DCAT Sharp Sourcing, a one-day conference organized by the Drug, Chemical & Associated Technologies Association (DCAT), brought together executives representing the entire pharmaceutical value chain, ranging from raw materials to finished drug product manufacturing and packaging. The annual event, which took place June 27 in New Brunswick, N.J., is focused on providing practical insights from industry experts as well as specialized educational forums specifically aimed at buyers and suppliers.
Best practices in outsourcing
One key session looked at best practices in outsourcing from the perspective of the pharma company, with Michael Semo, advisor, external R&D strategy, small molecule at Eli Lilly, and Sean Johnston, former vice president, manufacturing at Paratek Pharmaceuticals, leading the discussion.
Semo explained that Eli Lilly is these days largely reliant on third parties when it comes to manufacturing and a large amount of R&D work is also done outside. He said that the partners must be able to provide supply assurances and encouraged the partner companies to under promise and over deliver. Communication via multiple channels and pathways is critical, as are flexibility, transparency and creativity, he said.
To facilitate collaboration with all these partners, Eli Lilly started a virtual CMC team. For the virtual team, being co-located is key as it enables planned and unplanned meetings. As new team members join the team, they bring to the group new perspectives. Semo also emphasized the need to take a long-term view with the CDMOs; if issues arise, it is important to work through them together.
Johnston explained that requirements to partners vary from phase to phase. In preclinical and early clinical phases, companies care about speed. With small quantities required, it is acceptable if the manufacturing process is not robust. However, in later phases you need to worry about supplier capabilities and capacity.
He also shared with the audience his opinion that, despite the current trend toward CDMOs offering end-to-end services, no CDMO can offer you everything you need because each outsourcing need is unique.
Using omadacycline, a novel tetracycline antibiotic, as a case study, he explained that for advanced intermediates, his company used in pre-clinical phases several partners whom it knew would not be able to deliver commercial quantities. For phase I to III, his team worked with a company that had some capacity issues and therefore couldn’t be the primary source for commercial quantities. For commercial quantities of the advanced intermediate, they used Cipan, a company that had a drug master file for the material, which helped to reduce risk. Meanwhile, when it came to the active ingredient, they used Bayer for pre-clinical quantities and Carbogen Amcis for clinical and commercial quantities.
A key success factor, Johnston said, is good documentation, which is key to oversight, facilitates technology transfer, ensures that all learnings are captured and provides flexibility to work with multiple vendors.
He said that despite intentions to stick with certain suppliers, you need to be flexible. One of the variables is the success of the product, which can be difficult to predict early on in the process. Once you have real data about how the product is doing in the market, you may realize that the fit between the scale required and your chosen manufacturer may not be right.
Update on the outsourcing sector
Starting off the day in a track focused on suppliers, Daniel Cohen, managing director at RBC Capital Markets, provided a financial overview of the pharmaceutical industry. Overall, he explained that the industry is healthy, although many players are facing pricing pressures, uncertainty over government actions and, in some cases, have weak pipelines. The business performance in the CRO (contract research organization) and CMO (contract manufacturing organization) segments is particularly strong thanks to continued outsourcing by pharmaceutical companies, Cohen said. As a result, the pharmaceuticals outsourcing sector is currently one of the hottest in the life sciences.
To read Kate Kuhrt’s full report from DCAT Sharp Sourcing 2017, please click here.
Attending CPhI Worldwide? Join Kate onsite at her presentation “API Sourcing & Manufacturing Update” on October 23, 14:00 – 14:40, Portalhaus, Frankfurt Messe. Register.