Drug Development

Scoop: Novartis’ retreat on CAR-T includes axing most of its senior execs on the team

Usman "Oz" Azam

Usman “Oz” Azam

Novartis’ plan to pull back on CAR-T includes purging most of the senior execs involved in the project, signaling the pharma giant’s R&D retreat is more extensive than the company has wanted to admit so far.

Endpoints News, which broke the story on Novartis’ surprising R&D move, initially obtained the top fragment of an internal corporate memo authored by Usman “Oz” Azam at Novartis spelling out that the company is dissolving its cell and gene therapy unit responsible for its pioneering work on CAR-T. Now we have the rest of it, and it includes this on the team execs:

Unfortunately a number of colleagues will be impacted by this change as many positions are being eliminated. Impacted US-based associates are being notified in meetings today. Associates based in Basel will learn more about their individual circumstances on Thursday. The majority of the CGTU Leadership Team members, who are among the best I have worked with, are also impacted.

Earlier in the week, Novartis portrayed the decision to integrate the unit into its oncology division as an efficiency move, something Novartis does on a regular basis. The company, a spokesperson noted, would continue to work in the field and “with a new integrated development model, we can efficiently advance our work on CART as part of our focus in immuno-oncology by reintegrating the functions.”

Eliminating the executive team underscores concerns that Novartis, one of the three key leaders in CAR-T, along with Kite and Juno, is stepping away just as the first CAR-T therapies are nearing approval. And Novartis has said that it will continue to push its lead program CTL019 in pediatric r/r ALL to the FDA in early 2017 and the EMA later in 2017.

Just two years ago, in a Forbes cover story, Novartis CEO Joe Jimenez vowed to pursue CAR-T with a no-expenses-spared approach to curing cancer. But how serious can it be about CAR-T when the senior team leaders are being axed as part of a move to eliminate 120 jobs out of the 400 affected?

I asked Novartis representatives that question early Friday, but have yet to hear back. (Update: Here’s their response.)

Azam goes on at one point to assure the 400-member group, many of whom were about to be axed, that “We have led the industry in transforming the practice of medicine with CART therapy…the clinical and regulatory teams will move to Global Drug Development and specifically Oncology Global Development, and our colleagues who are supporting commercial readiness will move to the Oncology organization.”

Here is the entire memo obtained by Endpoints:

Dear Colleagues,

I still vividly remember the moment that David Epstein invited me to lead a new Unit dedicated to Cell & Gene Therapies. It was a mixture of excitement and fear – a feeling that fuels my entrepreneurial spirit, and one that so many of you share. The risk of embarking on a new adventure in uncharted territory is that things don’t always work out how you envisioned. Today, I have the unfortunate task of announcing that we are dissolving the Cell & Gene Therapies Unit. The adventure started years ago with the initiation of the Penn collaboration. After recognizing the uniqueness of this therapy, the organization implemented our CGTU design structure to bring together bright minds in disparate functions from across Novartis to act as a SWAT team and figure out how to make this a success. And we did. In the space of two years we completed an unprecedented tech transfer of CAR technology to a commercial-grade, GMP quality, scalable manufacturing site in Morris Plains, gained clarity on the indications with the greatest benefit/risk profile, initiated and fully enrolled two global multi-site clinical trials in two different indications, and laid the groundwork for the evolution of future cell processing. But most importantly, as Kathy says, we saved the lives of several kindergarten classes and dozens of parents and grandparents.

We have led the industry in transforming the practice of medicine with CART therapy.

While we were focused on cell and gene therapies, the larger Novartis organization continued to evolve. We elevated the role of Oncology, we have integrated our global development function, and we are operating, more than ever, as one Novartis. This is the time to re-integrate the Unit back to the functions. We have grown, the organization has grown, and it’s time to come back together. An integrated Morris Plains footprint including Tech Ops, Quality and IT process development will move under BTDM, the clinical and regulatory teams will move to Global Drug Development and specifically Oncology Global Development, and our colleagues who are supporting commercial readiness will move to the Oncology organization.

Unfortunately a number of colleagues will be impacted by this change as many positions are being eliminated. Impacted US-based associates are being notified in meetings today. Associates based in Basel will learn more about their individual circumstances on Thursday. The majority of the CGTU Leadership Team members, who are among the best I have worked with, are also impacted.

I know this news may be difficult, and I know you have questions. I would like to elaborate on what I have shared here in a Town Hall this afternoon at 15:00 CET/3:00 PM EDT. I know this is short notice, so we have arranged many ways for you to connect from multiple time zones. We have booked rooms in East Hanover, Morris Plains (where I will be) and Cambridge, or you can dial in via Webcast or teleconference if you would like to hear more. A meeting invitation will follow.


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