AT A GLANCE
Meet Mike
- 30 years of industry experience
- Previously Managing Director, Life Sciences at Accenture and CIO, R&D IT at Merck
- Career-long commitment to digital innovation in the life sciences
CONNECT
“Phones DOWN.”
On day one of the 2023 Digital CMC Summit, the morning’s featured panel discussion started with an unflinching announcement from the moderator.
“Smartphones away. This is a conversation. It WILL be interactive.”Â
For many of us who’ve met Mike Stapleton, this came as no surprise. Not his candor and certainly not his leadership and insight over the next hour of thought-provoking discussion.Â
Recognized across the industry for his dynamic insight, Mike is a true life sciences luminary who has helped shape the industry’s continuing journey toward digital transformation. For us at QbDVision, he has also been a longtime advisor for our business and a valued voice in countless critical decisions.Â
Now, we’re proud to announce that he has joined the QbDVision board of directors. And if the Digital CMC Summit is any indication, it’s the start of a bold new chapter for our team, technology, and the Digital CMC movement.
“You see a lot in 30 years. But you’ve never seen it all.”
A distinguished leader in every way, Mike brings over 30 years of industry experience and a track record of success to his role as board director. He’s spent those decades at the forefront of digital innovation in our industry.
After all that time, there’s one thing Mike will say about drug development transformation: No matter how much you’ve seen, you’ve never seen it all.
“In many ways, the drug development industry may change relatively slowly,” Mike notes, “But it is always evolving. And that’s one of the best parts of being in this space. You get to see how science, medicine, business and technology grow and change together.”Â
Few leaders can say they’ve seen as much: Mike not only has an extensive background in the life sciences, but also in software, consumables, instruments, services, and consulting. Across his many roles, he has proven his ability to drive industry transformations and deliver results.
“In many ways, the drug development industry may change relatively slowly – but it is always evolving. And that’s one of the best parts of being in this space. You get to see how science, medicine, business and technology grow and change together.”
Among his many accomplishments, Mike developed and managed Accenture’s North America Life Sciences innovation practice, developed and deployed novel cloud-based data and analytics offerings at Merck, and built and led PerkinElmer’s scientific software business. In each of those roles, he saw many consistent themes in the life sciences’ digital evolution.Â
“Of course every organization has its own unique advantages and challenges when it comes to business transformation,” Mike observes, “but in the life sciences, there are long-term trends and enduring forces that define our whole industry’s journey to digital maturity.”Â
“And they’re exactly what QbDVision is focused on, and exactly where I hope to see us push the whole industry forward.”
First stop: The cloud
The next frontier Mike aims to fully open for drug developers: virtual data infrastructure.Â
“When you look at most other science or engineering-led industries, you see a robust ecosystem of cloud-native organizations and supporting vendors,” Mike notes. “But historically, drug developers have struggled with the organization and adaptation needed to fully leverage the cloud. That’s changing, but there’s a lot of work to be done.”Â
"QbDVision is building cutting-edge data architecture on best-in-class cloud infrastructure from providers like AWS. In many ways we’re creating the playbook for cloud adoption by technical and process development programs.”
The potential is immense: As cloud pioneers like AWS have shown, virtualizing drug development’s data infrastructure can save significant costs, connect information silos, and capture substantial efficiencies across their business. So long as they can navigate the skills gaps and unmanaged data lakes that often stand between drug developers and successful cloud migration.
The secret to the industry’s cloud adoption so far: the small number of organizations that have come together to inform and create standards for cloud infrastructure in the life sciences.Â
“Oracle, Microsoft, AWS, Google, Veeva, Salesforce – all these organizations have made a concerted investment in helping healthcare and life science customers reach the cloud,” Mike points out. “But while all of these providers have figured out how to build a cloud for life sciences, their success has always depended on a few pioneering companies leading the adoption charge.”
But while drug discovery and clinical development have found their pioneers, CMC programs are still working to catch up – and QbDVision is stepping up to help.
“We’re building a cutting-edge data architecture on best-in-class cloud infrastructure from providers like AWS,” Mike adds, “and in many ways we’re creating the playbook for cloud adoption by technical and process development programs.”
“That gives us the opportunity to be the driving force behind real, impactful advances in the drug development cycle.”
“Look at the industry’s digital roadmap, and you still see a lot of unknowns.”
While great potential lies ahead, Mike is quick to note that many steps in the industry’s digital roadmap are still uncertain at best.Â
“There are a number of fundamental questions that still need to be answered and foundational decisions that still need to be made,” Mike observes. “What data model will we standardize on to enable automation and AI? How will digital regulatory submissions ultimately take shape? What’s the best way to incentivize cultural shifts in businesses that want to be more data-centric?”
“With these big, essential questions,” he adds, “it’s not about how we solve them, technically speaking – no one platform will be the answer. The most important part is who will solve them. Who will be the leaders from the industry, scientific, and regulatory communities who step up to invest in the kind of collaboration that these answers will require?”
"With these big, essential questions,” he adds, “it’s not about how we solve them, technically speaking – no one platform will be the answer. The most important part is who will solve them."
That’s where he believes the Digital CMC community can play a critical role in helping advance transformation in the drug development process. He hopes to see the movement attract more and more innovators who will sustain and advance the kinds of forward-thinking discussions started at the Digital CMC Summit.Â
“We need leaders to step up and invest the time, thinking, and funds that will ultimately help us all deliver tangible results – like a standardized data model, like automatable regulatory submissions.” QbDVision is already doing so, he notes, but many more collaborative minds will be needed to develop fundamental models, approaches, and frameworks that the whole industry can unite around.Â
“I’m excited for QbDVision to be a leader in the Digital CMC endeavor,” Mike adds. “But navigating the many uncertainties in this process will take many, many more allies and partners.”
“Ultimately, it’s all about making drug development more efficient and effective.”
As Mike is always quick to note, every strategy and solution we develop needs to be grounded in patients’ needs – and what patients need most is new effective therapies, developed and delivered as efficiently as possible.Â
“One of the most exciting things about QbDVision,” Mike notes, “is that it’s directly focused on both the biggest challenges and the biggest opportunities in our industry today.”
“In the life sciences, we all know that patient-centricity is key, and that for us that means more, better, and more efficiently developed drug products. QbDVision puts that goal squarely in reach. It’s the scalable, cloud-based, data-centric framework drug developers need to put modern digital momentum behind their new innovations.”
As top biotech companies and cutting-edge biomanufacturers have all discovered, that momentum can help streamline and accelerate numerous critical areas of the drug development process – from tech transfers, to regulatory processes, to platform and franchise PLM. And with Mike’s guidance, we couldn’t be more excited to bring that kind of performance to more of our industry’s innovators.
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