project timelines, what analytical tasks are on the critical path,
and their impact on other project deliverables. The sharing of
technical information previously acquired by the contracting
pharma can contribute significantly to increasing the
efficiency of methods development in the analytical lab. In our
business, the analyst is an active and involved participant at
project team meetings with the client so they can grasp a
thorough understanding of the entire project objectives,
timelines, and activities that they impact, or those that impact
the deliverable items for which they are directly responsible.
Dr. Grant:
Pharma should begin discussions with their
CRO immediately upon determining that outsourcing will be
required. Early discussions at the level of analytical scientists,
several months before the expected date of study initiation, is
the best way to assure your chosen lab will perform to
expectations when it comes time for sample analysis. To
minimize risk, scheduling goals for study planning should
include that the validation activities are completed before
animals or subjects begin treatment. At SNBL USA, scientists
are assigned to analytical projects based upon their relevant
expertise. To foster and support a partnering relationship,
regular and frequent communication is maintained between the
sponsoring laboratory personnel and CRO scientists
throughout the development and validation processes. This
two-way communication from early development or method
transfer through preparation of reports ensures seamless
bioanalysis of client samples with minimal surprises.
CIALTY PHARMA MARCH 2009 Vol 9 No 3
Dr. Ciupidro: Outsourcing experience and product
knowledge are two significant factors determining the amount
of interaction required between a contracting pharma company
and an outsourced analytical service provider for a successful
drug development project. At Xcelience, we understand that
the parameters for an ideal partnership will differ based on a
number of factors, including company size, company type,
project goals, knowledge of API, and therapeutic area
expertise. Overall, the ability to remain flexible to different
client needs is critical as we work with contracting companies
to create tailored solutions that enable them to accelerate
development, meet critical milestones, or manage capacity.
For contracting pharma companies with defined project goals
and core areas of expertise, the ideal outsourcing relationship
may require a mode of interaction that optimizes their ability
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to manage capacity overflow. In this case, Xcelience and the
contracting pharma company may work together to devise a
full time equivalent (FTE) program, enabling the contracting
company to rely on a core group of personnel as an outsourced
resource, with the option and flexibility to increase headcount
during peak project periods. Once the program is initiated,
contracting companies rely on a dedicated project manager as
a single user interface for analytical methods transfer, access
to scientific personnel, status updates, and final reports. For
pharma companies seeking access to drug development
expertise, or with limited knowledge of API, or those seeking
an alternate service provider to help restore a project when a
timetable has slipped, partnership takes on quite a different
meaning. The ideal interaction balances expertise and
flexibility. Where prior analytical method development efforts
have stalled, or contracting pharma companies have
encountered timing issues or double-booked capacity,
Xcelience will work with contracting companies to develop a
step-by-step plan and quickly mobilize a project team. Our
experienced staff will perform an evaluation of analytical
methods to determine whether they are suitable for
qualification and validation according to the intended use.
Keeping end-goals in mind, we will optimize run time, attempt
to combine methods where possible, and evaluate linearity,
specificity, selectivity, accuracy, and precision. Having an
experienced staff and dedicated project management function
are two key elements that contribute to our ability to back up
these commitments.
Mr. Ludwig: The easy answer is…as much as possible, and
more communication is always better. We recognize that not
only do sponsors want constant updates, but they want to be
immediately involved in any changes or potential issues. We
have found the best way to start a program is with a kick-off
meeting, either face to face or via teleconference. This allows
the project scope, requirements, direction, and timelines to be
known and agreed upon by all parties. A complete technology
transfer is also important. This usually includes follow-up
questions and possible in-lab familiarization. Routine project
reviews with sponsor contacts are also helpful to maintain
timelines and discuss any technical issues. We recognize that
even with the best technology transfer, the contracting lab
experts have additional information that may help resolve
issues quickly and efficiently. Interactions with the sponsors
