Congress may let SBIR authority lapse this week

From AlleleBlog: http://allelebiotech.com/blogs/2010/09/congress-may-let-sbir-authority-lapse-this-week/

The SBIR/STTR/CPP now appears likely to expire on Thursday night, September 30.
Some will deny it but here’s what’s happening.

Allegedly the Senate and House were close to a compromise complete with an 8 year
reauthorization of SBIR/STTR/CPP but each time it goes back to the House (Nydia &
Day), they change the VC language to masquerade 100% VC involvement as a compromise.

Because time is so short, the Senate passed a bill (S.3839) to simply extend
SBIR/STTR/CPP through January 31, 2010. The House was going to pass it on Wednesday
with the President signing Thursday. However, the word on the street is that Nydia
Velazquez, chair of the House Small Business Committee, and her illustrious second,
Michael Day, are rejecting the bill and are poised to let SBIR expire if necessary,
at least in the short term.

It seems that Velazquez’s hope is to move the SBIR reauthorization into the lame
duck session and incorporate all her Wall Street investors’ 100% non-compromise VC
ownership and jumbo award support into a must pass, end of the year omnibus bill
that can’t be touched by her detractors.

This sounds like a script for TV, but several years ago we had a similar year end
omnibus situation involving Nydia (as ranking member) and Sam Graves (subcommittee
chair) and BIO/NVCA, but the main difference was that the small business committee
chair was Donald Manzullo who nipped it in the bud. In our scenario today we have
to look to the House leadership to do it, but it will take your involvement.

Many senior people in the democratic party called for the House to support the
Senate compromise bill H.R. 2965, but Nydia ignored those calls, as did Jason
Altmire, the creator of this infamous Altmire Quagmire. Now Nydia’s really “miffed”
because last week she tried to “scrub” H.R.5297, the Small Business Jobs Act of
2010, but the Obama administration and Speaker Pelosi rolled her over and passed it.

CALL TO ACTION

If SBIR is important to you and your company, it’s time to get serious and realize
that this program can, and will go away unless you make a big noise to let your
politician’s know how you feel. All of us are sick of this, and we’re now facing a
lapse. Eight times this program has been deemed important enough to keep going (via
a CR) but will Nydia be successful in blocking this ninth attempt?

Voting will occur in the House on Wednesday and this may be the last time until
after the election that the SBIR extension bill could voted on. That means we must
act on Tuesday, September 28.

Here are some suggestions and rationale behind them.

CALL CALL CALL the House Tuesday September 21! Call Nancy Pelosi’s office at (202)
225-4965, Steny Hoyer (majority leader) at (202) 225-4131, Nydia Velazquez (202)
225-2361, also the House Small Business Committee line (202) 225-4038

Those of you who are good democrats, call the remaining House Democratic caucus
leaders: John Larson 202- 225-2265, Xavier Becerra 202-225-6235, Jim Clyburn
(202)225-3315

Those of you who are good republicans, call John Boehner (202) 225-6205, Eric Cantor
202-225-2815

Tell them in your own words that SBIR is about to expire and is being held hostage
by Nydia Velazquez. Let them know how important continuation of SBIR is to your
business and the country. Ask them to please support S.3839 (additional temporary
extension of programs under the Small Business Act and the Small Business Investment
Act of 1958) to keep the program from lapsing this week.

I realize that I’m asking you to do something that requires a good chunk of your
time. However, at the risk of losing you as a reader I must tell you that I donate
a large share of my time to try and keep you informed about this program, and I’m
not asking you to do anything for me, only for you and others like you. We do have
some good representatives from both parties BUT they need to hear from you and
quickly.

If you’re bold ask, “I would like to know how a party can let itself get hijacked by
a few people (like Nydia) on a vitally important, highly regarded and accepted
program. This action is to the detriment of your constituents, the country, and
yes, even your own party!”

Here’s what’s going on in the back rooms (formerly smoke filled) The Senate agreed
on a 4 month extension for SBIR because they (Senate) largely (including many on the
Republican side) did not feel a reasonable bill could be passed in the lame duck
session. The Senate has offered up some huge compromises that some believe even
James Greenwood from BIO could live with. The very long shot is that with enough
pressure we might get a compromise bill passed by Thursday.

WHAT HAPPENS IF SBIR LAPSES, EVEN FOR A SHORT TIME

This is an interesting question. Theoretically those projects (grants and
contracts) that are already in place should be okay, but some not. All new unsigned
agreements would stop. Agency comptrollers may start adjusting their budgets to put
the overall 2.8% SBIR/STTR back into their own research pools. Administrative
funding for SBIR could be severely cut back. Remember, all of your grants and
contracts are “subject to the availability of funding.”

On the other hand, SBIR can be voluntary, so some agencies may choose to keep their
SBIR doors open, hoping for, or expecting the reinstatement of the program.

In any event, this is bad for you and the agencies.

The Insider will be on the Hill Wednesday and Thursday, so we’ll do a follow up
report to you asap.

Rick Shindell
SBIR Gateway
Zyn Systems
40 Alderwood Dr.
Sequim, WA 98382
360-681-4123
rick@zyn.com
www.zyn.com/sbir

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Entrepreneurs Roundtable in San Diego: How to Get Seed Funding

Wednesday July 28th at 5:00 p.m.



Johnson and Johnson Auditorium

3210 Merryfield Row, San Diego, CA

Hear from successful entrepreneurs
Make connections
Take your idea or company to the next stage

Program

5:00 - 6:00 p.m. Networking & Refreshments

6:00 -7:00 p.m. Roundtable & Discussion: How to Get Seed Funding

Confirmed Speakers

Court Turner (Avalon Ventures)

Raj Krishnan (Founder, Biological Dynamics)

Malcolm Bohm (Founder, Trialytics)

Moderator: Doug Lappi

7:00 -7:15 p.m. 30 Second Pitch Segment

(pitch your company/service in 30 sec.)

Please send a short pitch proposal to pitch@sdentrepreneurs.org by July 26th for consideration

Please register via

http://seedfundingjuly28th.eventbrite.com

This event is free to the public. Refreshments provided. Donations and sponsorship are welcome.

The event is sponsored by the San Diego Entrepreneurs Exchange (www.sdentrepreneurs.org). The SDEE was founded by local entrepreneurs in order to provide a voice for the early stage technology startup, to encourage new entrepreneurs, and to sponsor networking and educational events to help develop the skills necessary to bring funding and business to the San Diego area.

Allele News Release, editor JW http://www.allelebiotech.com/News//index.php?mod=article&cat=OtherNewsRelease&article=692

From Nature Biotechnology: SBIR grants wax

Awards under the Small Business Innovation Research (SBIR) program have just been given a boost. As of March 30, the cap for SBIR phase I awards has risen from $100,000 to $150,000, and for phase II awards from $750,000 to $1,000,000. The increases are intended to take account of inflation since 1992 when the threshold amounts were last set by Congress. "This will have an important positive impact at a critical [juncture] in the aftermath of the nation's great recession," says Simcha Jong, university lecturer in management science and innovation at University College London. Jong says that, historically, the SBIR program helped forge links between university science and industry and, at this pivotal time, could help kick-start the US job engine. The Senate has passed a bill to extend the SBIR and related Small Business Technology Transfer through July 31 (Nat. Biotechnol. 27, 1065-1066, 2009). Even more generous than SBIR grants are the new Small Business Helping Investigators to Fuel the Translation of Scientific Discoveries (SHIFT) awards launched on March 5 by the US Department of Health and Human Services. These awards, aimed at fostering translational research, offer companies up to $2.65 million over five years. "The main point is to encourage current academic researchers to apply, and use it to move to biotech," says Jiwu Wang, president and CEO of Allele, a San Diego-based company that has taken products to market with SBIR support. "It is a great idea."

Emma Dorey, Nature Biotechnology

SDEE Entrepreneurs Roundtable - How to Get Government Grants: The Insider’s View

From Allele News: http://www.allelebiotech.com/News//index.php?mod=article&cat=OtherNewsRelease&article=517

After our first organization event proved to be a great success, SDEE is organizing a second event focusing on getting grants.  This topic was actually the main issue for founders of our organization.  Learning how to get SBIR from people who have written and reviewed applications and people who had started companies with those grants should be helpful to many in our field.  Issues about the recent changes and the future of the SBIR program may also be interesting topics that directly relate to hundreds of companies in San Diego.  Come and join us.

Wednesday May 19th at 5:00 pm
Johnson and Johnson Auditorium
3210 Merryfield Row, San Diego, CA

Please register for this free event via: http://sdee-mayevent-grants.eventbrite.com

• Hear from study section members and successful NIH SBIR grant writers
• Make connections
• Take your idea or company to the next stage.

Program
5:00 – 5:45 p.m. - Networking & Refreshments
5:45 – 6:45 p.m. - Roundtable & Discussion: How to Get Government Grants
Keynote:
John Finn, Chief Scientific Officer of Trius Therapeutics, “SBIR grants as a key source of funding for start-ups: the Rx3 Pharmaceutical Experience”

Panel Discussion:
John Finn, CSO Trius
Scott Thacher, CEO of Orphagen Pharmaceuticals
Dave Larocca, Founder and CEO of Mandala Biosciences
Scott Struthers, CSO and Founder of Crinetics Pharmaceuticals
Moderator: Deborah Slee

6:45 – 7:15 p.m. - Pitch your company or service (30 sec maximum).
Please send a short pitch proposal to pitch@sdentrepreneurs.org by May 17th for consideration. Space is limited and preference will be given to entrepreneurs.

This event is free to the public. Refreshments provided. Donations and sponsorship welcome.

To read more AlleleNews, visit here: http://www.allelebiotech.com/News/ 

NIH Announces SHIFT SBIR Grants to Help Academic Researchers Get Jobs in Biotech

The National Institutes of Health (NIH) just announced a new type of Small Business Innovative Research (SBIR) grants. Called SHIFT SBIR, these grants are designed to “(1) to foster research that is translational in nature and (2) to transform academic scientific discoveries into commercial products and services,” according to the NIH announcement, and to also facilitate licensing of intellectual properties from academic institutions as well as promote better access to academic resources. The PI transitioning from the academic institution must be primarily employed by his/her research institution at the time of application and must be primarily employed (more than 50% time) by the company by or at the time of award.

One very attractive aspect of these grants is that they mean more money than standard SBIR grants. Up to $200,000 total costs per year and time periods up to 2 years may be requested for Phase I. Well-justified budgets up to $750,000 total costs per year and time periods up to 3 years may be requested for Phase II. That is sufficient for a good researcher to build a team to do research in one direction within pretty much any small company setting.

A little background about SBIR grants: SBIR programs sponsored by federal funding agencies including the NIH, NSF, DOE, FDA, the military departments, etc. have been a major source of funding for many biotech companies like Allele Biotech during their startup phases. SBIR grants can also be used to facilitate continued research and help business expansion even as the company grows. As an example of the effects of SBIR grants, Allele Biotech obtained 5 such grants from 2000 to 2003 and built a company from just ideas to one with a patent in RNAi, an out-licensing deal with Promega, a product line in oligo synthesis, and a structure that helped launch currently ~1,500 products since 2004. We then carried out 2 more SBIR contracts for the NIH from 2007 to now, which moved us into the field of special antigen production, iPS using Bacmam systems, viral packaging services, and hopefully more advanced antibodies in the pipeline.

The link to the full NIH announcement is here.

To read more blogs on SBIR related topics, click here.

The current topics of SHIFT SBIR solicitation is listed below for Allele Blog viewers’ convenience:

• Applying opportunities in genomics and other high throughput technologies to understand fundamental biology, and to uncover the causes of specific diseases
• Translating basic science discoveries into new and better treatments
• Development of diagnostics, preventative strategies and therapeutic tools
• Development and clinical evaluation of biomarkers for alcohol exposure and alcohol-induced tissue injury
• Therapeutic development for alcoholism treatment
• Diagnostic assessment and treatment of alcohol use disorders and comorbidity
• Alcohol biosensors and data analysis systems
• Prevention, diagnosis, and treatment of fetal alcohol spectrum disorder and alcohol-related birth defects
• Minimal dose post-exposure vaccine for rabies
• Immunotherapy to kill HIV-infected cells
• Asthma therapeutic vaccine
• Novel antifibrotic therapies for progressive liver failure
• Diagnostic measurement devices or methods for assessment of urinary leakage and incontinence
• Therapeutics for diabetic wound healing
• Pediatric formulations
• Robust diagnostic biosensors for infants
• mHealth tools for assessing and addressing health in children and families
• Wearable diagnostic and therapeutic devices for physiologic monitoring and interventions
• Wearable biosensors for persons with genetic sensitivity to environmental factors
• Therapeutic interventions for persons with physical and developmental disabilities
• Advancement of novel botanical therapies for effective symptom management of non-life-threatening conditions
• Development of interactive technologies to improve and expand delivery of mind/body interventions
• Discovery of improved methodology for the characterization of plants and their secondary metabolites
• Development of standardized, objective methods to assess patient adherence to specific CAM treatment interventions;
• Development of devices/tools to assess consistency and fidelity of practitioner approaches and other aspects of protocol implementation
• Virtual settings or online tools for clinician training and implementation of fidelity monitors
• Development and validation of enhanced patient-reported outcome assessment tools for CAM (e.g. new user (clinician, researcher, and/or patient/study volunteer)–friendly interfaces, methods to improve compatibility with research and health informatics systems currently in use)
• Development of measurement tools for assessing expectancy for effects of CAM mind-body medicine, acupuncture, and manual therapy interventions
• Novel technologies that enhance/track/monitor “real time” adherence to drug abuse (and HIV+) treatment regimens
• Technology to improve the efficacy of substance abuse treatment, treatment adherence, and reduce recidivism among criminally-involved patients
• Mobile and/or internet technology based treatment interventions to augment traditional substance use disorder (SUD) treatments and their outcome
• Technologies and/or devices to boost medication adherence for SUD patients
• Technology-based treatment platforms to standardize interventions and to make them more community-friendly
• Integrate item response theory and computer adaptive testing in measures of addiction liability.
• Brief screening tools to assess relapse risks in and out drug treatment settings
• Use of the internet to link community based outreach and HIV testing services to facilitate access by drug users and their sex partners in neighborhood settings.
• Development of novel therapeutics, diagnostics, and devices for treating heart, lung, blood and sleep diseases and disorders
• New or improved measures, analytical methods, and instruments for gene expression in individuals with heart, lung, blood, and sleep disorders and diseases
• Health-care systems and outcomes research, including development of new quality measures for evidence-based heart, lung, blood, and sleep health care
• Models of behavior modification and other approaches to behavior change related to heart, lung, blood, and sleep diseases and disorders
• Devices and technologies to prevent cardiac ischemia/reperfusion injury
• Vaccines for the prevention or treatment of heart, lung, and blood diseases
• Non-invasive methods to diagnose DVT and PE
• Technologies and strategies to advance cellular therapies for heart, lung and non-malignant blood diseases
• Therapies to treat hematologic diseases and cytopenic states
• Technologies for in vitro reduction, inactivation or removal of microorganisms and other infectious moieties from blood, blood components, and plasma derivatives
• Development of products, technologies and services to diagnose, treat and/or prevent skin and rheumatic diseases, muscle disorders, and joint and bone diseases

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New Focus by NCI’s CPTC Targets Vendors to Bring Deliverables to Research Community

Originally posted: October 30, 2008 By Tony Fong GenomeWeb ProteoMonitor

CAMBRIDGE, Mass. — With its technology-development programs well under way, the National Cancer Institute’s Clinical Proteomic Technologies for Cancer initiative has begun turning its attention to the big vendor community.

Its aim is to get those companies tools into the research community and to invest big commercial players more heavily into CPTC’s efforts, its director, Henry Rodriguez, told ProteoMonitor this week.

When it was created two years ago, CPTC initially focused on boot-strapping its three programs directed at technology development: the Clinical Proteomic Technology Assessment for Cancer, the Advanced Proteomic Platforms and Computational Sciences, and the Proteomic Reagents and Resource Core.

But as these programs have enabled materials, such as antibodies, reagents, and protocols, to begin making their way into the CPTC’s pipeline, the organization last year began to shift its emphasis to also include vendors. The initial target was smaller shops and at its second annual meeting, held here this week, some of the results from that effort were highlighted as a number of small proteomics companies presented technology developed with funding by CPTC.

Now, the push will be directed at the larger commercial vendors, Rodriguez said.

“We tried to emphasize the private-public partnerships” at this meeting, Rodriguez said. “Even though we’re producing the science, we’re also producing materials as a program. … And while we give them back to the community, it quickly dawned on us that the community may already have some platform that is commercially sold.

“So we said, ’Let’s put out solicitations now to the small-business community with these platforms and at the same time, if they’re successful, they will start to adopt the reagents that we’re developing and that could go back to the community,’” he said.

To do so, his office last year worked with NCI’s small-business office to issue a solicitation to encourage small businesses to adapt their own platforms to techniques and methods developed by the CPTC, and to use materials produced by the CPTAC group.

The result can be seen in work performed by, for instance, Allele Biotechnology in San Diego, which used a Phase 1 SBIR grant from the NCI to develop a panel of antibodies with high affinity and specificity against 10 cancer-related antigens, company CEO Jiwu Wang said during a presentation at the CPTC conference. The antibodies, he said, can be formatted to be specific to mice, rabbit, and other model organisms, or be developed into full IgG antibodies.

Improving MS Capability

Now as the CPTC shifts its attention to larger vendors, much of its attention will be directed at mass spectrometry. CPTAC, which comprises five teams and a host of collaborators, is in the process of publishing three papers on work it has done studying reproducibility with mass spectrometers [See PM 09/04/08]. When those are published, CPTC anticipates hosting a teleconference with the major mass-spec vendors “to say to them, ‘Here are the things that we’re producing that add a lot of value. What are the needs that you have … that either we are addressing that we can work with you, or that we’re not addressing to see if we can also build that into the program?’” Rodriguez said.


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“What we can bring to [the table] is to say, “Here’s a program with this network. It doesn’t focus on one platform, but we recognize that universally, across them all, we can develop some very nice metrics that add not just [an] advantage to one … but advantages across the board.’”

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Even before CPTC was created, NCI met with mass-spec vendors to get their views on what such a project could do for that community. What the agency heard, for example, was that manufacturers needed help in improving, from a computational approach, their instruments’ detection and identification capabilities, Rodriguez said.

To be sure, each vendor has its own R&D personnel working on such problems, but CPTC offers a greater breadth of researchers working on methods to improve the instruments, Rodriguez said, citing work by Richard Smith at Pacific Northwest National Laboratory.

At the two-day conference, Smith presented research being done by his lab on a high-throughput platform based on a liquid chromatography coupled with an ion mobility spectrometer that is in turn interfaced with a time-of-flight mass spec. In addition to improved throughput, the platform offers greater sensitivity, robustness, and quantitative capabilities for biomarker discovery, verification, and preclinical validation, Smith said.

“What we can bring to [the table] is to say, ‘Here’s a program with this network,’” Rodriguez said. “It doesn’t focus on one platform, but we recognize that universally, across them all, we can develop some very nice metrics that add not just [an] advantage to one … but advantages across the board.”

CPTC also plans to meet with the major reagent vendors in order to get them into the fold, he added.

No Discovery Work Here

CPTC is one of several federal initiatives and programs focusing on proteomics to tackle diseases such as cancer and neurological ailments, and to address biodefense issues. But unlike other federal efforts, CPTC is directed not at discovery work but at improving a proteomics scientist’s workflow: its goal is to provide solutions to challenges such as reproducibility, standards, and poor study designs that have hindered the field.

CPTC would like to take the technologies developed through its programs to other proteomics programs being funded by the NIH as well as other agencies, and say, “’Here’s a robust workflow, a methodology that we know can give you give you the power to identify where variability occurs, and if you can account for it, we’re there; if you cannot eliminate it, we can tell you how to best deal with it,’” Rodriguez said.

A more recent challenge in proteomics Rodriguez and others have identified is specimen quality, which can introduce biases into an experiment.

CPTC is focused on the analytical and pre-analytical aspects of research, but is also working with the NCI’s Office of Biorepositories and Biospecimen Research to overcome that challenge by developing common protocols for specimen collection and handling, Rodriguez said.

Papers and Antibodies Coming Soon

During the meeting, an update was also provided on CPTAC’s continuing work on mass-spec reproducibility. To date, the group has performed six studies, with the first looking at a 20-protein mixture and eight instrument types, and later studies steadily progressing to a more complex yeast-reference mixture and the use of ion trap mass specs.

With each progressive study, the group incorporated more refined standard operating procedures such as standardized chromatography and common statistical phase distribution.

While Daniel Liebler, who is heading the CPTAC team at Vanderbilt University, one of five CPTAC teams, declined to discuss in detail the findings from the studies, he said during a presentation that one of the deliverables from the research so far is that the yeast proteome potentially could provide a model for biomarker research via a shotgun proteomics platform.

The CPTAC teams are preparing three papers on their research: one describing their findings with the yeast proteome; another describing metrics that can serve as reference points for mass specs; and one describing the work they did looking at variability in peptide and protein identification between and across systems.

Finally, Tara Hiltke, program manager at CPTC, provided an update on its antibody initiative [See PM 11/29/07]. The antibodies resulting from its first funding round will become available to the public by the end of the year, she said. A third funding round to develop antibodies against about 40 antigens will be announced in January.