The American Association of Pharmaceutical Scientists (AAPS) held its annual meeting from October 23-27. Approximately 9000 attendees and exhibitors gathered in Washington D.C. for the 2011 Meeting and Exposition. The society and meeting focus on every stage of bringing a new drug to the market. This includes drug discovery, development, formulation, and delivery method. Therefore, this meeting brought together a number of researchers and exhibitors covering areas such as CRO and service providers, manufacturing equipment vendors for encapsulation, particle analysis, sample prep, as well as reagent and instrumentation providers. BioTek was looking to demonstrate the capabilities of its instrumentation to be used in the higher throughput methods typically incorporated in the pharmaceutical industry. To that end, we presented three posters showing research in biological formulation studies, drug metabolism, and cytotoxicity using high density plate formats.
An opening Keynote Address to the conference was given by Janet Woodcock from the FDA, entitled "FDA-The Next 25 Years". Her talk focused on current and future trends that will affect not only the FDA, but the pharmaceutical industry as a whole. An initial point was the call in the industry for less regulatory controls by the FDA. It has been shown that drugs can be approved by European or Asian regulatory agencies faster than by the FDA, which can cause delays in product launches in the US and therefore delays in the recouping of development costs for that drug by the company. Another important point was the rise of developing countries in the market. Most pharmaceutical development at the current time takes place within countries that have adapted ICH (International Conference on Harmonisation) guidelines. However, many countries not currently under the ICH blanket are now beginning their own drug development industries. This will force regulatory agencies within the US, EU, and Japan to be part of a larger, more global group of regulators. In addition, there will also be a need to pressure these countries to adapt ICH guidelines to maintain common practices within the industry as a whole. The hope of regulators within the FDA is to become a leaner, more efficient agency in the future that is able to make faster decisions, using more complete data sets. This will put the emphasis back onto the industry to continue to develop better testing methods to generate the most in-vivo-like data as possible, to expedite the decision process.
By, BioTek Instruments, Brad Larson, Principal Scientist and Jared Amuan, Field Applications Specialist