A Medical Device Daily

The Critical Path Institute (C-Path; Tucson, Arizona) and Ventana Medical Systems (also of Tucson) yesterday released additional information about C-Path’s $2.1 million grant from Science Foundation Arizona (SFAz) to fund a collaboration project with the (FDA) and the National Cancer Institute (NCI; Bethesda, Maryland) to develop a standard testing and evaluation process for companion diagnostics and their associated targeted cancer therapies.

Currently, there is no proven development pathway for FDA approval of the necessary companion diagnostic tests and their associated targeted therapies. The goal of this collaboration is to establish the performance standards that would serve as the model for future FDA co-submissions of these companion diagnostic tests and their targeted drug therapies. With the SFAz grant, C-Path and Ventana will work closely with the FDA and NCI to apply these standards to one of Ventana’s in-process companion diagnostic tests for lung cancer.

Gary Kelloff, Senior Scientist at the National Cancer Institute said, “We applaud the collaboration among the Science Foundation Arizona, The Critical Path Institute and Ventana Medical Systems on the important project of creating a standardized evaluation process for diagnostic tests. The results of this work will complement the anticipated collaborative project with the NCI.”

C-Path’s Chief Scientific Officer and Principal Investigator on this initiative, Jeffrey Cossman, MD, said, “The award from Science Foundation Arizona will fund an important step toward making the next generation of important patient care solutions a reality. The ultimate goal of the project is to guide the choice of targeted therapy so that patients receive the most effective treatments.” President/CEO Raymond Woosley, MD, PhD, added, “This is extremely important work, and we are fortunate to have Ventana, a global leader in cancer diagnostics, as our partner.”

Christopher Gleeson, president/CEO of Ventana, commented, “Ventana’s collaboration with C-Path furthers our commitment to personalized medicine and our view that companion diagnostics will increasingly become a key factor in the development and administration of many new cancer therapies.”

C-Path’s mission is to help implement the FDA’s Critical Path Initiative by developing faster, safer and smarter pathways to new medical products.

Ventana develops instrument/reagent systems that automate tissue preparation and slide staining in clinical histology and drug discovery laboratories worldwide.

In other agreements:

• PacificGMP (San Diego), a contract manufacturing organization specializing in the development and manufacturing of biologics through single-use bioprocessing components, reported that it has signed an agreement with BD Biosciences, a segment of BD (Becton, Dickinson and Company; Franklin Lakes, New Jersey), whereby PacificGMP will generate and provide storage for Master and Working Cell Banks and perform antibody manufacturing for BD Biosciences.

The Master Cell Bank and antibody manufacturing will be conducted in compliance with current good manufacturing practices (cGMP) standards. Master and Working Cell Banks are a well-documented two-level storage system of mammalian cells. Cells from these banks may be used in production of biopharmaceuticals such as monoclonal antibodies, viral vectors or recombinant DNA products.

• ReBuilder Medical Technologies (Charles Town, West Virginia), an emerging medical device manufacturer founded by medical device inventor David Phillips, PhD, reported it has agreed with Helio Health to market the ReBuilder System to its customers via the Internet and its mail order catalogs.

“We can bring this new technology from ReBuilder to our customers and because many of our customers are medical professionals looking for new technologies for pain, we feel that this will be a good fit,” says Josh Lefkowitz, president of Pain Technologies, parent company to Helio Health. “At Helio Health, we specialize in new products that the physician has not been aware of previously. For example, we released an inexpensive heating/cooling pad for neuropathy patients last year and went from 0 sales to over $800,000 in the first year alone.”

Sheldon said the company will target the addition of 400 new dispensing medical professionals to its customer list in 2007-2008. “Professional unit sales will lead to increased home-use sales, based on product sales history. Home unit sales will generate significant revenues plus dispensable, consumable support items like electrolyte, pads and replacement cables will add to our bottom line.”

Bioject Medical Technologies (Portland, Oregon), a developer of needle-free drug delivery systems, said that it has entered a three-year supply agreement with Merck Serono, a division of Merck (Darmstadt, Germany), for the delivery of the cool.click and Serojet spring-powered needle-free devices for use with Merck Serono’s recombinant human growth hormone drugs.

• Vision-Ease Lens (Ramsey, Minnesota), a maker of eyeglass lenses, reported that it has entered a partnership with Schering-Plough HealthCare Products, which is part of Schering-Plough (Kenilworth, New Jersey) to license the company’s Coppertone brand for a line of polarized sun lenses.

Through the agreement, Vision-Ease Lens will manufacture Coppertone branded lenses that will feature its patented polarized film technology. This partnership emphasizes the dedication of Vision-Ease Lens to develop and offer products that promote eye protection against harmful ultraviolet (UV) and high energy visible (HEV) rays.