Newsletter | June 6, 2025

06.06.25 -- Inside The Trials Aiming To Stop Vision Loss For Rare Eye Disease Patients

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Discover the future of gene therapy at Cell & Gene Live's Advancing Gene Delivery: LNPs, Adenovirus, Lentivirus, and More. Explore how innovative delivery platforms beyond AAV—like LNPs, adenovirus, and lentivirus—are transforming therapeutic development. Industry experts will share key insights on emerging technologies, challenges, and strategies shaping the next generation of gene delivery. This virtual discussion is essential for researchers and biotech leaders in the cell and gene therapy space.

FOCUS ON SUPPLY CHAIN

Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services

The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?

A Comprehensive Solution For Critical Sample Analysis

Discover how Germfree Laboratories overcame challenges for the Royal Canadian Mounted Police by designing a mobile lab with advanced biocontainment and state-of-the-art communication systems.

SUPPLY CHAIN SOLUTIONS

Fluid Transfer Bags - Charter Medical

FOCUS ON CLINICAL TRIALS

Inside The Trials Aiming To Stop Vision Loss For Rare Eye Disease Patients

Ocugen Chief Medical Officer Huma Qamar, MD, MPH, CMI, discusses two rare disease trials and how the company's managed their protocol design, PI selection, and patient recruitment.

Reimagining The Protocol For The Future Of Research

Clinical trial protocols are the blueprints of research, yet they remain locked in static, text-based documents that must be manually reinterpreted across each clinical system.

Balancing Science With Intellectual Property

Joshua Kresh, Emily Michiko Morris, and Mark Schultz from IPPI: The Intellectual Property (IP) Policy Institute discuss the dos and don’ts of IP and trade secrecy protections for biotech.

Commercializing Rare Disease Treatment With Near Real-Time Alerts

How did Quest help a leading pharmaceutical company overcome the data latency challenges associated with traditional EHR when recruiting eligible patients for a rare blood disorder drug?

The Flexibility Of Reconsent In Clinical Trials

Explore the common misconceptions surrounding reconsent, as well as the reality of its ability to be a flexible, ethics-driven communication practice grounded in respect for participant autonomy.

Community-Focused Site Networks Transforming Clinical Trials

Leveraging a site network has proven to ease study enrollment, contracting, and budgeting, while also reducing overall study cost and timelines.

The High Cost Of CRO Turnover (And How You Can Avoid It)

Though some turnover is an inevitable part of a business’s life cycle, there are several strategies available to ensure a consistent CRO team throughout the span of your trial.

How To Establish Effective, Scalable Drug Safety Ops Across Vendors

Numerous factors impact a drug safety program, but proper management of three key elements drives success while creating a scalable drug safety model.

CLINICAL TRIALS SOLUTIONS

Navigating The Early Oncology Landscape: Market Trends And Insights - Novotech

Partnering With Leading Innovator TrakCel To Support CGTs - Cencora

Get It Right The First Time: Strategic Clinical Development - Veristat, Inc.

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