Veristat Announces Global Cell and Gene Therapy Center of Excellence

Cell and gene therapies represent the next great wave of therapeutic innovation and have led to the development of promising therapies worldwide.

Veristat, a scientific minded clinical research organization, announced today the launch of their Global Cell and Gene Therapy Center of Excellence (COE). The COE comprises a multi-disciplinary team of scientific experts who are adept at strategy and execution across this complex clinical development pathway. Veristat's experience supporting these unique programs in the Americas and Europe enables them to implement impactful advisory and tactical services to support the challenging decisions required to advance a cell and gene therapy to market. Leveraging the learnings from the support of numerous client cell and gene therapy programs, including the first gene therapy approved in Europe, the Global COE will serve as a powerhouse for sponsors and as a mechanism to share insights, successful strategies, and best practices.

"We understand how high the stakes are with cell and gene therapy programs," stated Alecia Barbee, Executive Vice President, Operations at Veristat, "and that nothing is standard about the therapies, the studies or the regulatory processes in this specialized area. Veristat has successfully supported more than 100 cell and gene therapy projects across the entire clinical development life-cycle, and with the launch of our center of excellence, we are formalizing our processes to assist sponsors around the globe to bring these advanced therapies to market quickly."

Every cell or gene therapy is unique, often coming with a complicated regulatory approval process and unique therapeutic challenges. Even the best therapeutic may not reach patients who need it if the study design and execution are not optimal. Veristat offers tailored solutions across the entire clinical development pathway to combat these challenges, including:

• The ability to develop your therapeutic with accelerated approval pathways and/or special designations
• A review of operational aspects of the protocol and feedback on any potential obstacles/challenges that could impact the protocol execution at the clinical research sites
• Novel strategies including implementation of a centralized site model and remote monitoring with direct-to-patient capabilities
• Expertise in logistics and handling of live cellular material
• Development of bespoke regulatory strategies for the type of cell and gene therapy and the unmet clinical need acceptable to the regulatory agencies
• Long-term follow-up strategies to meet global regulatory requirements

"The challenges of developing cell and gene therapies requires a committed and experienced partner," stated Patrick Flanagan, Chief Executive Officer at Veristat. "Cell and gene therapies offer uniquely curative potential for disorders that are intractable to other treatment modalities. They can save lives. The challenge now is to scale the opportunity they offer to their full potential. Our years of experience in this specialized area and reputation for success will make Veristat the CRO of choice for small and medium biopharmaceutical companies who want to bring their cell or gene therapies to patients worldwide."

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 26 years' experience in clinical trial planning and execution, Veristat is equipped to support any development program. Our team has prepared nearly 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 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.