C5: A Checklist for Launching a Specialty Drug in 2020 - Pacific Ballroom 25-26
F3: Trends in Cold/Ultra-Cold Temperature Storage, Distribution and Logistics - Pacific Ballroom 23-24
With over 20 years of pharmaceutical supply chain experience, Rob Besse established a strong track record collaborating with leaders of specialty pharmaceutical manufacturing, consulting and wholesaling launching almost 100 new drugs and enhancing existing product programs, primarily into the physician and clinic space. His broad career affords him the opportunity to provide a unique insider perspective offering creative solutions related to selecting a launch channel strategy, contracting with distributors / wholesalers / 3PL, data/EDI requirements, program pricing, REMS logistics, cold chain logistics, rebate programs, compliance concerns and changes to commercialization strategy.
Prior to joining Archbow, Rob served as Vice President, Operations at Besse Medical, part of the AmerisourceBergen Corporation. He was responsible for business development, procurement, contracting, compliance and overall divisional operations. He served in that role from 1998 to 2018 and was part of the management team that grew that division into a multi-billion dollar organization during that timeframe.
Mr. Besse started his career as a third-generation pharmacist working in the family business that instilled within him the responsibility to keep the health of the patient an absolute priority no matter where he resides within the healthcare system. He graduated from The Ohio State University with a B.S. in Pharmacy and resides in Lebanon, Ohio.
F1: Traceability Dispenser Panel - Pacific Ballroom 21-22
Ron Bone is a consultant in the area of Pharmaceutical Traceability and is currently focusing on the implementation of the U.S. 2013 Drug Quality and Security Act. Ron retired from McKesson Corporation where he held the position of Senior Vice President, Distribution Support. His responsibilities included Regulatory Affairs and leading McKesson's product security initiatives through the use of electronic track and trace.
Ron spent 41 years with McKesson Corporation in various operations, sales and financial management positions. He was a member of the of the GS1 Process Oversight Committee, a member of the Leadership Teams of GS1 Global Healthcare and GS1 US Healthcare, and was a member of the Industry Relations Council for the Healthcare Distribution Management Association (HDMA). In 2008, Bone testified before the U.S. House of Representatives, Energy and Commerce Committee as an industry expert on anti-counterfeiting. In 2007, he was the recipient of HDMA’s Nexus Award, which is the industry’s highest honor recognizing leadership, exemplary service and professional excellence.
Ron received his BS and MBA degrees from San Jose State University.
A5: Economic and Regulatory Outlook for the U.S. Trucking Market - Pacific Ballroom 25-26
Andrew Boyle is co-president of Boyle Transportation, a specialized trucking firm that provides exceptional quality, safety, and security to select clients in defense and life sciences. Prior to returning to the company in 2003, Andrew was an investment banker with J.P. Morgan. He earned an MBA from Northwestern University's Kellogg School of Management and an AB from Bowdoin College.
Andrew is vice chair of the American Trucking Associations and is a board member of the American Transportation Research Institute (ATRI). He is past chair of the Trucking Association of Massachusetts and is a member of Northwestern University Transportation Center’s business advisory committee. He’s also a trustee of Eastern Bank and serves on boards and committees of several non-profit organizations including House of Hope and The Hole in the Wall Gang Camp.
Andrew and his wife Keri live in suburban Boston with their three children. He’s an active youth basketball coach.
Protecting Supply Chain Integrity - Marriott Grand Ballroom 5-9
Special Agent Dan Burke started his federal law enforcement career with the IRS-Criminal Investigation Division in 1995. In 1997, he transferred to the U.S. Customs Service where he primarily investigated on-line child pornography, drug and financial investigations. In 2002, he was promoted to Supervisory Special Agent for U.S. Customs, which is now known as ICE’s-Homeland Security Investigations, where he managed a Financial Investigations Task Force. In 2005, Dan joined FDA’s Office of Criminal Investigations (OCI).
During his career, Dan has completed a number of successful cybercrime investigations spanning the globe and is also part of OCI’s cadre of digital forensics specialists. In 2012, Dan was promoted to Manager of the Cybercrimes Investigation Unit (CcIU) and also began the development of OCI’s international expansion and liaison efforts. In 2019, Dan was promoted to manager of the Cyber Operations Branch and currently oversees OCI’s Digital Forensics, Cybercrime Investigations and Technical Surveillance Units. Dan has attained a variety of certifications in the field of digital and cyber-forensics, is listed on the United Nations Security Council Roster of Experts and has testified before the U.S. Senate on behalf of the FDA. He holds a master's degree in Criminal Justice Administration from the University of Colorado-Denver where he is currently a member of their adjunct faculty.
A3: Successful 340B Implementation - Marriott Grand Ballroom 10-13
Chris Clement has 19 years of experience in 340B, pharmaceutical distribution, and generic Rx strategies. Chris has spent the last 5 years working for the 340B Prime Vendor, Apexus, and is Director of the Prime Vendor Distribution Network consisting of 29 traditional, specialty and medical-surgical distributors. He has been a guest speaker at a number of industry conferences regarding 340B operations and implementation, and has served on the 340B University faculty. Chris is also a 340B Apexus Certified Expert (ACE).
Prior to joining Apexus, Chris built his career through 13 years with AmerisourceBergen as a subject matter expert on the generic pharmaceutical marketplace, as well as a field sales coach, trainer, analyst and key account contact. His diverse background in the wholesaler industry gives him unique insight into the generics marketplace, and in understanding the 340B supply chain.
F2: Controlled Substances Legal Panel - Marriott Grand Ballroom 1-4
Larry Cote is one of the nation’s foremost Drug Enforcement Administration (DEA) compliance attorneys. He focuses his practice on counseling clients across the spectrum of regulatory compliance and enforcement issues involving the Controlled Substances Act (CSA). Having spent six and a half years heading up a national law firm’s DEA Compliance and Litigation Practice Group, Larry took the practice to his own firm, Cote Law PLLC, in 2018. Immediately before his law firm tenure, Larry was associate chief counsel for the Diversion and Regulatory Litigation Section at DEA. In this position, he took a prominent role in many of DEA’s most significant enforcement actions and compliance efforts.