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2021 Traceability Webinar Series

Webinars

Traceability | April 15–May 19

Speakers

Ilisa Bernstein  
Ilisa B.G. Bernstein, JD, PharmD, SVP, Pharmacy Practice and Government Affairs, American Pharmacists Association

Dr. Ilisa Bernstein is the SVP, Pharmacy Practice and Government Affairs at the American Pharmacists Association. Prior to that position, she was the Deputy Director of the Office of Compliance in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). She led this Office in promoting and protecting public health through outreach, strategies and actions that minimize consumer exposure to unsafe, ineffective and poor quality drugs. From 2006 to 2010, Ilisa was the Director of Pharmacy Affairs at FDA and from 1991-2002 and 2003-2006, she was a Senior Advisor in the Office of the Commissioner. From 2002 to 2003, Ilisa was a Senior Associate Director at Pfizer in the Regulatory Liaison Office in Rockville, Maryland. Ilisa started her career at FDA in 1988 as a Pharmacokinetic Reviewer in CDER.

Ilisa completed a post-doctoral residency at the National Institutes of Health, focusing on clinical and research pharmacokinetics. Ilisa received her PharmD from The University of Michigan College of Pharmacy and her JD from The American University Washington College of Law.

Ronald Bone  
Ronald N. Bone, HDA Consultant, Ronald N. Bone Consulting LLC

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.

 
Kevin Capatch, Director, Process Engineering, Geisinger Health System

As a Director at Geisinger Health, Kevin utilizes Lean Thinking to focus on magnifying the value and eliminating the waste in the core value streams. Kevin’s evangelistic leadership style and manufacturing-based operational expertise, combined with his information systems background, has allowed him to stimulate new thinking and promotion of process redesign in Geisinger’s supply chain information and care support delivery systems. He is a foundational leader with the Healthcare Transformation Group (HTG), the Community Advisory Board (CAB) for GS1 U.S. Healthcare, and now serving on the Board of the newly formed Partnership for DSCSA Governance (PDG).He is active on multiple GS1, AHRMM, ASCx12, and C4SCS workgroups.He has completed AHRMM’s Healthcare Supply Chain Leadership Institute and completed his master’s degree in Project Management. In his spare time, he and his wife Diane, support their two son’s passion for cooking, and auto and motorcycle restoration.

Chris Chandler  
Chris Chandler, Supply Chain Strategy, Franciscan Missionaries of Our Lady Health System

y assurance, regulatory standards, and informatics experience in the pharmacy supply chain. Structured and led U.S. Department of Veterans Affairs (VA) formation of the National Pharmacy Benefits Management Strategic Health Group, Quality Assurance Team for the Consolidated Mail Outpatient Pharmacy, and supported Pharmacy Supply Chain and Regulatory Standards Adoption with the Office of Informatics & Analytics Bar Code Resource Office, GS1 US and Franciscan Missionaries of Our Lady Health System (FMOLHS) for traceability and compliance for Unique Device Identification (UDI), Drug Supply Chain Security Act (DSCSA) and United States Pharmacopeia (USP) Supply Chain Standards.

Melva Chavoya  
Melva Chavoya, Clinical Database Manager , Walgreens

Anita Ducca  
Anita T. Ducca, Senior Vice President, Regulatory Affairs, Healthcare Distribution Alliance

Anita T. Ducca is HDA’s Senior Vice President of Regulatory Affairs. She serves as the chief liaison and advocate on behalf of HDA with federal regulatory agencies, including FDA and DEA. She has been with the organization since 2002.

Prior to joining HDA, Ms. Ducca was the Director of Regulatory Affairs for the American Red Cross Biomedical Services (ARC), where she was responsible for internal and external regulatory, compliance and health and safety. Anita also served in a regulatory advocacy capacity for the American Petroleum Institute. Earlier, she has also served on the staff of several federal regulatory agencies, including the Food and Drug Administration, the Office of Management and Budget and the Environmental Protection Agency.

Ducca has a BA in Mathematics from Boston College and a MS in Biostatistics from Georgetown University.

Jeffrey Falardeau  
Jeffrey J. Falardeau, Manager, Pharmaceutical Information Technology, Cardinal Health, Inc.

Jeff has been involved in software development for the manufacturing and healthcare industries for 32 years. He joined Cardinal Health in 1997, supporting their pharmaceutical distribution business, and over the last eight years has been managing software solutions development for regulatory-related needs. He began his serialization involvement in 2008 to lead serialization and track-and-trace solution development for California and federal regulations.

Jeff is an active participant in GS1 and HDMA. He is a graduate of Le Moyne College in Syracuse, N.Y., where he received his BS in Computer Science.

Justine Freisleben  
Justine M. B. Freisleben, Vice President, Industry Relations, Healthcare Distribution Alliance

Justine Freisleben is Vice President of Industry Relations at the Healthcare Distribution Alliance (HDA). In this role she is responsible for the development and coordination of strategies, initiatives and projects to help healthcare distributors understand and use standards, emerging technologies and best practices to increase their efficiency and productivity in the movement of information and products throughout the healthcare supply chain. Additionally, she guides development of voluntary industry guidelines for implementing and maintaining technical standards related to product identification and electronic commerce ,and represents HDA on key work groups, particularly related to the development of standards and processes to support implementation of traceability.

Prior to this role she worked for a chemical trade association focusing on international trade advocacy and international regulatory compliance.

Justine holds a BA in government from Franklin and Marshall College and a MA/MBA from American University.

Elizabeth Gallenagh  
Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance

Elizabeth A. Gallenagh, Esq., is the Senior Vice President, Government Affairs and General Counsel for HDA. She is responsible for overseeing federal and state advocacy on behalf of HDA member companies and is the organization’s chief in-house attorney. Additionally, she serves as HDA’s primary expert on prescription drug traceability, distributor licensure and tax issues.

Since joining HDA in 2003, Ms. Gallenagh led the Alliance's industry-wide efforts to replace a 50-state patchwork of pedigree laws with one national traceability solution, which became a reality through the enactment of Title II of the Drug Quality and Security Act in November 2013. In 2014, she was honored by the industry with the Distribution Management Award for Industry Leadership, which honors an individual who has exhibited the highest standards of honesty and integrity, working to enhance industry relations and knowledge, as well as supply chain efficiency and security.

Gallenagh holds a JD from the George Mason University School of Law and a BA from The George Washington University.

 
Raymond T. Lake, M.S., R.Ph., Corporate Director of Pharmacy Operations, MedStar Health

 
Michael D. O'Neal, BS, DPh, MBA, Director of Pharmacy - Procurement & Inventory Management, Vanderbilt University

Tish Pahl  
Tish E. Pahl, Principal, Olsson Frank Weeda Terman Matz PC

Tish Eggleston Pahl is a principal at Olsson Frank Weeda Terman Matz PC. She is regulatory counsel to drug, cosmetic, dietary supplement and food clients with concerns before the Food and Drug Administration, the Federal Trade Commission, and other federal agencies. Her work has encompassed representation of companies making and marketing human and animal prescription and over-the-counter (OTC) drugs, dietary supplements, and cosmetics. She has particular expertise in the areas of health care communications, advertising and labeling of FDA-regulated products. Further, she advises trade association clients on a range of antitrust and trade regulation issues.

Since November 2013, Tish has been heavily involved with implementation of the Drug Quality and Security Act (DQSA). She has advised pharmacy compounders and outsourcing facilities on their new FDA responsibilities under Title I of the DQSA. She has worked closely with pharmaceutical supply chain stakeholders, including manufacturers, repackagers, and wholesale distributors, on implementation of Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA).

Tish is a regular participant in HDA activities, providing FDA regulatory and antitrust counsel to the Public Policy Council, the Traceability Implementation Work Group, the Regulatory Affairs Committee, the Returns Task Force, and other committees.

Tish graduated from Northwestern University and earned her Juris Doctor from Northwestern University (cum laude).