Newsletter | July 25, 2025

07.25.25 -- Unlocking Value In Biopharma Operations: A C-Suite Call To Action

FOCUS ON SUPPLY CHAIN

Unlocking Value In Biopharma Operations: A C-Suite Call To Action

Operational readiness will separate the leaders from the laggards, whether you lead a pharma/biotech innovator, CDMO, or a combination of both.

 

 

Understanding The Cold Durability Performance Of Fluoropolymer Bags

Although polymer bags are an excellent choice for cold chain use, not all polymer films perform the same way, even if their specifications rate them for use at low temperatures.

 

Understanding Refrigerator, Freezer, And Incubator Performance Metrics

Learn more about how refrigerators, freezers, and incubators are vital to scientific progress to preserve samples, support experiments, and ensure the integrity of life-saving research in every modern laboratory.

SUPPLY CHAIN SOLUTIONS

Single-Use Flexible Freeze Containers For Bulk Drug Substance - W.L. Gore & Associates

DEHP-Free CryoProtect Bio-Container - Charter Medical

FOCUS ON CLINICAL TRIALS

4 Centralized Comparator Sourcing Models To Fortify Supply Chains

A team at Novartis developed models to address the often-overlooked challenge of clinical trial comparator sourcing, a weak link that can derail trials.

 

 

Mastering GMO & Companion CDx Trials: The EU Regulatory Playbook

This presentation offers strategic and operational guidance for navigating the regulatory challenges of conducting gene-modified organism (GMO) trials in Europe.

 

EHR-To-EDC Success In A Complex Oncology, Adaptive Platform Trial

The I-SPY 2 Trial represents a groundbreaking approach in oncology, with a key component of the trial's success being the integration of EHR with EDC via OpenClinica's Unite platform.

 

What Clinical Trial Decision Makers Are Prioritizing In 2025

In 2025, clinical trial operations are undergoing a transformative shift driven by the need for speed, cost-efficiency, and patient-centered approaches.

 

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.

 

Why Team Integration Makes Or Breaks Marketing Applications

True team integration transcends basic collaboration, requiring the dismantling of barriers between sponsors and vendors, eliminating departmental silos, and cultivating mutual accountability.

 

Remote Patient Monitoring Using Mobile Health Technology

This study investigates the attitudes of cancer patients towards the adoption of mHealth technologies, including applications and wearable devices, for monitoring purposes during or after their treatment.

 

Enabling Investment In Community Hospitals To Improve Patient Access

Learn why enabling community hospitals to alleviate system constraints would usher a change in the future of cell and gene therapy delivery.

 

Informed Consent In Clinical Trials Involving Neurologic Disorders

Informed consent is essential in clinical research. However, when participants lose decisional capacity, a Legally Authorized Representative (LAR) is needed to provide consent and uphold ethical standards.

 

5 Essential Capabilities For Decentralized Clinical Trials

Learn how to develop and utilize a successful DCT framework, enabling your study to enhance patient access, improve data quality, and streamline study operations.

CLINICAL TRIALS SOLUTIONS

Proven Success For Oncology Trials- Improved Enrollment & Retention - MRN - Medical Research Network

Avance Clinical's Specialist Areas Of Focus - Avance Clinical

The SaaS Clinical Data Science Platform - Revvity Signals Software, Inc.

Unlocking Healthier Futures With Cell And Gene Therapy - Cencora

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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