This is a particularly opportune time for innovative drug development outside the private sector.  First, the information technology (IT) revolution affords ready and cheap access to information from diverse sources for virtually everyone without respect to geographical boundaries.  Thus patients will become an increasingly major force in bringing interesting therapies to the attention of GlobalCures and in shaping its agenda, which is highly patient centric at its core.
Second, the genomics revolution has given scientists a complete “parts list” for the first time.  New technologies are allowing for monitoring of many biological variables in a patient.  These advances are allowing the medical community to start individualizing therapy.  It is the perfect time to incorporate these methods into the drug development process itself, thus saving cost, time and avoiding needless toxicity.

GlobalCures is ideally suited to capitalize on this situation, since it is not concerned about diminished financial return resulting from therapies that target narrowly defined patient populations.

No. GlobalCures’ efforts will be complementary to those in biotech and pharmaceutical companies.  Each will play a critical role in the broad need for drug development.

Yes, GlobalCures intends to approach a number of charities.  The pitch will be simple.  There are unexplored therapies/drugs that might benefit cancer patients now but they need rigorous validation.  That is GlobalCures’ major mission: to find these, evaluate them, perhaps combine them and then subject them to careful clinical studies.  To date, clinical trials have been supported primarily by the private sector, whereas both the government and cancer charities have largely supported laboratory research.  GlobalCures aims to change this paradigm: it is time to support investigator initiated clinical trials that have a sound scientific basis but which industry may not find commercially attractive.  Thus, GlobalCures will encourage cancer charities to either support such efforts directly or provide funding to GlobalCures.

No.  GlobalCures’ research will either validate or disprove some of the more promising therapies that fall under this rubric.  A negative result will also have considerable value, saving time and money, especially to patients with cancer, who can ill afford to try therapies not known to be efficacious.  It should be noted that some of GlobalCures’ candidates are as “targeted” as the newest cancer therapies, but they have not been tested rigorously in humans. 

A GlobalCures drug candidate may be added onto a currently accepted regimen.  In this case, a partnership with the pharmaceutical company manufacturing the currently used drug will be considered.  A fledgling biotech company may not have the funds to build biomarkers into its Phase I trial that would make the trial more informative – i.e. provide what is referred to in the industry as a “proof-of-concept” study.   Is the intended target in the tumor tissue being affected by the therapy?   GlobalCures might partner with such a company to fund such studies.  Another example: there are not enough patients being enrolled in a trial to provide statistical power to evaluate a particular endpoint.  GlobalCures might provide resources to fill that need.  In exchange for providing such resources, GlobalCures will expect to derive some revenue from the drug company if the drug is approved.

This is at the heart of GlobalCures’ mission.  Without such trials, one may never know if the drugs/therapies in question are really working or not.  They may work for a while and then fail later.  They may work best in conjunction with standard chemotherapy.  They may have unexpected side-effects.  They may work only in a sub-group of cancer patients.  These are the types of questions that will be answered by the clinical trials that GlobalCures will conduct.  Most importantly, physicians will be reluctant to prescribe these therapies without such data, i.e. potential patient benefit versus risk of the therapy.  In addition, physicians worry about losing their license or being sued for prescribing unvalidated therapies; they may get derided by their colleagues, and they may not understand the rationale for the therapy or its interaction with more conventional therapies in the absence of rigorous data.