Newsletter | September 26, 2025

09.26.25 -- Redefining Heart Failure Treatment With Precision Autologous Cell Therapy

FOCUS ON CLINICAL TRIALS

Redefining Heart Failure Treatment With Precision Autologous Cell Therapy

In this episode of Cell & Gene: The Podcast, Host Erin Harris sits down with Peter Altman, Ph.D., CEO of BioCardia, to discuss the company’s evolution from a cardiac biotherapeutic delivery firm to a developer of autologous and allogeneic cell therapies for cardiovascular and pulmonary diseases.

Navigating Project Optimus And The Changing Oncology Development Landscape

Project Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.

Comply With The New NIH Transparency Rules For r/sNA Molecule Research

Review new transparency requirements for NIH-funded institutions engaged in research involving r/sNA molecules and regulations for Institutional Biosafety Committees (IBCs).

GLP‑1 Clinical Trial Eye Safety: Semaglutide Eye Risks

While GLP-1 receptor agonists offer significant health benefits, proactive eye care and vigilance are essential to mitigate the risk of irreversible ocular conditions.

Leveraging AI To Transform Neurodegenerative Drug Development

Learn how AI is redefining the development pipeline for neurodegenerative diseases (NDDs), offering a path forward in the quest for effective, disease-modifying treatments.

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.

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 leveraging a technology approach.

Planning Your IND: When And Why To Engage The FDA

This presentation explores how and when to initiate IND activities, highlighting that sponsors can strategically open an IND to access FDA guidance and enable U.S. clinical trials.

Rethinking Clinical Trial Site Selection: Improve Efficiency

Emerging clinical trial site networks enable faster site activation, scalable operations, and improved patient recruitment by embedding trials directly in patient communities.

10 Roadblocks To Traditional Vendor Selection And How ClinAI Solves Them

Vendor selection in clinical trials is a pivotal process. Explore ten widespread inefficiencies in the current approach and how you can resolve them.

CLINICAL TRIALS SOLUTIONS

Partnering With Leading Innovator TrakCel To Support CGTs - Cencora

Data Licensing For Clinical Trial Planning - Quest Diagnostics

FOCUS ON SUPPLY CHAIN

The Regulatory Imperative To Improve Environmental And Sustainability Stewardship In Biopharma

As the industry faces increasing pressure to align with environmental, social, and governance (ESG) standards, companies must evaluate how to integrate supply chain management with these initiatives to drive sustainability and mitigate risks.

What You Need To Know About Fluoropolymer Bag Cold Chain Durability

Drug manufacturers seek packaging that maintains integrity during processing and freezing, scales up to larger volumes easily, and remains robust throughout the temperature-controlled supply chain.

SUPPLY CHAIN SOLUTIONS

DEHP-Free CryoProtect™ Bio-Containers - Charter Medical

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

Connect With Cell & Gene: