T cells

New FDA guidance: cell therapies and patient identifiers

When the US Food and Drug Administration (FDA) recently made two draft guidance documents for the cell and gene therapies available for comment, the Vineti team was quick to scan for one three-letter phrase that is core to our mission – COI.

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October 17, 2019

Supply chain vs. value chain: need-to-know essentials

In a recent blog post about Quality Risk Management, we talked about the importance of considering the entire “value chain” when...

October 10, 2019

Design for personalized therapies: reframing “delight” as the goal

Sometimes, in the world of UX and product design, “delight” means getting out of the way. Read about general approaches...

September 19, 2019

The road ahead for #regenmed

This fall, it will be 15 years since regenerative medicine faced a crisis of funding and support in the United...

August 27, 2019

In September, here’s why it’s all about data management

Next month, my colleagues at Vineti and I will be speaking, writing, and presenting on a topic of critical importance...

August 22, 2019

September events! A Big Data webinar with Dr. Scott Burger, and a talk at CAR-TCR Summit

September marks the start of the autumn conference season in cell and gene therapy, and this fall I’m looking forward to...

August 13, 2019

Patient experiences – three inspiring stories

Every person working in cell therapies and gene therapies does so for the potential to improve patients’ lives. Emily Whitehead,...

August 8, 2019

Cell therapy and gene therapy news: updates from some of our biopharmaceutical partners

We’re always excited to support the innovation pursued by our biopharmaceutical partners as they work toward improved patient outcomes. Here...

July 22, 2019

Cell therapy and gene therapy — three summer reads that “get it”

In cell therapy, gene therapy, and personalized cancer vaccines, most media coverage understandably focuses on the medicine — the amazing...

July 10, 2019

Supply chain management readiness, Part 4: quality risk management

Note: this post is the last of a four-part series on supply chain planning for personalized therapies such as cell...

July 1, 2019

Vineti selected as Technology Pioneer by the World Economic Forum

Each year, the World Economic Forum welcomes leading early-stage companies from around the world into its Technology Pioneers community. Today, I’m both thrilled and...

June 30, 2019

Reasons for hope on the journey to personalized medicine “kaizen”

One of my very favorite writers, Siddhartha Mukherjee, published an article in The New Yorker this month on the importance of pursuing kaizen in balance...

June 26, 2019

Vineti joins the leadership of the Standards Coordinating Body

At Vineti, we’re pushing every day to help the field of advanced therapies — cell therapy, gene therapy, personalized cancer...