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