QbDVision and ZAETHER Team Up To Accelerate Digital Transformation

Together, we’re focused on nurturing the nascent transformation of pharma and biotech.

Ask the industry’s digital transformation experts, and they’ll happily tell you: the green shoots have taken root. 

Drug developers and manufacturers are finally achieving real momentum in their efforts to modernize their information infrastructure – albeit often incrementally and with some firm prodding by regulators. The case for “if” is closed. From scrappy startups to global enterprises, it’s all about “when” and “how soon.”

Pharma enterprises, biotech companies, and CDMOs have no time to waste answering those questions. The entire drug product value chain is under intense pressure to innovate faster and deliver sooner – and as McKinsey recently noted, that will mean moving far beyond “scratching the surface” of digital transformation. And doing so… yesterday. 

That will mean overcoming some long-standing challenges. The single biggest one, according to McKinsey’s 2022 report? *Drumroll*

“Lack of integrated data sources” – both existing and new. 

To finally close the digital maturity gap, drug developers and manufacturers need to start with their sprawling, fragmented, semi-structured information ecosystems. And that’s precisely where QbDVision and ZAETHER saw our opportunity to make a transformational difference.

From seeing synergies to harnessing, applying, and amplifying shared expertise

Dig into industry evolution trends, and there’s another thing those transformation experts will quickly tell you: for digital projects and their stakeholders, “pilot” is now a dirty word.

Together, QbDVision and ZAETHER aim to drive transformation initiatives past the usual cut de sacs – isolated trials, limited point solutions, and siloed solution tryouts – and straight to comprehensive evolution of customers’ operating models.

“We’ve known there was a natural fit for some time,” notes Yash Sabharwal, President and CEO of QbDVision, “and we’ve already seen the benefits in multiple customer engagements.” 

The partnership was intuitive from the start: the natural combination of a cutting-edge platform innovator and industry-leading digital enablement know-how. QbDVision and ZAETHER have synergistic expertise that was meant to sync.

“ZAETHER is focused on designing holistic solutions that transform and accelerate drug development and biomanufacturing,” adds John Seffernick, Managing Director at ZAETHER. “Forming a partnership with QbDVision is a clear opportunity to drive unparalleled efficiency, optimization, and compliance for our pharma, biotech, and CDMO clients.”

Now, with transformation in the wings across the industry, it was the perfect time for QbDVision and ZAETHER to take the next step. Together, we offer a powerful, holistic combination of modern information infrastructure and expert implementation strategy – exactly what customers need to move from strategic alignment to real, sustainable modernization.

QbDVision and ZAETHER offer a powerful, holistic combination of modern information infrastructure and expert implementation strategy

Taking aim at some of the biggest challenges in the industry’s information ecosystem

As Yash points out, both QbDVision and ZAETHER knew exactly where to focus: the patchwork of scattered, siloed, analog data sources that continues to hamper transformation efforts for both drug developers and bio-manufacturers. 

“The will to modernize is definitely there now,” he notes. “We’re not having that many ‘is this necessary’ conversations anymore. Today, when we talk to customers about modernizing data management, we’re hearing ‘where do we start’ and ‘how do we make this technically feasible.’”

For QbDVision and ZAETHER, the first answer was clear. To truly accelerate time-to-market – while still protecting regulatory compliance – drug developers and manufacturers need to start with the ways they collect, connect, and leverage their vast knowledge and information resources. 

ZAETHER and QbDVision share a vision for empowering the biotech industry to meet current and future challenges in a human-centered way. We are both focused on enabling clients to be more productive and work more seamlessly and intelligently across processes.

“Using data intelligently starts with consistently structuring data,” John points out. “To harness organizational knowledge in powerful, impactful ways, it has to be organized, contextualized and integrated in ways that facilitate modern data applications,” including automation, predictive analytics, large language models, and more.

Together, QbDVision and ZAETHER offer an ideal set of solutions for customers ready to bring their knowledge and data management practices into the 21st century. It’s the perfect synergy of assets and expertise: state-of-the-art knowledge management tools combined with deep experience navigating the people, process, and technology challenges that come with transforming information infrastructure. 

And when it comes to proving technical feasibility, our two teams also knew exactly where to begin: with one of the most common and critical disconnects in the industry’s knowledge continuum.

“Start by breaking the bottlenecks:” Why we’re focused on the PD/MES transition

At a lot of drug developers and CDMOs, Yash observes, “tech transfers are one of those challenges that everyone just accepts. They’re assumed to be time-consuming and expensive, with a significant margin for error.” 

“At QbDVision and ZAETHER,” he adds, “we don’t accept that.” 

“One of the first goals of our partnership is to show that it’s possible to break that all-too-common bottleneck,” John notes, “to create a truly efficient, digital-first approach to transitioning new drug products from process development to commercial-scale manufacturing.” 

Our collaboration with ZAETHER will allow us to deliver an unprecedented level of connectedness and efficiency to biopharma companies. We look forward to making a substantial positive impact together.

For QbDVision and ZAETHER, the solution starts with identifying the real roots of the challenge: dispersed, poorly structured knowledge, siloed teams, and “tool-first” approaches that often rely on isolated point solutions instead of integrated IT strategies. 

The predictable results: slow and error-prone processes, delayed regulatory submissions, and many other points of friction on the path to market. 

“For far too many new drug products,” Yash says, “the process-to-production roadmap looks like a tough day on the Southern California highway system. But QbDVision and ZAETHER are perfectly positioned to reimagine how therapies can navigate that transition from innovative molecule to commercial product.”

We’ll start by further developing our teams’ shared vision for digital tech transfer processes powered by modern strategies and structures for knowledge management. Those building blocks will enable our customers to seamlessly connect teams, workflows, and data across their information ecosystem – the groundwork for exponentially accelerating key knowledge exchanges and regulatory deliverables.

Digital transformation discussion abound at June 2023's link-up and learn sessions on "Creating a Culture of Digital Change," co-hosted by QbDVision and ZAETHER in Boston

Our new message for customers: Innovation, efficiency, compliance. Why not all three?

Looking ahead, the first key goal of our collaboration is bold but essential: guiding the next phase of customers’ transformation journey by helping them break down information silos, integrating their data resources, and accelerating the development and manufacturing lifecycle. All while maintaining strict alignment with fast-evolving regulatory standards and expectations (including new developments like M4Q(R2)).

It’s a tall order, but this is the combined team that will make it happen, says John. “We both share a vision for empowering the biotech industry to meet current and future challenges in a human-centered way. And we’re both focused on enabling customers to be more productive and work more seamlessly and intelligently across processes.”

With initial joint projects already in development, that vision should begin to deliver tangible value in the very near future. Until then, as Yash notes, there’s excitement all around at both QbDVision and ZAETHER. 

“Our collaboration will allow us to deliver an unprecedented level of connectedness and efficiency to biopharma companies. We look forward to making a substantial positive impact together.”

About QbDVision

QbDVision is the first modern digital CMC workspace: a cloud-based SaaS solution designed to enhance the curation, utilization, and integrity of process development data to accelerate therapies to patients. Developed by a world-class team of drug development experts, QbDVision provides a structured digital framework for integrating CMC workflows, embedding best practices for process design, and managing product and process knowledge.


ZAETHER is the leading digital enabler for organizations developing and manufacturing next-gen biotech products.  Combining knowledge of the industry landscape with an understanding of people and workflows, ZAETHER creates hyper-connected biotech organizations that can bring their cutting-edge innovations to people faster and more efficiently.


Learn more about this transformative collaboration.

Want to see how our shared expertise can help you accelerate your breakthroughs to patients in need? Reach out to schedule a consultation. 

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, 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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