· How Pharmaceutical Supply Chain Security and Material Quality Insects During a Pandemic
Jim Fries (CEO Rx-360)
· Essential Elements of Supply Chain Security Audit
Anthony Yan (Takeda)
· The APEC Supply Chain Security Toolkit
Reggie Jackson (Pfizer) and Tony Zook (Merck)
· The value of Remote Auditing
Jaye Greene (Rx-360)
Jim Fries is a success based executive with over 25 years of experience building medical device and diagnostic companies from a sales, market access, and external validation standpoint. Jim became CEO of Rx-360 in February of 2018, as a way of fulfilling his personal lifelong commitment to patient safety. Jim’s backgroud includes, product development, FDA pathways, market access, and strategic collaboration initiatives.
Jim’s strategic vision, fit well with the Rx-360 Mission of supply chain security and pateint safety. His roll up the sleeves mentality, is creative and has been proven as a best practice in achieving both short and long term goals. Jim’s leadership style has consistently been described as collaborative, mentoring, and accountable.
Jim, has successfully built and managed multiple teams and organizations that have exceeded growth expectations. He has successfully developed and integrated not only customer retension and acqusition programs but also built sales, regulatory, clinical, and market access teams for multiple organizations. Jim has also managed key opinion leader and advisory boards for multiple companies which resulted in published concensus papers and treatment guidleines. His formal collaborations both commercially and development wise within multiple product and disease states have been benchmarks in driving value within growth oriented companies.
Product protection role in Asia –APAC/GC/Japan. Responsible for anti-counterfeiting & Illegal diversion investigation. Prevent and protect products to mitigate the risk throughout end to end supply chain. Conduct Audit & assessment to the 3rd party partners. Provide Training and education program for implement the supply chain security standard and requirements.
20+ years working experiences for corporate security, manufacturing security, supply chain security role in multi-national companies.
Graduated at University of International Business & Economics Beijing with major of international trading
Certificate of ISMA –a security management certification issued by Georgetown University.
Certificate of TAPA –Issued by TAPA Asia
Reggie has worked for Pfizer for over 19 years in a variety of roles. He currently leads Pfizer’s efforts for their Supply Chain Integrity and Security program worldwide. This program, which he has led for 4 years, works to prevent, detect and respond to issues of suspect and illegitimate product throughout the legitimate supply chain across the world. Reggie has a Chemical Engineering Degree and an MBA from North Carolina State University and lives in Raleigh, NC.
Reggie has been an active participant in Rx-360 for 6 years, as chair of the Supply Chain Security Steering Committee and a member of the Board of Directors.
Tony serves as Merck’s Executive Director of Product Integrity, with responsibility for the development and execution of the Company’s strategy that protects Merck products from illicit actions, including counterfeiting, diversion, tampering, and theft. His work focuses on securing the supply chain, investigation and enforcement of illicit activity, and building stakeholder awareness to this growing threat to public safety.
Tony joined Merck in 2002 as a Sr. Scientist in Merck's central analytical laboratory supporting Manufacturing. He spent four years in the lab as the primary scientist leading Merck's counterfeit detection efforts. During this time, he developed the Merck’s protocols and technical capabilities for the forensic analysis of suspected counterfeit products. As Merck's efforts related to pharmaceutical anti-counterfeiting increased, Tony moved through related positions of increasing responsibility to his current role. As Executive Director Product Integrity in Merck's Global Security Group, Tony holds responsibility for strategic and tactical operations related to Supply Chain Security, Product Security, Product Integrity Operations, Forensic Services, and Financial Integrity.
Tony serves as Merck's Subject Matter Expert on counterfeit and illicit pharmaceuticals and is a qualified Expert Witness on the subject. He is actively engaged in the on-going collaborative discussions regarding anti-counterfeiting and supply chain security in the external pharmaceutical and law enforcement community, serves as Technical Advisor to the Pharmaceutical Security Institute, serves on the Board of Directors for the International Anti-Counterfeiting Coalition and Rx-360, and is an active member of the Rx-360 Supply Chain Security Steering Committee, and the APEC LSIF Supply Chain Security Steering Committee. Tony holds a B.A. degree in Chemistry from Franklin and Marshall College, Lancaster, PA, and a Ph.D. in Analytical Chemistry from the University of Florida, Gainesville, FL.
Jaye Greene as Head of Audit Operations and Quality at Rx-360 leads a cross functional team, that focuses on Audit scheduling, execution, and report licensing. Jaye also provides oversight to the Consortium quality programs, and compliance.
Jaye has a successful track record in the industry that includes 15 years at Nordson Medical. Her roles at Nordson Medical included Regulatory Affairs in which she was responsible for Nordson ISO site certifications and FDA compliance. While at Nordson, Jaye was also a key team member of the Rx-360/BioPhorum Single Use System Pilot Program. Jaye began her career at Nordson in sales in which she grew her career from a customer service role to helping in restructuring the sales department. While in this position she acquired a tremendous knowledge base within the molded medical connector arena and became skilled in technical guidance.
Jaye graduated from Henderson State University, and resides in Duluth, Minnesota with her family.