Cell and Gene Therapy – Center of Excellence
Cell and Gene Therapy (also known as Advanced Therapy Medicinal Products or ATMPs) holds the promise to deliver transformative outcomes in a wide array of hard-to-treat diseases. Unfortunately, so far most have failed in development and few have been successful in the marketplace.
Our Cell and Gene Therapy – Center of Excellence helps clients around the world accelerate their novel, advanced therapeutic products to market. Our team commands more than 25 years of experience delivering unique lifesaving treatments to market in both EU and US regulatory environments. We have a diverse talent pool of technical, scientific, and regulatory professionals to support you across the full development life cycle with the aim to bring products to patients effectively and efficiently through clinical trials and marketing authorization.
At ProPharma Group, our approach is to begin with the end in mind. We identify potential challenges and help craft strategies and solutions before you are confronted with them during a regulatory assessment.
Guidance and Services for Cell and Gene Therapy
There are many FDA/EMA regulatory, technical, and scientific challenges that can significantly impact the successful outcomes in product development for cell and gene therapies.
- Classification advice – is your product a CGT/ATMP, a medical device, or a combination?
- Assessment/gap analysis of data packages against IND requirements or EU requirements for Clinical Trial Applications (CTA)
- Consulting on appropriate development strategies (e.g. biodistribution, tumorigenicity, orphan designations)
- Data summary and document writing (e.g., IMPD, IB)
- Clinical Trial Applications, including genetically modified organism (GMO) applications
- Preparation for Agency discussions with FDA and EMA
- FDA and EMA classification and certification procedures for CGTs/ATMPs
- Regulatory aspects of grant applications
- Clinical investigations for biomaterials
While the science, regulation, and clinical use of cell and gene therapy evolves, companies need a partner that can define appropriate development strategies to manage the ever-changing regulatory environment and anticipate what will be required in years to come.
A Global Team Bringing Broad and Deep Expertise in Cell and Gene Therapy
Our Cell and Gene Therapy – Center of Excellence nurtures a think tank of Cell and Gene Therapy experts. We offer more than hiring just one expert resource with access to a full team of industry experts. Through our team, we provide a comprehensive suite of integrated services and solutions to advance products faster while maintaining the highest standards of compliance. Our team’s expertise supports you throughout the full lifecycle of cell and gene therapy product development from early-stage concept development through commercialization.