Will explore pathway’s scientific, regulatory, legal, and business complexities
UPPER MONTCLAIR, N.J. (PRWEB) AUGUST 21, 2019
The nonprofit Scientists Advancing Affordable Medicines, Inc. (SAAMnow) recently announced plans for its second annual fall workshop and third-ever event since launching in 2018. SAAMnow, with assistance from The 505(b)(2) Platform – a non-profit business association focused on improving knowledge and strategies for 505(b)(2) new drug applications to enhance market value – has designed the three-day gathering to demystify the entire 505(b)(2) pathway.
Slated to run from Oct. 16 – Oct. 18, 2019, the workshop will take place at the Philadelphia 201 Hotel at 201 N. 17th Street, Philadelphia PA 19103.
“For this year’s agenda, we really wanted to dissect a hot topic in the pharmaceutical space right now: 505(b)(2)s,” said Chuck Bon, a SAAMnow founding board member. “Our goal is to help remove some of the mystery surrounding this NDA pathway. We will take a thorough look at the processes involved with this type of submission. At the same time, we want to debunk some of the many misconceptions about 505(b)(2) NDAs that are out there.”
The SAAMnow workshop will include a wide range of expert speakers, panelists, and moderators from both Industry and FDA. Topics will address everything from the science and regulatory side of 505(b)(2) development to the legal and financial aspects sponsors should consider.
“We are very excited to be able to offer this timely and much-needed event, and in a highly interactive format. Our unique program provides ample time and opportunity for Q&A, interaction with FDA and industry experts, case studies, and networking among sponsors, service providers, and investors,” said Charlie DiLiberti, a founding SAAMnow board member and the nonprofit’s treasurer.
SAAMnow currently is offering an early-bird discount through September 16. Workshop details and registration are available at http://www.saamnow.com.
Scientists Advancing Affordable Medicines, Inc. (operating under the SAAMnow tradename) is a 501(c)(6) Nonprofit Trade 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 accomplishes 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.
SAAMnow’s activities 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, the organization strives to remain impartial and politically neutral.
Demystifying 505(b)(2) Development: Navigating the Scientific, Regulatory, Legal, and Business Complexities Oct. 16-18, 2019