Newsletter | October 10, 2025

10.10.25 -- Inside Sanofi's Genomic Medicine Vision With Mike Quigley, Ph.D.

SPONSOR

Join Cell & Gene Live on October 16 at 11am ET for a virtual panel discussion on Designing Early Manufacturing for Long-Term Success in CGT. Registration is free with support from Thermo Fisher Scientific.

FOCUS ON CLINICAL TRIALS

Inside Sanofi's Genomic Medicine Vision With Mike Quigley, Ph.D.

On episode 112 of Cell & Gene: The Podcast, Michael Quigley, Ph.D., Chief Scientific Officer and Global Head of Research at Sanofi talks to Host Erin Harris about the establishment of Sanofi’s dedicated Genomic Medicine Unit (GMU). Dr. Quigley emphasizes in vivo delivery and process optimization to improve patient experience, scalability, and global access.

LBPs: Unique Quality, Manufacturing, And Nonclinical Considerations

Live biotherapeutic products (LBPs) are emerging as a dynamic area of drug development, and their development demands tailored strategies that address both manufacturing and nonclinical complexities.

Remote Patient Monitoring Using Mobile Health Technology

Investigate the attitudes of cancer patients towards the adoption of mHealth technologies, including applications and wearable devices, for monitoring purposes during or after their treatment.

The New Era Of Project Optimus: Implications For Oncology Development Strategy

See expert speakers bring the impact of Project Optimus to life through real-world case studies and practical examples. Gain insight into the initiative of transforming oncology drug development.

How AI Is Reshaping The Future Of Clinical Research

Artificial intelligence (AI) is rapidly transforming clinical research, with innovative applications in key areas such as real-world evidence generation, regulatory submissions, and biomarker discovery.

Phase 1 Clinical Trial Designs And Strategies

With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.

8 Key Applications Of Real-World Data In Multiple Myeloma Therapy Development

Explore how therapeutic area (TA) datasets can be leveraged to address the challenges multiple myeloma (MM) presents in the field of hematologic malignancies.

Targeted Indication Selection Using Adaptive Design

What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?

SPONSOR

As cell therapy programs progress into later clinical stages and regulatory scrutiny tightens, early analytical strategy has never been more important. At the 7th Cell Therapy Analytical Development Summit unite with your peers to build robust, predictive and compliant analytical frameworks that can withstand the next wave of analytical hurdles. See the new agenda.

CLINICAL TRIALS SOLUTIONS

Getting Biotechs GlobalReady - Avance Clinical

Data Integrity Drives Every Step Of Your Clinical Trial - Biorasi

Implementing Complex Ordering Workflows Has Never Been Easier - InspiroGene

Unlocking Recruitment Potential In Trial-Naïve Sites - MRN - Medical Research Network

FOCUS ON SUPPLY CHAIN

QC Sampling Post-Thaw And Scaling Up Automated Processes For iPSCs

During this portion of our Cell & Gene Live, Optimizing Storage Solutions for iPSCs, expert panelists, 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 continue the discussion on post-thaw processing, focusing on QC sampling and the challenges of scaling up automated thawing.

SUPPLY CHAIN SOLUTIONS

Single-Use Solutions: Cell Growth - Charter Medical

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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