The convergence of scientific discovery, computing technology, the regulatory framework, and supply chain management intersected at the Bio Supply Management Alliance conference. Industry supply chain leaders gathered to learn the best practices and new approaches to achieve improved operational results.
Devendra Mishra, Executive Director of the Bio Supply Management Conference, opened the just concluded conference by stating, “This industry is obviously driven by scientific discovery, but also by technology advances and supply chain management. As an industry, we are of course subject to extensive governmental regulations.”
The opening plenary session, a panel titled “Dealing with Change,” featured industry veterans Mark Buck, Global Supply Chain & Procurement, Bio-Rad Laboratories; Susanne Somerville, VP, Regional Head, North America Supply Chain, Genentech; Kevin Pegels, VP Global Supply Chain Management – PS Biotech, Bayer; and Richard Dawe, Professor, Ageno School of Business, Golden Gate University. Moderated by Wayne McDonnell, Pharma and Life Sciences Advisory at PwC Consulting, each panelist identified the big changes impacting them and methodologies to effect change in their company. Mr. Buck and Mr. Pegels both pointed to the frantic pace of new product introductions and the impact of data in the supply chain. Pegels noted four big change factors at Bayer, “A rich pipeline of products that translates to future growth; emerging markets projected to reach 50% of sales within 5-7 years; the transition from in-house production to CMOs; and regulations, particularly translating RFID and serialization requirements into positive ROI.”
Providing the ultimate insight into the status of California’s e-pedigree law, Virginia Herold, Executive Officer, California State Board of Pharmacy, said, “Our next step occurs on October 25, at the conclusion of the current 45 day requirement for public comment and our regulatory framework will then be in place.” Of her many insightful comments, she particularly noted, “Illegal and otherwise compromised drugs come from a very complex network of wholesalers, retailers, and various brokers. Their activities compromise patient health and cause lost revenue for the original manufacturer.” She also updated attendees on the regulatory status of the e-Pedigree law and said, “We don’t know if Congress will pass an e-Pedigree law that will supersede the California law. Until that happens, we’re proceeding with the regulatory process.”
The third plenary session focused on Big Data Analytics presented by David Wiggin, Program Director, Healthcare and Life Sciences, Teradata. His presentation focused on “Analytics 3.0”, the new combination of Big Data and Advanced Analytics and their impact on the biopharma supply chain. He cited four examples of cases that included Global Supply Chain Visibility, Demand Signal Response, Supplier/Vendor Management, and BoM Track-and-Trace. Expanding on Ms. Herold’s comments, he said, “Implementing BoM track-and-trace reduced market share losses from 12% to 0% and field service costs by 7%.”
In the final plenary session, Friedhelm Lotz, Partner and Audit Practice Leader, Global Risk Experts AG presented profound insights into the methodology to assess and mitigate supply and distribution risks. He compared visual images from high-risk API vendors with GMP compliant facilities, leading him to state, “The Compliance/ Performance divide in API factories can be quite significant because compliance typically focuses on paperwork issues, records, and contractual terms. Unfortunately, actual shop-floor performance often reflects questionable record keeping practices and increased physical risks.”
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