Blog | November 1, 2022

"Lean On Me": Defining Risk-Sharing In Cell & Gene Therapy Manufacturing Partnerships

Source: Cell & Gene Collaborative
ARW Edit Headshot 2

By Anna Rose Welch, Editorial & Community Director, Advancing RNA


In August, my company Life Science Connect held its first all-hands-on-deck company town hall in our brand-new office space in Cranberry, PA. Like many small companies these days, we had/have a lot of hiring, financial, and square-footage growth to celebrate. This meeting was a chance to celebrate where the company currently stands and all that we’re capable of working towards in the future. But beyond the LSC-branded “merch” and glossy action shots of collaborating colleagues and executives before PowerPoints, this meeting was also about confronting where we fall short in serving each other internally and in serving our external clients/advertisers and our readers.

Prior to this meeting, we were asked to read a book called Leading Without Authority: How the New Power of Co-Elevation Can Break Down Silos, Transform Teams, and Reinvent Collaboration. If I were to boil this 200-page book down to its core message, it would be this: to solve the challenges keeping you up at night, you should start by asking a colleague with whom you work — or should be working with more closely — “How can I be of service to you?” It’s often in helping others solve their own problems that you find your own solutions and a stronger, supportive framework to boot.

As I listened to our VP of Technology discuss Life Science Connect’s multifaceted relationships with its many vendors, I inevitably found myself making connections to the world of advanced therapies. The ATMP industry — namely CGT innovators and CDMOs — are faced with a similar set of considerations today as it relates to scientific/manufacturing innovation and leadership, partnership, and collaborative problem-solving. In particular, I couldn’t stop thinking about a panel discussion I watched a few months ago, during which a panelist reiterated an increasingly common ATMP industry question: How do we — innovators and CMOs — define risk-sharing in this scientifically and strategically diverse industry? Just as our ATMP products want for more “definition,” structurally and functionally speaking, the concept of “sharing risk” is one that could also use a more concrete definition.

It's regularly said that the science and quality expectations of the ATMP industry demand a shift in outsourcing business practices/models. To fully understand co-elevation and risk sharing as it relates to the ATMP space, I think it’s important to look first at how innovators and CDMOs are approaching outsourcing in this new space as separate entities, and, secondly, how these in-house business/strategic efforts bring them together as a (hopefully) single, risk-sharing entity. While I cannot define precisely what (or which) shape(s) risk-sharing will take for the multitude of unique CGT products in the works, I’ve been privy to several conversations that go a long way toward defining the current state of these evolving ATMP outsourcing partnerships and business models.

In the following three parts, we’ll start first by examining the considerations innovators are faced with as they evaluate a hybrid outsourcing model. Part two will discuss how the currently platform-less ATMP space is challenging CDMOs’ business models beyond the physical facility requirements. Finally, in part three, I’ll share a few articles illustrating which types of partnerships being established today are laying the groundwork for a future of greater risk-sharing.