ABOUT VERISTAT, INC.
Veristat, a scientific-minded global clinical research organization (CRO), enables sponsors to solve the unique challenges associated with bringing cell and gene therapies to market. With experience in supporting over 100 cell and gene therapy trials, including the first gene therapy approved in Europe, Veristat is adept at strategy and execution across this complex clinical development pathway.
Veristat understands how high the stakes are with cell and gene therapy programs and that each therapy is unique, often coming with a complicated regulatory approval process and therapeutic challenges. We offer tailored solutions 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 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
- Long-term follow-up strategies to meet global regulatory requirements
The complexities of developing cell and gene therapies requires a committed and experienced partner. Veristat has assembled an extraordinary team of scientific experts worldwide who have mastered therapeutic development intricacies in this specialized area. Whatever the study’s unique considerations – patients, products, process, follow-up, regulatory – Veristat can successfully get you through it. For more information, visit www.veristat.com.
Comparability studies are a significant issue for those working in biotherapeutics development. Consider these factors when playing the comparability game in biotherapeutics development.
While improving patient safety measures, learn how MDR’s Article 117 is causing implications for manufacturers, as they must fulfill a significant set of additional requirements.
When developing a new therapy for a rare disease, learn why a thoughtful, strategic approach early in the development process supports a well-designed study and agreement to your approach from regulatory authorities.
Listen as members of Veristat’s regulatory team bring to light the invaluable contributions and responsibilities of the Regulatory Project Manager, known for their problem-solving mindset.
Listen as members of Veristat’s Regulatory team delve into the analytical and clinical science of biosimilars and their regulatory pathway.
In this podcast, Kevin Hennegan, Veristat’s Director of North American Regulatory Affairs, takes us through the many nuances key to the success of an Emergency Use Authorization application.
Hear members of Veristat’s Regulatory team guide listeners through several publishing best practices to consider when planning your marketing application.
Listen as members of Veristat’s regulatory team outline the fundamentals— and the pitfalls— as you determine your readiness to file an Investigational New Drug (IND) from a manufacturing perspective.
Listen as members of Veristat’s regulatory team shed light on orphan drug designation classifications and the strategic use of subsets in study design.
Listen as Rachel Smith, Portfolio Director at Veristat, reviews considerations for setting up Natural History studies and the value they bring to rare and ultra-rare clinical research, despite the challenges in their design.
Listen as we replay some of Ewan Campbell’s insights from a recent webinar where Ewan provides a historical recap of the approved cell and gene therapy treatments over the past decade along with insights on where we are headed.
Listen as Robin Bliss describes the appropriate execution of PROs using clearly defined endpoints, measurable changes within context to the indication and disease progression, and several other key considerations for deployment in cell and gene therapy studies.
Administering advanced therapy products during a clinical trial can bring about many unique circumstances. Listen as Rachel Smith discusses Convection Enhanced Delivery (CED) which delivers medicines directly into the brain. Learn how to prepare for its challenges and what it can mean for patients, clinical teams, and sponsors.
Listen as Ewan Campbell, Advanced Therapy and Biotech Director for Veristat outlines some of the unique challenges faced when developing advanced therapies and shares some of his experience gained in neurodegenerative disease studies over the past 20 years.
Listen as Kevin, North American Regulatory Affairs Director for Veristat, identifies some of the key components of a cell & gene therapy marketing application in the US and EU, and outlines several of the most common pitfalls and gaps that he has encountered with sponsor applications.
The pros, cons and future of allogeneic versus autologous therapies are explored as Rachel Smith, Portfolio Director for Veristat, shares her observations on the impact of these techniques on advanced cell-based therapies and what the next decade may hold.
Rachel Smith, Portfolio Director for Veristat, discusses the three types of post-marketing requirements that can be requested by the EMA and draws upon the recently approved therapies – Tecartus, Zolgensma and Libmeldy, Skysona and Abecma– for real-world context.
Robin Bliss, PhD, and VP of Strategic Consulting for Veristat, takes us through the how-to’s of selecting appropriate endpoints for an early phase study, the importance of considering endpoints in the context of clinical meaning, and the value of ensuring that endpoints are measurable within a reasonable amount of time.
Mariana Oviedo, Project Manager for Veristat, provides an overview of the key items that must be taken into consideration when designing and running a long-term follow-up study for a gene therapy product.
Hear from Rachel Smith, Portfolio Director for Veristat, as she uses our recent work with a biotech company to illustrate the importance of a comprehensive shipping and traceability strategy, tight management of the patient journey, and adoption of a well-conceived protocol and process documentation to support the commercialization strategy.
Rachel Smith, Portfolio Director for Veristat, takes us through a number of pitfalls to avoid when planning a gene therapy study. With the stakes high and having conducted trials for the first gene therapy approved in Europe, put Rachel’s lessons learned to work when determining your regulatory pathway, logistics strategies and donor screening requirements.
Listen as Kevin Hennegan, Senior Regulatory Strategist for Veristat, shares some of the common hurdles drug developers face when bringing cell therapies to market including international regulatory variability, patient safety assurance, planning for long-term follow-up and more.
134 Turnpike Road, Suite 200
Southborough, MA 01772
Contact: Lauren Willis
Explore some of the key takeaways from the Tufts CSDD Roundtable on quantifying the value proposition of decentralized clinical trial deployments.
Consider these key points when deciding if a functional service approach could better serve a clinical team and their study.
Discover how this terminology change will require the investment of time and resources to deliver its full potential.
Explore how effectively managing the publishing of documents required for a marketing application submission can help accelerate the time it takes to bring your product to market.
In this blog, explore both autologous and allogeneic approaches, the solutions needed to optimize the development processes for commercial viability, and the future landscape of cell therapies in the rare disease space.
Read this webinar presentation as panelists share lessons learned and recommendations for designing protocols that enable flexibility in your virtual trials’ conduct.
Today, the shift and the changes in how we work has affected how clinical trial monitoring is conducted and performed. Explore how re-tooling the clinical monitoring in clinical trials has become imperative.
The recent FDA guidance entitled "Human Gene Therapy for Neurodegenerative Diseases" (ND) provides recommendations for Sponsors who are developing human gene therapy (GT) products for neurodegenerative diseases, which affect adult and pediatric patients. It focuses on considerations for product development, preclinical testing, clinical trial design and marketing approval pathways. This article outlines several areas to consider when preparing for regulatory agency interactions.
Discover how a European multinational pharmaceutical company gained support for several international studies to test the efficacy, tolerability, and safety of its RBD dimer recombinant protein vaccine for SARS-CoV-2.
Learn how a clinical-stage biopharmaceutical company was able to reach a unanimous decision after a safety review committee data review meeting to close Phase II and advance to Phase III.
Discover how a clinical-stage biotechnology company was able to successfully file its IND submissions and complete CSR publishing tasks, in addition to creating a synchronized team.
Learn how to navigate the complex challenges of accelerating therapies through clinical development to regulatory approval and commercialization.
Learn how the clinical trial design and the statistical foundation of the special protocol assessment (SPA), which helped drive to regulatory agreement, was transformed in this case study.
In this case study, delve into how the team used intratumor RECIST (itRECIST) criteria as the solution to measuring the effectiveness of a novel cancer therapeutic.
Most complex studies are considered challenging, but not impossible. Learn from a collective of experts on how to create successful decentralized clinical trials.
Orphan Drug Designation: The Considerations, The Rewards, And How They Differ Between The US And Europe
The National Institutes of Health (NIH) estimates that 1 in 10 Americans are affected by a rare disease or condition. Find out the challenges and regulatory framework for rare disease in this webinar.
Explore the challenges of designing and running an extraordinary complex natural history study - with both retrospective and prospective data – which then had to pivot to virtual patient visits mid-way through the data collection process.
In this webinar experts explore how to develop your marketing application strategy, analyze the benefits and risks associated with your data migration strategy and coordinate with the medical writing team so that all the information needed to write and complete the modules of the submission is provided with adequate time for review and quality control.
Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a new drug or biologic product. But, are you ready? In this webinar, experts explore the minimum required content for an IND submission and the strategic considerations for developing more than the minimum necessary data before filing an IND.
Nothing is standard about the study design, study conduct or the regulatory process in cell and gene therapy trials. Every cell and gene therapy is different due to the specific characteristics of each product, with a complicated regulatory approval process and unique therapeutic challenges. In this webinar, participants will learn an end-to-end approach to bringing a cell and gene therapy to market.
- Enhancing Trial Efficiency With Thoughtful Database Design
- Autologous Vs. Allogeneic Cell And Gene Therapies
- Shortening Development And Approval Timelines For Novel Medicinal Products
- Lessons Learned For Better Planning Of Decentralized Clinical Trials
- Similarities And Differences Between The CTA And IND
- When And Why To Hold A Pre-IND Meeting With FDA
- Guidelines For Response Criteria For Use In Oncology Trials
- What Is An IND And Why Do I Need One?
- The DCT Continuum: Finding The Right Model And Right Fit For Small And Mid-Size Sponsors
- FDA Meeting Types: Timing, Purpose & Examples Of Type A, B & C Meetings With CDER And CBER
- FDA Expedited Pathways
- The Time For Virtual Trials Is Now
- Considerations For Natural History Studies
- Benefits Of A Central Site Model
No two new drug applications (NDAs) or marketing authorization applications (MAAs) are the same. Learn the key strategies that can be implemented to propel even the most complex submissions to successful regulatory conclusions.
- Running Successful Clinical Programs Using A FSP Model
- Solving Challenges With Customized DCT Solutions
- CRO Of Choice For Cell And Gene Therapies
- Expert Regulatory Filings To See Your Regulatory Strategy Through
- Endocrine & Metabolic Expertise To Enable Your Success
- NDA/MAA Preparation Survival Guide: Overcoming Data Analysis Hurdles
- Bringing Life-Changing Therapies To Patients Everywhere
- Regulatory Consulting & Planning For Clinical Development Success
- NDA/MAA Preparation Survival Guide: Managing Operational Complexities
- NDA/MAA Preparation Survival Guide: Three Guiding Principles
- Think Bold. Think Scientific. Think Veristat.
- Bring More Confidence To Your Post-Marketing Pharmacovigilance And Safety Surveillance
- The Importance Of A Trusted Pharmacovigilance Partner
- Bold Thinking Overcomes Oncology Clinical Development Challenges
- Bold Thinking And Scientific Strategies To Treat Rare/Ultra-Rare Diseases
- Gene Therapy: Creative Solutions For Complex Clinical Development Pathways
- Roadmap To Market For Cell And Gene Therapies