Though most pharmaceutical manufacturers have been primed on basic serialization timelines and expectations, there are many serialization challenges unique to contract manufacturing organizations (CMOs).
Because CMOs are service providers to pharma companies, the lines between the two parties are blurred in terms of financial and data management responsibilities. In the interest of improving understanding across the industry, Optel Vision and Supply Chain Wizard LLC hosted a first-of-its-kind Serialization Roundtable for CMOs in Philadelphia.
The event was created to introduce CMOs to available IT technologies, best practices, financial advice and lessons learned. More than 100 attendees representing 65 CMOs, pharmaceutical manufacturers, and suppliers, including Novartis, Mylan, Domino Amjet and Apace Packaging, met to listen to educational presentations and participate in roundtable discussions to promote communication across the industry.
Keynote speeches by Teva’s Vivian McCain and Par Pharmaceutical’s Aladin Alkhawam emphasized the need for speed as the November 2017 deadline approaches, as well as the challenges they face in working with CMOs and implementing serialization across multiple sites, respectively.
McCain candidly spoke of what makes a CMO stand out, including proactive communication with manufacturers, explaining, “When CMOs reach out, it sends a strong message.” He also brought up the elephant in the room—Who should pay for serialization implementation?—and advised that CMOs factor in time for efficiency losses upon implementation.
Alkhawam’s challenge mitigation tips included partnering with consultants to fill gaps in resources and maximizing efficiency across lines as much as possible by standardizing documentation like functional and design specs, and then rolling them out to individual sites.
The unanimous crowd favorite was the roundtable discussion section facilitated by leaders from Teva, Apotex, Actavis, Par, and Supply Chain Wizard. Attendees were broken out into small groups and assigned one of nine topics to discuss, including IT connectivity, master data management, and CMO serialization readiness. The multi-disciplinary groups worked through lists of questions, with facilitators presenting the key talking points at the close of the event.
People of varying serialization readiness felt the roundtables were a great way to voice concerns and lessons learned, and work together in teams of manufacturers, CMOs and suppliers. One attendee who has recently begun serialization efforts remarked, “I thought the event was great. It was good to see competitors come together and share ideas. That’s not something you see every day, competitors helping each other solve problems.”
Regulations: Priya Gopal, Senior Consultant at Supply Chain Wizard, cleared up some requirement ambiguities in the U.S. law, and explained the pros and cons of adding aggregation now (which is not a requirement until 2023). In addition to some global requirements and increased visibility, “It helps with recalls and returns, but how well your technical operations team is connected to your trade operations team will govern how important it is to add now.”
Strategy: Supply Chain Wizard CEO Evren Ozkaya made a moving speech about the spirit of law in promoting patient safety, and revealed the benefits of the unprecedented visibility that serialization provides. “How you turn this risk into opportunity is up to you.”
Packaging and Financing: Optel Vision’s JP Allard talked about the equipment challenges specific to CMOs who must package, label and aggregate multiple packaging sizes for different customers. Optel Vision CEO Louis Roy empathized with CMOs who are tasked with investing in costly implementation, for which they won’t profit for several years and offered potential step-by-step solutions as well as financing advice.
IT Connectivity: Burak Tiftikci, Managing Partner, Supply Chain Wizard shed light on the key exchange data and the ways that CMOs can connect with customers. He advocated for early involvement of the IT team, along with extensive training so that they can resolve issues once lines are running.
Optel Vision and Supply Chain Wizard are leading an effort to foster collaboration across the industry in the face of regulatory demands and safety concerns, and already have plans for the 2nd Serialization Roundtable for CMOs in Frankfurt on February 4, 2016