As 2024 comes to a close, I’ve taken time to reflect on all of the insightful pieces written by our life sciences experts this year. From data integrity to QMS vendor selection, our experts shared their knowledge and perspectives on the latest trends and opportunities in the life sciences industry for this year and beyond. Below, I’ve compiled a list of some of our top life sciences insights from 2024. To explore more of our life sciences insights, click here. 

Top 10 Life Sciences Insights from 2024 

1. Integrating Data Integrity into Your Quality System 

With such a heavy focus on data integrity by the FDA in its assessment of quality systems, it has become vital for the pharmaceutical industry and its regulatory agencies to embed data integrity into the center of their quality approach. If you’re an organization seeking guidance for integrating data integrity into your quality system to ensure regulatory compliance, LaToya Lee Jones and Vinay Vattikuti shed light onto key considerations in this post.   

Learn more about integrating data integrity into your quality system > 

2. The Value of R&D Data Accessibility for Exploratory Analysis 

Life sciences organizations – from international pharmaceutical behemoths to bench-top bio-techs – all generate mounds of non-clinical and clinical data that can and should be leveraged to empower better patient outcomes, further exploratory research, and more agile science. In this article, Clarkston experts Catherine Ault and Aaron Chio explore the value of R&D data accessibility for exploratory analysis and considerations for companies looking to get started with an effective R&D data strategy.  

Explore the value of R&D data accessibility for exploratory analysis > 

3. Establishing an Integration Management Office (IMO) for M&As in the Life Sciences Industry 

The integration of two entities post-merger is a complex task that calls for strategic coordination and careful planning. Post-merger integration is particularly complicated in the life sciences industry due to the myriad of operational, developmental, and regulatory business elements at play. Hence, it’s essential to have an IMO, a dedicated unit responsible for coordinating and facilitating integration efforts. This guide by Ling Lin outlines best practices in establishing an Integration Management Office (IMO) to guide post-merger integration of companies in the life sciences industry. 

Read more about establishing an Integration Management Office > 

4. Exploring IT Infrastructure Qualification Practices for GMP Environments 

Imagine this: you put in a new firewall for your good manufacturing practices (GMP) facility. A few months later, you realize it’s not working as intended. Perhaps the firewall allowed traffic that was not part of the network. How long has this issue been going on, and what problems has it caused? Yikes! This is why we have IT infrastructure qualification practices for GMP environments, and this eBook by LaToya Lee Jones outlines our best practices on the topic. 

Dive into IT infrastructure qualification practices for GMP environments > 

5. How Empower CDS Enhances Laboratory Efficiency and Precision 

Within the realm of laboratory operations, efficiency, accuracy, and compliance are paramount in simplifying and maintaining product integrity. Empower is a software that labs can utilize to achieve this and more. In this piece, Tina Yauger unpacks how Empower CDS enhances laboratory efficiency with precision by enabling the exploration of the intricacies of implementations and the strategic use of calculations within its interface. 

Learn how Empower CDS enhances laboratory efficiency > 

6. Key Questions to Ask Your QMS Software Vendor 

Selecting the right Quality Management System (QMS) can play a key role in the long-term success of a quality organization. Often, organizations can rush to implement systems without considering the long-term implications of their choices. In other words, organizations need to evaluate whether a system that will work in the short term is sustainable for long-term growth. Before selecting a QMS, consider these three key questions outlined by Azmat Shah and Susan Shockey.   

Check out three questions to ask your QMS software vendor > 

7. Exploring 2024 AI Trends in the Life Sciences Industry  

Artificial Intelligence has been a big buzzword for a reason. Currently, 86% of healthcare providers, life sciences companies, and technology vendors use some sort of AI technology, and the market value for AI in life sciences is currently valued at 2.88 billion dollars. As AI technology continues to make advancements, life sciences companies will increasingly begin to implement AI to expedite drug discovery, optimize clinical development and operations, and enhance the patient experience. In this post by Mary Trbovich and Saif Murad, explore three 2024 AI trends in the life sciences industry. 

Explore 2024 AI trends in the life sciences > 

8. Optimizing the Market Research Process in Biotech 

In this case study, Lorraine Mackiewicz and Michael Fein explore Clarkston’s recent partnership with a biopharma client in optimizing the market research process at their organization. The client, a well-recognized biopharmaceutical company that specializes in developing therapeutics using RNA interference (RNAi), identified the need for a streamlined process for conducting market research projects to improve efficiency in MLR reviews. Clarkston was engaged to support standardizing the process with adherence to relevant standards to meet the needs of the market research team. 

Learn more about optimizing the market research process > 

9. Latest Updates to the Drug Supply Chain Security Act: DSCSA 2024 Deadline Extension 

The FDA, in an announcement from October 9, is granting exemptions from specific requirements under the Drug Supply Chain Security Act (DSCSA). These exemptions apply to certain trading partners in the pharmaceutical supply chain. In this post, Clarkston’s Robin Dolan, Michael Marrone, Sebastian Valencia, and Dave Treadaway unpack what you should know about the DSCSA 2024 deadline extension. 

Read more about the DSCSA 2024 deadline extension > 

10. Understanding the Impact of Hurricane Helene on the Medical Supply Chain 

On September 27, 2024, Hurricane Helene made landfall as a Category 4 storm and swept through the United States from Florida to North Carolina and Tennessee. Western North Carolina is not generally affected by hurricanes, but this storm caused unprecedented disaster in the area, including impacts on major medical device manufacturing sites. Allyson Hein, Stacey Erickson, and Susan Shockey further explore the impacts of the hurricane in this article. 

Gain a better understanding of the impact of Hurricane Helene on the medical supply chain > 

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