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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

Featured Speakers

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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  

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Irena Maksimovic​

Cell Therapy Performance Transformation Lead, Bristol Myers Squibb

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Carol Shultz​

Senior Director, Global Clinical Supply, Merck

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Claudia Sandoval​

Senior Director Supply Chain, GSK

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Martina Endzhova​

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

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    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

    Next Sponsor
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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/

    Next Sponsor
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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, RISK MANAGEMENT & END-TO-END SUPPLY EXCELLENCE

      11:40 AM

      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 significantly 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
      Abhinav Singhvi
      Enabling Procurement Manager, Bayer

      12:10 PM

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

      • Understanding local, regional, and centralized sourcing approaches
      • Assessing the benefits, risks, and trade-offs of local sourcing
      • Ensuring global standardization while accommodating country-specific 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

      12:40 PM

      CASE STUDY: Clinical Supplies Due Diligence: Evaluating External Drug Programs and Managing a Seamless Transition 📊 LIVE POLL

      • The Clinical Supply Role: Discuss how Clinical Supplies representatives can contribute to due diligence
      • Program Evaluation: Assess an external drug program's fit, viability, and ability to deliver before acquisition
      • Risks and Evidence: Know what to look for and ask during confidential data reviews to uncover risks and avoid surprises
      • Counterpart Collaboration: Build cross-functional relationships that support smooth operations and prevent missed activities

      Speakers

      Paul Larochelle
      Senior Director Global Clinical Supply Chain,
      Takeda

      1:10 PM

      Lunch and networking

      STREAM B – STRATEGIC SOURCING, RISK MANAGEMENT & END-TO-END SUPPLY EXCELLENCE

      2:15 PM

      CASE STUDY: Navigating Global Trade Volatility: Sustaining Trial Continuity Through Agile Logistics and Digital Technology in a Changing Regulatory Landscape – Lessons from Latin America 📊 LIVE POLL

      • 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

      2:45 PM

      CASE STUDY: Closing the Loop: When the Forecast Meets the Patient

      • Real-Time Visibility: Learn how connecting real-time RTSM data with resupply workflows transforms live trial activity into smarter, faster supply decisions
      • Risk & Waste Optimization: Discover practical strategies to minimize investigational product waste without increasing stock-out risks at clinical sites
      • AI + Human Judgment: See where AI adds true value in forecasting, and why human expertise remains vital to navigating complex trial dynamics

      Speakers

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

      3:15 PM

      Afternoon refreshments and networking

      4 PM

      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

      STREAM B – Digital Accessibility & The Patient Experience

      4:30 PM

      INTERACTIVE 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.

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

      Speakers

      Stephen Framil
      Founder & Executive Director Accessibility Perspectives, Former Chief Accessibility Officer, Merck
      Sylvia Park-Ekecs
      Global Head of Consumer eXperience + Design, Sanofi

      5:30 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

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      Amaury Jeandrain
      CTS Strategy Advisor, N-SIDE

      OPERATIONAL EXCELLENCE & RESPONSIBLE INNOVATION

      9 AM

      OPENING REGULATOR KEYNOTE: Navigating Biological Material Importations: Partnering with CBP and Regulating Agencies 📊 LIVE POLL

      • 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

      9:25 AM

      INTERACTIVE INDUSTRY KEYNOTE: How to make Planning a Successful Role through People, Processes and Performance? 📊 LIVE POLL

      Planning is one the most critical roles in the cynical supply chain. Planners decide how much study drugs produce, source package and distribute and when to do so. Consequently, all the clinical supply chain’s performance indicators (waste, costs, inventories, shortage risks, CO2 emissions, etc) are intimately linked to their actions. While systems help, they are not the main driver of a planning organization’s success.

      • The 4 "P" (People, Process, Product, Performance) for a successful organisation
      • How to structure a team, including roles and responsibilities to make planning a strategic role
      • What are the essential processes to enable a high-performing CTS planning
      • How to make performance a priority and improve it through planning
      • Illustration through business cases, benchmarks and good practices

      Speakers

      Amaury Jeandrain
      CTS Strategy Advisor, N-SIDE
      Dan Caramore
      Strategic Account Manager, N-SIDE

      9:55 AM

      INTERACTIVE FIRESIDE CHAT: Governing AI in Regulated Operations: Scaling Innovation with Patient Safety, Quality, and Compliance 📊 LIVE POLL

      • Scaling AI in regulated life-sciences operations: Where AI can improve decision-making, process efficiency, and performance across CMC, drug-product operations, and enterprise functions-without compromising GxP expectations
      • Building quality and regulatory guardrails: How organizations should address data integrity, validation, documentation, human oversight, change control, and accountability when AI influences regulated processes
      • Moving from experimentation to responsible adoption: What it takes to embed AI into day-to-day work through workforce enablement, cross-functional collaboration, clear governance, and a consistent focus on patient safety and product quality
      Moderator: Manda Pasarkar,  Global Regulatory Affairs CMC Head, Small Molecule, Sanofi

      Speakers

      Manda Pasarkar
      Head of Global Regulatory Affairs CMC, Sanofi
      Irena Maksimovic
      Cell Therapy Performance Transformation Lead, Bristol Myers Squibb
      Camille Pataki
      Senior Computational Product Discovery Engineer, AI Projects, Eikon Therapeutics

      10:25 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

      10:55 AM

      Morning Refreshments & Networking

      STREAM A: FROM AI PILOTS TO AGILE CLINICAL SUPPLY OPERATIONS

      11:40 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

      12:10 PM

      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

      12:40 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 inefficiencies 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: Amaury Jeandrain, CTS Strategy Advisor, N-SIDE

      Speakers

      Amaury Jeandrain
      CTS Strategy Advisor, N-SIDE
      Irena Maksimovic
      Cell Therapy Performance Transformation Lead, Bristol Myers Squibb
      Carol Shultz
      Senior Director, Global Clinical Supply, Merck
      Frank Leu
      CEO, Novapeutics

      1:10 PM

      Lunch and networking

      STREAM A – FROM AI PILOTS TO 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

      CASE STUDY: Closing the Loop: When the Forecast Meets the Patient

      • Real-Time Visibility: Learn how connecting real-time RTSM data with resupply workflows transforms live trial activity into smarter, faster supply decisions
      • Risk & Waste Optimization: Discover practical strategies to minimize investigational product waste without increasing stock-out risks at clinical sites
      • AI + Human Judgment: See where AI adds true value in forecasting, and why human expertise remains vital to navigating complex trial dynamics

      Speakers

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

      3:15 PM

      Afternoon refreshments and networking

      4 PM

      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

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

      4:30 PM

      INTERACTIVE BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝 📊 LIVE POLL

      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 "firefighting" 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.

      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

      5:30 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

      7:45 AM

      Registration and refreshments

      8:30 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.

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

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

      3. 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

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

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

      6.From Blind Forecasts to Smarter Automation: Overcoming Early-Stage Clinical Trial Predictive Challenges
      Lucas Outcault, Manager, Clinical Drug Supply & Logistics, Regeneron

      Speakers

      Martina Endzhova
      Global Clinical Trial Technology Category Lead, RWD/RWE, Bayer
      Shawn Gehen
      Senior Manager, Clinical Supply, Lexeo Therapeutics
      Elliot Ortiz
      Chief Agriculture Specialist, Area Port of Philadelphia, US Customs and Border Protection
      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
      Frank Leu
      CEO, Novapeutics
      Lucas Outcault
      Manager, Clinical Drug Supply & Logistics, Regeneron

      REGULATORY COMPLIANCE & OPERATIONS STRATEGY

      9:20 AM

      Chair’s Opening Remarks

      Speakers

      Priya Ravisekara
      Senior Pharma Analyst, GlobalData Plc

      9:25 AM

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

      • How to format Global Import Documentation: Master FDA filing requirements for APIs and clinical materials to help eliminate border holds caused by missing IND numbers, label mismatches, and improper valuation
      • How to resolve a notice of detention: Navigate the response process, coordinate with FDA investigators to address deficiencies, and help avoid formal product refusals or delays to clinical trials
      • How to Protect US Pipelines from Global Friction: Secure US-bound supply chains by managing extended lead times and maintaining compliance through changing regulatory and trade environments

      Speakers

      Bobbie Whiddon
      Supervisor, Office of Inspections and Investigations, FDA
      Tonya O. Corbin
      Supervisor, Office of Inspections and Investigations, FDA

      10 AM

      CASE STUDY: Driving Cross-Functional Alignment and Demand Planning Through S&OP/IBP📊 LIVE POLL

      • How can businesses without commercial sales effectively apply S&OP/IBP principles to stabilize operations?
      • What proven approaches can foster active cross-functional participation and ensure accountability across departments?
      • How can long-term forecasting strengthen supplier collaboration, secure priority capacity, and ensure supply continuity to support patient needs?

      Speakers

      Rashi Gupta
      Senior Consultant, Practice Manager, Dark Horse Consulting Group

      10:30 AM

      Morning Refreshments & Networking

      BUILDING SUSTAINABLE SUPPLY CHAIN & CHINA’S TRAIL BOOM

      11:15 AM

      GREEN BIOPHARMA KEYNOTE: Building an End-to-End Sustainable Supply Chain: From Baseline to Execution 📊 LIVE POLL

      • Baseline & Scope: Define 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

      11:45 AM

      CASE STUDY: 5 Questions Every Sponsor Must Ask About Their Clinical Supply Chain for Faster, Leaner Trials!

      • Identifying Kit Waste: What are the primary root causes of kit waste across your trial portfolio?
      • Pinpointing Errors: Where and why are dispensing errors occurring in your supply chain?
      • Quantifying Timelines & Bottlenecks: Exactly how much study delay is caused by kits entering quarantine?

      Speakers

      Claes Kalderén
      Chief Revenue Officer, TSS

      12:15 PM

      KEYNOTE: China’s Biotechnology Sector and What It Means for America!

      • China’s Rise as a Clinical Trial Hub: How rapid patient accrual, cost advantages, and government support are diverting early-phase development offshore
      • The Global Regulatory Reality: Navigating FDA expectations for multi-regional data while leveraging overseas trial efficiency
      • Western CRO Competitiveness: Adapting to aggressive competition from Chinese trial scale through niche domain expertise, specialized therapeutic focus, and process automation

      Speakers

      Sebastian De Beurs
      Co-Founder, Healis Therapeutics

      12:45 PM

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

      • What has driven China's remarkable shift from fast follower to global innovator in drug development and clinical trials?
      • Regulatory reform and aligned incentives as the engine behind "China Speed" and the growth of China's clinical trial ecosystem
      • How can the US clinical trials industry use local partnerships and smart planning to navigate China's rapidly growing R&D sector and unlock new opportunities for global success?
      • What China's growing role in global licensing and partnering means for R&D strategy, market entry and cross-border collaboration

      Speakers

      Priya Ravisekara
      Senior Pharma Analyst, GlobalData Plc

      1:15 PM

      Lunch & Networking

      2:15 PM

      🏆 PRIZE DRAW 🏆 in the Exhibition Hall

      DRIVING INTERNAL CHANGE: CULTURE, MOTIVATION & WORKFORCE STRATEGIES

      2:30 PM

      INSPIRATIONAL KEYNOTE: Drawing on Military Lessons to Inspire Your Workforce to Lead the Change!

      Change is easy on paper, so how do you get your workforce to actually buy in and take the lead?

      When organizational transformation stalls, the bottleneck is rarely strategy, it is the human element. Executing complex clinical change requires far more than top-down mandates; it demands genuine frontline buy-in. Drawing directly on time-tested leadership lessons from the military, this inspiring keynote reveals how to overcome change fatigue, align high-level vision, and empower your workforce to move from passive compliance to proactive leadership. Walk away with actionable, battle-tested strategies to build a culture of unshakeable trust, operational momentum, and shared ownership across your organization.

      Speakers

      Ryan McCool
      Supply Chain Leader, Author, Keynote, J&J + McCool Leadership Development

      3:15 PM

      INTERACTIVE AUDIENCE EXCHANGE: A chance to share your perspective and explore what is working (and where the challenges lie) within your own organization

      Speakers

      Ryan McCool
      Supply Chain Leader, Author, Keynote, J&J + McCool Leadership Development

      3:30 PM

      End of conference

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      Speakers

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      Back
      Bobbie Whiddon
      Supervisor, Office of Inspections and Investigations, FDA

      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:

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

      2026-11-05, 9:25 AM

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      Tonya O. Corbin
      Supervisor, 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:

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

      2026-11-05, 9:25 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:

      OPENING REGULATOR KEYNOTE: Navigating Biological Material Importations: Partnering with CBP and Regulating Agencies 📊 LIVE POLL

      2026-11-04, 9:00 AM

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

      Session Details:

      OPENING REGULATOR KEYNOTE: Navigating Biological Material Importations: Partnering with CBP and Regulating Agencies 📊 LIVE POLL

      2026-11-04, 9:00 AM

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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, 8:30 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, 11:40 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 FIRESIDE CHAT: Governing AI in Regulated Operations: Scaling Innovation with Patient Safety, Quality, and Compliance 📊 LIVE POLL

      2026-11-04, 9:55 AM

      Session Details:

      Interactive Breakfast Roundtable Discussions

      2026-11-05, 8:30 AM

      Session Details:

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

      2026-11-04, 11:40 AM

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      Irena Maksimovic
      Cell Therapy Performance Transformation Lead, 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, 12:40 PM

      Session Details:

      INTERACTIVE FIRESIDE CHAT: Governing AI in Regulated Operations: Scaling Innovation with Patient Safety, Quality, and Compliance 📊 LIVE POLL

      2026-11-04, 9:55 AM

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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: Sustaining Trial Continuity Through Agile Logistics and Digital Technology in a Changing Regulatory Landscape – Lessons from Latin America 📊 LIVE POLL

      2026-11-04, 2:15 PM

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      Sylvia Park-Ekecs
      Global Head of Consumer eXperience + Design, Sanofi

      Session Details:

      INTERACTIVE BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

      2026-11-04, 4:30 PM

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      Manda Pasarkar
      Head of Global Regulatory Affairs CMC, Sanofi

      Session Details:

      INTERACTIVE FIRESIDE CHAT: Governing AI in Regulated Operations: Scaling Innovation with Patient Safety, Quality, and Compliance 📊 LIVE POLL

      2026-11-04, 9:55 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, 12:40 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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      Claudia Sandoval
      Senior Director Supply Chain, GSK

      Session Details:

      GREEN BIOPHARMA KEYNOTE: Building an End-to-End Sustainable Supply Chain: From Baseline to Execution 📊 LIVE POLL

      2026-11-05, 11:15 AM

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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, 11:40 AM

      Session Details:

      Interactive Breakfast Roundtable Discussions

      2026-11-05, 8:30 AM

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      Abhinav Singhvi
      Enabling Procurement Manager, Bayer

      Session Details:

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

      2026-11-04, 11:40 AM

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

      Session Details:

      INTERACTIVE BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝 📊 LIVE POLL

      2026-11-04, 4:30 PM

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

      Session Details:

      INTERACTIVE BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝 📊 LIVE POLL

      2026-11-04, 4:30 PM

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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: Clinical Supplies Due Diligence: Evaluating External Drug Programs and Managing a Seamless Transition 📊 LIVE POLL

      2026-11-04, 12:40 PM

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

      Session Details:

      INTERACTIVE BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝 📊 LIVE POLL

      2026-11-04, 4:30 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 BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝 📊 LIVE POLL

      2026-11-04, 4:30 PM

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      Sebastian De Beurs
      Co-Founder, Healis Therapeutics

      Session Details:

      KEYNOTE: China’s Biotechnology Sector and What It Means for America!

      2026-11-05, 12:15 PM

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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, 12:40 PM

      Session Details:

      Interactive Breakfast Roundtable Discussions

      2026-11-05, 8:30 AM

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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, 8:30 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, 8:30 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 BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

      2026-11-04, 4:30 PM

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      Shawn Gehen
      Senior Manager, Clinical Supply, Lexeo Therapeutics

      Session Details:

      Interactive Breakfast Roundtable Discussions

      2026-11-05, 8:30 AM

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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, 12:45 PM

      Session Details:

      Chair’s Opening Remarks

      2026-11-05, 9:20 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.

      Session Details:

      Interactive Breakfast Roundtable Discussions

      2026-11-05, 8:30 AM

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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, 10:25 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:

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

      2026-11-04, 12:10 PM

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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 BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝 📊 LIVE POLL

      2026-11-04, 4:30 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, 4:00 PM

      Session Details:

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

      2026-11-04, 4:00 PM

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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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      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, 8:50 AM

      Session Details:

      INTERACTIVE INDUSTRY KEYNOTE: How to make Planning a Successful Role through People, Processes and Performance? 📊 LIVE POLL

      2026-11-04, 9:25 AM

      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, 12:40 PM

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      Fiona Geiger
      Vice President, 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.

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      Andy Maltun
      Vice President, Product Management, Endpoint

      Andy Maltun is a technology and clinical supply leader with expertise in clinical trial forecasting, supply chain optimization, software engineering, and artificial intelligence. As Co-Founder and former CEO of Bluefin, he helped develop innovative forecasting and planning solutions that enable sponsors to automate clinical supply decisions, reduce waste, and improve trial efficiency. Prior to Bluefin, Andy held engineering leadership roles at Procore Technologies, where he scaled global product and engineering teams and led the development of enterprise software platforms serving complex operational environments. With an earlier foundation in medical device engineering, he brings a unique perspective that combines technology innovation, operational excellence, and practical problem-solving to advance clinical trial execution and supply chain performance

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      Rashi Gupta
      Senior Consultant, Practice Manager, Dark Horse Consulting Group

      Strategy and operations consultant specializing in clinical and commercial biopharma supply chains, with expertise in launch readiness and end-to-end execution.

      Session Details:

      CASE STUDY: Driving Cross-Functional Alignment and Demand Planning Through S&OP/IBP📊 LIVE POLL

      2026-11-05, 10:00 AM

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      Claes Kalderén
      Chief Revenue Officer, TSS

      Session Details:

      CASE STUDY: 5 Questions Every Sponsor Must Ask About Their Clinical Supply Chain for Faster, Leaner Trials!

      2026-11-05, 11:45 AM

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      Dan Caramore
      Strategic Account Manager, N-SIDE
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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: Clinical Supplies Due Diligence: Evaluating External Drug Programs and Managing a Seamless Transition 📊 LIVE POLL

      2026-11-04, 12:40 PM

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