C&EN talked with outsourcing decisionmakers in the pharmaceutical industry. As the following excerpts show, the extent and requirements of custom synthesis vary with the drug development stage and the type of customer.
Steven M. Hutchins, director of outsourcing in the research operations department at Merck, on outsourcing drug discovery chemistry:
"The most important attribute that we look for in a collaborator is staff expertise for the project at hand. Once the collaborator has been selected, the big key to success is communication. It has to be frequent, open, and honest. If there are hitches in a project, we want to know. We've been in situations where things haven't gone well because the other company thought it had to try to solve all the problems. They didn't bring the problems out in the open so that we could both work as a team to try and solve them.
"Companies that offer custom synthesis from milligram to ton scales typically are very good at one end of the scale but not the other. We work with a couple of one-stop shops because we think that discovery is their forte. I've compared notes with my counterparts in manufacturing. I don't think we have identified one one-stop shop that we all want to work with. Being a one-stop shop is not an advantage per se."
Ioannis I. Valvis, group leader, sourcing strategy and capacity management for process R&D at Bristol-Myers Squibb Pharmaceutical Research Institute, on outsourcing chemical process development:
"At this stage, we're still trying to understand the process and we're focused on putting together a supply chain that will provide high-quality active ingredients. It is at this stage that quality requirements for the product are set. For this reason, the most important criterion in vendor selection is the track record for producing right-quality material. We qualify suppliers based on performance, not price.
"I will go to vendors that can take the manufacture all the way to commercialization. Getting involved early with such a vendor saves time and ensures product quality."
Joseph R. Colleluori, director of strategic outsourcing for Merck & Co., on outsourcing manufacturing:
"Outsourcing is decided on a project-by-project basis. Historically, Merck has awarded business to companies that have done business with us and have met our criteria of cost, competence, and creativity. We prefer suppliers that can provide us with materials through the life cycle of the product, from the early phase of clinical development, to launch, to product maturity.
"Our sourcing decisions are based on many criteria, including technology, innovativeness, facilities to handle complex operations, provisions for catastrophic occurrences, capital resources for innovation, cost competitiveness, respect for intellectual property, and commitment to Merck's business."
Daniel D. Burgess, chief operating officer of Hollis-Eden Pharmaceuticals, San Diego, Calif., on selecting a manufacturing partner:
"Several factors made one medium-sized custom manufacturer in Portugal come out on top when we interviewed different companies to supply the active ingredient for a drug candidate. They had a good process development group, they understood the needs of a small biotech company in terms of flexibility and timing, and they were willing to work with us to develop a product.
"We looked at companies bigger and smaller than the one we chose. The most important consideration from our perspective was being confident about their expertise in process development and scale-up. We got very comfortable that our selected company had the capability and systems in place to be a reliable long-term partner."
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