December 2011

BIOMEDICAL research commercialized

INSIDE THIS ISSUE:

2 - Technology Transfer Services 3 - Biotechnology Interest Group 4 - SBIR/STTR Programs 4 - Material Transfer Agreement

Research INKlings RESEARCH INKLINGS IS AN ON-LINE MONTHLY NEWSLETTER PREPARED BY THE OFFICE OF RESEARCH DEVELOPMENT PROVIDING RESEARCH NEWS, POLICY CHANGES AND OTHER RELEVANT INFORMATION FOR MUSC FACULTY, STAFF AND STUDENTS.

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Two successful pharmaceutical based startup company exits in one year is a rare event for a research university. But two companies based on research from the Medical University of South Carolina (MUSC) did just that, bringing economic success and, more importantly, bringing an opportunity for new drugs to reach the market thereby improving patient care and saving lives.

Commercializing early stage university research opportunities is a major goal of the MUSC Foundation for Research Development (FRD). “The two successful company exits are a success story that has many contributors,” says W.C. “Chip” Hood, Jr., J.D., Executive Director of FRD. “It starts with very talented researchers – without their creativity and scientific skill, none of this could happen,” says Hood. He noted that it also takes highly skilled patent attorneys, driven business leadership, and investors willing to take a risk on early stage

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technologies.

A true local success story is that of Immunologix, a Charleston based biotechnology company that specialized in the discovery of fully human antibody-based therapeutics. Immunologix was a startup company incubated by FRD and based on the discovery of MUSC researchers – Drs. Natalie Sutkowski and Semyon Rubinchik. A local management and scientific team successfully orchestrated the acquisition of Immunologix by Intrexon, a privately held company, in October of this year. Current plans have the lab remaining in Charleston with the potential for expansion.

Leading off the year was the successful acquisition of Taligen Therapeutics. Taligen was a startup company based on technology from MUSC and the University of Colorado. Drs. Steve Tomlinson, Gary Gilkeson, and Barb Rohrer contributed technology to Taligen via a patent license from FRD. In early 2011, Taligen was acquired by

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publically traded Alexion Pharmaceuticals. The acquisition was completed with an upfront cash payment of $111 million for 100 percent of Taligen's equity interests. Additional contingent payments would be earned upon reaching various clinical efficacy and product approval milestones in both the US and European Union for up to six products.

With FRD as the interface, MUSC startup companies have attracted substantial investment dollars into our state and continue to create high paying jobs. “These activities result in a contribution to MUSC’s overall economic impact for our state and nationally”, stated Dr. Stephen M. Lanier, MUSC’s associate provost for research.

Continued on page 2

Research Inklings PAGE 2

Technology Transfer Services

The Foundation for Research Development (FRD) serves as the technology transfer office for MUSC discoveries. As a resource for MUSC faculty, staff, and students with new ideas and discoveries, FRD enables the translation of research results into commercial products and provides the following services: • Intellectual Property (IP)

Commercialization Review-advising and working with investigators to protect the rights of your invention and providing a commercial assessment including market factors and potential next steps to enhance the commercial potential of your discovery.

• IP Protection/Patents-providing guidance in planning an effective IP protection strategy including patents and copyrights, and handling implementation of intellectual property protection plans.

• Industry Partnering/Licensing-creating technical and market assessments and marketing MUSC technologies to industry partners, negotiating IP based research and license deals, and employing strategies to leverage MUSC intellectual capital into revenue generating relationships with the private sector.

Request a consultation to learn more about the technology and intellectual property resources at MUSC by contacting frd@musc.edu.

Foundation for Research Development Staff

Chip Hood, J.D., M.S. Executive Director

Michelle Garbiras Chief Financial Officer

Robert Donato, J.D. Legal Counsel

David Holman, Ph.D. Technology Development Officer (in conjunction with SCTR)

Pamela Kaufman Patent Administrator & Executive Assistant

Mary Hedrick Todd Administrative Assistant

Call 843.876.1900 or E-mail frd@musc.edu

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Since its operational inception in 1998, FRD has received over 600 new invention disclosures, filed over 200 new patent applications, received 54 issued US patents, executed 82 options and licenses with industry, received over $9M of license income, and spawned 29 startup companies, all based on MUSC discoveries. In fiscal year 2011, FRD saw 46 new invention disclosures, filed eleven patent applications on new subject matter, executed eleven options and licenses with industry, and had five new startup companies formed based on MUSC intellectual property. “Our recent success, including these successful startup company exits, and a record year for numbers of new deals and startups, wouldn’t have been possible without the support from MUSC leadership and the exceptional industry expertise we have on the FRD Board” said Hood. In past years, FRD has been limited by staff size and budgets. However, with a

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renewed commitment from MUSC, FRD has been able to grow the staff this year and provide improved customer service. One of the newer members to the FRD team is David Holman, Ph.D., a joint hire with SCTR. As the technology development officer, Dr. Holman manages the technology transfer process for university technologies. He is a registered patent agent with the U.S. Patent and Trademark Office and has 12 years of experience as a bench scientist that span both the private and academic sectors of biomedical research. He is also a graduate of MUSC. Dr. Holman’s office, conveniently located on the first floor of the new Bioengineering Building, will enhance interaction with faculty interested in science and clinical discovery. For more information, please contact the Foundation for Research Development by emailing frd@musc.edu or visit the FRD website.

Biomedical Research continued from page 1

Research Inklings PAGE 3

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On October 31 and November 1, MUSC’s Office of Research Development, in conjunction with the Hollings Cancer Center and SC Clinical and Translational Research (SCTR) Institute, conducted two Grantsmanship Workshops. These workshops were well attended by approximately 70 faculty, staff and students. The first workshop, Developing Pilot Projects, described the pilot programs offered by the Hollings Cancer Center (HCC) and SC Clinical and Translational Research (SCTR) Institute. The workshop was co-lead by Dr. Israel Goldberg, president of Health Research Associates, Ms. Carla Frichtel, research development coordinator, and Anita L. Harrison, associate director of administration, of the HCC, along with Dr. Dayan Ranwala, SCTR science program manager, and Mr. Randal Davis, SCTR project director, where they shared strategies for developing award winning intramural research proposals. Writing Your First NIH Application, the second workshop in the series, was lead by Dr. Israel Goldberg, the founder of Health

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Research Associates, who spent 13 years in research administration at the NIH prior to becoming an independent consultant. Dr. Goldberg focused his seminar on strategies for preparing biomedical research proposals, with an emphasis in writing for the peer reviewers. Topics included how to develop specific aims that state concisely the goals of the proposed research and summarize the expected outcome(s), incorporating the impact that the results of the proposed research will exert on the scientific community. In addition to the workshops, Dr. Goldberg provided junior and experienced faculty as well as collaborative teams with independent feedback regarding their R01, R21, and career development proposals. During these, 30-minute meetings, Dr. Goldberg evaluated summary statements and discussed developing a strategy for revising and resubmitting their proposal. To suggest topics for upcoming research education and training workshops, please contact Wanda Hutto, Research Development at huttow@musc.edu.

Grantsmanship Workshops

Biotechnology Interest Group (Big)

To promote biotechnology entrepreneurship and technology development with the South Carolina Clinical and Translational Research Institute (SCTR) member institutions, the Biotechnology Interest Group (BIG) was developed. Faculty members and students with an interest in any area of biotechnology are encouraged to participate in BIG. This group meets bi-monthly and sessions typically include a presentation or round-table discussion of an issue affecting biotechnology commercialization, with an emphasis on facilitating the growth of university spin-out life sciences companies. For more information, please contact Dr. Chuck Smith at smithchd@musc.edu.

Medical University of South Carolina

Foundation for

Research Development

Board of Directors

Daniel D. Adams

Admiral Albert J. Baciocco, Jr., DSc (Hon.)

Harold E. Chappelear, LLD (Hon.)

Mark Currie, Ph.D.

Carl Ehmann, M.D.

Cotesworth Fishburne, Jr., D.D.S.

Raymond S. Greenberg, M.D., Ph.D.

Stephen M. Lanier, Ph.D.

George Lykos, J.D.

Perry B. Molinoff, M.D.

Etta D. Pisano, M.D.

Thomas C. Rowland, Jr., M.D.

Charles D. Smith, Ph.D.

Mark S. Sothmann, Ph.D.

John Vournakis, Ph.D.

Jonathan Zucker

Ex Officio Lawrence S. Olanoff, M.D., Ph.D.

Emeritus James L. Ferguson

Charles B. Hanna, M.D.

Joseph C. McDonald

Research inklings December 2011

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) PRogramS

Material Transfer Agreement

Material Transfer Agreement (MTA) is a contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. Biological materials, such as reagents, cell lines, plasmids, and vectors, are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds and even some types of software. Three types of MTAs are most common at academic institutions: transfer between academic or research institutions, transfer from academia to industry, and transfer from industry to academia. At MUSC, the Office of Research and Sponsored Programs (ORSP) reviews and approves incoming and outgoing MTAs. To expedite the process of negotiation, MUSC investigators are asked to complete MUSC’s standard MTA which can be found on the ORSP website or provide ORSP with the electronic version of the provider’s MTA. For more information regarding MTAs, please contact Cindy Brown, program manager for corporate research in ORSP (browncyn@musc.edu).

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The US Small Business Administration (SBA) Office of Technology administers the Small Business Innovation Research (SBIR) Program and the Small Business Technology Transfer (STTR) Program. Through these two competitive programs, SBA ensures that the nation's small, high-tech, innovative businesses are a significant part of the federal government's research and development efforts. Eleven federal departments participate in the SBIR program; five departments participate in the STTR program awarding $2 billion to small high-tech businesses. For more details, visit the NIH current solicitations and other federal agencies program information provided on the website. SBIR/STTR are not traditional research programs - they are technology

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development and commercialization grants and/or contracts that are designed to prove feasibility and develop technologies so the small business entity is in a position to raise outside funds, partner and/or license to existing business to propel the technology into the marketplace. The applications and scope are vastly different than traditional research grants and must include information with which researchers are often unfamiliar including business plans, potential customers and market research data.

In general, the SBIR/STTR Programs are structured in three phases:

Phase I-to establish the technical merit, feasibility, and commercial potential of the proposed R/R&D efforts.

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Phase II-funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the Phase II project proposed.

Phase III-for the small business (where appropriate) to pursue commercialization objectives resulting from the Phase I/II R/R&D activities.

South Carolina Research Authority's (SCRA) SC Launch SBIR/STTR Phase I matching grant program is designed to award matching funds to South Carolina-based companies that have been granted a federal SBIR and STTR Phase I award. For more information related to these programs, please contact Dr. Andrea True Kelly (kelly@musc.edu) of SCTR.

Lowcountry Partnership for Biomedical Innovation

Speaker Series On Thursday, December 1, 2011 at 4 pm, please join the Lowcountry Partnership for Biomedical Innovation project as Dr. Jeffrey E. Sohl presents “Learn about the Landscape, Players, and Current Trends in Angel Investing for the Medical and Biotech Industry.” Dr. Sohl is the director of the Center for Venture Research and professor of Entrepreneurship and Decision Sciences at the Whittemore School of Business and Economics at the University of New Hampshire. The presentation will be held at the Beatty Center located on 5 Liberty Street, Charleston, SC.