Vertistat Program Supports 12% of all FDA NME Approvals in 2018

Jan 8, 2019 | FDA Approval, Regulatory Findings, Vertistat

Veristat Findings

Veristat is an innovative full-service, science-focused clinical research organization (CRO) with over 20 years of experience in supporting clinical trials and regulatory submissions for pharmaceutical, biotechnology, and medical device companies. Veristat offers comprehensive clinical development services, including biostatistics, statistical programming, medical writing, clinical monitoring, project management and data management, for a single study or an entire clinical program, as well as preparation of integrated summary documents and submission-ready CDISC data for regulatory filings.

A scientifically oriented clinical development and regulatory submission partner, Veristat announced today that it supported its biopharmaceutical clients on 12% of the US Food and Drug Administration (FDA) approvals granted in 2018, a record-setting year. In 2018, the FDA approved 59 drug and biologics therapeutic submissions for New Molecular Entities (NMEs) 1. Veristat provided strategic planning as well as statistical analysis and medical writing for 12% of those approvals, including breakthrough oncology products as well as therapies for rare genetic-based disorders and infectious diseases.

Over the past 10 years, Veristat has prepared regulatory submissions for nearly 7% of all the NMEs approved by the FDA. In that time, our teams supported a total of 56 global regulatory submission projects. Of those, 40 have received approvals to date from the FDA, the European Medicines Agency (EMA), Health Canada and the Pharmaceuticals and Medical Devices Agency of Japan (PMDA) in a wide range of therapeutic areas, with many pending.

“ From our first FDA submission nearly 25 years ago, we have continued to provide our clients with collaborative strategic thinking and scientific insight into the regulatory submission planning and preparation required for submission to the FDA and other regulatory agencies,” said John P. Balser, Ph.D., President and Co-Founder of Veristat. “We are then able to implement the submission strategy through the efforts of our biometrics and regulatory medical writing divisions, providing a seamless submission process. But regardless of our successes, we never lose sight of our ultimate goal of helping our clients get therapies approved quickly to improve the lives of patients and their families.”

The FDA approvals that our clients achieved in 2018 led to new treatment options for numerous cancers, hard-to-treat bacterial infections, and other rare diseases. Approvals from 2018 included TIBSOVO®, the first and only targeted therapy for adult patients with relapsed/refractory Acute Myeloid Leukemia and an IDH1 mutation, and ONPATTRO™ (patisiran), a lipid complex injection for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

“Preparing regulatory submissions to achieve approval is a core strength for Veristat and our impact in 2018 and throughout the course of the past decade is impressive,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “As we launch into 2019, our impact will improve with the further strategic growth of our clinical, biometric, medical writing and regulatory expertise that is specifically designed to plan and run more efficient clinical trials enabling the preparation of successful marketing applications.”

Veristat delivers integrated submission preparation, full service clinical program expertise and the ability to achieve seemingly impossible deadlines. Our success lies in our ability to strategically navigate conceptually and operationally complex submissions, overcome data analysis challenges, and streamline the medical writing process with an integrated team focused on creativity, flexibility, and quality. Learn more.

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