"A very broad-based steering committee of industry executives has embarked upon addressing one of the most formidable challenges faced by the industry, namely management of risk in the end to end supply chain,” says Devendra Mishra, the Executive Director of BSMA and adjunct professor of Pepperdine University’s Graziadio School of Business & Management. “The leaders have demonstrated that achieving resilience in the supply chain while optimizing risks and rewards requires a collaborative effort amongst the stakeholders."
Chris Sam, chairman of the Risk Management Steering Committee observed, “We share a universal mission of supplying life-saving drugs to grievously ill patients. To do this, we strive to make supply as perfect and reliable as possible, in ensuring drugs and medical devices are safe, efficacious, secure, and delivered in a timely manner to patients. The patient-focused supply chain is perhaps more complex today than it has ever been, from raw materials that may be sourced on multiple continents, to global manufacturing that may be done in several stages around the world, to transporting these sensitive drugs through a complex, rapid distribution network of patient populations that are truly global.”
“All of this happens seamlessly and relatively invisible to patients, as it should. Their focus has to remain on getting better,” says Sam. “We do this by carefully evaluating and managing risks inherent in a complex supply chain, to ensure the weakest points in this chain are clearly identified and understood, with mitigation plans in place to ensure we can serve every patient, every time. This is an unyielding expectation of our patients, regulators, and investors. The Risk Management Steering Committee is made up of a truly talented group of professionals dedicated to continuously improving the industry’s management of supply risk, to ensure we can keep this complexity in check by managing risk in supply, seamlessly and invisible to patients”.
The Risk Management Steering Committee members are:
Chris Sam, Chairman, is the Executive Director of Craigshannock a Management Consulting firm providing enterprise, strategic and Operational Risk services. Prior to Craigshannock Chris led Amgen’s Operations Risk Management organization since its inception in 2006. Chris’
Ron Bone is the Senior Vice-President of Distribution Support at McKesson Pharmaceuticals. Ron has spent 38 years with McKesson Corp. in various operations, sales and financial management positions. His responsibilities include regulatory affairs and leading the company's product security initiatives through the use of electronic track-and-trace using RFID and Barcode technology. Mr. Bone is a member of the Leadership Teams of GS1 Global Healthcare and GS1 US Healthcare and a Member of the Industry Relations Council of HDMA. He received his Bachelor of Science and MBA degrees from San Jose State University.
Arun Cavale is a founding principal at NexInfo. He leads the Supply Chain and Manufacturing consulting practice. Arun provides thought leadership in the areas of Forecasting, Demand Management, Supply-Chain Planning and Risk Management. An active member of OAUG, APICS, IBF and other Supply Chain Organizations and is a recognized speaker on supply chain performance improvement issues.
Fred Gvillo blends strong business acumen with an appreciation of science and exceptional interpersonal skills, Fred is a master in the art of balancing science with the business of R&D. He has worked in Global Research Administration for Schering AG; Business Development / Alliance Management with Codon; Supply Chain Management for Berlex Biosciences;
Lewis T. Kontnik is Director of Brand Protection for Amgen. Mr. Kontnik leads Amgen’s Brand Protection program, a part of the company’s Operations Risk Management function. In this role he developed and leads the company’s functionally based global program responsible for fighting illegal counterfeiting, diversion and other brand attacks. He also leads the company’s serialization and pedigree regulatory requirements activities. He served as a founder and chief technical consultant to the www.SafeMedicines.org partnership, consulted with the US Food and Drug Administration, World Health Organization and has spoken internationally on a various anti-counterfeiting topics. He is a member of the Washington, D.C. bar.
Jane Lavine has spent 20+ years in the insurance and risk management industry focusing on emerging life science companies. As Client Executive for Life Science clients, she was responsible for consultative risk management analysis. She holds a Masters degree in Finance along with CPCU, ARM and CFE designations.
Michael Mooney is Director of Risk Management & Insurance – America’s for Expeditors, niche specialists in the supply chain risk management business helping customers build security, visibility and resilience into their existing supply chains. Michael is a graduate of Santa Clara University in finance. Michael also received his Associate in Risk Management Designation and is currently enrolled in the Executive MBA program through Seattle University.
MS Sikka is the founder and CEO of Sensitel, Inc. MS leads Sensitel's strategy and execution with the twin goals of reducing cost of product recalls and securing global supply chains. Prior to Sensitel, MS was Senior Director of Operations for NaturipeFarms, the largest Blueberry supplier in US. MS is also the founder of RFID Security Alliance. Mr. Sikka graduated as a Master of Manufacturing Engineering from Boston University and received his B.S. in Manufacturing Engineering from Indian Institute of Technology (IIT), Kharagpur. MS is an avid runner and recently ran the Marine Corps Marathon in Washington D.C.
Tom Smith is Director of Supply Chain / Materials Management for Shire Human Genetic Therapies where he is the corporate supply chain leader of Materials Planning and Purchasing, Supply Chain Systems, and Warehouse Operations. Tom leads the assessment and development of a Raw Materials Risk Mitigation program to address business risks introduced by single and sole source suppliers to Shire HGT’s Drug Substance supply chain. Tom is engaged in re-engineering the internal supply chain planning processes that drive the company’s internal manufacturing operations. Tom holds an MBA from Babson College.
Yingming Yue, CPIM, is the Associate Director, Supplier Management with Nektar Therapeutics, a leading biopharmaceutical company with a robust pipeline of novel therapeutics. Prior to Nektar, He was an operations consultant with Deloitte Consulting and Pittiglio Rabin Todd & McGrath (PRTM). Mr. Yue received an MBA degree from The University of Chicago and MS in Applied Chemistry from Tianjin University. He also attended Operations Management Program from University of Texas at Austin. Yingming Yue is certified in Production and Inventory Management (CPIM) by APICS.
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About the Bio Supply Management Alliance
The Bio Supply Management Alliance was born of the need to create a worldwide community of operations and supply chain management leaders and professionals in the biotechnology industry. Based in the San Francisco Bay Area, home to more than 600 biotech firms, the Alliance provides a forum for collaboration, learning and best practice sharing of practitioners, executives and thought leaders in these uniquely demanding industry sectors. Founders Tim Salaver and Devendra Mishra have forged relationships with key industry leaders and defined initiatives with a vision to create process, people, and policy improvements in this vital sector. Because life depends on us, the Bio Supply Management Alliance supports B2B networking, continuous learning and career improvement of bio supply management professionals.
For more information, go to http://www.biosupplyalliance.org.