Newsletter | September 4, 2026

09.04.26 -- Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology

SPONSOR

 

The evidence gap in Hematology: From trial endpoints to patient outcomes

As hematology trials become more complex, sponsors face increasing pressure to accelerate development while generating stronger evidence, mitigating recruitment risk and supporting faster patient access. Join Parexel's experts to discover how RWD/RWE can help you make smarter decisions earlier, mitigate risk and strengthen your path from development to approval. Don't miss this opportunity — register today.

FOCUS ON CLINICAL TRIALS

Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology

REVTORPYK's FDA approval highlights the broader push toward precision therapies that address complex disease biology, overcome resistance, and deliver more durable patient benefit.

 

 

Navigating High-Stakes Hurdles Across Gene Therapy Development

Take a high-level look at the full gene therapy journey. Explore key hurdles across discovery, preclinical research, process development, manufacturing, regulatory steps, and clinical trials.

 

AI Tools In Informed Consent: What Sponsors Need To Know About Risk

Uncover how artificial intelligence impacts participant communications, where bias or inaccuracies emerge, and why human review remains vital for maintaining clinical trial integrity.

 

Overcoming High Drop-Out Rates With Decentralized Trial Design

High drop-out rates threaten clinical trial integrity. Implementing decentralized solutions and proactive support strategies during protocol design can significantly improve patient enrollment and retention.

CLINICAL TRIALS SOLUTIONS

Simplify Your Investigational Drug Management - McCreadie Group

Data-Driven Paths To Rare And Ultra-Rare Disease Therapy Approval - Veristat, Inc.

FOCUS ON SUPPLY CHAIN

 

Reducing Risk And Product Loss In Bulk Drug Cold Chain Operations

Look at practical strategies for streamlining handling steps, mitigating product loss risks, and improving operator efficiency throughout bulk drug substance freezing and cold chain storage.

 

Data-Driven Manufacturing And Case Management In Autologous Cell Therapy

Learn how data-driven manufacturing and end-to-end supply chain orchestration help cell therapy developers address production roadblocks, reduce costs, and scale commercial programs efficiently.

SUPPLY CHAIN SOLUTIONS

Single-Use Disposable Containers For Bulk Lyophilization - W.L. Gore & Associates

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