SAAMnow is continuing its series of webinars on 505(b)(2) NDAs and will present the third session on June 17, 2020. The session will be up to 2 hours duration with three speakers and two presentations of 30-40 minutes followed by chat questions and answers.
Why Should You Attend:
This session will focus on the commercial/marketing pillar for successful 505(b)(2) product development, and will feature three speakers that participated in SAAMnow’s successful workshop on Demystifying 505(b)(2) Development: Navigating the Scientific, Regulatory, Legal, and Business Complexities (October 16-18, 2019, Philadelphia, PA). The workshop highlighted the diversity, simplicity and complexity of the 505(b)(2) application process, and via these webinars we want to continue to fill the basic educational gap in understanding and characterizing the 505(b)(2) pathway by giving participants an opportunity to learn from experts in this field.
Webinar Session 3: Commercialization strategies and considerations for successful 505(b)(2) NDA Drug Development
When: Wednesday, June 17th |11:00 am EDT (Eastern US)|Duration: 120 minutes
Presenter 1:
Stephen Casey, Managing Partner, Omni Healthcare Communications: Value by Design – Commercialization Diligence
Areas Covered:
Commercialization Diligence is the critical and often overlooked element of a 505(b)(2) development and eventual market success. During this webinar you will learn more about:
- The importance of Commercialization Diligence,
- Early stage techniques to help maintain Commercialization Diligence and product value,
- Examples of ways to enhance 505(b)(2) products and increase the commercial value, and
- A Commercialization Diligence process designed to enhance product value.
Presenters 2 and 3:
Josef Magpantay, Principal, and Tom Evegan, Vice President of Life Sciences, IntegriChain®: Commercialization Readiness: Government and Commercial Program Considerations
Areas Covered:
- Outlining market access landscape.
- Defining key operational considerations.
- Overview: understanding the payer and purchaser.
- Commercial landscape
- Government landscape
