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Why Attend?

Solving the Global Clinical Supply Puzzle!

As international trials grow more complex, your strategy must evolve. We’re exploring how to integrate cutting-edge technology and streamlined protocols to ensure your clinical supply chain is as agile as the science it supports.

Two Days of Insight. Infinite Connections.

Immerse yourself in a high-impact program of presentations, interactive roundtables, and expert panels. From tackling global supply chain bottlenecks to adopting emerging trends, this is your unmissable opportunity to gain the tools and the network you need to lead the industry.

Get in touch now and secure your place!

 

WHAT TO EXPECT FOR 2026?

Master Strategy. Build Connections. Drive Success.

Join the premier gathering for the East Coast pharma and biotech community.

Discover how to excel in supply chain execution while building the strategic connections your future demands.

300+

Attendees

35+

Exhibitors

20+

Speakers
300+

Attendees

35+

Exhibitors
20+

Speakers

Testimonials

See What It's All About

2026 Sponsors Include:

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Company Information

N-SIDE is a trusted partner for life sciences and energy organizations, delivering cutting-edge software and services to optimize critical resources and drive data-driven decisions. With over 20 years of expertise in the clinical trial supply chain, we collaborate with 65% of the top 20 pharmaceutical companies to streamline clinical supply forecasting and planning. Powered by advanced applied mathematics and AI, our solutions accelerate clinical plans, reduce costs by up to 50%, and mitigate risks. By combining deep industry expertise with transformative technology, we empower clinical supply leaders to make faster, safer, and smarter decisions—ensuring life-changing medications reach patients efficiently and sustainably.

Company Website

To learn more, please visit our website - https://www.n-side.com/en/

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Company Information

Valeris is a trusted life sciences commercialization partner offering end-to-end solutions across the healthcare value chain. With deep industry expertise, advanced technology, and a patient-first approach, Valeris helps life sciences companies enhance access, adherence, and outcomes. Serving over 500 clients, the company delivers data insights, patient support, and provider engagement tools that drive product success. Headquartered in North Carolina and Indiana, Valeris has supported millions of patients. Learn more at www.valeris.com.

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Company Information

Clinical Services International (CSI) is a global company that specializes in sourcing and management of comparator drugs for clinical trials. With headquarters in London and offices in the UK, US, Germany and China, CSI provides worldwide clinical trial supply solutions. We have extensive experience and strong relationships with manufacturers, allowing us to provide custom-made solutions to address complex requirements. CSI aims to accelerate drug development and reduce timelines by offering a fully integrated service that addresses regulatory, quality, operational and clinical requirements. We manage the entire supply chain and offer tailor-made solutions, with comprehensive expertise in Oncology and Biosimilar products. CSI is a trusted partner of leading Biopharmaceuticals, CROs and CMOs.

Company Website

To learn more, please visit our website - www.csint.com

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Company Information

Endpoint Clinical is a leading clinical trial technology and service partner, delivering adaptable RTSM solutions with a focus on security, stability, and trust. With decades of expertise and a proactive, innovation-driven approach, Endpoint minimizes friction, reduces risk, and enables your teams to focus where it matters most—on trial success.

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Company Information

YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone.

We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster.

Company Website

To learn more, please visit our website - http://www.yprime.com/

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Company Information

Taikun Pharma Services is an expert in global clinical packaging, storage, distribution, and IRT services. Whether it’s optimizing flexibility in clinical supply timelines or assisting with regulatory guidelines and packaging design, Taikun Pharma Services is committed to delivering client centric solutions to support the success of clinical trials globally.

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Company Information

Founded in 1992, we are a privately owned clinical trial services company based in Kortrijk, Belgium.

 

We specialize in:

  • Customized Packaging & Labeling for IMPs and Auxiliary Medicines
  • QP Services, including GMP Audits of Manufacturing Sites outside the EEA
  • Global Distribution to Trial Sites
  • Sourcing of Commercial Medicines for Clinical Trial Use
  • Returns, Accountability & Destruction

To learn more, please visit our website – www.novitan.com

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Company Information

Veeva MedTech helps medical device and diagnostics companies streamline the complete product development and commercialization lifecycles to deliver products to patients with greater speed and efficiency. Veeva MedTech’s offering includes applications that advance clinical, regulatory, quality, commercial, and medical operations.

Company Website

To learn more, please visit our website - https://www.veeva.com/medtech/

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Company Information

Acnos Pharma is privately-owned, specialized pharmaceutical company operating globally in the clinical trial supply landscape. The headquarter is in Germany, Aachen. We offer flexible, cost efficient and quality sensitive customized solutions for individual trial requirements. We offer a broad range of clinical trial services supply chain management, clinical trial procurement and logistics.
The combination of passion and expertise leverages our global reach and maximizes customer satisfaction.

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Company Information

Clinical Trial Label Experts: AWT Healthcare was founded as Citation in 1963. Our expertise, attention to project details, and continual focus on R&D allow us to improve and innovate labels for the future. Today, as AWT Healthcare, we continue to provide the highest quality clinical labeling solutions with industry-leading service times.

Visit www.awtlabelpack.com or email Matt Hodgdon and Jackson Young at: NY-Sales@awtlabelpack.com

Company Website

To learn more, please visit our website - http://citlabels.com/

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Company Information

QuickSTAT provides 24/7/365 trusted global life science logistics and transportation solutions for companies worldwide combining industry expertise and innovative technology. Our team of logistics experts specializes in time- and temperature-sensitive shipping of clinical research samples, CGT, vaccines, investigational drugs, CTS, etc., helping bring new drugs and medical protocols to market.

Company Website

To learn more, please visit our website - www.quickstat.com

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Company Website

To learn more, please visit our website - http://www.bappharma.com/

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Company Information

Jupiter Research Services is a global, one-stop solution for comprehensive clinical supply chain management.

We specialize in Comparator Sourcing, Labeling, Secondary Packaging, and Temperature-Controlled Storage & Distribution, with regulatory compliant GxP facilities, delivering end-to-end support to the pharmaceutical, biopharma, CRO, and CMO industries.

Our quality-focused, tailor-made services are designed to ensure the most efficient delivery of effective and accessible treatments worldwide.

Company Website

To learn more, please visit our website - www.jrsllc.com

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Company Information

The CCL Clinical Business Unit is the global specialist of CCL Industries Inc. for products and services in the clinical trials sector. Leveraging over two decades of expertise and operating across various manufacturing sites, we stand poised as your premier partner for clinical trial labeling. With a combined portfolio, worldwide reach, and dedicated local assistance, CCL Clinical emerges as your ultimate destination for excellence in clinical trial labeling services.

Company Website

To learn more, please visit our website - https://cclhealthcare.com/cclclinical/

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Company Information

NewLife Medicals (USA), Inc. has proven to be the strongest source to large multinational companies, CROs and sponsors for RLD supplies. Our GDP (Goods Distribution practices) compliant warehouse in the USA provides storage & distribution facilities and plays a vital role in the global supply chain of RLD for CRO and Sponsors.

NewLife Medicals (USA), Inc has been the catalyst of growth for NewLife Medicals and it has represented the group in most of the exhibitions in the USA. Our foray into Clinical Trial Supplies and expansion into various states is a major growth driver for years to come.

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Company Information

Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite – an evolution built on more than 20 years of proven clinical research technology. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality – helping them bring life-changing therapies to our families and communities around the world.

Company Website

To learn more, please visit our website - www.signanthealth

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Company Information

Since 1997, Clinigen has offered market-leading clinical trial supplies and biological sample management services to meet the most complex clinical supply challenges. Part of Clinigen Group’s global supply chain facility and depot network, we deliver tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.

Company Website

To learn more, please visit our website - www.clinigencsm.com

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Company Information

Catalent solves today’s clinical trial supply challenges and develops innovative solutions for the future. Catalent’s commitment to quality and service excellence is evident in its comprehensive and flexible solutions for small molecules, biologics and advanced therapy medicinal products (ATMPs). With modern global facilities, and 25+ years’ experience reliably supplying thousands of studies of all sizes and complexities around the world, services include:

  • Clinical supply management
  • Integrated formulation development, clinical manufacturing & blinding
  • Specialty handling (potent, cytotoxic, controlled)
  • Direct commercial product sourcing
  • Clinical packaging/labeling
  • Extensive clinical storage, cold chain capabilities & global distribution
  • Demand-led supply
  • Direct-to-patient solutions
  • Clinical returns, reconciliation & destruction.

Company Website

To learn more, please visit our website - https://clinical.catalent.com/

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Company Information

Converge Consulting, a Division of Dark Horse Consulting Group, serves the life sciences industry with strategy, operations, and execution expertise, collaborating with biotech, pharmaceutical, and CGT companies to achieve critical business objectives. Converge’s approach focuses on bridging the gap between sound strategy and reliable execution.

Company Website

To learn more, please visit our website - https://convergeconsulting.com/

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    Agenda

    • 4 Nov 2026
    • 5 Nov 2026
    Expand All

    Streams

    Stream one

    STREAM A

    Stream two

    STREAM B

    STREAM B: STRATEGIC SOURCING & ENHANCING STRATEGIC PARTNERSHIPS

    11:20 AM

    ASK THE EXPERT: Beyond the Bulk: Maximizing Value Through Full-Service CDMO Integration 📊 LIVE POLL

    • How to expand focus beyond core manufacturing to master late-stage packaging, multi-market labeling and ultra-cold chain logistics
    • How to build connected workflows by aligning client-vendor QMS and governance structures to eliminate communication silos
    • Shifting from a transactional vendor relationship to a strategic alliance that accelerates speed-to-market and mitigates supply chain risk

    Speakers

    Jarrod Longcor
    Chief Operating Officer, Cellectar Biosciences

    11:50 AM

    CASE STUDY: Navigating Sourcing Models in Global Clinical Studies: Balancing Local Needs with Global Consistency

    • Understanding local, regional, and centralized sourcing approaches
    • Assessing the benefi ts, risks, and trade-offs of local sourcing
    • Ensuring global standardization while accommodating country-specifi c operational needs
    • Proven strategies for scaling local sourcing across multinational clinical studies
    • Impact of sourcing strategy on timelines, quality, cost, and stakeholder experience

    Speakers

    Michelle Novak
    Regional Director, Business Development, Inceptua

    12:20 PM

    CASE STUDY: Accelerating Clinical Procurement with Generative AI for Market Reviews and Complex RFIs 📊 LIVE POLL

    • Learn how a customized generative AI approach streamlined a complex RFI process, slashing time and effort while enhancing, rather than replacing, human expertise
    • Discover real-world results and data showing exactly how Clinical Procurement can accelerate market reviews and signifi cantly lower operational burdens
    • Smarter, Faster Clinical Decisions: See how these combined strategies empower Clinical Development teams to make high-impact, rapid, and well-informed decisions

    Speakers

    Martina Endzhova
    Global Clinical Trial Technology Category Lead, RWD/RWE, Bayer

    12:50 PM

    Lunch and networking

    STREAM B – RISK MANAGEMENT & END-TO-END SUPPLY EXCELLENCE

    2:15 PM

    CASE STUDY: From Phase I to Market: Building Commercial Readiness into Your Clinical Supply Chain

    • Aligning early-stage packaging, labeling, and inventory models with future commercial market access requirements
    • Identifying single-source dependencies, cold chain vulnerabilities, and regulatory bottlenecks before Phase III trials
    • Selecting CDMO and logistics partners capable of seamlessly transitioning from small-batch clinical trials to full-scale commercial manufacturing

    Speakers

    Eric Elbel
    Former Associate Director, Logistics for Geron Corporation

    2:45 PM

    PRACTICAL CASE STUDY: From Protocol to Patient: Where Clinical Supply Risk Lies

    • Uncovering Hidden Risks: Spotting underestimated supply bottlenecks from complex protocols and comparator sourcing to global regulatory compliance that threaten trial timelines
    • Protecting Patient Continuity: Understanding the real-world operational impact on patient treatment and trial viability when clinical supply chains fail
    • Early Strategic Planning: Applying proactive forecasting and robust sourcing frameworks early to ensure seamless trial execution and protect commercial goals.

    Speakers

    Vanessa Dekou
    Managing Director, CSI

    3:15 PM

    CASE STUDY: Navigating Global Trade Volatility: Guaranteeing Trial Continuity Through Agile Logistics and Digital Tech in Changing Regulatory Landscape

    • Mastering Rapid Import/Export Adaptation
    • Proactive Delays & Cost Management
    • Digital Solutions for trade resiliency

    Speakers

    Laura Sourwine
    Director, Clinical Supply Chain Logistics Americas Warehousing & Distribution, Bristol Myers Squibb

    3:45 PM

    Afternoon refreshments and networking

    STREAM B IRT vs. Clinical Supply Chain: How to Stop Firefighting and Start Syncing

    4:15 PM

    🍻INTERACTIVE BEER BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

    Many clinical supply chains treat Interactive Response Technology (IRT) as a passive transaction log rather than the strategic brain of their trial logistics. This disconnect routinely leads to rigid system setups, massive clinical waste, and exhausting, reactive "fi refi ghting" when protocols inevitably shift.
    In this interactive, live-case boardroom session, four IRT specialists will break down the invisible walls between system programming and physical supply chain management. Abandoning standard PowerPoint slides, our panel will guide the room through an interactive "Trial Autopsy" to map out the critical blind spots in the clinical lifecycle.

    Key Takeaways & Interactive Themes:

    • Lost in Translation: How to actually communicate with your IRT vendor or internal specialists during setup so your supply rules don't get butchered.
    • The "Just in Case" Trap: Why over-buffering your site stock creates a nightmare of waste, and how to let live data do the heavy lifting instead.
    • Playing Offense, Not Defense: Moving away from panicked, reactive fi xes and confi guring your IRT to spot bottlenecks weeks before a patient walks through the clinic door.

    Moderator: Keaton Fonvielle, Head of Client Services, Atreo.io

    Speakers

    Keaton Fonvielle
    Head of Client Services, Atreo.io
    Meghan Hasson
    Sr. Manager, IRT Supply Chain Systems, Deciphera
    Marc Lava
    RTSM Product Development Owner, Johnson & Johnson Innovative Medicine
    Jason Bellman
    Associate Director, IRT Systems & Clinical Supply, Cullinan Therapeutics
    Jason Williams
    Senior Manager, Clinical Trial Tools & Technologies IRT Lead, Takeda

    5:15 PM

    Chair’s summary and close of day 1 + 🍷 Drinks reception – Join us to network and unwind over a selection of fi ne wines

    🏆 PRIZE DRAW: Visit our exhibitors’ booths throughout the day and collect stamps to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

    8 AM

    Registration and refreshments

    8:40 AM

    Chairperson’s opening remarks

    Speakers

    Amaury Jeandrain
    CTS Strategy Advisor, N-SIDE

    AI, DIGITAL TRANSFORMATION, & COMPLIANCE

    8:45 AM

    OPENING INTERACTIVE PANEL DISCUSSION: The Ethical AI Blueprint: Scaling Clinical Trials with Patient Safety First 📊 LIVE POLL

    • How the industry can align on responsible AI practices to guarantee end-to-end patient safety
    • Deconstructing the FDA/EMA joint AI Guidance: How to promote responsible innovation while maintaining rigorous regulatory standards
    • How do you actually implement AI within these strict frameworks without paralyzing your development cycles?
    • Purpose-Driven AI Governance: The Importance of defining a precise context of use for AI tools to guarantee regulatory compliance, robust validation and patient safety

    Moderator: Henry Ames, Co-Chair, PDA (Parenteral Drug Association) TBC

    Speakers

    Jennifer Gormley
    Executive Director, Global Clinical Supplies, Merck
    Irena Maksimovic
    Sr Director, Strategy and Business Operations – Clinical Supply Chain, Bristol Myers Squibb
    Manda Pasarkar
    Head of Global Regulatory Affairs CMC, Sanofi

    9:15 AM

    INTERACTIVE INDUSTRY KEYNOTE: Unifying the Clinical Supply Chain: Implementing a Solid DNOP to Conquer Silos, Uncertainty & Cost 📊 LIVE POLL

    • Break Down the ClinOps-Manufacturing Silo: How to transition from fragmented to a unified, single source of truth that connects real-time trial demand with production capacity
    • How to build solid strategies to create a responsive DNOP process that helps you anticipate enrollment volatility, protocol shifts and regulatory delays before your timeline is disrupted!
    • Risk vs. Waste Framework: How to structure a real-time cost model that aligns ClinOps, Manufacturing, and Finance on intentional spending to eliminate budget shocks

    N-Side

    9:45 AM

    REGULATOR KEYNOTE: Navigating Biological Material Importations: Partnering with CBP and Regulating Agencies

    • CBP’s Bio-Defense Role: Overview of CBPAS and BTOS missions in protecting U.S. agriculture and resources from foreign biological threats
    • Multi-Agency Compliance: Guidance on navigating partner agency requirements (USDA, CDC, FDA, FWS, EPA) via the ACE portal
    • Import Best Practices: Key steps for properly classifying, packaging, and documenting biological imports to avoid delays, seizures, or research disruptions

    Speakers

    Sharon Taylor
    Biological Threat Operations Specialist, US Customs and Border Protection
    Jose L. Sandoval
    Chief Agriculture Specialist, U.S. Customs and Border Protection , Area Port of Philadelphia

    10:10 AM

    PRACTICAL KEYNOTE: From Concept to Clinic: Operationalizing the Pharmacy Card Model to Decentralize Supply and Accelerate Patient Access

    • Understanding the Pharmacy Card Model
    • The Program Lifecycle: From Design to Delivery
    • A day in the Life: Sponsors & Sites
    • Proof of Performance: Feedback and Case Studies

    Speakers

    Tom Gottschalk
    VP Business Development, RxStudy Card, Valeris

    10:40 AM

    Morning Refreshments & Networking

    STREAM A: SCALING AI BEYOND PILOT

    11:20 AM

    CASE STUDY: Real-Life AI in Clinical Supply Chain: What’s Working Right Now for EIKON 📊 LIVE POLL

    • How Eikon is deploying AI today across vendor oversight, demand planning, compliance documentation and stakeholder communication
    • Separating Real-World Value from the Hype: Discover what worked, what failed, and what the team would do differently, gaining a grounded perspective on where AI delivers genuine ROI versus where it falls short
    • Learn how practical AI tools are uncovering hidden logistics risks and driving operational efficiencies in ways traditional supply chain software simply cannot match

    Speakers

    Reid Tonik
    Senior Director, Clinical Supply Chain, Eikon Therapeutics
    Camille Pataki
    Senior Computational Product Discovery Engineer, AI Projects, Eikon Therapeutics

    11:50 AM

    KEYNOTE: AI and the Importance of a Single Data Model 📊 LIVE POLL

    • Why throwing more AI at fragmented systems cannot fix inconsistent, non-reproducible data, and how to build a base for trusted outputs! 
    • The importance of avoiding the dangers of fragmented data, including hallucination risks, brittle integrations, and compromised regulatory audit trails
    • RTSM, Forecasting, and Inventory systems need a unified model across Study, Subject, Product, Execution, and Organization data, not data mappings

    Speakers

    Andy Hinks
    Director, Product Management, Signant Health

    12:20 PM

    ASK THE EXPERT PANEL: Foundation before Digitalization: How to Build a Solid AI Foundation for your Clinical Supply Chain 📊 LIVE POLL

    • How to implement Lean & Six Sigma methodologies to eliminate ineffi ciencies before attempting to digitalize
    • How to optimize and streamline current workflows to ensure AI models automate high-value processes, not bad habits
    • How to shift focus from a traditional organizational chart to a dynamic operating model designed to support and deliver AI capabilities

    Moderator: Vendor opportunity

    Expert: Irena Maksimovic, Cell Therapy Drug Product Operations Performance Transformation Lead, Bristol Myers Squibb
    Expert: Carol Shultz, Senior Director, Global Clinical Supply, Merck
    Expert: Manish Gang, Associate Director, IT Applications, Hikma Pharmaceuticals
    Expert: Frank Leu, CEO, Novapeutics

    Speakers

    Irena Maksimovic
    Sr Director, Strategy and Business Operations – Clinical Supply Chain, Bristol Myers Squibb
    Manish Gang
    Associate Director, IT Applications, Hikma Pharmaceuticals
    Frank Leu
    CEO, Novapeutics
    Carol Shultz
    Senior Director, Global Clinical Supply, Merck

    12:50 PM

    Lunch and networking

    STREAM A – AGILE CLINICAL SUPPLY OPERATIONS

    2:15 PM

    CASE STUDY: From Pilot to Production: Building a Winning Business Case for Digital Transformation in your Clinical Supply Chains

    • How to move beyond qualitative promises by building a hard-data business case that measures time-to-market acceleration, waste reduction, and compliance risk avoidance
    • Key strategies for aligning clinical operations, IT, and fi nance around shared digital goals, addressing operational resistance, and justifying initial capital expenditure
    • Actionable frameworks for transitioning successful digital supply chain proofs-of-concept into fully integrated, enterprise-wide production workflows without disrupting ongoing trials

    Speakers

    Carol Shultz
    Senior Director, Global Clinical Supply, Merck

    2:45 PM

    PRACTICAL CASE STUDY: Master Clinical Supply Chain Uncertainty with DIGITAL TWINS “What-If” Scenarios

    • Simulating Disruptions: Testing the impact of sudden supplier failures, customs delays, or enrollment spikes virtually before they disrupt real-world trials
    • Optimizing Budgets & Inventory: Running predictive scenarios to find the perfect balance between overproducing expensive investigational drugs and risking stockouts
    • Driving Aggressive Lead-Time Reduction

    Speakers

    Fiona Geiger
    VP, Operational Delivery, Endpoint
    Andy Maltun
    Vice President, Product Management, Endpoint

    3:15 PM

    CASE STUDY: Mastering the 6-4-2 Shift: A Supply Chain Roadmap to the 12-Digit NDC

    • How to identify where NDCs are hardcoded in your clinical packaging, labeling, and warehouse management systems
    • The Burden of Dual-Format Management: Strategies for handling the messy transition period where both 10 - and 12-digit codes will coexist in the market.
    • A step-by-step checklist to align regulatory, clinical operations, and IT partners for a seamless system overhaul

    Speakers

    Manish Gang
    Associate Director, IT Applications, Hikma Pharmaceuticals

    3:45 PM

    Afternoon refreshments and networking

    STREAM A Digital Accessibility & The Patient Experience

    4:15 PM

    🍻INTERACTIVE BEER BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

    Pharma’s multi-billion dollar investments in Omnichannel Personalization, Generative AI, and Digital Health Transformation are failing to deliver their promised ROI when accessible design is absent.

    When digital touchpoints assume an "ideal user" without visual, motor, auditory, or cognitive impairments, they systematically exclude up to half of the adult patient population, particularly older adults and those managing chronic conditions.

    Accessibility at Scale is not a post-launch IT check; it is the fundamental architecture that turns digital transformation investments into measurable patient health outcomes, trial retention, and brand trust.

    Speakers

    Stephen Framil
    Founder & Executive Director Accessibility Perspectives, Former Chief Accessibility Officer, Merck

    5:15 PM

    Chair’s summary and close of day 1 + 🍷 Drinks reception – Join us to network and unwind over a selection of fi ne wines

    🏆 PRIZE DRAW: Visit our exhibitors’ booths throughout the day and collect stamps to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

    Streams

    Stream one

    STREAM A

    Stream two

    STREAM B

    11:15 AM

    Reserved for a vendor

    11:45 AM

    CHINA SPOTLIGHT: Not Just a Drugmaker: How China is becoming the New World Leader in Clinical Trials

    • What accounts for China's remarkable transition from pharmaceutical free rider to global innovator?
    • NRDL reform as the primary mechanism boosting China’s trials and drug development
    • How can the USA Clinical Trials Industry leverage local partnerships and smart planning to navigate the rapid growth of China's R&D sector and unlock new opportunities for global success?
    • The importance of enhancing registry protocols and appropriate quality controls not only to ensure data accuracy and completeness but also foster global collaboration and transparency in clinical trials

    Speakers

    Priya Ravisekara
    Senior Pharma Analyst, GlobalData Plc

    12:15 PM

    Reserved for a vendor

    8:15 AM

    Registration and refreshments

    8:55 AM

    Chair’s opening remarks

    Speakers

    Priya Ravisekara
    Senior Pharma Analyst, GlobalData Plc

    9 AM

    Interactive Breakfast Roundtable Discussions

    🗣️ ROUNDTABLE SESSIONS offer a valuable opportunity to connect with peers, share best practices, and collaborate on solutions to key industry challenges. These interactive discussions also help you expand your network and learn from others’ experience and expertise. Vendors Opportunities

    1. Shifting from reactive vendor management to strategic, transparent, patient-focused partnerships
    Martina Endzhova, Global Category Lead, RWD/RWE, Bayer

    2. Architecting the ATMP Supply Chain: A Practical Guide to Planning & Orchestration Excellence
    Tom Walls, Former Head of Supply Chain Planning, Spark Therapeutics

    3. How IRT integration eliminates blind spots between CMO production and 3PL distribution
    Shawn Gehen, Senior Manager, Clinical Supply, Lexeo Therapeutics

    4. Streamlining Biological Imports: Overcoming CBP & Partner Agency Regulatory Bottlenecks in Evolving Clinical Trials ; Elliot Ortiz, Port Director; Jeffrey Yocum, Supervisory Import Specialist, David Ng, Senior Agriculture Operations Manager, U.S. Customs and Border Protection , Area Port of Philadelphia

    5. Beyond the Molecule: Managing ancillary sourcing to keep trials on track
    Marsha G. Meron, Sr Manager Clinical Drug Supply Logistics - Ancillary Supply Management, Regeneron

    6. Overcoming the Legacy Trap: How to start modernizing your clinical supply systems
    Camille Pataki, Senior Computational Product Discovery Engineer, AI Projects, Eikon Therapeutics

    7. Unblinding the Forecast Process: How Modern Tools Are Resolving Early-Stage Clinical Trial Forecasting Lucas Outcault, Manager, Clinical Drug Supply & Logistics, Regeneron

    Speakers

    Martina Endzhova
    Global Clinical Trial Technology Category Lead, RWD/RWE, Bayer
    Tom Walls
    Former Head of Supply Chain Planning, Spark Therapeutics & Independent Consultant
    Shawn Gehen
    Clinical Demand Planning Manager (Contractor), Seagen
    Elliot Ortiz
    Port Director; Jeffrey Yocum, Supervisory Import Specialist
    David Ng
    Senior Agriculture Operations Manager, U.S. Customs and Border Protection , Area Port of Philadelphia
    Marsha G. Meron
    Sr Manager Clinical Drug Supply Logistics - Ancillary Supply Management, Regeneron Pharmaceuticals
    Camille Pataki
    Senior Computational Product Discovery Engineer, AI Projects, Eikon Therapeutics
    Lucas Outcault
    Manager, Clinical Drug Supply & Logistics, Regeneron

    10 AM

    US IMPORT LOGISTICS & CHINA INNOVATION

    REGULATORY KEYNOTE: Navigating US FDA Import Enforcement: Avoiding Holds & Mastering the Border Pipeline 📊 LIVE POLL

    • How to format Global Import Documentation: Master FDA fi ling requirements for European and Chinese APIs and clinical materials to eliminate border holds caused by missing IND numbers, label mismatches, and improper valuation
    • How to resolve a notice of detention: Navigate the critical 30-day response window, coordinate with FDA investigators to fi x errors, and avoid formal product refusals or trial delays
    • How to Protect US Pipelines from Global Friction: Secure US-bound supply chains against surging Chinese volumes by managing extended lead times, navigating fluctuating trade tariffs, and maintaining compliance through political shifts

    Speakers

    Bobbie Whiddon
    Supervisor, Office of Inspections and Investigations, FDA Import Shield
    Tonya O. Corbin
    Supervisory Consumer Safety Officer, Division of Northeast Imports Compliance Branch, Office of Inspections and Investigations, FDA

    10:30 AM

    Morning Refreshments & Networking

    11:15 AM

    PRACTICAL CASE STUDY: S&OP/IBP, the importance of cross-functional supply and demand planning

    • Why companies need S&OP/IBP even though they don't have "Sales"
    • How to obtain cross-functional participation and benefi ts
    • How long-term planning benefi ts your supplier relationships

    Speakers

    Jennifer Foulkes
    Director, Clinical Supply Chain Practice, Converge Consulting

    11:45 AM

    CASE STUDY: How to Evaluate External Drug Programs & Manage a Seamless Transition

    • Creating a smart evaluation framework to assess external drugs program to accurately determine their strategic fit, commercial viability and long-term value before making the acquisition
    • Uncover hidden risks and verify facts: Learn exactly what to look for and what to ask during confidential data reviews to avoid surprises
    • How to build collaborative, cross-functional relationships with your counterparty teams to ensure smooth operations and prevent activities from slipping through

    Speakers

    Paul Larochelle
    Senior Director Global Clinical Supply Chain,
    Takeda

    12:15 PM

    Reserved for a vendor

    12:45 PM

    CLOSING GREEN BIOPHARMA KEYNOTE: Building an End-to-End Sustainable Supply Chain: From Baseline to Execution

    • Baseline & Scope: Defi ne Scope 1–3 environmental impacts across all supply chain stages
    • Operationalize & Measure: Establish actionable KPIs, updated SOPs, and governance models
    • Execute & Scale: Prioritize initiatives that balance carbon reduction, cost, and supply continuity

    Speakers

    Claudia Sandoval
    Senior Director Supply Chain, GSK

    1:15 PM

    LUNCH, NETWORKING AND 🏆 PRIZE DRAW 🏆

    3 PM

    End of conference

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    Bobbie Whiddon
    Supervisor, Office of Inspections and Investigations, FDA Import Shield

    A seasoned FDA regulatory professional with 12 years of experience in imports and entry review, Bobbie Whiddon has developed deep expertise in admissibility determinations, compliance assessment, and enforcement actions under the Federal Food, Drug, and Cosmetic Act. Skilled in evaluating foreign shipments across a broad range of FDA-regulated commodities, Bobbie brings a thorough understanding of import regulations, risk-based decision-making, and interagency collaboration. Since August of 2025, Bobbie has led a team of FDA Import Shield reviewers, the agency's nationalized entry review program for import compliance.  Prior to FDA service, Bobbie worked in industry and brings over 20 years of experience in food safety, medical foods, medical devices, and pharmaceuticals.  

    Session Details:

    US IMPORT LOGISTICS & CHINA INNOVATION

    2026-11-05, 10:00 AM

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    Tonya O. Corbin
    Supervisory Consumer Safety Officer, Division of Northeast Imports Compliance Branch, Office of Inspections and Investigations, FDA

    Tonya Corbin is a Supervisor in the Division of Northeast Import Compliance Branch at the U.S. Food and Drug Administration (FDA), where she oversees import compliance operations and regulatory enforcement activities involving FDA-regulated imported products. With more than 24 years of experience at the FDA, she specializes in import compliance, regulatory enforcement, admissibility review, and interagency collaboration.  

    Throughout her career, she has managed complex compliance and enforcement matters involving a broad range of FDA-regulated imported products. She has collaborated with federal, state, and local regulatory and law enforcement partners, including U.S. Customs and Border Protection (CBP) and the FDA Office of Criminal Investigations (OCI), to support enforcement actions, ensure compliance with FDA laws and regulations, and protect public health.  

    She began her FDA career in 2002 as a Consumer Safety Officer conducting inspections of domestic food manufacturers. In 2004, she transitioned to import operations as an Entry Reviewer responsible for making admissibility decisions on FDA-regulated imported products. In 2011, she became an Import Compliance Officer before advancing into her current supervisory role in 2020.  

    She earned a Bachelor of Arts in Biology from Rutgers University in 2001 and a Master of Public Administration from Delaware State University in 2023.  

    Session Details:

    US IMPORT LOGISTICS & CHINA INNOVATION

    2026-11-05, 10:00 AM

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    Reid Tonik
    Senior Director, Clinical Supply Chain, Eikon Therapeutics

    Reid Tonik is Senior Director of Clinical Supply Chain at Eikon Therapeutics, where he leads supply for a global portfolio of clinical programs from Phase I through commercial launch readiness. He holds an MBA from Temple University. For more than 20 years, he's run clinical supply chains on many sides of the table — at large sponsor companies to small start-ups to CDMOs. His experience includes a 2-year stint in the UK that improved his vocabulary but not his weather tolerance.  

     At Eikon he built the clinical supply chain function from scratch — which is a polite way of saying he's accountable for keeping their global portfolio supplied, and he's fortunate enough to have a top-notch team that makes that feel easy.   

     Today he's here to talk about what AI is actually doing in clinical supply chain right now — the real use cases, the ones that worked, the ones that didn't, and the gap between the demos and the day job without the hype  

    Session Details:

    CASE STUDY: Real-Life AI in Clinical Supply Chain: What’s Working Right Now for EIKON 📊 LIVE POLL

    2026-11-04, 11:20 AM

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    Camille Pataki
    Senior Computational Product Discovery Engineer, AI Projects, Eikon Therapeutics

    Camille Pataki is an Applied AI Engineer and AI Strategy Coordinator at Eikon Therapeutics, bridging drug discovery, clinical development, and AI. She holds a Ph.D. in Biochemistry from Stanford and has spent nine years in drug discovery and personalized medicine, extracting meaning from biological data and building systems that turn research questions into actionable signals.    

    At Eikon, she's leading the development of agentic systems and doing the unglamorous work of making AI adoption real, in the sense of getting tools into actual workflows and making them stick. A big part of that is helping people develop judgment: knowing when to use AI, and knowing when a problem calls for a Tuesday afternoon fix versus enterprise-scale infrastructure.Today she's here to talk about what AI enablement actually looks like in practice.  

    Session Details:

    Interactive Breakfast Roundtable Discussions

    2026-11-05, 9:00 AM

    Session Details:

    CASE STUDY: Real-Life AI in Clinical Supply Chain: What’s Working Right Now for EIKON 📊 LIVE POLL

    2026-11-04, 11:20 AM

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    Irena Maksimovic
    Sr Director, Strategy and Business Operations – Clinical Supply Chain, Bristol Myers Squibb

    Session Details:

    ASK THE EXPERT PANEL: Foundation before Digitalization: How to Build a Solid AI Foundation for your Clinical Supply Chain 📊 LIVE POLL

    2026-11-04, 12:20 PM

    Session Details:

    OPENING INTERACTIVE PANEL DISCUSSION: The Ethical AI Blueprint: Scaling Clinical Trials with Patient Safety First 📊 LIVE POLL

    2026-11-04, 8:45 AM

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    Carol Shultz
    Senior Director, Global Clinical Supply, Merck

    Session Details:

    ASK THE EXPERT PANEL: Foundation before Digitalization: How to Build a Solid AI Foundation for your Clinical Supply Chain 📊 LIVE POLL

    2026-11-04, 12:20 PM

    Session Details:

    CASE STUDY: From Pilot to Production: Building a Winning Business Case for Digital Transformation in your Clinical Supply Chains

    2026-11-04, 2:15 PM

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    Manda Pasarkar
    Head of Global Regulatory Affairs CMC, Sanofi

    Session Details:

    OPENING INTERACTIVE PANEL DISCUSSION: The Ethical AI Blueprint: Scaling Clinical Trials with Patient Safety First 📊 LIVE POLL

    2026-11-04, 8:45 AM

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    Claudia Sandoval
    Senior Director Supply Chain, GSK

    Session Details:

    CLOSING GREEN BIOPHARMA KEYNOTE: Building an End-to-End Sustainable Supply Chain: From Baseline to Execution

    2026-11-05, 12:45 PM

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    Martina Endzhova
    Global Clinical Trial Technology Category Lead, RWD/RWE, Bayer

    Session Details:

    CASE STUDY: Accelerating Clinical Procurement with Generative AI for Market Reviews and Complex RFIs 📊 LIVE POLL

    2026-11-04, 12:20 PM

    Session Details:

    Interactive Breakfast Roundtable Discussions

    2026-11-05, 9:00 AM

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    Paul Larochelle
    Senior Director Global Clinical Supply Chain,
    Takeda

    Paul Larochelle currently serves as Senior Director (Planning Team Lead) for Global Clinical Supply Chain at Takeda, where he serves as a member of the GCSC Leadership Team and is responsible for managing a team of professionals overseeing the forecasting and planning of clinical study supplies. His role encompasses the strategic and operational aspects of clinical supply chain management in therapeutic areas such as oncology, neuroscience, gastrointestinal diseases, vaccines, and rare diseases. Paul's leadership extends to cross-functional projects aimed at implementing new capabilities, conducting due diligence of potential acquisitions by the company, and improving existing processes.  

    Previously, Paul held various roles at Biogen Corporation and Genzyme, a Sanofi Company, where he honed his expertise in clinical asset planning and clinical supplies management. His contributions to these organizations included serving as a lead contact for multiple clinical programs, developing supply chain strategies, leading continuous improvement projects, and serving as Fellowship Coordinator and Student Preceptor for dozens of students.  

    Paul has a BS in Biology from Providence College, PharmD from MCPHS Boston, and an MBA from Worcester Polytechnic Institute. He also completed a Post-PharmD Industry Fellowship in Clinical Research/Investigational Product Management with MCPHS-Worcester and Genzyme Corporation. He is Chair of the Dean's Advisory Board at MCPHS School of Pharmacy – Boston,  a member of the Pharmacy Advisory Board at Western New England University, and a member of the Advisory Board for the Clinical Trial Supply global conference series.  

    Session Details:

    CASE STUDY: How to Evaluate External Drug Programs & Manage a Seamless Transition

    2026-11-05, 11:45 AM

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    Meghan Hasson
    Sr. Manager, IRT Supply Chain Systems, Deciphera

    Session Details:

    🍻INTERACTIVE BEER BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

    2026-11-04, 4:15 PM

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    Marc Lava
    RTSM Product Development Owner, Johnson & Johnson Innovative Medicine

    Marc Lava is the RTSM Strategic Implementation Owner at Johnson & Johnson, responsible for advancing the company’s Randomization and Trial Supply Management strategy and leading transformational initiatives that drive innovation and deliver long-term value.  With more than 15 years of industry experience, including over a decade at Johnson & Johnson, he has developed deep expertise in RTSM through a diverse range of operational and leadership roles, providing him with a unique perspective on the evolving RTSM landscape.    A strong advocate for industry-wide standardization, Marc is passionate about harnessing the power of RTSM data to drive smarter decision-making and improve the efficiency and sustainability of the clinical supply chain.

    Session Details:

    🍻INTERACTIVE BEER BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

    2026-11-04, 4:15 PM

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    Jason Bellman
    Associate Director, IRT Systems & Clinical Supply, Cullinan Therapeutics

    Session Details:

    🍻INTERACTIVE BEER BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

    2026-11-04, 4:15 PM

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    Manish Gang
    Associate Director, IT Applications, Hikma Pharmaceuticals

    Manish Garg is a Global Serialization Regulatory Compliance and Track & Trace expert and he has expertise in the enterprise architecture connecting clinical and commercial supply chain systems with large and complex global manufacturing and supply chain environment. With over 20 years of experience spanning enterprise technology and life sciences operations, Manish specializes in product identity architecture, regulatory traceability, and the systems implications of large-scale identifier transitions. He actively leads the national NDC-12 Cross-Industry Pilot Program discussions and contributes to the cross-industry and integrations working groups involving FDA, GS1, and GS1, shaping the industry's strategy, planning, and technical response to the 6-4-2 transition. Manish serves on the Editorial Advisory Boards of Pharmaceutical Technology and Pharma Focus America and is a Senior Member of IEEE.

    Session Details:

    ASK THE EXPERT PANEL: Foundation before Digitalization: How to Build a Solid AI Foundation for your Clinical Supply Chain 📊 LIVE POLL

    2026-11-04, 12:20 PM

    Session Details:

    CASE STUDY: Mastering the 6-4-2 Shift: A Supply Chain Roadmap to the 12-Digit NDC

    2026-11-04, 3:15 PM

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    Jarrod Longcor
    Chief Operating Officer, Cellectar Biosciences

    Mr. Longcor brings to Cellectar Biosciences, Inc. more than 20 years of pharmaceutical and biotech experience and was previously the Chief Business Officer for Avillion LLP. In this role, he was responsible for executing the company’s unique co-development partnership strategy. Prior to Avillion, Jarrod was the Vice President of Corporate Development for Rib-X Pharmaceuticals, Inc. (now Melinta Therapeutics) where he was responsible for identifying and concluding several critical collaborations for the company, including a major discovery collaboration with Sanofi Aventis valued over $700M. Prior to Rib-X, Mr. Longcor has held key positions in several small to midsized biotech companies where he was responsible for business development, strategic planning and operations. Jarrod holds a Bachelor of Science degree from Dickinson College, a Master of Science from Boston University School of Medicine and a Master of Business Administration from Saint Joseph’s University’s Haub School of Business.

    Session Details:

    ASK THE EXPERT: Beyond the Bulk: Maximizing Value Through Full-Service CDMO Integration 📊 LIVE POLL

    2026-11-04, 11:20 AM

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    Frank Leu
    CEO, Novapeutics

    Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.

    Session Details:

    ASK THE EXPERT PANEL: Foundation before Digitalization: How to Build a Solid AI Foundation for your Clinical Supply Chain 📊 LIVE POLL

    2026-11-04, 12:20 PM

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    Tom Walls
    Former Head of Supply Chain Planning, Spark Therapeutics & Independent Consultant

    Session Details:

    Interactive Breakfast Roundtable Discussions

    2026-11-05, 9:00 AM

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    Stephen Framil
    Founder & Executive Director Accessibility Perspectives, Former Chief Accessibility Officer, Merck

    As the Corporate Global Head of Accessibility at Merck & Co., Inc., Dr. Stephen Framil has been an ardent advocate and practitioner of equitable access across the range of human experience: including the built environment, food sustainability, education, performing arts, and the digital landscape. With over 30 years of executive leadership in business strategy and innovation, policy and governance, procedure and operations, and portfolio management expertise, Steve continues to lead and champion accessibility in multinational corporations, non-profit education, and the performing arts. Steve resides in the Greater Philadelphia area with his wife Natalia, children Aren and Sasha, cats Mila and Jana, and dog Benji. Steve maintains an active music career as the founding Executive & Music Director of Camerata Philadelphia and the Port City Music Festival (Wilmington NC). To make this all happen as a CRC Survivor (2024 NED), Steve energizes through marathons and triathlons, and is a 3X Ironman (2022, 2024, 2025)—why be bad at one sport, when you can be bad at three!

    Session Details:

    🍻INTERACTIVE BEER BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

    2026-11-04, 4:15 PM

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    Andy Hinks
    Director, Product Management, Signant Health

    Andy Hinks is Director of Product Management at Signant Health, where he leads product development for clinical supplies management solutions. He brings nearly 20 years of experience in clinical technology and supply chain, including prior experience as a team lead in clinical supply chain before joining Signant. At Signant, Andy has progressed from Senior Business Analyst through consultant roles to his current position, developing deep expertise in clinical forecasting and supply planning.

    Session Details:

    KEYNOTE: AI and the Importance of a Single Data Model 📊 LIVE POLL

    2026-11-04, 11:50 AM

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    Michelle Novak
    Director of Business Development, Inceptua

    Michelle Novak has more than 25 years of experience in the healthcare industry, having held positions within both global and emerging pharmaceutical and medical device organizations. Over the past eight years, she has specialized in supporting sponsors with their clinical supply needs, developing strategic solutions that enhance clinical trial execution and operational success.

    Michelle currently serves as Regional Director, Business Development at Inceptua, a global clinical supply company, where she partners with sponsors to navigate the complexities of clinical supply chain management across all phases of development. Throughout her career in clinical supplies, she has supported global clinical trials across multiple countries, regions, and study phases, helping organizations optimize study execution through the effective use of pharmacy-based distribution models and local, regional, and centralized sourcing strategies.

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    Keaton Fonvielle
    Head of Client Services, Atreo.io

    Keaton Fonvielle is Head of Client Services at Atreo, where she leads client services strategy, project management, and operational delivery.  She brings more than 14 years of experience in RTSM across both CRO and technology organizations, with a background in project delivery, client leadership, team development, and operational transformation.  Keaton is particularly passionate about leveraging technology to make peoples’ lives better – creating positive experiences for clients, internal teams, and most importantly, patients.

    Session Details:

    🍻INTERACTIVE BEER BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

    2026-11-04, 4:15 PM

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    Marsha G. Meron
    Sr Manager Clinical Drug Supply Logistics - Ancillary Supply Management, Regeneron Pharmaceuticals

    Marsha Meron is a Senior Manager of Clinical Drug Supply & Logistics, Ancillary Supply Management at Regeneron, where she leads global ancillary supply strategies that support the successful execution of clinical trials. With extensive experience in supply chain operations, sourcing, logistics, and vendor management, she specializes in developing efficient and compliant supply solutions for complex global studies. Throughout her career, Marsha has focused on optimizing supply chain processes, driving cross-functional collaboration, and implementing innovative approaches that balance patient needs, operational efficiency, and cost management. She works closely with Clinical Operations, Global Development, Procurement, and external partners to ensure the timely delivery of critical ancillary supplies worldwide. Marsha is also passionate about process improvement, standardization, and leveraging data-driven insights to enhance clinical trial supply performance

    Session Details:

    Interactive Breakfast Roundtable Discussions

    2026-11-05, 9:00 AM

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    Lucas Outcault
    Manager, Clinical Drug Supply & Logistics, Regeneron

    Luke Outcault is the Manager of Clinical Drug Supply and Logistics at Regeneron Pharma, where he currently oversees the Investigational Product Supply Chain initiation, management, and close out across numerous phase 1, 2, and 3 trials. With over 10 years of experience in the biotechnology sector, Luke specializes in study forecasting, clinical packaging and labeling, and cross-functional process design. Throughout his career, he has continuously pushed to bridge the gap between Clinical Operations and Manufacturing. Luke holds an Masters in Healthcare Admin from the University of Miami and a green belt in Lean Six Sigma.   

    Session Details:

    Interactive Breakfast Roundtable Discussions

    2026-11-05, 9:00 AM

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    Amaury Jeandrain
    CTS Strategy Advisor, N-SIDE

    Amaury Jeandrain has a Master’s Degree in Business Engineering with a specialization in supply chain optimization. He joined Clinigen in 2015, then N-SIDE in 2016 where he last  held the position of VP of Strategy for clinical supply solutions.

    Over the past decade, his objective has been to make clinical trial supply chains more efficient by redefining CTS strategies and driving measurable performance improvements. His expertise also includes forecasting, planning, waste reduction, and shortage risk mitigation.

    Since 2024, while accompanying his wife on humanitarian missions abroad (Niger, then Colombia), Amaury has continued his work as a CTS advisor and trainer, partnering with pharmaceutical companies worldwide to enhance clinical supply performance.

    Session Details:

    Chairperson’s opening remarks

    2026-11-04, 8:40 AM

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    Jennifer Gormley
    Executive Director, Global Clinical Supplies, Merck

    Session Details:

    OPENING INTERACTIVE PANEL DISCUSSION: The Ethical AI Blueprint: Scaling Clinical Trials with Patient Safety First 📊 LIVE POLL

    2026-11-04, 8:45 AM

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    Jose L. Sandoval
    Chief Agriculture Specialist, U.S. Customs and Border Protection , Area Port of Philadelphia

    Session Details:

    REGULATOR KEYNOTE: Navigating Biological Material Importations: Partnering with CBP and Regulating Agencies

    2026-11-04, 9:45 AM

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    Andy Maltun
    Vice President, Product Management, Endpoint

    Session Details:

    PRACTICAL CASE STUDY: Master Clinical Supply Chain Uncertainty with DIGITAL TWINS “What-If” Scenarios

    2026-11-04, 2:45 PM

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    Laura Sourwine
    Director, Clinical Supply Chain Logistics Americas Warehousing & Distribution, Bristol Myers Squibb

    Session Details:

    CASE STUDY: Navigating Global Trade Volatility: Guaranteeing Trial Continuity Through Agile Logistics and Digital Tech in Changing Regulatory Landscape

    2026-11-04, 3:15 PM

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    Jason Williams
    Senior Manager, Clinical Trial Tools & Technologies IRT Lead, Takeda

    Session Details:

    🍻INTERACTIVE BEER BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

    2026-11-04, 4:15 PM

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    David Ng
    Senior Agriculture Operations Manager, U.S. Customs and Border Protection , Area Port of Philadelphia

    Session Details:

    Interactive Breakfast Roundtable Discussions

    2026-11-05, 9:00 AM

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    Jennifer Foulkes
    Director, Clinical Supply Chain Practice, Converge Consulting

    Session Details:

    PRACTICAL CASE STUDY: S&OP/IBP, the importance of cross-functional supply and demand planning

    2026-11-05, 11:15 AM

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    Sharon Taylor
    Biological Threat Operations Specialist, US Customs and Border Protection

    Sharon Taylor is a Biological Threat Operations Specialist (BTOS) with U.S. Customs and Border Protection (CBP), Office of Field Operations (OFO) in the Area Port of Philadelphia.  Ms. Taylor began her career in October 2006 at JFK International Airport, NY before transferring to her hometown of Philadelphia, PA in 2009.  Ms. Taylor has 17 years of public service with CBP working in a variety of environments such air passenger, maritime and express carrier locations. During that time, she has worked as an Agriculture Specialist, K9 Handler and with several specialized units/teams within CBP.

    Session Details:

    REGULATOR KEYNOTE: Navigating Biological Material Importations: Partnering with CBP and Regulating Agencies

    2026-11-04, 9:45 AM

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    Eric Elbel
    Former Associate Director, Logistics for Geron Corporation
    • Work in Pharmaceutical Logistics since 2003
    • Management of lots of change and new technologies in the last 20+ years
    • Work history in small and large logistics companies, medical device manufacturing, vaccine manufacturing, and in the gene therapy field
    • Dangerous goods expertise, logistics & supply chain management of multiple clinical trials, depth of knowledge of the pharmaceutical cold chain

    Session Details:

    CASE STUDY: From Phase I to Market: Building Commercial Readiness into Your Clinical Supply Chain

    2026-11-04, 2:15 PM

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    Jennifer Merriman
    Senior Manager, R&D Global Trade Compliance, Johnson & Johnson Innovative Medicine
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    Shawn Gehen
    Senior Manager, Clinical Supply, Lexeo Therapeutics
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    Priya Ravisekara
    Senior Pharma Analyst, GlobalData Plc

    Priya Ravisekara, MSc,is a senior analyst at GlobalData in London, UK, where her primary responsibilities include producing analytical reports, improving and maintaining database functionality through quality assurance testing, updating and monitoring Global Data’s Clinical Trials Intelligence Database, and answering queries directly from clients. Priya holds a Masters in Clinical Drug Development from Barts and The London School of Medicine and Dentistry, and a Bachelor of Science in Biochemistry from Brunel University, London.​

    Session Details:

    CHINA SPOTLIGHT: Not Just a Drugmaker: How China is becoming the New World Leader in Clinical Trials

    2026-11-05, 11:45 AM

    Session Details:

    Chair’s opening remarks

    2026-11-05, 8:55 AM

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    Elliot Ortiz
    Chief Agriculture Specialist, Area Port of Philadelphia, US Customs and Border Protection

    Elliot Ortiz is a Chief CBP Agriculture Specialist with U.S. Customs and Border Protection (CBP), Office of Field Operations (OFO) in the Area Port of Philadelphia.  Mr. Ortiz began his career in December 2000 in the Port of Mayaguez, Puerto Rico.  Mr. Ortiz has more than 22 years of public service with CBP, and has worked in a variety of environments, including on the pre-clearance, maritime, air passenger, and cargo locations.  He has also been able to assist in several past domestic and international CBP events.

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    Jeffrey Yocum
    Supervisory Import Specialist, U.S. Customs and Border Protection , Area Port of Philadelphia
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    Tom Gottschalk
    VP Business Development, RxStudy Card, Valeris

    Tom has worked in the life sciences industry since 1997, with the first 10 years spent as a pharmaceutical representative and marketing product manager for Bertek, Merck and GSK.

    Tom joined Valeris in 2008, created the RxStudy Card offering in 2009 and since then has been focused on changing the paradigm of the traditional clinical trial supply process to one of greater efficiency.

    Session Details:

    PRACTICAL KEYNOTE: From Concept to Clinic: Operationalizing the Pharmacy Card Model to Decentralize Supply and Accelerate Patient Access

    2026-11-04, 10:10 AM

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    Vanessa Dekou
    Managing Director, CSI

    Vanessa is a scientist and entrepreneur with extensive experience across the biopharmaceutical and healthcare sectors. She began her career at Scotland Yard before joining LGC Group and later IQVIA, where she worked with leading biopharmaceutical and biotech companies across drug development, registration, market access, and commercialization. She has secured registration for several orphan and first-in-class medicines and previously served as Chief Commercial Officer of a leading clinical-trial technology company.

    Vanessa serves on the Enterprise Advisory Board of Chelsea and Westminster Hospital’s CW+, the Board of UCL’s Global Business School for Health, and formerly served on the Board of Cambridge Judge Business School. She holds a PhD in Cardiovascular Genetics from UCL, an MBA from the University of Cambridge, and a Master’s in Market Access from the University of Lyon.

    Session Details:

    PRACTICAL CASE STUDY: From Protocol to Patient: Where Clinical Supply Risk Lies

    2026-11-04, 2:45 PM

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    Fiona Geiger
    VP, Operational Delivery, Endpoint

    Fiona Geiger is a senior clinical operations and supply chain leader with deep expertise in interactive response technology (IRT), e‑clinical systems, and global clinical trial supply delivery. She has led large, cross‑functional teams supporting complex global studies, driven the design and implementation of enterprise‑level IRT platforms, and established scalable, regulatory‑compliant processes supporting end‑to‑end clinical supply chains. Known for bridging technology and operations, Fiona brings a strong background in project management, system validation, regulatory readiness, and operational excellence, with a track record of improving delivery models, strengthening client partnerships, and enabling reliable, high‑quality execution across clinical programs.

    Session Details:

    PRACTICAL CASE STUDY: Master Clinical Supply Chain Uncertainty with DIGITAL TWINS “What-If” Scenarios

    2026-11-04, 2:45 PM

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    Advisory Board

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    Chris Wallace
    Head of Distribution EMEA, Argenx

    Chris has over 35 years’ varied supply chain experience, having worked for several blue chip companies in a number of industries including 3rd party logistics services, automotive, medical device, nuclear fuels and biotech/pharmaceuticals.

    Originally from the UK but now based in Switzerland, he has been involved in life science - biotech/pharmaceuticals & medical device - for over 20 years of his career and has latterly been SVP Global Supply Chain at Clover Biopharmaceutical before last year moving to Argenx as Head of Distribution EMEA.

    He has developed, implemented and managed global healthcare supply chain strategies and operations on 6 continents. This has included different set-ups in multiple countries, including many in the Emerging Markets as well as the developed world.

    Chris has a degree in economics from Manchester University, an MBA from Aston University and a postgraduate diploma from London University. In his spare time, he plays golf badly and loves to sample great Italian food and red wines!

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    Luiz Barberini
    Head of External Manufacturing, Latin America, Bayer
    • Over 25 years’ experience in Logistics, Supply Chain, Procurement and Demand Planning areas.
      Solid knowledge and experience in the whole S&OP process and its KPI´s inter-relationships with stakeholders
    • Demand Planning process management - pre-S&OP, with Sales, Marketing, Trade Marketing, Industrial Planning and Finance and customized tool design for such process
    • Management skills: experience with multidisciplinary and international teams (Brazil / Latin America / US).
    • Experience in S&OP, 3PL and Supply Chain Organization projects' implementation
    • Strong experience with Pharmaceutical and Consumer companies and Brazilian distribution model / 3PL contracts
    • Solid team management skills, as well as Customer Service relationship and management
    • Teacher for major Post Graduation Schools - Demand Planning and Procurement/Negotiation areas

    CSCP & CPIM APICS. Logistics & Supply Chain driven strategy. Distribution & Logistics, Demand Planning, S&OP, Procurement and Export experiences, focusing on Business necessities through effective leadership.

    Working as External Manufacturing Operations Manager Latin America at Bayer, in charge for external partners for CHC Division. Previously as Relationship Associated Director at Merck , Logistics Manager at Takeda/Nycomed Pharma, focusing on demand management, planning and distribution activities. Also has worked as Pfizer´s Logistic Manager and EFD´s Supply Chain Manager. Souza Cruz´s Procurement Manager and Rhodia's Logistic Supervisor.

    Specialties: Logistics, Supply Chain, Materials, Procurement , Services, Negotiation, 3PL contracts, S&OP, Demand Planning

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    Amanda Briceno
    Clinical Supply Management & Patient Centricity Unit Manager, Chiesi Farmaceutici

    Amanda Briceno is an experienced clinical supply professional with over 10 years in clinical research and supply chain operations. Originally from Venezuela, now based in Italy. She currently serves as Clinical Supply Manager and Head of the Patient Centricity Unit at Chiesi Farmaceutici, where she leads initiatives to design and deliver patient-focused clinical supply solutions that improve trial compliance and enhance the experience of both patients and site staff.

    Her career began as a Clinical Research Associate at IQVIA, where she gained extensive experience in global trial monitoring and operations. Since joining Chiesi, Amanda has held positions of increasing responsibility within the Clinical Supply department, before assuming her current leadership role.

    Amanda holds a Master’s degree in Drug Biotechnology from the Università degli Studi di Milano and a Bachelor’s degree in Medical Biotechnology. Amanda brings a strong blend of technical knowledge and operational leadership. Passionate about innovation in clinical supplies, she is dedicated to advancing more accessible, patient-centric clinical trials.

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    Paul Hingst
    Supply Chain Consultant, Crinetics Pharmaceuticals

    Paul is an experienced Clinical Supply Chain Professional with a 25-year career in the BioPharmaceutical industry.  His extensive career includes roles at major companies like Amgen and Thermo Fisher Scientific, where he honed his skills and made a significant impact.  He has served in varied roles from basic research and contract manufacturing to client services and account management.  He is a Principal Consultant and Co-Founder of Beacon BioPharm Associates, a clinical supply chain consulting firm, providing variable staffing solutions to small and mid-sized BioPharm clients.  Paul is an industry veteran and respected leader known for his expertise in clinical supply chain.

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    Arnaud Dourlens
    Global Head of Clinical Supply Chain Operations, Sanofi

    Arnaud Dourlens is an Arts et Métiers engineer, he began his industrial career in the FMCG sector where he held growing responsibilities. Then he joined the LVMH group where he reorganized new product launches and industrial investments in the Make-up segment in order to adapt to the need for innovation and time to market, thus providing a competitive advantage. He then managed the entire portfolio of industrial launches and investments in Perfumes, Skincare and Make-up for Parfums Christian Dior Group.

    During his career Arnaud held a wide variety of industrial roles. He joined Sanofi in 2017 as Production Director of a major solid oral form production site (>2.5 billion € turnover). He has been a key player in the development of the continuous improvement mindset and in the transformation of the site through IT projects, investments and activity growth following the acquisition of Boehringer Ingelheim consumer healthcare portfolio.

    Since the beginning of 2020, he’s been the global head of Sanofi Clinical Supply Chain Operations, managing worldwide clinical supply teams involved in more than 300 clinical studies.

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    Paul Larochelle
    Senior Director Global Clinical Supply Chain,
    Takeda

    Paul Larochelle currently serves as Senior Director (Planning Team Lead) for Global Clinical Supply Chain at Takeda, where he serves as a member of the GCSC Leadership Team and is responsible for managing a team of professionals overseeing the forecasting and planning of clinical study supplies. His role encompasses the strategic and operational aspects of clinical supply chain management in therapeutic areas such as oncology, neuroscience, gastrointestinal diseases, vaccines, and rare diseases. Paul's leadership extends to cross-functional projects aimed at implementing new capabilities, conducting due diligence of potential acquisitions by the company, and improving existing processes.  

    Previously, Paul held various roles at Biogen Corporation and Genzyme, a Sanofi Company, where he honed his expertise in clinical asset planning and clinical supplies management. His contributions to these organizations included serving as a lead contact for multiple clinical programs, developing supply chain strategies, leading continuous improvement projects, and serving as Fellowship Coordinator and Student Preceptor for dozens of students.  

    Paul has a BS in Biology from Providence College, PharmD from MCPHS Boston, and an MBA from Worcester Polytechnic Institute. He also completed a Post-PharmD Industry Fellowship in Clinical Research/Investigational Product Management with MCPHS-Worcester and Genzyme Corporation. He is Chair of the Dean's Advisory Board at MCPHS School of Pharmacy – Boston,  a member of the Pharmacy Advisory Board at Western New England University, and a member of the Advisory Board for the Clinical Trial Supply global conference series.  

    Session Details:

    CASE STUDY: How to Evaluate External Drug Programs & Manage a Seamless Transition

    2026-11-05, 11:45 AM

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