As we all begin to think about, prepare and plan for 2009, I thought that it made sense to take an “informational temperature” of the pharmaceutical industry—what are the top priorities, concerns and opportunities as we position ourselves for a new year.
This was not a formal, statistically projectable study. Rather, it was based on my firm belief that if you ask any handful of smart, qualified people a question, you will get an awfully good idea of what is really happening out there. I have found that my LinkedIn network is a very conducive tool for conducting these dialogs, so if you are interested in participating in mini dialogs every few weeks and in seeing what your peers and industry counterparts have to say, feel free to pop me a LinkedIn invitation. I believe you will find the following insights interesting, however, because this questioning was not conducted within the context of a formal research study, there are likely industry functions that are underrepresented.
Without further ado, the following are the Top 10 priorities, opportunities and concerns for the manufacturing, operational and development areas of the pharmaceutical industry in 2009 (the list is presented in David Letterman style descending order).
#10
Availability of patient populations to support the growing number of clinical trials, coupled with regulatory pressures forcing companies to undertake more clinical trials.
#9
The cost of capital is anticipated to rise in 2009 warranting a close look at how to improve operational efficiencies.
#8
Navigating increasing cost pressures on western manufacturers due to increased Indian and Chinese manufacturing input. Competitive impacts from fast growing international regions such as
#7
Managing and preventing (as much as possible) Intellectual Property rights violations in markets like
#6
The uncertainty of the current regulatory environment is a factor on the industry’s mind. In addition, responding effectively to increased regulatory demands is a priority.
#5
Working to develop serialization/pedigree programs and technologies to improve supply chain security.
#4
Determining how to fill the pipeline with innovative new products within an industry environment that is sometimes more focused on M&A activity and other financial moves rather than supporting true innovation.
Adopting Quality by Design (QbD) principles to assure a more risk-based approach to pharmaceutical development and manufacturing.
#2
Adopting LEAN planning/production principles, increasing efficiencies in manufacturing/production
#1
(This is a BIGGY—nearly universally at the top of the list of all who participated in this dialog—no surprise to anyone given the events of 2008)
Maintaining quality, cGMP compliance and supply chain integrity amongst all supply chain participants particularly when working with partners in developing regions such as
“It is my personal opinion that an adequate strategic vision of the outsourcing dynamics is going to be one of the major challenges for the next future; nowadays the balance between owned manufacturing facilities versus the TPM facilities is rapidly going to the latter, increasing the need of continuous support to the cGMP standards compliance management of the externalized network; this could be a demanding exercise, requiring focused resources able to well judge the business demand versus the compliance expectations, streamlining the effort required to maintain the highest level of control without drifting the related costs.”
-Compliance/External Audits Director, Leading Pharmaceutical Company
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