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End-To-End CDMO Business Model Roundtable

July 24, 2019
Article > Inside the Trenches: End-To-End CDMOs/CMOs

Inside the Trenches: End-To-End CDMOs/CMOs

By Patricia Van Arnum – DCAT® Editorial Director

CordenPharma Roundtable Contribution by
Dr. Michael Quirmbach, Chief Business Officer, CordenPharma

DCAT Value Chain Insights, July 24, 2019

What does it take to implement an end-to-end-business model, meaning a single CDMO/CMO providing development and manufacturing services for both active pharmaceutical ingredients (APIs) and drug products? DCAT Value Chain Insights gains input from end-to-end CDMOs/CMOs.

To gain a better understanding of the implementation of the end-to-end service model in terms of sponsor relationship, project management, and supplier metrics, DCAT Value Chain Insights, gained the input of some end-to-end providers for an “inside-the-trenches” view.

Question: From your experience, do you find that the use of the end-to-end service model is applied more frequently for early-stage development as opposed to later stage development or commercial manufacture? Can you comment on the use of the end-to-end model across development stages?

Quirmbach (CordenPharma): 
We currently see the end-to-end service model being applied more frequently for early-stage development projects compared to late-stage and commercial manufacturing. In my view, the reason is simply that the full-service model has only recently experienced more interest, traction, and acceptance in the industry and buy-in from our customers, whom have started to think differently about outsourcing integrated development projects. In addition, more and more CDMOs are offering end-to-end services not available a few years ago by entering into the field or complementing their services with missing capabilities in either drug-substance or drug-product manufacturing. Customers tend to need to establish trust and first gain experience by outsourcing an early-stage project as a test before proceeding to any commercial project. However, we have also seen cases where a customer either re-launched or in-licensed a commercial product and were only looking for an integrated partner as part of their strategy to rebuild the supply chain, but these cases have been limited when comparing to the early-stage inquiries and ongoing projects our organization has received.

Question: From your experience, in terms of the types of sponsor companies interested in the end-to-end business service model, is it applied more for smaller pharma companies compared to larger companies?

Quirmbach (CordenPharma): 
Over the years, we have seen strong interest from Biotech and small-to-midsized Pharma companies toward the integrated supply concept in an effort to efficiently use their, compared to Big Pharma, fairly limited procurement, sourcing and CMC (chemistry, manufacturing and control) resources.

Within smaller companies, the decision-making for outsourcing API and drug-product manufacturing very often resides within a small team of people, or sometimes even just with one person, who sees the benefit of reducing complexity by engaging with one company. Smaller companies with limited resources appreciate the streamlined interaction with one partner, which includes a global project team consisting of one primary key account manager and one global project manager, who together coordinate the program across the manufacturing infrastructure within the organization.

We have nevertheless started to see an interest from large pharma companies, albeit a gradual interest, probably due to the more siloed structures within these organizations, collaborations with which an extra effort might be required to spark mutual agreement amongst departments and the service provider.

Question: From your experience, what are some key reasons sponsor companies seek to use an end-to-end business service model compared to the traditional model having separate providers for API and drug-product development and manufacturing?

Quirmbach (CordenPharma): 
In my opinion, key reasons for adopting a fully integrated supply model include more efficient interaction with the service provider, overall faster execution of a program, and responsibility of the CDMO to manage internal know-how transfer between the departments (API and drug product) rather than the customer having to coordinate two different external companies.

Other important advantages for consideration are the ability to utilize a harmonized safety, health & environment (SHE) concept, which is an important issue when handling highly potent compounds, as well as sound compliance policies across organizations. Finally, the streamlined contract negotiation process (ideally one contract) and overall lower costs (both internal and external) represent a strong financial benefit for the customer’s successful program completion in accordance with its end goals.

This point is important to reiterate since the burden of any delays caused by the service provider’s API site will fall on its internal team to manage within agreed timelines, instead of on the customer to sort out between separate companies operating with different procedures. Our experience has proven that the customer clearly gains more leverage with an integrated project, thereby creating, where technically feasible, a win-win situation for all involved.

Question: From an implementation perspective, how does the end-to-end service model differ from the traditional service model as it relates to project management? Any key differences in terms of frequency or type of communication, cycle times, and the “hand-off” of drug substances for formulation development/drug product manufacturing or other issues?

Quirmbach (CordenPharma): 
Most importantly, the implementation of an efficient and successful end-to-end service model first requires a thorough understanding of the customer’s consumption chain and ability to address the key points of each stakeholder in their ecosystem. Secondly, key account managers, together with assigned global project managers, are key facilitators in this model, where frequent and transparent communication (weekly/bi-weekly) are mandatory with the customer. Lastly, hand-off to other functions within the organization requires superior project management processes be in place, with involvement of both global and local project teams.

Question: From an implementation perspective, how does the end-to-end service model differ from the traditional service model as it relates to supplier metrics? Are there any unique metrics or key performance indicators (KPIs) at play?

Quirmbach (CordenPharma): 
The supplier metrics for a fully integrated service model are the same as the traditional model. Major key performance Indicators center around DIFOT (Delivered In Full On Time) and budget. Certainly, the effective implementation of global project management, in conjunction with the right set-up of cross-functional and cross-site teams on the part of the service provider, are also critical factors for a successful program.

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