Scientists Advancing Affordable Medicines, Inc. (operating under the SAAMnow tradename) is a nonprofit (tax-exempt status pending) 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. The organization will accomplish this by soliciting input from a broad group of pharmaceutical stakeholders including, but not limited to those involved in manufacturing, packaging, testing, research & development, supplying material and equipment, providing services, academia, regulatory science, and government agencies such as FDA and EMA.
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. Our focus is on those scientific elements that are crucial and specific to the development, manufacturing, testing, and commercialization of affordable medicines.
In order to effectively service the scientific needs of our stakeholders, SAAMnow’s initial platform will be an annual workshop that will be of interest to, and attended by, various affordable medicine stakeholders. As we grow, we aspire to diversify the venues and media through which we continue to foster the development of affordable medicines, for example, by branching out to provide additional conferences, workshops, webinars, newsletters, web materials and training sessions. Similarly, we expect to be able to expand our focus from a US-centric one toward a global one. The organization’s activities will span a broad range of scientific disciplines including, but not limited to, formulation development, manufacturing technology, analytical chemistry, biopharmaceutics, bioequivalence (in vivo and in vitro), pharmacokinetics, bioanalytical chemistry, non-clinical testing, clinical science, statistics, and regulatory science. Because SAAMnow’s underlying goal is to benefit patients through cutting-edge science, we will strive to remain impartial and politically neutral.