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IAB Minutes - October 7, 2004

Attendees

Members: Jim Burke, Fred Cahn, Shu Chien, Bryan Cornwall, Bill Craig, Dave Gibbons, Dave Gough, Steve Halpern, Chris Loryman, Mike Magers, Jonathan Mansbridge, Laurie Phillips, Tony Ratcliffe, Bob Sah, Christophe Schilling, Geert Schmidt- Schönbein, & Douglas Sexton

Guest: Gabriel Silva

Staff: Rowella Garcia, Jennifer Griffin, Imani Tyus

Chair: Bill Craig

The meeting began with welcoming remarks by Dr. Bill Craig and Dr. Shu Chien.

Approval of Minutes from June 30, 2003 Meeting-The minutes were approved as submitted.

Dr. Shu Chien introduced Dr. Gabriel Silva, Assistant Professor in Bioengineering and Ophthalmology at UCSD. Dr. Silva’s laboratory focuses on experimental and theoretical neural and cellular bioengineering aimed at increasing our fundamental understanding of neuroscience and developing new approaches for the clinical regeneration of the neural retina and central nervous system (CNS). Dr. Silva received his Honors Bachelor’s of Science in physiology and biophysics and a Master’s in neuroscience and neuropathology from the University of Toronto. From University of Illinois in Chicago, he received his doctorate in bioengineering and visual neurophysiology. Dr. Silva served as the first postdoctoral fellow in the Institute of Bioengineering and Nanoscience in Advanced Medicine (IBNAM) at Northwestern University in Chicago, focusing on applications in nanotechnology to neuroscience and neuropathology.

Presentation by Faculty – Gabriel Silva

The following information regarding Dr. Silva’s projects is taken from his Lab website at http://www.silva.ucsd.edu/.

“Our research represents very interdisciplinary approaches that converge towards functional clinical regeneration of the central nervous system (CNS), with a particular focus on the neural retina following degenerative retinal disorders (which is literally an extension of the brain and an excellent model of the CNS). We are essentially focusing on two different approaches to achieve these clinical goals:

1. The development of cellular replacement and transplantation strategies that make use of adult stem cells as the source of donor cells, and the development and integration of molecular bioengineering approaches for their ex vivo differentiation and delivery (i.e. transplantation) into target CNS sites of injury. In particular, we are focusing on the differentiation and in vivo delivery of adult stem cells into retinal photoreceptor neurons, which are lost following degenerative retinal disorders.

2. We are attempting to study and understand how complex neural networks in the CNS change following CNS injury. We are interested in understanding quantitatively how a remodeling of the connections between CNS cells (both neurons and macroglia, the two main cell types in the CNS involved in information transmission) can lead to the induction and maintenance of disease. Our approach is to use advanced forms of cellular imaging to accumulate data that can than be studied in an quantitatively using network theory and related mathematical and computational tools. In particular, we are focusing on the molecular details of a neuropathological process called reactive gliosis across large groups of reactive macroglial cells, which is a biochemical and physical barrier to neuronal regeneration following essentially almost all forms of CNS trauma and degeneration. We are attempting to understand how it is initiated, how it is maintained, and how it contributes to the disease process not by studying the molecular details of a single reactive glial cell, but by studying large groups of them simultaneously while still concentrating on the molecular and cellular details.”

“To achieve these scientific and clinical objectives we are developing two major sets of tools, which in themselves will represent major scientific objectives in our group. 1. We are developing and investigating various nanoengineered materials and devices specifically targeted towards CNS cells and processes. Because nanoscience focuses on engineering materials and devices in a controlled way at spatial scales that are similar to those of the constituent building blocks of cells themselves (i.e. a physical scale that is on par with the scale of proteins, receptors, DNA, RNA, etc.), this approach represents a very powerful way of integrating technology and physiological systems in order to limit or reverse underlying disease processes. In particular we are interested and investigating three classes of nanomaterials: Chemically functionalized quantum dots designed to target neural cells, the development of self-assembling bioactive three dimensional matrices that mimic the extracellular matrix and can interact with cells, and conducting polymers that can putatively stimulate target cells types. 2. In order to study and understand the contribution of complex cellular neural networks following CNS injury, we are developing high throughput systems neurobiology techniques for mapping the functional network structure or architecture of large groups of neurons and macroglial cells. This is not trivial, since functional connections and signaling between CNS cells does not necessarily require physical contact between cells, so that it is difficult to trace and map their network structures in a high throughput way (i.e. for large numbers of statistically meaningful cells in a fast way). To achieve this, we are combining our quantum dot nanotechnology with confocal microscopy and the development of computational methods. In particular, we developing software that will automate the detection and mapping of complex cellular networks, and even allow their analysis and characterization within the mathematical structure of network theory. By studying both healthy CNS networks and networks following injury or degenerative events (first in vitro- based on cell culture models being developed in our lab that mimic pathological processes that occur in vivo following neurological insults, and later in vivo in rodent models of CNS disorders), we will be able to gain an understanding of how complex neural cellular networks participate in disease and develop approaches to reverse this, regenerate the CNS, and develop novel clinical strategies to treat neurological and neural retinal disorders.

von Liebig Center- Steve Halpern

Dr. Chien introduced Steve Halpern, Managing Director of the von Liebig Center. Mr. Halpern has over 25 years of cross-industry experience as an entrepreneur, senior executive, educator and consultant to Fortune 100 and technology start-up companies. He has been a visionary in the commercialization of cutting edge technology to augment businesses and to create opportunities in a variety of industries.

The von Liebig Center with National Collegiate Inventors and Innovators Alliance (NCIIA) will co-host and organize a day-long workshop at UCSD on November 6, 2004 called Invention to Venture. The event is one in a series of workshops and conferences around the country in technology entrepreneurship for students, faculty, regional entrepreneurs, business leaders as well as investors interested in cutting-edge technologies. It will be held at International House, Great Hall, UCSD Campus, La Jolla, CA.

Mr. Halpern also announced von Liebig Center’s sixth solicitation for project funding. Funding up to $50,000 is available for new projects or the continuation of existing projects. The funding may be used to assess and confirm the commercial potential of UCSD technologies, including prototype development, proof-of-concept demonstrations, feasibility testing and market studies. They also offer 4 courses in Entrepreneurism that are designed to enhance the effectiveness of Jacobs School of Engineering students who in graduation will join fast-moving, innovative, high-tech organizations. Go to: http://www.vonliebig.ucsd.edu

Mr. Steve Halpern thanked Dr. Chien for introducing him to the members.

BUILD- Bioengineering Undergraduate Industry Link for Design- Robert Sah & Jim Burke

Dr. Jim Burke gave credit to Dr. Sah for coming up with the name acronym BUILD (Bioengineering Undergraduate Industry Link for Design). It is a team design project supported jointly by BREG and the UCSD Department of Bioengineering. Its mission is to introduce the students to the frontiers of modern biomedical research and to promote students' learning. Through the process of project goal identification, problem analysis, and problem solving, students have the opportunity to experience what it is like to be an engineer and to solve real world engineering problems. Dr. Sah said that they are in the stage of getting the faculty from academic side and Industry from the board side to come together to form teams in which they can pursue their goals. They are currently applying to the Committee of Education Policy (CEP) at UCSD to implement a formal senior Capstone Design. They are looking for ideas and projects from the IAB members. Sponsors are needed. Dr. Burke commented that these research projects are very inexpensive (approximately $1,000 per project). Through such projects BREG was able to screen students for positions in the company. .

Dave Gibbons offers Office of Technology Transfer and Intellectual Property’s support and assistance to define more clearly how intellectual property works with the students.

Dr. Laurie Phillips mentioned that Biogen Idec has a 41-acre campus built behind the Renaissance, La Jolla. They will be providing educational training to students from high school to the college level.

Imani Tyus, Bioengineering Internship Coordinator, passed out 7 Masters of Engineering resumes. She is looking to match students with the companies. Students will not be available to work until Spring and Summer based on their school schedule. They are willing to be trained 10-20 hours per day and can work full-time during the summer. She will email worksheets as far as job descriptions are concerned. Industry members are urged to send Imani job descriptions. Imani can set up interviews with the students. Undergraduate students are also looking for internships, for either full-time or part-time, paid or unpaid. Imani serves as the intermediary and the hiring decision is made solely by the companies. She also mentioned that one of the Master students is currently working fulltime for BREG.

Dr. Chien thanked Drs. Burke and Sah for this marvelous project. It is a great benefit to both the Department and our industry members.

Report Bioengineering 10^th Anniversary– Dr. Shu Chien

On August 14^th, the Bioengineering had a wonderful celebration of its 10^th anniversary outside at the Warren Mall here at UCSD. The Bioengineering program was founded in 1966 by Drs. Y.C. Fung, Marcos Intaglietta and Benjamin Zweifach, but it did not become a department until 1994. UCSD’s Chancellor (Designate at that time) Mary-Ann Fox was the guest speaker. The celebration started at 2:00pm and was followed by a reception at the Fung Auditorium. The reception included poster presentation, tours and activities for children. There were almost 250 people who came to share this special occasion with us.

Report on MTLF Meeting – Drs. Shu Chien and Bill Craig

The Medical Technology Leadership Forum (MTLF) was held on July 29^th and 30^th here at UCSD in the Eucalyptus Point. The forum was entitled Innovative Approaches to the Regulation of Combination Products & New Sciences: Options for Policy Makers. The MTLF has convened four groups: Washington, DC, San Diego, Atlanta, and Minneapolis. On the 29^th of July, the regional work groups shared their work and recommendations to prepare for a formal presentation to FDA officials the following day. On July 30^thMTLF members, invited guest and FDA officials shared ideas and perspectives using the findings of the work groups. Among the FDA officials were Mr. Mark Kramer, the Director of Combination Products, Dr. Dan Schultz, Director of the Center for Devices and Radiological Health (CDRH), and Dr. Jesse Goodman, Director of Center for Biologics Evaluation and Research (CBER), as well as Dr. David Fiegal, formerly Director of the Center for Devices and Radiological Health in FDA. Dr. Jonathan Mansbridge, Chris Loryman, Dr. Bill Craig and Dr. Anthony Ratcliffe were among the IAB members who participated. There were 70 participants from all over the country. Following internal review of the four task force reports, MTLF identified four key areas for the dialogue with FDA officials

Primary Mode of Action – Office of Combination Products. TEP should be assigned to CDRH. Kramer responded that the suggestions are very good.

Approval Process – The proposal should be predictable, stable, flexible, understandable and clear to the sponsor. Be able to create a balance between the pre and post market. Be able to develop a cross Center matrix and maximize coverage collaboration between the FDA and industry.
Role of Outside Experts –Create a virtual task force, “housed in the OCP but not owned by it,” that would be available to assist in the product assignment and review oversight.
Role of the Office of Combination Product – OCP’s role should be to make consistent, predictable product assignments, provide guidance and ensure a smooth working relationship when a product consult or more than one approval is necessary.

- West Work Group suggested the creation of a Matrix Management System reporting to the OCP.

- South (Atlanta) Work Group suggested that OCP move toward becoming a Center in its own right and proposed a new process that would serve as an alternative to the pathway in existing centers.

Senator Durenberger, who founded MTLF, Susan Foote, and Dr. Robert Nerem will meet again in Washington with the FDA to come up with a final action.

Commenting on the MTLF Forum, Dr. Tony Ratcliffe of Synthasome said that it was a very productive meeting and that the real message was that something needs to be done.

Dr. Bill Craig said that one of the objectives is to get everybody to engage a little bit more, and the meeting was successful in that aspect.

Breakfast With the Industry (BWI) – Dr. Shu Chien

The ninth annual Breakfast with Industry will be held the morning of November 12, 2004. This unique professional event, sponsored by the Department of Bioengineering and the Whitaker Institute of Biomedical Engineering (WIBE), offers a distinct opportunity for industrial representatives to interact on a one-to-one level with UCSD Bioengineering graduate students and faculty to discuss current and future research goals. The event will include brief remarks on the status of the Bioengineering Department by the Chair (Shu Chien), and a keynote address by Dr. Charles Cantor, Chief Scientific Officer of Sequenom.

The Breakfast with Industry will be held at the Faculty Club on the UCSD campus from 7:30 to 9:30 a.m. on Friday, November 12^th. Industrial participants will be seated with Bioengineering graduate students who have similar interests. In addition, attendees will receive a copy of the 2004 Bioengineering Student Resume Book. This book offers information about the research at UCSD and both graduate students and post-doctoral fellows in the Department.

*Jennifer Griffin will send out the invitation to all, including the IAB members, on Monday, October 11^th .

Dr. Bill Craig said that this breakfast event gives the students the first opportunity to meet with the companies. He really enjoys this event and attends every year.

*Dr. Laurie Phillips asked if Imani could send electronically the CV’s that were handed out. She also said that on these CV’s, the students tend to forget to mention they really want to do in the field and asked Imani to make sure this is specifically stated.

NuVasive, Inc. – Dr. Bryan Cornwall

Dr. Bryan Cornwall, Vice President of Research and Technology, introduced himself and his company, NuVasive, Inc.

NuVasive is an innovations-based medical device company focusing on the design, development and marketing of products for surgical treatment of spine disorders. They have made 100 medical devices. They have been selling products since 2001. Dr. Bryan Cornwall is the Vice-President of Research Development. Two UCSD alumni currently work for them. For more information go to: http://www.nuvasive.com

Dr. Cornwall requested the profiles of all the IAB members and the summary of the profiles of each company.

The meeting was adjourned at 9:00am.

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