Sameer Tandon
A few emerging themes have been at the forefront of discussions surrounding study feasibility assessments. Despite technological
improvements and real-time access to data, we continue to be
plagued by some common mistakes often overlooked in our feasibility
steps. For example, most sponsors and CROs continue to provide very
limited information and time to sites to respond to protocol feasibility.
Eric S. Langer
Outsourcing of non-core activities continues to be a value-driven calculus, as the biopharmaceutical manufacturing industry remains very much focused on productivity gains. However,
there are signs that the outsourcing landscape has moved beyond its
traditional concentration on non-core activities.
QbD (Quality by design) and DOE (Design of experiments)
related to formulation development have been increasingly
outsourced to increase the efficiency of research experiments and decrease
the time needed to perform them. Novel formulation development
strategies (solid dispersions, supersaturated drug delivery systems, selfemulsifying
drug delivery systems) as well as technologies that increase the
solubility of poorly soluble compounds are also increasingly outsourced.
New techniques for physicochemical characterizations, in vitro and PK
modeling techniques, and cGMP facilities are gaining focus in outsourcing
and becoming an integral part of drug development programs.
Stuart G. Levy, PhD
The successful establishment of an emerging pharmaceutical company’s clinical drug supply depends on the outcome of work
performed by vendors to which the work is outsourced.
Dr. Nicola Spiggelkötter
International guidelines on Good Distribution Practice clearly stress the importance of supply chain integrity. This is first demonstrated in
maintaining quality of the medicinal preparations to the final point of distribution and sales (the delivery of the product to the end user/patient),
and second, in ensuring the robustness of distribution channels against the
invasion of falsified medicines. The second has served as a key argument for updating the EU Good Distribution Guideline in March 2013. This
article will focus on the first aspect.
Dennis Jenke, Ph.D., Michael Ruberto, Ph.D
Packaged pharmaceutical drug products can interact with their
packaging, resulting in the migration of substances from the
packaging and into the drug product. The presence of migratory
substances in the finished drug product is of concern due to the impact
that such substances could have on the finished drug product’s suitability
for use.