Versterking van het trackrecord van succesvolle resultaten voor de goedkeuring van de regelgeving door klanten

SOUTHBOROUGH, Mass. – (BUSINESS WIRE) – Veristat, een wetenschappelijk ingestelde wereldwijde klinische onderzoeksorganisatie (CRO), heeft vandaag aangekondigd dat ze de marketingaanvragen voor 10% van de nieuwe geneesmiddelengoedkeuringen van de Amerikaanse Food and Drug Administration (FDA) in 2020 ondersteunden. De FDA keurde 53 nieuwe geneesmiddelen goed, door de FDA gedefinieerd als New Molecular Entities (NME’s) i, en Veristat-experts op het gebied van regelgeving, statistiek en medisch schrijven waren een integraal onderdeel van de voorbereiding van vijf van deze NME New Drug Applications. Veristat heeft ook NDA / BLA’s opgesteld voor drie niet-NME FDA-goedkeuringen en één Marketing Authorization Application (MAA) die in Europa is goedgekeurd.

“Ondanks de wereldwijde uitdagingen in 2020, bleef Veristat zijn missie om klanten te helpen bij het verkrijgen van wettelijke goedkeuring van nieuwe medische therapieën, verder uitwerken”, aldus Patrick Flanagan, Chief Executive Officer bij Veristat. “Nu, meer dan ooit, is Veristat gericht op het bieden van deskundige begeleiding om de snelle goedkeuring van therapieën te vergemakkelijken die het leven van patiënten en hun families over de hele wereld verbeteren.”

Veristat Supported Marketing Applications for 10% of All FDA Novel Drug Approvals in 2020

Strengthening its Track Record of Successful Client Regulatory Approval Outcomes

SOUTHBOROUGH, Mass.–(BUSINESS WIRE)– Veristat, a scientific-minded global clinical research organization (CRO), announced today that they supported the marketing applications for 10% of the 2020 US Food and Drug Administration (FDA) novel drug approvals. The FDA approved 53 novel drugs, defined by the FDA as New Molecular Entities (NMEs)ⁱ, and Veristat regulatory, statistical, and medical writing experts were integral in preparing five of these NME New Drug Applications. Veristat also prepared NDA/BLAs for three non-NME FDA approvals and one Marketing Authorization Application (MAA) that received approval in Europe.

“Despite the global challenges in 2020, Veristat continued to advance its mission of helping clients achieve regulatory approval of novel medical therapies,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “Now, more than ever, Veristat is focused on providing expert guidance to facilitate the rapid approval for therapies that improve the lives of patients and their families around the world.”

Veristat has collaborated with biopharmaceutical clients around the globe to prepare more than 110 marketing applications. More than 65% of these marketing applications are for rare and ultra-rare diseases, with nearly 50% for cancer therapies. While most of these engagements were with the FDA, the Company also boasts a proven track record of success with the European Medicines Agency (EMA), Health Canada, and the Pharmaceuticals and Medical Devices Agency of Japan (PMDA).

Our project teams excel at navigating complex clinical development nuances and exploring the appropriate regulatory pathways to quickly get therapies to patients. We understand that the stakes are high when preparing a marketing application, so we have assembled a cross-functional team of statistical, medical writing, and regulatory experts adept at navigating the process of preparing, publishing, and defending marketing applications.

“What differentiates Veristat is our ability to both conceptualize and operationalize the entire pathway of development from initial evaluations of effectiveness and safety through to the primary clinical trial basis for regulatory action. We accomplish this through diligent application of scientific principles and close collaboration with our clients,” said John Balser, Ph.D., President & Chief Statistical Officer at Veristat. “In 2021, Veristat will continue to strengthen our scientific expertise, integrated team approach, and regulatory capacity around the globe so we can meet the demands of our sponsors.”

About Veristat

Veristat, a 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 26 years’ experience in clinical trial planning and execution, Veristat is equipped to support any development program. Our team has prepared over 100 marketing applications for approval with global regulatory authorities in the last ten years.

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. We apply this knowledge base every day 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. For more information, visit www.veristat.com.

ⁱ https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020

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Contacts

Veristat Contact:
Gillian Dellacioppa, Marketing Director

gillian.dellacioppa@veristat.com or +1 508-306-6336