We offer carefully-constructed strategies to gain patent protection through our innovative drug delivery approaches, by rendering unique and improved properties to a known drug entity.
Shikha Barman, Ph.D., CEO/CTO of Integral BioSystems, LLC
Bedford, Massachusetts (PRWEB) September 18, 2012
According to the CEO of Integral BioSystems, LLC, Shikha P. Barman, Ph.D., instead of investing dollars and time in a lengthy approval process for a new chemical entity (NCE), pharmaceutical companies are seeking to reduce risks and costs by finding new uses for existing products. Companies that take this approach fit naturally within the risk reduction model because they start with approved compounds with established history of use in humans. This approach to drug development, using repurposed, already-approved compounds, can make it possible for new drug formulations to enter the clinical development phase more rapidly and at much lower cost than when NCEs are used.
Companies that take this approach to "repurpose" drugs use one or a combination of the following strategies: (a) reformulating to “improve" efficacy, (b) discovery of new targets of old drugs, (c) reformatting an old drug with an established mechanism of action for another indication or (d) repurposing existing drugs to identify novel uses. While these approaches offer easier regulatory approval paths compared to the lengthy approval process for a New Drug Application for a new chemical entity, new challenges have emerged in terms of gaining patent protection and product exclusivity for the new "repurposed" products.
Patent Attorney and CEO of Patents Etcetera Dave Karasic provides expert advice to drug development companies on patentability of their drug and its proposed clinical indication and the strategic formulation of methods/ways to gain new patent protection for off-patent and/or repurposed drugs. The strategies and approaches are developed in collaboration with drug delivery/ drug development experts at Integral BioSystems, LLC.