Cell & Gene Therapy
Access new resources for advanced therapy development, from candidate identification through market authorization.
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Americas
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Asia & Oceania
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A-I
J-Z
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Regions
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Americas
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Asia & Oceania
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Europe
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Middle East & Africa
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Americas
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Asia & Oceania
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Europe
Europe
- Adriatic
- Belgium
- Bulgaria
- Czech Republic
- Deutschland
- España
- France
- Greece
- Hungary
- Ireland
- Israel
- Italia
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
SOLUTIONS
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Research & Development
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Real World Evidence
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Commercialization
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Safety & Regulatory Compliance
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Technologies
LIFE SCIENCE SEGMENTS
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THERAPEUTIC AREAS
- Cardiovascular
- Cell and Gene Therapy
- Central Nervous System
- GI & Hepatology
- Infectious Diseases and Vaccines
- Oncology
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Impacting People's Lives
"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
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Harness the power to transform clinical development
Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
Research & Development OverviewResearch & Development Quick Links
Real World Evidence. Real Confidence. Real Results.
Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.
REAL WORLD EVIDENCE OVERVIEWReal World Evidence Quick Links
See markets more clearly. Opportunities more often.
Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
COMMERCIALIZATION OVERVIEWCommercialization Quick Links
Service driven. Tech-enabled. Integrated compliance.
Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
COMPLIANCE OVERVIEWSafety & Regulatory Compliance Quick Links
Intelligence that transforms life sciences end-to-end.
When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
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COMPLIANCE, SAFETY, REG PRODUCTS
BLOGS, WHITE PAPERS & CASE STUDIES
Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
DISCOVER INSIGHTSTHE IQVIA INSTITUTE
An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
SEE LATEST REPORTSFEATURED INNOVATIONS
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IQVIA Connected Intelligence™
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IQVIA Healthcare-grade AI™
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IQVIA AI Assistant
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Human Data Science Cloud
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IQVIA Innovation Hub
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Decentralized Trials
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Patient Experience Solutions with Apple devices
WHO WE ARE
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NEWS & RESOURCES
Unlock your potential to drive healthcare forward
By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.
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IQVIA AI is Healthcare-grade AI
Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.
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Meet the IQVIA AI Assistant
Your new expert analyst is here. Be at the forefront of data-driven decision-making with a new generative AI tool that enables you to interact with our products and solutions like never before. Get results you can trust, faster.
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Your healthcare data deserves more than just a cloud.
The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
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Innovations make an impact when bold ideas meet powerful partnerships
The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.
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Proven, faster DCT solutions
IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.
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IQVIA Patient Experience Solutions with Apple devices
Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm.
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Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.
LEARN MORELIFE AT IQVIA
Careers, culture and everything in between. Find out what’s going on right here, right now.
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WE’RE HIRING
"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.
SEARCH JOBSWhite Paper
Making the Move: Bringing Cell and Gene Therapy Development Programs to the United States
Aug 27, 2018
Cell and gene therapies (CGTs) represent the next great wave of therapeutic innovation and have led to the development of promising therapies worldwide. While a few of the initial therapies have received marketing approval in the United States (U.S.), there are a number of promising therapies in development outside of the U.S. As these therapies advance through preclinical and clinical development, many companies are considering if, when, and how they should bring their therapies to the U.S. to unlock the commercial potential of the world’s largest biopharmaceutical market.
The unique aspects of each therapy, along with the rapidly changing regulatory environment, have led to a variety of development options. Sponsors considering bringing CGTs to the U.S. at various points during preclinical and clinical development must take into consideration the variety of potential implications to their development plan, including impact on development cost, timeline, feasibility and ability to leverage existing data.
This whitepaper summarizes the process and considerations for bringing a preclinical or clinical state CGT to the U.S. for development towards a successful submission of an Investigational New Drug Application (IND). By understanding the implications of each of the core components of an IND submission. CGT companies will be prepared to navigate the potential complexities of the U.S. regulatory and drug development landscape.
Leveraging a collaborative regulatory process
Before bringing investigational therapies to the U.S., ex-U.S. CGT companies should first determine how to navigate the U.S. regulatory approval process and successfully submit an IND. The U.S. Food and Drug Administration (FDA) has established a collaborative regulatory process for CGTs with early and regular engagement with the Sponsor, as well as special regulatory designations useful for many CGTs. Specifically, to support the development of CGT products to reach regulatory milestones in the U.S., the FDA offers increased interaction and collaboration with the Sponsor leading up to the submission of an IND while the special regulatory designations described later in the paper can allow for more frequent interactions with the FDA during the clinical phase of development.
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Related solutions
Functional Services
Decrease clinical development costs and increase study quality using our global functional resources and flexible services, and get more value from your R&D spend.