Pharmaceutical Processing: What are your views on specialization and diversification? Can a company that specializes in clinical trial services see the big picture and,
conversely, can a company that provides a wide range of
pharmaceutical contract services provide the attention
needed to keep clients happy?
Joe Iacobucci: Xcelience has a terrific
advantage in that we have a suite of
services ranging from preformulation,
analytical services, stability, formulation
What are your thoughts on the future of clinical trial ma-
development, manufacturing and com-
pleting the pathway with our clinical
packaging, logistics and distribution,
and return drug services. We are truly
specialized in our individual areas of
expertise yet diversified in our full range
of service offerings. Xcelience has a
strong infrastructure that allows us to
establish a supportive and robust chain
of custody for our client’s projects as
their products move through each phase
of production. Handovers are structured and controlled, giv-
ing our clients the security that they need. Having this wide
range of services has allowed us to see a bigger picture of
the industry and connect with a broad range of clients.
terial outsourcing services?
Joe Iacobucci: Clinical trial material outsourcing services
will continue to see accelerated growth in the years to
come. The knowledge and expertise provided to our clients
will only be increasing. We can see this clearly through the
use of our project coordinators to provide management
of projects in this complex and sophisticated clinical supplies landscape. Companies such as Xcelience that have an
intense focus on the specialized requirements in clinical
supplies will be sought after to manage the global clinical
supply chain function. There is increased pressure in the
industry to perform global clinical trials using sophisticated
IWRS and forecasting systems with tighter timeframes and
enhanced efficiencies. The solution to these pressures is to
outsource more. The future looks bright! ■
Pharmaceutical Processing: Can you tell me the types of
clinical trial services you provide?
Joe Iacobucci, Vice President, Clinical Supplies, Xcelience:
Xcelience provides a full suite of services from preformulation through clinical distribution. Our global clinical supply
services include project coordination, clinical packaging and
labeling of open or blinded (randomized)
clinical trial supplies, distribution and
logistics, storage, and streamlined return
drug accountability and destruction. We
are here to provide exemplary customer
service and assist our customers with
their unique clinical trial needs.
Pharmaceutical Processing: What
trends are you seeing in clinical trials
- have they become more complex,
costly, time consuming? If so, why?
Joe Iacobucci: On a macro level, the
increasing momentum towards outsourcing by the industry has moved much of
the clinical supply operational workload to companies such
as Xcelience. In recent years this outsourcing trend has also
caused a shift towards sophisticated project coordination.
At Xcelience, we are very much involved in driving projects
from beginning to end. On a micro level, the clinical supply
logistics and distribution area has become much more complex and costly due to the increase of large global studies,
cold chain and ambient monitored shipments.
Pharmaceutical Processing: What has the impact of equipment technology been on your business? Has new technology made your business more efficient? Or, has it generated so much data - that it has slowed down the pace
of clinical trials?
Ted Koontz, Vice President, Operations, Xcelience:
Technology has affected us in a very positive way. The
data that we can provide to clients now is much more accurate, precise and thorough. It has also reduced the overall
amount of paperwork required in many areas. Of course
there are times when it has slowed down certain aspects,
but overall the net affect has been very positive.
■ By Mike Auerbach, Editor in Chief
Experts at Xcelience comment on current and future CTM outsourcing trends
■ 58 MARCH 2014 | PHARMACEUTICAL PROCESSING
■ PHARMPRO. COM
■ OU TSOURCING
"There is increased pressure
in the industry to perform
global clinical trials using
sophisticated IWRS and
forecasting systems with
tighter timeframes and