Sponsor Profile | Columbia and the Continuum of Biomedical Science

MOVING AN IDEA FROM PAPER TO PRODUCT

Ofra Weinberger heads Columbia University Medical Center's STV office, which is a researcher's initial stop on the road to commercialization. STV staff members help investigators identify research with potential value for the development of drugs, devices, and medical technologies, then secure a patent to protect the idea and develop a commercialization plan. The office provides assistance in identifying commercial partners, securing funding, and negotiating contracts. The hallmarks of STV's approach are flexibility, creativity, and responsiveness.

As the senior associate dean for institutional and global initiatives, Joanna Rubinstein coordinates research partnerships between university investigators and outside sponsors. She promotes the partnerships as an important way to advance science with advantages for both parties. A pharmaceutical company, for instance, may get earlier access to research, while academic medical centers may be able to more quickly improve patient care by helping the market develop drugs.

This year's deal between Columbia University and Guidant, a manufacturer of lifesaving cardiovascular medical products, illustrates her point. In August, Columbia announced that it will collaborate with Guidant and Stony Brook University to develop a new therapy based on the application of genetically engineered cells to help pace the heart.

PUTTING WALLS AROUND AN IDEA

After an idea leaves the tech transfer office, a next logical stop could be the Audubon Biomedical Science and Technology Park, New York City's first university-related research park. The park's Business and Technology Center has 22 companies focused on Alzheimer's disease, burns, cancer, heart disease, renal disease, and other ailments. The offices that occupy the incubator range in size from 220 square feet to 14,320 square feet, a range that reflects each company's various stage of development.

"Our focus is enhancing the academic medical center by providing the real estate," Gipson says. "We are perfectly willing to rent relatively small spaces for a short time. We try to make the facility an entry point to other services in the medical center."

This type of flexibility has allowed Audubon Park to nurse along a number of young companies since opening its doors in 1995. When Ortec International Inc., a biomedical company focused on tissue engineering, took up space in the incubator it had five people on staff. Its product, composite cultured skin, was still in the early developmental stages. Over the years, the skin product for burn patients proved effective in clinical trials, and the company began making the product in-house. Along the way, it was able to expand and contract its space according to its needs. The publicly traded company, with a Food & Drug Administration-approved product and about 40 people on staff, remains in the building.

From Left: 2000 Nobel Prize winner Eric Kandel, 2004 Nobel Prize winner Richard Axel, and Columbia University Medical Center Executive Vice President Gerald Fischbach celebrate Dr. Axel's Nobel Prize, the second for the medical center in four years.

"We were able to help them manage their growth as they were constantly changing in size," Gipson says of Ortec. "That is a very rare thing in the marketplace." Memory Pharmaceuticals, Kandel's company, grew to 45 employees and 10,000 square feet by the time it left the incubator in 2000, expanding from the initial three employees and roughly 3,500 square feet when it set up shop in 1998.

MATCHING PRODUCT WITH PATIENTS IN CLINICAL TRIALS

Many of the university's success stories could not have happened without the Clinical Trials Office, one of the last stopping points before FDA approval of a drug or device. The office is the administrative arm of clinical research for Columbia University Medical Center and New York-Presbyterian Hospital, coordinating every aspect of clinical research for investigators. Whether negotiating contracts, developing protocol for trials, or reviewing clinical trial budgets, the office frees investigators to focus on research and patient care. "We do a lot of the paperwork and things that may be troublesome, when investigators are trying to think scientifically," says director Eileen Enny Leach.

Clinical trials staff members come from all sectors of the workforce and have experience in business, government, industry, and law, thereby bringing unique perspectives and capabilities to their jobs. (Leach herself has worked in the pharmaceutical industry.) The professional diversity of the office creates a "customer focus," whether the "customer" is the clinical investigator or an outside sponsor such as a pharma company testing a drug. Sponsors can feel confident that experts are overseeing a particular part of the trial, be it an accountant working on the budget or a former government employee making sure the regulatory guidelines are followed. "We speak the language of our customers," Leach says.

The Research Pharmacy within the Clinical Trials Office supports both Columbia University investigators and industry partners by providing accountability – ensuring that a drug or device under investigation remains in constant control and keeping logs of patients and their medications. This is important, Leach emphasizes, because the lack of accounting can lead to a delay in FDA approval.

In the end, Leach's mission at the Clinical Trials Office is no different from that of Gipson's at Audubon, Weinberger's at Science & Technology Ventures, or Rubinstein's in the medical center's administration: to help investigators move their ideas through the research pipeline to the biotech market. Leach sums up her role with a sentence that aptly applies to all: "We leave the true work of science and patient care to the researchers."

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