Integral BioSystems and Patents Etcetera Jointly Offer Integrated IP-Drug Development Strategies

October 17, 2012

Publish Date: 09/20/2012

Two Boston area firms, contract research organization (CRO) Integral BioSystems, LLC and intellectual property (IP) law firm Patents Etcetera have joined forces in offering drug development services that start with an IP strategy review.

Instead of investing dollars and time in a lengthy approval process for a new chemical entity (NCE), many pharmaceutical companies are seeking to reduce risks and costs by finding new uses for existing drugs. 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 taking this approach to "repurpose" drugs use one or a combination of the following strategies: (a) reformulating to “improve" efficacy, (b) discovery of new targets for 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 (NDA) 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 Dave Karasic (DBA Patents Etcetera) advises drug development companies about the patentability of their drug and its proposed clinical indication, suggesting 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.

 Integral BioSystems excels in the conceptualization and design of innovative drug delivery solutions for drug candidates that are unstable, intrinsically tissue impermeable, or incompatible with physiological fluids. With extensive experience developing sustained release systems incorporating microspheres, nanospheres, liposomes, depots, etc., Integral BioSystems specializes in the removing “roadblocks” preventing companies from leveraging the full potential of their proposed drug products.

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