Doing “What Works” Is Working

Basic science funding was partially restored in this weekend’s deal to avert a government shutdown. But don’t think for a moment that life science commercialization will easily survive the administration’s anti-science budget stance. The fight to stave off R&D starvation has just begun.

Mosquito-borne Zika has no respect for national borders nor will it enjoy a summer recess. New shared development strategy to spread the rising costs and risk of developing much-needed anti-viral drugs has changed the drug development game into a shared enterprise for pharmaceutical companies.  But fresh tactical approaches to vaccine development have not altered the old thinking of price-based B-D march-in crusader KEI’s Jamie Love and his Senate spokesman Bernie Sanders. They objected to an award of shared financial support to vaccine-maker Sanofi to help underwrite two-stage clinical trials that could produce concrete evidence of a potentially safe, effective and investible Zika vaccine by June. If Phase II testing is successful, NIH’s Dr. Fauci says the vaccine’s Phase III trials would require massive support from a yet unnamed drug company partner.

The US Army Office of Research and Technology Applications (ORTA) issued a letter last week reporting that the Army would pay much of this trial’s bill. The letter implied that granting Sanofi an exclusive license was a reasonable and necessary means to harness the capital and expertise needed to win FDA approval for an unproven technology. Sanofi was the only company interested in pursuing this collaborative Phase II research agreement.

Love and Sanders rottenly complained that an exclusive Phase II award might lead later to Sanofi’s charging for the vaccine “whatever astronomical price it wants.”  What Love and Sanders fail to say is how they propose to defend against a baby-maiming virus creeping up our nation’s coast. Worse, what they never seem to understand is that unless this new vaccine’s later stage development can attract private sector investment capital, there will be no such vaccine. Continue reading Doing “What Works” Is Working

Elimination of Further R&D Funding

Bayh-Dole’s (B-D) commercialization of federally-funded basic research is the bridge connecting annual $130+ bn. congressional funding to its congressionally intended public benefits of jobs, economic development and scientific progress. This B-D bridge’s on-ramp is controlled by federal grant agencies, each with its own mission. Life science’s on-ramp is supervised by NIH. Its off-ramp exit is policed by the FDA. Life science’s high-risk commercialization crossing to the off-ramp is difficult, long and costly. Its chances of reaching and using the FDA managed off-ramp are statistically slim. Continue reading Elimination of Further R&D Funding

CRADA. . .Market Reasonable vs. Politics Reasonable

Like the proverbial “tango”, research university commercialization of basic research “takes two”; university TTOs and private sector investors. To attract such investment its subject matter must promise prudently estimated commercial development returns. Investors also must estimate that such development can be executed and competitively distributed at a price sufficient to provide a reasonable return on their investment. Such “reasonableness” in markets is a function of lost alternative opportunity costs, applied research risk, development and added capital costs, endpoint market demand and sometimes regulatory approvals. Patents may provide protection from competitive duplication for a limited period, but sales at the product’s optimal price point are the ultimate determinant of investor success. Optimal price selection combines experience, economics, art and science in functional complexity not normally housed in government. Bayh Dole’s market-based dynamic does not intrude on the price selection of product developers because in its absence prospective investors cannot prudently estimate their potential return on investment. The wisdom of this approach is not only theoretically obvious, we have seen this movie before with “CRADA”. Continue reading CRADA. . .Market Reasonable vs. Politics Reasonable

Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits – The New York Times

This New York Times above-the-fold hit piece is designed to support price-based march-in and generally damage Bayh-Dole. It tells us that enemies of B-D obviously plan to engage again and to use drug pricing as their weapon of choice. Engineered by James Love of KEI, it attacks a seemingly successful CRADA partnership, refers to unrealized capital gains as “profit’ (which could be wiped out by a future adverse FDA ruling), misstates NIH’s repeated conclusions that price-based BD march-in is not authorized by BD, factually saying it is now available to curb drug pricing. Continue reading Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits – The New York Times

Replace and Thus Repeal Bayh-Dole Commercialization

Whatever its outcome, this election marks the start of political turmoil for months to come. In the coming “fog of war”, anti-patent activists will seek fresh support for stale schemes to crush Bayh-Dole’ (B-D’s) commercialization cornerstone. Mega-tech muscle will push new versions of HR 9 litigation on Capitol Hill. Continue reading Replace and Thus Repeal Bayh-Dole Commercialization