AMP® Bespoke Gene Therapy Consortium (BGTC) Regulatory Playbook

Last Updated: May, 2025

This playbook is intended to support adeno-associated virus (AAV) gene therapy drug developers of all backgrounds, designed to act as roadmap for streamlining product development and navigation of the regulatory pathway, with the goal of getting new treatments to patients sooner.

Introduction to the BGTC Regulatory Playbook

Formal FDA meeting types

Expedited pathways and designations

IND preparation and submission

Browse by category

Platform-based approach for AAV gene therapies

INTERACT meeting

Pre-IND meeting

Clinical trial planning, design and execution: Considerations and best practices

Patient engagement and patient-centricity: Considerations and best practices

Study site management

Long-term follow-up

Resources - Regulatory templates

Resources - Official FDA Submissions and Responses

BGTC in action

Why Timelines are Tough: Communicating the Path to Gene Therapy | Empowering Patients 2026

Video thumbnail link to What is a Pre-IND Meeting

Community Quick Take: What is a Pre-IND Meeting?

Video thumbnail link to Manufacturing Matters

Community Quick Take: Manufacturing Matters

AMP® Bespoke Gene Therapy Consortium (BGTC) Regulatory Playbook

Introduction to the BGTC Regulatory Playbook

Formal FDA meeting types

Expedited pathways and designations

IND preparation and submission

Browse by category

Platform-based approach for AAV gene therapies

INTERACT meeting

Pre-IND meeting

Clinical trial planning, design and execution: Considerations and best practices

Patient engagement and patient-centricity: Considerations and best practices

Study site management

Long-term follow-up

Resources - Regulatory templates

Resources - Official FDA Submissions and Responses

BGTC in action

Why Timelines are Tough: Communicating the Path to Gene Therapy | Empowering Patients 2026

Community Quick Take: What is a Pre-IND Meeting?

Community Quick Take: Manufacturing Matters

Recently Modified Articles

Recently Created Articles

Most Viewed Articles

Documentation Index

AMP® Bespoke Gene Therapy Consortium (BGTC) Regulatory Playbook

Introduction to the BGTC Regulatory Playbook

Formal FDA meeting types

Expedited pathways and designations

IND preparation and submission

Browse by category

Platform-based approach for AAV gene therapies

INTERACT meeting

Pre-IND meeting

Clinical trial planning, design and execution: Considerations and best practices

Patient engagement and patient-centricity: Considerations and best practices

Study site management

Long-term follow-up

Resources - Regulatory templates

Resources - Official FDA Submissions and Responses

BGTC in action

Why Timelines are Tough: Communicating the Path to Gene Therapy | Empowering Patients 2026

Community Quick Take: What is a Pre-IND Meeting?

Community Quick Take: Manufacturing Matters

Recently Modified Articles

Recently Created Articles

Most Viewed Articles