Jeff Marra, Ph.D.
Like chess, which is easy to learn but difficult to master, engaging
a CMO for API manufacture is a straightforward process yet
delivering the proper amount of API on time, on budget and within
specifications presents challenges. With each API comes a distinct set of
requirements, and with each CMO comes a distinct set of capabilities.
Making a match that results in harmonious collaboration and successful
API manufacture is a task that is difficult to master.
Charles Forsaith
The effective management of pharmaceutical supply chains has
become one of the top public health concerns with respect to
consumer safety. The globalization of pharmaceutical distribution
networks has exposed, at times negatively, the complications and
vulnerabilities surrounding these types of delicate distribution
networks. Criminal enterprises, unethical entities, and noncompliant
trading partners along the pharmaceutical supply chain can potentially
introduce contaminated, adulterated, and even counterfeit medicinal
goods. When any of these situations occur, there are potentially
dangerous consequences. Four examples are given below:
The forces supporting the globalization of clinical trials are
powerful: universal acceptance of ICH-GCP, the saturation of
research sites in the US and Europe, cost containment pressures, need
for larger patient pool, and the growth of the pharmaceutical market
in emerging countries. Notwithstanding, other factors act in favor of
keeping the trials where they have always been, and they come in two
flavors. Some are objective, such as greater logistic complexity, lack
of harmonized regulations, less experienced sites, and variations in
medical practices. Others are subjective and no less important; they
reside in the minds of decision makers.
Dennis Jenke, Ph.D., Michael Ruberto, Ph.D
Packaged pharmaceutical drug products can interact with their
packaging, resulting in the movement of substances from the packaging
and into the drug product. The presence of such substances in the
finished drug product is of concern due to the impact that they could
have on the finished drug product’s suitability for use.
Laszlo Otvos, Ph.D.
Although biotechnology investors and preclinical pharmacology
experts may not always concur, peptide therapeutics offer
demonstrable commercial success [1]. More than 50 peptide
drugs, with annual sales in excess of $1 billion each, were marketed
in 2010. Primary therapeutic indications include cancer and metabolic
disease, but a wide range of novel uses such as vaccines, antimicrobials,
and contraceptives are actively under development.
The type of work that is outsourced depends on a complex series
of factors – including, most importantly, (a) the capabilities of
the outsourcing company and the partner organization, and (b)
the needs of the project. For companies that do not have in-
house capabilities, outsourcing is central to their operations and
a key driver for their pharmaceutical development activities.
For companies that do have the capabilities and routinely carry
out at least some work in-house, outsourcing is meant to be a
cost cutting and efficiency improvement measure focused on
routine, repetitive work. For the purpose of my responses to
this questionnaire, I would focus on the latter set of outsourcing
companies (that do have in-house capabilities).
Health Canada Therapeutic Products Directorate, Health
Products Food Branch is the governing regulatory body over
the marketing of drug products in Canada.