BeiGene USA

Joel Finkle

I joined BeiGene in late 2020 after 16 years in the software and service industry, returning to the pharmaceutical sponsor side of the world where I’d gotten my start – but a distinct shift into the Regulatory department versus the IT-based roles I’d had before (this is the first job I’ve had where I’m not the admin on my laptop). The challenge that made the role attractive is the chance to implement Regulatory Information Management (RIM) incorporating registration management and to update our content management system (Veeva Vault Submissions) to meet the challenges of organizational growth and scalability and the changing regulatory environment —especially with mandates such as IDMP on the horizon.

At that point, we were about eight months into pandemic lockdown… but it was nothing new for BeiGene: Our CEO, John Oyler, says we are a company without a defined headquarters, and jokes that it is on Zoom. Remote work is just business as usual except for essential categories such as laboratory and manufacturing. That does not mean that coordination of all stakeholders’ needs isn’t challenging, with major presence on both coasts of the US, several facilities in China, and a growing European regulatory group it is literally impossible to gather everyone for a common meeting time. The distributed nature of our company, along with internal teams dedicated to large versus small molecule products, and hematology versus solid tumors, on top of the usual technical groups (Regulatory, Nonclinical, Clinical, Medical Writing, Labeling, CMC, Regulatory Operations, IT) led to the creation of a very large stakeholder team which we called the Global Submission Forum (GSF).

The expectation is that the GSF will meet periodically to review proposals for directions for the systems that Regulatory Operations supports for the use of the entire company, but that means reaching a steady-state environment that we’re not yet at: With projects underway for modern RIM replacing manual spreadsheets, and re-configuration of content management (among others), the demands of the GSF members are quite high.

At present (the end of 2021) we’re at a midpoint: the RIM system has been selected with contracting underway, and we are around 40 percent through the configuration process for the updated content management. The key learnings from these processes are as follows:

Acquire Support from Experts

One of our key success factors was to include a major regulatory consulting firm in the project. Aside from providing resources for project management, user requirements gathering, and RFP generation and analysis, they provided two important functions:

1. They served as a gateway between us and the vendors: they opened some doors for contacts, and kept the vendors from overwhelming the stakeholders.

2. They served as an independent judge of the information gathered about each vendor: scoring the proposals, the surveys of our opinions on demonstrations, and the questionnaires after completing the exercises in the vendor sandbox environments.

Without their experience and active support, our project would undoubtedly have taken longer.

Identify Key Engaged Stakeholders: Transparency Does Not Have to Mean Equity

This is a lesson we’re still learning: just because people are holding a stake, it doesn’t mean they have to – or will – participate in every part of the project. Except for my immediate team, this isn’t anyone’s primary function, and work getting medicines to patients always takes first priority. Some of our virtual meetings have had as many as 70 people invited. It quickly became obvious who regularly contributed, and versus those just observing. Use those passionate users, but make sure everyone has the opportunity to contribute.

Especially in this age when providing a recording of a meeting with all the presentations is just the click of a button, we are working to reduce the size of the committees, and asking people to watch the videos, or read the notes – but remember it isn’t necessarily in your vendors’ best interests to provide you with those detailed notes of what they commit to.  This has been leading to giving Europe less live time – but never none – as US time zone evenings work reasonably well for US and Asia.

Communications become the most important part: regular (brief) newsletters, clarity on who must attend meetings (but open them to all), and readily available lists of open and resolved issues.

Design for Use, Not Design for Construction

In other words, challenge your vendors. Don’t limit the design to out-of-the-box, make sure that the vendors can provide the integrations that are essential to daily life. In the end our choice of RIM solutions really came down to how well it would play with our content management platform, since the submissions, labels, and correspondence stored there tie so closely into registration processes. The term “design for construction” comes from the auto industry where products are designed to reduce the cost to build… but that should never come at the expense of the usability by the customer.

Find Time for Play, But Finish Your Homework First

The final vendor shootout for selection of RIM was done as a live sandbox environment, where we attempted to execute the use cases in the initial RFP. But those use cases were relatively narrow, and a tool like a Registration Management system needs to be able to handle more than that. Providing extra ‘office hours’ for examination of the system in a more free-form manner helped significantly. On the flip side, engaging some of the remote teams – particularly where English isn’t the first language and RIM system a very foreign concept – meant that more hand-holding was needed to ensure that they understood the scripts for the use cases.

The project is still months from completion, but just getting to a choice was a major accomplishment. We are in another vendor selection project, and the lessons learned here are making that go more smoothly. That thankfully is offsetting other annoyances… but as Alton Brown says, that’s another show.