2023-06-07
US FDA End-of-Phase 1 Meeting Preparation and Application
EffPha’s highly specialized scientific team, led by directors with over 30 years of experience in leading pharmaceutical companies, possesses integrated knowledge of drug development. We are ready to support pharmaceutical and biotech organizations of all sizes in all stages of their product development.
The Challenge
We were approached by a pharmaceutical company for assistance in preparing for an End-of-Phase 1 (EOP1) meeting with the FDA, which was recommended by the Agency during the pre-IND meeting.
The client has completed two Phase 1 studies in oncology patients in the US and Taiwan with their novel small molecule drug, and plans to initiate a Phase 1b/2 study in patients with brain tumors using a new and improved formulation.
The Solution
The EffPha team has been supporting the client throughout their development process, and helping them design pre-clinical and clinical studies, achieve regulatory approval, and manage the two Phase 1 clinical studies. This enduring partnership enabled us to develop a deep understanding of the client’s product and closely aligned our efforts with their objectives.
Our team worked closely with the client, reviewing the available preclinical and clinical data, discussing design features, including the target patient population, eligibility criteria, primary and secondary endpoints, and the statistical plan. We then helped prepare the meeting request and the meeting package.
Results
With well-defined questions and scientifically robust supporting information in the meeting package, FDA was able to evaluate the adequacy of the non-clinical and clinical data, and provide specific feedback and guidance in their written response.
The EffPha team revised the clinical protocol based on the Agency’s recommendations. As a result, the proposed Phase 1b/2 study successfully obtained approval from both the FDA and the Taiwan Food and Drug Administration (TFDA), thus ensuring a smooth pathway to the next clinical phase.
The Challenge
We were approached by a pharmaceutical company for assistance in preparing for an End-of-Phase 1 (EOP1) meeting with the FDA, which was recommended by the Agency during the pre-IND meeting.
The client has completed two Phase 1 studies in oncology patients in the US and Taiwan with their novel small molecule drug, and plans to initiate a Phase 1b/2 study in patients with brain tumors using a new and improved formulation.
The Solution
The EffPha team has been supporting the client throughout their development process, and helping them design pre-clinical and clinical studies, achieve regulatory approval, and manage the two Phase 1 clinical studies. This enduring partnership enabled us to develop a deep understanding of the client’s product and closely aligned our efforts with their objectives.
Our team worked closely with the client, reviewing the available preclinical and clinical data, discussing design features, including the target patient population, eligibility criteria, primary and secondary endpoints, and the statistical plan. We then helped prepare the meeting request and the meeting package.
Results
With well-defined questions and scientifically robust supporting information in the meeting package, FDA was able to evaluate the adequacy of the non-clinical and clinical data, and provide specific feedback and guidance in their written response.
The EffPha team revised the clinical protocol based on the Agency’s recommendations. As a result, the proposed Phase 1b/2 study successfully obtained approval from both the FDA and the Taiwan Food and Drug Administration (TFDA), thus ensuring a smooth pathway to the next clinical phase.