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Novum’s Pina D’Angelo, Invited to Present at ASA Workshop
Sep 12, 2016
Pittsburgh, PA: Pina D’Angelo, MSc, Novum’s Senior Director, Scientific Affairs (Biostatistics), will be a Featured Presenter for the 2016 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, to be held on September 28th – 30th. The conference will include sessions co-chaired by statisticians from industry, academia, and FDA.
On September 29th at 1:15 p.m., Ms. D’Angelo will be discussing the topic of “Statistical Analyses and Issues in the Testing of Means and Proportions in Clinical Endpoint Studies for Evaluation of Generic Products”. This session will provide an overview of the current FDA recommendations for generic submission of clinical endpoint studies for which the primary objective involves testing of means (continuous endpoint) or proportions (dichotomous endpoint) for assessment of superiority of active to placebo products and equivalence of test and reference products.
For over 40 years, Novum has been considered one of the world’s leaders in the conduct of clinical trials; Early Phase Research from First in Human studies to large bioequivalence studies are conducted at Clinical Pharmacology units in Houston, Texas; Las Vegas, Nevada; and Fargo, North Dakota. A separate division, managing Late Phase Research requiring patient populations across multiple therapeutic areas, is lead by the Clinical Trials Division headquartered in Pittsburgh, Pennsylvania.