Dr. Tausif Monif
President – Global Operations
Dr Tausif brings with him a rich experience of more than 24 years in the Clinical Research Industry. During his tenure with Ranbaxy and subsequently Sun Pharmaceuticals, he played a pivotal role in the success of the company’s multiple marketing authorizations in the US, EU and RoW markets. He was also in parallel heading their Clinical Operations in Eastern Europe.
He has numerous publications and academic accreditations to his credit and has successfully faced multiple Regulatory Audits across the world in his illustrious career.
His last assignment was as Vice President-Sun Pharmaceuticals heading their Clinical Pharmacology and Pharmacokinetic division globally and played a pivotal role in advancing their New Drug Development portfolio with his varied experience.
VP, Clinical Trials and Data Management
Ms. Gongas has 23 years of experience within the science and clinical medicine fields; 20 years of that experience is with Novum. She has held a wide range of positions with increasing responsibility. In a career spanning cost analysis, project management and study conduct, Ms. Gongas currently has a senior leadership role with Novum. Her understanding of the complexity of clinical research has helped her to direct the management and daily operations of all clinical endpoint studies and data management services. Ms. Gongas helped to establish the one-of-a-kind Novum Clinical Research Associate Academy. In this innovative program, clinical research associates receive structured, comprehensive training in all aspects of clinical research.
Ms. Gongas is a member of the Society of Clinical Research Professionals and the Society of Clinical Research Associates.
Mr. Niraj Shethji has more than 17 years of research experience working at CROs and Pharmaceutical companies, supporting the early and late phase clinical trials. Before joining Novum, Mr. Shethji served at Sun Pharmaceuticals, Pharma Medica Research, Biovail Corp. and Watson Pharmaceuticals (currently Teva) in variety of roles and increasing responsibilities. He joined Novum in Yr. 2011 to provide scientific leadership to the talented team of scientists, technical writers, statisticians and programmers. In addition to his broad experience with the conventional oral dosage forms (solid/liquid), he gained wide-spread exposure to the design and conduct of the biostudies for complex dosage forms such as transdermal, topical (including corticosteroids), injectable, nasal/inhalation, vaginal/rectal products.
Mr. Shethji has hands on experience in developing study designs and protocols for the NDA/ANDA/505b2 submissions, statistical evaluation/presentation of data and generating high-quality study reports. Mr. Shethji’s diverse experience in fields of PK, PD, bioanalysis, biostatistics, efficacy trials and regulatory sciences assists in directing Novum team in day-to-day functions and guiding clients in their development/submission strategies. He has been greatly involved with Novum’s project management in providing the scientific and operational support to meet client’s expectations. Mr. Shethji received Masters of Pharmacy (Pharmacology) and BS in Pharmacy from University of Pune.
Dr. Alan K. Copa, PharmD
Dr. Copa joined Novum in 2013 to lead the Pharmacy Operations and the Client Services Division which oversees all Phase-I project management. He has more than 20 years of experience in contract research organizations, serving in a variety of roles ranging from director of Clinical Research to Site President, and most recently Chief Scientific Officer of a 554-bed clinical pharmacology unit (CPU). The CPU specialized in FIH studies, cardiac safety studies, bioequivalence studies and topical product studies.
Dr. Copa received his Doctor of Pharmacy degree from the University of Minnesota College of Pharmacy. He then completed a two-year fellowship in cardiovascular research and critical care medicine through the University of Minnesota.