Exemplary commitment

The Regents voted to approve the NCTM (again).

“The NCTM exemplifies the Texas A&M System’s commitment to public service through education and research,” said Dr. Michael Pishko, head of Texas A&M’s department of chemical engineering, who will lead the NCTM team.

Just think how great this will be if it comes anywhere close to the System's commitment to shared governance.

About G-Con

Earlier, we wondered about the identity of G-Con, the industry partner that local officials and Texas A&M are planning to work with to "bring a large biomedical research and vaccination manufacturing center to Bryan". At the time, G-con's website looked brand new, and didn't have information about who they are. But Vision 1920 just checked the site again and we see that the about page has been updated:

Dr. Barry Holtz, President of G-Con, is a recognized international expert on design and construction of pharmaceutical facilities. David Haselwood, an experienced life science entrepreneur, investor and operator, heads up business operations for G-Con.

Barry Holtz appears to be the proprietor of Holtz BioPharma Consulting

Dr. Holtz has 30 years of experience in the development of bioproducts and biopharmaceuticals. Serving 15 years as Senior Vice President for Large Scale Biology Corporation, Dr. Holtz was responsible for the product development, clinical development and manufacturing compliance of the company's proprietary therapeutics portfolio. These projects included leading development and manufacturing teams that successfully brought a recombinant, plant-made, patient specific vaccine, for treatment of indolent Non-Hodgkin's lymphoma,from the bench to human clinical trials. Dr. Holtz was also responsible for the design, construction and commissioning of the LSBC biopharmaceutical production facility in Owensboro, Kentucky. Dr. Holtz has also designed and built two other bioproducts facilities for other clients. Recent efforts have included design and construction of cancer vaccine facilities, implementing proteogenomics into vaccine manufacture and international development of biotechnology development in resource challenged countries.

Prior to Large Scale Biology, Dr. Holtz was the founder and President of Holtz Bio-Engineering. Over its' nine year history, the company was involved in the development of bioreactor based processes for the biotechnology sector and developed a proprietary line of bioreactors and distributed logic control systems for cell culture. Holtz Bio-Engineering was merged into Large Scale Biology in 1989.

Dr. Holtz has held research management positions at Foremost-Mckesson and was on the faculty of Ohio State University. He received his Ph.D. at Pennsylvania State University and was an NSF Postdoctoral Fellow at Scripps Institution of Oceanography. Dr. Holtz has been awarded 22 US patents and has published over 50 scientific papers. Dr. Holtz was awarded the Pennsylvania State University, Outstanding Alumni Award in 2003.

Pubmed finds some papers that could be from Holtz's graduate and postdoctoral work. More relevant to the NCTM is this paper from Large Scale Biology Corporation describing production of anticancer vaccines using Tobacco Mosaic Virus vectors in plants. This has been used by Bayer, in collaboration with Icon Genetics (a competitor of LSBC?), which is also listed under the projects page at G-Con.

Large Scale Biology Corporation appears to have published the paper a couple of years after going bankrupt.

David Haselwood is a 2004 Berkeley MPH/MBA who has also been with Gradalis since 2008. From 2004-2006, he worked at Burrill & Company, a venture capital firm focusing on biotech.

G-Con game?

In today's Eagle

The Texas A&M University System and local government leaders are working to firm up plans to bring a large biomedical research and vaccination manufacturing center to Bryan, officials said Tuesday.

The proposal hasn't been finalized, but officials said they hope the biomanufacturing company G-Con, LLC will build a 100,000-square-foot facility near the system's new Health Science Center that's under construction.

Vision 1920 is excited! Not that we know much about G-Con LLC. They do have a website, though.



We can tell that there's serious science going on at G-Con by looking at those two people pipetting dry ice vapor out of that bottle. Clearly, the G-Con folks scoff at pansies who think they should be using safety glasses or do this in a hood. They'll fit right in here at A&M.

Officials, who said word on funding may come within three weeks, expect the project to bring almost 150 jobs to the area with an average salary of $75,000 a year.

The project is likely to spur more development in the biomedical industry around the Health Science Center and the Institute for Innovative Therapeutics, helping develop a "biotechnology corridor" on the periphery of A&M's campus near Texas 47.

G-Con's website doesn't describe them (whoever they are) as vaccine manufacturers who will use NCTM's next generation facilities to make their vaccines. They describe themselves this way:

G-Con’s mission is to revolutionize the biomanufacturing industry by providing its clients with a comprehensive GMP manufacturing solution that is cheaper to build, flexible, cheaper to maintain and easier to operate than any existing solution on the market.

G-Con provides its partners with comprehensive biomanufacturing services including (as appropriate) facility design, facility construction, module design and module maintenance.

...which sounds like they're planning on selling these services to the NCTM, not buying from the NCTM. Interestingly, the collective resume of G-Con team members includes:

National Center for Therapeutics Manufacturing, Texas A & M University

Members of the design team

Unlike some of our prior industrial partners, G-Con is clearly going to be able to sell their products. We can guarantee it.

Onward with the NCTM!

As predicted, the Regents approved the NCTM on Friday. The Houston Chronicle reports

Friday's vote wasn't a surprise; regents already had earmarked $42.5 million of the grant to build the center, and the building is expected to open in 2011.

But the transition from a good idea with a fancy building to a profitable research enterprise and business venture will depend upon A&M officials finding additional funding and forming partnerships with other academic and health care enterprises.

Giroir said he expects an announcement on that subject soon.

Stay tuned.

A number of faculty members and alumni initially opposed the idea, citing it as a factor in no-confidence votes over the summer by both the A&M Faculty Senate and the Council of Principal Investigators, which represents faculty involved in research.

But the most vocal criticism appears to have died down.

That must mean they don't oppose the idea any more, right? What other possible explanation could there be?

BoR meeting

The BoR is meeting again this week. The next phase of NCTM approval is on the agenda. Thanks to a vigorous campaign of dealing with the insurgency, open dissent seems to have been successfully crushed.

Vision 1920's sources indicate that the attitude among the faculty is that even if the NCTM turns out to be a wildly overoptimistic money sink, it will get a new building for Engineering so it's not all bad. And it's not their money that will be thrown down the rathole. Assuming the IDCs really won't be swept... which is not a problem for those faculty who don't generate any IDCs anyway.

Resistance is futile

Another opponent of the Vision 1920 steps aside

The chair of a group representing the Texas A&M research community stepped down last week, saying in an e-mail to members that she was leaving for personal reasons and to pursue research interests.

Deborah Bell-Pedersen, whose yearlong term was scheduled to end in May, on Saturday announced in an e-mail that she was leaving her post at the Council of Principal Investigators. The group in recent weeks has been critical of the A&M System's proposed National Center for Therapeutics Manufacturing and a pair of other therapeutics-related centers.

Nancy Amato, a computer science professor, will serve as interim chair of the group. Neither Bell-Pedersen, who was out of the country, nor Amato could not be reached for comment.

Looks like the faculty are starting to understand which way the wind is blowing.

Pandemic alert

Loren Steffy takes shots at A&M again in the Houston Chronicle

Texas A&M's plan to develop a world-class medical research facility could use an injection of integrity.

In January, the state awarded A&M $50 million from the Emerging Technology Fund, which purports to benefit private-sector technology startups, for the National Center for Therapeutics Manufacturing, which plans to develop new vaccines.

Unfortunately, the infusion of taxpayer money is showing some disturbing symptoms that have been found in other state economic development deals: a web of political relationships and arrangements with financially shaky companies with ties to key decision makers in the process.

Steffy reviews material that will mostly be familiar to readers of the Vision 1920 blog. There are a few things we've missed here, though:

Bob Pearson, an Introgen director at the time of the grant and a Perry campaign contributor, is also a member of the 17-member advisory board that reviews the tech fund grants.

Introgen was founded by David Nance, a major Perry supporter who's currently on the statewide finance committee for the governor's re-election campaign. Nance, who quit Introgen just before the bankruptcy, donated $50,000 to Perry's campaign in 2005 and 2006, records show, and Perry has appointed him to three different technology committees — including the tech fund advisory panel — dating to Perry's stint as lieutenant governor.

Steffy has been a potbanger over A&M's tech vision before. He loses credibility, though with this:

“There's not a single dollar I've gotten off of any patents,” he [Giroir]said. “I never took a single dime from Xoma.”

Maybe not, but the A&M System has taken five million dimes from taxpayers, and they deserve better. The public may benefit from the NCTM's vaccine research, but it's the sort of deal that leaves taxpayers feeling sick.

5 million dimes is only $500K. The NCTM got five hundred million taxpayer dimes.

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.
...
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.
...
"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.

Giroir's chicken explained

Previously Vision 1920 was perplexed by this figure in Brett Giroir's presentation. At his open presentation today, Dr. Giroir used it again, and explained what he has against chickens: As explained in this Scientific American article

Today's flu vaccines are prepared in fertilized chicken eggs, a method developed more than 50 years ago. The eggshell is cracked, and the influenza virus is injected into the fluid surrounding the embryo. The egg is resealed, the embryo becomes infected, and the resulting virus is then harvested, purified and used to produce the vaccine. Even with robotic assistance, "working with eggs is tedious," says Samuel L. Katz of the Duke University School of Medicine, a member of the vaccine advisory committee for the U.S. Food and Drug Administration. "Opening a culture flask is a heck of a lot simpler."

One of the goals of the NCTM is to revolutionize vaccine production by moving it out of eggs. This cutting edge idea is a niche in the vaccine industry where A&M can clearly leap ahead of the competition, which only includes the likes of Novartis, Baxter, and Merck.

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.
...
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.

Disposable income

The Chancellor's extended notes (pdf) suggest that ex-President Murano was not on board with the plans the NCTM. An example of her "Active opposition to System" includes:

Pankratz (or CFO) - [Eco info on Xoma - W???? Paper]
- * Real numbers on NCTM, [Elsa ??ed for CEO meeting & really no explanation or understanding & NO Request for info PRIOR ("I gotcha...

There is also another reference to the 3rd "W????" Paper over bullets for Xoma and GLP/GMP.

As explained in our Vice Chancellor for eHarmony's presentation to BioHouston, the NCTM will be an academically-owned, privately-operated GMP manufacturing facility for biological therapeutics. It will be the international leader and regulatory benchmark for flexible, disposable manufacturing technologies.

Vision 1920 does not understand why Murano was standing in the way of TAMUS becoming an international leader. Perhaps she was concerned about initial costs

The decision to be GMP compliant can add considerable expense to a project and should be carefully considered. Process engineering is one aspect that frequently has unexpected higher costs, especially in an institutional setting. Increased requirements for specialized consulting, validation, detailed documentation, and process engineering can increase capital expenses as much as 25 to 30 percent.

Maybe she was worried about operating costs

Once the facility is built, the hard part begins. In addition to maintaining the ongoing validation of all processes, the facility must maintain a full-time quality control and quality assurance staff to support that operation. There will also be a heightened need to market the facility and maximize its use in order to recover the significant added costs.

GMP facilities generally have operating budgets on the order of just a couple million per year. Maybe she was worried about whether income would offset the costs:

“I can’t stress enough the importance of getting out there and promoting these facilities because they don’t run on their own. It’s great to have one or two researchers with projects going but you have to find a lot more support within your university and healthcare network to feed this type of lab,” says Orton.

But that's not a problem, since, as Dr. Giroir points out, the NCTM can

Service new start biotechs particularly those spawned by ETF and CPRIT.

All we have to do is have the State make sure ETF money only goes to companies that promise to use TAMUS facilities. No problem!

GMP - a perfect fit for Aggieland

The National Center for Therapeutics Manufacturing has been the target of some potbanger criticisms. Some of this is based on a tempest in a teapot stirred up by our Governor's critics.

Although the fund's normal procedures were largely followed, a small legislative firestorm has broken out because of several factors: Texas A&M is Perry's alma mater. The grant was five times as large as any other given from the fund. The money was transferred from another economic development fund with a different purpose. And an advisory board that usually votes on such projects did not in this case.

But as we know, the ends justify the means, and the ends here were described by two of our fearless System leaders

“We’re creating a prototype that is absolutely critical for improving the nation’s ability to develop new vaccines and therapeutics in an accelerated and cost-effective manner. It will be especially important in the larger goal of protecting our citizens from the threat of bioterror weapons such as anthrax and Ebola virus,” Giroir said.

“This Center sets a national standard for aligning the strengths of academic research and commercial application for a broad-ranged public benefit,” said Diedrich. “The system has been at the forefront of creating marketplace models of innovative collaborations that show the tremendous power of technology to dramatically reshape the economy and our lives. Those efforts come together in this world-class facility.”

The key to this is the ability to make biological therapeutics and vaccines under Good Manufacturing Practice (GMP) methods. Nature Bioentrepreneur examined GMP facilities at universities in 2003:

But regulatory officials should hold university facilities to the same standards as industry manufacturers, particularly when a product nears human testing, says Nadine Ritter, an independent Biotechnology Product consultant based in Washington, DC. "University labs want to do things cheaper and faster and that's fine—until the product goes into a patient," Ritter adds, cautioning that universities are not scrutinized as rigidly as industry.

Here at Texas A&M we expect to be scrutinized as rigidly as any industry, building on our experience with the CDC.

Jim Cahill, a regulatory analyst who assesses industrial laboratories for Cato Research Institute (Philadelphia, PA, USA), agrees that universities face barriers to securing GMP status because "GMPs are designed to ensure that researchers do things over and over in exactly the same way," says Cahill, "but universities are designed to make people think."

This is what makes Texas A&M ideal for GMP. We do things over and over in exactly the same way and call it Tradition.

Pishko defends the NCTM

On the little-read CPI discussion board, Prof. Pishko objects to the inclusion of the NCTM in the CPI resolution of no confidence

I reviewed the membership of the CPI and there is not one individual on the CPI who has been involved in any of the NCTM discussions. How is anyone on the CPI to know where funding for NCTM may come from when they have not been involved in the discussions? The answer is they cannot. Did the CPI bother to talk to anyone who has been working on the project? The answer is no.

Indeed. How could they know where the funding came from?