Modernizing Expedited Development Programs

Natalie Kim | November 10, 2020

Each year, the Friends of Cancer Research (Friends) Annual Meeting addresses critical issues in the development of new oncology drugs and features experts proposing unique approaches toward current challenges in drug development. On Day 1 of the 2020 Friends Annual Meeting, panelists will discuss FDA’s expedited development programs and discuss proposals outlined in the white paper “Modernizing Expedited Development Programs.”


Expedited programs at the FDA are intended to facilitate, expedite development, and review drugs that address unmet medical need and treat serious or life-threatening conditions. Expedited pathways include: Fast Track, Breakthrough Therapy, Regenerative Medicine Advanced Therapy (RMAT), Priority Review, and Accelerated Approval. Between 2012-2019, 90% of new oncology drug approvals utilized an expedited program compared to only 55% of new non-oncology drug approvals.


A multi-stakeholder working group conducted a landscape analysis assessing the utilization of available expedited pathways by comparing the features and characterizing learnings from the wealth of experience gained in oncology drug development. While expedited development programs continue to bring life-saving therapies to patients safely and quickly, reflecting on learnings from past experiences, the working group identified ways to harness the benefits of expedited pathways that can maximize their use moving forward. This overarching analysis, which is characterized in the white paper, led the working group to recommend three proposals that can translate into actionable opportunities to enhance oncology drug development. 


“The expedited programs have been particularly relevant in oncology, driving innovation and allowing for approvals of transformative therapies, in many cases cutting years of development. Through reevaluation of these programs in our working group we have been able to describe and explore challenges from a regulatory, industry, and advocacy perspective, identifying key areas for further advancement and inquiry.” - Julia Beaver, Chief of Medical Oncology, Oncology Center of Excellence, FDA


Proposal 1: Streamline expedited programs into a unified pathway that delineates expedited development tool designs to facilitate early stage versus late-stage development.  This can help simplify their use and alleviate potentially redundant administrative processes for the FDA and drug Sponsors. 


Proposal 2: Codify best practices and processes to ensure expedited programs are used optimally and appropriately. This process would outline actions within the FDA and best practices for Sponsors leading up to and following qualifying for Breakthrough Therapy designation. 


Proposal 3: Ensure emerging therapies, such as cell and gene therapies and next-generation immunotherapies can benefit from expedited pathways. For example, Breakthrough Therapy and RMAT guidance documents should clearly describe opportunities for establishing earlier dialogue to initiate an expedited development plan for key stages of development (e.g., manufacturing, diagnostic test development, clinical development.)


Expedited programs that accelerate the development of drugs addressing unmet need are highly utilized in oncology drug development. Improving the interactions and downstream processes between the Sponsor and the Agency will strengthen these pathways and the regulatory review process for the next generation of emerging therapies.

To register for the 2020 Friends Annual Meeting, click HERE.
 

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