Segmentation and integration aren't opposites at Wyeth. In fact, the company's packaging teams are encouraged to do both.
Wyeth’s vision is “Leading the way to a healthier world.” If recent revenue is any indication, Wyeth’s corporate strategy has led the company to healthy success as a pharmaceutical frontrunner.The company’s 2006 net revenue topped off at roughly $20 billion-a record 9% growth from the previous year-and 2006 revenue from biotechnology products reached $5.7 billion, making it a third of Wyeth Pharmaceuticals’ total revenue. The company’s nutritionals segment is also experiencing unprecedented demand.
Recent introductions like the innovative ClickCase for Lybrel and the SureClick auto-injector for Enbrel show that Wyeth excels at packaging as well as processes. Wyeth’s strive for excellence in design and production drive practices that increase efficiency and foster growth. The inner workings and interplay throughout the company, and within packaging disciplines, provides a blueprint for continued success.
Wyeth’s transformation and its many accomplishments along the way are why we’ve selected them as our Drug Packager of the Year for 2007.
Out of the holding pond
Back in 2002, Wyeth experienced a rebirth when it changed from a diversified holding company to the global pharmaceutical company it is now.What came about as a result of the restructuring was an entirely new growth strategy, with individual business units focusing on specific markets but sharing best practices and techniques across platforms. According to Charlie Portwood, president of Technical Operations & Product Supply (TO&PS), CEO Bob Essner and Chief Operating Officer Bernard Poussot have driven the company’s growth. (Poussot will take over as CEO in January.)
“The vision of these two gentlemen has enabled Wyeth to become a totally integrated pharmaceutical company,” Portwood says.
The global manufacturing organization now consists of four main operational units: Pharmaceuticals, Biotech, Consumer Healthcare and Nutritionals. The growth and integration was achieved through four key strategic initiatives: (1) improving site networks and investing in new plants; (2) building sustainable plants with common policy and practice throughout all plants; (3) implementing operations effectiveness by creating a global manufacturing organization broken down by platforms; and (4) leveraging integrated standard systems.
This strategy is leading the way to a healthier, more integrated research, design, development and manufacturing platform that excels within focused markets.
“This really allowed us to become much faster, agile and focused on those businesses, and to drive improvement much more quickly,” Portwood says. “It’s paying great dividends.” (For an example of how Wyeth runs a facility, see “Operational excellence at work” on p.34.)
The drive for improvement extends to the company’s manufacturing practices and new design processes. Wyeth follows Process Analytical Technology (PAT), a system “for designing, analyzing and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality,” based on the FDA definition.
But the company is going one step above ensuring quality once the product and package get to the production line. Now, Wyeth is dedicated to a Quality by Design philosophy, a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Building quality into the product is integral to packaging development.
Where packaging comes in
With a streamlined development process for new drugs and the integration of functions such as package design into the development process early, Wyeth ensures a smooth and transparent transition into manufacturing.According to Jim Robinson, assistant vice president for global packaging, technology and systems, “Today, we get involved early in the development with primary package design, which has improved considerably over the past five years.”
But because drugs could take years to get through trials and approvals, designing a package early on isn’t always the best tactic. By the time the drug is ready to be launched, newer packaging or delivery systems could have evolved that provide ease-of-use features or decreased production costs. The packaging teams also keep close tabs on the competition right up until a product launch to make sure they provide a compelling point of difference.
For the Biotech business unit, the packaging team is trying to get involved earlier on and become part of the lifecycle management programs for drug development. According to David Linton, senior director of biotech technology and engineering for drug products, the team starts planning packaging as far ahead as five years before launch. The earlier the packaging units get involved in research and design, the less chance they’ll run into stability issues down the road.
Being first to market, though, is a constant challenge, and often results in subsequent changes to modify or replace the packaging.
“We typically start out with a package that will get the product out to market the fastest, but that might not necessarily be the most convenient system for the patient,” Linton says.
Convenience and ease of use are prime considerations, though. Portwood says, “We work hard to make sure that products are packaged in a way to be more user-friendly.” (For details on some of Wyeth’s recent packaging innovations, see “Wyeth makes packaging easy to look at, easy to use” on p.30.)
Research is hands-on. “We first ask, what are the patient needs? How will the package be used? What environment will it be used in?” says Jim Powers, senior director, global packaging technology and engineering for pharmaceuticals. “We often take trips to hospitals and doctors’ offices and talk to the health care practitioners.”
Once they have customer input, they go to work in a systematic, efficient way. Wyeth has formalized its packaging design process so that engineers follow a logical path of development. “People tell you that designing a package is more an art than science. I disagree,” Powers says.
Wyeth’s formal process ensures consistency, accuracy and creativity. “It’s not a process developed to limit creativity. It ensures and builds robustness into the development process. If I had 20 engineers and gave them each the same project, some designs might be similar, but I’d get a lot of different ones,” Powers says. His point is that going in with no ground rules squanders resources.
With this system, they’ve been able to save time and effort. “We’re not repeating the same tests for every pack,” says Powers. They are able to share information from one similar project to another.
Material considerations
The complexity of the drugs themselves often dictate the type of packaging material required for global distribution to protect the product physically, as well as for efficacy. It’s a matter of controlling the environment, inside and out.According to Jim Regan, senior director of global packaging for consumer health, the teams often look for better materials to perform in countries where high heat and humidity are constant factors.
“We’re collaborating a lot closer with leading packaging suppliers,” Regan says. “It’s a matter of getting the right material for the product and proving stability as quickly as possible to get products to market.”
As Portwood mentioned earlier, one of Wyeth’s strategies is to leverage standards across the company. Accordingly, the business units have worked hard in the past few years to standardize their packaging components. For example, by standardizing bottle types, Wyeth was able to reduce its number of suppliers nationally and globally.
Collaborate, communicate
With so much activity at the company, constant communication helps keep everyone connected. Aside from knocking on each others’ doors at the headquarters in Collegeville, Pa., the packaging departments have an annual Packaging Technology Networking meeting during which they share best practices. They also participate in a quarterly conference call.In between regularly scheduled events, colleagues use multiple computer support systems as needed:
• The OEnet (an intranet site for operational excellence) allows employees to post questions and get answers in real time. “This has become a powerful tool for us,” Powers says, “because it allows us to tap into the experience and knowledge of all employees.”
• On a day-to-day basis, the packaging teams use a specification system to communicate and share information. The system has the capability of storing, tracking, retrieving and editing documents on a variety of platforms. It also includes strong security features so Wyeth can uphold strict quality control measures and follow regulatory compliance.
Wyeth is constantly engaged in finding the best practices and making sure the benefits of implementation reach all business units.
The future's prescription
Now that it has momentum, the new integrated Wyeth expects to achieve some impressive goals. In the coming years, customers can expect to see significant growth, especially in biotech and nutritionals.“Launching one new product is a challenge, let alone multiple products,” Portwood says. “And the second challenge is doing it better every time, improving our processes to develop robust drugs right from the beginning.”
Securing product security
The pharmaceutical industry as a whole is struggling to deal with an incredible growth in incidences of counterfeit products, and Wyeth is no exception.Recently, Wyeth created a special Global Product Security Office and this group is responsible for developing global standards for managing reports of suspected counterfeit products.
Additionally, the company is:
• Taking steps to reduce the risks of Wyeth products being counterfeited and to allow for easier identification of counterfeit products;
• Educating employees, patients, health care providers, pharmacists and customers about Wyeth products and the risks of counterfeit products; and
• Collaborating with suppliers, distributors, trading partners, pharmacists, health care providers, lawmakers and regulators to maximize the Global Product Security program’s effectiveness.
They are currently testing and implementing various track-and-trace and anti-counterfeiting packaging technologies. Based on the global nature of Wyeth’s businesses, the group has an increased challenge to develop different solutions based on country-specific regulatory requirements, geographic distribution and primary package types.
For the American market, where most pharmaceuticals are packaged in bottles, the focus is on track-and-trace technologies such as radio frequency identification (RFID) or two-dimensional bar codes that can follow an individual package from point of manufacture to the dispenser level. The track-and-trace effort also involves the creation of an electronic pedigree to assure against counterfeit product entering the supply chain.
In Europe, where the blister pack is the preferred solid dose package, the emphasis is on point-of-dispense authentication to reduce the possibility of counterfeiting and reimbursement fraud. So the solutions there are more focused on bar coding technologies.
