"Let's Get Real"
A Blog from "The Boss"
This is not another
"news" letter
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With more than 30 years experience, we've launched our Techno-Blast emails and two new websites to keep you up to date
on the latest technological advancements and "best practices" for biological product development and production.
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Provided by William Ward, PhD (wward@brighterideasinc.com), Rutgers University, New Brunswick, New Jersey:

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New From the US Food & Drug Administration

Draft Guidance for Industry:
Clinical Considerations for Therapeutic Cancer Vaccines

Draft Guidance for Industry:
Potency Tests for Cellular and Gene Therapy Products

Suggested Reading
TAG Vaccine: Autologous Tumor Vaccine
Genetically Modified To Express GM-CSF and
Block Production of TGFß2
A Statistical Analysis of
Adenovirus Reference Material Assay Results
Manufacture and Stability Study of the
Recombinant Adeno-Associated Virus Serotype 2
Vector Reference Standard
 
Up in the Blogosphere
Let's Get Real

Just when you thought there couldn’t be another blog created, I’m doing just that. My blog will serve as the primary portal for reader feedback and contributor submissions, and become a vital component of our information service to the bioprocessing industry. As it takes form, we’ll be adding features that make it more useable and valuable, as well as a powerful forum for discussing the issues that cause the most trouble. Then to keep up with the times, we’ll offer the interface mechanisms for social networking services such as LinkedIn, Facebook, and Twitter.

But now let’s get down to brass tacks. Why are we still seeing so many talented people lose their jobs and so many promising companies close their doors? Of course “it’s the economy, stupid,” but I think it’s more than that. The business development models are all wrong and have been so for years, and the recession just made the structural flaws more destructive. Somehow we’ve developed a mindset in which every entrepreneur’s primary goal is to sell his business, and every big company wants to grow through acquisition. Guess what? It isn’t working and we’ve got to get back to basics and quit letting the finance people ruin our industry. They’ve been taking us down the “financial industry path” by creating a few companies that are too big to fail, an environment in which others can’t compete, and a resulting cost cutting frenzy which puts talented people on the street. 

Every industry, including ours, is better served by more, smaller companies. Most of the innovation and jobs come from smaller companies, but we don’t have an environment in which small firms can prosper, and certainly not one that entices entrepreneurs to risk everything. All the economic development programs are geared toward large firms, even while extolling the importance of small companies. For example, small companies can’t use tax incentives unless they can show a profit. But this is essentially all they are offered.

What small biotech companies have always needed are loan guarantees and the right strategic partners. These partners would benefit by licensing intellectual property, manufacturing rights, and marketing rights for the discoveries of these smaller and more innovative firms. And the small companies would be able to keep operating with grants, contract service income, licensing fees, and milestone payments. Sound familiar?

In addition, start-up firms need REAL incubator space with wet labs. The vast majority of “incubators” are simply real estate deals that cater to large, academic grant holders. Unless someone is willing to subsidize the cost of this space, or as the Wall Street folks say: “Take the haircut,” it’s essentially worthless for economic development. So who’s going to take the haircut to jumpstart economic development for our industry? I know right now it won’t be the universities, and so far, it hasn’t been the vast majority of state or local government entities.

Let’s get real about putting our industry back on a sustainable path.

The-Boss@BioTechnoBlog.Net, BS ChE, MBA

(We look forward to hearing from you. Responses sent to the boss will be published in the next issue of the Techno-Blast.)

 
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Your Contributions
SUBMISSIONS: Please submit materials via email to the techie, but be sure to zip the file if it exceeds 2 MB. Another option is to mail us the file on a key drive, but note that we won’t return your drive since we collect them and it isn’t worth the handling cost.

And then, you can upload the file to your FTP site and send us the URL and password we’ll need to download it. Or you can simply email us a link so we can view the material on another website. Depending on the content and format of the material, we will post links to wherever it can best be viewed or downloaded.

All submissions must address a recent advancement or solidify a “best practice” for biologic product development or production. The material format can be streaming video, YouTube postings, automated PowerPoint presentations; as well as PDF, HTML, Word, and Excel docs. Be sure to include complete contact information for the corresponding submitter, an introduction of no more than 75 words, and a list of key words.

CONTACT US: We hope you enjoy visiting our site and find the content both valuable and timely. We are committed to posting the best technical content we can collect as we do our best to make your interaction a pleasurable experience. We look forward to reading your comments to
the boss.

Blasts From the Past
To view prior Techno-Blasts,
visit our archives.
Call for Articles
Accepting Manuscripts
for the Winter 2009
Issue and Beyond
Content
Development
Headlines and links will take you to various postings on our site, and when appropriate, to the sites of various contributors. Postings will include articles, presentations, assays, techniques, protocols, blog chats, reviewer comments, product tutorials, virtual tours, application data, and pretty much any other form of online material that's needed to develop and produce safe and effective products.
Applications

Our initial focus is on the toughest applications which tend to receive very little coverage elsewhere.  These include viral gene vectors and cellular vaccines. But as things progress and interest is expressed, we're adding Development Groups to cover applications such as vaccines, antibodies, recombinant proteins, and tissue regeneration. 

Each technology and application will have its own Development Group with one or more Reviewers and numerous contributors.

Development
Groups

» Viral Vectors
» Cellular Vaccines
» Vaccines
» Antibodies
» Recombinant Proteins
» Tissue Regeneration
» Cell Engineering
» Cell Banking
» Facilities
» Quality Systems
» Safety and Efficacy

Technologies
Technologies will include essentially all the unit operations and support functions involved in bioprocessing, such as cell engineering and banking, cell culture scale-up, filtration, purification, media development, assay development, regulatory affairs, and facility design.
Format
Content formats will include streaming video, YouTube postings, automated PowerPoint presentations--and of course--PDF, HTML, Word, and Excel docs.
Supplier Technology

We will be posting valuable information from key technology supply firms. As with our other primary content, these postings will have been assessed for their balance and credibility, and will include application data, tutorials, articles, presentations, and case histories.

Then in our Supplier-Side column, we will post materials with clear commercial content such as infomercials, ads, press releases, and promotions. And while some of these will be sponsored postings, other valuable resources will appear with no strings attached.

Reviewers
If you would like to help review submissions for a specific application or technology area, please contact the boss. Include your full contact information, the area(s) in which you would like to contribute, and any relevant experience you’ve had on a review or advisory board.