Business Wire

MA-VERISTAT

Share
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 .

Link:

ClickThru

Social Media:

https://www.facebook.com/VeristatCRO/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

SES Receives All Required Regulatory Approvals to Complete Intelsat Acquisition14.7.2025 22:15:00 CEST | Press release

SES received the final regulatory approvals for the SES-Intelsat transaction, including the US Federal Communications Commission. On 30 April 2024, SES and Intelsat announced an agreement for SES to acquire Intelsat for a cash consideration of $3.1 billion (€2.8 billion). The transaction was subject to receipt of relevant regulatory clearances and other relevant requirements which all have now been obtained. As a result, SES plans to close the transaction on or about Thursday, 17 July 2025. Once closing has occurred, a press release will be published to confirm that the transaction has successfully closed. Follow us on: Twitter | Facebook | YouTube | LinkedIn | Instagram Read our Blogs > Visit the Media Gallery > About SES SES has a bold vision to deliver amazing experiences everywhere on Earth by distributing the highest quality video content and providing seamless data connectivity services around the world. As a provider of global content and connectivity solutions, SES owns and ope

Loomis Sayles Celebrates 15 Years of Growth Equity Strategies Team Under Leadership of Aziz V. Hamzaogullari14.7.2025 22:05:00 CEST | Press release

Loomis, Sayles & Company: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250714614048/en/ 90.7 160 1 BILLION IN ASSETS UNDER MANAGEMENT COMBINED YEARS OF INVESTMENT EXPERIENCE INVESTMENT PHILOSOPHY GES Team As of 5/31/2025 GES Team As of 5/31/2025 Supported by a seven-step research framework Loomis, Sayles & Company proudly celebrates the 15-year anniversary of a differentiated approach to growth equity investing under the leadership of Aziz V. Hamzaogullari, CFA, the founder, chief investment officer and portfolio manager of the Loomis Sayles Growth Equity Strategies (GES) Team. Aziz is also an executive vice president and a member of the firm’s Board of Directors. GES is a cohesive team with nearly 19 years of alpha generation and a long-term, private equity approach to investing. Under Aziz Hamzaogullari’s leadership since 2010, assets under management for GES have grown from $1.9 billion to nearly $91 billion as of 31 Ma

Cessna Skyhawk Soars With Enhanced Efficiency: Solid-State Dual Electronic Ignition System Introduced to the Industry-leading Piston14.7.2025 18:00:00 CEST | Press release

The industry-leading training aircraft, the Cessna Skyhawk, now features a dual electronic ignition system (dual EIS), enhancing maintenance, efficiency and overall operation of the single-engine, high-wing piston. The dual Lycoming electronic ignition system is now standard on all new Cessna Skyhawk aircraft. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250714759359/en/ Cessna Skyhawk soars with enhanced efficiency: solid-state dual electronic ignition system introduced to the industry-leading piston (Photo Credit: Textron Aviation) The Cessna Skyhawk is designed and produced by Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company. The dual EIS replaces the previous dual magneto ignition system on the Skyhawk, incorporating advanced electronic components and reducing the number of internal moving parts to optimize operation. This solid-state electronic technology improves maintenance intervals, fuel efficiency and en

The 2025 Empire State Building Run-Up Returns Oct. 814.7.2025 17:48:00 CEST | Press release

Presented by NYU Langone Health and Powered by the Challenged Athletes FoundationLottery Opens July 14 The Empire State Building (ESB) announced today general lottery registration for the annual Empire State Building Run-Up (ESBRU) on Oct. 8, 2025, at 8 p.m. ESB also announced the ESBRU will be presented by NYU Langone Health and powered by the Challenged Athlete’s Foundation. General lottery registration will be open from July 14 through July 28, 2025. In the 47th annual Run-Up, 225 runners will race up the iconic building’s 1,576 stairs to the world-famous Observatory. This year’s heats will include elite men and women, media, celebrities, New York City real estate brokers, building tenants, CAF athletes, members of the NYPD and FDNY, and the public, among others. On July 30, registered runners will be notified of their race status with participation costs of $175 per runner to be charged only upon acceptance from the lottery. “We are delighted to welcome NYU Langone Health as our ne

Taicang: A Model for China-Europe ESG Cooperation14.7.2025 16:11:00 CEST | Press release

Located in the Yangtze River Delta, Taicang City in Jiangsu Province is known as the “Hometown of German Enterprises in China.” At the recent 2nd Sino-European Corporate ESG Best Practice Conference, Taicang received the prestigious “Zero-Carbon City” Best Practice Award, further solidifying its reputation as a benchmark for green urban transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250714458209/en/ A glimpse of Taicang City, Jiangsu Province, China. According to the jury, “By integrating ESG indicators into its urban development strategy, Taicang has demonstrated visionary leadership and has become a model for sustainable city and industrial development.” In response to the global challenges of climate change and sustainable growth, Taicang has proactively aligned with China’s “dual carbon” strategy. It has positioned itself as a modern garden city driven by green development, integrating ESG principles into

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye