Bio/ImageBase organizes FDA applicationsBio-Imaging Technologies couldn't be happier about efforts toreform the U.S. health-care system. The new-found emphasis oncost constraints has put a premium on information about the earlyperformance of new
Bio-Imaging Technologies couldn't be happier about efforts toreform the U.S. health-care system. The new-found emphasis oncost constraints has put a premium on information about the earlyperformance of new drugs and new medical devices in clinical trials,according to William L. Robbins, vice president of business developmentat the West Trenton, NJ, company.
"The pharmaceutical and biotechnology industries are undergreat pressure to reengineer their clinical development processesto select more effective compounds and to weed out compounds thatpose problems for future development," Robbins said. "Thatrequires better methods to assess those compounds."
That's where Bio-Imaging Technologies comes in. The companyspecializes in the digital processing and analysis of medicalimages taken during human clinical trials and preclinical animalstudies. Last year the company processed information in supportof 34 projects run by such companies as Bristol-Myers Squibb,GE Medical Systems, the Genetics Institute, Mallinckrodt Medicaland Sterling Winthrop. In each of these projects, specialistsat Bio-Imaging Technologies examined the effectiveness of therapeuticdrugs, in vivo diagnostic agents or medical devices.
The company uses proprietary medical imaging and computer technologyto visualize and measure the effects of drugs and devices in thehuman body and in animals. The first step is to translate analogimaging data, such as radiographs or ultrasound videos, into digitalformat, or to input data from digital modalities such as MRI orCT. The images can then be subjected to various forms of quantitativeanalysis, such as image segmentation or region-of-interest analysis,to quantify phenomena such as blood perfusion or tumor volume,according to Robbins.
By measuring drug and device effects, results from clinicaland animal trials can be presented with greater precision, accuracyand reproducibility, he said. The key is to replace subjectiveassessments of product efficacy with objective, quantifiable analysesthat are performed in a standardized way. That is done by measuring,for example, the exact amount that a tumor has shrunk as the resultof therapy, or whether the administration of a drug in animalstudies was able to reduce damage resulting from stroke.
"Images typically are evaluated by expert reviewers whomake some subjective classification, such as a tumor being reduced25% to 50% in size," Robbins said. "Using image processingand quantitative analysis, you can measure the size of the tumorexactly and you can quantify in a more objective fashion the effectof treatment."
The company has developed a software applications package calledBio/ImageBase, which links a relational database to an image displayand processing module. Bio/ImageBase imposes a computerized formatacceptable to the Food and Drug Administration on medical imagedata and related clinical information. The data can then be submittedto the agency to support new drug applications and product licenseapplications.
"This combination would enable an FDA reviewer to performad hoc queries and customized searches and comparisons on medicalimage data and related clinical data as well as electronic documentinformation," Robbins said.
Bio/ImageBase is compatible with Apple Macintosh systems andwill be expanded later this year to run on IBM-compatible machines.
Another advantage of the service from Bio-Imaging Technologiesis the ability to electronically organize and submit medical imagedata for regulatory review.
"Prior to Bio/ImageBase, it was impractical to submitlarge volumes of films from clinical trials to the FDA,"he said. "But in a digital format, images can be displayedand organized by digital headers so you can establish a relationaldatabase to search and sort the information."
Revenues climb. Bio-Imaging Technologies was founded in 1990by Dr. James Conklin and Harold Loats. Conklin, a specialist innuclear medicine and internal medicine, is chairman and chiefscientific officer of the company. He previously worked for Cytogenand Centocor. Loats has since left the firm for a position aspresident of a Maryland-based image processing software developer.
The company's executive suite is rounded out by Rex D. Bright,who was named interim president and CEO last month after the company'sprevious chief executive, Terrence Brennan, left the company.Bio-Imaging Technologies has begun a search for a new chief executive.
The firm's revenues appear to be on the upswing. For the firstquarter of fiscal 1995 (end-December), the company reported revenueof approximately $757,000, compared to $266,000 for the same periodin fiscal 1994. The company reported a net loss of about $38,000for the quarter, compared to a net loss of $545,000 for the sameperiod the year before. The stock is traded on the NASDAQ stockexchange.
Bio-Imaging's strategic business direction is to market itstechnical consulting services to pharmaceutical or medical devicecompanies. The company last year began entering into strategicalliances with other firms to expand its scope of clients. Inmid-1994, the company entered into a cooperative agreement withAmersham International of Buckinghamshire, England. Under theagreement, the companies agreed to jointly promote the Amershambrain SPECT imaging agent, Ceretec, and Bio-Imaging's medicalimage processing services to the pharmaceutical and biotechnologyindustries.
"In particular, we are interested in exploring appropriateapplications for SPECT images to measure blood flow in patientswho are treated with neuroprotectant drugs," Robbins said.
Also last year, the company entered an agreement that allowsG.H. Besselaar Associates, a unit of Corning, to market Bio-Imaging'sservices and its Bio/ImageBase software product. Besselaar's services-- namely, consulting on clinical plan design, management, biostatisticsand regulatory issues -- were then made available to Bio-Imaging'sclients.
In addition, Bio-Imaging Technologies signed on with GE MedicalSystems to provide medical imaging-related data management servicesto that vendor's image-guided therapy program, which used focusedultrasound in conjunction with interventional MRI for noninvasiveimaging and treatment of breast disease (SCAN 11/17/93).
Meanwhile, the company has continued to nurture its growingrelationship with the pharmaceutical industry. In January, forexample, Bio-Imaging announced a $573,000 contract with a majorpharmaceutical company to provide medical image processing anddigital imaging management services for the clinical trial ofa neurologic drug that may protect ischemic brain tissue. Robbinsexpects the popularity of such contracts to grow.
"We believe there is an increasing use of medical imagingin clinical studies because of the stage of development of imagingtechnology itself," he said. "You can now target andidentify organs and disease processes, even physiological changes,in the human body with imaging tools. Pharmaceutical companiesare very interested in using these tools to help them in the clinicaldevelopment process."