Overview

G&L Healthcare Advisors was engaged to provide medical writing support for a leading global biopharmaceutical company’s Antibody Drug Conjugate (ADC) programs targeting HER2-expressing cancers.

The client needed experienced medical writers to lead clinical development efforts and global regulatory submissions across early- and late-stage development programs.

Challenges

The client faced several significant challenges in their medical writing and regulatory submission processes:
Urgent onboarding needs: The client required rapid onboarding of senior-level medical writers capable of taking on leadership roles in developing regulatory documents.
Diverse documentation requirements: G&L’s writers needed to handle a variety of regulatory documents, including EU and U.S. Food and Drug Administration (FDA) Briefing Books, Module 2 summaries, Information Requests (IRs), and Clinical Study Reports (CSRs).
Streamlining processes for future support: The client needed a scalable model to quickly onboard additional writers as their programs expanded.

G&L’s Approach and Solution

Within this engagement, G&L employed an integrated approach to address the client’s medical writing challenges. Key activities included:
Rapid onboarding and team integration: G&L provided five senior-level medical writers who were fully integrated into the client’s development teams within one month.
Lead document development: The G&L writers acted as lead authors for various documents and submissions, including protocols, Module 2 summaries, and regulatory submissions.
Strategic input and process familiarity: The writers provided strategic input during content development and participated in development team meetings while managing document finalization processes.
Train-the-trainer model: G&L developed a 'train-the-trainer' model to streamline onboarding for future medical writers, ensuring efficient integration and continuity.

Impact and Outcomes

As a result of G&L’s support:
Achievement of regulatory milestones: The client achieved critical clinical and regulatory milestones for their ADC programs.
Extended engagement for future support: The client extended G&L’s engagement for another year and onboarded additional medical writers to support future submissions.
Time and resource savings: G&L’s expertise helped the client save time and resources, contributing to successful regulatory filings for their HER2-expressing cancer programs.