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Preconference Workshop

Biopharmaceuticals (includes Biologics and Drugs)

Maximizing Opportunities to Engage With the FDA

Tuesday, September 17, 2024

8:30 AM – 4:00 PM PDT

Location/Room: 104 A

Workshop Leader(s)

Jewell Martin, MA, MBA, PMP, RAC

Director for US Regulatory Policy
BioMarin Pharmaceutical, Inc.
Sonday L. Kelly, MS, RAC, PMP

Director
Division of Regulatory Operations and Programs / Office of Regulatory Operations / Center for Biologics Evaluation and Research / Food and Drug Administration

Slides

Presenter(s)

Angela W. Corona, PhD

Senior Scientific Director
BOLDAPPROVALS

Slides
Christy Cottrell

Chief Project Manager
FDA/CDER

Slides
RS

Ramani Sista, PhD

Director
ORMRR/OTP/CBER/FDA

Slides

Description: Understand various avenues to engage FDA under new PDUFA VII commitments for formal meetings between sponsor/applicants and FDA and pilots for increased communications; Discuss challenges faced and suggestions for enhancing interactions from both industry and FDA (CDER and CBER) perspectives.

Workshop Agenda (Subject to Change)

7:30-8:30 am
Networking Breakfast & Welcome for Preconference Workshops Registrants

8:30 – 9:00 am
• Welcome
• Workshop Overview
• Brief overview of PDUFA and Impact on FDA Programs

Speaker(s):
Jewell Martin, BioMarin
Sonday Kelly, CBER/FDA

9:00 – 10:15 am
FDA Formal Meetings:
• FDA Guidance
o Meeting Management Goals

What's New Under PDUFA VII
• Meeting Type D
• INTERACT
• WRO - Follow up meetings
• Meeting Request Overview
• Q&A
• Test Your Knowledge - Case Scenarios with audience feedback

Speaker(s):
Christy Cottrell, CDER/FDA

10:15 - 10:30 am
Best Practices for In-Person/Virtual/Hybrid FDA Meetings from Industry Perspective

Speaker(s):
Angela Corona, BOLDAPPROVALS

10:30 - 11:00 am
All Workshop Registrants: Refreshment Break

10:45 - 11:15 am
Participants Table Discussion and Report Out

Moderator:
Sonday Kelly, CBER/FDA

11:15 am - 12:00 pm
Meeting Packages

Overview:
• Submitting better packages
• Timing of Meeting Package Submission

Speaker(s):
Ramani Sista, CBER/FDA

12:00 - 12:30 PM
• Enhanced Review and Transparency
• Informal Communication
• Industry Best Practices

Speaker(s):
Christy Cottrell, CDER/FDA
Jewell Martin, BioMarin

12:30 - 1:30 pm
All Workshop Registrants: Lunch

1:30 – 2:15 pm
• Welcome to the afternoon
• Interactive Q&A game

Speaker(s):
Sonday Kelly, CBER/FDA

2:15 – 2:45 pm
Best practices to Prepare for Advisory Committee Meetings
• Interactions and communications involved with AdComms
• Timelines and best practices for preparations

Speaker(s):
Angela Corona, BOLDAPPROVALS

2:45 - 3:50 pm
Audience Feedback and Discussion With Panel: What challenges have you or your team faced with FDA interactions?
• Q&A

Speaker(s):
Sonday Kelly, CBER/FDA
Angela Corona, BOLDAPPROVALS
Christy Cottrell, CDER/FDA
Ramani Sista, CBER/FDA

Jewell Martin, BioMarin

3:50 – 4:00 pm
Closing Remarks

Speaker(s):
Sonday Kelly, CBER/FDA
Jewell Martin, BioMarin

Learning Objectives:

Understand various avenues to engage FDA, including those under new PDUFA VII commitments for formal meetings between sponsor/applicants and FDA.
Discuss challenges faced and opportuities for enhancing interactions from both industry and FDA (CDER and CBER) perspectives.
Discuss factors that should be considered to maximize interactions with FDA.