Start-ups are still the best way to commercialize university IP, according to David Lerner, a serial entrepreneur, angel investor, and director of the Venture Lab at Columbia University Tech Ventures. However, university TTOs should imitate the start-up culture in their deal-making. In a post on peHUB, the public forum for private equity, Lerner recounts two business paradigms outlined by Chris Dixon, an early-stage investor and founder of the web site Hunch. The first, Dixon explains on his blog, is a transactional/legalistic approach to business that exchanges labor for money in the form of a contractual relationship. The second approach to business is based on trust, verbal agreements, reputation, and “enforcement” by the community rather than the legal system. Start-ups, Dixon says, are overwhelmingly governed by the latter approach.

Lerner juxtaposes these paradigms against the composition of U.S. university TTOs — most of which are steeped in the transactional/legalistic business culture, he asserts. “Most university administrators place great importance and faith in the opinions and judgment of their Office of General Counsel, and with good reason,” he observes. “Universities are often at the economic, cultural, and educational nexus of entire cities and must protect their interests and reputation, not to mention their endowments.” Since university tech transfer was only born in 1980 as a result of the Bayh-Dole Act, commercialization activity has been layered over an existing culture in most schools.

Nevertheless, TTOs should understand the distinction between licensing IP to large, existing companies and licensing IP to a fledgling entity that is being formed for the express purpose of commercializing that IP, Lerner maintains. “A small start-up comprised sometimes by nothing more than a courageous entrepreneur, a laptop, and some meager seed money can hardly wait six months to ink a deal with a university,” he writes. “Nor is it reasonable to expect such a person to pay large up-front licensing fees, immediately reimburse patent expenses incurred long before he/she entered the picture, or submit to massive and arcane paperwork.” Instead, TTOs should take their cues from the investment and entrepreneurial community, using these foundational steps:

• Assign a seasoned entrepreneur and investor as the dedicated point person for the TTO’s entrepreneurial/venture activities. This individual must come from and have the confidence and respect of the early stage entrepreneurial community.
• Shed as much of the “transactional/legal” paradigm as possible from the venture operation and adopt the business paradigm based on trust/reputation and community. The entrepreneurial and investment community will immediately recognize this as major progress.
• As an equity partner, treat start-ups in the TTO’s portfolio as partners, not simply licensees. Work with partners to facilitate success and delay compensation and upside revenues to the back end as much as possible.
• Streamline license and stock purchase agreement templates to speed up and facilitate deals.
• Keep deal terms fair and simple. Commercialization “is not about what you can ‘get’ from the entrepreneur along the way,” Lerner writes. “Rather, it’s about enabling them to win in what is an exceptionally difficult endeavor. An eventual sale or IPO of the company should be the shared goal — nothing else.”

Source: peHUB

Posted March 10th, 2010 under Tech Transfer. [ Comments: none ]

Leaders of the U.S. Senate Judiciary Committee have released details of compromise legislation aimed at reforming U.S. patent laws. The bill ostensibly makes significant steps toward resolving longstanding differences in legislative efforts to modernize U.S. patent law and make it more compatible with international laws. Referred to as the managers’ amendment to S.515, the bill must go to the full Senate for a vote and must be passed in the House of Representatives. According to background materials circulated by members of the Judiciary Committee, the managers’ amendment includes nearly all of the improvements to U.S. patent laws that were part of the reported version of the Patent Reform Act of 2009, as well as changes designed to strike a better balance among users of the patent system. In particular, the legislation preserves:

• changes to improve patent quality, including allowance for third parties to comment on pending patent applications;
• a first-window post-grant review proceeding to weed out patents that should not have issued;
• the gatekeeper compromise on damages;
• the compromise on venue;
• fee-setting authority for the USPTO to address its backlog problem;
• amendments to best mode;
• the new district court pilot program; and
• increased incentives for government labs to commercialize inventions.

The proposed reform would largely eliminate the first-to-invent priority system in the U.S. The bigger deal is that the proposal would eliminate the one-year grace period unless the inventor was the “first-discloser.” A “derivation” proceeding would replace interferences. The proposed reform also would eliminate the right of “any person” to file a false marking claim. Rather, those claims would be limited to individuals who have “suffered a competitive injury.” This change would apply to eliminate standing of already-filed cases.

The damages revision is less significant than previous iterations. Under the proposed revision, a court would be required to “identify the methodologies and factors that are relevant to the determination of damages, and the court or jury shall consider only those methodologies and factors relevant to making such determination.” The parties also would be required to “state, in writing and with particularity, the methodologies and factors the parties propose for instruction to the jury in determining damages … specifying the relevant underlying legal and factual bases for their assertions.” The provision generally creates a better situation for accused infringers but does not necessarily limit damage awards. The managers’ amendment provides these additional changes:

• Shortens the first-window post-grant review from 12 to nine months and raises the threshold for instituting a proceeding to a showing that it is “more likely than not” that at least one claim is unpatentable.
• Slightly raises the threshold for instituting an inter partes review (IPR) to a “reasonable likelihood” that the challenger would prevail in invalidating a claim of the patent, creates additional safeguards to prevent a challenger from using the administrative process to harass patent owners, and inserts “reasonably could have raised” estoppel to prevent a challenger from raising in court an argument that could have been raised during an IPR instituted by the challenger.
• Codifies recent case law that requires willfulness to be demonstrated by clear and convincing evidence that the infringer acted with objective recklessness and adds substantive and procedural safeguards for alleged infringers.
• Removes the provision that would have required the federal circuit to accept interlocutory appeals of claim construction determinations.
• Requires that the USPTO reduce fees by 50% for small entities and by 75% for the new classification of “micro-entities” created by the bill.
• Permits a patent holder to provide additional, potentially material prior art regarding the patent to the USPTO. If the USPTO considers the information and determines it has no effect on patentability, that information cannot later serve as the basis for an inequitable conduct claim in court.

Sources: Intellectual Property Watch and Patently-O

Posted March 10th, 2010 under Tech Transfer. [ Comments: none ]

TTO budgets are notoriously skimpy — and economic conditions haven’t helped, to say the least. Many offices are struggling to operate effectively with fewer resources, and cost-cutting has gotten its fair share of attention by most. But there is another way to stretch your TTO budget that takes the opposite approach: adding resources and dollars from industry collaborators. The fact is that, even without specific IP, many well-heeled companies want to be on your speed dial and develop relationships with the university, hoping to be first in line for critical new technologies and anxious to get a glimpse at what’s going on behind the laboratory doors. For cash-strapped TTOs, these companies can be a wellspring of needed resources and funds beyond the typical licensee or sponsored research relationship. What’s more, these relationships often lead directly to future licensing deals, bringing even more benefit to your tech transfer program.

To help you tap into these industry resources and funds, Technology Transfer Tactics’ Distance Learning Division has partnered with a TTO executive who has made it his mission to offset tight money constraints by forging corporate partnerships and utilizing industry funding to further the office’s aims and bolster its budget. Mike Rondelli, Director of Technology Transfer and Commercialization, has successfully led San Diego State University’s TTO to consistent high performance in the ratio of research dollars spent to licensing revenues earned. Find out how SDSU’s secrets of success by joining us on April 8th for Stretch Your TTO’s Budget: Tap Into Industry Resources and Partnerships, a 90-minute distance learning event that will offer first-hand advice on how to offset tight budget constraints by forging partnerships, utilizing industry resources, and more. CLICK HERE for full details or to register.

PLUS, coming March 30th: The Bilski Decision: Expert Strategies to Manage Its Impact on University IP

Posted March 10th, 2010 under Audioconferences, Tech Transfer. [ Comments: none ]

Minneapolis-based Upwind Medical Partners is launching a $6 million to $8 million early-stage fund that will focus on commercializing IP from health care and research institutions such as the University of Minnesota (UMN), Wisconsin Alumni Research Fund (WARF), Allina Hospitals & Clinics, and Johns Hopkins Hospital. Founded by Jim O’Reilly, a former health care executive, software entrepreneur, and VC exec, Upwind hopes to create up to three companies a year and exit them in no more than four years. The goal is to create enough returns in a condensed time frame by focusing on IP with a clear path to market, and pouring some of the exit dollars back into the fund while also keeping investors happy, according to O’Reilly.

Minnesota, traditionally a land of scarce early-stage capital, has seen a burst of recent activity. Affinity Capital Management in Minneapolis is partnering with Triathlon Medical Ventures in Cincinnati to create a $10 million seed/early-stage fund. Coordinate Capital LLC, backed by veteran biotech investor Steven Burrill, is trying to raise $25 million partly to finance start-ups that will incubate at the planned Elk Run BioBusiness Center outside Pine Island, and UMN is collaborating with private real estate developers to launch a $20 million fund to back new companies housed at a planned accelerator adjacent to the school’s Biomedical Discovery District. In addition, Twin Cities Angels recently raised an estimated $50 million for its second fund, and the Minnesota legislature is close to passing a $40 million, four-year angel investment tax credit.

The activity couldn’t come at a better time. A weak economy and tougher regulatory requirements have scared away investors, leaving some of Minnesota’s most promising medical start-ups to cut back or wither away. Since December, Transoma Medical, Leptos Biomedical, and Disc Dynamics have shut down. Plymouth-based Lumen Biomedical, Inc., sold one of its two clot-removing devices to boost its balance sheet, and VitalMedix, Inc., a drug company spun out of UMN, has filed for Chapter 7 bankruptcy. The dearth of early stage money is especially acute at academic research institutions that have great IP but lack financial resources to commercialize the technology. “Every tech transfer office has gotten more aggressive,” O’Reilly says. “They haven’t had the success they had in the past.”

Upwind plans to create companies based on near market-ready IP that can deliver liquidity in a relatively short period of time through a sale or licensing. While VC firms typically fund one or two potential blockbusters over several years, Upwind will generate modest returns from developing many less ambitious companies in a lot less time. “We’re looking for lots of singles and doubles, not necessarily home runs,” O’Reilly says. Upwind’s limited partners will own 70% of the fund and also will receive a pro-rated percentage of each company in the portfolio. For example, a $1 million investment in a $7 million Upwind fund earns an investor a 10% equity stake in the fund and 10% in each of the two or three start-ups it launches every year.

Source: MedCity News

Posted March 10th, 2010 under Tech Transfer. [ Comments: none ]

Successful negotiation of start-up funding leaves most new entrepreneurs flush with excitement. But investors will almost always slip an option pool into the equation, which means the share value to the founding group can sink in a flash. It can be a throttling experience for the uninitiated. Depending on the number and caliber of upper-echelon hires a new company must make, it’s critical to provide an option pool, which is an equity set-aside that can be issued at a later date to entice attractive new hires. These stock options are also used for board members, consultants and even vendors. Most high-quality start-ups give these kinds of key players a stake in order to remain competitive.

But the option pool is always a key point of negotiation for start-ups during initial funding rounds with venture capitalists. It’s a push-pull scenario because funders want the company to keep this pool fluid while the initial stock holders don’t want their investments diluted. The pool “is usually in the 10% to 20% range. A lot of times the investors want to see that because it’s a way to attract highly qualified employees and be

competitive. What usually happens during valuation is that the entrepreneurs think they have a lot of shares. But once you account for 10% to 20% after it’s financed, they see their ownership percentage declines,” says Tom Taulli, author of seven financing books including The Complete M&A Handbook, and an advisor to technology companies. It’s important for technology transfer professionals to orient new entrepreneurs to the concept

and process of option pools as a part of valuation so that the company founders clearly understand the value of their stakes, Taulli stresses. A detailed article on navigating option pool provisions appears in the February 2010 issue of Technology Transfer Tactics. To view the entire article and begin a subscription, plus gain access to the entire 3-year archive of how-to articles and best practices, CLICK HERE.

Posted March 10th, 2010 under Tech Transfer. [ Comments: none ]

The University of Texas at San Antonio (UTSA) has opened its New Venture Incubator (NVI) — a facility with laboratory, office, and meeting spaces — to support technology start-ups in greater San Antonio. Housed on UTSA’s main campus, the NVI is designed to support companies that are commercializing UTSA IP or sponsoring research in the school’s labs. The incubator also is designed to fit into San Antonio’s broader technology commercialization environment as a source of new ventures. UTSA has established a Commercialization Council, which includes an influential group of top executives, to guide the NVI’s relationship to San Antonio’s entrepreneurial ecosystem. “The goal of the Commercialization Council is to develop the linkages between organizations that can play a key role in the region’s technology-based entrepreneurship,” says Cory Hallam, director of the UTSA Center for Innovation and Technology Entrepreneurship. “Ultimately, we want tech entrepreneurs to look at San Antonio the same way they look at Austin or Silicon Valley.”

Currently, the Council includes representatives from UTSA, Southwest Research Institute, Southwest Foundation for Biomedical Research, San Antonio Technology Accelerator Initiative, Biomed SA, South Texas Technology Management, The Small Business Development Center, and AT&T. “UTSA recognizes the potential of establishing a campus-based technology incubator for San Antonio entrepreneurs that have direct ties to the university,” Hallam explains. “By working with promising new companies that are aligned with the university’s research strengths, we create a win-win partnership that benefits the university through increased research funding and IP licenses while providing start-ups with connections to the support they need to become successful freestanding enterprises.”

Biopharmaceutical firm ViroXis Corp. will be the first start-up to occupy space in the NVI. The company aims to identify and patent botanically derived compounds for use in infectious disease and cancer therapies. Over the next two to three years, ViroXis will work to develop a rapid, cost-effective, and proven botanical prescription drug targeting human papillomavirus (HPV), which causes skin and genital wart infections and is the leading cause of cervical cancer.

Source: Earth Times

Posted March 10th, 2010 under Tech Transfer. [ Comments: none ]

Researchers at the University of Nebraska Medical Center (UNMC) have taken a significant step forward in developing a vaccine approach to reverse the neurological damage seen with Parkinson’s disease. Parkinson’s results from the loss of neurons that produce dopamine, a nerve-signaling chemical that controls movement and balance. Neurodegeneration occurs when a normal protein called alpha synuclein becomes  clumped, changes shape, and accumulates in the brain. The body subsequently attacks the protein through inflammation and causes destruction of dopamine-producing nerve cells. Degeneration and loss of these dopamine-producing neurons typically occur after age 60, and it is estimated that one person in 20 over the age of 80 has Parkinson’s.

UNMC researchers reversed the neurodegenerative effects of alpha synuclein by changing immune responses to it. The vaccine strategy trains the immune system to elicit neuroprotective responses in damaged brain regions. In mice with an experimental form of Parkinson’s, injection of the vaccine produced cells that were able to reverse the disease. After receiving the treatment, these mice were found to have a similar number of dopamine-producing nerve cells and fibers as mice without Parkinson’s. The findings appear in the Journal of Immunology. “We believe this could be a revolutionary means for Parkinson’s disease therapeutics,” says Howard Gendelman, MD, professor and chair of UNMC’s department of pharmacology and experimental neuroscience (PEN).

Gendelman and R. Lee Mosley, PhD, associate professor in the PEN department, led the research team, which found that the vaccine enabled T-cells in the treated mice to migrate to the damaged area of the brain and triggered a neuroprotective response that reduced disease-linked reactions in the brain. “The identical immune deficits seen in mice are being looked at in humans with Parkinson’s disease,” Mosley says. “Early results are encouraging. This should pave the way for researchers to begin follow-up studies on the Parkinson’s treatments and open up new opportunities to realize an immunization approach for other neurodegenerative disorders.” Human studies are being conducted at the University of Alabama-Birmingham and UNMC to determine if the immune deficits seen in mice also are present in humans with Parkinson’s. UNeMed, UNMC’s TTO, has filed a patent application on the vaccine and will soon commence discussions with commercial partners on bringing the vaccine to the clinical setting.

Source: Medical News Today

Posted March 10th, 2010 under Tech Transfer. [ Comments: none ]

Through a new partnership with Life Science Analytics, 2Market Information Inc. is offering access to specialized drug pipeline reports that offer an unprecedented level of detail on drug development activity in more than 150 specific therapy areas. You can choose only the individual reports you need in PDF format, or subscribe to the entire database and receive updated pipeline information whenever you need it throughout the year. These rich intelligence resources will arm you with powerful information you can use to:

• Keep track of competitors and new product concepts
• Identify white space in specific therapy areas
• Guide research and drug development priorities
• Assess likely licensees and partners
• Understand the IP landscape for specific indications
• Gain critical market intelligence to guide allocation of resources and investments

Therapy Area Pipeline Reports provide comprehensive detail on the full pipeline status for the specific therapeutic indications you’re most interested in. Each report provides specific, up-to-date information on deals and alliances, research activity, licensing, marketing, competition, and the latest news and developments for each specified drug therapy. For details and to view a list of the reports offered by therapy area, CLICK HERE.

Posted March 10th, 2010 under Tech Transfer. [ Comments: none ]

Researchers at the University of Akron (UA) and Washington University School of Medicine in St. Louis have developed an antibiotic treatment for pulmonary infections, including pneumonia and cystic fibrosis, with the potential to significantly increase survival among patients with lung infections. The nanoparticle antibiotic treatment is composed of encapsulated silver carbene complexes (SCC), developed by Wiley Youngs, PhD, UA distinguished professor of chemistry, and colleagues. The nebulized antimicrobials, administered once daily, offer effective and convenient drug delivery, encouraging patient compliance, reducing illness severity, limiting development of resistance to antibiotics, and potentially decreasing the spread of epidemics, according to the researchers.

During mouse studies, all untreated animals died while all of those treated with the aerosolized, nano-sized, silver-based antibiotics survived an infection of Pseudomona aeroginosa — a common bacteria that infects the respiratory tract in humans, especially those who are immunocompromised, on mechanical ventilator support, or afflicted with cystic fibrosis. Treatment with the SCC-loaded nanoparticles also minimized weight loss and the bacteria burden in the lung, while also reducing the spread of bacteria from the lung through the blood stream to the spleen. The researchers are commercializing the technology through the UA Research Foundation start-up Akron Research Commercialization Corp. They plan to file a U.S. Food and Drug Administration application for Investigational New Drug status for their first product offering, called Silvamist.

Source: The Universtiy of Akron News

Posted March 10th, 2010 under Tech Transfer. [ Comments: none ]

Researchers at Johns Hopkins University (JHU) have developed a noninvasive infrared scanning system to help doctors determine whether pigmented skin growths are benign moles or melanoma, a potentially lethal form of cancer. The prototype system looks for the tiny temperature difference between healthy tissue and a growing tumor. The researchers have begun a pilot study of 50 patients at JHU to help determine how specific and sensitive the device is in evaluating melanomas and precancerous lesions. If the system works as envisioned, it could help physicians address a serious health problem by identifying a mole that may be melanoma at an early, treatable stage. Currently, doctors look for subjective clues such as the size, shape and coloring of a mole, but “we don’t have any objective way to diagnose this disease,” says Rhoda Alani, MD, adjunct professor at JHU’s Kimmel Cancer Center and professor and chair of dermatology at Boston University School of Medicine. “Our goal is to give an objective measurement as to whether a lesion may be malignant, [which] could take much of the guesswork out of screening patients for skin cancer.”

Alani has teamed with heat transfer expert Cila Herman, professor of mechanical engineering in JHU’s Whiting School of Engineering, who is developing new ways to detect subsurface changes in temperature. Because cancer cells divide more rapidly than normal cells, they typically generate more metabolic activity and release more energy as heat. Herman uses a highly sensitive infrared camera to detect subtle temperature differences between cancerous and healthy skins cells. The researchers cool a patient’s skin with a harmless one-minute burst of compressed air, then immediately record infrared images of the target skin area for two to three minutes. Cancer cells typically reheat more quickly than the surrounding healthy tissue, and the difference can be captured by the infrared camera and viewed through sophisticated image processing.

“The system is actually very simple,” Herman says. “An infrared image is similar to the images seen through night-vision goggles. In this medical application, the technology itself is noninvasive; the only inconvenience to the patient is the cooling.”

In the pilot study, dermatologist-identified lesions undergo thermal scanning with the new system, then a biopsy is performed to determine whether melanoma is actually present. “We, at this point, are not able to say that this instrument is able to replace the clinical judgment of a dermatologist, but we envision that this will be useful as a tool in helping to diagnose early-stage melanoma,” Alani says. The researchers envision a hand-held scanning system that dermatologists could use to evaluate suspicious moles. The technology also might be incorporated into a full-body scanning system for patients with a large number of pigmented lesions. The skin cancer scanning system is protected under an international patent application submitted by JHU’s TTO, which has engaged in talks with investors and medical devices firms concerning possible licensing deals.

Source:  EurekAlert!

Posted March 10th, 2010 under Tech Transfer. [ Comments: none ]

The University of Notre Dame has awarded an exclusive license to the privately held biotech company Molecular Targeting Technologies Inc. (MTTI) of West Chester, PA, for sensing technology developed by Bradley Smith, PhD, Emil T. Hofman professor of chemistry and biochemistry. The technology can selectively target dead and dying mammalian cells as well as bacteria. When the targeting component is attached to a fluorescent probe, it has been successfully used to target mammary and prostate tumors and bacterial infection in mice. “This unique probe has the potential to image cell death as a means to intervene early in diseases and rapidly determine the effectiveness of treatments,” Smith says. “Imaging of cell death is broadly useful for treatment of numerous conditions, including cardiovascular diseases, neurology, renal diseases and even transplant rejection.”

The targeting probe can be used for in vitro applications as well as for in vivo molecular imaging. “We believe this technology has the potential to target myocardial ischemia, Alzheimer’s disease, cancer and bacterial infections,” says Chris Pak, president and CEO of MTTI, which develops medical imaging products for the diagnosis of cardiovascular disease and cancer. Initially, MTTI will launch a range of fluorescent versions of the phosphatidylserine (PS) targeting molecule for research applications. Products are expected to be available in spring 2010 under the name PSVue.

Source: Inside INdiana Business

Posted March 10th, 2010 under Tech Transfer. [ Comments: none ]

Cases of food poisoning and contamination in recent years have highlighted the threat that pesticides and chemicals pose to public health and the environment. Researchers at City University of Hong Kong (CityU) have devised a rapid and cost-efficient chemosensing analysis method to test medicines and detect pesticides in foods, pollutants in water, and toxins in fish. Chemosensing is a chemical-detection method in which targeted analytes are detected by molecular-level sensors known as chemosensors. Application of the technique has been limited by high costs, but CityU researchers overcame technical barriers with molecular imprinting technology. The technology, known as template-directed polymerization, costs one-tenth that of current testing techniques and provides results within one minute. The technology is easy to manage, and the materials are small and portable.

Molecularly imprinted polymer materials can be used in commercial applications to detect numerous chemicals, including harmful pesticides in agricultural products, such as DDT; contaminants in drinking water, such as HCH; toxins in seafood, such as histamine; leaked poisonous gas; and Tributyltin (TBT), a harmful substance in marine coatings that can damage the auditory systems of dolphins. CityU’s Knowledge Transfer Office is applying for a patent on the technology.

Source: Nano Patents and Innovations

Posted March 10th, 2010 under Tech Transfer. [ Comments: none ]

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