Newsletter | June 27, 2025

06.27.25 -- The Power Of Partnerships And The Rise Of iPSC

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Explore the evolving role of exosomes and extracellular vesicles (EVs) at the next Cell & Gene Live. Chief Editor Erin Harris moderates a discussion with Capricor’s Linda Marbán and Aegle’s Dr. Gloria Matthews on clinical and commercial advances, including applications in rare and cardiovascular diseases. Gain insights into the future of exosome-based therapies from leaders driving innovation across R&D, manufacturing, and commercialization.

FOCUS ON CLINICAL TRIALS

The Power Of Partnerships And The Rise Of iPSC

During the Cell & Gene Live, Unlocking the Potential of iPSC Therapies in Regenerative Medicine, Julie Allickson, Ph.D., Chief Technology Officer at Mayo Clinic's Center for Regenerative Biotherapeutics and Erin Kimbrel, Ph.D., Head of Cell & Gene Therapy Research at Astellas emphasize that partnerships and collaboration are essential to advancing regenerative medicine and iPSC-based therapies.

Successful Regulatory Submission Via The Trifecta Of Awesomeness

Article | inSeption Group

Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.

Blueprint For Early Phase Clinical Pharmacology Studies In Dermatology

White Paper | By Robert Rissmann, Matthijs Moerland, and Martijn BA van Doorn, CHDR

Explore the landscape of dermatological drug development through a comprehensive framework for rational early-phase dermatological trials, centered around five foundational pillars.

5 Ways Lab Data Can Help Commercialize Your Therapy

Article | Quest Diagnostics

In this text, we delve into five pivotal insights for leveraging lab data effectively.

Linking Neurology And Ophthalmology For Clinical Trials

Article | 20/20 Onsite

Learn more about the innovative approach being taken to incorporate ophthalmology into neurology and central nervous system (CNS) research.

Evaluating Adaptive Trials: Do They Align With Your Study's Goals?

Video | Veristat, Inc.

In this short video as Robin Bliss, Vice President, Strategic Consulting at Veristat, shares four key questions that she likes to ask when planning an adaptive design clinical trial.

CLINICAL TRIALS SOLUTIONS

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Reviewing Protocols Across Therapeutic Areas - BRANY

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Home Trial Support - MRN - Medical Research Network

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Driving Early-Phase Success In Advanced Solid Tumors Study - TFS HealthScience

FOCUS ON SUPPLY CHAIN

8 Ways To Drive Resilience In Oncology Drug Supply Chains

By Kerim Ozbilge, EY

From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.

Navigating Cold Chain Challenges In Cell And Gene Therapy

Poster | InspiroGene

Experts highlight critical concerns regarding insufficient cold chain infrastructure for cell and gene therapies, emphasizing an urgent need for robust, scalable solutions to meet future demand.

Trends In Cold Chain Storage For Biologics

Article | By Joe Cintavey, W.L. Gore & Associates

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.

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