6

Financial Challenges

Several participants noted financial challenges linked to cancer drug development, including the expense of developing knockout1 and other animal models, RNA sequence libraries, and creating enough study drug to test, which is especially problematic for biologics. Most of these challenges pertain to combination therapy development as well as drug development in general. Dr. Stern noted that investigators rely on RNA libraries to do screening, but those libraries are often prohibitively expensive and suggested the federal government could become involved in supporting those libraries.

Dr. Doroshow pointed out that standard grants from the National Institutes of Health (NIH) do not provide funding for validating assays, despite the growing importance of patient selection assays in clinical trials.

Dr. June noted that clinical trials for many immunotherapies are expensive because the cells need to be manufactured, “so we are paying for both the cost of the drug, which is a biologic or a cell, and the standard clinical trial costs. Raising funds is a very large challenge and the NCI grants don’t cover these kinds of trials. It requires multiple kinds of support from grants, foundations, and philanthropy.” He pointed out that cell therapies are not necessarily more expensive than antibody therapies

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1 A knockout mouse is a laboratory mouse in which researchers have inactivated, or “knocked out,” an existing gene by replacing it or disrupting it with an artificial piece of DNA, in order to better understand how a similar gene may cause or contribute to disease in humans.



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OCR for page 53
6 Financial Challenges Several participants noted financial challenges linked to cancer drug development, including the expense of developing knockout1 and other animal models, RNA sequence libraries, and creating enough study drug to test, which is especially problematic for biologics. Most of these chal - lenges pertain to combination therapy development as well as drug devel- opment in general. Dr. Stern noted that investigators rely on RNA libraries to do screening, but those libraries are often prohibitively expensive and suggested the federal government could become involved in supporting those libraries. Dr. Doroshow pointed out that standard grants from the National Institutes of Health (NIH) do not provide funding for validating assays, despite the growing importance of patient selection assays in clinical trials. Dr. June noted that clinical trials for many immunotherapies are expensive because the cells need to be manufactured, “so we are paying for both the cost of the drug, which is a biologic or a cell, and the stan - dard clinical trial costs. Raising funds is a very large challenge and the NCI grants don’t cover these kinds of trials. It requires multiple kinds of support from grants, foundations, and philanthropy.” He pointed out that cell therapies are not necessarily more expensive than antibody therapies 1 A knockout mouse is a laboratory mouse in which researchers have inactivated, or “knocked out,” an existing gene by replacing it or disrupting it with an artificial piece of DNA, in order to better understand how a similar gene may cause or contribute to disease in humans. 53

OCR for page 53
54 COLLABORATIONS TO DEVELOP COMBINATION CANCER THERAPIES because they do not have to be given for as long a period of time. “The cost of goods for us to manufacture one of these cell therapy infusions is $15,000, which is less than 3 months of antibody therapy. Right now, patients are often getting antibodies for their lifespan. If you have a self- replicating cell that can continue to make antibodies, the cells may actu- ally in the end be more cost-effective,” Dr. June said.