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As stakeholders debate fair market value in clinical trial budgeting, a new task force works to align sponsors, CROs, and sites on transparency, sustainability, and efficiency.

Exploring Perspectives of Fair Market Value in Clinical Trial Budgeting

According to the session panelists, tackling challenges and finding efficiencies is imperative for success.

DPHARM 2024: Problem Solving in the Clinical Trial Realm 

As clinical research continues to globalize and grow at pace, there is a risk that global greenhouse gas emissions will escalate unless mitigation strategies are actively included in corporate strategies. 

Pivoting Toward Sustainable Supply Chains in Clinical Research

Siloed systems can make it difficult to marry data to support timely and informed decision-making and optimize clinical trial operations.

The Argument for Data Alignment and Integration in Clinical Supply Management 

Insights on leveraging outsourcing partners to gain expert, streamlined, and personalized support.

Trends Impacting Clinical Trial Supply Management

In this video interview, Ron Lanton, partner, Lanton Law, highlights how tariffs on active pharmaceutical ingredients could affect resources for maintaining and accelerating R&D pipelines.  

Rising API Tariffs Are Forcing Pharma to Shift R&D Resources

, Ron Lanton, partner, Lanton Law, discussed the impact of drug cost increases on clinical research, predicting a reduction in government-sponsored trials due to higher R&D costs and potential funding cuts. Lanton also touched on FDA inspection cuts and how they are expected to slow down the clinical trial supply chain, leading to longer approval times and reduced site readiness.

ACT: How could the threat of tariffs impact the active pharmaceutical ingredients (APIs) market? Could this increase the cost of conducting clinical trials?

I think tariffs on APIs will definitely increase costs to everybody who has touch points in the supply chain. Pharma obtains a significant amount of APIs from the global market, and I think that's going to lead to increased expenses and a lot of difficulties in sourcing essential ingredients that we need for the APIs. I think the companies might respond to these challenges by reallocating resources meant to maintain or maybe accelerate their R&D pipelines in order to address the issues, but I definitely think it's going to result in an increase of cost.

Videos

In this video interview, Ron Lanton, partner, Lanton Law, highlights how tariffs on active pharmaceutical ingredients could affect resources for maintaining and accelerating R&D pipelines.

In this video interview, Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical trial timelines. 

How FDA Cuts Are Creating New Bottlenecks in Clinical Operations

ACT: How could cuts to spending devoted to FDA inspections impact the clinical trial space?

I think, despite assurances that inspectors would not be affected, the FDA layoffs that occurred last April eliminated a lot of support staff who handled a lot of visas and travel arrangements and other logistical operations of the inspections, and in doing so, that effectively made the availability of inspections go down, because inspectors are now responsible for an additional workload, so you can kind of see like a supply demand issue here. Fewer inspections will mean longer wait times for approvals, longer periods between clinical trial stages are going to happen. I think the longer the wait between that stuff, the bigger possibility that a site's private funding will also be cut or put on hold. I think that while demand for site partnerships from pharma sponsors that's at an all-time high of what we've been seeing, I think a reduction in site readiness will significantly slow down the entire clinical trial supply chain, which it's unfortunate.

Clinical Trial Supply Chain

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