Overview

G&L Healthcare Advisors has maintained a long-term partnership with a leading global biopharmaceutical client, providing 12 senior-level regulatory strategists to support their oncology and immunology portfolios.

Within this collaboration, G&L assigned a dedicated Global Regulatory Lead to oversee the regulatory strategy for a multiple myeloma cell therapy program. 

This program is pivotal in the client’s oncology portfolio, addressing a critical unmet need in the treatment of multiple myeloma through advanced cell therapy approaches.

Challenges

The multiple myeloma cell therapy program presented unique challenges that needed G&L's sophisticated regulatory strategies, including:
Global regulatory alignment: To ensure seamless development progress across the US and European markets, the program required precise alignment between all U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) interactions.
Integration with client team: The regulatory lead needed to seamlessly integrate with the client's internal cross-functional teams, taking full ownership of the regulatory components while maintaining cohesion with the client’s internal strategy.

G&L’s Approach and Solution

G&L’s approach in this long-term engagement was focused on providing expert regulatory leadership that aligned seamlessly with the client’s internal teams. This was achieved through:
Regulatory leadership: G&L assigned an experienced regulatory strategist to act as the Global Regulatory Lead for the multiple myeloma cell therapy program. This strategist worked closely with the client’s internal cross-functional teams, offering regulatory representation at key decision-making stages and providing strategic guidance throughout the development process.
Preparation for key regulatory interactions: As part of G&L’s regulatory leadership, the team led the preparation for pivotal meetings with both the FDA (End of Phase II Meeting) and the EMA (Scientific Advice Meeting). 
Development of Briefing Books: G&L developed these for both FDA and EMA meetings, ensuring that materials were aligned with each agency’s requirements and expectations.
Cross-functional team preparation: G&L guided the project team through the preparation process, ensuring that the strategy for both meetings was cohesive and strategically sound.
Leading regulatory interactions: G&L's experts led all interactions with the regulatory agencies, ensuring that all aspects of the multiple myeloma cell therapy program were presented clearly and in a way that facilitated productive discussions.

Impact and Outcomes

G&L's engagement led to multiple positive outcomes, including:
Seamless integration with client teams: G&L’s regulatory strategists integrated seamlessly with the client’s cross-functional development teams, acting as an extension of the client’s internal staff. This ensured continuity and efficiency in regulatory processes, enabling the client to focus on the broader aspects of their oncology portfolio.
Ownership of high-profile programs: G&L’s strategists took full ownership of the multiple myeloma cell therapy program, operating at the same level as the client’s internal staff and driving the regulatory strategy forward. This demonstrated the depth of expertise and the trust that G&L earned from the client.
Growth of partnership: The success of G&L’s engagement in the multiple myeloma program led to an expansion of the partnership, with G&L continuing to provide strategic regulatory support across other critical areas of the client’s oncology and immunology portfolios.