New York, NY (PRWEB) June 26, 2012
The Wall Street Journal reports that the United States Food and Drug Administration (FDA) has granted Fast Track status to galeterone, a new drug candidate produced by Tokai Pharmaceuticals. Brent Bankosky, noted professional in the pharmaceutical industry, explains the multiple ways in which this designation will improve the development of the medication.
Galeterone is a potential treatment option for prostate cancer that is currently in the developmental stage. Tokai Pharmaceuticals believes that the Fast Track designation approved by the FDA indicates that the organization is confident in the future success of the drug.
Martin Williams, the President and Chief Executive Officer of Tokai Pharmaceuticals, stated: "We are very pleased with this Fast Track designation and believe the FDA's decision further validates the potential therapeutic utility of galeterone for the treatment of prostate cancer."
While this is a tremendously significant event for Tokai Pharmaceuticals, many members of the general public have expressed confusion as to what Fast Track entails. Brent Bankosky explains that this designation will improve the time it takes to approve the drug, should it pass the required tests.
"Tokai Pharmaceuticals is the latest biopharmaceutical company to receive FDA Fast Track status for their prostate cancer drug, galeterone (TOK-001)," commented Brent Bankosky. "This is an important and meaningful step for Tokai and is also important for future discussions with potential licensing and acquisition partners. FDA Fast Track status may allow for potential approval based on a surrogate marker endpoint that is reasonably expected to predict clinical benefit."
But the Fast Track program provides more perks to pharmaceutical companies. Brent Bankosky continues: "FDA Fast Track status will also allow for more frequent meetings between the sponsor and the FDA and enable an accelerated review cycle with the FDA for potential approval. FDA Fast Track status indicates that there is a clear unmet medical need and should facilitate a faster time to approval. All of the benefits of FDA Fast Track status are important to potential partners and will enhance the value of galeterone if just by shortening the cycle time to approval."
Brent Bankosky understands the value that this designation holds, and hopes that by shortening the approval process it can begin to improve the lives of men with prostate cancer sooner.
About::
Brent Bankosky is a business development and corporate strategy executive who has a strong background in the pharmaceutical industry. Through his work, he has assisted multiple companies in the development and strategy associated with the approval and marketing of pharmaceutical products. Additionally, Brent Bankosky has accrued global experience, allowing him to understand the international implications of innovations within the pharmaceutical industry, as well as work well with professionals from a variety of backgrounds and cultures.
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