Overview

G&L Healthcare Advisors partnered with an innovative biopharmaceutical company to provide regulatory expertise in support of their lead compound, a novel treatment for life-threatening infectious diseases.

The compound was being developed under the U.S. Food and Drug Administration (FDA) accelerated programs, requiring strategic regulatory guidance and seamless interaction with the FDA.

Acting as the client’s virtual regulatory function, G&L guided the company through regulatory filings and FDA interactions, including the utilization of the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).

Challenges

The client, a biopharmaceutical company specializing in novel anti-infective treatments, faced key regulatory challenges:
Accelerated drug development program: The lead compound was being developed under the FDA’s accelerated pathways to address a critical unmet need in infectious disease.
Need for virtual regulatory support: The client required end-to-end support for FDA submissions and interactions.
FDA pre-IND meeting preparation: The client needed strategic support to prepare for an essential pre-Investigational New Drug (IND) meeting with the FDA to discuss their planned Phase 2a pivotal study.

G&L’s Approach and Solution

G&L provided a comprehensive, tailored regulatory solution to meet the client’s needs:
Regulatory strategy development: G&L identified the compound’s eligibility for the LPAD, a specialized regulatory route for accelerating the approval of life-saving anti-infective treatments.
Preparation for FDA pre-IND meeting: G&L assembled a multidisciplinary team to guide the client through preparation for a pre-IND meeting with the FDA. The meeting was crucial for aligning the Phase 2a pivotal study with FDA expectations.
Gap assessment: G&L conducted a non-clinical and clinical gap assessment to identify areas needing further clarification or data, ensuring that all regulatory questions were addressed in the FDA Meeting Request.
Authoring of FDA Meeting Briefing Book: G&L worked closely with the client’s Subject Matter Experts (SMEs) to craft a detailed FDA Meeting Briefing Book, including regulatory strategy, study design, and anticipated questions from the FDA.
Coaching for FDA meeting: G&L provided coaching to the client’s SMEs, ensuring they were well prepared for the FDA meeting and familiar with the processes and expectations, resulting in a smooth and productive interaction.

Impact and Outcomes

As a result of G&L’s comprehensive regulatory support, the following was achieved:
Successful FDA pre-IND meeting: The client successfully navigated the pre-IND meeting with the FDA, receiving endorsement for their ongoing development plans.
Regulatory guidance for accelerated programs: The client was able to leverage G&L’s regulatory expertise to maximize the benefits of the LPAD pathway, ensuring a faster route to approval for their life-saving anti-infective therapy.
Long-term regulatory partnership: Based on the success of the initial engagement, the client requested G&L to continue supporting all regulatory activities, including Investigational New Drug (IND) and New Drug Application (NDA) filing, submission authoring, and Electronic Common Technical Document (eCTD) publishing.