U.S. AND CUBA LIFE SCIENCES: NEXT STEPS

 

U.S.-Cuba collaborations on life sciences projects keep making news.

In August, I wrote a special report for Bloomberg BNA and blogged about innovations developed in Cuba as result of the country’s need to create its own life sciences industry due to the U.S. trade embargo of Cuba. I noted U.S. companies and nonprofits have been using the few time-intensive mechanisms that have existed until now to pursue U.S.-Cuba collaborations for these projects.

Two weeks ago, I wrote an article and blogged about the Oct. 14 White House announcement that the Treasury Department's Office of Foreign Assets Control (OFAC) will permit approval of Cuban pharmaceuticals by the Food and Drug Administration and will allow them to be imported for marketing, sale and distribution. OFAC will also allow individuals subject to U.S. jurisdiction to engage in joint medical research projects with Cuban nationals.

Then on Oct. 28, the FDA announced it approved a U.S. clinical trial of the CimaVax treatment for non-small cell lung cancer developed by Cuba’s Center of Molecular Immunology (CMI). The clinical trial, which will be held at the Roswell Park Cancer Institute (RPCI) in Buffalo, N.Y., will examine the efficacy of the vaccine, which has previously shown improvement in overall survival for lung cancer patients in comparison with a control group.

RPCI representatives at the BIO 2016 International Convention in San Francisco discussed how they had received an OFAC license to work with the CMI on CimaVax and the RPCI’s efforts to obtain approval for a U.S. clinical trial. And now the clinical trial is going to begin.

U.S. companies and nonprofits have expressed interest in collaborating with the Cuban government and Cuban companies on other drugs and vaccines that I discussed in the special report for marketing in the U.S.

I am looking forward to seeing how their efforts progress in this new environment.

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