Visit a trade show with conferences and exhibits and you’re likely to hear speakers offer the seemingly obligatory thank you to sponsors, with encouragement to visit their booths. At the 11th Annual Cold Chain GDP & Temperature Management Logistics Global Forum held at Chicago’s McCormick Place, presenters throughout the day on Oct. 2 made it a point to acknowledge that these vendors are actually driving technology, leading the way for pharmaceutical/biologics/medical device manufacturers, continuing a trend Healthcare Packaging has seen in recent years.
Conference Chairman Rafik H. Bishara, PhD, Technical Advisor and Leader of the Parenteral Drug Assn.’s Pharmaceutical Cold Chain Interest Group (PCCIG) noted that pharmaceutical/biopharmaceutical firms for years were seen as the leaders in providing technologies, and many continue to view themselves as such, yet he said it was the suppliers that were now taking the lead in many instances.
“Suppliers have really stepped up. The vendors are now the experts, not necessarily the pharmaceutical companies,” noted Jeff Seeley, Sr. Manager Cold Chain Technology, GMS Packaging Services, Packaging Technology & Innovation with Pfizer Inc.
In fact, supplier input in developing documentation was welcomed by Mary Foster, U.S. Pharmacopeia’s Chair Expert Committee, Packaging, Storage and Distribution of Drug Products. Foster’s presentation, “New Direction for USP on Supply Chain and Drug Distribution,” noted that the Pharmacopeial Convention continues to seek experts in a variety of distribution, logistics, and packaging functions to help write meaningful chapters of knowledge to help industry.
She said that there needs to be input from suppliers to help end-user companies, with that input provided in an informative, noncommercial way.
Foster’s presentation was moved up to fill in a gap created when a scheduled presentation by a U.S. Food and Drug Administration member was cancelled, presumably due to the government shutdown.
Among other takeaways from Oct. 2 sessions were the following:
• This year’s event included 720 on-site attendees and approximately 80 vendor exhibitors.
• Speaker Riekert Bruinink, Group Chairman of the PIC/S GDP Working Group, and Member of the EMEA GDP Drafting, Dutch Health Care Inspectorate, noted that the European Union now includes 28 “member states” with more than 500 million people.
• Foster pointed out that USP is making every effort to make sure it focuses on future industry needs and does not replicate existing efforts by other organizations. “We need to better understand who uses USP and add value for them.” She hinted the organization would look into Internet pharmaceutical sales as a possible subject for a future chapter.
• In a panel session, David Ulrich, QA Director—Distribution & Supply Chain Strategic Quality Initiatives with AbbVie Inc., noted that over the years he’s continued to see regulatory bodies from different countries “holding hands” in terms of coming closer to looking for similar controls and documentation. He said there’s a need for manufacturers to provide supporting proof to various ministries that their product that is going to the patient is safe and efficacious.
Typically at pharmaceutical/biologic-centric trade shows/events, attention is given to the manufacturer-to-distributor link in the supply chain, with more limited discussion given to what some refer to as “the last mile” of distribution, when a medicine gets to the patient, be it at a hospital bed or to a patient’s home.
Because this final step may be beyond the control of many in the traditional supply chain, it’s understandable why this “last mile” can be so vexing. In her presentation, “Direct to Patient Home Delivery—Is it the Logistical Solution for Multi-Country Trials?” Ariette Van Strien noted, “There are no regulations out there covering the last mile.”
Van Strien, Senior Vice President Commercial Operations for Marken, said that this DTP (direct to patient) segment would continue to grow rapidly. Much of this growth, she said, is expected to come from large-molecule biologics, vaccines in particular, “which are temperature-sensitive.” Leading the way, according to Marken research, will be the growth of orphan drugs.
Van Strien said that by 2018, 23% of the top 100 products in this sector will be biologics, representing a notable 51% of market value. She said FDA is helping to push rapid development of these therapies through the clinical trial stage as a way to benefit patients requiring treatments for specific diseases.
Orphan drugs will need to be shipped DTP, often to remote rural areas around the globe. “DTP delivery makes it easier for patients to participate in clinical trials because they won’t need to travel to receive treatment that could benefit them. These products raise the complexity of temperature-controlled distribution throughout the supply chain, yet make it more likely that patients will stay in a clinical trial and benefit from the treatment,” she said.