~ Devendra Mishra, Executive Director, Bio Supply Management Alliance (BSMA)
The holistic value of supply chain management has evolved in a quantum leap over the last sixty years when Jay Forrester, professor emeritus in the MIT Sloan School of Management, proposed system dynamics as a precursor to supply chain management. His first book Industrial Dynamics published in 1961 presented how system dynamics analyzed industrial business cycles and dealt with the simulation of interactions between objects in dynamic systems. Arising from a project with General Electric, he wrote about the expanding effects down the supply chains due to fluctuations in demand, thenceforth known as the “Forrester effect” or bullwhip effect. Forrester’s systems view of an industry became the nexus of supply chain management.
~~ Getting Patients a Drug That Works
October 25, 2017
MENG, Keck Graduate Institute
Supply chain integrity is a fundamental component of effective patient treatment. The 10th annual Biosupply Management Alliance Conference highlighted many challenges and solutions in this space.
Thermal and vibrational shocks were singled out as major sources of deviation and product loss. Biologic therapeutics can undergo irreversible changes that reduce or eliminate their effectiveness if they are exposed to temperatures outside an acceptable range. Per CargoSense’s presentation, temperature deviations within the supply chain inflict $35 billion of losses on the pharmaceutical industry each year. Excessive physical stresses from handling and movement can similarly impact product integrity in transit. According to UPS’s presentation, drug product can be subjected to over 100,000 shocks from tarmac vibrations in a single shipment and these shocks are the greatest source of product loss in the pharmaceutical supply chain.
Oct 18, 2017
When the Bio Supply Management Alliance (BSMA) was born a decade ago right here in the Bay Area, the goals were lofty: create a worldwide community of operations and supply chain management leaders and professionals in the biotech, biopharma, and biomedical device industries. Since then, I’ve been overwhelmed by the growth and success of the global industry, and in particular, the role that California and Silicon Valley have played in its success.
Not surprising then that I didn’t have to look far to find keynote speakers for our 10th annual conference in Foster City. Supply Chain executives from Kite Pharma, Illumina and Roche shared case studies that reinforce California’s leading-edge in employing new technologies that are rapidly advancing how life-saving products are being produced and delivered.
BSMA Conference Report
October 17, 2017
Master of Engineering, Biopharmaceutical Processing 2018
Keck Graduate Institute
As a graduate student studying various process developments and manufacturing platforms, I never looked into what happens to my drug product afterwards. I naively assumed shipping the product to the pharmacies and hospitals around the world was the easiest step. The BSMA conference was beneficial in that it gave me a snapshot of what supply chain is, current problems plaguing the industry and stakeholders involved.
As biopharmaceutical process engineers-in-training at KGI, most of us are only exposed to the R&D, process development, quality and regulatory features of the industry. I’m sure that the other BSMA conference attendees in my cohort would agree that the experience has really opened our eyes to the supply chain aspect of the biotech industry. The supply chain was something we took for granted and therefore overlooked, but clearly it is one of the most important aspects of the industry. Simply put, the supply chain is the bridge to the people that the industry serves. Here are some of the key take-aways that stood out to me during the conference:
Addressing Global Risk and Opportunities
Response to regulatory uncertainties and rapid innovation in the global supply chains for temperature-controlled medicines were highlighted at the 8th Annual Conference of the Bio Supply Management Alliance (BSMA). Although much attention was naturally placed on large molecule biotech drugs, several speakers made the point that every product has prescribed temperature ranges, even tablets shipped at “ambient temperatures”. A veteran of the cold chain industry, Douglas Wettergren of Envirotainer remarked, “This was our seventh year attending the BSMA fall event and this was by far the largest one in terms of delegate attendance. It is nice to see the interest grow as this is my most valued and favorite industry show of the season. BSMA sets the bar as the best opportunity to network with executive level decision makers in the Biotech industry.” (more…)
Innovations to Meet Regulatory Requirements, Reduce Costs, and Improve Efficiency
Calabasas, November 12, 2015. The 2015 Bio Supply Management Alliance (BSMA) Conference met in Foster City, CA at the Crowne Plaza Hotel. Executives from over 40 biopharma companies addressed challenges and exchanged solutions for Clinical Supply Chain Management which poses one of the biggest challenges for supply chain managers in the biopharma industry. The fundamental takeaway for the clinical supply professionals was that growth in the number of trials, increased compliance and the global scope of trials, are spurring companies to automate outdated paper-based or spreadsheet based clinical supply chain processes. Based on detailed global surveys of clinical sites, vendors and sponsors have a great deal of improvement to help their sites be more successful. Presenters cited compliance issues – frequent production, protocol, formulation or labeling changes; multiple clinical sites; and, end-to-end clinical supply chain issues stretching all the way to the patient; as the biggest challenges (more…)
Foster City, CA, November 3, 2015: When the 2015 Bio Supply Management Alliance Conference met in Foster City, CA on October 15th this year, every supply chain professional in attendance was in agreement about one thing. The way that we think about and approach the career path of young professionals in biotech hoping to move up the supply chain management ladder is fundamentally flawed. (more…)
Foster City, CA, October 29, 2015: The 2015 Bio Supply Management Alliance Conference met in Foster City, CA at the Crowne Plaza Hotel. The 240+ members in attendance heard a broad spectrum of speakers address the major issues confronting supply chain executives in the biopharma industry, namely genomics-data-driven incubation, improved processes in the end-to-end supply chain of this highly regulated industry, and SCM innovations and technologies driving dramatic changes. The collaboration between BSMA and the Council of Supply Chain Management Professionals (CSCMP) produced a town-hall-like environment at the extraordinary summit of professionals. (more…)
The biopharmaceutical sector is rapidly evolving – can your supply chain keep up?
By Prashant Yadav, Director of Healthcare Research at the William Davidson Institute, and faculty member of the Ross School of Business at the University of Michigan, USA ~ published in “The Medicine Maker” June 26th, 2015
The biopharmaceutical industry is undergoing a striking transition. In developed markets, one-size-fits-all medicine is being replaced with higher-efficacy treatments for targeted populations. In emerging markets, a burgeoning middle class and larger public investments in healthcare infrastructure are resulting in rapid growth of the pharmaceutical sector. In some developed and emerging markets, reimbursement lists favor domestically produced pharmaceuticals, making local manufacturing a requisite for market entry. Smaller target markets for each molecule; volatility in regulatory and political environment in emerging markets; and stronger payer influence in developed markets are resulting in more frequent changes in commercial decisions. All of these trends are stepping up pressure for speed, flexibility and reliability in the pharmaceutical supply chain. (more…)