It’s time for me to reflect on some of our top life sciences insights from 2025! Over the past year, our experts have shared their lessons learned, best practices, project wins, and industry perspectives, and I’m excited to recap some of that content below. You can also take a look at all of our life sciences content from the past year here. 

Top 11 Life Sciences Insights from 2025

1. Developing New Patient Start Likelihood Programs in Pharma 

Clarkston partnered with a mid-sized biopharmaceutical company to develop new-patient-start likelihood models that forecast when a patient’s treatment is likely to advance and when they may qualify for the client’s therapy. These models help commercial teams by equipping treating physicians with timely insights on relevant patients, enabling them to mobilize resources more effectively, better support patients in rare-disease settings, improve care delivery, and strengthen commercial impact. Elise Watson and Sham Karim share more on the project in this case study. 

Read about developing new patient start likelihood programs >>  

2. Preparing for a GxP Commercial Launch: What Do Quality Leaders Need to Know? 

As an organization approaches the readout of its Phase 2 trial, and with early indicators looking positive, leadership often begins turning its attention to the design, launch, and execution of Phase 3. While clinical and supply chain teams may lead much of the work, the role of the Quality leader remains essential. This piece by Wesley Ange highlights how to use the Phase 3 preparation period to lay the groundwork for a smooth and compliant GxP commercial launch. 

How can quality leaders prepare for GxP commercial launch? >>  

3. Conducting an LIS Vendor Selection for a Diagnostics Company 

A diagnostics company relying on a customized ELN as its Laboratory Information System was managing core sample workflows and generating reports for roughly 200 daily orders. As the business prepared for rapid growth and broader test claims, it became clear that their current setup needed to evolve, so they engaged the Clarkston team for support. In this case study, LaToya Lee Jones shares more about how our team evaluated the client’s operations and identified whether a LIMS or LIS would best support their future needs. 

Explore the LIS vendor selection case study >>  

4. 3 Steps to Strengthen Sales Models in the Life Sciences with Data 

Sales in the life sciences industry have transformed significantly over the last 15 years, moving from a traditional rep-to-provider model to a far more complex, insight-driven function. Today, organizations can use detailed analytics to understand provider needs and personalize the sales approach to best fit their specific preferences or needs. In this piece, Jessica Wagner outlines practical steps companies can take to strengthen their sales models in this new, data-enabled environment. 

Read about strengthening your sales model >> 

5. Post-Merger Clinical Operations Support for an Oncology Division 

A leading oncology therapeutics company sought to integrate a portfolio of acquired clinical assets and ongoing trials from multiple global markets under a new sponsor. They engaged our team to assess their operations and create a strategic plan to complete the end-to-end integration within a six-month timeframe. Drawing on our expertise in clinical operations and M&A, we delivered a comprehensive roadmap, coordinated cross-functional alignment, and helped the client navigate the transition smoothly and with minimal risk – read more about the project in this case study by Nicolas Charron, Laurie Stone, George Adams, and Aaron Chio.  

Explore the post-merger clinical operations support case study >> 

6. Veeva AI: Benefits, Risks, and How Organizations Can Prepare 

Veeva’s newly announced AI capabilities for the Vault Platform and its applications stand to significantly reshape clinical, commercial, regulatory, quality, medical, and safety operations across life sciences. These enhancements offer the promise of stronger data interpretation, improved productivity, and faster clinical timelines, but they also require thoughtful planning to ensure regulatory compliance and organizational alignment. This piece by Eric Borries explores Veeva’s evolving AI functionality, the opportunities and risks it presents, and key steps to prepare for successful adoption. 

Learn more about Veeva AI >> 

7. Key Considerations When Planning Your Clinical Trial Data Migration 

Managing clinical trials over many years often leads to outdated or incomplete systems, prompting organizations to modernize their trial management platforms and evaluate whether legacy data should be migrated. Because clinical trial data is vast, complex, and tightly regulated, successful migration requires a clear understanding of the underlying processes, data types, and risks involved. In this eBook, Courtney Woodson outlines essential considerations, strategies, and steps needed to plan and execute an effective CTMS data migration. 

Explore the 8 recommendations for a clinical trial data migration >>  

8. How the Executive Order to Cut Drug Prices Could Affect the Pharmaceutical Industry 

The Trump Administration’s recent Executive Order aims to lower prescription drug prices by tying U.S. costs to those paid in comparable higher-income countries under a “Most Favored Nation” approach. This action follows the Inflation Reduction Act’s earlier drug pricing reforms, which are still facing legal challenges from manufacturers. This piece by Janel Firestein explores how the MFN policy could impact pharmaceutical companies and reshape the broader drug pricing landscape. 

Read more about the EO to cut drug prices >> 

9. Developing a Commercialization Roadmap for Cell Therapy Operations 

A clinical-stage biotech preparing to launch its first autologous cell therapy in the U.S. evaluated whether to build commercial capabilities in-house or outsource them. The decision considered overall strategy, investment needs, and the minimum capabilities required for regulatory compliance and scalable growth. Looking for strategic advisory, the client partnered with Clarkston to develop capability roadmaps and resource estimates for both commercial model options. Marcus McCray and Lorraine Shirley share more in this case study. 

Explore the commercialization roadmap for cell therapy case study >> 

10. Unpacking the Potential Implications of the TrumpRx-Pfizer Deal 

Earlier this year, the White House announced TrumpRx, a new direct-to-consumer site allowing Americans to purchase certain prescription drugs at reduced prices. Pfizer will offer some drugs on the platform and, in return, receives a three-year exemption from national security-related tariffs if it invests in domestic manufacturing. In this piece, Janel Firestein and Irene Birbeck unpack the potential implications of this deal and what it could mean for the pharma industry. 

What are the potential implications of the TrumpRx-Pfizer deal? >>  

11. The Latest ICH E6(R3): Guidance: Why Preparation Starts Now 

On September 8, 2025, the FDA released the final version of E6(R3) Good Clinical Practice (GCP), making it officially available in the U.S. as a reference for sponsors, CROs, and regulators. While the guidance reflects the FDA’s current expectations, it’s not legally binding, unlike the EMA’s version, which became effective on July 23, 2025. U.S. organizations now have a milestone reference for global clinical research, though a formal compliance date has not yet been announced. Read more in this article by Laurie Stone. 

Read more about the latest ICH E6(R3) guidance >>