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Este informe no está disponible en español. CARIBBEAN BUSINESS ISS and AAC Group: Helping pharmaceuticals with FDA compliance By AUGUSTO DURAN May 27, 2005 On the pharmaceutical industry’s highly competitive drug development and marketing scene, a company’s ultimate goal is to get its product to market faster than its competition. However, getting a drug through a clinical development program is a challenging process. A clinical research organization (CRO) is vital to the timely accomplishment of a new drug’s clinical development program. Regulatory compliance with the Food & Drug Administration (FDA) isn’t an easy hurdle to overcome. In fact, several Puerto Rico operations are encountering regulatory problems with the FDA. This places huge financial, operational, stock-market, and public-image burdens on the parent companies facing these compliance issues with the FDA. This is where ISS Corp., in collaboration with AAC Consulting Group, Kendle’s Regulatory Affairs consulting subsidiary in Rockville, Md., enters the scene. ISS is now in a position where it can offer more than construction management, project management, or any of its customary services. "Our alliance with AAC-Kendle allows us to offer support with clinical studies," said Edgar Guerrero, president of ISS. "What this means to a pharmaceutical operation is the assurance that its clinical development program is well-covered from conception through all product-development stages." This CRO’s full life cycle involvement safeguards the company’s regulatory compliance until its new product reaches medical endorsement and benefits the end user. Dr. Thomas Agrait, director of validation & regulatory compliance services at ISS Corp., said this collaboration agreement addresses all aspects of the pharmaceutical and medical device industries in Puerto Rico. This includes compliance in areas such as construction management, project management, information technology, drafting, and mechanical integrity. The validation area is critical to product integrity, purity, content consistency, and performance. ISS and AAC Consulting to celebrate collaboration To celebrate the collaboration agreement reached between ISS and AAC Group, both companies will hold a cocktail dinner at the San Juan Marriott Resort on May 26. Anthony C. Celeste, senior vice president of Kendle Regulatory Affairs, will be present at the activity. Celeste is one of three recipients of the 2005 FDA Distinguished Alumni Award. His most recent work experience has been with AAC. He served as president of AAC for more than 20 years and, since 2004, has worked as senior vice president. While at AAC, Celeste has been involved in a full range of FDA-regulated products and practices and has provided assistance to companies regarding enforcement, strategic planning for regulatory compliance, interpretation of current good manufacturing practices, and many other issues. Kendle has conducted clinical trials or provided regulatory and validation services in 70 countries. It offers competitive advantages in clinical development services to include regulatory consulting and submission, auditing and validation, medical writing and quality assurance, clinical data management, biostatistic and scientific programming, proactive and innovative designs, and value added pre- and postlaunch services to leverage study results. New and improved CRO service opportunities "If the compliance and regulatory capacity attainable through the collaboration agreement between ISS and AAC group were extended to all companies doing business in Puerto Rico, there would be a lot less FDA noncompliance situations than there are now," Agrait said. Most of these problems with the FDA could be avoided or solved by using the powerful resources provided by this collaboration agreement between ISS and AAC Group. AAC is the fourth-largest global regulatory consulting firm. Kendle is among the world’s leading global clinical research organizations, delivering innovative and robust clinical development solutions to biopharmaceutical companies, from first-in-human studies through market launch and surveillance, maximizing product life cycles and growing market share. Both in the U.S. and in Europe, pharmaceutical companies are moving toward outsourcing of research and regulatory compliance activities to highly specialized firms like ISS and AAC Group. "FDA’s harsh regulatory approach, coupled with other U.S. tendencies to allow foreign [Canadian] drug makers to enter the U.S. market, is causing a lot of insecurity among drug makers," said Agrait. "This is where the collaboration agreement between ISS and AAC Group has the potential to become a regulatory and compliance clearinghouse to safeguard the interests and effectiveness of our pharmaceutical industry’s concerns." ISS now a global pharmaceutical solutions provider This collaboration agreement between ISS and AAC Group represents an opportunity for the local pharmaceutical industry to obtain high-quality, regulatory consulting services face-to-face, 24 hours a day, seven days a week. Also, since AAC Consulting Group’s staff is mainly made up of ex-FDA professionals, the validation project’s life cycle will be managed from the initial consulting phase and will continue through the execution and final phases under a quality-service approach based on FDA perspective and experience. "It is very important and a great value for any pharmaceutical company to receive excellent regulatory and compliance consulting services," Guerrero stated. "But the equation is maximized when the same company can also provide the right tools and expert resources to execute the plan with a consistent approach." This collaboration agreement between ISS and AAC Group represents a "one-source solution." "From the marketing point of view, Interphex is the perfect tradeshow for ISS," Guerrero asserted. "Having been selected among the top players in this prestigious group of companies gives us the additional corporate exposure and confidence we need to continue offering our services as an excellent solutions provider for the pharmaceutical industry around the world." This Caribbean Business article appears courtesy of Casiano Communications. or
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