Consulting Services for Cell & Gene Therapy Sponsors

Get the expertise you need to effectively plan for your cell therapy clinical trial … and beyond

How do I build an allogeneic cell bank that meets the needs of my target population? What’s the best way to design, optimize and execute the clinical trial for an allogeneic or autologous cell therapy? How do we develop an allogeneic or autologous cell therapy that meets regulatory requirements in different countries?

Questions like these are common as cell and gene therapy sponsors plan for clinical trials. We have unique experience and knowledge of managing the cell therapy supply chain and the clinical aspects of cell therapies developed over our long history. Importantly, we have physicians on staff with the cell therapy expertise you need.

We’re bringing that knowledge to companies like yours through consulting services in the areas of:

• Immunogenetics and bioinformatics
• Clinical research including biorepository capabilities, pre-clinical and clinical trial design and support, and data analysis
• Quality and regulatory compliance
• Physicians with direct experience in designing and executing clinical trials in the field of cell therapy

We’ve conducted cell therapy research for decades

We conduct research and help cell and gene therapy sponsors design and execute protocols through the CIBMTR.

For investigators conducting prospective and retrospective clinical studies for autologous or allogeneic cellular therapies, the CIBMTR offers services such as:

• Trial design and management
• Statistical support
• Sample management
• Publication support

The CIBMTR has infrastructure in place for multicenter prospective Phase I-III trials and observational studies requiring statistical and/or logistical support.

For cell and gene therapy sponsors who have commercial therapies, the CIBMTR collects long-term outcomes data that can be used to meet regulatory follow-up requirements.

Our team understands global regulatory compliance is critical

Our regulatory specialists work with clients to help them overcome domestic and/or international regulatory challenges. They advise clients on developing de novo collection protocols that meet both FDA and international regulatory requirements. The team is well-versed in the U.S. regulatory requirements for cellular therapy starting material, including 21 CFR Part 1271 GTP and 21 CFR Part 211 GMP. The team is also familiar with international starting material requirements such as: European Union Directives 2004/23/EC, 2006/17/EC, 2002/98/EC and 2004/33/EC; Australia’s Therapeutic Goods Order No.108 and 109; Canadian standards CAN/CSA-Z900.1.22 and CAN/CSA-Z900.2.5.22; and Japan’s MHLW Notification No. 375 and No. 0907-3.

Examples of international regulations that our team has helped clients successfully integrate into their protocols include:

• European Directives 2002/98/EC and 2004/23/EC (European Union)
• CAN/CSA-Z900.1-17 (Canada)
• Therapeutic Goods Order No. 88 (Australia)

Our quality and regulatory specialists support the advancement of cell therapies by:

• Understanding unique product requirements and supply chain
• Identifying applicable U.S. and/or global regulatory requirements
• Consulting with clients to develop cell collection specifications that meet regulatory requirements