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INFORMEX Show Daily | Thursday February 21 2013 | Anaheim Convention Center Anaheim California 9
Five Minutes With…
Denis Geffroy
Vice President of Business Development
Almac
Among the challenges the industry
faces, which do you think are the
most pressing
There continues to be an ongoing
funding challenge for pharmaceutical
development. Increasing complexity of
treatments, combined with increase safety
testing, and increased price controls, creates
a major challenge in developing a profitable drug. Although the science continues
to advance, we are reaching a stage at which funding development of life-saving
treatments may become unsustainable. Creative solutions for cost control are being
implemented throughout the industry.
And what do you believe are the most creative solutions
Partnerships and collaborations are being implemented to take advantage of
strengths of various organizations. Big pharma is partnering with academics (for
example, decisions by Pfizer and Novartis among others, to move drug discovery
to Cambridge, MA to take advantage of proximity to academic excellence) and
BioTechs to increase the efficiency and reduce cost and timelines of early drug
development. Big pharma seems to have finally embraced outsourcing of significant
CMC work as a way to reduce overhead and costs. These two strategies have
provided opportunities and challenges to CMOs and CROs. Although development
pipelines have been slashed, increased outsourcing has kept the flow of CMC
development work reasonably healthy.
Although ‘one stop shop’ has carried significant negative connotations in our
industry for many years, the reality is that an efficient offering of related services
applied throughout the development cycle from a single provider has been shown
to result in significant efficiencies in both time and cost savings. The key element
is that the provider of the related services must operate a near seamless process of
delivering these services.
For example, at Almac a project can enter our business at the earliest phase
of development and benefit from chemical development and physical form
optimization (both salt and / or polymorph), analytical methods development and
biomarker or companion diagnostic development. Undertaking these early clinical
development activities can also help to reduce attrition rate – common for many
new compounds. As the compound advances into clinical trials, biocatalysis might
be employed to greatly improve the manufacturing process. The early formulation
can be quickly and efficiently developed and GMP supplies of API and Drug Product
supplied. During clinical development a radiolabeled API and DP can be provided
for ADME studies and the API process and formulation can be further refined and
scaled-up. The clinical product can be packaged, labeled and distributed worldwide
using sophisticated Drug Supply Management programs and Interactive Voice/
Web Response Systems (IXRS). Finally, the process and analytical methods will
be validated, and ultimately commercial quantities manufactured, packaged and
See 5 Minutes With…Almac page 15