Interview: Mike Stapleton Outlines His Vision for the Next Frontier of Digital Drug Development

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.” 

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

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. 

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.” 

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. 

“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.” 

“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. 

“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.” 

"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. 

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. 

“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

“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. 

“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. 

“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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Vijay Raju

Vice President, CMC Management, Flagship Pioneering

Vijay currently leads CMC activities to deliver on Pioneering Medicines portfolio. The portfolio is built on Flagship Pioneering’s bio-platforms covering multiple modalities (small molecules, biologics, cell & gene therapies). Vijay was previously in technical leadership roles at Novartis.

Greg Troiano

Head of cGMP Strategic Supply & Operations, mRNA Center of Excellence, Sanofi

Greg serves as Head of cGMP Strategic Supply and Operations at the mRNA Center of Excellence at Sanofi, where he is responsible for all aspects of clinical production and raw material supply chain. He joined Sanofi via acquisition of Translate Bio, where he was Chief Manufacturing Officer and responsible for Technical Operations. Over his 20+ year career in the drug delivery field, Greg had various roles leading the pharmaceutical development of complex formulations, including numerous nano- and microparticle based systems. Greg received his MSE and BS in Biomedical Engineering from The Johns Hopkins University and was elected and inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows in 2020 for recognition of his accomplishments in drug delivery.

Pat Sacco

Senior Vice President Manufacturing, Quality, and Operations, SalioGen

Pat is a Biotechnology technical operations executive with 30+ years of experience leading and managing technical operations functions at numerous innovative companies in the biotech and life sciences industries. He has a passion for advancing and implementing best practices in pharmaceutical manufacturing.

Diana Bowley

Associate Director, Data & Digital Strategy, AbbVie

Diana is the Associate Director, Data & Digital Strategy in S&T-Biologics Development and Launch leading the organization’s Digital Transformation since October 2021. She joined AbbVie in 2012 in the R&D-Discovery Biologics group focused on antibody and multi-specific protein screening and engineering, leading multiple programs to the cell line development stage. In 2017 she joined Information Research and led a team of IT professionals who supported AbbVie’s Discovery Scientists in Biotherapeutics, Chemistry, Immunology and Neuroscience. She has a PhD in Molecular Biology from The Scripps Research Institute and Bachelor of Science in Chemistry from The University of Northern Iowa.

Robert Dimitri, M.S., M.B.A.

Director Digital Quality Systems, Thermo Fisher Scientific

Robert Dimitri is a Director of Digital Quality Systems in Thermofisher’s Pharma Services Group. Previously he was a Digital Transformation and Innovation Lead in Takeda’s Business Excellence for the Biologics Operating Unit while leading Digital and Data Sciences groups in Manufacturing Sciences at Takeda’s Massachusetts Biologics Site.

Devendra Deshmukh

Global Head, Digital Science Business Operations, Thermo Fisher Scientific

Devendra Deshmukh currently leads Global Business Operations for Digital Science Solutions at Thermo Fisher Scientific. In this role he oversees operations broadly for the business across its product portfolio and leads the global professional services, technical support, and product education teams.

Grant Henderson

Sr. Dir. Manufacturing Science and Technology, VernalBio

Grant Henderson is the Senior Director of Manufacturing Science and Technology at Vernal Biosciences. He has years of expertise in pharmaceutical manufacturing process development/characterization, advanced design of experiments, and principles of operational excellence.

Ryan Nielsen

Life Sciences Global Sales Director, Rockwell Automation

Ryan Nielsen is the Life Sciences Global Sales Director at Rockwell Automation. He has over 17 years of industry experience and a passion for collaboration in solving complex problems and adding value to the life sciences space.

Shameek Ray

Head of Quality Manufacturing Informatics, Zifo

Shameek Ray is the Head of Quality Manufacturing Informatics and Zifo and has extensive experience in implementing laboratory informatics and automation for life sciences, forensics, consumer goods, chemicals, food and beverage, and crop science industries. With his background in services, consulting, and product management, he has helped numerous labs embark on their digital transformation journey.

Max Peterson​

Lab Data Automation Practice Manager, Zifo

Max Petersen is the Lab Data Automation Practice Manager at Zifo responsible for developing strategy for their Lab Data Automation Solution (LDAS) offerings. He has over 20 years of experience in informatics and simulation technologies in life sciences, chemicals, and materials applications.

Michael Stapleton

Board Director, QbDVision

Michael Stapleton is a life sciences leader with success spanning leadership roles in software, consumables, instruments, services, consulting, and pharmaceuticals. He is a constant innovator, optimist, influencer, and digital thought leader identifying the next strategic challenge in life sciences, executing and operationalizing on high impact strategic plans to drive growth.

Matthew Schulze

Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering

Matt Schulze is currently leading Digital for Pioneering Medicines which is focused on conceiving and developing a unique portfolio of life-changing treatments for patients by leveraging the innovative scientific platforms and technologies within the ecosystem of Flagship Pioneering companies.

Daniel R. Matlis

Founder and President, Axendia

Daniel R. Matlis is the Founder and President of Axendia, an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues. He has three decades of industry experience spanning all life science and is an active contributor to FDA’s Case for Quality Initiative. Dan is also a member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials and co-chaired the Product Quality Outcomes Analytics initiative with agency officials.

Kir Henrici

CEO, The Henrici Group

Kir is a life science consultant working domestically and internationally for over 12 years in support of quality and compliance for pharma and biotech. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE – she currently serves on the PDA Regulatory Affairs/Quality Advisory Board

Oliver Hesse

VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals

Oliver Hesse is the current VP & Head of Biotech Data Science & Digitalization for Bayer, based in Berkeley, California. He has a degree in Biotechnology from TU Berlin and started his career in a Biotech start-up in Germany before joining Bayer in 2008 to work on automation, digitalization, and the application of data science in the biopharmaceutical industry.

John Maguire

Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence

With over 18 years of process engineering experience, John is an expert in the application of process engineering and operational technology in support of the production of life science therapeutics. His work includes plant capability analysis, functional specification development, and the start-up of drug substance manufacturing facilities in Ireland and the United States.

Chris Kopinski

Business Development Executive, Life Sciences and Healthcare at AWS

As a Business Development Executive at Amazon Web Services, Chris leads teams focused on tackling customer problems through digital transformation. This experience includes leading business process intelligence and data science programs within the global technology organizations and improving outcomes through data-driven development practices.

Tim Adkins

Digital Life Science Operations, ZÆTHER

Tim Adkins is a Director of Digital Life Sciences Operations at ZÆTHER, serving the life science industry by assisting companies reach their desired business outcomes through digital IT/OT solutions. He has 30 years of industry experience as an IT/OT leader in global operational improvements and support, manufacturing system design, and implementation programs.

Blake Hotz

Manufacturing Sciences Data Manager, Sanofi

At Sanofi’s mRNA Center of Excellence, Blake Hotz focuses on developing data ingestion and cleaning workflows using digital tools. He has over 5 years of experience in biotech and holds degrees in Chemical Engineering (B.S.) and Biomedical Engineering (M.S.) from Tufts University.

Anthony DeBiase

Offering Manager, Rockwell Automation

Anthony has over 14 years of experience in the life science industry focusing on process development, operational technology (OT) implementation, technology transfer, CMC and cGMP manufacturing in biologics, cell therapies, and regenerative medicine.

Andy Zheng

Data Solution Architect, ZÆTHER

Andy Zheng is a Data Solution Architect at ZÆTHER who strives to grow and develop cutting-edge solutions in industrial automation and life science. His years of experience within the software automation field focused on bringing innovative solutions to customers which improve process efficiency.

Sue Plant

Phorum Director, Regulatory CMC, Biophorum

Sue Plant is the Phorum Director of Regulatory CMC at BioPhorum, a leading network of biopharmaceutical organizations that aims to connect, collaborate, and accelerate innovation. With over 20 years of experience in life sciences, regulatory, and technology, she focuses on improving access to medicines through innovation in the regulatory ecosystem.

Yash Sabharwal​

President & CEO, QbDVision

Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.

Joschka Buyel

Senior MSAT Scientist at Viralgen, Process and Knowledge Management Scientist at Bayer AG

Joschka is responsible for the rollout and integration of QbDVision at Bayer Pharmaceuticals. He previously worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.

Luke Guerrero

COO, QbDVision

A veteran technologist and company leader with a global CV, Luke currently oversees the core business operations across QbDVision and its teams. Before joining QbDVision, he developed, grew, and led key practices for international agency Brand Networks, and spent six years deploying technology and business strategies for PricewaterhouseCoopers’ CIO Advisory consulting unit.

Gloria Gadea Lopez

Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering

Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.)

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