Industry Insights

1. Cell & Gene Therapy Financing: What Is The Role For Private Equity And SPACS? 8/26/2021

   This article explains how SPACs help cell and gene companies go public with some advantages.

2. How To Approach Tech Transfers And Sponsored Life Sciences Research In An AI Age 3/27/2025

   Two IP attorneys examine the patentability of AI-conceived inventions and share tips for technology transfers and sponsored research in pharma/biotech.

3. Is The BIOSECURE Act The First Real Step Toward Reshoring? 11/22/2024

   The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?

4. FDA's COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers 2/19/2021

   Published in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.

5. Proactive Quality Systems: FDA Has Made Them A Priority — Has Your Organization? 3/19/2018

   FDA’s traditional compliance requirements establish a uniform quality system framework, but do not ensure device quality across the ecosystem. Furthermore, a compliance audit will tell a manufacturer whether the system they have established is compliant with current regulations but offers no insight into how they might improve the device, the system, or the development process.

6. Opportunities For AI To Assist Cell & Gene Therapy Companies 10/10/2023

   Although AI/ML is still in a nascent stage in the cell and gene therapy sector, it has an enormous amount of potential to transform overall business models, early R&D, clinical trials, manufacturing and operations, and regulatory compliance support in these key ways.

7. A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions 8/30/2024

   Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster.

8. The Dating Game – Trust & Compatibility In Outsourcing Partnerships 5/12/2020

   By doing your due diligence in selecting an appropriate outsourcing partner, some of the challenges can be turned into planned objectives as you move closer to (hopefully) positive results in the clinic. Pre-selecting a contract development and manufacturing organization (CDMO) based on not only capabilities but compatibility and trust will help throughout the journey.

9. Clinical Study Risk Management During The COVID-19 Pandemic 4/6/2020

   While COVID-19 has proven to be an extremely trying obstacle for the life science community, it is crucial for organizations to not only focus on the short-term impacts of COVID-19 but on developing a long-term plan of action for how we return to business once the pandemic subsides.

10. How Mechanistic Modeling Eases Wet Lab Dependence 6/20/2024

    Mechanistic modeling mimics process steps in a computational environment, thereby substantially reducing the dependence on physical experiments.