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As overseas sourcing arrangements become more and more common, it may be time to look again at the advantages of having suppliers closer to home.
Contract manufacturing of clinical test materials (CTMs) and preclinical active pharmaceutical ingredients (APIs) is becoming a global business. More supply options mean better pricing, but they often come with increased potential for late-delivery and quality issues. For biotech companies, where funding is often limited and is tied to achievement of milestones, these added risk factors need very careful consideration.
Time is a critical factor during the drug development process. Drug development timelines are often based on cash balance, burn rates, and the next milestone that will bring another influx of investment money. It often seems that the timeline is worked backwards. A date is determined for filing an investigational new drug (IND) application, and then developers calculate the time needed to conduct the required preclinical biology studies and to develop and prepare the Phase I clinical formulation. Whatever is left is the time available for further investigation into the chemical optimization of the molecule and the process development and scale-up activities needed to obtain sufficient quantity of material to conduct the biology and formulation work.
API delivery is often on the critical path of the drug-development timeline. Late API delivery can result in missing an important milestone, such as an IND filing date, which can have significant negative financial consequences. Risk associated with time delays can be minimized by using an experienced and easily accessible contract research organization (CRO) to supply API during the time-critical development phase. Easy access often correlates with proximity. For US companies, ease of access can be achieved by using a domestic CRO versus an offshore supplier. Among the benefits of proximity are the ability to communicate by voice or Internet during the same business day, and the ability to easily make on-site visits.
Communication is vital to the success of a development project. The development phase is characterized by rapid technology development and change—the lead compound changes, the chemical route changes, the raw materials change, the specifications change, the impurities change—but the overall milestone (the IND filing date) and the required delivery date for the API seldom change to accommodate the problems encountered. A CRO must be able to assimilate these changes while keeping the API delivery on track. The contracting biotech or virtual company must make sure that the CRO being considered for the API scale-up or production project is up to the challenge. There is only one way to ensure this—visit the facility and meet the project team.
Site visits to potential CROs allow assessment of capabilities, staff expertise and experience, and quality systems. The CRO's culture is a critically important item that is often overlooked or undervalued. Supplying API during the development phase is a service, not a product. The CRO is making a commitment to provide the required quantity of in-specification API at a defined time in the future using a developmental process. The time commitment made by the CRO is factored into the overall drug development plan. The overall timeline attracts much attention from all levels within a company and from their financial sources. Stress and nervousness often surround this timeline: there is rarely much room for error or missed milestones. Cultural compatibility helps to reduce risk by ensuring a sense of ownership and accountability to the overall project goals and timeline.
The benefits of proximity continue after selection of a CRO and project initiation. Consider how a domestic partner can add value to some of the activities typical of an API drug-development project:
The marketplace currently faces shortages in the pharmacology/toxicology capacity and animal supplies required for drug-development studies. These constraints have forced companies to reserve biology CRO capacity 3–6 months in advance. In addition to delaying ultimate approval and revenue, any deficiency in API quantity or quality at this stage can trigger significant penalties as CROs demand compensation for scheduled work that must now be postponed—and essentially paid for twice.
In the end, it is critical to have confidence that the CRO selected for API production during drug development will deliver. There is no better way to gain this confidence than through the personal interactions experienced during a site visit. All of this interaction builds understanding and trust with the CRO and will result in a true collaboration rather than a simple material supplier-buyer relationship.
Paula Lorence is the vice-president of business development and Walt Stalzer is the vice-president of project management at Ricerca Biosciences LLC, 7528 Auburn Road, PO Box 1000 Concord, OH 44077-1000, tel. 888.742.3722, Lorence_P@Ricerca.com