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Scientists Advancing Affordable Medicines, Inc. is a nonprofit 501(c)(6) organization that seeks to provide a dedicated platform for scientists to share cutting-edge research that facilitates the development of high-quality, affordable medicines, thereby improving their accessibility to patients. Because we are sharing approaches now for the affordable medicines of tomorrow, we have adopted the tradename SAAMnow.
Statistical and Data Analysis Issues and Solutions for ANDAs and 505(b)(2) NDAs (a workshop in memory of Chuck Bon and Sandy Bolton)
Date/Time: June 10-12, 2024 (8:30 AM – 11:45 AM EDT)
Location: Online
This workshop is dedicated to the fond memory of two leaders in the world of pharmaceutical statistics, the late Chuck Bon, who was a founding member of SAAMnow, and Sandy Bolton, who together with Chuck co-authored the widely-used book Pharmaceutical Statistics – Practical and Clinical Applications. A tribute to Chuck will be given by his son, Stephen, at the opening of the workshop.
Biostatisticians and scientists from industry and the FDA will present on various topics related to statistical and data analysis issues and solutions for ANDAs and 505(b)(2) NDAs. The workshop will explore some of the latest methods, research, and regulatory changes addressing how we design and analyze data from bioequivalence (BE) and bioavailability (BA) studies, including in vitro, pharmacokinetic (PK), pharmacodynamic (PD), and clinical endpoint studies. The format of the workshop is three half-day (morning) virtual sessions with five 20- to 30-minute presentations followed by a panel discussion each day.
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SAAMnow offers individuals the opportunity to potentially impact the availability of affordable medicines through cutting-edge research. SAAMnow is looking for individuals involved/interested in research & development, formulation/manufacturing science, analytical chemistry, clinical science, statistics, quality systems, regulatory science, marketing, and allied disciplines associated with the development, manufacturing, testing, and commercialization of high quality affordable medicines. Affordable medicines are broadly defined as those that take advantage of abbreviated regulatory filing pathways, resulting in development cost savings that can then be passed on to patients. Examples include conventional generic pharmaceuticals, biosimilars, and products filed via hybrid regulatory pathways, such as the 505(b)(2) route.
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