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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 deeptech company that empowers organizations in the life sciences to make better decisions and optimize the use of critical resources. We’re doing so by combining deep industry expertise with applied mathematics and artificial intelligence into easy to use and cutting-edge software that transforms uncertainty and complexity into deterministic outcomes. We are an active player in clinical trial supply chain management for over 20 years and have the majority of the top 20 pharmaceutical companies as clients.

With our software solution, the N-SIDE Suite, and expert services, we streamline the clinical supply of pharmaceutical and biotech companies by accelerating clinical plans, mitigating risks and curbing drug waste. We empower clinical leaders to make better, faster and safer decisions for patients waiting for life-changing medications.

Company Website

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

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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 - www.CCLClinical.com

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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: OPTIMIZING PARTNERSHIP, NETWORK & INFRASTRUCTURE

    11:30 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

    12 PM

    CASE STUDY: Internal Control vs. External Agility in Modern Pharma Supply Chains 📊 LIVE POLL

    • The Seduction vs. The Reality: Dissecting the gap between a CDMO’s glossy sales pitch and actual operational delivery
    • The Sovereignty Trap: Identifying where cost-cutting turns into a dangerous loss of internal technical expertise, and how to maintain "intellectual sovereignty" over your own product
    • Is it actually cheaper and easier to hire outside help when we get super busy, or will managing those outsiders create more work than it saves!

    Reserved for vendor

    12:30 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 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

    12:50 PM

    💡 TECH SPOTLIGHT: Building the Backbone of Clinical Trials with a Robust IRT SYSTEM

    • Designing for Modern Trial Complexity: Handling adaptive designs and mid-study protocol amendments seamlessly
    • Mastering the Integration Ecosystem: Connecting IRT with other internal softwares to eliminate data silos
    • Risk-Mitigation & Site Empowerment: Minimizing user error at the clinical site while automating inventory alerts

    Vendor Opportunity

    1:05 PM

    Lunch and networking

    STREAM B – STRATEGIC SOURCING & END-TO-END SUPPLY EXCELLENCE

    2:15 PM

    ASK THE EXPERT PANEL: Navigating High Costs, Restricted Access & Regulatory Friction in Modern Comparator Supply Chains 📊 LIVE POLL

    • Learn how to bypass manufacturer limits and get the exact commercial products your trials need
    • How to implement data-driven forecasting to mitigate skyrocketing costs and minimize waste when procuring high-cost biologics
    • Mastering regulatory traceability to navigate strict global compliance mandates to maintain uninterrupted, audit-ready clinical supply chains

    2:45 PM

    CASE STUDY: Beyond the Molecule: Managing ancillary sourcing to keep trials on track

    • How to identify and manage ancillary supplies as a critical path risk early in study planning
    • How to handle long lead times, global sourcing challenges, and align sourcing with packaging, labeling, and distribution
    • How to mitigate risks and leverage supplier relationships for reliability and flexibility

    Reserved vendor

    3:10 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 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 "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.

    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 fixes and configuring your IRT to spot bottlenecks weeks before a patient walks through the clinic door.

    Speakers

    Meghan Hasson
    Sr. Manager, IRT Supply Chain Systems, Deciphera
    Marc Lave
    RTSM Product Development Owner, Johnson & Johnson Innovative Medicine
    Jason Bellman
    Sr, Manager IRT Systems and Clinical Supply, Cullinan Therapeutics

    5 PM

    Chair’s summary and close of day 1

    Don’t forget to leave us your feedback through our app! Your insights help us make future sessions even better.

    5:05 PM

    🍷 Drinks reception – Join us to network and unwind over a selection of fine 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

    AI, DIGITAL TRANSFORMATION, & COMPLIANCE

    8:50 AM

    Chairperson’s opening remarks

    9 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

    FDA & EMA: Invited

    9:30 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

    10 AM

    DIGITAL TRANSFORMATION VISION KEYNOTE: How to Revolutionize your Clinical Supply Chain at Every Level to Eliminate Logistics Disruptions & Transform your Manufacturing with a Data-Centric Vision

    • The Power of Connected Digital Systems: How to replace paper workflows to optimize supply chain traceability, streamline patient scheduling and accelerate manufacturing release times with zero-error
    • Site-Sponsor Digital Integration: How to leverage collaborative platforms to align clinical programs with manufacturers, backed by clear frameworks to assess digital maturity and prioritize high-impact transformation
    • How to leverage Digital Twins to simulate clinical trial material manufacturing and packaging to anticipate any bottlenecks and optimize clinical supply chain ahead of physical execution

    Speakers

    Saurabh Dhiman
    Global Head Digital Health and Science, Sanofi

    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
    Vice President Business Development, Valeris

    10:45 AM

    Morning refreshments and networking

    STREAM A: SCALING AI BEYOND PILOT

    11:30 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 PM

    INDUSTRY CASE STUDY: Balancing Fluid Science & Rigid Supply Chains: AI-Driven Forecasting in Clinical Trials

    • How to leverage AI forecasting models to stop over-forecasting and overproducing costly investigational drugs, relieving manufacturing pressure without risking trial delays
    • How to embed AI into daily workflows to predict trade lane delays, optimize routes based on risk exposure, and flag real-time shipment anomalies using global data signals
    • Mitigate friction between rigid manufacturing constraints (long lead times) and volatile clinical trial changes like protocol amendments or rapid global expansion

    Reserved vendor

    12:30 PM

    FIRESIDE CHAT: 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

    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

    💡 TECH SPOTLIGHT: 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

    Vendor Opportunity

    1:05 PM

    Lunch and networking

    STREAM A – AGILE CLINICAL SUPPLY OPERATIONS

    2:15 PM

    ASK THE EXPERT PANEL: Overcoming the Legacy Trap: Modernizing Clinical Supply Systems for Market Access 📊 LIVE POLL

    • How to navigate the heavy complexities of transitioning mid-to-large-sized companies away from rigid, slow legacy systems that have been deeply embedded for years!
    • How to pivot clinical trial operations away from a purely execution-focused approach and toward a strategic market access and feasibility mindset
    • How to optimize the sourcing and management of comparator drugs by replacing outdated system silos with agile, modernized data footprints designed for global trial demands

    Speakers

    Stephen Bonsu
    Senior Director, Commercial Product Regulatory & Supply Strategy, Eli Lilly and Company
    Camille Pataki
    Senior Computational Product Discovery Engineer, AI Projects, Eikon Therapeutics

    2:45 PM

    The Tech-Driven Trial: Syncing Clinical Operations Innovations with Next-Gen Supply Strategies 📊 LIVE POLL

    • How to re-engineer the supply chain for Direct-to-Patient (DtP) delivery models, ensuring "last-mile" cold chain integrity and regulatory compliance in a home setting
    • How to leverage eConsent and Remote Monitoring data to trigger automatic resupply shipments, reducing the burden on both patients and site staff
    • How to adapt supply strategies for "Continuous Trials" and adaptive designs where patient cohorts and dosages change dynamically based on incoming data

    Reserved vendor

    3:10 PM

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

    Speakers

    Carol Shultz
    Senior Director, Global Clinical Supply, Merck

    3:45 PM

    Afternoon refreshments and networking

    STREAM A AI with a Human Touch: Practical Strategies for Smart, Safe Adoption

    4:15 PM

    🍻INTERACTIVE BEER BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

    AI is powerful, but the drug and the patient come first. This boardroom explores how teams can leverage AI safely, integrate it into workflows, and maintain human control with strong processes.

    Outcome: Each table will collaborate to create practical strategies, and governance approaches that balance AI capabilities with human oversight, ensuring AI enhances decisions rather than replacing critical thinking.

    A variety of alcoholic and soft drinks will be served

    5 PM

    Chair’s summary and close of day 1

    Don’t forget to leave us your feedback through our app! Your insights help us make future sessions even better.

    5:05 PM

    🍷 Drinks reception – Join us to network and unwind over a selection of fine 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

    STREAM B – END-TO-END SUPPLY QUALITY & COMPLIANCE

    11:45 AM

    CASE STUDY: FDA Expectations for Deviation Closures & CAPA Effectiveness

    • Move beyond superficial human error classifications by implementing robust RCA methodologies that identify the true systemic vulnerabilities in your clinical operations
    • CAPA design matrix: Designing corrective actions that fix the underlying issue and preventive actions that protect other trials
    • Tracking and analyze repeat deviations across multiple clinical protocols to catch systemic failures before an inspector does

    Speakers

    Herbert Anthony
    Senior Director, Quality Assurance, Kolon TissueGene

    12:15 PM

    INDUSTRY CASE STUDY: Clinical Integrity in Transit: Safeguarding Global Supply Chain Quality

    • Navigating complex multi-country labeling requirements and implement proactive customs safeguards to prevent devastating temperature excursions during transit delays
    • Establishing risk-based validation protocols for global shipping routes before clinical trials begin, ensuring investigational product stability and effectiveness from start to finish
    • Implement strict "Chain of Condition" protocols, combining real-time data loggers to confidently release or quarantine clinical materials upon arrival

    Vendor Opportunity

    12:45 PM

    ASK THE EXPERT PANEL: Synchronized from Day One: Aligning Protocol Design with Manufacturing & Logistic Reality 📊 LIVE POLL

    • How to transition from isolated clinical forecasting to unified, cross-functional demand planning that includes operations, quality, and CMOs from early on
    • Protocol best practices: What helps clinical supply succeed, what gets written into a protocol that limits our options or creates complexity later on?
    • The importance of integrating manufacturing lead times, capacity limits, and supply chain volatility directly into early-stage protocol design to build operational resilience
    • How proactive communication allows the entire cross-functional chain to dynamically adjust to enrollment fluctuations without compromising compliance, timelines, or budget

    Moderator: Irena Maksimovic

    Speakers

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

    1:15 PM

    LUNCH, NETWORKING AND 🏆 PRIZE DRAW 🏆

    8:15 AM

    Registration and refreshments

    9 AM

    Chair’s opening remarks and early birds prize draw – 🏆 Top 3 LinkedIn posts with hashtags 🏆

    9:10 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. Architecting the ATMP Supply Chain: A Practical Guide to Planning & Orchestration Excellence
    Tom Walls, Former Head of Supply Chain Planning, Spark Therapeutics

    3.How clinical supply teams work with 3PLs and carriers to design bulletproof shipping lanes, build smart backup plans, and ensure that high-value biologics survive the realities of global transit; How to manage "just-in-time" logistics for cancer drugs with ultra-short shelf lives, where even a brief flight delay can ruin the therapy. How to meet big pharma standards on a startup budget: Scaling compliance with limited staff and high regulatory burdens
    Small vs. Large CDMOs/CMOs: How to choose the right partner for agility, scale, and clinical supply success

    4. How to start implementing AI in your day to day workflows to deliver real outcomes in your clinical supply

    5. Integrated Program Planning: Syncing CMC, Manufacturing, and Clinical Supply for Accelerated Timelines

    6.How to accelerate clinical decision-making through system integrity: Moving beyond manual data reconciliation to gain instant, cross-functional visibility

    7. Moving away from audit nightmares to real-time accountability and audit readiness approach

    8. How to leverage consultants to fill expertise gaps, optimize QP resources, and stay audit-ready without scaling internal teams

    CHINA INNOVATION & US IMPORT LOGISTICS

    10 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

    Reserved for Global Data

    10:25 AM

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

    • How to format Global Import Documentation: Master FDA filing 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 fix 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

    11 AM

    💡 TECH SPOTLIGHT: Innovation isn’t just happening in the lab, it’s happening in the Supply Chain

    The landscape of clinical trials is shifting rapidly. Advanced digital enablement tools are completely transforming supply chain operations by:

    • Delivering real-time insights to anticipate and mitigate disruptions before they happen
    • Fostering Global Supply chain continuity, ensuring life-saving therapies move from lab to patient faster and more reliably than ever before

    11:15 AM

    Morning Refreshments & Networking

    STREAM A – CARRIER RESILIENCE, SMART DISTRIBUTION & LAST-MILE DELIVERY

    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

    INDUSTRY CASE STUDY: Connected Logistics: Preventing Temperature Failures & Last-Mile Mistakes

    • How 3PLs and carriers can share data instantly to keep shipments moving smoothly from the warehouse shelf all the way to the patient's bedside
    • How to use smart, real-time tracking tools to spot temperature issues early and intervene before the medicine is ruined
    • Avoiding Last-Mile Mistakes: Simple strategies to prepare clinical sites for high-stakes deliveries, ensuring onsite staff don't leave fragile medicines sitting on a warm loading dock

    Vendor Opportunity

    12:45 PM

    ASK THE EXPERT PANEL: Why Smart Clinical Packaging Adoption is still low – and how to move forward 📊 LIVE POLL

    • Deconstructing Adoption Barriers: Analyze the real friction points keeping smart packaging grounded from site level to tech fatigue and heavy vendor qualification timelines to the lack of standardisation across clinical platforms
    • Pinpointing Value Hotspots: Identify protocols where smart packaging is non-negotiable, specifically high-risk at-home dosing and decentralized trials (DCTs) where patient adherence is critical to trial data
    • Scaling Without Overinvestment: Move beyond isolated pilot projects by weighing the explicit ROI of data-rich packaging against traditional methods

    Speakers

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

    1:15 PM

    LUNCH, NETWORKING AND 🏆 PRIZE DRAW 🏆

    ENHANCING SUSTAINABLE SUPPLY CHAIN PRACTICES

    2:15 PM

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

    • 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

    THE BIOTECH FRONTIER: CHALLENGES, TRENDS & FUTURE STRATEGIES

    2:45 PM

    BIOTECH HOT TAKES: INSIGHTS FROM INDUSTRY LEADERS 🔥

    3–4 Philadelphia biotech companies share their perspectives in short, dynamic talks (5–10 minutes each)

    Speakers

    Jarrod Longcor
    Chief Operating Officer, Cellectar Biosciences

    3:15 PM

    End of conference

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    Speakers

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

    Session Details:

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

    2026-11-05, 10:25 AM

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

    Session Details:

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

    2026-11-05, 10:25 AM

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    Reid Tonik
    Senior Director, Clinical Supply Chain, Eikon Therapeutics

    Global clinical supply chain expert with over 20 years of industry experience and a proven track record of successfully managing multiple clinical trial programs and teams from initial design through study close-out. Experience includes a 2-year international assignment, team and budget management, and optimizing departmental productivity by identifying opportunities for greater efficiencies and quality.

    Session Details:

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

    2026-11-04, 11:30 AM

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

    Session Details:

    ASK THE EXPERT PANEL: Overcoming the Legacy Trap: Modernizing Clinical Supply Systems for Market Access 📊 LIVE POLL

    2026-11-04, 2:15 PM

    Session Details:

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

    2026-11-04, 11:30 AM

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

    Session Details:

    FIRESIDE CHAT: Foundation before Digitalization: How to Build a Solid AI Foundation for your Clinical Supply Chain 📊 LIVE POLL

    2026-11-04, 12:30 PM

    Session Details:

    ASK THE EXPERT PANEL: Synchronized from Day One: Aligning Protocol Design with Manufacturing & Logistic Reality 📊 LIVE POLL

    2026-11-05, 12:45 PM

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    Carol Shultz
    Senior Director, Global Clinical Supply, Merck

    Session Details:

    FIRESIDE CHAT: Foundation before Digitalization: How to Build a Solid AI Foundation for your Clinical Supply Chain 📊 LIVE POLL

    2026-11-04, 12:30 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, 3:10 PM

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    Manda Pasarkar
    Head of Global Regulatory Affairs CMC, Sanofi

    Session Details:

    ASK THE EXPERT PANEL: Synchronized from Day One: Aligning Protocol Design with Manufacturing & Logistic Reality 📊 LIVE POLL

    2026-11-05, 12:45 PM

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    Saurabh Dhiman
    Global Head Digital Health and Science, Sanofi

    Session Details:

    DIGITAL TRANSFORMATION VISION KEYNOTE: How to Revolutionize your Clinical Supply Chain at Every Level to Eliminate Logistics Disruptions & Transform your Manufacturing with a Data-Centric Vision

    2026-11-04, 10:00 AM

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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

    2026-11-05, 2:15 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, 12:30 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: How to Evaluate External Drug Programs & Manage a Seamless Transition

    2026-11-05, 11:45 AM

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    Stephen Bonsu
    Senior Director, Commercial Product Regulatory & Supply Strategy, Eli Lilly and Company

    Stephen Bonsu is an accomplished leader with over 20 years of experience in biopharmaceutical development and business strategy.  He has extensive expertise in healthcare, clinical development, and commercialization across pharmaceutical and biotech portfolios. His career spans leadership roles focused on strategic portfolio management, regulatory affairs, and global supply chain coordination, with a strong emphasis on cross-functional team leadership and talent development.

    • Leadership in Biopharma Development: Stephen Bonsu is a visionary and transformational leader with experience managing matrix teams across CMC, clinical operations, and regulatory affairs to drive organizational goals and portfolio execution.
    • Expertise in Drug Development and Regulatory Strategy: Stephen has contributed to drug research, clinical development, and regulatory sciences, supporting global clinical trials and product delivery strategies, including risk mitigation and supply chain adaptation.
    • Senior Roles at Eli Lilly & Company: Since January 2024, Stephen serves as Senior Director, overseeing commercial product regulatory and supply strategy for cardiometabolic and neuroscience portfolios, partnering with multiple functions to ensure clinical and commercial supply alignment.
    • Leadership at Bristol-Myers Squibb: From 2018 onward, Stephen led clinical supply programs and global supply chain strategies for over a dozen portfolio assets across major therapeutic areas, managing risks for high-revenue brands and fostering cross-functional collaboration.
    • Program and Talent Development: Stephen has led leadership development initiatives within the BMS BOLD ERG organization, focusing on minority talent growth and diversity, equity, and inclusion goals.
    • Experience in Biologics and Biosimilars: Stephen headed CMC integration and program management at Adello Biologics, driving biosimilar clinical development and regulatory submissions with significant budget oversight.
    • Entrepreneurial Venture: Stephen Founded and operated Teylev Café, managing business planning, operations, supply chain, and team leadership while maintaining a biopharma career.
    • Educational Background and Skills: Stephen holds a Master of Business & Science with concentrations in drug discovery and development, and a Bachelor of Science in Physics. Certified in project management and Six Sigma, with proficiency in program leadership, clinical and commercial drug development, and budget management.

    Session Details:

    ASK THE EXPERT PANEL: Overcoming the Legacy Trap: Modernizing Clinical Supply Systems for Market Access 📊 LIVE POLL

    2026-11-04, 2:15 PM

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    Herbert Anthony
    Senior Director, Quality Assurance, Kolon TissueGene

    Session Details:

    CASE STUDY: FDA Expectations for Deviation Closures & CAPA Effectiveness

    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 Lave
    RTSM Product Development Owner, Johnson & Johnson Innovative Medicine

    Session Details:

    🍻INTERACTIVE BEER BOARDROOM: COLLABORATE, SOLVE, SHARE 🤝

    2026-11-04, 4:15 PM

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    Jason Bellman
    Sr, Manager IRT Systems and 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

    Session Details:

    FIRESIDE CHAT: Foundation before Digitalization: How to Build a Solid AI Foundation for your Clinical Supply Chain 📊 LIVE POLL

    2026-11-04, 12:30 PM

    Session Details:

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

    2026-11-04, 3:10 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, 11:30 AM

    Session Details:

    BIOTECH HOT TAKES: INSIGHTS FROM INDUSTRY LEADERS 🔥

    2026-11-05, 2:45 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:

    FIRESIDE CHAT: Foundation before Digitalization: How to Build a Solid AI Foundation for your Clinical Supply Chain 📊 LIVE POLL

    2026-11-04, 12:30 PM

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    Tom Walls
    Associate Director - Supply Chain Planning, Spark Therapeutics, Inc.
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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:

    ASK THE EXPERT PANEL: Why Smart Clinical Packaging Adoption is still low – and how to move forward 📊 LIVE POLL

    2026-11-05, 12:45 PM

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    Advisory Board

    Select a member to learn more

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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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    Amaury Jeandrain
    Strategy Advisor, Clinical Supply, 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.

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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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    Sheraton Valley Forge, King of Prussia, PA, USA

    CTSEC November 2025 Start Date: Wednesday, October 29, 2025 End Date: Sunday, November 09, 2025 Hotel(s) offering your special group rate: • Sheraton Valley Forge King of Prussia for 209.00 USD per night - Last Day to Book : Thursday, October 02, 2025

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