7:39 AM
Jan 08, 2019
 |  BC Extra  |  Politics & Policy

Gottlieb describes innovation office, biosimilars policies at JPM

Editor's Note: This article was updated on Jan 08, 2019 at 1:52 PM PST

FDA Commissioner Scott Gottlieb described plans to create a new office dedicated to advancing innovation in drug development, and telegraphed upcoming initiatives aimed at facilitating competition from biosimilars and generic drugs in remarks delivered to the J.P. Morgan Healthcare Conference.

Forthcoming guidance will include a structured application for biosimilars manufacturers to seek designations that their products are interchangeable with original biologics, Gottlieb said. The lack of guidance has prevented sponsors from seeking interchangeability.

The agency is also looking for ways to legally allow interchangeable biologics and biosimilars to be compared to biologics that are sourced outside the U.S. if the original biologics are identical to those sold in the U.S., Gottlieb said. This could dramatically reduce the cost of developing interchangeables and biosimilars, as procurement of reference biologics for analytical tests and clinical trials constitutes a major portion of development costs.

The proposed Office of Drug Evaluation Science is part of a larger effort to “change the whole contour of how we do drug review,” Gottlieb told the J.P. Morgan conference.

Gottlieb described the proposed new office in an interview Monday with BioCentury. It will, he said, create tools that would make it less expensive and risky to create new drugs. “The whole reason the cost of drug development is high is that the science of prediction is costly and uncertain. We think these tools can help us better define the science of prediction.”

The Office of Drug Evaluation Science, which would have an initial staff of about 51, would be located in the Center for Drug Evaluation and Research’s Office of New Drugs. It would have divisions dedicated to promoting the development and implementation of clinical outcome assessments, biomedical informatics and safety analytics, and biomarker development.

The office would focus FDA resources on the development of tools that sponsors can use to develop drugs, and also on creating tools for FDA to improve its review activities, Gottlieb told BioCentury.

“We believe the time has come to make the science of drug development a more formal scientific discipline within the new drug approval process, along with the components that it comprises.”

The initiative aims to make tools such as patient-reported outcomes and biomarkers “a much more formal part of drug development and review, make our approach to these tools much more structured and disciplined, and to elevate these components as formal elements of the drug development and review process.”

Under the proposal, the new office would start out with 11 staff dedicated to biomarkers. They would create more structured processes for the agency to evaluate the use of biomarkers in drug applications, provide advice to drug reviewers and help FDA develop policy guidance. The new Division of Research and Biomarker development would have oversight of the Biomarker Qualification Program, and work with drug developers, academic researchers and patient advocates to develop biomarker standards.

The increased focus on biomarkers reflects scientific advances, Gottlieb said. “Finally, the science is becoming more rigorous, so we have an opportunity to understand biomarkers much better and their predictive value, given the better scientific tools we have now. This creates an opportunity for a much more structured approach to evaluating biomarkers with a new and more rigorous process.”

The Division of Biomedical Informatics and Safety Analytics, with an initial staff of 18, would create tools and provide services that are intended to help clinical reviewers make data-driven decisions.

“The first place where we’ll be building a structured approach to data evaluation will be on the safety data we get, where we are building a standardized tool for capturing and formatting safety data we get so that we are doing a much more structured and consistent review of safety data across all drug programs,” Gottlieb said.

The goal, according to Gottlieb, is to support the transition to a revamped drug review process. “Applications will be cloud based and instead of taking the sponsors charts and tables and evaluating their charts and tables, we’ll be pulling down their bottom line data and formatting it through our own assessment tools and creating our own charts and tables to do the evaluation.”

The Division of Clinical Outcomes Assessments in the new office would have oversight over FDA’s Clinical Assessment Outcome Assessment Qualification Program, a program that assesses and qualifies patient-focused endpoints.

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