P&S Annual Report
Collaborations in Innovation

Taking Science to the Marketplace 

Innovation by P&S faculty benefits from collaboration with government, industry, and other external organizations. Academic-industrial liaisons not only help the economy at large, they return revenue to the researcher and to the University, providing money for further research. 

Technology transfer's financial gains benefit both P&S and the collaborator and attest to the excellence of P&S research. Beyond providing financial benefits, P&S innovation results in life-saving or life-enhancing technologies. Without collaborators from beyond the University, such innovations would take a longer route to benefiting the human race. 

* Columbia Innovation Enterprise-Research and innovation are two major endeavors of any large university. Last year alone, the faculty of Columbia University reported 141 inventions, received 24 U.S. patents, and filed 129 patent applications. Columbia ranks in the top two private universities in revenues generated from technology licensing and steadily increasing revenues from research and license agreements over the past 10 years. 

A partner in that success is Columbia Innovation Enterprise, established in 1982 as one of the first university technology transfer offices following passage of the Bayh-Dole Act, which gave U.S. universities the right to own the technology derived from federally sponsored research. 

Since 1982, CIE's efforts have resulted in 203 research collaborations, 656 industrial license agreements, a number of start-up companies, and more than $200 million in royalties, license fees, and research payments universitywide. In the Health Sciences Division alone, research revenues last year totaled more than $4 million, license revenues were nearly $40 million, and 34 active research agreements and 74 active license agreements were established. CIE's total revenues in the Health Sciences Division for 1995-96 were $43.6 million, an increase of $6.8 million, or 18 percent, over the previous year. GenQuest, a new start-up company, was formed with a venture capital group and is based on gene discovery technology developed in the lab of Dr. Paul Fisher. Two Columbia licenses received U.S. Food and Drug Administration approval for new products. Pharmacia & Upjohn, a pharmaceutical company, received FDA approval to market Xalatan, a glaucoma drug discovered by Dr. Laszlo Z. Bito. Biogen, a biotechnology company, received approval for Avonex, a drug to treat multiple sclerosis; principal investigators were Dr. Richard Axel and Dr. Saul Silverstein. 

* Clinical Trials-Numbers alone suggest why other medical schools consider the Office of Clinical Trials (a joint program with Presbyterian Hospital) a model. The office has been a hugely successful catalyst to attracting new clinical research programs and funding. 

Since the office was created in 1992, the number of clinical trials, the revenues derived from clinical trials contracts, and the number of clinical trials sponsors (government, industry, foundations) have risen impressively. In the year before the office opened, 34 clinical trials contracts worth $3.6 million were processed. The number of new trials has risen to 115 valued at $25 million in 1995-96. 

Since 1992, the Office of Clinical Trials has awarded $2.5 million to 50 new investigators. Twenty-four of those awardees have completed their projects and have generated $9.7 million in revenues for the University. 

Among initiatives undertaken by the office in 1995-96: 
 -- In cooperation with the Irving Center for Clinical Research, a program was established based on a successful program at the New York State Psychiatric Institute to recruit Hispanic subjects and staff for clinical research. Since 1990, the Hispanic Anxiety and Depression program at the Psychiatric Institute has recruited Hispanic monolingual Spanish-speaking subjects into trials funded by the NIH and pharmaceutical companies. Because it is not feasible or practical for every research group interested in enrolling Hispanic subjects to hire medically trained bilingual staff, the Hispanic Recruitment and Research Center and will assist research groups within the medical center with recruiting and enrolling Spanish-speaking subjects in a cost-efficient manner. 
 
-- A training program teaches researchers the standards of good clinical practice (GCP). Over the years, industry, government, and private research organizations have developed standards for research involving human subjects to ensure safety, quality, and adequate documentation to the appropriate governmental regulating body, such as FDA. The program covers the rights of human subjects, ensures the integrity of data, guarantees the reproducibility of data, and makes the research methodology clear. The GCP training program at CPMC simplifies the application process and ensures accurate record-keeping practices. The goal is for every member of the staff involved in clinical trials to take the course to standardize clinical practices throughout CPMC. "To the best of my knowledge," says Mr. Leahey, "Columbia is the first medical center in the United States to propose having its entire staff certified in GCP." 

The Office of Clinical Trials manages a fund used to enrich the clinical research infrastructure at CPMC. The funds provide total or partial support for intramural projects or programs that reinforce research, education, and patient care. An overview of this year's awards: 

* Jay Dobkin and Ellen Morrison for a computerized data base for the CPMC AIDS program, $55,000. 

* J. John Mann and Ronald Van Heertum for 3D reconstruction of PET images project, $62,700. 

* Richard Deckelbaum and William Blaner for developing a center to study vitamin and antioxidant measurements in tissues and fluids, $111,475. 

* Elsa-Grace V. Giardina, for the Center for Women's Health: Educational and Research Mission, $100,000. 

* Annetine C. Gelijns and Alan J. Moskowitz for advancing clinical trials in surgery at CPMC (with matching funds from the Department of Surgery), $171,112. 

* Henry Ginsberg for molecular biology core facility, $90,754. 

* Richard K. Scher for dermatology clinical research unit expansion (with matching funds from the Department of Dermatology), $80,113. 

* Robert L. DeLapaz for functional brain imaging with echo-planar magnetic resonance imaging, $100,000. 

The Clinical Trials Research and Development Committee Awards are $50,000 each. Ten projects were chosen from a group of 24 applicants. The 10 winners: 

* Stephen J. Donovan for "Divalproex Sodium (Depakote) VS Placebo in Teenagers with Explosive Tempers and Severe Mood Swings." 

* Randolph S. Marshall for "Functional Reorganization After Acute Stroke." 

* Robert Fine for "Inhibition of the Blood-Brain Barrier to Facilitate Cancer Chemotherapy of Brain Tumors." 

* Paul E. Harris for "Characterization of CTL Epitopes in Breast Cancer." 

* Tuan H. Vu for "Mitochondrial DNA Defectors in Inclusion-Body Myositis." 

* Michael Flamm for "Retroviral Gene Transfer of PNH." 

* Angela M. Christiano for "Development of Genetic Therapies for Recessive Dystrophic Epidermolysis Bullosa." 

* Leroy E. Rabbani for "Inflammatory Cytokines and the Acute Ischemic Syndrome." 

* Paula Annunziato for "Diagnosis of Varicella-Zoster Associated Skin Rashes by in Situ Hybridization." 

* Mitchell F. Berman for "Continuous Quality Improvement: A Pilot Project for the Perioperative Period." 

* Heart Booster-Through a five-year $4,350,000 contract from the National Heart, 
Lung and Blood Institute, Columbia cardiologists are working with Abiomed, a Massachusetts-based developer, manufacturer, and marketer of advanced heart support systems, to develop a ventricular assist device. The device, temporarily dubbed the "heart booster," is designed to treat congestive heart failure and will surround the outside of the heart and assist its pumping action. Unlike other devices, such as artificial valves, the heart booster will not contact flowing blood. Preliminary designs for the booster will be tested in preclinical studies at CPMC. The researchers estimate that tests on humans may begin in five years. The final design will be fully implantable in the body and the researchers hope to design the booster so that it can be implanted with only a small incision. CPMC, a world leader in heart surgery, conducted the first successful pediatric heart transplant in 1984 and has the nation's largest heart transplant program. 

* Joint Healing-Orthopaedic Research Lab members filed patent applications for a novel design for the trapeziometacarpal joint prosthesis to treat arthritis of the basal joint of the thumb, which affects 16 percent of all women and 6 percent of all men ages 55 to 64. The patent-pending enzymatic procedure to enhance joint healing with autologous periosteal-bone allographic constructs could prove more effective than the chondrocyte transplant method offered by biotech companies. The lab will identify industrial collaborators who might further develop the technology. 

* Center for Device Research-Established in 1995, the center is a multidisciplinary group of specialists in medicine, surgery, computer science, engineering, physiology, and business that assists inventors and entrepreneurs in taking an idea for a new medical device through the stages of design, bench testing, clinical testing, regulatory approval, and marketing. 

Led by Dr. Howard Levin, the center's team collaborates to provide a comprehensive study of any new device or technique. 

The center will help small-device companies acquire space in the Audubon Business and Technology Center and help faculty use the facilities of the Audubon Center to develop their inventions into products. 

Faculty in the Center for Device Research have gained much of their expertise through the development of cardiac assist devices. CPMC is a major center for research in left ventricular assist devices (LVADs), which assist the function of the left ventricle of the heart, the chamber responsible for pumping oxygen-rich blood from the lungs throughout the body. 

CPMC is the coordinating medical center for the REMATCH trial, an investigation of the use of LVADs as a permanent alternative to medical therapy in patients with heart failure who are not candidates for heart transplants. In addition to the REMATCH trial, CPMC participates in the development of new LVADs and is constantly improving current models. CPMC researchers are specifically working to improve the connecting system and the surface of the device and to reduce the risk of infection. 

Researchers at the device center are working with computer science faculty to develop better control algorithms for enhancing the performance of LVADs. 

* Israeli Delegation at Audubon-Columbia University, U.S. Congressman Charles Rangel, the Upper Manhattan Empowerment Zone, and the Harlem International Trade Center hosted a gathering at the Audubon Park of academics, public officials, and business people from Upper Manhattan and Israel to celebrate entrepreneurship, job opportunities for the disenfranchised, community development, and international partnerships. Israel's Technological Incubator Program, which presented findings and inventions, was established in 1991 to help absorb a large influx of highly educated Russian immigrants into the economy and to support all technological entrepreneurs in the early stages of invention. The presence of the Israeli delegation was an inspiration to the community and academic representatives who wish to see the Audubon Biomedical Science and Technology Park become a similar resource for start-up companies and the surrounding Washington Heights community.