Blog

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When the US Food and Drug Administration (FDA) recently made two draft guidance documents for the cell and gene therapies available for comment, the Vineti team was quick to scan for one three-letter phrase that is core to our mission –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.
Data management for advanced therapies, Part 4: working with multiple stakeholders
Note: this post is the fourth in an eight-part series on data management strategies for personalized therapies, such as cell...
Vineti Announces New Board of Directors Member
SAN FRANCISCO, January 15, 2020 — Vineti, Inc., the provider of the leading digital platform of record for personalized therapeutics,...
Data management for advanced therapies, Part 3: working with living cells
Note: this post is the third in an eight-part series on data management strategies for personalized therapies, such as cell...
Advanced therapy supply chains: lessons from 100 meetings
You can learn a lot in 100 meetings. In 2019, I conducted more than 100 discussions on advanced therapy supply...
WoVen, a podcast from Canaan featuring Amy DuRoss
One of Vineti’s board members, Nina Kjellson, General Partner, at Canaan started a podcast called WoVen, about women who venture. We’re excited to...
Data management for advanced therapies, Part 2: unique data features
Note: this post is the second of an eight-part series on data management strategies for personalized therapies, such as cell...
Data management for advanced therapies, Part 1: the need for new strategies
Note: this post is the first of an eight-part series on data management strategies for personalized therapies, such as cell...
Design for Healthcare IRL at Vineti, a Meetup
More and more of today’s healthcare happens online and digital is just one part of the picture. Much of the...
Eight million pages, the Space Shuttle, and other highlights from BMWS 2019
If you’re producing cell therapy products for 10,000 patients a year, how many release tests will be required? If making...
More kaizen for cell and gene therapy
Today, Vineti is excited to announce a new partnership with a global contract manufacturing company serving cell and gene therapies — and...
Chain of Identity and Chain of Custody in personalized therapies — core differences from traditional pharma
In pharmaceutical manufacturing, Chain of Identity and Chain of Custody may not be new — but in advanced therapy manufacturing,...
Q&A with Dr. Mike Pellini: the need for advanced software to scale cell and gene therapies
Mike Pellini, M.D., is a member of Vineti’s Board of Directors, a Managing Partner at Section 32, and the former...