News & Insights
“Weight of Evidence vs Carcinogenicity Testing (Part 1)” with Bruce Pearce
The ICH has released a new guidance which may allow you to forgo animal carcinogenicity testing in favor of a weight of the evidence argument. We begin our two-part discussion of why this has been added, including the goals of the addendum, on this episode of Insight at Biologics featuring expert Bruce Pearce. And, tune in next time for part 2 to find out how to go about this.
“Navigating Institutional Memory & Preserving Knowledge” with Kerin Ablashi
In this episode of Insight at Biologics, industry expert Kerin Ablashi delves into institutional memory and knowledge management in the pharmaceutical industry. Discover exactly what institutional memory is, the role it plays in regulatory compliance, operations, and product development, as well as how you can develop knowledge management systems and continuity plans to support your organization, no matter what size.
“Understanding Cell & Gene Therapy Potency Assay Development” with Diana Colleluori
In this episode of Insight at Biologics, industry expert, Diana Colleluori, explains everything that cell & gene therapy manufacturers need to know about potency assays. Learn about the definition, FDA guidances and regulations, best practices, and how to overcome the hurdles in potency assay development on this episode of Insight at Biologics.
“How To Maximize Your Product’s Potential with a Regulatory Consulting Group” with HeeSun Smaldore
On this episode of Insight at Biologics, HeeSun Smaldore, Business Unit Lead, shares some helpful thoughts about the intricacies of deciding when to hire an outside consultant.
“Understanding The IND Review Process” with Dr. Emily Place
On this episode of Insight at Biologics, Senior Consultant and industry expert Dr. Emily Noonan Place from Biologics Consulting chats with James Taylor about IND submissions and the review process. The fact is that the regulatory agency doesn't get a lot of time with your IND submission. How, then, does one optimize their IND submission to make the most of the allotted time in the review? And, how do you avoid the most common pitfalls? Find out all of this and more on this episode of Insight at Biologics.
“FDA Gap Analysis: The What, Why, and How” Featuring David Pepperl
Are you working on a drug or device submission? An FDA gap analysis can actually save you time and money by ensuring your regulatory compliance. David Pepperl explains the importance of performing a gap analysis and more in this episode of Insight at Biologics.
“What is Ex Vivo Gene Therapy, and What Regulatory Challenges do Developers Face?” Featuring Robert Kutner
Using your own cells to help you heal isn't science fiction anymore. Today, we’re diving deep into the exciting world of ex vivo cell therapy with Robert Kutner of Biologics Consulting, exploring exactly what ex vivo cell therapy is, how it helps fight rare diseases and cancer, and the regulatory disadvantages that producers face.