Speeding up drug development
New governance structure
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A phone call with consequences

Great ideas abound, as do stranded projects. But what is the difference between a good idea that can be turned into reality and one that is stowed away in a drawer? In drug development, communication seems to make a key difference when it comes to understanding why some molecules make it to the finish line and others idle in a dusty archive. At Novartis, a new governance structure aims to reflect this insight and help speed up drug development.

Text by Goran Mijuk and K.E.D Coan, illustration by Lehel Kovács, photos by Andy Kwok and Laurids Jensen

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Marty Lefkowitz: Listening creates opportunities.

arrow-rightSpeeding up drug development
arrow-rightNew governance structure

Published on 20/09/2023

Boerje Haraldsson, a former scientist at the Novartis Institutes for BioMedical Research (NIBR), had nowhere else to turn when he picked up the phone sometime in 2017 to ring his colleague Marty Lefkowitz to talk about an innovative molecule that could potentially be moved into clinical trials.

The reason he called Lefkowitz was that they were both nephrologists by training, and that Novartis had no kidney development unit at the time. “As kidney specialists, we knew each other from previous encounters,” Lefkowitz said. “And this was actually the key reason he called me to discuss his idea.”

It took little for Lefkowitz to grasp the importance of what Haraldsson had to offer – a new molecule that could interfere in parts of the immune system and that seemed potentially effective to treat kidney and other disorders.

Lefkowitz, who works in the clinical trial space on the Novartis Campus in East Hanover, traveled to Basel to discuss the idea with Haraldsson and the team of scientists who had been working on the molecule for the past few years.

“After the meeting in Basel, I presented the project to my colleagues within the Global Drug Development (GDD) unit, who embraced the idea relatively quickly, both for its scientific and medical value,” Lefkowitz said. “It was sort of a catalyst for a new way of collaboration.”

Setting up a new structure

The chat between the two nephrologists not only prompted Novartis to start a new project in the kidney disease arena. Their discussion also had wider repercussions as the company started to build new interfaces to help discovery and development teams better align and collaborate more intensively.

Up until this moment, most research within NIBR had been primarily focused on the discovery side of pharmaceutical science, with less guidance on preparing for the many subsequent steps that are needed to successfully bring a new molecule to the clinic and usher through the complex development and commercial process.

But thanks to the initial connection established by Lefkowitz and Haraldsson, an open conversation started to evolve between the two groups. This made it possible to incorporate studies into NIBR’s discovery and translational medicine work, which helped advance the development of the drug and move it more quickly to the clinic.

To this end, Novartis built, among others, what is today known as a Global Program Team – a cross-divisional team with NIBR representation led by a Global Program Head within GDD that manages the strategy and execution of a program.

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Guido Junge: Working together – from day one. That's the magic.

Spee­ding up drug de­ve­lop­ment

“We were absolutely focused on the clinical problems we wanted to solve and what it would take to efficiently accomplish this so that we could bring a wonderful molecule to the clinic to do something good for patients,” said Guido Junge, a NIBR scientist who was part of the core team from the start.

He also highlighted that this mindset was decisive in bringing people together from varied units and functions to help make a success of this molecule, which had seen a volatile early development as it was first tested in ophthalmology before scientists experimented with the molecule in other disease indications.

“Novartis didn’t have dedicated units in these disease areas, but our scientists still saw the potential of this molecule and they became committed to making it a success, on top of their usual business priorities,” Junge said.

Thanks to GDD’s collaboration and guidance, the NIBR colleagues, for example, modified their initial proof-of-concept trial – a trial that usually establishes whether a drug actually elicits a physiological reaction – not only to prove the biological mechanism and pathway, but also to lay the groundwork for the ensuing clinical trials.

Following this close collaboration and shift of focus, the NIBR scientists also identified a biological signature – a biomarker – that provided even more supporting evidence to move the molecule into the clinic.

“The real difference here, in my view, is that we did this together from day one,” said Guido Junge. “And all of us were collaborating with a view to beat development timelines in a very competitive space. This made it possible for the team to submit the molecule for approval within five years of their first clinical trial, which is faster than usual,” he added.

Full commitment to the molecule

While chance played its hand, the teams grabbed the emerging opportunity by the horns. “What really made the difference,” Marty Lefkowitz remembered, “is that we understood the science and were convinced that something could be made out of this molecule that would provide an important benefit to patients.”

Junge also emphasized that communication was essential between the discovery and development groups and that the researchers aligned their goals with a view to speeding up the project, which is now moving forward in late clinical trials for several different diseases.

Some of the early team members have been so committed to the project that they have switched positions to continue supporting the molecule’s progress. One of them was Nicholas Webb, a pediatric nephrologist by training.

When the project officially moved from NIBR to GDD, Webb switched with the molecule to a role in the development organization, where he is now the medical director for several of the kidney programs. “I was sad to leave NIBR, but when I had the chance to see this molecule through to registration, it was an opportunity I couldn’t turn down,” Webb said.

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Nicholas Webb: Switching roles to help patients.

New go­ver­nan­ce struc­tu­re

The success of the program has since prompted Novartis to include kidney diseases into what is known today as the Cardiovascular-Renal-Metabolism Development unit. But, furthermore, following the valuable learnings from this work model, the company has also taken steps to rejig its governance structure to start collaboration between the discovery and development teams much earlier.

“The new structure is aimed at ensuring that we work on an even more results-oriented basis in the early phase of our research programs and are in principle guided more closely by our product portfolio in the choice of research projects,” Chairman Joerg Reinhardt said during the company’s Annual General Meeting in 2023.

“For us, it is primarily about better integrating promising molecules from the early phase of our research into the development organization, so they can be included more quickly in clinical trial programs,” he detailed.

This approach is set to spur innovation even more. Novartis is already among the world’s most innovative medicine companies in the world, having developed more than 40 new drugs in the past 20 years. With an annual research and development budget of some 9 billion US dollars and several thousand scientists and clinical experts in centers such as Basel, Cambridge, Emeryville and San Diego, the momentum is thus set to accelerate.

Success, however, will still depend on how well scientists and clinicians communicate with each other. “Besides setting up a new structure as part of our project, what also happened was that NIBR and GDD got to talk and work together much earlier than would normally be the case,” said Nicholas Webb. “This probably made all the difference and may do so going forward.”

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