Technology Transfer Between Contractors, A Panel Discussion, Part 2

Maintaining technical oversight of a contract organization without slipping into micromanagement is a persistent challenge for sponsor companies. In a roundtable discussion, four industry experts—Lauren Nolan, senior director of operations in sterile injectables at Kindeva; Yash Sabharwal, CEO and Co-Founder of QbDVision; Judyta Suskiewicz, director of business development at Mabion; and Katy MacLellan, technical team leader at Symbiosis—described the governance mechanisms and regulatory coordination that make technology transfer partnerships work.

Governance Built on Trust, Not Adversarial Oversight

Asked how sponsors can maintain meaningful oversight without creating an adversarial dynamic, Suskiewicz said the answer starts with “the partnership, which is based on trust and transparency,” noting that Mabion's “governance framework turns technical oversight into collaborative problem-solving.”

She described a three-tier governance structure. The first, operational tier is “the joint project team,” anchored by “weekly touch points with direct subject matter expert (SME) to SME communication.” The second, tactical tier is the joint steering committee, which reviews milestones, budget, and active risk registers. The third, strategic tier involves executive oversights. Suskiewicz added that “real-time visibility and access to the raw run data” is an approach that “can protect us from micromanagement and on the other hand gives some feeling of the safeness to our client.”

Nolan built on that point, arguing that “a strong quality agreement does much more than satisfy regulatory expectations.” In her experience, it “eliminates ambiguity, establishes decision rights, defines communication pathways, and removes unnecessary debate when issues arise,” complementing the governance tiers Suskiewicz outlined and providing what Nolan called “a strong foundation to build” as part of the tech transfer process.

Sabharwal said digital tools are accelerating this collaborative model. A shared digital structure lets teams “compare a digital process at the receiving site with a digital process at the sending site automatically, using technology, artificial intelligence, and other tools to automatically flag changes between the sites.” Instead of manually hunting for discrepancies in equipment, ranges, or process parameters, teams simply review what's flagged; automation that Sabharwal said has helped some organizations cut 80% of their time down for clinical tech transfers. He expects this approach to shape how transfers are managed.

MacLellan agreed with Nolan on the value of the quality agreement, emphasizing the benefit of defining “escalation pathways in advance” so teams can be clear “about the severity of the issue,” who needs to be told, and “how quickly that needs to be communicated.” That clarity, she said, builds trust and helps avoid situations where a client might otherwise feel micromanagement is necessary.

Synchronizing Transfer Timelines with Regulatory Strategy

Technology transfer to a new site often triggers regulatory activity, such as site changes, comparability protocols, or new marketing authorization applications, that must be aligned with execution timelines to avoid commercial supply gaps.

Suskiewicz said Mabion works to “synchronize the current site safety stock production, PPQ execution, and regulatory agency review windows,” planning all of these pathways together to secure both the transfer and the regulatory submission at the same time.

Nolan cautioned against treating regulatory strategy as something that begins after process transfer. It is a parallel activity that begins before the first transfer activity. Operations, quality, regulatory, validation, and the sponsor should all be involved in building “one integrated timeline” within the project plan. Central to that is critical path management by evaluating every major activity based on “whether it ultimately impacts the regulatory approval or commercial supply,” supported by “a good feedback loop around what truly is critical path and what could potentially pose a risk.”

Across both topics, the panelists converged on a shared principle: structure, transparency, and early alignment through tiered governance, clearly defined escalation paths, and regulatory planning that runs parallel to transfer execution from day one. This principle allows sponsors and contract organizations to move fast without sacrificing oversight or trust.

Click on the video above to watch the discussion.

Click her to watch Part 1 of this panel discussion.

About the Speakers

Katy MacLellan is technical team leader at Symbiosis.

Lauren Nolan is senior director, Operations, Sterile Injectables at Kindeva.

Yash Sabharwal​, PhD, is CEO and Co-Founder of 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 three companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.

Judyta Suskiewicz is director of Business Development at Mabion. As the Business Development Director at Mabion S.A., I leverage a strong scientific foundation in biotechnology and quality control to drive strategic growth and partnerships in the biologics sector. Focused on operational excellence and Lean management methodologies, I help partners seamlessly accelerate their biological products from development through to commercial manufacturing.