Veristat Supported Marketing Applications for 12% of all FDA Novel Drug Approvals in 2021

Jan 11, 2022

Bridging the Gap between Trial and Treatment by Supporting the Approval of Several Novel Therapies for Rare Diseases

Posted by Veristat, LLC

SOUTHBOROUGH, MA – January 11, 2022 – Veristat, a scientific-minded global clinical research organization (CRO), announced today that the Company supported clients in preparing marketing applications for 12% of the 2021 U.S. Food and Drug Administration (FDA) novel drug approvals. This surpasses the number of approvals supported in 2020. In 2021, the FDA approved 50 novel drugs, defined as New Molecular Entities (NMEs). 

Veristat’s bold thinking, focus, and extensive experience supporting complex drug development in rare and ultra-rare diseases significantly impacted these transformational medicines designed for patients with few or no treatment options. The work of Veristat’s innovative regulatory, statistical, and medical writing experts was vital in preparing six of these NME New Drug Applications (NDAs) and Biologics License Applications (BLAs). Veristat also prepared one supplemental New Drug Application (sNDA) for a non-NME that received FDA approval and one Marketing Authorization Application (MAA) that received approval in Europe.  All but one of these 2021 approvals are for rare diseases. 

“Throughout 2021 and in collaboration with our sponsors, we were able to successfully overcome the many scientific, regulatory, and data challenges that novel therapy research presents. We are grateful for the opportunity to have collaborated with our clients to achieve their goals and to bring novel therapies to patients,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “Despite the remarkable advances in recent years in the understanding of rare diseases and in the approval of medicines to treat them, many unmet needs of patients remain. Our work continues with efforts such as the expansion of decentralized clinical trials that bring clinical research closer to the patient’s home.”

Since the Company’s founding 27 years ago, Veristat has collaborated with hundreds of biopharmaceutical clients around the globe to prepare more than 140 marketing applications. More than 65% of these marketing applications for rare and ultra-rare diseases. While a large majority of these engagements were with the FDA, the Company also holds an impressive track record with Health Canada and the European Medicines Agency (EMA). And with the recent acquisition of European regulatory consultancy agency Drug Development and Regulation (DDR) — and with it Dr. Xavier Luria, former Head of Safety and Efficacy of Medicines at the EMA— Veristat can provide clients with a deep understanding of the EMA and other key regulators.

“Advancing complex therapies for challenging diseases is what motivates us every day,” said John Balser, Ph.D., President & Chief Statistical Officer at Veristat. “It is gratifying to know that our scientific-minded teams were instrumental in helping clients prepare these marketing applications for therapies that received approval, thereby helping to improve the lives of patients and their families. A large part of our success, and what distinguishes Veristat, is the ability of our multi-disciplinary project teams to draw the appropriate connections amongst the fundamental constructs of the science, the practical and operational requirements of the clinical program, and the regulatory pathway, that combined provide the evidentiary basis for product approval.  In 2022, Veristat will build upon our world-class biometrics, clinical, and regulatory capabilities to successfully tackle challenging diseases and meet the goals of our clients.”

About Veristat

Veristat, a scientific-minded global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 27 years of experience in clinical trial planning and execution, Veristat is equipped to support any development program.

Veristat’s focus on novel drug development has led to success when handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare disease, advanced therapies, oncology, and infectious disease trials. Every day, we apply this knowledge base to solve any clinical program’s challenges, from the simplest to the most complex. Veristat has assembled an extraordinary team of experts worldwide who have mastered therapeutic development intricacies, enabling sponsors to succeed in extending and saving lives.


Veristat Media Contact:
Lauren L. Brennan, Director of Marketing


Learn More:   Veristat’s Marketing Application Expertise

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