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Dr. Waksman has over 30 years of experience in the pharmaceutical industry, on both the Rx and OTC sides, in several therapeutic areas. He has been the lead statistician and helped guide strategic planning for several successful NDAs, including Rx-to-OTC switches. Prior to joining Brightech International, Dr. Waksman was Assistant Vice President of Biostatistics & Data Management at Wyeth Consumer Healthcare, where he helped grow the department and led all statistical, programming, and data management activities for a wide range of clinical trials, marketing support efforts, and advertising litigation. During his tenure there, he represented the Consumer Healthcare Products Association (CHPA) as a lead statistician. He has also worked for Janssen Research Foundation and Ayerst Laboratories (now part of Pfizer). Dr. Waksman holds a Ph.D. degree in Statistics from the State University of New York at Stony Brook.
Dr. John K. Whisnant had a career of more than 30 years in pharmaceutical/biotechnology drug development, and for the last 9 additional years has provided consulting services for clinical and regulatory strategies and for implementing projects in oncology, immunology and metabolic diseases. He also held numerous academic appointments for more than 14 years.
In addition to his role at Brightech, Dr. Whisnant provides consulting services in drug development under Product Development Resources, LLC and with the Kinexum, LLC group since March, 2006, consulting on clinical and regulatory and strategic business projects. Dr. Whisnant's career oppportunities have included the best of Pharma R&D groups, working at Wellcome from 1973 to 1987, at DuPont to 1991, and at Fujisawa in 1992. He led North American Clinical Development for Novo Nordisk from 1995 to 2002, which included successful registration of products in diabetes, women's healthcare and hemophilia. Dr. Whisnant's experiences in applying medicine and science to business goals have included Ivax Corp from 1992 to 1995 and Coley Pharmaceuticals during development of two oligodeoxynucleotide products. His consulting assignments have included ad hoc appointments for several companies, as CMO, VP Development, Medical Monitor, and team leader for oncology, diabetes/metabolism, and immunology projects.
Dr. Whisnant received his BA in Chemistry from Duke, his MD from Wake Forest University and is Board Certified in both Pediatrics and Immunology. He completed residency and fellowship training at NC Baptist Hospital (Winston-Salem), Albert Einstein (Bronx, NY) and Duke University (Durham NC). He trained in vaccine development and immunogenetics at the NIH during 1970-1972. His dual career in academic medicine and pharmaceutical drug development began at the Burroughs Welcome Co at RTP, NC where he was team leader for cancer and immunology projects. His work in biotechnology led to an appointment in the NCI's Biologic Response Modifiers Committee, and he was the founding Exec Sec/Treas of the International Society of Biological Therapy of Cancer (iSBTc). He has held clinical faculty appointments and contributed actively to patient care, research and drug development in clinical Pediatrics, Immunology, Infectious Diseases, and Hematology/Oncology. Dr. Whisnant has published widely and is an active member of learned societies.
Dr. King Lee is serving as the Executive Director of Regulatory Affairs at Brightech International and Vice President of Regulatory Affairs of Axella Research. Both companies have been jointly working on numerous projects since 2015. Prior to that, Dr. Lee was the Vice President of Regulatory and Clinical Affairs for Cornerstone Pharmaceuticals, Inc., a company that develops novel anti-cancer agents such as Altered Energy Metabolism-Directed (AEMD) compounds that affect tumor-specific pyruvate dehydrogenase complex (PDC), since 2004. Dr. Lee was also an independent consultant to a number of companies, including ExSAR Corporation and ZYWIE LCC, providing regulatory affairs services in the development of new products for the treatment of metabolic diseases such as Tay-Sachs disease and Gaucher’s Disease. Dr. Lee is also a consultant to Pars Pharmaceuticals, which a CRO providing various services to pharmaceutical companies. Previously, he was the Vice President of Regulatory Affairs for Acorda Therapeutics, Inc. Prior to Acorda during the years 2001-2003, Dr. Lee was Executive Director of Regulatory Affairs/Quality Assurance for ATON Pharma, Inc. (acquired by Merck), and worked with drugs such as ZOLINZA™ (vorinostat) which was approved by the FDA in 2006 for the treatment of cutaneous T-cell lymphoma. Prior to ATON, Dr. Lee was the Director of Regulatory Affairs/Quality Assurance for VION Pharmaceuticals, Inc. from 1996 to 2001, responsible for Regulatory Affairs, preclincal and clinical assessments of several types of oncology products including ribonucleotide inductase inhibitors, novel alkylating agents, and biologics. He was the Manager of Regulatory Affairs/Clinical Affairs for IBEX Technologies, Inc. from 1993 to 1996, responsible for an IND and clinical development of hematological products. Prior to IBEX, Dr. Lee was with Sterling-Winthrop from 1987 to1993, where he was involved with several INDs that led to NDAs and FDA approval of drugs such as congestive heart failure products including Primacor (milirinone) and MRI contrast agents including Omniscan™ (gadodiamide). Dr. Lee began his career in the pharmaceutical industry at Wyeth in 1985. He has been an adjunct professor at Quinnipiac University since 2006, and from 1982 to 1983 was a part-time faculty member of Eastern Kentucky University. Dr. Lee has authored and co-authored over 40 publications (scientific and professional papers, books and review articles) and numerous scientific abstracts. Dr. Lee received his Ph.D. in Pharmacology from the College of Medicine of the University of Kentucky in 1983 and was certified by the Regulatory Affairs Professionals Board in 1994.
Dr. Wang has 15 years of pharmaceutical experience in the design of clinical trials, planning of statistical activities, protocol development, preparation of statistical analysis plans, statistical analysis and summary report of clinical study data, management of statistical/programming activities. Dr. Wang's experience covers Phase I-IV clinical trials in various therapeutic areas, especially in oncology. He also worked on integrated summaries of safety (ISS) and efficacy (ISE) for two successful new drug applications (NDA) in oncology and neuroscience. He has a strong technical expertise in SDTM and ADaM mapping. His experience also extends to Quality Control of statistical analysis. Before joining Brightech, Dr. Wang worked at Eli Lilly, Abbott Laboratories, TAP, Centocor, Sanofi Pasteur, ImClone and Eisai.
Patricia Rivera has 18 years of Clinical Data Manager experience working at Pharmaceutical companies and CROs. Her data management experience covers Phase II-IV clinical trials in multiple therapeutic areas, including Oncology, Cardiovascular, Immunology and Endocrinology.
Her experience encompasses database start-up to database lock, which includes eCRF development, User Acceptance Testing of databases/data validation checks, preparing study data management documentation, Data Review, Local laboratory range management and SAE reconciliation. She has experience in the databases Oracle Clinical/RDC, ClinTrial and Medidata Rave.
Prior to joining Brightech, Patricia worked at Novartis Pharmaceuticals, Abbott Laboratories and Schering Plough and multiple CROs. Patricia holds a Bachelor of Science degree in Nursing from William Patterson University of which prior to working in Data management was a Registered Nurse for 6 years.
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