Webinar Session 1: Strategies, Considerations, Initial Due Diligence and Early Conceptualization for Successful 505(b)(2) NDA Drug Development

Webinar Session 1: Strategies, Considerations, Initial Due Diligence and Early Conceptualization for Successful 505(b)(2) NDA Drug Development

When: Wednesday, April 26^th |11:00 am EST (Eastern US)|Duration: 120 minutes

Presenter 1:

William Salminen, PhD, DABT, PMP, Vice President, Nonclinical Safety and Toxicology, 505(b)(2) Center of Excellence, Premier Research Consulting: Pillars of success for 505(b)(2) drug development

Presenter 2:

Julie Bullock, PharmD, Senior Vice President, Global Head of Clinical Pharmacology, Certara, Integrated Drug Development: Define your Target Product Profile (What will your label look like?)

Presenter 3:

Jonca Bull, MD, Vice President, Value & Development Consulting: Gap analysis for CMC, regulatory, preclinical/toxicology, and clinical

Panelists:

Speakers: William Salminen, Julie Bullock, Jonca Bull,

Invited: Ruth Stevens, PhD, MBA, Senior Advisor to Premier Research, 505(b)(2) Center of Excellence, Premier Research Consulting

Areas Covered:

• Five pillars for successful 505(b)(2) product development: science, regulatory, medical, commercial and legal/IP/business.
• What is a Target Product Profile (TPP) and why is a TPP important for a 505(b)(2)?
• Identifying and addressing gaps in CMC, regulatory, preclinical toxicology, and clinical.