Newsletter | July 24, 2025

07.24.25 -- The Potential Impact Of U.S. Tariffs On The Biotech Sector

SPONSOR

Discover how to apply ICH E6 R3 in practice during this expert-led discussion on risk-proportionate approaches in clinical trials. Learn how to integrate and analyze data to streamline oversight, enhance compliance, and improve patient safety. Registration for this Clinical Leader Live digital event is free thanks to the support of Revvity and Medable.

REGULATORY & COMPLIANCE

AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 1

This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices. 

We Need Regulatory Clarity—Not Complexity In Clinical Trial Technology

The current U.S. deregulatory momentum should not diminish compliance standards but instead serve as a call to streamline and modernize regulatory guidance.

Precision Medicine: Improving Outcomes With Timely Testing

This panel of biotech, pharma, and CRO leaders discusses how precision medicine, data-driven tools, and biomarkers are transforming clinical research and trial strategies globally.

Why Biotech Leaders Can't Afford Delays In Document Review

Document review is a hidden bottleneck in biopharma. Learn how inefficiencies in this critical process can delay drug development and what you can do to accelerate time to market.

Shortening Drug Development Timelines With Asian Ethnobridging Trials

Discover how ethnobridging streamlines the approval process in Asian markets and addresses potential disparities in drug metabolism between Asian and non-Asian populations.

How Does RWE Impact Clinical Trials?

Explore the growing impact of Real-World Evidence (RWE) on clinical trials, particularly in rare disease research.

SPONSOR

Revolutionize your approach to clinical trials at DPHARM: Disruptive Innovations to Modernize Clinical Research, taking place September 16–17, 2025, in Philadelphia. This conference showcases cutting-edge strategies and technologies designed to reduce patient and site burden, streamline operations, improve data quality, and accelerate access to therapies. Use code LSL20 for 20% off your registration.

OUTSOURCING MODELS

The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials

Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

Reducing Time To First-In-Human Trials With Robotic SFF Services

Discover how robotic gloveless isolator sterile fill-finish (SFF) systems can accelerate early-phase drug development, ensuring enhanced sterility and streamlined processes for biopharma innovation.

The Global CRO For Biotechs

The full-service Contract Research Organization (CRO) with operations in Australia, New Zealand, AsiaNorth America, and Europe.

Blister Solutions

With over 6,000 tooling parts and an in-house machining center to ensure precision, explore this versatile blister service that provides both Thermoformed and Cold-Formed solutions.

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You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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