Secrets to Successful Pre-IND Meetings for 505(b)(2) NDA Drug Development

  • Friday, March 26, 2021
  • 11:00 AM - 1:00 PM
  • Online

Registration

  • SAAMnow is conscious that the pandemic may have affected your financial position. Also, we recognize there are individuals retired, on fixed incomes who wish to participate in our webinars. SAAMnow is offering those individuals 50% off Webinar fees and membership fees.
  • These are discounted rates in the wake of the COVID-19 pandemic.
  • These are discounted rates in the wake of the COVID-19 pandemic.

Registration is closed

This session will focus on the preparation of a pre-IND Meeting Package for 505(b)(2) product development, and will feature one speaker (Aloka Srinivasan) 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) and one speaker (Candis Edwards) from the pharmaceutical industry. 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 5: Secrets to successful pre-IND meetings for 505(b)(2) NDA drug development

When: Friday, March 26th |11:00 am EDT (Eastern US)|Duration: 120 minutes

Presenter 1:

Aloka Srinivasan, Ph.D., 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

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
  • Some Case studies for 505(b)(2) applications

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

Areas Covered:

This presentation will provide details on the following steps for a successful pre-IND meeting:

  • Preparation
    • 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
    • Internal summary and FDA meeting minutes


We look forward to having you join us for our upcoming webinar. Topics under consideration for future SAAMnow webinars:

  • Beyond bioequivalence: phase I studies commonly needed to support 505(b)(2) applications
  • 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
SAAMnow wishes to thank Biopharma Services for their dedication to this topic and support of the organization.

SAAMnow is conscious that the pandemic may have affected your financial position. Also, we recognize there are individuals retired, on fixed incomes who wish to participate in our webinars. SAAMnow is offering those individuals 50% off Webinar fees and membership fees.