15th Annual Clinical Trial Supply New England 2026

Arena will be returning to the Westin Waltham for our 2026 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.

14 - 15

April

2026
  • The Westin Waltham Boston, MA, USA
  • Complimentary
  • 2025 Agenda
  • Advisory Board
  • 2025 Speakers
  • Plan Your Visit
  • Event Gallery
  • 2025 Sponsors
  • Media Centre
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2025 Sponsors Include:

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Company Information

S-CLINICA is the leader in advanced clinical supply management, specializing in Supply Forecasting, Cost and Risk Analysis, Production Planning and RTSM on a single-platform solution – ClinVision, designed to streamline trial execution.

With built-in supply demand planning and risk analysis, our system enables sponsors to evaluate multiple scenarios and make data-driven decisions to optimize production and distribution.

By supporting continuous planning and real-time updates, ClinVision ensures that supply strategies align with study needs and adapt seamlessly to changes as they happen.

Our proven technology reduces waste, minimizes risk, and accelerates trial timelines, helping biopharma companies execute clinical studies with greater efficiency and confidence.

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 leader in Clinical Trial Supply (CTS) and Early Access Programs (EAP), committed to delivering life-changing medicines to patients worldwide. We partner with leading pharmaceutical and biotech companies to offer tailored solutions for their clinical trial needs.

Our CTS division provides unmatched global access to medicines and ancillaries, leveraging a vast network of manufacturers and distributors, supported by an in-house Quality and Regulatory team. From local sourcing in emerging markets to global distribution of high-value commercial drugs, we deliver customized, end-to-end supply solutions.

Our interactive CTS Sourcing Portal enables clients to manage and monitor their supply chain in real time, enhancing transparency and efficiency.
With strategically located distribution centers across Europe, North America, LATAM, APAC, and Africa, we ensure timely delivery while meeting regulatory standards. Bionical Emas is dedicated to ethical, flexible, and reliable support for clinical trials worldwide.

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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    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

    2025 Agenda

    • 14 Apr 2026
    • 15 Apr 2026
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    8:15 AM

    Registration and refreshments

    9 AM

    Chairperson’s opening remarks

    Speakers

    Paul Larochelle
    Senior Director Global Clinical Supply Chain,
    Takeda

    9:15 AM

    Navigating multiple regulatory agencies to help expedite supply chain times

    • Understanding the requirement and options for declaring biological materials to U.S. Customs and Border Protection (CBP)
    • Review of key U.S. regulatory agency authorities, such as CDC, FDA, USDA, and CBP
    • Discovering the latest non-compliant shipment issues for biological materials and pharma products and tips to avoid them
    • Learning about valuable resources and contacts for assistance

    Speakers

    Sean Smith
    Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection
    Baljeet Kaur
    Agriculture Operations Manager,
    U.S Customs and Border Protection

    9:45 AM

    Fireside Chat: The power of the Pharmacy Manual and IRT management as vital tools for improving clinical supply operations

    • IRT and Pharmacy Manual alignment
      • How both tools are connected
      • Challenges and ways of working
    • IRT and the Pharmacy Manual as useful tools for Clinical Operations engagement
      • Examples of each and how it’s driven engagement and alignment with Clinical Operations

    Speakers

    Imran Shakur
    Director, IRT and Technology Lead,
    Alexion Pharmaceuticals
    Jenn Mahon
    Director Clinical Supply & Pharmacy Manual Lead,
    Alexion

    10:15 AM

    Morning refreshments and networking

    11 AM

    Selecting, managing and oversight of clinical supply vendors

    • Deciding which vendors to use: selection process
    • Building and managing relationships to ensure good communication lines
    • Agreeing timelines and establishing your oversight requirements

    Speakers

    Deirdre Casale
    Former Senior Director, Supply Chain,
    Alnylam Pharmaceuticals

    11:30 AM

    Global virtual clinical trial supplies: The benefits of implementing a virtual supply strategy for commercially available medications and ancillary supplies

    • Optimize employ effort
    • Minimize waste and risk
    • Appreciate significant savings
    • Sustainably friendly

    Speakers

    Tom Gottschalk
    Vice President, Business Development, Mercalis

    12 PM

    Implementing the right packaging & labelling strategy to meet your supply requirements

    • Deciding your strategy: in advance, just in time or hybrid?
    • Considering regulatory packing & labelling requirements for the locations of your study supply
    • Identifying the best packaging and labelling solution to accelerate your drug supply
    • Improving expiry date challenges to avoid re-labelling or wastage

    Speakers

    Mark Lovell
    Senior Director, Head of Supply Chain,
    Pyxis Oncology

    12:30 PM

    Exploring the RTSM – supply forecasting ecosystem: Bringing efficiency and savings into the clinical supply chain

    The session will look to look at:

    • The impact of wastage in clinical supply chains
    • Key aspects of savings and efficiency brought by accurate supply forecasting in clinical trials
    • The promise of AI and what it really means
    • The RTSM ecosystem and how Supply forecasting fits
    • What supply managers and sponsors need to look for when considering this

    Speakers

    Jasvinder Osan
    Vice President - Business Development,
    S-CLINICA
    Brian Langin
    Director North America
    S-CLINICA

    12:45 PM

    Lunch and networking

    2 PM

    Protecting your clinical supply chain: minimizing disruption through effective risk mitigation planning

    • Identifying and assessing risks across clinical supply chain
    • Building contingency protocols from the start of trial to be better prepared for the unexpected
    • Incorporating risk assessment into project management plans
    • Reducing risks caused by supply chain delays

    Speakers

    Francesco Santo
    Director Clinical Supply Chain,
    Orano Med

    2:30 PM

    Panel Discussion: Exploring strategies for flexible clinical trial supply manufacturing

    • Evaluating important criteria to consider when sourcing CMOs
    • Considering steps to take when selecting and managing a CMO in early phase trials
    • Reviewing changes and additional factors that become relevant as develop into late phase and commercial

    Speakers

    Carlos Candido
    Vice President External Manufacturing & Supply Chain,
    Be Biopharma
    Scott Sutton
    Senior Director, Supply Chain,
    MorphoSys
    Matthew Birmingham
    Senior Director Supply Chain and External Manufacturing,
    Prime Medicine

    3:15 PM

    Afternoon refreshments and networking

    3:45 PM

    Internal and external communication strategies to forge strong partnerships as a clinical supply professional

    • Considering strategies to create and maintain successful internal relationships
    • Collaborating effectively with external stakeholders
    • Sharing communication hurdles and ways to overcome them

    Speakers

    Paul Larochelle
    Senior Director Global Clinical Supply Chain,
    Takeda
    Sam Horne
    Global Clinical Supply Fellow,
    Takeda

    4:15 PM

    Panel Discussion: Improving communications between clinical supply, clinical operations and their partners

    • Interacting earlier for supply to give input and gain information sooner so they can assist and be prepared
    • Establishing clinical team needs: what, when and where
    • Building and maintaining strong relationships between teams

    Speakers

    Carlos Candido
    Vice President External Manufacturing & Supply Chain,
    Be Biopharma
    Ingrid Abrahamsen
    Executive Director, Head of Clinical Operations,
    Fulcrum Therapeutics
    Matthew Birmingham
    Senior Director Supply Chain and External Manufacturing,
    Prime Medicine
    Terry Walsh
    Director Comparator Strategy & Operations,
    Regeneron

    5 PM

    Chairperson’s closing remarks

    Speakers

    Paul Larochelle
    Senior Director Global Clinical Supply Chain,
    Takeda

    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:
    Importing and exporting biological materials to or from the U.S
    Sean Smith, Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection

    ROUNDTABLE 2:
    Comparator sourcing effectively to ensure timely acquisition of supplies
    Scott Sutton, Senior Director Supply Chain, MorphoSys

    ROUNDTABLE 3:
    Managing clinical supply vendor relationships to ensure effective partnerships

    Speakers

    Sean Smith
    Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection
    Scott Sutton
    Senior Director, Supply Chain,
    MorphoSys
    Douglas Meyer
    Senior Director Global Clinical Supply Chain Operations, Vendor Management and Centralized Ancillary Support,
    Takeda

    10:30 AM

    Morning refreshments and networking

    11:15 AM

    Sharing best practice for importing FDA regulated biologics

    • Entry screening/admissibility
    • FDA regulatory requirements for CBER regulated products
    • Making ACE work for you: Importing biological products
    • Q&A session
    • Close-out

    Speakers

    Troy Petrillo
    Supervisory Consumer Safety Officer, U.S Food and Drug Administration (FDA)

    11:45 AM

    Building resiliency in supply chains: Trends to watch in 2025

    • Identifying opportunities for CDMOs, sponsors, and suppliers using data analytics
    • Understanding the clinical trials landscape to facilitate strategic planning
    • Addressing issues impacting pharmaceutical supply chains to prepare for and avoid potential disruptions

    Speakers

    Katarina Zahedi
    Analyst,
    GlobalData Healthcare

    12:15 PM

    Ensuring end to end cold chain integrity

    • Identifying logistical challenges and how to overcome them
    • Understanding and complying with regulatory requirements
    • Mitigating against cold chain risks

    Speakers

    Scott Sutton
    Senior Director, Supply Chain,
    MorphoSys

    12:45 PM

    Lunch, networking and prize draw

    2 PM

    Case Study: Leveraging a scorecard tool to drive meaningful vendor performance improvements

    • Transforming anecdotal stakeholder feedback into impactful data to drive performance discussions
    • Identifying meaningful metrics and indicators to include in the scorecard
    • Automating metric data collection for incorporation into a scorecard
    • Lessons learned in implementing the scorecard successfully

    Speakers

    Douglas Meyer
    Senior Director Global Clinical Supply Chain Operations, Vendor Management and Centralized Ancillary Support,
    Takeda

    2:30 PM

    Panel Discussion: Implementing clinical trial supply in emerging markets outside of Europe and USA: where, why and how?

    • Considering other locations and less saturated markets
    • Assessing the differences, benefits and challenges of supplying in these regions
    • Discussing considerations for supply models, logistics, regulation and importation

    Speakers

    Francesco Santo
    Director Clinical Supply Chain,
    Orano Med
    Erika T. Vidal-Faulkenberry
    Global Head Trade Compliance,
    Biogen

    3:15 PM

    Chairperson’s closing remarks

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions,
    GlobalData

    END OF CONFERENCE

    2025 Speakers

    Select a speaker to learn more

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    Sean Smith
    Biological Threat Exclusion Coordinator (BTEC), 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/ Biological Threat Exclusion. 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 has more than 17 years of public service with CBP, and has worked in a variety of environments, including on the southern land border, maritime, air passenger, and cargo locations.  He has also been able to assist in several past domestic and international CBP disaster recovery operations.

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2025-04-09, 9:00 AM

    Session Details:

    Navigating multiple regulatory agencies to help expedite supply chain times

    2025-04-08, 9:15 AM

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    Scott Sutton
    Senior Director, Supply Chain,
    MorphoSys

    Scott Sutton is the Sr. Director, Supply Chain for MorphoSys in Boston, MA. He has 20 years of experience managing both clinical and commercial supply chains across a wide variety of drugs and therapeutic areas, with an emphasis in oncology and rare disease. Scott’s supply chain experience ranges across Phase I to Phase IV clinical trials, commercial product launches, global supply management, vendor sourcing, international logistics, and sales & operations planning management.

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2025-04-09, 9:00 AM

    Session Details:

    Ensuring end to end cold chain integrity

    2025-04-09, 12:15 PM

    Session Details:

    Panel Discussion: Exploring strategies for flexible clinical trial supply manufacturing

    2025-04-08, 2:30 PM

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    Douglas Meyer
    Senior Director Global Clinical Supply Chain Operations, Vendor Management and Centralized Ancillary Support,
    Takeda

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2025-04-09, 9:00 AM

    Session Details:

    Case Study: Leveraging a scorecard tool to drive meaningful vendor performance improvements

    2025-04-09, 2:00 PM

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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

    2025-04-09, 8:50 AM

    Session Details:

    Chairperson’s closing remarks

    2025-04-09, 3:15 PM

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    Deirdre Casale
    Former Senior Director, Supply Chain,
    Alnylam Pharmaceuticals

    Over 20 years of experience in successfully building supply chain and quality organizations from the ground up, developing systems, procedures, & solid collaborative teams that successfully brought clinical trials to product commercialization. Deep expertise in end-to-end supply chain, quality assurance (QA), quality control (QC), chemistry manufacturing controls (CMC), streamlining systems & infrastructure, supplier relationship management (SRM), and building/leading high-performing teams.  Deirdre's career includes leading teams and working in growing organizations including Biogen, Millennium, Shire, & Alnylam.

    Session Details:

    Selecting, managing and oversight of clinical supply vendors

    2025-04-08, 11:00 AM

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    Francesco Santo
    Director Clinical Supply Chain,
    Orano Med

    A highly experienced and passionate Director Clinical Supply Chain, 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.

    Session Details:

    Protecting your clinical supply chain: minimizing disruption through effective risk mitigation planning

    2025-04-08, 2:00 PM

    Session Details:

    Panel Discussion: Implementing clinical trial supply in emerging markets outside of Europe and USA: where, why and how?

    2025-04-09, 2:30 PM

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    Paul Larochelle
    Senior 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:

    Internal and external communication strategies to forge strong partnerships as a clinical supply professional

    2025-04-08, 3:45 PM

    Session Details:

    Chairperson’s closing remarks

    2025-04-08, 5:00 PM

    Session Details:

    Chairperson’s opening remarks

    2025-04-08, 9:00 AM

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    Sam Horne
    Global Clinical Supply Fellow,
    Takeda

    Session Details:

    Internal and external communication strategies to forge strong partnerships as a clinical supply professional

    2025-04-08, 3:45 PM

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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.

    Session Details:

    Fireside Chat: The power of the Pharmacy Manual and IRT management as vital tools for improving clinical supply operations

    2025-04-08, 9:45 AM

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    Jenn Mahon
    Director Clinical Supply & Pharmacy Manual Lead,
    Alexion

    Session Details:

    Fireside Chat: The power of the Pharmacy Manual and IRT management as vital tools for improving clinical supply operations

    2025-04-08, 9:45 AM

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    Mark Lovell
    Senior Director, Head of Supply Chain,
    Pyxis Oncology

    Session Details:

    Implementing the right packaging & labelling strategy to meet your supply requirements

    2025-04-08, 12:00 PM

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    Tom Gottschalk
    Vice President, Business Development, Mercalis

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

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

    Session Details:

    Global virtual clinical trial supplies: The benefits of implementing a virtual supply strategy for commercially available medications and ancillary supplies

    2025-04-08, 11:30 AM

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    Carlos Candido
    Vice President External Manufacturing & Supply Chain,
    Be Biopharma

    Session Details:

    Panel Discussion: Improving communications between clinical supply, clinical operations and their partners

    2025-04-08, 4:15 PM

    Session Details:

    Panel Discussion: Exploring strategies for flexible clinical trial supply manufacturing

    2025-04-08, 2:30 PM

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    Ingrid Abrahamsen
    Executive Director, Head of Clinical Operations,
    Fulcrum Therapeutics

    Ingrid Abrahamsen is an experienced clinical research leader with a focus on clinical trial management and clinical operations. Her 15 years of experience have been concentrated in early and late phase rare disease and oncology clinical research. Her experience in the span of  the last 5 years has been focused in the cell and gene therapy (CGT) industry, contributing to the clinical development of multiple autologous cell and gene therapies. Most recently, Ingrid was leading clinical operations at Editas Medicine in the development of reni-cel, an AsCas12a gene-edited cell therapy in severe sickle cell disease (SCD). In her Clinical Operations leadership roles, Ingrid has formed and led teams to optimize clinical trial execution and build cross-functional relationships. Ingrid is currently the Head of Clinical Operations at Fulcrum Therapeutics, leading the advancement of their small molecule pipeline with their lead clinical program in SCD.

    Ingrid holds an MS and BS from Penn State University and is a Certified Clinical Research Professional (CCRP) via the Society of Clinical Research Associates (SOCRA).

    Session Details:

    Panel Discussion: Improving communications between clinical supply, clinical operations and their partners

    2025-04-08, 4:15 PM

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    Matthew Birmingham
    Senior Director Supply Chain and External Manufacturing,
    Prime Medicine

    Matt Birmingham is a seasoned operations leader with over 24 years of experience managing clinical and commercial operations in the biologics and cell and gene therapy (CGT) industries. His career includes extensive experience leading teams and operations at Genentech where he oversaw quality engineering and validation of computerized systems and laboratory equipment, clinical and commercial production planning and commercial product distribution and logistics for high-value biologics and small-molecule products.  Matt has spent the last 10 years playing pivotal roles in building and strengthening supply chains for leading CGT companies, contributing to the successful launch of four commercial CGT products. As Senior Director of Supply Chain and External Manufacturing at Prime Medicine, Matt leads all clinical manufacturing and supply chain operations for autologous cell and in vivo gene therapies.

    Matt holds an MBA from the University of Maryland, a Bachelor of Science in Business Administration from the University of Vermont, and is APICS Certified in Production and Inventory Management.

    Session Details:

    Panel Discussion: Improving communications between clinical supply, clinical operations and their partners

    2025-04-08, 4:15 PM

    Session Details:

    Panel Discussion: Exploring strategies for flexible clinical trial supply manufacturing

    2025-04-08, 2:30 PM

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    Terry Walsh
    Director Comparator Strategy & Operations,
    Regeneron

    Session Details:

    Panel Discussion: Improving communications between clinical supply, clinical operations and their partners

    2025-04-08, 4:15 PM

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    Baljeet Kaur
    Agriculture Operations Manager,
    U.S Customs and Border Protection

    Baljeet Kaur is an Agriculture Operations Manager (AOM) for U.S. Customs and Border Protection (CBP) at the Boston Field Office (BFO) consisting of six New England States (MA, ME, VT, NH, CT, and RI).  As an AOM, Ms. Kaur is charged with providing guidance to personnel within the BFO on various agriculture matters including, but not limited to: regulated garbage compliance, regulation of biological material, and entry requirements for regulated agriculture commodities.  Ms. Kaur has more than 15 years of public service with CBP, and has worked in a variety of environments including, air passenger, air cargo, and maritime.

    Session Details:

    Navigating multiple regulatory agencies to help expedite supply chain times

    2025-04-08, 9:15 AM

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    Troy Petrillo
    Supervisory Consumer Safety Officer, U.S Food and Drug Administration (FDA)

    Troy R. Petrillo has been employed by the Federal Government for over 33 years. He started his career with the Department of Commerce / National Oceanic and Atmosphere Administration/ National Marine Fisheries Service / Seafood Inspection Program in 1987, where he spent 11 years as a Consumer Safety Officer and HACCP Auditor within the seafood industry.

    In August of 1998, Mr. Petrillo joined the FDA / ORA Investigation Branch in the New England District Office as a Food Investigator. In December of 2004, Mr. Petrillo was promoted to the position of Food Specialist for the District where he conducted numerous inspections of food manufacturers domestically and internationally. In 2009, he accepted a position as a Supervisory Investigator with responsibility for import operations and is currently in that position reporting to the Division of North East Imports.

    Session Details:

    Sharing best practice for importing FDA regulated biologics

    2025-04-09, 11:15 AM

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    Katarina Zahedi
    Analyst,
    GlobalData Healthcare

    Session Details:

    Building resiliency in supply chains: Trends to watch in 2025

    2025-04-09, 11:45 AM

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    Erika T. Vidal-Faulkenberry
    Global Head Trade Compliance,
    Biogen

    Session Details:

    Panel Discussion: Implementing clinical trial supply in emerging markets outside of Europe and USA: where, why and how?

    2025-04-09, 2:30 PM

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    Jasvinder Osan
    Vice President - Business Development,
    S-CLINICA

    Jas started his career in the 90s, as a data manager within clinical trials when these were done predominantly on paper - and has over the years seen the industry change and evolve.

    He has a degree in Applied Physics, and has worked over the last 25 years within eClinical technologies and solutions, with global responsibilities in project management, solutions consulting and sales. Jas's role within S-CLINICA is to bring new business, and build strategic relationships with customers.

    Session Details:

    Exploring the RTSM – supply forecasting ecosystem: Bringing efficiency and savings into the clinical supply chain

    2025-04-08, 12:30 PM

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    Brian Langin
    Director North America
    S-CLINICA

    Session Details:

    Exploring the RTSM – supply forecasting ecosystem: Bringing efficiency and savings into the clinical supply chain

    2025-04-08, 12:30 PM

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    Advisory Board

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    Chris Wallace
    Head of Distribution EMEA, Argenx

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

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

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

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

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

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

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

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

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    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
    Director Clinical Supply Chain,
    Orano Med

    A highly experienced and passionate Director Clinical Supply Chain, 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.

    Session Details:

    Protecting your clinical supply chain: minimizing disruption through effective risk mitigation planning

    2025-04-08, 2:00 PM

    Session Details:

    Panel Discussion: Implementing clinical trial supply in emerging markets outside of Europe and USA: where, why and how?

    2025-04-09, 2:30 PM

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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
    Senior Director Global Clinical Supply Chain,
    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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    Sponsorship Enquiries

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    Jaz Sidhu

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    +44 (0) 20 7947 2755

    Speaker Enquiries

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

     

    Ruth Atterbury

    Clinical Trial Supply Portfolio Manager