Regulatory considerations from former FDA regulators

In this infographic, we’ve compiled some common questions our ex-FDA experts get asked when helping customers build their cell and gene therapy strategy.

Creating an effective cell or gene therapy communications strategy

In this infographic, we have outlined some engagement activities that can enhance your cell or gene therapy development and inspire your stakeholders.

CMC Considerations for Gene Therapy and Regenerative Medicine Studies

The unforeseen challenges with clinical trial execution in gene therapy and regenerative medicine studies, such as unchanging FDA regulations, discussed

Establishing Manufacturing Controls: A Hurdle for the Cell and Gene Therapy Industry

The State of Germline Gene Editing. What We Don’t Know!

Regenerative Medicine versus Regenerative Medicine Therapies versus Regenerative Advanced Therapy, What is the Difference?

Qualification as a Step Toward Assay Validation for CBER Regulated Cell and Gene Therapy Products

Updates on Regenerative Medicine Advanced Therapy (RMAT) Designations

Points to Consider for Manufacturing Biologics at the Clinical Site

Benefits of Identifying Critical Quality Attributes, and Correlating the CQAs with Clinical Outcomes for Biologic Products

Points to Consider for Establishing Biotechnological/Biological Product Comparability

Points to Consider When Designing a Biologics Manufacturing Facility, Planning for Success Early On!