Newsletter | August 8, 2025

08.08.25 -- FDA Priority Voucher Program Submissions Window Opens On New Website

SPONSOR

At the Bioprocessing Summit, August 18-21 in Boston, you'll explore cutting-edge science, share strategies with industry leaders, and address real-world challenges in bioprocess R&D, scale-up, quality, and analytics. From foundational science to emerging technologies, this is where the industry connects to learn, partner, and push the field forward. Learn more at BioprocessingSummit.com

FOCUS ON SUPPLY CHAIN

FDA Priority Voucher Program Submissions Window Opens On New Website

The Commissioner's National Priority Voucher program is accepting applications. Experts predict brisk competition since the agency is only awarding five vouchers for now.

Navigating The CGT Supply Chain: Key Logistical Challenges And Solutions

Commercializing cell and gene therapies demands tailored strategies for temperature control, compliance, and delivery to overcome logistical challenges and ensure a reliable supply chain.

The Evolution Of Nucleotide Production

From harsh chemicals to gentle enzymes: Explore the groundbreaking shift in nucleotide synthesis, making drug manufacturing cleaner, greener, and more efficient.

Breaking Through In Hematologic Malignancies

Explore the hematology-oncology landscape and a strategic preview of the challenges and opportunities that are redefining care for blood cancers today.

The Way Forward: Supply Chain Solutions

Learn how to build a resilient supply chain to navigate today's complex environment. Expert speakers share insights on optimization, innovation, and strategic planning to meet evolving market conditions.

FOCUS ON CLINICAL TRIALS

Atsena Therapeutics Advances Gene Therapy For XLRS

Atsena Therapeutics exemplifies the field’s growing shift toward non-oncology indications with its targeted gene therapy for X-linked retinoschisis, a rare inherited retinal disorder with no approved treatments.

New EDC Tools Enable Even Faster Self-Serve Study Builds

Discover an intuitive EDC solution that accelerates study builds, ensures data integrity and compliance, and empowers clinical teams to focus on impactful research outcomes.

Key Quality, Manufacturing, And Nonclinical Factors For Trial Entry

Live biotherapeutic products (LBPs) represent an emerging frontier in therapeutic development, harnessing living microorganisms to prevent, treat, or cure disease.

Commercializing Your First CGT: Five Best Practices For Planning

From patient identification to reimbursement, commercializing cell and gene therapies is uniquely challenging. Learn five best practices to ensure your innovative CGT reaches the patients who need it.

8 Critical Questions To Ask Your IRB

This article outlines eight essential questions to ask a potential IRB partner to assess their ability to help you navigate complex regulatory requirements while avoiding delays.

CLINICAL TRIALS SOLUTIONS

Lock Into Your Go-To Data Strategy - Biorasi

Integrated Trial Services - MRN - Medical Research Network

Accelerate Your Oncology Breakthroughs - Veristat, Inc.

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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