505(b)(2) Webinar Series Session 3: Commercialization Strategies and Considerations for Successful 505(b)(2) NDA Drug Development

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 17^th |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

Topics under consideration for future SAAMnow webinars:

• Beyond bioequivalence: phase I studies commonly needed to support 505(b)(2) applications
• Secrets to successful pre-IND meetings for 505(b)(2) NDAs
• Endogenous compounds: issues in study design, baseline correction, and bioanalytical
• In-vitro in-vivo correlation (IVIVC)
• In vitro dissolution profile comparisons
• In vitro binding studies
• Vasoconstrictor studies: issues in design and data analysis
• Formulation and manufacturing changes: to SUPAC and beyond
• Modeling methods for generics: applications and expectations
• Complex generics: drug-device combinations
• Dermal product approval process for ANDAs (IVRT and IVPT)
• PK and statistical considerations in single- and multiple-dose bioequivalence studies