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 with scientific and medical innovation in cell and gene-based therapiesKaizen means “improvement” in Japanese, but in western circles, we’ve also sloganized kaizen as “The Toyota Way” with reverence.  Thanks to kaizen, which means to continuously ameliorate standardized processes, equipment, and other daily production procedures, Toyotas are the best selling cars in the world.

While every day we seek to bring kaizen to cell and gene therapy,  we still have an important first step to accomplish as an industry (as we all know) — standardization.  Without standardization, we can’t optimize or achieve truly “lean” manufacturing and delivery that represents that blissful state of kaizen.   Fortunately, there are reasons for optimism even as there is much work ahead — I’d like to emphasize one important partnership announcement, as well as one trend that will help us accelerate our collective kaizen journey.

We have made public a close partnership with Lonza, one of the industry’s leading contract manufacturers, to promote a more standardized, ready-to-deploy approach to delivery for biopharma customers — at every stage of development through global commercialization. This partnership will offer a fully integrated offering to the industry, including logistics, scheduling, distribution, Chain of Condition, Chain of Custody, Chain of Identity, and Lonza’s proprietary solutions including MODA-ES.™  It is an honor for Team Vineti to be joining with Team Lonza to pursue continuous improvement together in service of personalized medicine. This is an important partnership for Vineti – and more to come!

We are seeing evidence of increased investment into cell and gene therapy manufacturing process, expertise, and equipment given the dawning realization among investors that “successful results in clinical trials will be meaningless without robust manufacturing processes ready to churn out usable drug products.”  At Vineti we are routinely asked by industry colleagues and leading investors our opinion on emerging innovation addressing all aspects of bioprocess and supply chain gaps.  It’s both an honor and deeply humbling to have “courtside” seats for some of the fantastic work entrepreneurs are pursuing on supply chain innovation. 

As Mukerjhee also notes, “innovators cannot ignore the most trivial-seeming details of the human and material factors of the manufacturing process [in cell and gene therapies].” Bring on the innovation — not trivial in the least —  in addition to the non-trivial investment support for the manufacturing and delivery side of the personalized medicine equation! Admittedly, it is hard work to keep pace with the torrent of scientific and medical discoveries, but continuous improvement on supply chain is a critical dependency in our quest to establish this phenomenally exciting area of medicine.  Kaizen means many many more patients gain access to cell and gene therapies, which is of course why we are all working so hard.

Thank you for reading. You can learn more about Vineti and how our software solution supports advanced therapies via our Data Sheet.

Amy DuRoss is the CEO and Co-founder of Vineti. If you’d like to learn more about how Vineti’s Personalized Therapy Management (PTM) is helping to standardize and industrialize workflows for personalized therapies, please contact us.