Industry Insights

1. FDA Introduces Quality Management Maturity Program 9/26/2023

   The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.

2. How To Lose A Batch In 10 Days 9/25/2023

   Inspired by the rom com How to Lose a Guy in 10 Days, this article spotlights the critical missteps that could lead you to lose a batch during the manufacturing process. By identifying these pitfalls, the author guides you toward best practices that will not only save your batches but also improve the quality, efficiency, and reliability of your operations. 

3. The Regulatory Genome: “Digital Software” For Drug Development 9/22/2023

   Next-generation sequencing (NGS) has allowed the industry to uncover all aspects of genomic activity, including the 98% of the traditionally unexplored genome, now known as the regulatory genome. Let's explore RNA as "digital software" for drug development, a look beyond NGS, and the role of long-coding RNAs in particular.

4. Understanding The FDA’s Current Focus On Risk Evaluation And Mitigation Strategies 9/21/2023

   The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios.

5. Pragmatic Computational Biology With Andrew Satz 9/20/2023

   This week's guest on the Business of Biotech, EVQLV's Andrew Satz, says AI and ML in biopharma are like sex in high school. "Many of the people who say they're doing it really aren't, and the ones who really are aren't talking about it," he says. So, when it comes to the computational biology buzz, what’s real? What’s yielding benefit?

6. Allogeneic Cell Therapy: Our Strategy, Learnings, & Advice 9/20/2023

   Celularity is a Florham Park, NJ-based biotech company developing off-the-shelf placental-derived allogeneic cell therapies. We caught up with Robert Hariri, CEO, founder, and chairperson of Celularity, to discuss the company’s facility site selection strategy and scale-up plans, lessons learned during early development, and more.

7. Essential Elements Of Technology Transfer 9/19/2023

   The principles of an effective technology transfer can apply at every stage of the drug development lifecycle for biotech companies of every size. Tech transfer programs are usually bespoke, but they share common essential elements. This article breaks them down.

8. Risk Tool Selection With ICH Q9(R1) In Mind 9/19/2023

   This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.

9. From Capacity To Comparability: The Shifting Onus In Cell & Gene Therapy Outsourcing 9/18/2023

   As we continue progressing beyond the COVID (i.e., the seller’s) economy, both Haskett and Graskemper agree we’re steadily seeing biotechs taking on a much more empowered role in negotiating with and securing CDMO partners. But they also see several shifts in the CGT development landscape that could impact both biotechs and their outsourcing partners equally — for the better, or if we’re not careful, for the worse.

10. Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy 9/18/2023

    If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.