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
BJ Centers is Senior Director of Distributor Contracting at Apexus, the HRSA-designated 340B Prime Vendor, where he oversees relationships with 28 authorized distributors to ensure that covered entities have access to 340B drugs. In this role, he supports wholesalers and distributors in 340B compliance issues and challenges as it relates to the supply chain. BJ also manages the Apexus Manufacturer Refund Service, facilitating manufacturer refunds of 340B pricing overcharges to covered entities in the form of credits through covered entity distributor pharmacy ordering accounts.
Throughout his 40-year career, working with group purchasing organizations in the healthcare industry, BJ has served in sales, operations and management roles at pharmaceutical wholesalers. He has held various management positions at both large and small pharmaceutical manufacturers, where he was responsible for national and managed accounts. His specialties include: controlled distribution service development; real-time unit-dosing strategies; acute and non-acute care class of trade program/service development; web-based contract compliance and procurement modeling; government contracting; and securing national contracts for brand and generic pharmaceuticals.
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.
F5: How to be More Interesting Than a Cell Phone - Pacific Ballroom 25-26
Deedre Daniel is the founder of The Interesting Conversations Company®. Prior to starting this company, she spent nearly two decades at GEICO, where she rose through the ranks from call center sales associate to head of the Affinity Marketing division. Her affinity marketing team was responsible for the marketing strategy to members of over 800 organizations. As a “paid professional schmoozer” she amassed well over 10,000 hours of networking time from over 11 years of attending conferences, events and other networking receptions for these organizations. )She also racked up more than 1,200 nights at Marriott properties!) She noticed most people struggled to make lasting connections with others at networking events and parties. This inspired her to write a training class called, How to be More Interesting Than a Cell Phone®. She also invented, The Very Interesting Game™ as an exercise to drive home the principles taught in the class, which serves as a tool to reinforce those long after the training has ended. Due to popular demand, this card game has been revamped as a stand-alone product for individual sales on Amazon. Deedre is a graduate of Florida Southern College and lives in Lakeland, Florida, with her husband, Robert, and her active imagination. When she isn’t busy fighting the “Loneliness Epidemic,” she is focused on the 501(c)(3) she founded called, The Big Fat Tip™ - which enlists the help of donors and volunteers to surprise people working in the service industry with unusually large gratuities of $1,000 or more. Total Random Acts of Kindness!
D2: State of the States - Marriott Grand Ballroom 1-4
As HDA’s Vice President, State Government Affairs, Matthew DiLoreto coordinates HDA's nationwide state government affairs efforts, while maintaining and developing relationships with key stakeholders as well as state policymakers and law makers throughout the country. Matt also coordinates closely with HDA’s members to develop, implement and execute effective advocacy strategies addressing state legislative and regulatory issues affecting the pharmaceutical supply chain.
Prior to joining the HDA team, DiLoreto served as the Senior Director of State Government Affairs for the National Community Pharmacists Association (NCPA) which represents the interests of approximately 22,000 pharmacy providers and owners nationwide. His responsibilities at NCPA included developing and executing NCPA's state legislative strategy, while working closely with the association's many state and federal partners across the nation. DiLoreto also was a registered federal lobbyist and actively advanced many of NCPA's federal legislative and regulatory initiatives. During his years at NCPA DiLoreto was responsible for supporting state efforts resulting in more than fifty enacted state laws based upon NCPA model state legislation. Such laws primarily focused on reforming pharmacy reimbursement and drug pricing practices, and on providing for a fair and accessible medication delivery marketplace.
Before moving to the Washington D.C. area, Matt advocated for the Pennsylvania Pharmacists Association in Harrisburg, Pennsylvania, as the Director, Government Affairs and also represented the Pennsylvania Dental Association.