Building The Digital Biotech Company

My first leadership roles in the biopharma industry were within a large pharma company. This was a phenomenal experience. I gained a strong understanding of how organizational infrastructures support established, global R&D, manufacturing and commercial enterprises to advance medicines to help patients. But I also saw how silos of information, a blend of analog processes and digital ones, and a lack of integration among heterogeneous systems and geographic locations led to many lost opportunities.

When I became CEO of bioMérieux, I inherited a global diagnostics company that was built, in large part, through a series of acquisitions since the company’s founding in 1963. The resulting patchwork was fraught with similar challenges facing pharma.

At the same time, some very powerful IT advancements were coming on the scene. I felt confident that incorporating new, creative IT solutions could help solve some of bioMérieux’s business and operational challenges. I needed a seasoned, imaginative IT exec to lead the way. Given limited expertise within the life sciences industry for the type and scale of digitization I was envisioning, I turned to the tech world. I hired Marcello Damiani out of Motorola. A year after joining bioMérieux, Marcello would become Chief Information Officer. My mission for Marcello: transform bioMérieux’s information flow, processes and infrastructure through digitization.

When I decided to leave bioMérieux – which at the time had 6,000+ employees, a market cap of €2.5 billion, and sales of more than €1.3 billion – to become the second employee at a stealth start-up called Moderna, some people thought I was a little crazy. I thought I was a little crazy.

But I also thought that Moderna was a once-in-a-lifetime opportunity. If ever there was a blank slate, it was building this specific company. While, historically, the scientific community recognized the possibilities if mRNA could be used as a therapeutic, nobody had ever figured out a way to do it. And the concept had been all but abandoned. But when Noubar Afeyan shared some of the initial data with me, I immediately saw that with Moderna’s technology the notion of using mRNA as a drug might just be possible. And, if successful, we had the chance to help many patients with many diseases.

"Based on my past experiences, one thing was very clear to me from day one. Infusing digitization from the ground up was not only an opportunity but a requirement if this company was going to succeed."

Once again, I turned to Marcello and asked him to join me as Moderna’s Chief Digital Officer. My mission for him this time: build THE digital biotech company.  

In our latest white paper, Marcello explores what being digital means for Moderna – and why and how it is a key enabler to advancing our Mission. 

In this post, I thought I would touch on the digitization drivers Marcello outlines in the white paper.  They are key to understanding Moderna’s goal to become The Digital Biotech Company – and why ‘digital’ is not just a buzzword for us.

Digitization Drivers

There are four key drivers that have compelled both our need and our ability to be fully digital:

1. Software-Like Nature of mRNA Technology

Using the same role mRNA natively plays in the human body trillions of times a day, our mRNA medicines are sets of instructions that we deliver to cells in the body. The body’s own cells then produce the proteins needed to prevent or fight disease. mRNA is the software of life – so the very essence of our medicines is digital. For each mRNA medicine, we are encoding for one or more mRNA molecules.

The software-like, digital nature of mRNA is its distinguishing characteristic in a sea of scientific and drug technology approaches. It is also the guiding factor by which we have built and continue to build the entire company. 

2. Modality-Centric Platform to Ensure Repeatability

We built a modality-based platform to promote the repeatability an mRNA approach should allow due to its software-like nature. By building a repeatability-enabling technology platform, we are starting to see our belief about the promise of mRNA translate to reality.

We combine key platform components – Chemistry, Bioinformatics, mRNA Engineering, Process, and Formulation – to develop toolkits called modalities. Once we determine how to configure a given modality to create an mRNA medicine, we can then use that same modality to create a family of medicines for different diseases. Just about the only thing that changes from medicine to medicine within a modality is the protein/s for which each medicine encodes. Most everything else remains the same.

"As an example of the speed and scale enabled by our modality-centric platform, we started to pursue prophylactic vaccines in 2014. At the start of 2017, we had eight prophylactic mRNA vaccines in our development pipeline, four already in clinical study and four advancing toward the clinic."

With our four development modalities and three research modalities – all of which have been created using our single scientific and drug technology platform – we are advancing mRNA vaccines and therapeutics for many diseases.  This approach and capability is quite distinct in our industry.

Digitization is the backbone upon which we have built our platform. It is both an enabler of our science and core to our science.

Incidentally, for a great read on the design, benefits and success stories of repeatable business models, I highly recommend Repeatability: Build Enduring Businesses for a World of Constant Change, by Chris Zook and James Allen.

3. Business Strategy: Massively Parallel R&D, Ecosystem Model

Given the software-like nature of our technology and the repeatability enabled by our platform, our business strategy is to advance a broad array of mRNA medicines for many disease simultaneously. To execute on this strategy, we have created a unique ecosystem that enables parallel progress and shared learnings.

Across our ecosystem, scientists within Moderna, scientists at our pharma partners and a bevy of academic collaborators are progressing dozens of mRNA R&D programs concurrently – all leveraging our platform.

This model is eliciting a network effect on two levels: 1.) within a modality; and 2.) between and among modalities. In both cases, scientists have access to real-time data readouts and information, and the resulting shared learnings are accelerating R&D efforts.

Digitization is enabling seamless integration across the ecosystem, the ability to share and access data in real time, the capability to scale, and the ability to meet ever-increasing demands for mRNA for both research purposes and clinical studies.

4. Embracing the IT Revolution

When I consider the advancements we’ve seen of both life sciences technologies and digital technologies from when I joined bioMérieux in 2006 to today, it is truly mind-blowing. In the span of just a decade or so, it already feels like we’re living in a completely different era.  

On the life sciences front, without advancements like human genome and proteome sequencing and next-gen sequencing, a mRNA approach wouldn’t even be feasible.

On the digital front, we have fully embraced several digital technologies (Cloud, Robotics, Artificial Intelligence, etc.) to create our infrastructure, support our ecosystem and advance our pipeline.

Moderna’s Digitization Blocks

The six digitation blocks we are employing individually and collectively enable the highest quality mRNA, scalability, speed and cost efficiencies. In some areas, we are relying on externally sourced technologies. Because ‘off the shelf’ solutions are often not an option for Moderna, we have built amazing internal bioinformatics and engineering teams who have created and continue to create a number of proprietary apps and automated solutions.  

• Cloud

• Integration (Business Processes)

• Internet of Things

• Automation

• Analytics

• Artificial Intelligence

In the digital white paper, Marcello further explores these digitization blocks and the specific benefits they bring to us.  In subsequent white papers, we plan to dig deeper into our specific digital implementation efforts across our Research Engine, Early Development Engine and personalized cancer vaccines.

Progress Enabled by Digital

Six years into the Moderna experiment we’ve accomplished a great deal.

As announced at the start of the year, we have 12 development candidates (DCs) across three therapeutic areas, 5 clinical studies underway, and seven DCs advancing toward the clinic. We also have multiple research programs advancing toward DC nomination.

I can say definitively that this progress and our efforts to help patients by delivering on the promise of mRNA medicines would not be possible without Marcello’s leadership and the accomplishments that he and his team have achieved in building a digital infrastructure tailored to Moderna.   

I often say that we are playing a very long game at Moderna. Digitization is a core pillar of our long-term vision and how we plan to mature our company through a 20-year innovation cycle. Where we will be in ten, even five years from now advancing our mRNA medicines, I can only imagine. But if the past six years are any indication, I can’t wait to see.