consent Decree remediation.
Leo J Letendre, Senior Regulatory CMC Consultant
Leo Letendre joins Pearl River Laboratories as a Scientific Advisor after a distinguished industrial career spanning over 38 years with emphasis on both analytical and commercial process development in the pharmaceutical arena. Most recently, Leo established the bioconjugation process development group within Pfizer at its Pearl River site. Leo holds 17 patents including key patents related to the commercial preparation of Celebrex®, Dynastat™, Inspra™, Mylotarg™ and Besponsa®. Additionally, Leo contributed to the development of several clinical antibody drug conjugate and vaccine candidates. He has also had extensive experience in developing regulatory filings for both small molecules and bioconjugates. Leo is currently the Principal of Leo Letendre Consulting, LLC.