Others point to the need for a broader set of services for small or emerging pharmaceutical companies. "The small or emerging
pharmaceutical company has a leaner development team in terms of skills, so this company will need the supplier to fill in
these areas of expertise relative to advising as well as executing the work," says Basham. "We supply pharmaceutical dose
formulation expertise to emerging companies from initial formulation to contract manufacturing. Most emerging company contracts
are full-scale development to manufacturing proposals that include analytical methods, stability, and dosage-form development
as well as manufacturing."
In contrast, larger pharmaceutical companies typically have narrower needs. "The larger pharmaceutical company usually comes
to us with all the details of the plan in place as it has many more skilled people in place to develop and execute the plan,"
says Basham. "The larger company usually needs more hands to move projects along. Metrics becomes a resource filling in the
missing pieces for the larger client. Sometimes this means pharmaceutical finish dose development and sometimes contract manufacturing
Best practices at work
Flexibility is a key to a successful outsourcing relationship, particularly with emerging and small pharmaceutical company.
"Changes can occur overnight and can be driven by anything from the availability of the active pharmaceutical ingredient to
waiting for funding to directional shifts in the development to good or poor results in preclinical or toxicology studies,"
says Guthrie. "These are the types of changes that would drive a rigid, contract organization to failure, so for us, our agility
is key to our success. Having a superior project management team in place is the key for any contract organization."
He offers examples in which flexibility is critical to a project's success. "Often, we support drug-development companies
with several compounds in their pipelines. Their workflow has high and low periods, which has a tendency to create scheduling
challenges in maintaining a core team to handle the flow," explains Guthrie. "One solution is to devise a full-time equivalent
(FTE) program that maintains a core group throughout the process and maintains the flexibility to increase headcount on the
project during peak periods, while maintaining the same core team throughout the low periods. This assists us with our scheduling
and provides the client with a true extension to its own in-house capabilities as well as almost eliminating lead times for
new project launches."
When working with small or emerging pharmaceutical companies, Guthrie again emphasizes the need for a CRO's agility and responsiveness
to changing development demands. "We have been approached on more than one occasion where a timetable has slipped due to
overbooking of resources or the inability to successfully develop a formulation or analytical method, and the client faces
a looming IND filing deadline. We have been able to mobilize project teams to put in place a step-by-step plan to meet that
The reliance of emerging pharmaceutical companies on their outsourcing partners for the success of their business models necessitates
a strong working relationship. "For the emerging company with one or two products or even a platform technology, the key is
trust. They are putting a significant portion of their future in the supplier's ability to perform," says Basham.
Project management is important to ensure success. "The best method of optimizing the working relationship is to set up specific
communication practices so that all parties know how the project is proceeding, when bumps are hit, and how they will be corrected
and that the schedule is being met," says Basham. "One way that we accomplish this is to assign key personnel to each project/customer."
Basham offers an example of using a series of performance contracts for a single project as a way to alleviate the initial
concerns of a virtual pharmaceutical company. "We broke a full-scale development proposal into separate performance contracts,"
explains Basham. "After a year of clear communication and successful goals, we have rewritten the contract so that baseline
work can continue with normal work in process while new changes can be implemented with typical change-order management. Of
course, these types of special arrangements are dependent on the project size."