Unlocking speed to market with tenured talent and strategic planning
Within the pharmaceutical industry, manufacturers rely heavily on third-party logistics (3PL) providers. All pharmaceutical distribution is both complex and highly-regulated; it’s even more so for certain specialty therapies, with very specific compliance procedures and requirements for temperature-controlled handling. With a 3PL provider, manufacturers can leave the intricate logistics management in the hands of experts who can help ensure the safe storage and handling of products, as well as timely delivery. A 3PL provider also can optimize a manufacturer’s supply chain operations and help minimize costs.
Based in La Vergne, Tennessee, the Cardinal Health 3PL Services and Packaging Solutions (CHPS) team brings supply chain solutions to the biopharmaceutical manufacturers we support. From a dedicated team of problem-solvers and account managers to experts in distribution, transportation, regulatory and international services, we take care of logistics behind the scenes so biopharmaceutical manufacturers can spend more time dedicated to bringing their life-saving therapies to market.
Joel Wayment, vice president and general manager of the 3PL and CHPS team, understands the challenges that come with navigating the complexities of the pharmaceutical manufacturing industry. Whether it’s logistics, billing, distribution or regulatory compliance, he and his team take into account the many variables and unknowns to help reliably get products into the hands of those who need them most. As manufacturers’ needs evolve, the 3PL and CHPs team is structured to scale with them to deliver reliable logistics solutions.
“There’s a real benefit of having packaging solutions and 3PL services within the same organizational structure,” Wayment said. “Having the two functions working hand-in-hand improves efficiencies, paves the way for strategic planning, and provides a one-stop-shop for manufacturers when bringing a therapy to market. At Cardinal Health, our packaging and 3PL facilities have similar processes and standards, and are geographically close, so there are fewer touchpoints for supply chain disruption.”
With deep foundational knowledge, industry regulation expertise and product understanding, the 3PL and CHPS team works closely with biopharmaceutical manufacturers to develop a supply chain plan that determines materials, suppliers, vendors, transit details and potential roadblocks. Each manufacturer’s packaging plan is based on the unique packaging and labeling needs of their new product. It includes a serialization plan that complies with the Drug Supply Chain Security Act (DSCSA); a channel strategy plan that aligns potential customers and establishes required contracting in advance; and a comprehensive launch plan that outlines roles, responsibilities and timelines surrounding the drug’s market debut.
Supporting manufacturers every step of the way
Our 3PL experts also consult with manufacturer customers to help them understand how Food and Drug Administration (FDA) regulations and requirements can impact the timing of getting new therapies to market, so that they can plan accordingly.
For example, the DSCSA (mentioned above), is slated to go into effect in 2025. It requires that certain prescription drugs can be traced at the package level throughout the supply chain and is designed to help prevent harmful drugs from entering the U.S. supply chain and detect harmful drugs if they do get into the supply chain. Wayment’s team consults with our manufacturer customers to not only help ensure they meet DSCSA requirements before bringing their product to market, but afterward, as well. Learn more here about how our team helps streamline DSCSA compliance strategies.
Another FDA regulation that impacts the pharmaceutical industry is the Prescription Drug User Fee Act (PDUFA), which was established to help expedite the FDA’s review process. (It was first established in 1992 and recently reauthorized to extend through 2027). The PDUFA gives pharmaceutical manufacturers the assurance of a 10-month approval timeline (in most cases).
The PDUFA date is the estimated deadline set by the FDA to review a New Drug Application (NDA) or Biologics License Application (BLA) and make a final decision on marketing approval. During this 10-month approval process window, the 3PL and CHPS team works with manufacturers on all the steps to prepare for commercialization prior to receiving final approval.
“We set up weekly and even daily meetings with our manufacturing partners as we approach the approved launch date,” said Wayment. “This is so critical: the communication commitment and coordination ahead of every new drug launch helps ensure that everyone involved is fully prepared."
Our 3PL and packaging team consults with manufacturers whenever they are ready to launch a product, but having a PDUFA approval date in place to work toward helps set the pace of the project. The team provides consultative support to help manufacturers strategically plan for when their product is approved, so they can bring it to market as quickly as possible, often within seven days. We set product launches up for success through a coordinated, comprehensive plan that takes into account any potential hurdles.
“When navigating PDUFA-approval timelines, our team goes above and beyond to help ensure manufacturers are equipped with the resources and capabilities they need to bring a product to market,” Wayment said. “Our team is tenured, knowledgeable and dedicated to supporting the manufacturers’ product as if it were our own.”
An expert on the team shares her perspective
The 3PL and CHPS team works closely with these manufacturers, integrating their culture, values and mission into each step of the strategic planning process and adapting to their needs based on the full spectrum of the supply chain along the way.
Claire VanWormer, senior implementation consultant, on the 3PL and CHPS team, plays a critical role in helping manufacturers get their products to market.
“Our packaging experts handle primary and secondary custom packaging for pharmaceutical manufacturers,” said VanWormer. “A typical day for me in this space requires a dynamic blend of planning, coordination and problem-solving. Seeing a product go from concept to reality, and helping customers overcome obstacles along the way is very meaningful. We know that the work we do every day is ultimately helping to improve patient care and patients’ quality of life.”
The 3PL and CHPS team offers primary packaging solutions for manufacturers that include bottling services and physician sample packaging; with secondary packaging solutions focused on cartons, kit assembly, medical device packaging and more.
“Manufacturers trust us to bring their products to market, and it is most satisfying seeing the excitement and pride once their product has launched, especially as we help them navigate the hurdles along the way,” said VanWormer.
Wayment added, "Our team brings sustainable solutions across the biopharmaceutical supply chain, as well as a deep passion for what we do to serve our customers. We understand that the work we do is key to Cardinal Health's journey to become healthcare's most trusted partner."
Note: You can view a recent Cardinal Health study to learn more about how our team members aim to set the industry standard by helping biopharmaceutical manufacturers get product from FDA approval to patient in just seven days.