AstraZeneca
PAULE BELONY, Director, Packaging Product Security & Traceability, AstraZeneca
Bristol-Myers Squibb
BRITTANY HANDZO, Senior Scientist, Forensics & Innovative Technologies, Bristol-Myers Squibb
Meet to learn and network with your conference colleagues.
09:00 - Chairperson opening remarks
MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting
09:10 – AI’s Coming Impact on Supply Chain Professionals: Drawing Parallels from Adjacent Industries to Identify Key Skills of the Future
• What do supply chain leaders, cybersecurity experts, and capital market traders have in common? Uncover the surprising overlap and learn how supply chain professionals can future-proof their careers by adopting the mindset and skills driving success across these high-stakes fields.
• Gain insight into must-have capabilities like AI literacy, data interpretation, and adaptive thinking, which are essential tools for thriving in increasingly autonomous and predictive supply chains.
• Walk away with a future-ready mindset—understand the parallels between supply chain transformation and quantitative finance, and how you can prepare your team for what’s next.
ANTHONY PULEO, Director, Data Science, AstraZeneca
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
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
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
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
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, Chemical Engineer, Retired, Former JnJ
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
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
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
09:00 - Chairperson opening remarks
PABLO MEDINA, Principal, Operations Strategy, Serialization & DSCSA, Ten Count Consulting
09:10 – DEA controls in the manufacturing equipment sector primarily those involving tableting and encapsulating equipment to include dies, molds, critical parts, etc
TODD BOYETT, Chemical Investigations Section, Diversion Control Division, Drug Enforcement Administration
09:40 – Pioneering Innovations and Best Practices in Pharma Logistics
• Ensuring adherence to global standards for safety, quality, and transportation of pharmaceutical products
• Strategies to address temperature excursions, supply disruptions, and logistical challenges
• Exploring cutting-edge solutions for temperature stability and product protection
• Implementing eco-friendly practices to reduce the environmental impact of cold chain logistics
• Enhancing transparency and accountability through advanced tracking and reporting systems
• Emerging technologies and innovations set to redefine the landscape of pharmaceutical logistics
HUMBERTO VEGA, Chemical Engineer, Retired, Former JnJ
10:10 – Solution Provider Presentation
For sponsorship opportunities please contact info.uk@virtueinsight.com
10:40 – Morning Networking Coffee / Tea & Discussion
11:10 - Panel Discussion with the experts - Serialization, Track & Trace - Compliance & Implementation
• Role of Serialization in Fighting Counterfeits: Unique ways to enhance supply chain security.
• Challenges in Implementation: Addressing technical, operational, and financial hurdles in adopting serialization and track-and-trace systems.
• Strategies to ensure seamless collaboration between manufacturers, distributors, and retailers.
• Protecting sensitive data while maintaining transparency and compliance.
• Discussing emerging trends and their potential to revolutionize pharmaceutical supply chain management.
• What are the current requirements to follow in serialisation? How to ensure that you are up to date with all global traceability regulations?
Moderator
PABLO MEDINA, Principal, Operations Strategy, Serialization & DSCSA, Ten Count Consulting
Panelists
SENTHIL RAJARATNAM, Senior Director, Global Packaging, Eli Lilly
PAULE BELONY, Director, Packaging Product Security & Traceability, AstraZeneca
NICK VYAS, Executive Director, USC Marshall Center for Global SCM
GREGORY GOGER, Global Traceability Lead, Abbvie
ERIC MARSHALL, Principal, Leavitt Partners
12:00 – Topic TBC
ANDREY ATANASOV, Director Business Development and Sales, SoftGroup
12:30 – Networking luncheon
13:30 – Digital Accessibility in Pharma Serialization & Supply Chain
STEPHEN FRAMIL, Corporate Global Head of Accessibility, Merck
14:00 - Panel Discussion with the experts – “Revolutionizing Pharma Supply Chains: Unlocking the Power of Emerging Technologies”
• Using AI to forecast demand, optimize inventory, and predict disruptions in the supply chain.
• Leveraging blockchain to improve data integrity, traceability, and combat counterfeiting in pharmaceutical distribution
• Bridging the Gap: Digital Accessibility in the Modern Supply Chain
• How the Internet of Things (IoT) enables real-time tracking, monitoring, and enhanced visibility across the supply chain
• How robotic systems streamline storage, picking, and packing processes, reducing human error and improving speed
• Analyzing large datasets to gain actionable insights, optimize routes, and improve decision making across the supply chain
• Ensuring the integrity of temperature-sensitive drugs through real-time temperature monitoring and automated alerts
• A look at upcoming technologies – Where are we heading?
Moderator
HEATHER LEIGH FLANNERY, CEO, AI MINDSystems Foundation
Panelists
ANTHONY PULEO, Director, Data Science, AstraZeneca
STEPHEN FRAMIL, Corporate Global Head of Accessibility, Merck
LENORA DIEYI, Investigator, Modeling & Simulation, GSK
14:50 – Closing remarks by chairperson and End of day conference
We wouldn’t be able to host our conferences without help from these amazing companies.
A huge thanks to all our sponsors and partners!
SoftGroup is a global software company with more than two decades of experience in delivering end-to-end serialization and aggregation solutions for the pharmaceutical industry. Our expertise spans the full compliance spectrum—from line-level software to centralized serialization management and seamless connectivity with regulatory and business partners.
At the core of our portfolio is the SATT PLATFORM® - an advanced, Azure-based Track & Trace brand line built for enterprise scalability, security, and regulatory alignment. The platform supports pharmaceutical companies in achieving real-time traceability, operational efficiency, and global compliance across diverse markets.
Trusted by over 130 pharmaceutical companies in 32 countries, SoftGroup supports a broad range of clients, including multinational corporations, regional MAHs, and CMOs. Our solutions are certified and approved by key national and international systems, including:
• European Medicines Verification System (EMVS)
• National Medicines Verification Systems (NMVS) in almost all EU countries
• AIS MT (Armenia)
• NIS MPT “Asl Belgisi” (Uzbekistan)
• IS MPT (Kazakhstan)
• IS EBD (Kyrgyzstan)
• DVTIS (Azerbaijan)
• Tatmeen (UAE)
• TRVST (UNICEF Vaccine Traceability System)
• and additional regional platforms across Eurasia and the Middle East.
SoftGroup is a Certified Gateway Provider of the EMVO, a recognized partner of the BgMVO, and a global partner of GS1.
Visit our website: www.softgroup.eu
Foster & Freeman will be demonstrating the VSC®9000 Video Spectral Comparator. VSCs have been used in forensic laboratories for over 40 years to examine items such as documents and packaging - utilizing a variety of visible and infrared lighting, to reveal security features, alterations, counterfeits, etc.
Visit our website: www.fosterfreeman.com
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Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.
Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.
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The conference was well organised and informative. It was just the right size to engage with presenters and also get to know other attendees better.
Very enjoyable and informative
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Please contact us if you are having trouble with ticket purchase:
Piyush Patel
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Piyush Patel
piyush@virtueinsightevents.com
+44 20 3509 3779