Author: Corporate Office

University of Nevada, Reno selects InfoEd Global Enterprise Software

For Immediate Release:

University of Nevada, Reno plans to implement the InfoEd Global System with the goal of streamlining research program support. 

ALBANY, New York — InfoEd Global, the leading provider of electronic Research Administration (eRA) software solutions, is pleased to announce the University of Nevada, Reno has joined the InfoEd family. The University plans to upgrade and modernize their processes by implementing the InfoEd Enterprise Solutions System utilizing the Grants and Contracts modules.  The University has also chosen to have InfoEd host their system as part of their effort to streamline the workflow of the Research Systems office.

Edward Johnson Jr., President of InfoEd, commented: “We are honored to add University of Nevada, Reno to the InfoEd family. The Research Administration team’s vision fits precisely with our goal of CPI, continuous process improvement, streamlining the University’s office and going toward a paperless system using InfoEd.”

Charlene Hart, Director of the Office of Sponsored Projects, commented:  “The implementation of InfoEd at UNR will enhance the proposal development process for our faculty as well as streamline the entire process from proposal to award and reporting. This is part of our overall initiative to enhance the infrastructure behind the significant research program here at the University of Nevada, Reno.”

Nevada’s land-grant university founded in 1874, the University of Nevada, Reno has an enrollment of 18,000 students and is ranked in the top tier of the nation’s best universities. Part of the Nevada System of Higher Education, the University has the system’s largest research program and is home to the state’s medical school. With outreach and education programs in all Nevada counties and with one of the nation’s largest study-abroad consortiums, the University extends across the state and around the world. For more information, visit www.unr.edu.

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Congratulations to Argonne National Lab on Receipt of four R&D 100 Awards

InfoEd Global is happy to congratulate Argonne National Laboratory  on receiving four 2012 R&D 100 Awards.  These awards which originated in 1962 are issued annually for the top technologically significant innovations introduced to the market that year and are unofficially known as the “Oscars of Innovation.”

The Award recipients represent examples of top emerging technologies, instruments, systems, computers, safety systems, chemicals, consumer products, and equipment, to name a few categories.  The highest number of awards in 2012 came from the Analytical Instrument category.

Argonne Lab’s awards this year include:

InfoEd and Argonne are currently working together to implement the InfoEd Global eRA Software Solution at the Lab.  InfoEd Global provides a comprehensive, fully integrated software solution specifically designed to reduce the cost, time, and inefficacy that confront today’s research offices.  InfoEd’s electronic research administration suite is flexible yet affordable.  InfoEd’s mission is to provide the world’s best and most comprehensive software systems and tools for research and its administration; meeting the needs of today while solving the challenges of tomorrow.

Congratulations once more to Argonne National Laboratory and all recipients of the R&D 100 Awards for 2012!

NIH Commercialization Assistance Program for SBIR and STTR Phase II Awardees

If the purpose of university technology transfer is to maximize the benefits of public and private investment in research, those offices cannot rely exclusively on traditional licensing efforts.  Some technologies lend themselves to a more entrepreneurial approach, where the total impact of a start-up may significantly exceed the monetary value of a license to an existing company, if such a license could even be executed.

Such entrepreneurial activity has increased over the past few years, however start-up companies face significant challenges.  The risk remains that the start-up company will cease operations, before the benefit of the technology is fully realized.  In order for the company to continue after the original founders have moved on, or for the operations to attract the interest of a buyer before initial funding has run out, the market needs to be developed further.

One of the programs of the NIH seeks to address this by providing individualized assistance to SBIR and STTR Phase II awardees, focused on specific commercialization objectives.

Similar to the NSF I-CORPS program, the primary mechanisms of the Commercialization Assistance Program (CAP) are mentoring and advice.

  • One-on-one business  mentoring with a principal advisor focusing on concrete deliverables.
  • Advice from industry  experts on regulatory and licensing issues, business strategy, investor pitch.

Unlike the NSF I-CORPS program, there is no financial component to CAP however however, participants with a current active SBIR or STTR Phase II award may rebudget funds within the award, to cover allowable travel expenses for CAP events.  Certain restrictions apply.

There are 75 positions available for participation in teh next round, separated into two tracks:

  • Commercialization Training Track (CTT) – With sixty (60) slots available, this track will apply to the majority of NIH SBIR/STTR Phase II companies. It is aimed at assisting participants with evaluating their commercialization options based on their specific technologies covering an 18-month period. It also assists participants in the development of market-appropriate tools to accomplish these objectives. Participants work one-on-one with a principal advisor and industry experts as needed.
  • Accelerated Commercialization Track (ACT) – With fifteen (15) slots, this track will apply to a select group of NIH-funded companies who have successfully commercialized products and/or services, generated revenue, established partnerships and/or otherwise achieved a level of market development that is sustainable over a definitive period. However, they may need to address a specific applicable issue whose resolution is key to their continued growth. This track specifically deploys industry experts to help participants achieve these outcomes.

The current application period opened on October 17 and will close on November 7.

For more information, including eligibility criteria, the scope of the program, and a link to the application process, please refer to Program NIH-CAP 2012-2013.

University of Houston selects InfoEd Global Enterprise Software

ALBANY, New York — InfoEd Gobal, the leading provider of electronic Research Administration (eRA) software solutions, is pleased to announce the University of Houston has joined the InfoEd family. The University plans to re-engineer their processes by implementing the InfoEd Enterprise Solutions System including Grants and Contracts, IRB, IACUC, Conflict of Interest, and Technology Transfer modules.  Houston has also chosen to have InfoEd host their system as part of their effort to streamline the workflow of the Research Systems office.

Edward Johnson Jr., President of InfoEd commented: “We are excited to add University of Houston to the InfoEd family. The Research Administration team’s vision fits precisely with our goal of CPI, continuous process improvement, streamlining the University’s office and going toward paperless using InfoEd.”

What are the Kefauver-Harris amendments?

October 2012 marks 50 years since the passage of the Kefauver-Harris Drug Act of 1962, known less formally as the Kefauver-Harris drug amendments. The bill, named for US Senator Estes Kefauver of Tennessee and US Representative Oren Harris of Arkansas, amended the Federal Food, Drug and Cosmetic Act of 1938 to require:

  • Substantial evidence from clinical trials of both safety and efficacy – the FD&C Act of 1938 only required safety data
  • FDA approval prior to marketing – previously, approval was automatic if FDA did not act on an application within 60 days
  • Adherence to current good manufacturing practices (cGMP)
  • Closer monitoring of clinical trials and informed consent of participants
  • Disclosure of side effects in advertising
  • Monitoring and reporting of post-marketing safety information

Oversight of prescription drug advertising was transferred from FTC to FDA. The bill also outlawed the then-common practice of repackaging generic drugs under new trade names, which generated huge revenues for pharmaceutical companies at the expense of the public. All drugs approved prior to 1962 were to be re-reviewed to determine whether they met the new efficacy standard (ultimately, about one third of the drugs approved between 1938 and 1962 did not). That process led to the establishment of the Abbreviated New Drug Application (ANDA) approval pathway for generic drugs.

Senator Kefauver had been working since 1959 to rein in the pharmaceutical industry, investigating economic issues such as patent protections, drug costs and advertising practices. Just as the 1938 FD&C Act was inspired by the <a title="Elixir sulfanilamide – Wikipedia" href="http://en.wikipedia viagra kosten in der apotheke.org/wiki/Elixir_sulfanilamide” >elixir sulfanilamide tragedy, passage of the 1962 amendments was helped considerably by the thalidomide tragedy. Another important figure in shaping the legislation was pharmacologist and physician Dr. Frances Oldham Kelsey, the FDA reviewer credited with blocking the approval of thalidomide in the US.

Critics viewed the 1962 legislation as an excessive expansion of government power, since it greatly increased FDA’s control over pharmaceutical manufacturing and research. Following the revelation in 1961 that thalidomide caused severe birth defects, however, the American public – and Congress – were ready to support a stronger FDA.

USPTO Promotes the Global Dossier Initiative

USPTO Director David Kappos describes in his blog the ongoing development of a global portal that could be used to handle patent filings across multiple offices.  The expectation is that this portal would improve both efficiency and quality of patents worldwide, allowing management of cross-filed applications; elimination of the need to file duplicate documents in multiple offices, and collaboration between patent examiners.

The concept was proposed by the USPTO in November, and endorsed at a meeting hosted by the EPO in June.