4th Annual Generic Drug ForumApril 6-7, 2006 Washington, DC
There are many issues that
Generic Drugmanufacturers face in expanding their product offerings and taking them to
market. When looking at the marketing and
business development side of the
generic drug market, there are a lot of challenges that companies are facing. It
becomes increasingly difficult for generic drug manufacturers to make decisions
on what drug would be the best to move forward into production. It is also
important to know what the branded pharmaceutical companies are planning for
future product developments, as well as with their current branded therapies, as
many companies, when considering the expiry of their blockbusters' patent, will
consider re-launching or redeveloping the therapy in order to elongate or
continue the brand. Reaching patients and creating access to generic drugs has
become one of the largest challenges faced by the industry as people, in
general, do not consider them to be "bioequivalent" to their branded partners.
From the production side, there are also a number of important issues to
consider. Generic drug manufacturers must insure that the drugs they are
producing are exact replicas of the branded drugs in accordance with FDA
regulations. This is of increasing importance, as many branded drugs are of an
increasingly complex nature, and thus require additional manufacturing quality
assurance programs. In some cases, generic drug manufacturers are being told
that they need to conduct small to mid-scale clinical trials to prove the
efficacy of their products! And, of course, there is increasing FDA
surveillance, resulting in large-scale recalls and, to a smaller extent, the
liquidation of generic houses. At this conference, we will address these issues
through the presentation of case studies and the conducting of panel discussions
highlighting the best practices of leading
generic drug companies.