Overview

G&L Healthcare Advisors was engaged by an innovative US-based pharmaceutical company developing a novel antibacterial treatment for a rare lung disease. 

The client required strategic and tactical medical writing support for their pre-Investigational New Drug (pre-IND) Meeting and subsequent Investigational New Drug (IND) and Australia Clinical Trial Application (CTA) filings.

Challenges

The client faced several critical challenges in their regulatory submission process:
Accelerated development timeline: The client’s lead drug candidate was being developed under accelerated programs, necessitating expert guidance to meet the compressed timeline.
Comprehensive document development: The client needed experienced writers to develop all non-clinical and clinical content, including the pre-IND Briefing Book, IND, and CTA filings.
Coordination across global submissions: The client required guidance on submission standards for both the U.S. Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA).

G&L’s Approach and Solution

G&L employed a focused approach to ensure the timely development of the necessary regulatory documents. Key activities included:
Regulatory document development: G&L medical writers acted as lead authors for all non-clinical and clinical content, including IND Module 2 summaries, the Investigator’s Brochure (IB), and the pre-IND Briefing Book.
Strategic guidance for FDA and TGA filings: G&L developed the FDA Briefing Book, including background and rationales for non-clinical safety and clinical study design, ensuring alignment with FDA standards.
Submission-ready formatting: All content was prepared in submission-ready formats compliant with Electronic Common Technical Document (eCTD) authoring templates and FDA/TGA standards.

Impact and Outcomes

As a result of G&L’s involvement:
Successful pre-IND meeting: A high-quality pre-IND Meeting Briefing Book was submitted, leading to a successful pre-IND Meeting with the FDA, which resulted in agreement on the clinical development approach.
Timely submission of IND and CTA: G&L successfully authored and submitted the IND and CTA, allowing the US and Australian studies to commence as planned.
Ongoing support for NDA filing: The client requested G&L’s ongoing support for New Drug Application (NDA) filing, including the authoring of Module 2 and Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) documentation.