16th Annual Pharma Anti-Counterfeiting, Serialization & Supply Chain Security 2025

09:00 - Chairperson opening remarks

MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting

MARKET ANALYSIS & OVERVIEW

09:10 – How pharma is fighting counterfeit drugs now? Critical lessons to learn to stop fake drugs

•   The escalating pharma counterfeit problem
•   There is still a lot of work to do, and the implementation time is short – How to manage?
•   How prepared is the industry in terms of product supply?
•   Serialization, reporting and product verification highlights
•   Practical experiences of medicine verification and authentication
•   Creating a global standard and Preparing for a new environment

ANALYTICAL TECHNOLOGIES

09:40 – Analytical Technologies for the Authentication of Counterfeit Drug Products

•   This presentation will provide insight into ongoing counterfeit trends and describe the roles and responsibilities of BMS in combating drug product counterfeiting.
•   Real suspect product investigations submitted to BMS will be highlighted, including counterfeit tablets and biologics.
•   Analytical techniques such as microscopy, vibrational spectroscopy (IR, Raman), UV-Vis, and chromatography are typically used during these forensics analyses.
•   Portable technologies are also utilized to detect potential counterfeits in the field.

BRITTANY HANDZO, Senior Scientist, Forensics & Innovative Technologies, Bristol-Myers Squibb

10:10 – Solution Provider Presentation

For sponsorship opportunities please contact info.uk@virtueinsight.com

10:40 – Morning Networking Coffee / Tea & Discussion

CHALLENGES & OPPORTUNITIES

11:10 – Keynote Panel Discussion: Counterfeit Drugs: Challenges & Opportunities for Effective Solutions.

•   Understanding the scale and consequences for public health and patient safety.
•   Evaluating existing policies and identifying gaps in enforcement across different regions.
•   Assessing vulnerabilities and implementing strategies to protect the pharmaceutical supply chain.
•   Exploring tools like blockchain, AI, and advanced serialization to combat counterfeiting.
•   Discussing the financial toll on healthcare systems and the ethical considerations in combating counterfeit drugs.
•   Cross-Sector Collaboration - Highlighting the role of partnerships among governments, pharmaceutical companies, NGOs, and tech providers.
•   Developing strategies to raise awareness about counterfeit drugs and their risks

Moderator
MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting

Panelists
SCOTT HUFFMAN, Associate Director, Forensics & Innovative Technologies, Bristol-Myers Squibb
SCOTT OULTON, Chief of Forensics, Drug Enforcement Administration
JOHN SCHETTINI, Supply Chain Director, Bayshore Pharmaceuticals
MICHAEL STEPANOVIC, Assistant Professor, UNC Eshelman

MANUFACTURING - INDUSTRY 4.0

12:00 – Revolutionizing Manufacturing: Your Strategic Guide to Embracing Industry 4.0

•   Maximizing Manufacturing Efficiency
•   Using advanced analytics to foresee equipment issues and minimize downtime
•   Implementing real-time monitoring and analytics to ensure product consistency and regulatory compliance
•   Adapting production processes to enable smallbatch, patient-specific drug manufacturing
•   Reducing waste and optimizing energy use through eco-friendly production methods
•   Innovations like blockchain, quantum computing, and advanced biomanufacturing shaping the next phase of pharma production

12:30 – Networking luncheon

SUPPLY CHAIN STRAGIES

13:20 – Keynote Panel Discussion: Streamlining Success: Advanced Supply Chain Strategies for Pharma

•   Current trends, challenges, and opportunities in the pharmaceutical supply chain for betterment
•   Strategies to identify, mitigate, and manage risks, including disruptions, regulatory compliance, and quality control
•   Best practices for balancing supply and demand while minimizing waste and costs
•   Integrating eco-friendly processes to meet global sustainability goals
•   Building strong partnerships with suppliers, distributors, and other stakeholders for seamless operations
•   Emerging technologies and strategies shaping the future of pharmaceutical supply chains

Moderator
MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting

Panelists
MAHFUZA AHMEDIN, Director, Packaging Tech Transfer & Validation, AstraZeneca
VICKRAM SRIVASTAVA, NJ, Head of Supply Chain - North America, Sun Pharma
HARRY GREEN, Global Manufacturing Operations Senior Leader, SupplyChain & Enterprise Lean Transformation, Novavax
MICHAL NOWINA KONOPKA, Director US Supply Chain, Kedrion Biopharma

14:10 - Lessons Learnt from GMP Compliance in Emerging Markets

EYAD SALMAN, Principle Manager, Genentech

AR

14:40 – How Augmented Reality is Revolutionizing Pharmaceutical Packaging?

•   Minimize Errors, Maximize Efficiency: Leverage AR technology to reduce human errors and enhance operational precision in pharmaceutical packaging
processes.
•   Compliance Meets Innovation: Ensure adherence to stringent regulatory standards by seamlessly integrating AR into critical workflows.
•   Elevating Quality and Integrity: Safeguard product quality while streamlining operations with cutting-edge AR-driven solutions.
•   With AR-driven tracking and monitoring, stakeholders gain better control and transparency across the packaging process
•   AR integrates compliance checks into workflows, ensuring adherence to stringent pharmaceutical regulations
•   By reducing errors and waste, AR optimizes resource usage, ultimately lowering operational costs

HUMBERTO VEGA, Global Head MSAT, Johnson & Johnson Innovative Medicine

15:10 - Afternoon Networking Coffee / Tea & Discussion

15:40 – Recent Federal and State Enforcement Efforts Pertaining to Supply Chain Security

This presentation will provide an overview of laws used to enforce supply chain security, including enforcement of the Drug Supply Chain Security Act and the SAFE DOSES Act, as well as a survey of recent federal enforcement actions and nationwide supply chain enhancement used in the accreditation process.

ANDREW J. HULL, Director, FDA, DEA, & Healthcare Enforcement Litigator, Hyman Phelps & McNamara
KARLA L. PALMER, Director, FDA and DEA Investigations, Hyman Phelps & McNamara

REGULATORY

16:10 – Panel Discussion: Regulatory Frontlines: Global Updates and Strategies to Combat Counterfeit Drugs

•   Global Regulatory Requirements: Navigating compliance standards across regions, including the EU (FMD) and the U.S. (DSCSA).
•   Recent Regulatory Developments: Highlighting updates from key global frameworks
•   Exploring how different countries and regions address counterfeit drugs through legislation and enforcement.
•   Discussing the importance of aligning regulatory measures to ensure global consistency.
•   Evaluating the effectiveness of regulatory actions through monitoring and reporting mechanisms.
•   Identifying unique issues faced by low- and middle-income countries and potential solutions.
•   Exploring collaborations between regulators, industry players, and international organizations to strengthen anti-counterfeiting efforts.

Moderator
RAM BALANI, CEO/Founder, eSTARHelper (CEO/Founder, FDASmart)

Panelists
ANNA LUCZAK, Associate Director, Serialization & Product Surety, Bristol-Myers Squibb
TRACY NASARENKO, VP of Community Engagement, Healthcare, GS1
ALADIN ALKHAWAM, Director Global Serialization, Par Pharmaceutical

17:00 – Closing remarks by chairperson and End of day 01 conference

17:10 – 18:15 – Networking Drinks