Working Holistically: A New Partnership Model for Biologics Supply
In case you missed the recent virtual event hosted by Fierce Biotech, where J.D. Mowery, President, CDMO Division, Bora Pharmaceuticals, and Stephen Lam, Chief Executive Officer, Bora Biologics, tackled the issue of biologics’ supply, check out the key takeaways from the discussion here.
The global biopharmaceutical supply chain has undoubtedly been strained over the past few years. In 2020, as a result of the pandemic, it became clear that there was an immediate need for companies to build greater resilience in their biopharma supply chains (1), and, more recently, unpredictable economic shifts and evolving geopolitical threats are continuing to cause disruptions.
According to a recent survey, performed by Deloitte US Center for Health Solutions, 36% of the life-science executives questioned believe that manufacturing and supply chain risks will pose unpredictable risks to companies in 2025 (2). Another concern, highlighted by the survey respondents, is the declining R&D productivity, leading to companies evaluating their strategies (2).
In a recent virtual event hosted by Fierce Biotech, J.D. Mowery, President, CDMO Division, Bora Pharmaceuticals, and Stephen Lam, Chief Executive Officer, Bora Biologics, set out to tackle the issue of biologics’ supply in an evolving industry and geopolitical environment, and how a new partnership model may help innovators overcome some of the challenges they’re facing (3).
Hurdles to innovation
When discussing the key challenges facing biopharma innovators, Mowery specified that there are a few factors at play. For one, as Deloitte reported in its annual report on pharmaceutical innovation (4), the increasing R&D costs per asset is driving “up the cost of goods that many of the innovators are dealing with,” Mowery said. Then, added to this issue is the elongated time-to-market many innovators are experiencing going through the clinical trial process, he continued.
“We’ve also been having a lot of conversations around capital allocation. The ‘build versus buy’ debate is an age old one, but in the current macro-economic conditions, how economic capital is being allocated is becoming more and more prominent,” Mowery added. “For [Bora] as an organization, we’re looking for opportunities to be able to help our partners make that decision even easier. So, when [an innovator] is talking about capital allocation, we want to be part of that solution.”
Adding to Mowery’s comments, Lam pointed out that a further challenge facing the biopharmaceutical sector is the increasing number of therapeutic modalities now entering the development pipeline. Through this increasing choice of modality, not only is the supply chain becoming more complex but also R&D is more intricate through the chemistry, manufacturing, and controls lifecycle, he remarked.
Providing more comprehensive services
“One of the opportunities that we have today is providing more comprehensive services as CDMO partners,” confirmed Lam. However, the one-stop-shop idea, which has been spoken about for a while within industry, hasn’t been as seamless as it should have been, he added.
This comprehensive offering is something that Bora Biologics and Bora Pharmaceutical CDMO division are striving toward, Lam explained. Ideally, the customer should feel like they are working with one holistic company and not like each individual site that they may need to deal with on a project is in isolation from each other.
“Having been on the customer side and been responsible for CDMO selection, you're always looking for simplification of your supply chain,” said Mowery. For innovators, having a service provider that is additive to their own supply chain and can augment their capabilities is the best-case scenario, he commented.
Trust is an important trait within a partnership, Mowery continued. With trust in the relationship, the innovator can be assured that their partner will bring value to the project, whether that be development capabilities or redundancy of supply that allows a patient to receive a therapy more quickly, he noted. “We want to be a part of that relationship and a part of that team that's trying to help deliver that therapy to that patient,” Mowery stated.
Communication is another critical facet to successful and enduring partnerships. “Obviously, COVID presented its own challenges, when you had to move to more of a virtual world, but being able to sit in a room and work on those relationships helps tremendously,” Mowery explained. “We’re getting back to a time where we can be more deliberate about those things. [Communication] truly is the foundation of the relationships, spending time asking questions, voice of the customer surveys, but really getting down to a relationship, to where you can ask each other the hard questions, making sure that information flows as freely as possible, so that decisions can be made collaboratively.”
It's important to spend the time early on to make sure the relationships and cultures of both partners match and that the relationship isn’t being forced in any way, Mowery specified. “It’s perfectly fine to say, ‘you know what, it’s not a good match,’ for both sides, because you’re engaging in a long-term relationship that’s going to navigate a lifecycle that’s very important,” he said.
Emerging challenges
Being able to predict and forecast what an initial launch for a commercial product will look like, while not necessarily an emerging challenge, is a struggle for industry, Lam remarked. However, for such tasks, CDMOs can really offer innovators more flexibility, he added.
In cases where a partnership is already in place and a project is approaching commercial launch, it can be beneficial for the innovator to re-evaluate the choice of CDMO to ensure the expertise being offered provides the best fit for the project’s needs, Lam asserted. Re-evaluation of the CDMO can be particularly helpful in de-risking regulatory submission and launch, he confirmed.
“It’s much easier for a CDMO to be able to absorb some of those ebbs and flows and capacity demands,” asserted Mowery. “From a capital allocation perspective, being able to take the cost of goods across multiple SKUs [stock keeping units] and multiple customers for a CDMO, it has far less impact on patient reimbursement models.”
Partnering with a CDMO that offers an end-to-end approach, such as Bora Biologics and the Bora Pharmaceuticals division, allows multiple innovators the opportunity to overcome cost and capacity constraints that are inherently limiting in the biopharmaceutical space, Mowery asserted. “[Such solutions] allow us to service multiple companies and multiple therapies in a more cohesive manner,” he summarized. “When you amplify [this approach] by using technologies like AI [artificial intelligence] to allow us to throttle our demand and capacity up and down in years to come, it’ll make it even more efficient than it is today.”
References
Socal, M.P.; Sharfstein, J.M.; Greene, J.A. The Pandemic and the Supply Chain: Gaps in Pharmaceutical Production and Distribution. Am. J. Public Health, 2021, 111(4), 635–639.
Lyons, P.; Konersmann, T.; Gupta, L.; Gosalia, D. 2025 Life Sciences Outlook. Deloitte Center for Health Solutions, Article, Dec. 10, 2024.
Hayden, C; Lam, S.; Mowery, J.D. “Shaping the Future of Biopharma; a New Model for Global Biologics Manufacturing,” Fireside Chat at the Advancing Complex Biologics into Real Treatments: Technologies, Experts and Partners to Know Virtual Event, Fierce Biotech, April 9, 2025.
May, E.; Taylor, K.; Gupta, L.; Miranda, W. Be Brave, Be Bold: Measuring the Return from Pharmaceutical Innovation — 15th Edition. Deloitte, Report (March 2025).
Click the above video to view the full Fireside Chat.