INDEMNIFICATION

Dr. Hohneker said that a major stumbling block for developing combination therapies with multiple sponsors and investigators is determining patient safety and attribution of and reparations for serious adverse effects that patients may incur during the course of a clinical trial. This can be particularly nettlesome for combination therapies of investigational agents for which the toxicities are not fully known. Determining indemnification and having institutions share risk in clinical trials is a major issue for combination immunotherapy clinical trials, Dr. June noted.

Dr. John Mendelsohn, president of the MD Anderson Cancer Center, suggested that if patients and FDA are willing to accept the risk of unexpected toxicities, clinical tests could go forward with such combination therapies. If a new toxicity develops, the clinical trial could then be suspended for 3 months or so until animal models reveal more appropriate dose combinations to test, he said. Dr. Saber indicated that FDA would not be averse to such a scenario, but thought the drug industry would be more cautious and unwilling to pursue this testing tactic. Dr. Mendelsohn added that “the biggest risk aversion occurs in our own IRBs—they are the ones slowing things down more than anything. We must work with them to teach them that if the patient wants to accept the risk, it’s okay.”

INTELLECTUAL PROPERTY

Several speakers pointed out that solutions are needed for some of the thorny intellectual property issues that arise with combination therapies, especially those with more than one industry sponsor. Dr. Schlom pointed out that a major impediment to companies sharing their cell lines and drug candidates preclinically is intellectual property issues, while others stressed that intellectual property rights impede clinical trials of combination cancer therapies.

As Ms. Anishiya Abrol, associate at Hogan Lovells, pointed out, intellectual property agreements can be complex because a number of variables have to be decided, including who owns the compound and the process for manufacturing it, as well as who owns the data and new indications that might stem from the collaborative research. All parties also have to agree on how patents will be enforced and whether patents will be worldwide or only focused on certain key countries. Trade secrets may still have to be protected even if no patentable inventions result from the research.

“These are difficult questions to ask and answer at a very early stage,” when there is so much uncertainty about what will result from the collaboration, Ms. Abrol said. But she added that “there’s been discussion



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