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Validation, cost issues, and the future of pharmaceutical packaging

Pharmaceutical, medical device, and combination product packaging authorities will make presentations at the May 26 Healthcare Packaging Conference & Workshops in Princeton, NJ.

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Reducing production and packaging costs, increasing patient compliance, and best practices for package stability and validation of combination product packaging, are among the topics for discussion at the May 26 Healthcare Packaging Conference & Workshops event in Princeton, NJ. Presenters and topics will include the following:

• Mike Wokasch, author of Pharmaplasia and long-time pharmaceutical industry veteran, will • address what today's pharmaceutical manufacturers must do to weather the uncertainties in the healthcare marketplace. As in his blog, Wokasch will underscore the need for a financially healthy pharmaceutical industry, and will identify specific actions companies must take to remain prosperous in an increasingly demanding and less-tolerant marketplace.

• Mike Drues, Ph. D., president, Vascular Sciences, will cover the latest developments in combination products and experience with clients in working with the FDA.

• Laure L. Larkin, packaging validation supervisor, Synthes USA, will focus on package stability aspects and validation of combination products. Larkin brings more than 20 years of experience in FDA-regulated industries, and has worked with both larger Fortune 100 companies and smaller entrepreneurial organizations. She has functional experience in validation activities related to stability, packaging, cleaning, equipment, software, and test methods, as well as general compliance and risk management.

• Karen K. Greene, CPP, vice president sales and technology, Life Packaging Technology, and Jan Gates, staff packaging engineer, Abbott Vascular, will address package integrity and how is it tested, as well as discuss the essential steps in the package development process, with an emphasis on regulation and industry standards and practices for package integrity. The presentation will explain package integrity as a design input for sterile medical packaging, pharmaceuticals, and biotechnology products.

• James Evans of the Novartis-MIT Center for Continuous Manufacturing, will describe why the batch-based manufacturing system currently employed by the pharmaceutical industry is costly and inefficient. The Novartis-MIT Center for Continuous Manufacturing is a 10-year research collaboration combining the industrial expertise of Novartis with MIT's scientific and technological leadership; the Center develops new technologies to replace industry's conventional batch-based system with a continuous manufacturing process.

• Russ Napolitano, vice president strategic development, Wallace Church, Inc., will speak on how the Rx and OTC pharmaceutical segments are highly competitive, with potential confusion between brands. In order to optimize success, brand identity, packaging structure, packaging graphics, professional and DTC advertising, Internet, and sampling strategies must consistently embrace the brand's core essence. Wallace Church is a New York City consultancy providing brand identity strategy, packaging and self-promotional materials. Mr. Napolitano will take attendees through the process of moving Pfizer and Wyeth brands from Rx to OTC. These case histories will demonstrate how to create a visual positioning strategy that articulates a clear, compelling, and relevant image for core loyalists, early adopters, and potential enthusiasts.

• Jim Chrzan, publisher, Healthcare Packaging, will speak candidly about his own life with 14-year-old son Casey, who has Down Syndrome and Autism, and how a compliance-prompting package has changed the entire family. A real life case history celebrates the innovation healthcare packaging brings to one Midwest family.

• Ed Bauer, Packaging Hall of Fame inductee and pharmaceutical packaging veteran, will look ahead to the future of pharmaceutical packaging, based on the many influences on the pharmaceutical industry that will alter the way drug products are packaged. The presentation will look at the impact on packaging from policy changes, how sustainable materials will make inroads into pharmaceutical packaging, and ideas on new manufacturing technologies that are needed to sterilize and package future products.
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