Technology Transfer Project Management Best Practices in the Era of COVID-19
Technology transfer is essential to advancing pharmaceutical products from development, through clinical and into commercial operation. The complexity of transferring the production of a product from a sending unit to the receiving unit is challenging even in the best of conditions. Since the onset of the COVID-19 pandemic the industry has shifted into high gear to develop, test and manufacture diagnostic tests, vaccines and therapies. With these developments, the speed, challenges and stakes involved in technology transfer have reached new heights.
Given these challenges, I recently presented a webinar highlighting technology transfer project management best practices in the era of COVID-19, find the recording here. I hope you enjoy the webinar and find the information helpful.
Following the webinar, I have received a number of questions. Responses to these questions are below.
Q: Has the supply chain been a major issue for these quick tech transfers during the pandemic?
A: Yes, definitely! The impacts are many. Let’s highlight a few here:
- Consumables: The supply chain is extremely tight for: PPE is chronically short. Vials, stoppers, caps are in critical shortage. Single use system consumable items can be a challenge. Specialized buffer and media can be in short supply.
- Capacity: Aseptic fill capacity is in very high demand. Every available line is being called into action to support production of vaccines and therapies for COVID. Viral Vector and plasmid production capacity is also extremely
- Labor: The market for skilled and experienced personnel is very tight. Companies are facing challenges to staff key roles to support COVID programs. It’s common to see companies pull together ‘A-teams’ to work on COVID projects, leaving gaps in other programs.
Q: What are the complications of working in a BARDA project?
A: The biggest challenge that I have seen in working with BARDA projects (and other government-funded programs) is the uneven pace of progress. A proposal for a great idea can sit for weeks or months waiting for government funding – and then when funding is approved the project is expected to immediately shift into hyperdrive to achieve extremely ambitious timelines. This poses challenges of keeping a core team in place and the project moving forward on a shoestring budget while awaiting funding – and then rapidly increasing staffing, equipment and materials when funding arrives. Of course, if funding is not approved, the project may get scrubbed if other sources of funding have not been lined up.
Q: Are there tasks that are needed to be done in parallel to optimize the timeline?
A: Yes! A successful project plan identifies critical path activities (those that must occur in sequence) schedules all other activities to occur as early as possible and in parallel with other activities, so as not to impact the critical path.
In the context of a tech transfer project, the overall ‘flow’ needs to progress through the major milestones as illustrated below, often with stage-gate reviews to demonstrate completion of each stage and readiness to proceed to the following stage.
For sure, within each of these stages, there is a multitude of activities that can and should be implemented in parallel. For example, during the planning phase, the overall effort of the Risk Assessment and Plan Development should be carried out as multiple parallel workstreams across all functional areas, and each of the inputs rolled up into a high-level plan.
Another opportunity to accelerate the schedule by working in parallel is to ‘pull forward’ key ‘long lead-time activities’ from future stages in the project and starting those very early in the project. Examples of these might include:
- Equipment selection and ordering (particularly long-lead and high-demand items such as fill lines, bioreactors, air handling units, etc.)
- Engineering studies to support any process changes (bioreactor design, formulation mixing, media selection, chromatography, filtration, etc.)
- Supply Chain Vendor Selection (Identifying suppliers that can support production at the new location / new scale, vendor audits and qualification, material equivalency studies, leachable and extractable studies, etc.)
- Staffing – assessment of local labor pool and hiring team leaders in key functional areas.
Q: What are the challenges of some less experienced companies developing products at a high pace?
A: Newly formed teams face a number of challenges – all of which are amplified by developing products a high rate of speed. A few considerations:
- Easy to say, not so easy to do. Laser-like alignment on achieving one goal dramatically increases the chances and speed of success in achieving that goal. Continuously engaging with the team to ensure all members of the team are aligned with the goal is the essential task of leadership.
- Swim lanes. Each member of the team needs to ‘own’ the duties, responsibilities and deliverables of their swim lane – and work cooperatively to support their teammates in adjacent swim lanes.
- Confidence that each team member is going to ‘own’ their swim lane in order to support the overall goal. Confidence builds as the team overcomes challenges and achieves successes on the road to their overall goal.
- Fail Fast & Learn. Identify high-risk items (technology, process, suppliers, etc.) and test them right away. Learn from the experience and pivot rapidly.
- Rapid innovation can be a jarring, zig-zag path as the team swims hard and fails fast. Agility is the ability of the team to rapidly communicate the need for change, adjust the plan to achieve the revised goal, re-orient all swim-lanes toward the updated goal, and get everyone swimming at full again.
Q: Are there differences with cell therapy tech transfers?
A: The answer to this question is highly dependent on the indication and the technology being employed. That said, two factors that play out-sized roles in the success of cell therapy tech transfers is the supply chain.
Supply Chain: Often times in cell therapy, the supply chain is a closed loop that starts and ends with the patient. Timelines are tight, and there is no room for error. Having a do-over is not an option when the patient is fighting advanced stages of a disease. A tech transfer project for a cell therapy product should develop a thorough supply chain map used by the sending unit, the planned supply chain map planned for the receiving unit and then conduct a thorough, cross-functional risk assessment for each step of the supply chain – as well as the supply chain as a whole. Key considerations include regulatory requirements, vendor qualification, packing system qualification, parameter monitoring system qualification, chain of custody and data integrity.
Batch Release: Cell therapy products often patients who are at very advanced stages of a disease, where every hour counts in delivering the treatment to the patient. Batch release for cell therapy products can be extremely challenging due to the variability of the starting materials and challenges in achieving optimum manufacturing process outcomes. Accordingly, a highly efficient batch release process must be implemented that employs a risk-based approach. This will enable a team can make the determination that the batch is safe and effective for patient treatment, while allowing certain steps of batch release deviations to remain open to enable deeper investigation and implementation of corrective and preventative actions.
Q: What technology can be used to facilitate technology transfers, particularly with COVID?
A: There are a plethora of tools designed to enable teams that are multi-site and/or virtual. Here are four categories of technology that have been very helpful in implementing tech transfer projects.
- Virtual Dry-Erase Board. Planning sessions, workshops, scheduling huddles, etc. are facilitated by dry erase board and a bunch of colored stickies. Today, this can be done virtually with software tools that enable scores of participants to simultaneously interact on a virtual dry erase board to draw, type, post stickies, keep lists, mind-map, and all kinds of helpful collaborative activities. These tools are as good as having everyone in the room.
- File Management tools. Having a shared space where all project documents are kept is essential. Tools that facilitate routine and version control are even better. Pushing documents back and forth by e-mail is inefficient and out of pace with technology.
- Cross-company Team Chat. Pretty much every company has a chat tool used to facilitate communication and productivity among members of the company. The same need for efficient communication and coordination among teammates is needed for tech transfer projects, but more often than not team members from Company A can’t chat with Company B, causing everyone to reach for their mobile phones to text each other. Good news. Many of the productivity platforms are enabling the creation of project spaces that allow internal and external teams to chat, voice call, video call and share documents.
- Virtual Presence Platforms. One of the most effective methods of knowledge transfer for operator processes is hands-on training. The gold standard has been to have the receiving unit send teams to the sending unit site to receive hands-on training. This was not always possible and is less feasible in the age of COVID. There are a whole class of training tools that use virtual presence (3-d goggles, streaming video, SOPs with video clips, etc.) to enable the receiving unit to virtually experience operations at the sending site. In some cases, the virtual presence tools are even more powerful in that they can create narrated ‘first person’ views of how to perform complex operations.
We appreciate your interest in technology transfer and welcome the opportunity to continue the discussion.
View the full presentation:
About the Author
As Global Director of Process and Manufacturing Technology, Charlie Maher leads CAI’s delivery of solutions that advance life science products through their lifecycle. Services include: Product development/QbD, development to clinical to commercial manufacturing scale-up planning/management, process and facility conceptual design, tech transfer, process validation, CMC regulatory support, in-service process engineering, aseptic processing, investigations and issue resolution, and supply chain management.