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.

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.