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Drug molecules that are the basis for a partnership agreement
are either New Chemical Entities (NCEs) that have not yet
been approved by the FDA or existing FDA approved drugs.
A partner developing a new chemical entity is often trying to
solve a problem, such as poor bioavailability, or the partner is
interested in creating additional patent protection for the NCE.
more... New Chemical Entities
A partner interested in using cocrystals to form the basis for a
product improvement, typically working in parallel with a
formulation strategy, using a known API that has been
previously approved by the FDA will be interested in the
505(b)(2) product strategy. more... FDA Approved Drugs
Renovo currently has an opportunity available to submit a
SBIR Phase II grant application to develop a product that
requires an improvement in bioavailabilty. Contact Renovo if
your company is interested in including your API in this
Many pharmaceutical companies interested in cocrystals
prefer to work on a strictly fee-for-service basis, which is
available though Triclinic Labs. more... Service Offerings
Partnering with Renovo
If the project meets certain requirements,
Renovo will share the risk and cost of
development of a cocrystal based product.
The partner must identify the API and describe
the 'problem' that needs to be solved or the
strategy for an improved product.
Renovo and the partner will collectively
determine the potential product specifications
and how cocrystals can be of benefit.
Renovo will screen, identify, scale up,
characterize, and determine the most
appropriate cocrystal that can meet the product
requirements. A provisional patent application
will be filed.
If initial dissolution and formulation experiments
suggest that the project is viable, the project
would enter the next phase. This point is usually
marked by the filing of the non-provisional patent
application. Further development is typically
performed either by the partner with the
assistance of Renovo, or by a third party.
cocrystals of pharmaceuticals...