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David Howard (shown), director product protection global brand integrity at Johnson & Johnson, spoke about how to implement a brand-protection program. “The first step in any organization is to know thyself,” Howard advised. “Where are your products made? How do you distribute? Where do you market? Are you local? Regional? Global? Who touches your products?” Without detailed answers to such questions, solutions being considered or the ones already being implemented may be misguided, Howard told the audience at the first Brand-Protection Packaging Forum.
More is going on in RFID apart from news of the decision by the California Board of Pharmacy to delay requirement for e-pedigree tracking of drugs until 2011. RFID analysts from ABI Research commented about RFID developments and drivers in pharmaceutical markets. Analyst Peter Poorman (shown here) says the current state of affairs in RFID is typical to that of many technologies. "After a period of excitement and then a period of disappointment, there follows a period of adoption on an upward ramp. I think we’re at the beginning of that ramp with RFID."
Pharmaceutical company packaging OEE's (Overall Equipment Effectiveness) are reported to be among the lowest in the industry. Experience teaches that those feeling the greatest amount of pain are the ones most likely to successfully drive change. Perhaps that is why three giant pharmaceutical companies reported on their efforts in this area at ARC's Forum on Winning Strategies and Best Practices for Global Manufacturers.
Jan Gates, principal sterile barrier (packaging) engineer, Abbott Vascular, offered the following recommendations when considering hiring a consultant, or working with consultants. Her comments come from the January 28 MD&M (Medical Design & Manufacturing) West Conference in Anaheim, CA:
• Hire a consultant when temporary assistance is required – new business deadlines, short term business problems, independent advise needed, searching for cost savings, etc.
Healthcare Packaging and Packaging World, producers of the Pharmaceutical Packaging Forum, and Ipack-Ima Spa, organizers of Pharmintech, announce a cooperative agreement in which Healthcare Packaging and Packaging World will offer promotional support to Ipack-Ima Spa, increasing the visibility for their Italian trade event, Pharmintech, to the U.S. pharmaceutical market. Pharmintech, held every three years in Italy, will next take place May 12th -14th, 2010 in Bologna, Italy.
Wyeth’s Charlie Portwood and Teva Global Generic Resource’s Uri Boneh will serve among the keynote speakers at The International Society for Pharmaceutical Engineering’s (ISPE) annual meeting Nov. 4 – 7 at Caesars Palace in Las Vegas. The event will feature more than 40 sessions, with topics including packaging, product quality lifecycle implementation, pandemic flu preparedness, personalized medicine, nanotechnology, disposables, and project management.
“With the rapid growth in the biopharmaceutical industry over the past two decades, the number of newly approved biological products has dramatically increased. In 2005, a record 21 biological products received U.S. Food and Drug Administration approvals, including therapies for the treatment of rheumatoid arthritis, diabetes, cancer, and rare genetic disorders,” says the Intl. Society for Pharmaceutical Engineering (ISPE). With that in mind, the organization has released the ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products .
The second Pharmaceutical Packaging Forum will be held March 12, 2008 at Philadelphia's Rittenhouse Hotel, the same site that hosted the sold-out initial PPF in March, 2007. Sponsored by Healthcare Packaging and Packaging World magazines, this year’s PPF will include conference presentations, networking opportunities, and exhibits.
Michael Becker, director of engineering, Pfizer GmbH, reported on a four-year project, “FAST,” (Fully Automated Supply and Transport), recently completed at the firm’s Freiburg, Germany plant. The plant produces tablets and capsules of Lipitor, Valoron and Neurotin for 80 different countries in a wide variety of package configurations. The highly automated, computer integrated plan helped the plant achieve OEE comparable with other industries, depending on the equipment measured.
• Biopharmaceutical and biomedical technologies and treatments will be advanced in large part by developing countries. Although only 5% to 7% of biological products now in clinical development will actually make it to the market, they will play an important role as the life sciences industry begins to develop custom solutions for individual patients rather than focusing exclusively on the larger market. But such treatments will require a change in packaging and processing methods, as well as regulatory procedures.
Three trends are emerging that warrant more attention. One is sustainability, which is all the rage in the general packaging press. But with all the demands already placed on a pharmaceutical or medical device package, do we have to be earth-friendly too?
At the Pharmaceutical Packaging Forum, Attorney Eric F. Greenberg revealed key Food and Drug Administration issues pertaining to healthcare packaging. Among them were drug safety, inspections, cGMPs, labeling of prescription and OTC drugs, and how a unique coalition came together last year to lobby for more FDA funding.
In pharmaceutical firms and consumer-packaged goods companies in general, packaging may be the last place in the corporation that has not been Six-Sigma’d to death. Companies have been looking for ways to squeeze time and cost out of the manufacturing process and they’ve finally arrived at packaging’s door. In this article, Kent St. Vrain of Paxonix reports on Six Sigma benefits, economic justification, and streamlining the process of getting product more quickly to market.
Product manufacturers in the pharmaceutical industry are finding it increasingly difficult to drive strong growth, for reasons such as governmental global cost-containment measures such as promoting more economical generic drugs. The pharmaceutical industry is suffering from low R&D productivity, which has fallen to its lowest levels in 20 years, despite companies making record levels of investment in R&D, according to a new report from Datamonitor, an online provider of global data, analysis and forecasting for major industry sectors.
Presenters from Merck, Schering-Plough, and Cardinal Health will help Summit Publishing launch the Pharmaceutical Packaging Forum 2007, scheduled at the Rittenhouse Hotel in Philadelphia Thursday, March 29, 2007.
RN Karen Kiefer discussed the impact packaging has on purchasing decisions at Texas Health Resources (THR) during HealthPack 2006.
Healthcare continues to change dramatically for professionals at THR, a faith-based, nonprofit U.S. healthcare system that includes 13 hospitals and more than 2,400 licensed beds and serves patients in the Dallas/Fort Worth area. As director, operating room supply chain management, Kiefer explained some of the key packaging challenges THR faces in her presentation, “The Impact of Packaging on Purchase Decisions.” They include the following:
A recent Packworld.com survey asked if senior drug plans will have an impact on packaging. Here’s a sampling of responses …
• “Seniors will be demanding lower-cost, higher-quality products,” said a respondent from a maker of pharmaceuticals and medical devices. “They will go with what is the most cost-efficient since they are on a fixed budget.”
• “The impact will be the requirement to make pharmaceuticals more in line with commodity goods instead of the super-high-profit business it was. This will require the implementation of processes such as Six Sigma for cost reduction and process improvement, or just-in-time manufacturing and automation.”
• Besides cost issues, a respondent from a maker of solid-dose and liquid pharmaceuticals said, “The big challenge is helping seniors self-manage their drug dosing given the increasing complexity of their regimens and their declining ability to handle complex tasks requiring memory and organization skills.”
• “Expect more diversity in how products are packaged. [That will create] additional confusion for consumers [with] the potential for medication errors and product confusion,” said the employee of a firm that makes all types of pharmaceuticals.
• Another respondent from a firm making pharmaceuticals, biopharmaceuticals, and lyophilized products predicted an “increase in blister packs, dosage-guided packages, and expanded-content labeling.”
• And how about this response from a professional with a company that makes a wide variety of pharmaceuticals, nutraceuticals, and medical devices: “Watch for direct-to-consumer in the next three to five years taking the place of traditional pharmacy operations.”
Focused questions posed by audience members at various healthcare conference seminars exemplify the complexity of issues on the plates of packagers. Through our Web site, Packworld.com, we asked healthcare packagers, “What packaging-related issue would you most like to resolve this year?”
Costs were the most frequently noted topic. “Cost of production,” “reduce the cost of drugs and save money for the customer,” “rising costs,” and “quality versus cost…what is the cost of quality?” were among the survey responses. Of course, costs affect virtually any packaging issue.
Similar to the inquisitive conference attendees, several of our recent survey respondents expressed a passion for specific topics. One of the most intriguing issue-related comments not focusing on costs came from one survey respondent who sought “improved prescription dispensing by retail and mail pharmacies.
“The packages [don’t] protect the medications, [they] omit protection such as moisture absorbents contained in the packages from [pharmaceutical] manufacturers, [and] they rely on child-resistant (CR) caps on bottles to provide CR assurance, [yet] with no regard for opening problems by our aging population. Why not have the FDA approve the dispensed packages from drug manufacturers and make the pharmacies dispense those packages?” Does this suggestion make sense? Why or why not?
Welcome to 2006. What does the new year hold for packagers of healthcare-related products? To find out, we spoke with veteran packaging professionals for a series of articles called “Forecasting the Future.”
Watch for the matching icon on stories in this issue about lean manufacturing at Smith & Nephew Orthopedics, pondering packaging machinery and materials advances, evaluating outsourcing and the use of contract packagers, packaging management strategies, and some candid views on validation.
The experts interviewed for this series are: Nancy St. Laurent, senior engineer of sterile facilities and packaging systems at Lockwood Greene;
No wonder. Your company is likely being squeezed by regulations, validation issues, new technologies such as advanced machine controls and RFID, not to mention a host of broader issues ranging from individual patient compliance to a potential global bird flu pandemic.
If that’s not enough to spike your blood pressure, all these challenges hit at a time when the public opinion of the pharmaceutical industry is about the same as it is for the tobacco business. That’s according to Carl Fearn, sales director for IMS Health in Australia, during his speech at last month’s ISPE Annual Meeting. Fearn attributed the information to a recent Harris consumer poll, declaring, “That’s just not right, since our products help save lives.”
Healthcare packaging professionals face numerous critical issues. One of the most alarming threats facing industry and consumers is counterfeit drugs. The topic was discussed at the ISPE meeting in Phoenix, as well as at October’s Cold Chain Distribution for Pharmaceuticals 2005 Conference in Philadelphia, at September’s Frontline Solutions Conference and Expo in Chicago, and at last month’s PIRA International Innovations in Security Technology Conference in Chicago.
In this Q&A, Jeff Jackson, product manager of Bosch Packaging Technology’s Pharmaceutical Division, lends insights into what’s on the minds of his pharmaceutical packager customers.
