Veristat Joins the Alliance for Regenerative Medicine (ARM) to Help Address Critical Issues Impacting the Advanced Therapy Sector

SOUTHBOROUGH, Mass.--(BUSINESS WIRE)-- Veristat, LLC, the Science-First Full Service CRO and Consultancy, announced it has joined the Alliance for Regenerative Medicine (ARM), the leading international advocacy organization championing the benefits of cell and gene therapies for patients, healthcare systems, and society. The announcement falls the week before members of Veristat’s Executive team are attending ARM’s Cell & Gene Meeting on the Med (#MeetingOnTheMed) being held in Rome, Italy.

“Advanced therapies have proven themselves as holding numerous benefits for patients struggling with rare and ultra-rare diseases, areas that account for 35% of our work,” stated Patrick Flanagan, Chief Executive Officer of Veristat. “Veristat is proud to have supported the development of the first gene therapy approved in Europe. As the transformative potential of advanced therapies continues to evolve scientifically and therapeutically, we are excited to join with ARM, and together champion a roadmap that removes barriers in clinical, regulatory, and reimbursement to expand access for patients.”

ARM represents more than 475 members across 25 countries, including emerging and established biotechnology companies, research institutions, and patient organizations. ARM’s mission centers on enabling the development of advanced therapies and the modernization of healthcare systems so that patients benefit from durable, potentially curative treatments.

“A key measure of Veristat’s success over our 30 years in business is how effectively we accelerate the pathway for advanced therapy innovation, which is significantly different from conventional drug development frameworks,” stated John Balser, Ph.D., Veristat’s Founder, President, and Chief Statistical Officer. “I am pleased we have joined with ARM to help bring the design, conduct, analysis, and regulatory submission of clinical trials current with the progress of science.”

Veristat experts use Science-First (#Veristat) thinking across its integrated clinical, biometrics, regulatory, and post-marketing capacities to solve problems, set strategies, map contingencies, and advance clinical trials for rare and complex advanced therapies.

In the last five years, Veristat has directly supported:

• 350+ rare/ultra-rare disease clinical trials and consulting projects
• The preparation of 40+ rare disease-related marketing applications
• 100 clinical trials and consulting projects for rare cancers
• 130+ cell and gene therapy clinical trials and consulting projects

“We are delighted to welcome Veristat as a member, bringing their scientific expertise to the organization as we envision a future in which more innovative therapies are brought to market for the benefit of patients,” stated Laura Stringham, VP of Membership & Events at ARM.

About Veristat

Veristat is the Science-First CRO™ and Consultancy that integrates full service clinical trial execution, regulatory affairs and safety, and strategic advisor services to rapidly advance the development, approval, and commercialization of advanced therapies (#AdvancedTherapies) around the globe. With 30 years of experience solving sponsors’ unique and complex clinical, statistical, and regulatory challenges, Veristat Science-First experts deliver timely, quality-driven results with solutions that are tailored to the needs of patients, clinical trial sites, regulators, sponsor teams, and key stakeholders.

Veristat’s focus on novel drug development has led to success when handling any unknown that arises, from the simplest to most complex, across numerous therapeutic areas including rare/ultra-rare disease, advanced therapies, oncology, and biologics including cell and gene therapies (#cellandgenetherapy), enabling sponsors to succeed in extending and saving patients’ lives. Sponsors collaborate with Veristat Science-First experts who care— like they do. It is not just business for Veristat, it’s personal.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240403994873/en/