BSMA Launches SCM Initiative for Molecular Diagnostics Testing Industry

Mike Crowell

Mike Crowell

Calabasas, CA, July, 18, 2013: The Bio Supply Management Alliance (BSMA) has appointed Mike Crowell as the Chairman of the “Molecular Diagnostics Testing” strategic steering committee in order to enable sharing of best supply chain management practices, technologies, governmental regulations and market opportunities in a rapidly growing market.

Devendra Mishra, Executive Director of BSMA, stated, “The market for molecular diagnostics is fragmented with more than 500 companies where 98% of them could benefit from being members of a community that shared best practices of supply chain management. Molecular diagnostic tools have a vast base of end-users, which includes hospital-based laboratories, reference laboratories, and others (physicians’ labs, research laboratories, other healthcare clinics, and government agencies. In order to achieve low product cost, high quality, compliance with governmental regulations, speed to market and customer service, companies must take a holistic view of the supply chain. We have Mike Crowell with over 20 years of leadership experience in supply chain management within the life sciences industry, currently with Verinata Health, an Illumina Company, heading the industry initiative.”

Mike Crowell pointed out, “The goal of the steering committee is to build a community of professionals dealing with supply chain matters in the LDT/CLIA diagnostic service testing markets. The unique regulatory and commercial challenges typically faced by these smaller and leaner enterprises still require a level of supply chain maturity to ensure that value is added and that the end customer, the patient, is receiving the highest quality in therapy guidance in a timely manner.” 

Mike Crowell, prior to Verinata Health, served as Director of Global Supply Chain at Tethys Biosciences and Monogram Biosciences, responsible for strategic sourcing, global logistics, planning, and inventory management. Prior to Monogram, Mike held positions of increasing responsibility in SCM functions at Athena Neurosciences and Elan Pharmaceuticals. Mike holds an MBA from UCLA Anderson School of Business and an MBA with Asian Pacific focus from the National University of Singapore. Mike holds a Certified Professional Supply Management (CPSM) and Certified Purchasing Manager (C.P.M) designation from the Institute of Supply Management. Certified in Inventory and Production Control (CPIM) from APICS, he holds a Global Logistics Specialist (GLS) certification from the California State University Long Beach. 

Crowell explained further that “One of the largest differences from a traditional manufacturer or distributor Make to Stock planning model is that the diagnostic testing environment often operates in a Make To Order environment. One never truly knows the level of demand until it arrives at the lab for testing. Today’s diagnostic labs and their supply chains require agility to respond to these higher levels of variability in demand while still being responsive enough to meet rigorous market driven turnaround time requirements. When you add to that the inherent variability in process steps due to human biology, the diagnosis testing lab oftentimes requires a different and evolving toolkit for supply chain success. Utilizing pull based replenishment techniques, administering Client kit vendor managed inventories, and proactively managing inbound sample logistics are just some of the strategies used to help balance supply and demand in such an environment.” 

Frost and Sullivan estimates that worldwide sales of molecular diagnostics, growing with a CAGR of 19 percent, the global molecular diagnostics market is expected to reach US$15 Billion by 2014. The fastest growing segment is infectious disease with 21% market share, as the dominant segment. The next 7 top applications of molecular diagnostics testing are for Infectious Disease, Blood Screening, Oncology, Genetic, Tissue Typing, Cardiovascular Disease, Neurological and Food Pathogen Detection. Approximately 800 medical laboratories—600 hospital and 200 independent—now perform high-volume testing requiring automated molecular diagnostic testing platforms and systems for simplifying and accelerating specimen preparation.

Factors like increase in awareness and acceptance of personalized medicine, advancements in molecular techniques, and increasing investments in genomics & proteomics research is spurring the molecular diagnostics market. Yet, reimbursement issues for non-coded tests and complex regulatory framework may restrict the growth of this market.  

REQUEST: Please contact Mike Crowell to get involved with this biotech industry initiative and if you wish to receive information.

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