Overview

G&L Healthcare Advisors partnered with a pioneering biopharmaceutical company developing an innovative platform to stimulate immune responses (killer T-cells) for treating both solid and blood cancers.

This novel therapy, targeting ovarian cancer, required comprehensive regulatory and clinical support to ensure successful engagement with key regulatory bodies, including the U.S. Food and Drug Administration (FDA) and Health Canada.

G&L provided strategic guidance in navigating the complex regulatory landscape, facilitating expedited development and submission processes.

Challenges

The biopharmaceutical company faced multiple challenges in the development of its lead compound for ovarian cancer, including:
Early-stage clinical and regulatory guidance: The client required expertise to review and enhance their early-stage clinical and regulatory data.
Expedited regulatory pathways: The company sought to leverage expedited regulatory programs, requiring precise engagement with the FDA and Health Canada.
Agency meeting preparation: They needed full support in preparing for regulatory meetings, including authoring, publishing, and submitting Electronic Common Technical Document (eCTD) documents for FDA and Health Canada interactions.
Cross-functional coordination: Effective coordination across clinical, regulatory, and scientific teams was essential for seamless document preparation and submission.

G&L’s Approach and Solution

G&L provided end-to-end regulatory and clinical support to ensure the client’s development plans were fully aligned with regulatory requirements. Key actions included:
Comprehensive data review: G&L conducted a thorough review of all available early-stage clinical and regulatory data for the lead compound targeting ovarian cancer. This assessment helped refine the client’s development plans and ensured their readiness for regulatory submission.
Cross-functional team leadership: G&L led a cross-functional team to develop and submit Agency questions and Briefing Books for meetings with the FDA and Health Canada. The briefing documents detailed the novel platform technology, results from completed clinical studies, and outlined the company’s development roadmap.
Meeting preparation and support: G&L guided the client through all aspects of regulatory meeting preparation, from slide development to drafting responses to potential regulatory questions. Our team also supported post-meeting activities, including debriefings and the preparation of official meeting minutes.
eCTD submission and documentation support: G&L assisted with the eCTD submission, managing the publishing process and ensuring that all regulatory documents were submitted on time and in compliance with the FDA and Health Canada’s requirements.

Impacts and Outcomes

With G&L’s strategic regulatory support, the client achieved the following key milestones:
Successful FDA and Health Canada meetings: The company received positive feedback from both regulatory agencies, enabling them to move forward confidently with their development plans for the novel cancer therapy.
Regulatory endorsement for future development: Both the FDA and Health Canada provided valuable guidance and endorsement of the company’s ongoing and future development strategies, positioning the client to leverage expedited regulatory pathways for quicker market access.
Strengthened regulatory positioning: By facilitating successful regulatory meetings and submissions, G&L helped the client secure a clear regulatory path for advancing their lead compound in ovarian cancer, enhancing their chances of future approvals.