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A cloud of uncertainty hangs over the pharmaceutical industry in Puerto Rico following the expiration of tax incentives from Section 936 of the U.S. Internal Revenue Code. Could emerging combinations of biopharmaceuticals and medical devices provide a silver lining? A report from Interphex Puerto Rico.
Since incorporating in 1993, North Brunswick, NJ-based Artegraft Inc. has used glass tubes to ship its U.S. Food and Drug Administration-approved Class III natural collagen vascular grafts to hospitals, clinics, or hospital distributors. But occasional breakage during distribution and the desire to trim costs led the company to make a change this year to Eastman Chemical’s Eastar Copolyester MB002 resin. Eastman worked with O.Berk Co. to make the conversion. As a result of its transition to the tube, which incorporates a flat side, Artegraft is preventing breakage and saving money.
Arguably, one of the most promising areas in the healthcare sector is biologics. Biologics-based products and combination products appeal to some pharmaceutical firms not just for their treatment potential, but for their financial prospects, and for their ability to extend patent protection. “There is a lot more patent protection around these [biologics] molecules,” says Robert Smith, a director at Genzyme in the U.K. “Proteins and biologics are larger molecules than typical drugs."
Pharmaceutical firms seek packaging line improvements to cut costs, biologics present packaging challenges, and medical device growth is driven by aging baby boomers. These treatment advances bode well for the healthcare/life sciences packaging community. Packaging materials need to offer protection from point of manufacture to the “last mile” where healthcare products reach a patient. Packaging materials must provide barriers for moisture, oxygen, light and heat, and they may include overt and/or covert security measures to combat counterfeiting and diversion. Equipment will need to package products more efficiently, be validatable and versatile.
At this year’s Interphex conference and exhibition event in New York, the Healthcare Compliance Packaging Council (HCPC) selected its 2006 Compliance Package of the Year awards. The PocketPak (shown) earned package of the year honors. Reportedly used in England by Boots Pharmacies, PocketPak uses a patented design developed by Burgopak and Structural Graphics.
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.
Hosted by Healthcare Packaging and Packaging World magazines, the first Pharmaceutical Packaging Forum featured speakers from Johnson & Johnson, Merck, Schering-Plough, AstraZeneca, the U.S. Department of Commerce, and the Healthcare Users Group. More than 175 people packed The Rittenhouse Hotel in Philadelphia for the March 29 event. The Forum’s exhibiting sponsors included Alcoa, Design Group, Bilcare, Rexroth Bosch Group, Intellitech, Parsec, Pharmintech, Uhlmann, United Silicone, and ZPI.
Jan Gates, principal packaging engineer at Abbott Vascular, offered the following advice during her presentation, “Medical Device Distribution Package Testing,” during the Medical Device & Manufacturing MD&M West show.
Spend an educational day with your peers and solution providers at the Pharmaceutical Packaging Forum (PPF) in Philadelphia March 29. The event is produced by Summit Publishing Company, publishers of Healthcare Packaging and Packaging World business publications. Seats are going quickly, so register soon.
Drug delivery devices, advances in combination products, and biologics/biopharmaceuticals will present both challenges and opportunities for packagers. New packages and drug delivery methods for over-the-counter (OTC) drugs, nutraceutical and cosmeceutical products are appearing on retail drug and grocery store shelves. (Part II of II)
Bioabsorbable stents, such as Abbott's Absorb, may soon open a new pathway in the treatment of coronary artery disease, and challenge the packaging process. In late October, Abbott Park, IL-based Abbott Laboratories delivered encouraging news regarding the initial results of a clinical trial involving its Absorb bioabsorbable drug-eluting stent for the treatment of coronary artery disease.
Vital issues include validation, FDA regulations, counterfeiting, and the challenges of shipping pharmaceuticals and biologics through the cold chain. (Part I of II)... Surely one of the most interesting developments to unfold lately in the healthcare product manufacturing arena is the formation of the Coalition for a Stronger FDA. The coalition came together officially on Sept. 25 with former government officials, patient group representatives, consumer advocacy organizations, and industry associations bringing it into existence.
Remember the classic science fiction movie Fantastic Voyage? Technological advances in medical science are bringing our society ever closer to that. Sound “Star Trekky”? Not so, according to Michael Drues, Ph.D., a speaker at Medical Design & Manufacturing East, acknowledging that it may be years before nano-medical devices are injected into a patient’s bloodstream armed with powerful biologics and drugs to repair damaged cells and tissues or destroy disease at its source. The healthcare implications of these products could be profound. So too their packaging requirements.
So what do some industry thought leaders see in the future for combination healthcare products? “It’s always difficult to say how quickly this area is going to grow because a lot of this is not only dependent on the FDA expertise, review, and how expeditiously they get these out, but it’s also tempered by how these will be reimbursed by Medicaid, Medicare, and so on,” says Carolyn Jones, associate vice president for technology and regulatory affairs for Washington, DC-based medical device association AdvaMed. “I believe that there will be more combination products in the future.”
Truly innovative products can improve the effectiveness of medical therapies, help to achieve efficiencies, and thus become part of sustainable solutions to healthcare challenges. In particular, there are significant opportunities for companies to take advantage of an emerging trend—the convergence of pharmaceuticals and medical devices in combination products. Often without the expertise to develop their own drugs, many medical device OEMs are looking for partnership and licensing opportunities with pharmaceutical companies or hiring pharma experts.
Opportunities abound for packagers who can get in on the ground floor of the combination products revolution. Packaging combination products requires regulatory understanding, and those in the industry that can make early inroads into this process will gain the unique advantage of “experience” in this largely uncharted market. The FDA regulations pertain not only to product purity, but also to factors related directly to the package itself, such as product expiration date, stability, and sterility.
Dr. Laura Bix at Michigan State University asserts that in addition to the benefits they provide, combination products will complicate package design and sterilization.
Hal Miller, industry consultant and president of PACE Solutions LLC, offers the following advice on packaging challenges, regulations, and sterilization.
Perhaps the most widely recognized combination product is the heart stent. Years ago, physicians inserted a metal stent into a patient’s clogged or occluded artery, using a balloon that would expand plaque against the artery walls. “It’s a mesh-like metal tube that adheres to the artery wall and stays in position,” explains Rolando Gonzalez, manager of pharmaceutical and packaging development for medical device maker Cordis Corp., a Miami Lakes, FL-based Johnson & Johnson company.
The term “solutions” is spreading through press releases and e-mails I receive, much like a case of influenza. This marketing buzzword seems contagious. At least one recent release I received didn’t even mention the product or service it was promoting. Instead, it offered “the” solution. Summit, publishers of HCP, recently publicized an upcoming event using the phrase “delivers packaging solutions.”
Marrying a drug and a medical device, a drug and a biological-based product, a biologic and a device, or all three into a combination product can deliver dramatic patient benefits. A drug-eluting stent exemplifies how a combination product is improving patient outcomes and helping to extend human life. Throughout this special issue, several industry authorities share their insights regarding the impact of combination products on packaging.
Agency speakers also discuss quicker inspections and combination drugs Feb. 16-17 at the new Puerto Rico Convention Center.
At Medical Device Puerto Rico, at least three FDA speakers were not shy about explaining that responsibilities for agency employees were increasing despite budget cuts.
The clearest of these messages was delivered in a keynote address by Gary Dykstra, regional food and drug director for the FDA’s southeast region. He pulled no punches in describing the federal government’s growing financial commitment to homeland security and related issues, presumably at the expense of funding FDA efforts. Dykstra singled out the current administration, saying he hoped change would come with the next presidential election.
At a conference called “Inspection Priorities, Warning Letters & Complaints,” the FDA’s Joseph Puleo noted that the agency “typically gives U.S. companies a week or two advance notice before coming to a plant for inspection.” Of course, this provides a manufacturer time to prepare for the visit, but as Puleo says, “it also benefits the FDA in that it allows them to communicate with the company so that the appropriate plant personnel are on-site for the inspection.”
Combining a medical device with a pharmaceutical to create a drug delivery device (like drug-eluting stents) is fraught with problems, yet it’s a great opportunity for both the device company and the pharmaceutical firm. Devices often perform better, with increased patient compliance and improved medical outcomes.
Pharmaceutical companies capitalize on the chance to take less profitable off-patent drugs and reintroduce them in a new way. Often the smaller medical device firm has to turn to its big pharma partners for help with funding, Food and Drug Administration (FDA) compliance, and so on.
Not only is the road to launching a new product longer, tougher, and more expensive, the actual application of the drug onto the device remains a difficult proposition at full production speeds. Virtual design programs are helping medical device firms conceive new products much more efficiently. Doctors call for more devices to be MRI-compatible, often dictating a change in materials.
