14th Annual Clinical Trial Supply New England 2025

Arena will be returning to the Westin Waltham for our 2025 Clinical Trial Supply, New England conference. The event will showcase talks from top industry players, unrivaled networking opportunities and the chance to find cutting-edge solutions in the exhibition hall.

8 - 9

April

2025
  • The Westin Waltham Boston, MA, USA
  • Complimentary
  • Why attend?
  • Agenda
  • Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • 2025 Sponsors
  • Media Centre
  • Why partner?
  • Contact Us
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2025 Sponsors Include:

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Company Information

S-Clinica offers VISION, a unique platform for the anticipatory management of your clinical trials.

From study concept to study closer, our system will help you handle your mission, smoothly and stress-free.

Say goodbye to drug wastage, patient loss, or recruitment delays. A team of our experts will guide you along the way!

Company Website

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

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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.

Th combination of passion and expertise leverages our global reach and maximizes customer satisfaction.

Company Website

To learn more, please visit our website - http://acnospharma.de/

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Company Information

Simply sourcing comparators – we offer a unique blend of small company flexibility and speed, backed with the large-scale buying power of the Orifarm Group, which is one of the largest pharmaceutical suppliers in Europe. With over €1.4B products sold in 2021 and more than 4,000 unique product lines sourced on a monthly basis, we have unparalleled access to “out of market” and manufacturer direct buying capability, both in the US and Europe.

Company website: www.Orifarm-CTS.com

Company Website

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

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Company Information

With over 30 years of experience, we offer clinical trial supply solutions such as global sourcing, packaging & labeling, QP release services and storage & distribution.

We are a trusted partner for both academic and non-academic studies, providing clinical supply services from Phase I to Phase IV.

Our in-house team of QP’s supports you in all stages of your process including the audit of the supply chain for GMP compliance in addition to certification of products for use in clinical trials.

We are strategically located and HQ in Belgium, a European leader in clinical trials.

We are operational in a newly built, innovative GMP facility with cleanroom for clinical trial labelling.

We are Ecovadis certified, an independent platform to assess corporate social responsibility and sustainable procurement.

We are a privately owned company with a long-term vision. We stand for flexibility, agility and operational excellence.

Company Website

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

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Company Information

Myonex provides tailored services and solutions to advance medicine through clinical to commercial stages with tailored drug sourcing and ancillary supply, to packaging, labeling, and distribution. With ten global locations, we offer flexible, efficient, and cost-effective support for clients across the pharmaceutical and biotech sectors.

 

Company Website

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

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Company Information

Bionical Emas is a global Contract Research Organization (CRO) combining Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) bringing life-changing medicines to patients around the world. Our Clinical Trial Supply Division has a global vendor network of manufacturers, wholesaler distributors and optimized sourcing strategies to support your study. Whether you require products locally sourced in emerging markets and distributed directly to trial sites, global sourcing of high-value commercial drug products, or a demand-driven sourcing approach, we have the right solution for you.

Company Website

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

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Company Information

Mercalis has a suite of Clinical Trial Support services designed to provide time and cost efficiencies.

RxStudy Card – Pharmacy provides commercially available medications and supplies through retail and specialty pharmacies. This supply strategy reduces supply process steps, requires less employee time, eliminates supply waste, and has fewer risks resulting in an 80% reduction in labor and a 50% reduction in costs.

RxStudy Card – Provider provides reimbursement for site sourced and administered medication and is essential for studies requiring biologics and oncolytics, which are more frequently being sourced directly by a provider and not through a pharmacy.

RxStudy Card – Procurement is an innovative GLOBAL clinical trial supply process that more efficiently provides commercially available medications and supplies. RxStudy Card – Procurement leverages “in country” sourcing and distribution, provides study teams and sites a simple online ordering experience for “just in time” “as needed” delivery, in quantities specific to each site and patients need with direct to site shipments and real time order and shipment status.

Company Website

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

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Company Information

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

Company Website

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

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Company Information

PCI is a leading global CDMO, providing integrated end-to-end drug development, manufacturing and packaging solutions to increase product speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the delivery of supply chain healthcare services.  With 30 sites across Australia, Canada, North America, the UK and Europe and over 4,300 dedicated employees, our mission is to bring life-changing therapies to patients. Leading technology and continued investment enable us to deliver development to commercialization solutions throughout the product lifecycle, collaborating with our clients to improve the lives of patients globally.

Company Website

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

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Company Website

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

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    Why attend?

    Elevating clinical trial supply expertise where industry leaders come together to discuss, debate and consider new technologies and processes to streamline supply chain operations and strategies.

    Content & Resources – The variety of presentations, roundtable discussions and panel discussions will provide lots of opportunities to interact and share best practice as well as hearing latest case studies and insights on key topical clinical supply areas from other sponsor companies.

    Professional Connections – The event is a premium experience and an invaluable opportunity to connect with peers across the biopharma industry. There are plenty of opportunities to network over coffee, complimentary lunch, and frequent networking breaks. 

    Business Prospects – Attendees will have ample opportunities to visit our exhibition hall featuring numerous vendor booths, with experts ready to help you find the latest, cutting-edge solutions and answer any questions you may have.

    Regulatory Insights – The conference is designed to provide participants with a comprehensive understanding of current regulations, offering information directly from both the FDA and U.S Customs and Border Protection.

     

    WHAT TO EXPECT FOR 2025?

    The annual Clinical Trial Supply conference is a leading summit for discovering exclusive expert-led insight, featuring major bio-pharma companies including Alexion, Regeneron and Takeda.

    The event will feature a mixture of presentations, fireside chats, panel discussions and roundtable discussions on the latest hot topics and trends within clinical supply.

    The Clinical Trial Supply series is a unique platform for clinical trial sponsors and solution providers. It is aimed at enabling knowledge-sharing, benchmarking, network-building and forging partnerships and innovation amongst biopharma industry peers.

    100+

    Attendees

    		30+

    Exhibitors

    		20+

    Speakers
    100+

    Attendees

    		30+

    Exhibitors
    20+

    Speakers

    Testimonials

    See What It's All About

    Agenda

    • 9 Apr 2024
    • 10 Apr 2024
    Expand All

    8:15 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s opening remarks

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    9 AM

    Importing FDA regulated Biological Products

    • Entry Screening/Admissibility
    • FDA Regulatory Requirements for CBER Regulated Products
    • Making ACE Work for You: Importing Biological Products

    Speakers

    Anthony Thomas
    Consumer Safety Officer, FDA
    Stephen King
    Compliance Officer, FDA

    9:30 AM

    An insurance policy for your trial: Technology to enable a worry-free CTS execution

    • Overview of the challenges associated with drug shortages in clinical trials
    • Forecasting & planning technologies overview
    • How technology acts as a good insurance policy to prevent drug shortages and supply chain disruption
    • What if things don't go according to plan?

     

    Speakers

    Maxime Derep
    Director of Solutions Engineering, N-SIDE
    Jake Levine
    Solutions Engineer, N-SIDE

    10 AM

    Optimizing drug utilization: strategies to tackle drug waste in healthcare

    • Exploring how precision medicine and personalized dosing can be leveraged to minimize drug overuse and reduce waste, considering factors such as patient variability and therapeutic response.
    • Discussing improvements in supply chain management to prevent overstocking and expiration of medications, emphasizing collaboration between healthcare providers and pharmaceutical suppliers to streamline inventory and reduce waste.
    • Highlighting the importance of patient education and adherence initiatives in reducing unnecessary drug consumption, and explore how healthcare professionals can work with patients to enhance understanding and compliance, ultimately minimizing medication waste

    Speakers

    Lisa Kaufman
    Director, Quality, Process and Risk Management, AstraZeneca

    10:30 AM

    Morning refreshments and networking

    11 AM

    Modernizing the way drugs are made: a transition to continuous manufacturing

    • Exploring batch vs continuous manufacturing
    • Pinpointing benefits of continuous manufacturing- reduced manufacturing costs, particularly over the long term, shorter production times, improved quality
    • A challenging but worthwhile transition revamping industry infrastructure

    Speakers

    Rajiv Panwar
    VP, CMC, Technical Operations and Clinical Supply Chain, Disc Medicine

    11:30 AM

    How implementing innovative processes and technologies results in a more efficient use of human resources, reduces the amount of logistical resources required, saves money and lowers the carbon footprint impact

    • Increasingly pharmaceutical companies are committing to reducing their carbon footprints in the execution of clinical trials
    • A more efficient and effective clinical trial supply chain can be created by implementing new clinical supply technologies and sustainable processes

    Speakers

    Tom Gottschalk
    Vice President, Business Development, Mercalis

    12 PM

    State of the biopharma industry: the outlook for drugs, trials, and manufacturing

    • What’s coming in the pharma pipeline?
    • Drug manufacturing for clinical trials
    • Emerging trends: gene therapy, mRNA, and AI
    • Opportunities for contract development and manufacturing organisations (CDMOs)

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    12:30 PM

    Supply Forecasting + RTSM: The next generation

    Meeting the requirements for today’s clinical trials

    • Key aspects - Forecasting Accuracy Speed & Flexibility
    • Meeting the challenges of todays trials - what and how to achieve
    • Unified Platform - Supply Forecasting +RTSM

    Speakers

    Irena Seredina
    Executive Director, S-Clinica
    Jasvinder Osan
    Vice President Business Development, S-Clinica

    12:45 PM

    Lunch and networking

    2 PM

    FIRESIDE CHAT: Digital supply chain and its impacts on clinical supply

    • Highlighting key challenges/complexities in the clinical supply chain
    • Digital Strategies for the optimal clinical supply chain
    • Discussing digital technologies (blockchain/AI) and its impact on the clinical supply chain

    Speakers

    Ajay Balasubramaniam
    Associate Director Supply Chain Systems, Pfizer

    2:30 PM

    Fostering Skills Development and Mentorship in Clinical Supply Chain Management

    • Emphasizing the critical role of skills development and mentoring programs in fortifying the clinical supply chain against disruptions.
    • Highlighting the significance of these programs in enhancing patient experiences and achieving significant cost savings.
    • Showcasing attendees gaining insights into mitigating supply chain challenges through acquiring essential competencies and fostering mentorship relationships.
    • Demonstrating through real-world examples and interactive discussions the role of continuous learning and mentorship in promoting resilience, efficiency, and innovation in clinical trial supply chain management

    Speakers

    Yves Dethier
    Business Leader, Boostcode

    3 PM

    Fostering a dynamic team culture for talent development within supply chain

    • Cultivating collaborative team dynamics
    • Emphasizing the value of diverse thinking for problem-solving and creative solutions
    • Implementing ongoing training programs to upskill team members and address skill gaps
    • Providing mentorship and coaching opportunities to nurture individual growth

    Speakers

    Paul Larochelle
    Director, Global Clinical Supply Chain, Takeda
    Sydney Reynolds
    Postdoctoral Fellow - Global Clinical Supply Chain, Takeda

    3:30 PM

    Afternoon refreshments and networking

    4 PM

    Investigating the necessities surrounding the import and export of biological materials

    • Emphasizing the critical role of thorough preparation
    • What relevant authorities to contact in advance to avoid unnecessary complications
    • CBP One – an application that allows scheduling inspection appointments in advance for biological products upon their air arrival into the U.S.
    • Understanding what Importer of Record is and how to become a registered one

    Speakers

    Sean Smith
    Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection
    Baljeet Kaur
    Agriculture Operations Manager, US Customs and Border Protection

    4:30 PM

    Consolidate, Streamline, Scale: Achieve Operational Excellence with Unified EDC & RTSM

    • Consolidate Roles and Specs: Eliminate the need for separate EDC and RTSM requirements, builds and validation events, and manage both with a single, unified specification.
    • Streamline Workflows: Reduce complexity and bottlenecks by leveraging a single platform for EDC and RTSM, eliminating integration challenges.
    • Scale Efficiently: Focus on user acceptance testing vs software validation, reducing effort and complexity as your programs scale.

    Speakers

    William Lander
    Sales Solutions Consultant, Presales, Oracle

    5 PM

    PANEL DISCUSSION Discovering the evolution in the clinical supply chain

    • Exploring the role of emerging technologies, such as blockchain, IoT, and AI, in revolutionizing the clinical supply chain and discuss how these innovations enhance visibility, traceability, and efficiency.
    • Effective use of technology to assist with planning and forecasting
    • Examining the shift toward patient-centricity in clinical trials and its influence on the supply chain, emphasizing how personalized medicine, decentralized trials, and direct-to-patient models are shaping the evolution of clinical supply strategies.

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData
    Gilad Beck
    Site Head, Operations and Manufacturing Director, Orgenesis
    Kristen DeVito
    Executive Director Clinical Supply Chain, Exelixis
    Antoine Remiot
    Antoine Remiot, Senior Director - Global Business Development & Partnerships, Clinical Supply Optimization, N-SIDE

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    END OF DAY 1 AND NETWORKING DRINKS

    8:15 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s opening remarks

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    9 AM

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    During the roundtable discussion session, the conference hall will be divided into three ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical supply chains. After 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

    ROUNDTABLE 1:

    A Q&A session examining U.S. Customs and Border Protection – help with any questions about how to import or export biological materials to or from the U.S.* 

    Sean Smith, Biological Threat Exclusion Coordinator, US Customs and Border Protection Baljeet Kaur, Agriculture Operations Manager, US Customs and Border Protection

    ROUNDTABLE 2:

    Fostering effective collaboration with suppliers and vendors across the clinical supply chain

    Jillian Byrne, Senior Manager, Clinical Supply Chain, Disc Medicine

    ROUNDTABLE 3:

    Investigating the difference in forecasting perspective from a small company to a large one

    Jennifer Case, Clinical Supply Chain Manager, Biogen

    Speakers

    Sean Smith
    Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection
    Baljeet Kaur
    Agriculture Operations Manager, US Customs and Border Protection
    Jennifer Case
    Senior Manager, Clinical Asset Planning, Biogen
    Jillian Byrne
    Senior Manager, Clinical Supply Chain, Disc Medicine

    10:30 AM

    Morning refreshments and networking

    11:15 AM

    Understanding strategies for preventing shortages and enhancing resilience in supply chain

    • Delving into the importance of building resilient clinical supply systems, exploring technologies and methodologies that enhance agility and responsiveness to prevent shortages in the face of unforeseen challenges
    • Discussing strategies for effective comparator sourcing, addressing potential bottlenecks, and exploring partnerships or alternative sourcing approaches to ensure a stable and consistent supply of comparators for clinical trials
    • Explore considerations and approaches for removing comparators from the free market, examining the potential impact on supply stability and discussing measures to mitigate market-related risks, ensuring a reliable and sustainable clinical supply chain

    Speakers

    Rakibou Ouro-Djobo
    Global Clinical Supply Chain & Logistics Lead, Bill & Melinda Gates Medical Research Institute

    11:45 AM

    Time and money savings for pharma logistics lanes

    • Improving supply chain efficiency and optimizing supply chains
    • Streamlining customs and security processes in order to reduce cost and decrease overall timelines
    • Flexible solutions for manufacturing, processing and repackaging

    Speakers

    Peter J. Skoutelas
    Chief Business Officer, Frontier Scientific Solutions

    12 PM

    Exploring how decentralized manufacturing can enhance clinical trial supply

    • High level overview of decentralized manufacturing – understanding what it means, the approach and how it’s done in practice
    • Recognizing how decentralized manufacturing can improve resilience of clinical trial supply
    • Maximizing upstream and downstream clinical supply efficiency through a decentralized framework
    • Envisioning the future of decentralized manufacturing and exploring its potential

    Speakers

    Gilad Beck
    Site Head, Operations and Manufacturing Director, Orgenesis

    12:30 PM

    The coming impact of new tissue stem cell quantification methods on cell supply for stem cell therapy and gene therapy clinical trials

    • New technologies for rapid and accurate quantification of tissue stem cells used for stem cell and gene therapy clinical trials
    • New capabilities for certifying cells supplied for stem cell therapy and gene therapy clinical trials
    • Future regulatory impact of emerging methods for certifying the specific dosage stem cells in cell therapy products

    Speakers

    James L. Sherley
    M.D., Ph.D. - President & Chief Executive Officer at Asymmetrex® LLC

    1 PM

    Lunch and networking

    2:15 PM

    A greener future for patients: the pharma supply chain’s journey to net-zero

    • The emergence of net-zero commitments and science-based targets to tackle climate change
    • Greenhouse gas accounting 101 – climate hotspots in the pharma value chain
    • Opportunities to drive decarbonization in clinical trial supply
    • Recent learnings from the implementation of Takeda’s net-zero roadmap

    Speakers

    Jessica Vieira
    Global Value Chain Environmental Sustainability Strategy Lead, Takeda
    Sarah Mandlebaum
    Lead, Global Environmental Sustainability & Life Cycle Assessment, Takeda

    2:45 PM

    Metrics and KPIs in the Clinical Supply Chain’

    • Identifying the key Clinical Supply Chain Metrics to measure organizational performance
    • Shaping KPI and metrics targets
    • Maximizing the value that metrics can provide
    • Improving metrics access

    Speakers

    Bjoern Rosner
    Global Lead, Clinical IRT and Supply Chain Digital Operations, Biogen

    3:15 PM

    PANEL DISCUSSION Harmonizing temperature excursion management: navigating conflicting policies at investigative sites

    • Addressing the challenges of integrating site-specific temperature excursion policies with the sponsor's requirements and proposing effective strategies for alignment.
    • Emphasizing the importance of open communication between sponsors and investigative sites to identify and resolve conflicts in temperature excursion management procedures.
    • Exploring the implementation of standardized procedures that accommodate both site-specific policies and sponsor requirements, ensuring effective temperature excursion management while respecting local protocols

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData
    Rakibou Ouro-Djobo
    Global Clinical Supply Chain & Logistics Lead, Bill & Melinda Gates Medical Research Institute
    Jamie Myers
    Senior Manager Clinical Supply Chain, Takeda
    Andrea Emery
    Senior Director, Head of Quality Assurance Operations

    4 PM

    Chairperson’s closing remarks

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    END OF CONFERENCE

    Speakers

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    Imran Shakur
    Director, IRT and Technology Lead, Alexion Pharmaceuticals

    Imran has 18 years of experience in the industry with the last 15 years focusing on IRT oversight from both the vendor and sponsor sides at companies that include ClinPhone, ICON, Takeda, Boehringer Ingelheim and currently Biogen. Imran is responsible for the clinical supply chain systems group where, in addition to IRT, he also oversees other supply chain capabilities like the demand planning and forecasting tool, temperature monitoring, and ERP systems.  Imran’s passion in clinical research, however, is devoted to thinking about how our industry can leverage the power of technology to make clinical trials more efficient and enable the delivery of effective investigational products to patients and their advocates.

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    Jenn Mahon
    Director Clinical Supply Lead, Alexion
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    Deirdre Casale
    Senior Director, Supply Chain, Alnylam Pharmaceuticals
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    Carlos Candido
    Vice President External Manufacturing & Supply Chain, Be Biopharma
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    Dan Solis
    Assistant Commissioner for Import Operations, FDA

    Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORA’s Office of Import Operations. Prior to this position he was the Division Director for the Division of West Coast Imports since February 9, 2018. He started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch.

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    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

    Session Details:

    Chairperson’s opening remarks

    2024-04-09, 8:50 AM

    Session Details:

    State of the biopharma industry: the outlook for drugs, trials, and manufacturing

    2024-04-09, 12:00 PM

    Session Details:

    Chairperson’s closing remarks

    2024-04-09, 5:30 PM

    Session Details:

    PANEL DISCUSSION Discovering the evolution in the clinical supply chain

    2024-04-09, 5:00 PM

    Session Details:

    Chairperson’s opening remarks

    2024-04-10, 8:50 AM

    Session Details:

    Chairperson’s closing remarks

    2024-04-10, 4:00 PM

    Session Details:

    PANEL DISCUSSION Harmonizing temperature excursion management: navigating conflicting policies at investigative sites

    2024-04-10, 3:15 PM

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    Francesco Santo
    Associate Director Global Clinical Supply Chain, HUYABIO

    A highly experienced and passionate Clinical Supplies Project Manager, Francesco has dedicated the past 17 years to ensuring the seamless execution of clinical trials by optimizing supply chain operations. His deep commitment to this field is driven by a relentless pursuit of excellence in delivering life-saving treatments to patients worldwide.  Throughout his career, he has honed a diverse skill set, encompassing:

    • Strategic Supply Chain Management
    • Regulatory Compliance
    • Cross-Functional Collaboration
    • Risk Management
    • Innovative Problem-Solving

    Francesco’s dedication to the clinical supplies industry is rooted in a profound understanding of the critical role it plays in advancing medical research and improving patient outcomes. He is committed to continuing his journey in this field, always striving to contribute to the betterment of global health.

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    Matthew Birmingham
    Head Clinical Supply, Prime Medicine
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    Mark Lovell
    Senior Director, Head of Supply Chain, Pyxis Oncology
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    Terry Walsh
    Director Comparator Strategy & Operations, Regeneron
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    Douglas Meyer
    Senior Director Global Clinical Supply Chain Operations, Vendor Management and Centralized Ancillary Support, Takeda
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    Paul Larochelle
    Director, Global Clinical Supply Chain, Takeda

    Paul is an experienced, motivated, and enthusiastic professional/pharmacist specializing in the area of Clinical Supplies/Investigational Product Management. He aspires to make an impact on patient lives by motivating, inspiring, guiding, and mentoring teams to see the value of the work that they do and the contribution it makes to the lives of the patients we serve globally. With over 15 years of training and experience in this area, he has served in a multitude of roles, including study supply management, asset management (DS/API/DP Management), management and oversight of a secondary packaging operations team, site and resource planning, and development of multiple custom systems and tools to enable staff to work more efficiently and distribute information more readily.

    Session Details:

    Fostering a dynamic team culture for talent development within supply chain

    2024-04-09, 3:00 PM

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    Sam Horne
    Global Clinical Supply Fellow, Takeda
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    Sean Smith
    Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection

    Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Agro/Bio-Terrorism Countermeasures. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.

    Mr. Smith joined CBP in 2005 as an Agriculture Specialist (CBPAS) and was promoted to Supervisory CBPAS in 2008. He has served CBP in the following ports of entry: San Diego, San Ysidro, Otay Mesa and Boston Logan Airport. From 2011- 2018, Mr. Smith served as the primary Public Affairs Liaison and Border Community Liaison, respectively, for CBP in New England. He has also volunteered to assist in past domestic and international CBP disaster recovery operations, including: Hurricane Ike (2008), 'Operation Safe Return' (Haitian Relief Effort- 2010), and Hurricane Harvey, DHS Surge Capacity Force (2017).

    Prior to CBP, Mr. Smith contributed to wildlife conservation for nearly a decade, completing field work on rare endemic Hawaiian birds on the Big Island of Hawaii, and raising rare and endangered birds (in some cases, extinct in the wild) at the San Diego Zoo's Avian Propagation Center. Also, Mr. Smith is a former reserve firefighter and EMT for the City of Borrego Springs in California. He holds a Bachelor of Science degree in Ecology and Systematic Biology from Cal Poly San Luis Obispo, California.

    Mr. Smith, his wife, two children, one dog, and one chicken live in an old farmhouse in Massachusetts.

    Session Details:

    Investigating the necessities surrounding the import and export of biological materials

    2024-04-09, 4:00 PM

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    Ingrid Abrahamsen
    Senior Director Clinical Operations, Editas Medicine
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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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    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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    Francesco Santo
    Associate Director Global Clinical Supply Chain, HUYABIO

    A highly experienced and passionate Clinical Supplies Project Manager, Francesco has dedicated the past 17 years to ensuring the seamless execution of clinical trials by optimizing supply chain operations. His deep commitment to this field is driven by a relentless pursuit of excellence in delivering life-saving treatments to patients worldwide.  Throughout his career, he has honed a diverse skill set, encompassing:

    • Strategic Supply Chain Management
    • Regulatory Compliance
    • Cross-Functional Collaboration
    • Risk Management
    • Innovative Problem-Solving

    Francesco’s dedication to the clinical supplies industry is rooted in a profound understanding of the critical role it plays in advancing medical research and improving patient outcomes. He is committed to continuing his journey in this field, always striving to contribute to the betterment of global health.

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    Arnaud Dourlens
    Head of Clinical Trial Supply, 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
    Director Global Clinical Supply Chain Planning, Takeda

    Paul Larochelle has over 17 years of experience in a variety of positions within Clinical Supplies, including roles in clinical planning, production scheduling and planning, secondary packaging operations management, and business expert for a clinical inventory management system. Paul currently leads a team of Clinical Planning Leads at Takeda and is a member of the Global Clinical Supply Chain (GCSC) Leadership Team. He also oversees Takeda’s GCSC Post-PharmD Fellowship Program in partnership with the Massachusetts College of Pharmacy and Health Sciences (MCPHS). Paul’s prior organizations include Genzyme/Sanofi and Biogen, supporting therapies across all indications and stages of development.

    In addition to his primary responsibilities, Paul served as a coordinator of Pharmacy Industry Fellowships for the Genzyme/Sanofi MCPHS Fellowship Program (2009-2014) and precepted over 50 pharmacy students interested in a career in industry for several schools. He is currently the Chair of the Dean’s Advisory Board for MCPHS Boston School of Pharmacy and a member of the Pharmacy Advisory Board for Western New England University. He is also a member of the Clinical Trial Supply Conference Series Advisory Board.

    Paul completed a Post-PharmD Industry Fellowship in Clinical Research/Investigational Product Management with Genzyme/MCPHS, a Doctorate in Pharmacy from MCPHS, an MBA from Worcester Polytechnic Institute, and a degree in Biology from Providence College. Paul has also served previously as President of the Board of Directors for the Massachusetts Pharmacists Association (MPhA), and as President of the MCPHS Alumni Association.

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    SPONSORSHIP ENQUIRIES

    Jaz Sidhu

    Senior Sponsorship Manager

    +44 (0) 207 9472755

    SPEAKING OPPORTUNITIES

    Ruth Atterbury

    Clinical Trial Supply Portfolio Manager

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    Jaz Sidhu

    Senior Sponsorship Manager


    +44 (0) 20 7947 2755

    Speaker Enquiries

    To enquire about speaking opportunities for the conference, please contact:

     

    Ruth Atterbury

    Clinical Trial Supply Portfolio Manager