Business Wire

Veristat Announces Global Cell and Gene Therapy Center of Excellence

Share

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Veristat Contact:
Lauren Willis, Marketing Manager
marketing@veristat.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Potential sale of HSBC SFH (France): Signing of a Memorandum of Understanding18.6.2021 15:30:00 CEST | Press release

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION HSBC Continental Europe (‘HBCE’) has today signed a Memorandum of Understanding (‘MOU’) with Promontoria MMB SAS (‘My Money Group’), its subsidiary Banque des Caraïbes SA (the ‘Purchaser’) and My Money Bank (‘MMB’), regarding the potential sale of HBCE’s retail banking business in France. My Money Group, MMB and the Purchaser are under the control, directly or indirectly, of funds and accounts managed or advised by Cerberus Capital Management L.P. The potential sale includes: HBCE’s French retail banking business; the Crédit Commercial de France (‘CCF’) brand; and, subject to the satisfaction of relevant conditions, HBCE’s 3% ownership interest in Crédit Logement, its 100% ownership interest in HSBC SFH (France) (‘HSFH’), and the transfer of rights and obligatio

UFC® Names Lumen® the Official Metabolic Tracker of the UFC Performance Institute18.6.2021 15:30:00 CEST | Press release

UFC®, the world’s premier mixed martial arts organization, has named Lumen® the Official Metabolic Tracker of the UFC Performance Institute®. To launch the new partnership, select UFC athletes will be using Lumen as a tool to optimize their performance under the guidance of the nutrition team at the UFC Performance Institute (UFC PI). These athletes will have access to real-time metabolic data to help improve their nutrition, performance, and body composition through optimizing their metabolic health and flexibility. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210618005278/en/ Dustin Poirier and Lumen (Photo: Business Wire) “The UFC PI strives to support athletes in fueling their body to achieve championship performances while also maintaining optimal health, all while meeting the weight management demands of mixed martial arts,” said Clint Wattenberg, UFC PI Director of Performance Nutrition. “Metabolic health and metabo

Sale of Retail Banking Business in France18.6.2021 15:30:00 CEST | Press release

HSBC Continental Europe (‘HBCE’) has today signed a Memorandum of Understanding (‘MOU’) with Promontoria MMB SAS (‘My Money Group’), its subsidiary Banque des Caraïbes SA (the ‘Purchaser’) and My Money Bank (‘MMB’), regarding the potential sale of HBCE’s retail banking business in France. My Money Group, MMB and the Purchaser are under the control, directly or indirectly, of funds and accounts managed or advised by Cerberus Capital Management L.P. Commenting on the Potential Transaction, Jean Beunardeau, HBCE CEO said: “This potential transaction is an important step towards achieving our strategic goal of being a leading wholesale bank in Continental Europe for Corporate and Investment Banking, Markets and Private Banking, anchored in Paris, connecting our customers to HSBC’s global network, and providing access to Continental Europe for HSBC’s customers around the world. As importantly, this potential transaction would allow HSBC’s French retail banking business to be sold to an expe

Hilton Doubles Down on Las Vegas Growth with Rapidly Expanding Portfolio and Grand Return to the Strip18.6.2021 15:07:00 CEST | Press release

After revolutionizing the Las Vegas hospitality experience decades ago, Hilton is building on its storied legacy in time for the return to travel by almost doubling its presence in the sought-after global destination over the past three years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210618005335/en/ Resorts World Las Vegas – Exterior (Photo: Business Wire) The company is slated to have more than 30 hotels and over 11,000 rooms across 12 brands in the market by the end of 2021. On the heels of Virgin Hotels Las Vegas, CurioCollection by Hilton’s June opening celebration, and just weeks before the anticipated debut of Conrad Hotels & Resorts, LXR Hotels & Resorts and Hilton Hotels & Resorts at the integrated Resorts World Las Vegas complex, Hilton is making an epic return to this top-tier travel destination, bringing new premium and luxury brands to the Strip. “Hilton helped create the Las Vegas we know today – the ente

Toshiba's Chairperson of the Board of Directors Issues Open Letter to Its Shareholders18.6.2021 11:06:00 CEST | Press release

Toshiba Corporation (TOKYO:6502) today announced that Osamu Nagayama, Chairperson of Toshiba’s Board of Directors, has issued an open letter to the company's shareholders. The full text of the letter is as follows: Dear Shareholders As the Chairperson of the Board of Directors of Toshiba Corporation ("Toshiba", the "Company"), I would like to express my deep regret regarding recent unacceptable events at the Company which have eroded your trust in us. You would have seen that we have already taken decisive and immediate action following the release of the Investigation Report, amending the slate of nominees for directors, committee members and executive officers ahead of the upcoming AGM on June 25. I, together with the Board, am fully committed to ensuring we improve your Company's governance fundamentally and enhance its corporate value. United, we shall be taking the following concrete steps with urgency: In order to stop recurrence, we will conduct an inquiry, with third party part

ISAE-SUPAERO Launches an App to Measure the Climate Impact of Aviation18.6.2021 10:30:00 CEST | Press release

While a referendum to include environmental protection in the Constitution could be held by the end of Emmanuel Macron's five-year term, climate protection initiatives are multiplying. To contribute to the debate, ISAE-SUPAERO is launching CAST: an innovative app that allows everyone to assess the climate impact of aviation by including all phases of the life cycle. A unique app that highlights the real carbon impact of aviation Thomas Planès, a doctoral student at ISAE-SUPAERO, has been working on this project for over a year as part of the CEDAR (*) eco-design research chair. Today, his research has resulted in a modeling tool that takes the form of an open access app. The CAST (Climate and Aviation - Sustainable Trajectories) tool allows anyone to estimate the impact that air transport will have on the climate up to 2050, depending on variables such as traffic volume, fuel consumption per passenger-kilometer, or the decarbonization of the fuel used. In addition to CO2 emissions, it

Ferrari Selects AWS as its Official Cloud Provider to Power Innovation on the Road and Track18.6.2021 08:30:00 CEST | Press release

Today, Amazon Web Services, Inc. (AWS), an Amazon.com, Inc. company (NASDAQ: AMZN), announced that it has entered into an agreement with Ferrari S.p.A. to become their Official Cloud, Machine Learning, and Artificial Intelligence Provider. Together, the companies will accelerate the pace of innovation across the entire Ferrari organization, including their road cars department, GT Competitions, the Ferrari Challenge, and the Scuderia Ferrari FORMULA 1 (F1) team. Ferrari will use AWS’s breadth and depth of services and proven global infrastructure, including the AWS Europe (Milan) region, to streamline design and testing of its cars, giving customers the most exciting driving experiences possible. In addition, Scuderia Ferrari will leverage AWS to launch a digital fan engagement platform, via its mobile app, to engage hundreds of millions of fans worldwide with exclusive, personalized content. This press release features multimedia. View the full release here: https://www.businesswire.c