Newsletter | July 18, 2025

07.18.25 -- Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis

SPONSOR

Webinar: Unlocking Global Oncology Success: The Strategic Advantage of Australia & Asia for U.S. Biotechs

The oncology clinical trial landscape is evolving, and U.S. biotech companies are increasingly seeking innovative solutions to accelerate their drug development programs. Join us as we explore how Australia, Taiwan, and South Korea provide a strategic advantage in conducting early, mid, and late-phase oncology trials, offering speed, cost efficiency, and global scalability. Register now.

FOCUS ON CLINICAL TRIALS

Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis

Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.

Roadmap To Successful Drug Therapy Partnerships

Erik Jerks of Eurofins highlights advanced strategies for bioanalytical method development, showcasing case studies and technologies for bispecific antibodies and AAV-based drug assay challenges.

Huntington's Disease Clinical Trials: Innovation, Challenges, And The Road Ahead

The Huntington’s disease (HD) landscape is undergoing rapid transformation driven by breakthroughs in gene-targeted therapies, small-molecule modulators, regenerative medicine, and digital innovation.

ThinkLive Cell and Gene Therapy Summit 2025 Summary

From patient support to intricate logistics, ThinkLive CGT Summit 2025 leaders tackled the essential commercial strategies needed to deliver these innovative therapies to patients globally.

Designing And Delivering Patient-Centric Clinical Trials For Oncology Patients

This presentation explores strategies for designing and delivering patient-centric clinical trials, with a focus on oncology.

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.

Decoding The Human Immune System

Michael Tolentino MD, Co-Founder and Head Scientific Consultant at Aviceda Therapeutics, discusses the power of glycol therapeutics in treating degenerative eye diseases. 

Blueprint For Early Phase Clinical Pharmacology Studies In Dermatology

Explore the landscape of dermatological drug development through a comprehensive framework for rational early-phase dermatological trials, centered around five foundational pillars.

Clinical Analytics Use Cases For AI

Automating FDA data validation rules and analyzing audit trail data can significantly reduce fraud and predict areas of concern. Discover how these advancements can transform your clinical trials.

Ensure Seamless Clinical Trial Transition Across Global Markets

If you want to increase speed and reduce costs while still procuring high-quality data for your clinical trial, consider the impact of launching an early-phase clinical trial in Australia.

Effective Recruitment Capabilities And Outstanding Customer Service

Hear from many customers who commend OpenClinica's effective recruitment capabilities, outstanding customer service, and adept problem resolution.

Precision In, Precision Out: Elevated Kitting Strategies For Clinical Trials

As biomarker-driven clinical trials become increasingly complex, the design and management of clinical trial kits play a pivotal role in ensuring operational success and scientific integrity.

SPONSOR

Get ready for ISPE's largest event of the year, the 2025 ISPE Annual Meeting & Expo, 26–29 October, in Charlotte, North Carolina, USA, and virtually. This year's theme is Pharma 4.0™, with sessions exploring the integration of digitalization across all stages of pharmaceutical processes. Attendees can explore the latest advancements, network with like-minded professionals, and discover new technologies. Learn more and register

CLINICAL TRIALS SOLUTIONS

Support for Navigating Therapy Complexities And Approvals - Veristat, Inc.

Integrated Services: Expertise At Every Step - InspiroGene

Central IRB Services - BRANY

BioPharma Services: Data Licensing - Quest Diagnostics

Expanding Diabetes-Related Eye Health Equity - 20/20 Onsite

FOCUS ON SUPPLY CHAIN

Why 'Which Is Best?' Is The Wrong Question In CGT Development

In cell therapy development, the instinct to seek a single “best” option is natural — but in reality, there’s rarely a universal winner.

PTFE Containment: Viable For Temperature-Sensitive Protection

See why single-use cold-chain containers made with polytetrafluoroethylene fluoropolymers may be less susceptible to failure and breakage at cold temperatures.

A Practical Guide To Help Choose The Right Cold Storage Solutions

Cold storage units like refrigerators, freezers, and ULT freezers are vital to scientific progress, which preserves sensitive materials and supports breakthroughs in medicine.

SUPPLY CHAIN SOLUTIONS

Next Generation GMP Facility For CRISPR Based Therapies - Synthego Corporation

EVENTS

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines.

 

Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

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