The process of turning a medical invention into a commercial success is long and difficult, but it does provide significant benefits to patients and supports future academic research at Northwestern.  Before initiating the scientific and regulatory processes required for commercialization, it is critical for an investigator to safeguard their intellectual property (a work or invention that is a result of your creativity) by disclosing the invention to the Innovation and New Venture Office (INVO) who will assist in evaluating your patent opportunities and, if appropriate, submit a patent application.  Northwestern University is the patent holder for all patents that result from innovations and inventions created at Northwestern.  The inventor/investigator can establish a startup company and then license the product to insure the legal right for development; alternately, a commercial company can acquire the license from INVO or a partnership can be established with a pharmaceutical company. 

The process of review and approval of an invention for human use is overseen by the Food and Drug Administration (FDA), which sets the standards for safety and efficacy for approval of inventions.  The initial hurdle is the Investigational New Drug Application (IND).  This document contains pre-clinical safety and efficacy data with the primary goal of demonstrating that the product is reasonably safe for initial use in humans, and that the compound exhibits pharmacological activity that justifies commercial development.  The IND also contains manufacturing methods for the final product and the protocol for the first in human clinical trial.

FDA encourages discussion with potential IND applicants and has established procedures for pre-IND meetings.  Northwestern Startup Companies and those with licensed inventions can contact FDA when they determine it is appropriate; investigators whose products are not licensed must contact the Office for Research prior to contacting FDA.

The FDA also requires that a Sponsor to be identified for each IND before an IND can be approved.  The Sponsor can be an investigator, an academic institution, an inventor’s startup company or a pharmaceutical company.  The Sponsor is responsible for the proper conduct of the clinical studies, safety of the study participants and reporting of information resultant from the clinical trials.  Northwestern’s sponsorship of an IND must be approved thru the Office for Research.   

The initial investigation of the invention in humans is referred to as a “First in Human Trial” or a Phase I clinical trial.  Phase I studies primarily evaluate the safety of the invention in either normal human subjects or in patients in the indicated population. Once initial safety has been demonstrated, the Sponsor amends the IND with additional clinical protocols.  The next set of required clinical protocols, Phase II studies, describe studies to be conducted in patients in the disease indication to establish additional safety and preliminary efficacy.  Finally, the invention is tested in a large population of patients in the indication to further characterize safety and demonstrate efficacy (Phase III studies).  Successful completion of the Phase III studies allows for the submission of a New Drug Application (NDA).  FDA approval of the application allows for commercialization of the drug. 

 

 

 

This website will focus on the process to complete and file an IND.

The IND Process

To explore each step in the IND process, please click here.

To learn more about the FDA, please click here