His areas of expertise include clinical pharmacology, dosage form design and clinical drug development. During his career, Dr. Najib Babul has been responsible for the securing seven Food and Drug Administration (FDA) orphan designations. He has also filed thirty-two provisional patent applications, culminating in eight 8 U.S. patents or applications, each supporting one or more drugs currently in development.
A graduate of the University of British Columbia, the State University of New York in Buffalo and the California Institute of Advanced Management, Dr. Babul is presently a drug development consultant to pharmaceutical companies, investment banks and I.P. law firms. He assists clients with due diligence for pharmaceutical licensing, orphan drug applications, scientific and regulatory support for FDA and EMA meetings, guidance on Risk Evaluation and Mitigation Strategies (REMS), pediatric studies and pediatric exclusivity, and attaining FDA fast track and breakthrough therapy designation. His expertise also extends to dosage form design, drug development planning, clinical trial design, contract research organization (CRO) selection and management, protocol development and data analysis.
Dr. Babul’s success with selecting drug candidates for repurposing and designing drug development programs has resulted in the entrepreneur being invited as a speaker at FDA advisory committee meetings, and national and international scientific meetings. He has been appointed Director of Medical and Pharmaceutical Consulting at the California Institute of Advanced Management, Chairperson of the Clinical Trials Shared Interest Group of the American Pain Society, and Adjunct Associate Professor of Medicine in the Department of Clinical Pharmacology at the Temple University School of Medicine in Philadelphia.
Dr. Babul belongs to a number of professional organizations, including the American Academy of Neurology, the American Association of Pharmaceutical Scientists, the American College of Rheumatology, the American Pain Society, the American Society for Clinical Pharmacology and Therapeutics, the American Society of Anesthesiologists, the American Society of Clinical Oncology, the College on Problems of Drug Dependence, the International Anesthesia Research Society, the International Association for the Study of Pain and the Society for Neuroscience.
Dr. Babul is the author of over 170 abstracts and manuscripts in leading medical journals and scientific proceedings, including the Lancet, the Journal of American Medical Association (JAMA), the Journal of Clinical Pharmacology, the Journal of Clinical Oncology, Cancer, Anesthesiology, Clinical Pharmacology & Therapeutics and Anesthesia & Analgesia. His publications have covered a wide range of issues, including postsurgical pain, cancer pain, osteoarthritis, peripheral neuropathy, opioid pharmacology, cancer supportive care, infectious diseases, psychiatry, chronic obstructive pulmonary disease (COPD), sickle cell crisis, clinical trials methodology and drug regulatory affairs.
Dr. Babul has also designed studies and written papers on MS Contin®, OxyContin®, Avinza®, Ultram® ER, Opana® ER, Palladone®, Levorphanol ER, MS Contin®, Buprenorphine ER, mepivacaine topical gel, and inhaled and intranasal morphine.