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Join SAAMnow for our 2023 series of webinars on 505(b)(2) NDA drug development starting April 26, 2023. There are three sessions. Each session will be up to 2 hours duration with three to four speakers and presentations of 20-40 minutes followed by a panel discussion with chat questions and answers.
The first two sessions (April 26th, 2023 and May 2nd, 2023) will focus on the 505(b)(2) NDA pathway for US FDA submission and session 3 (May 3rd) will focus on the preparation of a pre-IND Meeting Package for 505(b)(2) product development.
Registration is free for attendees. Current members of SAAMnow will have online access to content from these webinars. Non-members will have live access to the webinars for which they registered, but will not have access to the content after those events have ended.
Why Should You Attend:
This webinar series will highlight 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 1: Strategies, Considerations, Initial Due Diligence and Early Conceptualization for Successful 505(b)(2) NDA Drug Development
When: Wednesday, April 26th | 11:00 am EDT (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.
Sponsors:
Webinar Session 2: 505(b)(2) Bridges, Clinical Development Pathways, and Case Studies
When: Tuesday, May 2nd | 11:00 am EDT (Eastern US) | Duration: 120 minutes
Presenter 1: Seth DePuy, PhD, Manager, Regulatory Affairs, 505(b)(2) Center of Excellence, Premier Research Consulting: Strategic considerations for bridging in 505(b)(2) development
Presenter 2: Juan He, MSc.Phm, Vice President, Pharmacometrics, BioPharma Services Inc: A case presentation of 505(b)(2) clinical development
Presenter 3: Alicia Baker McDowell, DRSc, MS, Head of Regulatory Strategy, Product Development & Market Access Consulting, Labcorp Drug Development: Clinical considerations for 505(b)(2) NDA pathway
Presenter 4: Yaning Wang, PhD, CEO, Createrna Science and Technology: Orally inhaled drug products – regulatory perspective on 505(b)(2)
Panelists:
Speakers: Seth DePuy, Juan He, Alicia Baker McDowell, Yaning Wang
Invited:
– Ruth Stevens, PhD, MBA, Senior Advisor to Premier Research, 505(b)(2) Center of Excellence, Premier Research Consulting
– Scott Wesselkamper, PhD, Senior Manager, Regulatory Affairs, 505(b)(2) Center of Excellence, Premier Research Consulting
Areas Covered:
- 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.
- Case studies: 505(b)(2) programs for tramadol extended-release tablets and orally inhaled drug products.
- Designs for efficacy studies in various therapeutic areas.
Sponsors:
Webinar Session 3: Secrets to Successful Pre-IND Meetings for 505(b)(2) NDA Drug Development
When: Wednesday, May 3rd | 11:00 am EDT (Eastern US) | Duration: 120 minutes
Presenter 1: Aloka Srinivasan, PhD, Principal and Managing Partner, RAAHA LLC: To “b2” or not to “b2”: Importance of pre-IND meetings in determination of the pathway for an application
Presenter 2: Candis Edwards, Senior Vice President Regulatory Affairs, Amneal Pharmaceuticals: Preparation for, attendance at, and follow-up of Pre-IND meetings for 5050(b)(2) NDA drug development
Presenter 3: Angela Drew, PhD, Director of Regulatory Strategy, 505(b)(2) Center of Excellence, Premier Research Consulting: Recovering from an unsatisfactory/disastrous pre-IND meeting
Panelists:
Speakers: Aloka Srinivasan, Candis Edwards, Angela Drew
Invited:
– Ruth Stevens, PhD, MBA, Senior Advisor to Premier Research, 505(b)(2) Center of Excellence, Premier Research Consulting
– Scott Wesselkamper, PhD, Senior Manager, Regulatory Affairs, 505(b)(2) Center of Excellence, Premier Research Consulting
Areas Covered:
This presentation will provide an overview of PDUFA Formal Meetings including the following:
- Introduction: Where does a 505(b)(2) fit?
- Need for pre-IND meetings for 505(b)(2) applications.
- What constitutes a successful pre-IND meeting for 505(b)(2) applications.
- Challenges in preparing for 505(b)(2) related meetings.
- Building the right meeting team
- Preparing and submitting the meeting request and briefing book
- Meeting rehearsal to plan for an efficient meeting
- Attendance.
- Appropriate meeting behavior
- Types of questions to ask
- Meeting follow-up.
- Inadequate pre-IND examples and recovery plan for unsatisfactory meetings.
- Some Case studies for 505(b)(2) applications.
Sponsor:
