Newsletter | June 19, 2025

06.19.25 -- 3 Strategies For A Successful Journey Toward CGT Commercialization

OUTSOURCING MODELS

3 Strategies For A Successful Journey Toward Cell And Gene Therapy Commercialization

CTMC's Amy Hay provides 3 recommendations for teams developing cell and gene therapies, from clinical research through commercialization.

OUTSOURCING MODELS - INDUSTRY INSIGHTS

The Rescue Option: Course Correcting Struggling Clinical Trials

The willingness to seek expert support from Rescue CROs when clinical trials face critical challenges is not a sign of weakness but a demonstration of accountability and commitment to excellence.

Dermatology Drug Development: Key Takeaways From AAD 2025

The 2025 American Academy of Dermatology (AAD) Annual Meeting underscored pivotal advancements in dermatology drug development, highlighting the essential role of innovative dermatology CROs.

Streamline Development: Candidate Selection To FIH Clinical Testing

It is vital to choose molecules for pharmaceutical development very carefully. How do drug developers know which strategy and approach is right for their molecule at an early stage?

Who's In Charge? How To Ensure Effective Trial Oversight, Leadership

Gain valuable insights into the role of sponsor-side Clinical Operations leadership, the risks of over-relying on CROs, and key strategies for fostering collaboration between sponsors and partners.

Bioanalysis Solutions

Learn how a bioanalytical testing partner with comprehensive solutions and unwavering commitment to quality can help you bring safe and effective drugs to market with confidence.

Navigate The Early Phases Of Product Development With Ease

This full-service contract research organization has the expertise to get your early-phase clinical trial up and running safely and efficiently.

REGULATORY & COMPLIANCE

Insights From 250+ Regulatory Inspections

Elisabeth George, who has led more than 250 FDA inspections, shares practical advice for hosting audits — including preparation tips, team coordination, live documentation, and knowing exactly when to speak.

Infectious Diseases - Global Clinical Trial Landscape (2025)

The global infectious disease clinical trial landscape has rapidly expanded between 2020 and 2024, driven by the urgency of emerging threats, technological innovation, and evolving regulatory frameworks.

ISPOR 2024-2025 Top 10 HEOR Trends

This report outlines ten defining HEOR trends influencing global health decision-making.

Transforming First-In-Human Oncology Trials: A Strategic Guide

Drawing from extensive experience in early-phase oncology, this guide offers a strategic framework for executing first-in-human (FIH) oncology trials with a patient-centric and risk-based approach.

How Early-Stage Planning Strategies Are Optimizing Drug Development

Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

Intelligent, Automated Safety Document Distribution Software

Discover how psiXchange streamlines the distribution, tracking, and acknowledgment of key safety documents, saving time, resources, and costs for global drug manufacturers and research organizations.

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  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
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