INSIGHTS ON CELL & GENE REGULATORY ISSUES

• Microbiology And More — Unleashing The Power Of The MODA-EM Solution

  Nikon CeLL innovation Co (NCLi) needed an IT solution for environmental monitoring in their new cell and gene therapy facility. With a single IT system, they could minimize investment and maximize efficiency, quality and safety.

• The Importance Of Keeping DSMBs Independent

  DSMBs are supposed to be independent of the party who is conducting the research. This blog outlines when a sponsor or CRO can enlist a DSMB’s help, and why DSMB independence is critical to a successful study.

• High Stakes Change Management: Remediation Post FDA Warning Letter

  The overall combination of traditional project management combined with problem framing, variable control, and reflection provide the best chances to deliver high stakes change successfully without cultural damage.

• Research Equity and Enrolling Non-English Speakers

  Facilitating enrollment of individuals with limited English proficiency (LEP) gives the research community an important chance to foster clinical trial diversity and inclusion. However, careful forethought is needed to anticipate logistical challenges and balance the importance of fostering diversity with the costs of translation services

• Advarra In Conversations With... Digital Health Regulation

  In this Advarra In Conversations With... podcast episode, Advarra’s Vice President of Research Services & Strategic Consulting, James Riddle, is joined by Advarra IRB Chair, Luke Gelinas, in an enriching discussion on digital health and regulation in clinical trials. 

• Understanding International Data Transfer’s Impact

  The landscape of data privacy is certainly dynamic and, at times, imposing. In particular, transferring data across borders can be difficult to navigate. Does your journey to responsible and compliant data governance seem daunting? This blog post explores some of the data privacy implications and their impact on research.

• Navigating Analytical Requirements For GMP Viral Vectors

  The keys to success are establishing appropriate strategies and fundamental testing, expecting additional regulatory requests, preparing for assay variability, and ensuring that comparability studies will be possible by retaining material from preclinical batch runs and stability studies.

• Building A Bridge Of Equivalence To Facilitate And Implement Rapid Process Changes In Gene Therapy Manufacturing

  A clear path for establishing equivalency is needed to facilitate more rapid advances in the gene therapy field and ultimately to enable lower-cost gene therapies that reach patients faster than ever.

• Achieving Cell And Gene Manufacturing Scalability: A Conversation With AVROBIO’s Geoff MacKay

  Geoff MacKay, president and CEO of AVROBIO, talks with The Business of Biotech podcast about the scale up obstacles facing the cell and gene therapy space and how AVRO is working to tackle them.

• New Therapies Require A New Approach To Regulatory Interactions — A Discussion With bluebird bio’s Scott Cleve

  bluebird bio's Scott Cleve recently sat down with The Business of Biotech to talk about shifting regulatory standards and how pharmas can adapt how they engage with regulators.