Newsletter | October 24, 2025

10.24.25 -- BlueRock Advances Cell Therapy For Parkinson's Disease

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Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development. Gain insights across cell culture, therapy development, and CGT manufacturing, and learn from world-renowned leaders Bobby Gaspar (Orchard Therapeutics), Christof Von Kalle, (Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

FOCUS ON CLINICAL TRIALS

BlueRock Advances Cell Therapy For Parkinson's Disease

BlueRock Therapeutics has advanced its allogeneic stem cell-derived therapy bemdaneprocel into the pivotal Phase III trial for Parkinson’s disease, aiming to restore regulated dopamine signaling, improve quality of life, and potentially transform the treatment paradigm.

Accessing Unapproved Therapeutic Modalities In The USA And Australia

Learn about the regulatory frameworks developed by the United States and Australia to provide access to unapproved therapies for patients with serious or life-threatening conditions.

Revolutionizing Clinical Trials: The Power Of Patient-Focused Drug Development

Patient-focused drug development (PFDD) is gaining traction as clinical trials increasingly prioritize patient perspectives alongside traditional endpoints.

How To Ensure EHR Data Integrity Without Compromising

See how EHR-to-EDC integration can streamline clinical trials, boosting accuracy, efficiency, compliance, scalability, patient safety, and data quality.

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.

What's Next For Cell And Gene Therapies: Addressing Key Challenges

Delve into this exploration of the challenges and opportunities facing CGTs, including manufacturing, supply chain logistics, and the need for greater collaboration among stakeholders.

How AI & Biomarkers Are Reshaping The Next Frontier In Drug Development

Assimilate more about the importance of biomarker-driven drug development and the integration of laboratory science, clinical expertise, and regulatory strategy to accelerate targeted therapy development.

Insights From Facilitating Over A Billion Dollars In Vendor Contracts

By transforming vendor selection from a manual task into a data-driven, strategic process, sponsors can build stronger, more effective clinical trial teams.

Advancing Ovarian Cancer Therapies: Research Trends, Challenges, And Strategies

Ovarian cancer remains one of the deadliest gynecologic malignancies. Successful clinical trials in this space demand deep therapeutic expertise, operational agility, and global coordination.

CLINICAL TRIALS SOLUTIONS

Services Needed For Full End-To-End Patient And Order Management - Cencora

An End-To-End Clinical Data Science Platform - Revvity Signals Software, Inc.

FOCUS ON SUPPLY CHAIN

Ensuring Consistent Removal Of Residual Impurities

In this Cell & Gene Live segment, Pratik Jaluria, Ph.D., SVP Technical Development Strategy at BlueRock Therapeutics, Bruno Marques, Ph.D. VP, Process and Product Development at Century Therapeutics, and Kate Rochlin, Ph.D., COO at IN8bio discuss validating impurity removal in allogeneic cell therapies involves collecting extensive data from early research through GMP manufacturing to support regulatory submissions.

Trends In Cold Chain Storage For Biologics

Packaging is critical, as biotechnology products requiring colder storage become more valuable. Find out how you can improve your temperature-controlled supply chain and meet cold chain storage demands.

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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