Changing the game in vaccine research

In Wednesday's Wall Street Journal

Leaders of the Texas Plant-Expressed Vaccine Consortium today announced a biotherapeutic manufacturing initiative designed to show proof of concept for a landmark new technology that could dramatically increase the nation’s capability to produce vaccines for infectious diseases, including influenza.

We have a Texas Plant-Expressed Vaccine Consortium? Where have they been before now? Vision 1920 wonders if this is a new operation or if it has been around since A&M lost Charles Arntzen's project to express vaccines in bananas to Cornell. Or since A&Ms partnership with ProdiGene ran aground.

Project GreenVax, which utilizes tobacco plants rather than the current egg-based vaccine technology, holds the promise of shortening vaccine production to a fraction of the current time, allowing rapid response to newly emerging viruses not possible with current technology. The majority of funding for the project is provided by the Defense Advanced Research Projects Agency (DARPA).
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“Project GreenVax and the NCTM are game-changers. They have the potential to transform not just vaccine production, but the entire biopharmaceutical manufacturing industry,” said Dr. Brett Giroir, vice chancellor for research for the A&M System and executive director of the Institute for Innovative Therapeutics (IIT), the newly established institute representing the partnership between the system’s multiple state-of-the-art research facilities.

Bayer Cropsciences has already taken similar technology to phase 1 clinical trials. G-Con's team had some connection to the Bayer system, but it seems like there was a complex combination of collaboration and competition involved. G-Con's founder was with Large Scale Biology, which didn't lose...they just ran out of time.

Expect the potbangers to quibble about whether Project Greenvax is really game changing. But maybe that's not the game Dr. Giroir, who brings his DARPA connections to A&M, is talking about.

In other vaccine news:

In a move touted as by many experts as questionable at best, PharmAthene has seen millions of dollars added to a 2003 contract without competing for it.

PharmAthene, which held closes ties to the late Congressman John Murtha and current DHS Under Secretary Tara O'Toole, was originally awarded the contract by BARDA. This new influx of money is part of a 2008 HHS request for a proposal for a second-generation anthrax vaccine.

A proposal for the NCTM(j)

Vision 1920 thought that with the Regents' approval of tIIT, the National Center for Therapeutics Manufacturing was already approved. But earlier today, emails were circulating at TAMU seeking input on a proposal for the NCTM that VC for Engineering Kem Bennett wants to present at the next meeting of the BoR. Apparently the NCTM has only cleared the first hoop in System Policy 11.02.1 (pdf)

... Centers and institutes shall be discussed with the board in concept prior to full-scale development of a proposal for its approval except where the delay for such discussion would jeopardize grant and contract funding of the center or institute because of externally imposed deadlines....

The BoR only approved the concept and now has to consider the full-scale proposal.

Based on what Vision 1920 is hearing, the NCTM proposal may be attacked by the potbangers for not having a contingency plan in case the estimates of demand for partnerships in the industrial consortium are overly optimistic and the Center has a hard time generating the revenue needed to keep it going. About a year ago, BioPharm International Magazine discussed market trends for contract manufacturing organizations (CMOs) in pharma:

The biomanufacturing building boom is merging with several other industry trends to create a looming overcapacity situation in the industry.
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The excess capacity at the major bio/pharmaceutical companies could be a real challenge to the contract biomanufacturers. We've heard of at least one major company that has recently begun selling its excess capacity in the contract market. We've also heard from some CMOs that clients are reducing production at their CMOs in order to fill underutilized internal capacity.

This was before the economy crashed last fall. Because the NCTM won't be finished for several years, perhaps the plan is that TEES will be able to buy capability low now, and sell high when the economy rebounds. But this may not satisfy the critics.

Vision 1920 humbly offers an alternative contingency plan. We keep the NCTM acronym and tweak what it stands for. Faithful readers, Vision 1920 gives you a proposal for the:

National Center for "Therapeutic" Marijuana (NCTMj)

We admit that the inspiration for the NCTMj is comes from ideas to solve California's budget problems.

Ammiano introduced legislation last month that would legalize pot and allow the state to regulate and tax its sale — a move that could mean billions of dollars for the cash-strapped state. Pot is, after all, California's biggest cash crop, responsible for $14 billion a year in sales, dwarfing the state's second largest agricultural commodity — milk and cream — which brings in $7.3 billion a year, according to the most recent USDA statistics.

Texas is in a perfect position to exploit this market in the way we pwned California in the glory days of Enron. Some of the benefits of modifying the NCTM to the NCTMj include:

• Provides a role for AgriLife in tIIT
• Would help Texas A&M recruit football stars who would otherwise go to the "Bonghorns"
• Would stimulate business at Frito-Lay, a major Texas company
• Problems with the Federal DEA will be moot after Gov. Perry has Texas secede (Note that this would also simplify implementing the Texas Policy Foundation's proposal to have our own accreditation system)
• People would not have to ask "what are they smoking?" when evaluating the revised proposal

Skins game

The last part of Bret Giroir's presentation was about the administrative structure of the Institute for Innovative Therapeutics. Giroir talked about how the participating components - TAMU, TAMUHSC, TEES, and AgriLife would each have primary responsibility for one of the components. In the current plan, TAMU will run TIPS, TAMUHSC will run TIGM, and TEES will run the NCTM. AgriLife will eventually have responsibility for another component, as the Institute expands into a "One Health Plus" mission, and becomes a campus bridging space between the university and the site of the planned new medical center.

The idea is that each of the System components will have "skin in the game" for all of the Institute components, with a larger share of the responsibility and revenue for the piece they run. A preliminary version of how this would work is in the strategic plan (pdf) posted on the CPI website.

The Chancellor and the CEO constituency committee should develop a model for sharing shortfalls and excess revenues across the Institution and participating components

A recommended strategy would be to have the institutional shortfalls and excess revenues assumed according to the following type of structure, using TIPS as an example. The percentage allocation should be decided upon by the Chancellor and the CEO Constituency Committee but should adhere to the principle of shared "skin in the game":

• 60% assumed by the primary owner (e.g. TAMU as primary owner of TIPS
• 20% assumed by the Institutional Partners (e.g. HSC and TEES)
20% assumed by TAMUS

The percentages presented by Giroir yesterday were different. The primary owner shares where reduced to 40%. Vision 1920 did not catch how the exact percentages were adjusted for the other components, but the plan included a way for AgriLife to have significant skin in the game even before it becomes a primary owner of a component.

The story in today's Eagle touches on the question of how much exposure is involved

"We would like to understand much better where the money is coming from and what the risks are," said Tim Hall, a professor in the College of Science.
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"I would say the risks are incredibly* minimal," he said in an interview after the meeting. "Anything you do has risks. I can only say that we have done more financial due diligence and have more [backup] plans that I have seen at any university in my experience."

The fiscal risks are hard to estimate, as they require assumptions about the income streams of TIGM, TIPS, and NCTM. Interestingly, Giroir said he expected TIGM to continue to lose money; as a core facility it is designed to subsidize other research (currently that subsidy is to other institutions outside TAMUS). This makes the outdated technology of the TIGM knockout collection a feature, not a bug; if more labs ordered TIGM mice, it would have an even bigger deficit!

The documents posted by the CPI include a couple of different sets of fiscal estimates. In the strategic plan, which projects out to 2013, TIGM is projected to lose $2-3M/year. TIPS has two projections based on how fast imaging equipment is purchased. These show a $5M profit from a "Governor's loan" and two ETF projects in FY2009, followed by losses ranging from $2-6M/year. This does not include a hoped-for $65M deal with Xerion. The strategic plan does not have a projection for NCTM. The CPI has also posted a best/worst case analysis by Greg Anderson, the System treasurer. This shows a best case of rising profits of 1-3M/year for TIPS and $7-8M/year for NCTM by 2017. TIGM is projected to lose money in the best case scenario. The worst case scenario still shows NCTM making a $4M profit by 2014. In this scenario, long-term NCTM profits almost offset losses by TIGM and TIPS by 2017. The basis for the income projections is not clear.

*Incredibly = in(not)+credibly.

Umbrella, from the latin Umbra for shadow

The Eagle reports the expected announcement to go forward with tIIT.

Amid strong dissent from some faculty members, the Texas A&M University System Board of Regents took a step Friday toward creating a controversial new therapeutics research center at its flagship university.

Regents also voted to rearrange the structure of other therapeutics-related organizations within the system -- placing the organizations located throughout the system under an umbrella agency in System Chancellor Mike McKinney's office.

Vision 1920 can't imagine why faculty are concerned about some research being taken over by the System. Besides this part, we mean.

Regents asked Bennett and Pishko if they knew why faculty members were opposed to the plans. Both said they were baffled.

Pishko said that he had heard of opposition from the Council of Principal Investigators, a group representing hundreds of university researchers, but that most engineering professors supported the idea. No one from the council was involved in the center, he said.

He said he had no idea why the group opposed the plans and said he hadn't spoken to any members.

This refers to the NCTM; most faculty probably hadn't heard of the tIIT until now. According to Vision 1920's sources, the CPI asked Pishko to speak to them after the NCTM was mentioned in their resolution of no-confidence in the chancellor, but he declined. Bennett and Pishko are the engineering guys, so our confidence in them is not shaken by their failure to grasp the objections of their colleagues

"I think the concern is how this is going to be funded and that there are risks involved that have not been discussed in the open," said Deborah Bell-Pederson, a biology professor and chair of the council. She declined to comment further.
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Fully equipped and operational, the center will cost $65 million, Giroir said, but officials initially will spend only the $50 million from the governor's office. They hope to obtain the other $15 million with revenue from research grants and partnerships brought in once the center has successfully begun attracting income and researchers, he said.

Vision 1920 is confident that potential partners and grant agencies will be happy to pony up the shortfall, plus a share of the operating costs needed after the $65M setup (TIGM was reported to cost $2M/year to run. The GMP components of NCTM are likely to cost at least that much).

Vision 1920 is sure that with another executive director at the System level, an Operations Board, and the biotech talent we already have in the System offices, tIIT will find creative ways to hide its real costs raise the money needed. For example:

• By giving tIIT staff academic appointments, personnel costs can be buried in the University budget
• "research grants and partnerships brought in once the center has successfully begun attracting income and researchers" doesn't necessarily limit the System to grants to the center, just to awards made after some future date. Staff at the Office of Technology Commercialization can identify researchers whose research is relevant, whether they think so or not.
• Costs can be foisted off on the taxpayers by having our friends in Austin make sure that ETF funds go to companies that agree to contract with tIIT.
• Now that Murano is gone, we can go back to quietly making loans like the one that went to the Athletic Dept.

Grand Unification Theory

The Eagle previews what's coming up in the Regents' meeting. One highlight:

* Establishing the Institute for Innovative Therapeutics, which will serve as a "one-stop" biopharmaceutical program to research, develop and commercialize biomedical discoveries. The new institute -- which will consist of units already within the A&M system -- will "result in a single, unified biomedical enterprise," according to board documents.

As our faithful readers already know, Vice Chancellor Dr. Brett P. "eHarmony" Giroir plans to unite TIGM, TIPS, and the NCTM in a menage a trois based on their dimensions of compatibility.

In March the Institute for Innovative Therapeutics was presented as just "An integrated biomedical institute". Vision 1920 admires whoever comes up with the names of these things. Unlike other drug discovery programs, we are only interested in innovative therapeutics. We don't just have a Center for Therapeutics Manufacturing; we have a National Center for Therapeutics Manufacturing. And each component is the foremost resource its kind. At least between North Zulch and Old Dime Box.