The 505(b)(2) Platform and Scientists Advancing Affordable Medicines, Inc. Organize First-Ever Value Added Medicines Week

PHILADELPHIA, Oct. 6, 2021 /PRNewswire/ -- The 505(b)(2) Platform and Scientists Advancing Affordable Medicines, Inc. (SAAMnow) are partnering to host a first-ever Value Added Medicines Week (VAM Week). The virtual conference, scheduled for October 25-29, 2021, will bring together developers and marketers of repurposed, reformulated, repositioned and reauthorized products. Products approved as 505(b)(2) drugs account for 60% of all FDA approvals on an annual basis. Although they are considered new products, they face challenges different from other drug product categories.

"As regulatory bodies continue to wade through a backlog of repurposed drug applications, we believe this conference will be impactful for anyone looking to optimize their strategy and properly prepare for commercialization," said Stephen Casey, co-founder of The 505(b)(2) Platform.

Attendees will be able to participate in both a development and a commercialization track or select individual sessions. Each of the tracks features industry leaders from the regulatory, commercialization, legal and research fields.

Sessions offered and scheduled presenters include the following:

• Traditional Pre-clinical and Clinical Development Pathways – Aloka Srinivasan, David Rosen, Yaning Wang, Ruth Stevens, Mukul Agrawal
• Initial Due Diligence and Early Conceptualization of 505(b)(2) Pathway – Brendt Stier, Julie Bullock, Jonca Bull, Ron Filler, David Rosen
• 505(b)(2) Bridges – Keith Gallicano, Eric Kendig, Juan He, Mukul Agrawal, Alicia Baker
• Streamlined/Abridged Development Pathways – Charlie DiLiberti, Hao Zhu, Alicia Baker, Liang Zhan, Yaning Wang, Jim Mullins
• FDA Meeting/Communication Strategy – Catriona Roscoe-Cutting, Candis Edwards, Ruth Stevens, Aloka Srinivasan, Zan Fleming
• Commercialization is the New First Order Risk – Todd Smith, Tom Evegan, Tom Goss, Terri Bernacchi
• Planning the Journey – Ed Allera, Marvin Garrett, William Humphries, Jeff Rich
• Wisely Partnering to Increase – Steve Casey and Jim Iverson
• Regulatory with a Commercial Mindset – Barbara Binzak Blumenfeld, Howard Weisman, Mark Marino
• Developing your 505(b)(2) IP Portfolio – Matthew Fedowitz, Christian Calcagno

About The 505(b)(2) Platform^®
The 505(b)(2) Platform is a non-profit 506(c) business association. We educate and advocate for manufacturers of 505(b)(2) products on best practices in drug development and commercialization. Our mission is to enhance the understanding and acceptance of 505(b)(2) products in the development, regulatory and commercial arenas. Members of The 505(b)(2) Platform enjoy access to best practice information, a partnering platform, a marketplace of verified suppliers and consultants, and in-depth analysis of the 505(b)(2) regulatory and commercial issues. Learn more at www.505b2.org.  

About SAAMnow
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 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. Learn more at https://saamnow.com/ 

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SOURCE The 505(b)(2) Platform