SAAMnow is launching a series of webinars, the first of which will be on 505(b)(2) NDAs starting May 13, 2020. Each session will be up to 2 hours duration with two speakers per session and presentations of 30-40 minutes followed by chat questions and answers.
Why Should You Attend:
The first two sessions (May 13th and May 20th) will focus on the 505(b)(2) NDA pathway for US FDA submission, and will feature 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.
All registrants will receive a recording of the webinar following the actual webinar.
Please direct any webinar related inquiries to webinars@saamnow.com
Webinar Session 1: Strategies and considerations for successful 505(b)(2) NDA Drug Development
When: Wednesday, May 13th |11:00 am EDT (Eastern US)|Duration: 120 minutes
Presenter 1:
Eric Kendig, PhD, Director, Regulatory Strategy, Camargo: Pillars of Success for 505(b)(2) Drug Development
Presenter 2:
Brendt Stier, MSc, Senior PPD Consulting Director, Global Product Development, PPD: Bridging the gap, study strategies for 505(b)(2) Drug Development
Areas Covered:
- Five pillars for successful 505(b)(2) product development: science, regulatory, medical, commercial and legal/IP/business.
- Bridging studies (comparative BA/BE study, PK bridge, CMC bridge, nonclinical safety bridge, “paper” bridge, clinical safety bridge), with focus on the design and requirements for clinical/PK studies.
Webinar Session 2: Intellectual property and regulatory considerations for filing a 505(b)(2) NDA
When: Wednesday, May 20th |11:00 am EDT (Eastern US)|Duration: 120 minutes
Presenter 1:
Barbara Binzak Blumenfeld, PhD, JD, MA, Attorney at Law, Buchanan Ingersoll & Rooney PC: Optimizing Your 505(b)(2) FDA Regulatory Strategy
Presenter 2:
Matthew Fedowitz, JD, Attorney at Law, Buchanan Ingersoll & Rooney PC: Current Strategies for Obtaining, Maneuvering Around and Enforcing IP Involving 505(b)(2) Products
Areas Covered:
- Patent certification and intellectual property considerations for 505(j) and 505(b)(2) applications, including identifying Listed Drug and patents covering Listed Drug, developing your patent strategy and portfolio for Orange Book listed patents and non-Orange Book patents, navigating the appropriate certification to make, and timing of your 505(b)(2) NDA.
- Filing a 505(b)(2) NDA application: regulatory issues and approval requirements.
- Strategic considerations for a 505(b)(2) NDA, including business, development and marketing factors, and critical questions to consider in the scientific, medical, regulatory and market areas.
$50 per webinar for members and $100 for non-members, or attend both webinars for $75 (members) or $150 (non-members). These are discounted rates in the wake of the COVID-19 pandemic.
Topics for future SAAMnow webinars:
- 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