Newsletter | September 29, 2026

09.29.26 -- Dr. Heidi Overton And The FDA: An Outsourcing Perspective

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Cell 2026 | 12-13 November, London, UK

Advanced therapy development moves fast, and the companies shaping it are the ones connecting science, scale and strategy in the same room. Cell 2026 is where that happens. Partner with us to reach 800+ senior pharma, biotech and R&D decision-makers through guaranteed 1:1 meetings, speaking slots, roundtables and tailored digital campaigns. Get in touch and we'll design a package around your objectives.

INDUSTRY INSIGHTS

 

9 Logistics And Distribution Recommendations For CGTs

Cell and gene therapy commercialization requires tailored logistics strategies. Explore nine recommendations covering site readiness, reimbursement gaps, packaging, testing, and coordination.

 

The Case For Non-Viral Circular Single-Stranded HDR Donors

Enable efficient, low-toxicity genome editing without viral vectors. This cell-free circular ssDNA platform preserves stem cell fitness while supporting scalable manufacturing.

 

Consistency You Can Trust in Animal‑Free Raw Materials

Animal‑free raw materials ensure reliable bioprocessing through stable molecular weight profiles, consistent mineral levels, and controlled manufacturing for dependable lot‑to‑lot performance.

FEATURED EDITORIAL

Dr. Heidi Overton And The FDA: An Outsourcing Perspective

There’s something sadly predictable about negative media reaction to a woman whose professional accomplishments ought to command attention before anything else, writes Chief Editor Louis Garguilo. "But what interests others heading into the Heidi Overton nomination process for FDA Commissioner is whether she can guide the FDA to help us get medicines developed, manufactured, and approved. So what kind of FDA does the outsourcing supply chain need?" 

 

The U.S. Supply-Chain Uncovered: A Superior Search For Domestic Suppliers

The search for supply chain partners goes on. Intensely. But productively? Are we missing anything? We are about to learn the answer to that is yes.  Alan Davis, President & CEO, i5 Services says puzzling is how little these searches vary – and he's concerned that invariance has negative national supply-chain implications. He has a mission and a search platform to change that.

Is mRNA Manufacturing Overbuilt?

mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.

INDUSTRY INSIGHTS CONTINUED

 

Modern Lentiviral Platforms For Scalable Cell Therapy

A new platform approach streamlines lentiviral vector design and manufacturing, boosting yield, lowering costs, and accelerating access to gene‑modified cell therapies worldwide.

 

Lentiviral Solutions: Fast Lane To The Clinic

Vector redesign and regulatory hurdles can add years to development timelines. A single-partner approach helps streamline the process, secures timelines, and ensures smooth tech transfer.

 

The Advantages Of Off-The-Shelf GMP iPSCs With A DMF

Learn how off-the-shelf, GMP-grade iPSC lines with a Drug Master File (DMF) can accelerate cell therapy development, streamline regulatory approval, and reduce time and cost to clinic.

 

Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

 

From Cell Bank To Clinic Faster: GMP Manufacturing & Characterization

Accelerate your path to the clinic with an integrated, risk-based cell banking strategy that delivers speed, quality, and regulatory confidence at every stage.

 

Accelerated Development Backed By Experience

A biologics development strategy can achieve IND readiness in as little as six months by combining workflows, early risk mitigation, advanced technologies, robust analytics, and regulatory planning.

 

Nucleic Acid-LNP Ultrafiltration And Diafiltration

Downstream filtration can make or break LNPs at scale. See how membrane format, loading, and shear affect recovery and stability — and how alternative TFF lowers scale‑up risk.

SOLUTIONS

mRNA Development And Manufacturing Services

AAV Production Technology For Scalable, High-Quality Manufacturing

Expanding To Develop And Deliver Tomorrow's Cures

Groundbreaking Cryogenic Freezer Technology

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

 

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