Industry Insights

1. Evolving Trial Master Files Require Experienced TMF Resourcing 2/13/2023

   Inexperienced individuals will often produce a TMF that falls short in terms of quality, completeness, or timeliness. Unlock the secret to maintaining an up-to-date and inspection-ready TMF.

2. Strategies To Enhance Efficiency In mAb Bioprocess Development 8/16/2025

   Advanced computational methods coupled with bioinformatics can be used to navigate the complexities of bioprocessing by anticipating challenges before they arise.

3. Regulatory Implications Of The CARES Act On Over The Counter Drugs 8/3/2020

   The Coronavirus Aid, Relief, and Economic Security (CARES) Act, passed in response to the COVID-19 pandemic, reforms how OTC drugs are regulated in the U.S. In announcing the legislation, the FDA called the changes a “landmark step that will have an impact lasting long after the current public health emergency.”

4. How Is The Future Of Nuclear Medicine Evolving? 7/13/2023

   Nuclear medicine, with its fusion of medical imaging and therapeutic techniques, is reshaping the way diseases are diagnosed, treated, and managed. Let’s look at key market drivers, market restraints, and emerging trends and technologies.

5. Avoiding ISO 14971 Mistakes — Do You Really Understand The Term “Hazard”? 1/13/2021

   Identification of hazards, hazardous situations, and harms is foundational to analyzing the risks associated with a medical device. Yet, these terms are often misunderstood and misapplied. This first part of a three-part video series reviews the term “hazard” in detail, highlights areas of confusion, and illustrates a few examples to facilitate a better understanding and its application in risk analysis. 

6. 5 New Questions To Ask Before Signing With A Biologics CDMO 12/15/2023

   Outsourcing is now a true collaboration in which innovators and CDMOs co-create the future of medicine. Explore how the right CDMO can help sponsors unlock the full potential of their biotherapeutics.

7. Building And Applying A Configurable Clinical Study Model 4/25/2019

   Last month we introduced an approach for the rapid assessment and prototyping of digital and other clinical trial technologies. Advances in technologies and digital innovations targeting the clinical research environment are evolving at dizzying rates, and the need to efficiently assess and implement opportunities is greater than ever.

8. Navigating Regulatory Guidelines For Effective Tech Transfer 6/22/2023

   The authors discusses important aspects of tech transfer (the project management plan, gap analysis, risk assessment, and more) and share the notable FDA and WHO guidelines related to each area.

9. Accelerating Cell Line Development From DNA To Master Cell Bank 6/15/2023

   Cell line development is a complicated process, and partnering with a CDMO is an effective strategy to ensure these products are manufactured with speed and quality.

10. Put Your Continued Process Verification (CPV) Data To Work 5/22/2020

    Though the FDA’s process validation guidance has been in place for over a decade and other regulatory agencies (EMA, WHO, PIC/S) continue to accept the continuous process verification (CPV) concept, adoption has been slowed by the data governance, analytical capability, and technology challenges.