16th Annual Pharma Anti-Counterfeiting, Serialization & Supply Chain Security 2025
16th ANNUAL PHARMA ANTI-COUNTERFEITING, SERIALIZATION & SUPPLY CHAIN 2025
17th & 18th September, 2025
Hilton Washington Dulles Airport, United States
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5 Reasons
to attend the event
Knowledge
Gain insights from experts, researchers, and professionals to stay updated on the latest pharma advancements.
Convenience
Attend sessions from anywhere, eliminating travel hassles while accessing high-quality content at your own pace.
Cutting-Edge Insights
Discover the latest trends, innovations, and breakthroughs shaping the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with actionable strategies, real-world case studies, and learn best practices to implement in your work.
Knowledge
Gain insights from experts, researchers, and professionals on the latest pharma advancements.
Convenience
Attend sessions from anywhere, eliminate travel hassles & access quality content at your own pace.
Cutting-Edge Insights
Explore the latest trends, innovations, and breakthroughs driving the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with practical strategies, case studies, and proven best practices to apply in real-time.
Event Speakers
Scott Oulton
DEA
Todd Boyett
DEA
Scott Huffman
Bristol Myers Squibb
Senthil Rajaratnam
Eli Lilly
Anthony Puleo
AstraZeneca
Humberto Vega-M
JnJ (Former)
Paule Belony
AstraZeneca
Tracy Nasarenko
GS1
Anna Luczak
McKesson
Vickram Srivastava
Sun Pharma
Brittany H
Bristol-Myers Squibb
John Schettini
Bayshore Pharmaceuticals
Mahfuza A.
AstraZeneca
Harry Green
Novovax
Stephen Framil
Merck
Gregory Goger
Abbvie
Andrey Atanasov
SoftGroup
Eyad Salman
Genentech
Michal Nowina Konopka
Kedrion Biopharma
Aladin Alkhawam
Par Pharmaceutical (Former)
Lenora Dieyi
GSK
Heather Leigh Flannery
AI MINDSystems Foundation
Karla Palmer
Hyman Phelps & McNamara
Andrew Hull
Hyman Phelps & McNamara
Eric Marshall
Leavitt Partners
Ram Balani
eSTARHelper
Nick Vyas
USC Marshall Center for Global SCM
Mark Karhoff
Ten Count Consulting
Pablo Medina
Ten Count Consulting
Michael Stepanovic, PharmD, MS
UNC Eshelman
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Event Schedule
Meet to learn and network with your conference colleagues.
09:00 - Chairperson opening remarks
Speaker
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
AI & SCM
• 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
ANALYTICAL TECHNOLOGIES
• 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.
Speaker
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.
CHALLENGES & OPPORTUNITIES
• 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
Panellists
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
MANUFACTURING – 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
SUPPLY CHAIN STRAGIES
• 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
Panellists
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
Speaker
EYAD SALMAN
Principle Manager
Genentech
14:40 – How Augmented Reality is Revolutionizing Pharmaceutical Packaging?
AR
• 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
Speaker
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.
Panellists
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
REGULATORY
• 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
Panellists
ANNA LUCZAK
Director, Regulatory Affair and Patient Safety
McKesson
TRACY NASARENKO
VP of Community Engagement, Healthcare
GS1
ALADIN ALKHAWAM,
Former 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
Speaker
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
09:40 – Analytical Technologies for the Authentication of Counterfeit Drug Products
ANALYTICAL TECHNOLOGIES
• 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.
Speaker
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.
CHALLENGES & OPPORTUNITIES
• 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
Principal Consultant, SCM, Life Sciences,
Serialization, Ten Count Consultin
Panellists
Associate Director, Forensics & Innovative Technologies,
Bristol-Myers Squibb
Chief of Forensics,
Drug Enforcement Administration
JOHN SCHETTINI,
Supply Chain Director,
Bayshore Pharmaceuticals
Assistant Professor,
UNC Eshelman
12:00 – Revolutionizing Manufacturing: Your Strategic Guide to Embracing Industry 4.0
MANUFACTURING – 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
SUPPLY CHAIN STRATEGIES
• 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
Principal Consultant, SCM, Life Sciences,
Serialization, Ten Count Consulting
Panellists
Director, Packaging Tech Transfer & Validation,
AstraZeneca
Head of Supply Chain – North America,
Sun Pharma
HARRY GREEN,
Global Manufacturing Operations Senior Leader,
SupplyChain & Enterprise Lean Transformation, Novavax
Director US Supply Chain,
Kedrion Biopharma
14:10 - Lessons Learnt from GMP Compliance in Emerging Markets
Speaker
Principle Manager,
Genentech
14:40 – How Augmented Reality is Revolutionizing Pharmaceutical Packaging?
AR
- 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
Speaker
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.
Panellists
Director, FDA, DEA, & Healthcare Enforcement Litigator,
Hyman Phelps & McNamara
Director, FDA and DEA Investigations,
Hyman Phelps & McNamara
16:10 – Panel Discussion: Regulatory Frontlines: Global Updates and Strategies to Combat Counterfeit Drugs
DECENTRALISATION
- Understanding the Economic Impact on Decentralised Clinical Trials (DCTs): Adapting to cost constraints while maintaining trial efficiency.
- Optimising the Hybrid Model: Balancing decentralised and in-person trial elements for patient-centric and cost-effective solutions.
- Enhancing Patient Accessibility: Leveraging decentralisation to improve participation while minimising economic barriers.
- Technology Integration and Cost Management: Ensuring scalable, cost-efficient platforms to support DCT adoption.
- Regulatory and Operational Challenges: Navigating compliance and logistics in mixed trial models during economic uncertainty.
Moderator
CEO/Founder,
eSTARHelper
Panellists
Associate Director, Serialization & Product Surety,
Bristol-Myers Squibb
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
Speaker
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
TACKLING COUNTERFEIT DRUGS
Speaker
TODD BOYETT
Chemical Investigations Section, Diversion Control Division,
Drug Enforcement Administration
09:40 – Pioneering Innovations and Best Practices in Pharma Logistics
LOGISTICS / COLD STORAGE
• 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
Speaker
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
SERIALIZATION – TRACK & TRACE
• 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
Panellists
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
DIGITAL ACCESSIBILITY
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”
IMPACT OF TECHNOLOGY
• 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 automatedalerts
• A look at upcoming technologies – Where are we heading?
Moderator
HEATHER LEIGH FLANNERY
CEO
AI MINDSystems Foundation
Panellists
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
08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues
09:30 – Welcome Address
09:40 – Innovative methods for Clinical trial design
Clinical Trial Inspection
- Contemporary strategies to improve clinical trial design
- Setting up the best position to sustain an agile procedure for your study design
- The flexibility to redesign clinical trials at an intermediate stage
- How does AI transform key steps of clinical trial design from study preparation to execution to wards improving trial success rates?
- Effective trial design and improved compliance
Speaker
Head Medical Affairs,
Alkem Laboratories
10:10 – DISCUSSION WITH EXPERTS: Working together to accelerate trials - SPONSOR – SITE – CRO – PATIENTS - REGULATORS - “Collaborate, Communicate, Accelerate.”
SPONSOR – SITE – CRO – PATIENTS – REGULATORS
- Sponsors and CROs: Building strong partnerships to align goals, share data, and streamline trial processes.
- Sites and Sponsors: Enhancing collaboration to address operational challenges and drive trial efficiency.
- Patients at the Core: Ensuring patient input and experience guide trial designs for better recruitment and retention.
- Regulators and Transparency: Promoting open communication to expedite approvals and maintain compliance.
- Cross-Stakeholder Synergy: Bridging gaps between all players to foster shared accountability and results.
- Leveraging Technology: Enabling real-time data sharing and collaboration across teams and geographies.
Moderator
Founder & Director,
Zantus Lifesciences
Panellists
Associate VP & Head,
Development Center of Excellence Specialty Medicine,
Sun Pharma
Head – Medical, Regulatory, Vigilance & Quality (South Asia),
Fresenius Kabi
MUKESH GORI,
Director ESP Engagement PV & PS,
Novartis
Head Medical Affairs,
GSK
Bharat Serums and Vaccines
11:00 – Morning Coffee/Tea & Discussion
11:30 – DISCUSSION WITH EXPERTS: “Patients First, Always.” - Prioritising patients in trials – Bringing it all together to enhance the patient safety
PATIENT CENTRICITY
- Embedding Patient-Centric Practices: Strategies for integrating patient needs into every stage of clinical trials.
- Enhancing Patient Safety: Key measures to safeguard participants throughout the trial lifecycle.
- Improving Communication: Transparent, empathetic engagement to build trust and ensure informed participation.
- Customising Trial Designs: Adapting protocols to accommodate diverse patient populations and preferences.
- Leveraging Technology: Using digital tools to monitor, support, and ensure patient safety effectively.
Moderator
Founder Director,
Pharmawisdom
Panellists
Country Medical Head,
Novartis
Head Medical Affairs,
Alkem Laboratories
MANISH MAHAJAN,
GM – Lead Medical Affairs BU Biologics,
Zydus Group
Senior GM – Medical Affairs,
Ipca Laboratories
12:20 – From Discovery to Delivery: Harnessing AI, Data Management & Digital Transformation to Optimize Drug Development
In the fast-changing life sciences landscape, Dassault Systèmes is transforming drug development by fusing cutting-edge technology with extensive scientific knowledge, data power, and artificial intelligence. With tools like Clinical Data Studio for smooth data integration and compliance and Simulant for AI-powered trial optimization, Medidata propels clinical innovation. BIOVIA ensures manufacturing quality control while improving lab informatics, drug discovery, and predictive modeling. By enabling AI-driven simulations to enhance research design, enhance patient safety, and optimize operational efficiency, virtual twin experiences help to further create the future. When combined, these developments improve medical research, speed up discoveries, and enhance decision-making.
Speaker
Solution Consultant, Medidata,
a Dassault Systèmes company
12:50 –Networking luncheon
14:00 – Keynote Panel Discussion: Decentralisation - Sustaining DCT adoption in a challenging economic environment. Ensuring best blend of DCT & in-person elements
DECENTRALISATION
- Understanding the Economic Impact on Decentralised Clinical Trials (DCTs): Adapting to cost constraints while maintaining trial efficiency.
- Optimising the Hybrid Model: Balancing decentralised and in-person trial elements for patient-centric and cost-effective solutions.
- Enhancing Patient Accessibility: Leveraging decentralisation to improve participation while minimising economic barriers.
- Technology Integration and Cost Management: Ensuring scalable, cost-efficient platforms to support DCT adoption.
- Regulatory and Operational Challenges: Navigating compliance and logistics in mixed trial models during economic uncertainty.
Moderator
Founder Director,
Pharmawisdom
Panellists
VP, Medical Dept, Clinical Research & PV,
Bharat Serums and Vaccines
Director and Head,
Sanofi
JEROZE DALAL,
Head of Clinical Operations,
Medical Governance & Risk Management,GSK
AssociAte Director & Cluster Head Medical Affairs,
Cipla
Head – Study & Site Operations(SSO India),
Global,Clinical Operation(GCO), Novartis
14:50 - Clinical Trial Supply - What’s the new way forward?
- Current scenario & communication transparency
- Benchmarking success in avoiding common pitfalls & nightmares in clinical trial supply
- Quantifying and mitigating the risk of drug shortages
- Implementing true end-to-end visibility across the supply chain
- Enabling full traceability of clinical trial supplies
15:20 – Afternoon Tea/Coffee
15:40 – Clinical Trials – Market Analysis: Opportunities & Challenges
CHALLENGES & OPPORTUNITIES
- The India advantage
- Overview of global clinical trial challenges and myths and current reality of conducting trials in India
- Review the challenges the industry is facing and the impact of clinical trial progression
- Addressing challenges in recruiting diverse patient populations and ensuring long-term retention.
- Balancing trial budgets while maintaining quality, data integrity, and timelines.
- Learn lessons from experience / case studies
Moderator
Founder & CEO,
RENOVARE Healthcare
16:10 – DISCUSSION WITH EXPERTS: Outsourcing in Clinical Trials: Crafting Partnerships for Success
OUTSOURCING / PARTNERSHIPS
- Defining Clear Objectives: Establishing shared goals and expectations to align all stakeholders.
- Selecting the Right Partners: Key criteria for evaluating and choosing CROs and other service providers.
- Building Trust and Transparency: Strategies for fostering open communication and mutual confidence.
- Setting Metrics for Success: Establishing performance benchmarks to monitor progress and outcomes.
- Navigating Challenges: Proactive approaches to mitigate risks and resolve conflicts in partnerships.
Moderator
CEO, QBD International,
United Nations Adviser
Panellists
ASHISH GAWDE,
Country Medical Director,
Bayer
Medical Director,
Global Health Access, GSK
NISHITH VYAS,
Senior Global Management Consulting,
Novartis
Managing Director,
Proteomics International
Associate Director,
Strategic Engagements & Vendor Management,
Clinical & Medical Affairs, Organon
17:00 - End of conference Day 01
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Venue details
The venue is easily accessible, well-equipped with modern amenities, and offers a comfortable, professional setting for all attendees.
Venue
Hilton Washington
Dulles Airport, USA
13869 Park Center Rd,
Herndon, VA 20171,
United States
+1 703-478-2900
Venue – Hilton Washington Dulles Airport, USA
13869 Park Center Rd,
Herndon, VA 20171,
United States
+1 703-478-2900
