2025 Traceability Webinar Series | HDA

Speakers

Ilisa B.G. Bernstein

President

Bernstein Rx Solutions, LLC
- DSCSA in 2025: Lessons Learned (On-Demand)
  Thursday, January 23, 2025 | 8:00—9:00 AM
Ilisa B.G. Bernstein

President

Bernstein Rx Solutions, LLC
- DSCSA in 2025: Lessons Learned (On-Demand)
  Thursday, January 23, 2025 | 8:00—9:00 AM
Ilisa Bernstein, PharmD, JD, FAPhA, is President of Bernstein Rx Solutions, LLC, assisting clients in understanding and maneuvering through drug and pharmacy regulatory policy and compliance issues, strategies, and advocacy. She brings over 35 years of experience and expertise in the government, non-profit, and private sectors in achieving successful outcomes and advancing innovation.

Dr. Bernstein spent nearly 5 years at the American Pharmacists Association (APhA). For 13 months, she served as the 14th CEO and Executive Vice President of APhA, the first woman to lead as CEO in the 172-year history of the association. She led all operations and strategies for APhA, the Board of Pharmacy Specialties, and the APhA Foundation. She joined APhA in 2019 as Senior Vice President for Pharmacy Practice & Government Affairs and guided APhA as the voice of pharmacists in all practice settings.

For over 30 years, Dr. Bernstein held several senior leadership positions at the U.S. Food and Drug Administration (FDA). Notably, she was deputy director of FDA’s Office of Compliance in the Center for Drug Evaluation & Research, leading policies, compliance, and enforcement for drugs and for 19 years she had several senior policy advisor roles in the Office of the Commissioner. She started at FDA as a clinical pharmacology reviewer.
Recognized for her achievements, she proudly received the 2023 Distinguished Alumni Lifetime Achievement Award from the University of Michigan College of Pharmacy and was chosen as one of the 2023 Top 50 Most Influential Leaders in Pharmacy.

Dr. Bernstein was also senior associate director of worldwide regulatory affairs at Pfizer and completed a post-doctoral clinical residency at the National Institutes of Health. She earned her Doctor of Pharmacy from the University of Michigan College of Pharmacy and her Juris Doctor from American University Washington College of Law.
Elizabeth A. Gallenagh

Chief Legal Officer

Healthcare Distribution Alliance
- DSCSA in 2025: Lessons Learned (On-Demand)
- Navigating FDA’s Phased Exemptions
Elizabeth A. Gallenagh

Chief Legal Officer

Healthcare Distribution Alliance
- DSCSA in 2025: Lessons Learned (On-Demand)
- Navigating FDA’s Phased Exemptions
Elizabeth A. Gallenagh is the General Counsel and Senior Vice President, Supply Chain Integrity at the Healthcare Distribution Alliance (HDA). She is the organization’s chief legal officer, overseeing all legal matters for HDA. Gallenagh also serves as HDA’s primary expert on prescription drug traceability, supply chain safety and integrity, distributor licensure and tax issues.

Since joining HDA, 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 the Drug Supply Chain Security Act (DSCSA) in November 2014. 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 is a graduate of the George Mason University School of Law and The George Washington University.
Shiv Mahendran

Associate Director, Logistics and Inventory Management

Apotex Corp.
- Prioritizing Data Quality Issues
  Tuesday, February 18, 2025 | 2:00—3:00 PM
Shiv Mahendran

Associate Director, Logistics and Inventory Management

Apotex Corp.
- Prioritizing Data Quality Issues
  Tuesday, February 18, 2025 | 2:00—3:00 PM
David G. Mason

Director Supply Chain Compliance and Serialization

Novartis Pharmaceuticals Corporation
- Prioritizing Data Quality Issues
  Tuesday, February 18, 2025 | 2:00—3:00 PM
David G. Mason

Director Supply Chain Compliance and Serialization

Novartis Pharmaceuticals Corporation
- Prioritizing Data Quality Issues
  Tuesday, February 18, 2025 | 2:00—3:00 PM
Dave Mason is currently the Director of Supply Chain compliance and Serialization – Dave supports the Commercial Trade and Supply Chain teams, supporting the implementation of DSCSA for the Novartis group. Leading efforts to assure Novartis error rates are six sigman or less by assuring procedures are in place for serialization data quality and integrity, improving existing serialization processes and systems as information is provided by supply chain partners on the DSCSA processes. Dave represents Novartis in trade association, PDG and FDA public meetings. He communicates to the NTO Global Serialization team with new and existing requirements for other countries, and he assures that the validation approach is consistent within the organization and execution at the sites. Dave also supports the team to develop to support serialization as it is integrated into the normal business processes. Dave has worked on serialization since 2003 in California and helped implement global solutions.
Tish E. Pahl

Principal

Olsson Frank Weeda Terman Matz PC
- Navigating FDA’s Phased Exemptions
  Thursday, February 6, 2025 | 2:00—3:00 PM
Tish E. Pahl

Principal

Olsson Frank Weeda Terman Matz PC
- Navigating FDA’s Phased Exemptions
  Thursday, February 6, 2025 | 2:00—3:00 PM
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, foods, dietary supplements, cannabis, 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 Supply Chain Security Act (DSCSA). She has worked closely with pharmaceutical supply chain stakeholders, including manufacturers,
repackagers, and wholesale distributors, on implementation of the DSCSA and is a frequent speaker on the law’s implementation.

Tish is a regular participant in HDA's Traceability Implementation Work Group and the Verification Router Service.

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

Director, Industry Relations

Healthcare Distribution Alliance
- Navigating FDA’s Phased Exemptions
- Prioritizing Data Quality Issues
Jaidalyn Rand

Director, Industry Relations

Healthcare Distribution Alliance
- Navigating FDA’s Phased Exemptions
- Prioritizing Data Quality Issues
Matt Sample

SVP, Manufacturer, Quality and Replenishment Operations

Cencora, Inc.
- Prioritizing Data Quality Issues
  Tuesday, February 18, 2025 | 2:00—3:00 PM
Matt Sample

SVP, Manufacturer, Quality and Replenishment Operations

Cencora, Inc.
- Prioritizing Data Quality Issues
  Tuesday, February 18, 2025 | 2:00—3:00 PM
Matt Sample is the Vice President of Manufacturer Operations at AmerisourceBergen. He is responsible for the maintenance of vendor and item master data, driving the adoption of supply chain standards internally and with manufacturer trading partners, and leading the implementation of DSCSA across all AmerisourceBergen business units. In addition to the core drug distribution business responsibilities, Matt is responsible for the DSCSA serialization efforts within their pharmaceutical manufacturing and repackaging businesses and leads our Covid19 Therapies operations efforts with the United States Government.

He has over 17 years of experience in the medical device, pharmaceutical and life sciences industry, working both for manufacturers, wholesalers and for a large consulting firm. He has held various roles in the areas of product development, lean six sigma, business system implementation and operational leadership. Prior to joining AmerisourceBergen, Matt was the serialization program lead at a mid-size pharmaceutical company, and the UDI program manager a large medical device manufacturer.
Kala Shankle

Vice President, Regulatory Affairs

Healthcare Distribution Alliance
- DSCSA in 2025: Lessons Learned (On-Demand)
  Thursday, January 23, 2025 | 8:00—9:00 AM
Kala Shankle

Vice President, Regulatory Affairs

Healthcare Distribution Alliance
- DSCSA in 2025: Lessons Learned (On-Demand)
  Thursday, January 23, 2025 | 8:00—9:00 AM
Kala Shankle is Vice President of Regulatory Affairs. In this role, Shankle leads HDA’s regulatory activities and engagement for members’ priority issues.

Prior to joining HDA, Shankle was an attorney at Epstein, Becker and Green, where she counseled pharmaceutical supply chain stakeholders on regulatory and compliance matters. Previously, Shankle provided legal counsel, developed policy solutions and led regulatory engagement for the National Association of Chain Drug Stores (NACDS), the National Community Pharmacists Association (NCPA) and a state pharmacy association in Florida.

She received both her Juris Doctor and Bachelor of Science from Florida State University. She is a Board member for the American Society for Pharmacy Law.
Tim Stearns

Senior Director, Industry Relations

Healthcare Distribution Alliance
- Navigating FDA’s Phased Exemptions
  Thursday, February 6, 2025 | 2:00—3:00 PM
Tim Stearns

Senior Director, Industry Relations

Healthcare Distribution Alliance
- Navigating FDA’s Phased Exemptions
  Thursday, February 6, 2025 | 2:00—3:00 PM
Tim Stearns is a Senior E-Commerce Analyst with Baxter HealthCare, focusing primarily on the distributor customer base. With over 22 years of experience in information systems, he has integrated back–end systems and implemented numerous EDI transaction sets focused on contract/chargeback administration, customer credit and invoicing, returns processing, order management and shipping notices, track–and–trace /pedigree systems design, customer–to–HIN alignment with HIBCC and distributor Fee for Service/inventory management agreements. Tim has served twice as co–chair of the HDMA Business Technology Committee, member of the HDMA eCommerce Task Force, member of the CSOS Working Group and the Health Industry Business Communications Council E-Business Council.
Brian P. Waldman

Partner

ArentFox Schiff LLP
- Navigating FDA’s Phased Exemptions
  Thursday, February 6, 2025 | 2:00—3:00 PM
Brian P. Waldman

Partner

ArentFox Schiff LLP
- Navigating FDA’s Phased Exemptions
  Thursday, February 6, 2025 | 2:00—3:00 PM
Brian Waldman concentrates his practice in the area of food and drug law and advertising law, counseling clients primarily on pharmaceutical, medical device, food, dietary supplement and cosmetic issues, with particular emphasis on developing effective strategies for introducing and distributing new products. Brian advises clients on a broad range of legal and regulatory issues in all phases of a product’s life cycle, including (i) developing appropriate strategies for the introduction of new ingredients and finished products, (ii) coordinating pre-market safety, efficacy, and claims evaluations, (iii) preparing FDA-related applications and notifications, (iv) designing compliant and effective labeling, advertising, and promotional materials, as well as educational materials, (v) ensuring post-marketing regulatory compliance, including compliance with adverse event reporting requirements and limitations on off-label promotion, and (vi) responding to threatened enforcement action. Brian has been advising clients including HDA on drug distribution issues since 1995.