Meet our new Chief Business Officer: Industry Luminary Mike Stapleton

After joining our board last year, Mike is officially on our leadership team

For the global drug development community, Mike needs no introduction. He’s a digital pioneer, an insightful advisor, a leading voice for life science innovation, and, of course, a luminary presence at industry events like the Digital CMC Summit

Just 12 months ago, we were thrilled to have him join our board to help shape the strategic vision for QbDVision. And now, he’s taking another big new step with us as he moves from an advisory role to a leadership one: QbDVision’s Chief Business Officer.

“After joining the board, there was simply no way I wasn’t going to get more involved,” Mike states. “The opportunities QbDVision is creating are just immense. I couldn’t be more excited to pursue them with this exceptional team.”

It might just be the buzz from the last Digital CMC Summit, but we couldn’t agree more. 

Welcome, Mike!

From helping shape our roadmap to driving our continued growth

During his time on the QbDVision Board of Directors, Mike swiftly made a major impact on the trajectory of our business. It took him just a few months to strengthen critical partnerships, open dozens of new doors, and spark rich new cross-functional collaborations.

And now, fresh capital in hand, he’s poised to take us even further.

“In just the last year, Mike has already played a pivotal role in scaling our strategy for expanding market penetration and boosting adoption of Digital CMC methodologies,” says our CEO, Yash Sabharwal. “His new leadership position is purpose-built to plug his insight, experience, and network directly into our growth engine. We can feel the propulsion already.”

That unique hybrid role will harness Mike’s unique blend of strategic acumen, hands-on team-building skills, and respected industry profile. As our CBO, he’ll focus on developing and executing a comprehensive vision for QbDVision’s market leadership.

“He’s exactly who we need to help us reach the next level of performance, strategically, operationally, and commercially,” adds our co-founder and CTO Ryan Shillington. “We’re incredibly proud to have someone with his industry profile on our leadership team.”

“In just the last year, Mike has already played a pivotal role in scaling our strategy for expanding market penetration and boosting adoption of Digital CMC methodologies, His new leadership position is purpose-built to plug his insight, experience, and network directly into our growth engine. We can feel the propulsion already.”

Fostering new industry collaborations to accelerate CMC transformation

Project Artemis, a groundbreaking initiative announced at the 2025 Digital CMC Summit, will keep Mike especially busy. He’ll serve as a critical leader for the Digital CMC Consortium, a working group focused on fostering the pre-commercial collaboration needed to gestate data standards, shared process definitions, and many other frameworks essential to modern industry. Mike will be at the forefront of these efforts.

“Whether it’s new IT infrastructure, a fresh talent base, or a company’s first knowledge graph, nothing beats building the foundations,” Mike believes. “Throughout my career, that’s always been what I loved most. And that’s exactly what we’re doing for the CMC space: We’re bringing the right people together to create the foundations of modern technical development.”

With Project Artemis, he’ll work closely with an exclusive group of innovative organizations to tackle some of the most multifaceted complexities of the CMC ecosystem. He and the Digital CMC Consortium will tackle challenges in data management, knowledge sharing, regulatory compliance, technology integration, standardization, and more.

The most exciting part, Mike asserts: the focus on developing real, tangible, sustainable solutions. “As we welcome each new member of the Consortium,” Mike explains, “we make it very clear that we’re not here to discuss why or where CMC needs to evolve. We’re past that. Project Artemis is about how we’ll make that evolution possible: usable tools, accessible resources, and consistent standards that help make Digital CMC achievable industry-wide.”

“It’s a once-in-a-career opportunity to lay the groundwork for an entirely new era of our field,” he notes. “Not the kind of thing you pass up.”

A key growth driver in Mike’s sights: Deepening consultancy partnerships

Another key focus of Mike’s new role: Our thriving and fast-growing collaborations with ZAETHER, Accenture Life Sciences, Zifo, ZS, and other industry-leading consultancies. 

“These organizations are playing an increasingly vital role in enabling and facilitating CMC transformation for drug developers, especially at the enterprise level,” notes Yash. “For them, QbDVision is a critical piece of the strategy they rely on to implement Digital CMC strategies for their customers. I’m excited to see Mike further develop and expand these partnerships.”

For Mike, product-implementer team-ups are increasingly essential in an evolving CMC ecosystem where no one organization can unlock sustainable transformation for drug developers. 

“It’s a puzzle that still has many different pieces,” Mike observes, “and working with teams like ZAETHER and Accenture is a powerful way to bring many of those pieces together for our shared customers: the cutting-edge capabilities, the proven implementation strategies, and the guidance on how to make it all stick.” 

In the coming quarters, Mike will also aim to expand our range of consultancy partners to include many other groups eager to help break an urgent bottleneck in the drug development process. “The industry knows CMC needs to transform, and transform yesterday,” Mike notes. “We’re seeing lots of interest in being part of that effort.”

“The CMC ecosystem is a puzzle with many different pieces. Working with our consultancy partners is a powerful way to bring many of those pieces together for our shared customers: the cutting-edge capabilities, the proven implementation strategies, and the guidance on how to make it all stick.”

“There’s no standing still in this market. And the QbDVision team is ready to go the distance.”

As confident as he is in QbDVision’s future, Mike is all too aware of the many complexities that lie ahead: regulatory pressures, uncertain capital markets, shifting drug development workforces. The head-spinning pace of AI development. And he’s ready to help us tackle them. 

“You can’t pursue game-changing opportunities without navigating significant risks,” Mike points out. “They’re always dealt in the same hand. But with this product and this team, I’m fully confident that great successes are waiting—especially with the critical role QbDVIsion is now playing in the industry’s race to AI enablement. Our platform is fast becoming the foundation of that effort for drug developers industry-wide.”

“The next few years will be a turning point for drug development, a time when industry-scale forces finally drive technical science to catch up with medical science,” Yash adds. “Mike has a strong, clear vision for the future of CMC, and our place in it. That’s exactly what we need for the next chapter of QbDVision.”

We can’t wait to see where it takes us!

GET IN TOUCH

Want to learn more about what’s next for QbDVision?

Get in touch and we’ll be happy to share more about our product, our roadmap, and our vision for Digital CMC.

Tina Beaumont

Managing Director, Life Sciences Strategy, Accenture

Tina is a Managing Director in Accenture’s Life Sciences Strategy practice with over 15 years experience in the industry. 

Tina is a transformation leader and helps her clients to architect and implement complex enterprise programs, including digital and process transformations, strategic cost take-out programs, change management and process re-design & engineering.

2019 Philadelphia Business Journal Minority Business Leader Award, 2023 Healthcare Business Association Rising Star Honoree, 2025 Bryn Mawr Health Foundation Board Member.

Whitney Pung

Life Sciences Strategy & Consulting, Accenture

Whitney has dedicated her career to helping large biopharma companies accelerate new product introduction with Digital CMC and PLM capabilities.

Her passion lies within the democratization of data; enabling powerful product and process knowledge to seamlessly span early discovery through commercial manufacturing and quality.

Tommy Cronin

Digital Technical Manager, AbbVie

Experienced Technical Leader with many years of GMP pharmaceutical experience in multiple roles such as Technology Transfer Lead, Process Chemistry, Process engineering, Validation and QC analytical.

Delivery of NPI technology transfers and commercial product continuous improvement projects working with all levels within an organization.

Passionate about maximizing the use of data and digital tools to support pharmaceutical manufacturing and tech transfer.

Christoph Pistek

Vice President, Head of Sustainability and Technology, R&D, Takeda

Christoph Pistek is a senior pharmaceutical executive with 20 years of experience across the full continuum of the pharmaceutical product lifecycle. With an interdisciplinary engineering background, deep expertise in technology operations, and a strong foundation in business administration, he applies a holistic and strategic approach to pervasive change.

As Vice President, Head of Sustainability and Technology, R&D at Takeda, Christoph currently is accountable for large-scale global innovation, advancing emerging capabilities and novel approaches in drug discovery and development, while ensuring alignment with Takeda’s Net-Zero objectives.

His career is defined by end-to-end transformation across Research, CMC, Manufacturing, Quality, Regulatory, and Supply Chain, seamlessly integrating business excellence principles and technological advancements to accelerate efficient and scalable pharmaceutical operations.

Kevin Healy

CRO at Datahow LLC.

Kevin Healy brings over three decades of Pharmaceutical process development and manufacturing ranging from process optimization in plants, design-build of end-to-end bioprocesses from R&D through manufacturing scale to this topic of hybrid process modeling.  Over the last decade he has taken his real-world process knowledge and applied it to the digitalization of Pharmaceutical and other related Life Sciences processes.  

Kevin has an MS in engineering from Drexel University and is currently the CRO for DataHow.  DataHow has pioneered the development of AI-powered bioprocess models and methods and applied them to bioprocess development objectives.

Devendra Deshmukh

Head of Strategy, Product, & Partnerships, Thermo Fisher Scientific – Digital Science

Devendra has enjoyed a rich career on both the sell and buy sides of technology products and services, primarily within the life and laboratory sciences sectors.

Currently with Thermo Fisher Scientific, Devendra leads strategy, product management, marketing, and strategic partnerships for Digital Science. In this role, Devendra focuses on delivering innovative solutions to the biopharmaceutical industry, developed by Thermo Fisher as well as through a robust partner ecosystem, aimed at accelerating scientific progress and enhancing productivity from molecule discovery to medicine development.

Before joining Thermo Fisher Scientific, Devendra held leadership positions including GM for AlinIQ Global Services & Support at Abbott Diagnostics, leader of the Scientific Informatics practice in Boston at Accenture, Executive Director for Global Research IT at Merck, and VP and GM for PerkinElmer Informatics.

Lewis Shipp

Digital CMC Specialist, QbDVision

Pharmaceutical scientist and expert in drug development & manufacturing across various therapeutic areas. Currently a Digital CMC Specialist at QbDVision, helping global pharma/biotech companies streamline CMC workflows to accelerate therapy delivery.

Mike Greene

Principal Engineer – TS/MS Digital Strategy, Eli Lilly and Company

Mike Greene is currently Principal Engineer – Technical Services Digital Strategy at Eli Lilly and Company where he serves as the technical subject matter expert on Product Lifecycle Management (PLM), bringing together his expertise in process control strategy across modalities and networks with his passion for transformational digital initiatives. Previously, he worked on various global cross-functional initiatives supporting Quality, Manufacturing and Technical Services including data criticality assessments for multiple modalities of API, Drug Product, Device Assembly, and Packaging processes across over 10 sites. He began his career as a frontline Technical Services engineer supporting mAb API production and SME on select unit operations and instruments. Mike graduated from Purdue University with his bachelor’s degree in Chemical Engineering and in his free time enjoys hiking and exploring the wilderness with his friends and family as well as on solo adventures.

Bill Pasutti

Associate Director of Data Science, AskBio

Bill has worked in the pharmaceutical industry for over 15 years in R&D and process development at Merck, Novartis, and AskBio. In his current role as Associate Director of Data Science, he leads a company-wide effort in creating digital road maps and connecting data sources within pre-clinical manufacturing, process development, and MSAT. His efforts are meant to improve communication and collaboration through digitalization and promote data-driven decision-making.

Victor Goetz

PhD, Executive Director, TS/MS New Modalities and Data Strategy, Eli Lilly and Company

Victor is the Executive Director of Technical Services New Modalities and Data Strategy at Eli Lilly and Company. Leveraging his 35 years of industry experience in developing and commercializing nine novel medicines to enhance the exchange of knowledge needed to speed delivery of new medicines to patients. Previous to Lilly, he held process development, manufacturing support, and laboratory automation roles at Merck and holds a BS in chemical engineering from Stanford University and a PhD in chemical and biochemical engineering from the University of Pennsylvania.

Isabel Guerrero Montero

MSAT USP Senior Scientist, Viralgen Vector Core

Isabel currently works at Viralgen Commercial Therapeutic Vector Core as an MSAT Scientist part of the Technology Transfer team. She has years of experience in molecular biology, cell culture and fermentation research with industrial experience as an Upstream Technician responsible for batch record writing and reviewing.

Vijay Raju

VP of CMC

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.

Andy Zheng

Data Solution Architect, ZAETHER

A Data Solution Architect working at ZAETHER who strives to grow and develop cutting edge solutions in industrial automation and life science. Andy has 5+ years of experience within the software automation field providing innovative solutions to customers which improve process efficiency.

Tim Adkins

Director of Digital Life Sciences 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.

Ravi Medandravu

Associate Vice President, Manufacturing and Quality Tech, Eli Lilly and Company

Ravi Medandravu is a seasoned healthcare executive with over 20 years of experience in the pharmaceutical and medical device industries, specializing in global market access and health economics. He has successfully led teams to develop and implement strategies that enhance patient access to innovative therapies worldwide.

Barbara Tessier

Technical Project Lead, invoX Pharma

A great opportunity to connect with like-minded professionals in the pharma industry who are passionate about digital tools like QbDVision. Learning about advancements in Digital CMC, tech transfer, and AI in the pharma sector broadened my understanding and inspired me to explore innovative approaches in my work.

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.

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.

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.

Laurent Lefebvre - Headshot

Laurent Lefebvre

RA CMC Director, Novartis

Laurent is the Director of RA GDD CMC at Novartis. With over 10 years of experience working as a worldwide Regulatory CMC Project Lead on blockbuster brands, he is an expert in the entire CMC product lifecycle in global regulatory environments. Laurent has been a core team member of the Novartis Regulatory Strategy and Intelligence for IDMP since 2014 and a member of the EFPIA ICH M4Q support team. He is involved in regular collaborations cross-industry (IDMP roundtables, Pistoia Alliance), digital initiatives (RIM structured authoring, master data & PLM), reviewer of the ISO IDMP guidelines and a Novartis contributor to regulatory intelligence discussions.
Laurent Lefebvre - Headshot

James Maxwell

Life Sciences Innovation Lead, Accenture

James Maxwell is an Innovation Lead at Accentures Global Centre for R&D and Innovation. He leads strategic innovation programs with global Life Sciences organizations to solve challenges, rapidly prototype and prove value for future solutions across the end-to-end Life Sciences value chain. With a background in design, research and innovation strategy he has worked with multiple organizations to take an innovation approach for solving challenges across CMC.
Paul Denny-Gouldson - Headshot

Paul Denny-Gouldson

CSO, Zifo

Paul is the CSO at Zifo RnD Solutions, a global specialist scientific and process informatics service provider working across research, development, manufacturing and clinical domains. He obtained his Ph.D. in Computational Biology from Essex University in 1996 and started his career as a Post Doc, and subsequently Senior Scientist at Sanofi-Synthelabo Toulouse (now Sanofi) for five years, where he managed a multidisciplinary molecular and cell biology department. He has also founded a number of companies focused on combining science, technology and business, and authored more than 25 scientific papers and book chapters.
Chris McCurdy

Chris McCurdy

Chief Architect of Healthcare and Life Sciences at Amazon Web Services

Chris McCurdy serves as Chief Architect of Healthcare and Life Sciences (HCLS) for Amazon Web Services (AWS), where he leads teams responsible for architecting cutting-edge services, unlocking data assets, and opening novel analytics capabilities for customers. With over 20 years of industry experience, Chris plays a key role in envisioning and developing innovative solutions and services that accelerate customer value while improving patient outcomes.
Isabell Hagemann Headshot - Digital CMC Basecamp - QbDVision

Isabell Hagemann

Scientific Assistant, Biological Development, Downstream, Bayer AG

Isabell Hagemann is a biochemical engineer by training and has worked at Bayer AG in the biological development downstream department in 2017. In that time, she has worked on process development, process characterization, and the technology transfers of several biologics using high-throughput development systems, modeling approaches, and knowledge management tools.

Ganga Kalidindi

Global Head TRD Data Assets & Insights, Novartis

As the Global Head TRD Data Assets and Insights at Novartis, Ganga Kalidindi brings a unique combination of Information Technology and Product Development expertise to delivering in a regulatory landscape. Throughout his career, he has striven to make direct positive impact on business providing leadership that creates cross-functional high-performing teams. Focusing on complex business and technical challenges, leading through change, and creating success that takes programs and companies to a winning status.
Fran Leira Headshot - Digital CMC Basecamp - QbDVision

Fran Leira

Global Head of Process Engineering CoE, CSL Behring

Fran Leira is a biopharma Professional with over 20 years of experience in QC, MSAT/Tech Ops at companies like Genentech, GSK, Merck, and Lonza where he supported Product and Process Lifecycle Management at site-based and global roles. He is currently the Global Head of Process Engineering CoE at CSL Behring.

Florian Aupert Headshot - Digital CMC Basecamp - QbDVision

Florian Aupert

Lab Head, Biological Development, Bayer AG

Florian has a B. Sc. and M. Sc. in pharmaceutical biotechnology with a focus on bioprocess engineering. Since 2018, he’s worked at Bayer AG in Biological Development, concentrating on portfolio program management and tech transfer.

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.

Mark Fish

Managing Director, Scientific Informatics, Accenture

Mark Fish is Managing Director and Global Lead for Accenture’s Scientific Informatics Services Business. Mark has over 25 years of experience in leadership roles in Accenture, Brooks Life Sciences and Thermo Fisher Scientific delivering innovative solutions to the pharmaceutical sector and is passionate about drug discovery and development, translation research and manufacturing transformation. Mark has extensive experience in agile software development, data strategy, process engineering and robotic automation for research, analytical development and quality control in Life Sciences.

Chris Puzzo

Solution Architect, Digital & Data, Zaether

Chris is a Solution Architect with Zaether, focusing on delivering next-generation digital and data solutions for GxP Life Sciences customers. Chris has previously held technical operations roles within multiple gene therapy manufacturers, including Thermo Fisher Scientific’s CDMO organization where he supported various capital projects including the design, build, and startup of new GxP manufacturing capacity.

Victor Goetz, Ph.D

Executive Director, TS/MS New Modalities and Data Strategy, Eli Lilly and Company

Victor Goetz, Ph.D. is the Executive Director of Technical Services New Modalities and Data Strategy at Eli Lilly and Company. He has over 35 years of industry experience in developing and commercializing nine novel medicines to enhance the exchange of knowledge needed to speed the delivery of new medicines to patients. Dr. Goetz holds a BS in chemical engineering from Stanford University and a PhD in chemical and biochemical engineering from the University of Pennsylvania.

Rachelle Howard

Director of Manufacturing Systems Automation and Digital Strategy, Vertex Pharmaceuticals

Rachelle is the Director of Manufacturing Systems Automation and Digital Strategy for Vertex’s Small Molecule Manufacturing Center. She oversees the site Automation Engineering function and has co-led Vertex’s global Digital Manufacturing Transformation program since 2019. She leads several initiatives related to data integrity, data management, and employee education. Rachelle is a graduate of Tufts University and the University of Connecticut where she has degrees in Chemical Engineering and a PhD in Process Control.

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 a Senior Director in the Flagship Digital, IT, and Informatics team, where he leads and manages the digital evolution for Pioneering Medicines. His role is pivotal in ensuring that digital strategies align with the overall goals and objectives of the Flagship Pioneering initiative.

His robust background in digital life sciences includes expertise in applications, informatics, data management, and IT/OT management. He previously spearheaded Digital Biomanufacturing Applications at Resilience, a CDMO start-up backed by Arch, where he established a team responsible for implementing global manufacturing automation systems, Quality Assurance applications, laboratory systems, and data management applications.

Matt holds a B.S. in Biology and Biotechnology from Worcester Polytechnic Institute and an M.B.A. from the Boston University Questrom School of Business, where he focused on Strategy and Innovation.

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, ZAETHER

Tim Adkins is a Director of Digital Life Sciences Operations at ZAETHER, 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

Director of Product Management, QbDVision

Joschka Buyel is the Director of Product Management at QbDVision. He was previously responsible for the rollout and integration of QbDVision at Bayer and 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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