23rd Annual Clinical Trial Supply East Coast 2025

Covering all things CTS from reducing timelines and streamlining processes to handling clinical supplies in a decentralized trial world.

4 - 5

November

2025
  • Sheraton Valley Forge, King of Prussia, PA, USA
  • Free
  • 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

Clinical Services International (CSI) is a global leader of sourcing and management of commercially available medicines (comparators, concomitant medication) for clinical trials.
Headquartered in London and with operations in UK, Germany, Denmark, Japan and USA, we provide efficient solutions and serve worldwide trials. Our longstanding experience and relationships with manufacturers, enables us to provide custom made solutions to address the most complex requirements.
We accelerate drug development and reduce timelines by providing a fully integrated service.
Address Regulatory, Quality, Operational, Clinical requirements
Manage the entire supply chain and offer tailor-made solutions
Comprehensive expertise in Oncology and Biosimilar products.
Advanced Technology and Innovative approach
Trusted partner of leading Biopharmaceuticals, CROs and CMOs.
www.csint.com

Company Website

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

Veeva is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence and customer success, Veeva has over 150 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs.

Company Website

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

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Company Information

BMclinical, your global clinical trial supply partner. We offer worldwide commercial medicine supply, from analytical samples to bulk comparators, through to the supply of co-meds and pre-meds.  We can pack and label your IMP/commercial medicines from our GMP facility, where we also offer storage and distribution services. BMclinical is uniquely positioned to offer solutions for overage and unused clinical trial stock.

Company Website

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

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Company Information

Euromed Pharma deliver strategic services tailored to support companies in their quest to better healthcare. We support each industry player from drug development through the post-marketing phases. We offer solutions in CTS services, Clinical GMP Packaging, Labeling and Distribution, IMP management, Early Access and Named Patient Programs, Pharma Order to cash solutions, and Supply Chain & Logistics. We are present around the world with offices in Italy, Spain, Ireland, Germany, Singapore and the USA. Being one of the Petrone Group companies, Euromed Pharma is positioned at the forefront of innovation in pharmaceutical distribution.

Company Website

To learn more, please visit our website - www.euromed-pharma.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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    Why attend?

    We are excited to be hosting the next edition of Clinical Trial Supply East Coast to Sheraton King of Prussia.

    The conference covers all things CTS from reducing timelines and streamlining processes to handling clinical supplies in a decentralized trial world. Our expert panel will deliver case studies, thought leadership pieces, interactive panels and roundtable discussions.

    Clinical Trial Supply East Coast offers opportunities for both learning and networking with peers from across the CTS sphere, via informal networking breaks and lunches, as well as a relaxed drinks reception at the end of Day 1.

    We have the best delivery for clinical trials East Coast 2023 for which we have been chosen by online casino players among other deliveries. Also at the conferences, everything related to CTS is covered, we also talk about bills vs patriots dfs picks. Speakers from Pfizer, Merck, Janssen, online casinos and others perform on our first day.

    Our day one includes speakers from Takeda, Merck, Janssen and many more who will be covering the latest innovations in the clinical supply industry. The day will be split into two different streams, with a clinical supply operations category as well as a stream highlighting great innovation and technological updates.

    Our conference continues into day two with a stream dedicated to temperature controlled logistics as well as regulatory updates from US Customs and Border Control.

    Don’t miss out, join us in King of Prussia on the 4th and 5th of November 2025.

     

    BRINGING TOGETHER PHARMA AND BIOTECH EXPERTS TO DISCUSS NEW TRENDS AND OPPORTUNITIES

    The Clinical Trial Supply East Coast is the meeting place for the pharmaceutical and biotechnology community to discover how to excel in clinical supply strategy as well as form key connections for long-term success. It’s time to build relationships and take away valuable lessons to for clinical trial success moving forward so we look forward to seeing you there!

    300+

    Attendees

    		35+

    Exhibitors

    		20+

    Speakers
    300+

    Attendees

    		35+

    Exhibitors
    20+

    Speakers

    Testimonials

    See What It's All About

    Agenda

    • 4 Nov 2025
    • 5 Nov 2025
    Expand All

    Streams

    Stream one

    STREAM A: Clinical Supply Logistics and Operations

    Stream two

    STREAM B: Clinical Supply Technology and Innovation

    11 AM

    Establishing a robust IRT system

    • Evaluating initiatives that ensure an effective IRT system
    • Personalizing IRT systems to benefits supply chains
    • Creating a reliable and accurate data source for an efficient IRT system

    Speakers

    Jason Bellman
    Sr, Manager IRT Systems and Clinical Supply, Cullinan Therapeutics

    11:30 AM

    Reserved for featured sponsor

    12 PM

    PANEL: Investigating the use of AI by analyzing the latest trends

    • Overview of the latest advancements and understanding how they could benefit a supply chain
    • Evaluating new technologies against traditional methods to identify best practice
    • Implementing AI effectively into your company

    Speakers

    Kara Kaur
    Associate Director, Interactive Response Technology (IRT) Management, Genmab US Inc
    Irena Maksimovic
    Sr Director, Strategy and Business Operations – Clinical Supply Chain, Bristol Myers Squibb
    Matthew Birmingham
    Head - Supply Chain and External Manufacturing, Prime Medicine, Inc.

    12:30 PM

    Reserved for CCL Clinical

    1 PM

    Lunch and networking

    2 PM

    Accommodating a drug combination product in an increasingly complex clinical trial supply space

    • Understanding complexities of a drug combination product when planning a supply chain
    • Navigating regulation to reduce delays and setbacks
    • Coordinating teams to ensure streamlined processes and minimize risk

    Speakers

    Krishna Patel
    Director Quality Engineering, Immunovant

    2:30 PM

    Reserved for Thermo Fisher Scientific

    3 PM

    Encouraging innovation and agility through enhanced team management

    • Fostering open communication within teams for increased efficiency
    • Ensuring teams can adapt quickly to change and embrace new ideas
    • Implementing agile leadership practices to enhance collaboration

    Speakers

    Kara Kaur
    Associate Director, Interactive Response Technology (IRT) Management, Genmab US Inc

    3:30 PM

    Afternoon refreshments and networking

    3:50 PM

    EXHIBITION APPLE PRIZE DRAW

    Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall and you will need to be physically present to be eligible for a prize. Make sure you don’t miss out!

    4 PM

    What is new? Digital innovation in clinical trial supply chain methods

    • Exploring new technology and innovation that are reshaping the clinical trial supply space
    • Weighing up weaknesses in current supply chain approaches to identify where digital solutions could be placed
    • Incorporating new technologies into your company for a smooth digital transition

    Speakers

    Kimberly Buchanan
    Associate Director, Clinical Supplies Operations and Technology Quality, Merck & Co Inc

    4:30 PM

    Reserved for 4G Clinical

    5 PM

    How to execute a decentralized trial successfully

    • Enhancing strategies for a smooth decentralized trial
    • Harnessing technology for an efficient supply chain
    • Ensuring integrity of data through communication with sites

    Speakers

    Dr Sridhar Yeshamaina
    Vice President, Global Patient Safety and Clinical Affairs, Amneal Pharmaceuticals

    5:30 PM

    Chairperson’s closing remarks and networking drinks

    7:30 AM

    Registration and refreshments

    8:25 AM

    Chairperson’s opening remarks

    Speakers

    Kawa Chiu
    Chief Technical Officer, Abdera Therapeutics

    8:30 AM

    KEYNOTE PANEL: Navigating evolving regulations to ease the impact on clinical trial supply

    • Understanding geopolitical landscapes to overcome challenges and increase efficiency
    • Investigating regulatory changes and evaluating the impact on clinical supply chains
    • Learning how to implement strategies to decrease supply chain disruption

    Speakers

    Francesco Santo
    Director Clinical Supply Chain,
    Orano Med
    James Bardsley
    Associate Director, Clinical Supply Chain, Cullinan Therapeutics
    Brian Doel
    Vice President Clinical Supply Chain, Bristol Myers Squibb
    Krishna Patel
    Director Quality Engineering, Immunovant

    9 AM

    Reserved for N-Side

    9:30 AM

    Mastering importing and exporting of therapies in the US to minimize time and cost

    • Understanding regulatory requirements around the import and export of biological materials in the US
    • Incorporating sufficient information on packaging to reduce delays
    • Best practice when experiencing issues with packages

    US Border Force

    10 AM

    Reserved for Mercalis

    10:30 AM

    Morning refreshments and networking

    11 AM

    Qualifying vendors effectively by identifying supply chain needs

    • Evaluating vendors efficiently to ensure supply chain needs will be met
    • Simplifying vendor selection processes with a concrete qualifying strategy
    • Assessing vendor capabilities proficiently through communication tactics

    Speakers

    Kayode Odepe
    Global Procurement Category/Contract Manufacturing Lead, Bayer

    11:30 AM

    Reserved for CSI

    12 PM

    PANEL: Effectively communicating with CROs to enhance clinical supply chain functions

    • Conveying clear expectations to ensure smooth supply chain functions
    • Maintaining strong communication throughout supply chain timelines to reduce the impact of roadblocks
    • Ensuring efficiency through improved communication and collaboration

    Speakers

    Tom Walls
    Associate Director - Supply Chain Planning, Spark Therapeutics, Inc.
    Mary Llewellyn
    Director, Quality Assurance, Prelude Therapeutics Inc
    Gautam Pangu
    Associate Director, Biologics CMC Project Management, Incyte
    Stephen Bonsu
    Senior Director, Commercial Product Regulatory & Supply Strategy, Eli Lilly and Company

    12:30 PM

    Reserved for Inceptua

    1 PM

    Lunch and networking

    2 PM

    Planning ahead for efficient manufacturing and labelling

    • Weighing up manufacturing and labelling methods to best suit individual supply chains
    • Mapping and executing an optimized manufacturing and labelling strategy
    • Minimizing delays by communicating effectively with vendors to ensure key information is understood

    Speakers

    Gautam Pangu
    Associate Director, Biologics CMC Project Management, Incyte

    2:30 PM

    Reserved for Signant

    3 PM

    Navigating the comparator landscape for successful secondary sourcing

    • Assessing current challenges when comparator sourcing
    • Strategies to identify and secure a reliable vendor
    • Assessing regulation to minimize delays in study startup

    Speakers

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

    3:30 PM

    Afternoon refreshments and networking

    3:50 PM

    EXHIBITION APPLE PRIZE DRAW

    Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall and you will need to be physically present to be eligible for a prize. Make sure you don’t miss out!

    4 PM

    Creating a foolproof contingency plan by evaluating potential risk

    • Identifying potential risks to create an adaptable contingency plan that increases efficiency
    • Implementing a risk mitigation strategy to reduce cost and minimize delays
    • Establishing strong collaboration between teams to flag issues and reduce disruptions

    Speakers

    Francesco Santo
    Director Clinical Supply Chain,
    Orano Med

    4:30 PM

    Reserved for session sponsor

    5 PM

    Planning a supply chain for a global study that reduces delays and sticks to budget

    • Navigating new regulation to successfully plan an overseas supply chain
    • Evaluating sites and patient populations to increase success of global trials
    • Weighing up cost and logistics to stay in budget

    Speakers

    Brian Doel
    Vice President Clinical Supply Chain, Bristol Myers Squibb

    5:30 PM

    Chairperson’s closing remarks and networking drinks

    Streams

    Stream one

    STREAM A: Clinical Supply Logistics and Operations

    Stream two

    STREAM B: Clinical Supply Technology and Innovation

    9 AM

    Enhancing cold chain distribution: what is new?

    • Exploring innovations in cold chain to enhance distribution
    • Identifying and planning around risks to minimize delays and cost in temperature-controlled supply chains
    • Implementing strategies to improve efficiency and minimize delay

     

    Reserved for GlobalData

    9:30 AM

    Reserved for Endpoint Clinical

    10 AM

    Establishing a robust forecasting strategy

    • Implementing a robust forecasting strategy to optimize clinical supply chain management
    • Analyzing data to predict trends and accurately forecast supply chain needs
    • Utilizing data to enhance forecasting and minimize cost

    Speakers

    Stacy Gibbons
    Associate Director, Clinical Supply Management, Biohaven Ltd

    10:30 AM

    Morning refreshments and networking

    11 AM

    Successfully planning a clinical supply chain for new drug modalities

    • Overviewing trends and developments in drug modalities to evaluate differences in supply management
    • Strategizing an effective trial supply plan to minimize setbacks
    • Implementing changes in supply chain management across teams to best facilitate a new modality

    Speakers

    Matthew Birmingham
    Head - Supply Chain and External Manufacturing, Prime Medicine, Inc.

    11:30 AM

    Reserved for session sponsor

    12 PM

    How to set up a phase appropriate Biotech logistics process which is viable, reliable, and robust

    • Understanding key focus points when designing an effective logistics process
    • Establishing an effective contingency plan to overcome supply chain roadblocks
    • Enhancing communication between teams to ensure logistic process functions are completed in a timely manner

    Speakers

    Sebastian Tomlin
    Director, Distribution and Logistics, Cullinan Therapeutics
    Eric Elbel
    Associate Director, Logistics, Geron Corporation

    12:30 PM

    Lunch and networking

    1:30 PM

    Adopting a risk-based approach: utilising technology for smoother clinical trial supply functions

    • Evaluating how technology can enable data-driven decisions
    • Minimizing risk in studies by utilizing technology to detect issues quickly
    • Understanding how to implement a new approach to supply chain management

    Speakers

    Namita Mittal Pande
    Director Innovation Strategist AI, Pfizer

    2:30 PM

    Enhancing team performance to encourage growth and overall efficiency

    • Implementing a cross-functional approach that encourages peer-to-peer leaning amongst teams
    • Fostering a culture of feedback and continuous improvement
    • Broadening team abilities through enhanced learning opportunities

    Speakers

    Paul Larochelle
    Senior Director Global Clinical Supply Chain,
    Takeda
    Samantha Horne
    GCSC PharmD Fellow, Global Clinical Supply Chain, Takeda
    Arpita Patel
    Associate Director, Global Clinical Supply Chain Planning, Takeda
    Shilpa Thakor
    Associate Director, Global Clinical Supply Chain Planning, Takeda

    3 PM

    Afternoon refreshments and networking

    3:30 PM

    EXHIBITION APPLE PRIZE DRAW

    Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall and you will need to be physically present to be eligible for a prize. Make sure you don’t miss out!

    8 AM

    Registration and refreshments

    9 AM

    Establishing open communication with CROs to enhance forecasting

    • Ensuring relevant information is received quickly to accurately update forecasting strategies
    • Obtaining real-time data to effectively forecast trial timelines and minimize cost
    • Reducing impact of errors by encouraging collaboration and communication

    Speakers

    Kevin Shipe
    Director, Head of Strategic Sourcing and Study Start-up, INOVIO Pharmaceuticals

    9:30 AM

    Reserved for session sponsor

    10 AM

    Staying ahead of competition by navigating shorter timelines effectively

    • Adopting practices that allow for shorter timelines without compromising quality
    • Ensuring therapies are manufactured and transported in a timely manner
    • Keeping to budget with optimized clinical trial supply timelines

    Speakers

    Stephanie Au
    Associate Director - Clinical Supplies, Merck

    10:30 AM

    Morning refreshments and networking

    11 AM

    Enhancing communication between clinical operations and clinical supplies to optimize cross functional collaboration

    • Breaking down silos for end-to-end supply chain efficiency
    • Optimizing collaboration through a shared understanding of team workflows
    • Improving collaboration to address issues quickly and effectively

    Speakers

    James Foose
    Therapeutic Area Lead- Associate Director Clinical Drug Supply & Logistics, Regeneron

    11:30 AM

    Reserved for session sponsor

    12 PM

    What are the top risks in a supply chain and how can I mitigate them effectively?

    • Overviewing the clinical trial supply landscape to understand common risks
    • Planning ahead to increase supply chain agility and reduce roadblocks
    • Implementing a robust mitigation plan to minimize risk impact

    Speakers

    Umar Hayat
    Vice President, CMC and Supply Chain, Union Therapeutics

    12:30 PM

    Lunch and networking

    1:30 PM

    Continuing CRO oversight and management to ensure a compliant and reliable drug supply

    • Maintaining communication and contract adherence
    • Reviewing performance and metrics
    • Conducting periodic compliance assessments and management of risk

    Speakers

    Mary Llewellyn
    Director, Quality Assurance, Prelude Therapeutics Inc

    2:30 PM

    Clinical Supply Chain: Lessons Learned & Shared from a Forty-Five (45) Year Career

    • Are IMPs to be treated as ‘widgets’?
    • How do I work ‘effectively’ with stakeholders in Pharm Sci, Reg Affairs, QA/QP?
    • What do I do to incorporate ‘science’ in the management of IMPs?
    • Where do I get meaningful information about Comparators?
    • Why and how do I elevate the capabilities of my Clinical Supply Chain team?

    Speakers

    James Krupa
    Director, Clinical Supplies, Shire Pharmaceuticals Inc

    3 PM

    Afternoon refreshments and networking

    3:30 PM

    EXHIBITION APPLE PRIZE DRAW

    Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall and you will need to be physically present to be eligible for a prize. Make sure you don’t miss out!

    3:45 PM

    SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

    Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the clinical supply chain industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

    Each discussion lasts 30 minutes minute so you can choose up to two topics. The sessions will end with a summary of findings presented to the audience by each roundtable host.

    ROUNDTABLE 1: Strategies for successful comparator sourcing 

    Hosted by Stephen Bonsu, Senior Director, Commercial Product Regulatory & Supply Strategy, Eli Lilly and Company 
    ROUNDTABLE 2: How to implement AI in clinical supply chains effectively 

    Hosted by Irena Maksimovic, Sr Director, Strategy and Business Operations – Clinical Supply Chain, Bristol Myers Squibb
    ROUNDTABLE 3: Managing and consolidating a data source with slow enrolment
    ROUNDTABLE 4: Boosting sustainability in clinical trial supply

    Speakers

    Stephen Bonsu
    Senior Director, Commercial Product Regulatory & Supply Strategy, Eli Lilly and Company
    Irena Maksimovic
    Sr Director, Strategy and Business Operations – Clinical Supply Chain, Bristol Myers Squibb

    4:45 PM

    End of Conference

    Speakers

    Select a speaker to learn more

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    Kawa Chiu
    Chief Technical Officer, Abdera Therapeutics

    Session Details:

    Chairperson’s opening remarks

    2025-11-04, 8:25 AM

    View In Agenda
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    Dr Sridhar Yeshamaina
    Vice President, Global Patient Safety and Clinical Affairs, Amneal Pharmaceuticals

    Session Details:

    How to execute a decentralized trial successfully

    2025-11-04, 5:00 PM

    View In Agenda
    Next speaker
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    Kayode Odepe
    Global Procurement Category/Contract Manufacturing Lead, Bayer

    Session Details:

    Qualifying vendors effectively by identifying supply chain needs

    2025-11-04, 11:00 AM

    View In Agenda
    Next speaker
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    Stacy Gibbons
    Associate Director, Clinical Supply Management, Biohaven Ltd

    Session Details:

    Establishing a robust forecasting strategy

    2025-11-05, 10:00 AM

    View In Agenda
    Next speaker
    Back
    Brian Doel
    Vice President Clinical Supply Chain, Bristol Myers Squibb

    Session Details:

    KEYNOTE PANEL: Navigating evolving regulations to ease the impact on clinical trial supply

    2025-11-04, 8:30 AM

    Session Details:

    Planning a supply chain for a global study that reduces delays and sticks to budget

    2025-11-04, 5:00 PM

    View In Agenda
    Next speaker
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    Irena Maksimovic
    Sr Director, Strategy and Business Operations – Clinical Supply Chain, Bristol Myers Squibb

    Session Details:

    PANEL: Investigating the use of AI by analyzing the latest trends

    2025-11-04, 12:00 PM

    Session Details:

    SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

    2025-11-05, 3:45 PM

    View In Agenda
    Next speaker
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    Jason Bellman
    Sr, Manager IRT Systems and Clinical Supply, Cullinan Therapeutics

    Session Details:

    Establishing a robust IRT system

    2025-11-04, 11:00 AM

    View In Agenda
    Next speaker
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    James Bardsley
    Associate Director, Clinical Supply Chain, Cullinan Therapeutics

    Session Details:

    KEYNOTE PANEL: Navigating evolving regulations to ease the impact on clinical trial supply

    2025-11-04, 8:30 AM

    View In Agenda
    Next speaker
    Back
    Sebastian Tomlin
    Director, Distribution and Logistics, Cullinan Therapeutics

    Session Details:

    How to set up a phase appropriate Biotech logistics process which is viable, reliable, and robust

    2025-11-05, 12:00 PM

    View In Agenda
    Next speaker
    Back
    Stephen Bonsu
    Senior Director, Commercial Product Regulatory & Supply Strategy, Eli Lilly and Company

    Session Details:

    PANEL: Effectively communicating with CROs to enhance clinical supply chain functions

    2025-11-04, 12:00 PM

    Session Details:

    SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

    2025-11-05, 3:45 PM

    Session Details:

    Navigating the comparator landscape for successful secondary sourcing

    2025-11-04, 3:00 PM

    View In Agenda
    Next speaker
    Back
    Kara Kaur
    Associate Director, Interactive Response Technology (IRT) Management, Genmab US Inc

    Session Details:

    PANEL: Investigating the use of AI by analyzing the latest trends

    2025-11-04, 12:00 PM

    Session Details:

    Encouraging innovation and agility through enhanced team management

    2025-11-04, 3:00 PM

    View In Agenda
    Next speaker
    Back
    Eric Elbel
    Associate Director, Logistics, Geron Corporation

    Session Details:

    How to set up a phase appropriate Biotech logistics process which is viable, reliable, and robust

    2025-11-05, 12:00 PM

    View In Agenda
    Next speaker
    Back
    Gautam Pangu
    Associate Director, Biologics CMC Project Management, Incyte

    Session Details:

    PANEL: Effectively communicating with CROs to enhance clinical supply chain functions

    2025-11-04, 12:00 PM

    Session Details:

    Planning ahead for efficient manufacturing and labelling

    2025-11-04, 2:00 PM

    View In Agenda
    Next speaker
    Back
    Kevin Shipe
    Director, Head of Strategic Sourcing and Study Start-up, INOVIO Pharmaceuticals

    Session Details:

    Establishing open communication with CROs to enhance forecasting

    2025-11-05, 9:00 AM

    View In Agenda
    Next speaker
    Back
    Krishna Patel
    Director Quality Engineering, Immunovant

    Session Details:

    KEYNOTE PANEL: Navigating evolving regulations to ease the impact on clinical trial supply

    2025-11-04, 8:30 AM

    Session Details:

    Accommodating a drug combination product in an increasingly complex clinical trial supply space

    2025-11-04, 2:00 PM

    View In Agenda
    Next speaker
    Back
    Kimberly Buchanan
    Associate Director, Clinical Supplies Operations and Technology Quality, Merck & Co Inc

    Session Details:

    What is new? Digital innovation in clinical trial supply chain methods

    2025-11-04, 4:00 PM

    View In Agenda
    Next speaker
    Back
    Stephanie Au
    Associate Director - Clinical Supplies, Merck

    Session Details:

    Staying ahead of competition by navigating shorter timelines effectively

    2025-11-05, 10:00 AM

    View In Agenda
    Next speaker
    Back
    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:

    KEYNOTE PANEL: Navigating evolving regulations to ease the impact on clinical trial supply

    2025-11-04, 8:30 AM

    Session Details:

    Creating a foolproof contingency plan by evaluating potential risk

    2025-11-04, 4:00 PM

    View In Agenda
    Next speaker
    Back
    Namita Mittal Pande
    Director Innovation Strategist AI, Pfizer

    Session Details:

    Adopting a risk-based approach: utilising technology for smoother clinical trial supply functions

    2025-11-05, 1:30 PM

    View In Agenda
    Next speaker
    Back
    Mary Llewellyn
    Director, Quality Assurance, Prelude Therapeutics Inc

    Session Details:

    PANEL: Effectively communicating with CROs to enhance clinical supply chain functions

    2025-11-04, 12:00 PM

    Session Details:

    Continuing CRO oversight and management to ensure a compliant and reliable drug supply

    2025-11-05, 1:30 PM

    View In Agenda
    Next speaker
    Back
    Matthew Birmingham
    Head - Supply Chain and External Manufacturing, Prime Medicine, Inc.

    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: Investigating the use of AI by analyzing the latest trends

    2025-11-04, 12:00 PM

    Session Details:

    Successfully planning a clinical supply chain for new drug modalities

    2025-11-05, 11:00 AM

    View In Agenda
    Next speaker
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    James Foose
    Therapeutic Area Lead- Associate Director Clinical Drug Supply & Logistics, Regeneron

    Session Details:

    Enhancing communication between clinical operations and clinical supplies to optimize cross functional collaboration

    2025-11-05, 11:00 AM

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    James Krupa
    Director, Clinical Supplies, Shire Pharmaceuticals Inc

    Session Details:

    Clinical Supply Chain: Lessons Learned & Shared from a Forty-Five (45) Year Career

    2025-11-05, 2:30 PM

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

    Session Details:

    PANEL: Effectively communicating with CROs to enhance clinical supply chain functions

    2025-11-04, 12:00 PM

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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.

    Session Details:

    Enhancing team performance to encourage growth and overall efficiency

    2025-11-05, 2:30 PM

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    Samantha Horne
    GCSC PharmD Fellow, Global Clinical Supply Chain, Takeda

    Session Details:

    Enhancing team performance to encourage growth and overall efficiency

    2025-11-05, 2:30 PM

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    Arpita Patel
    Associate Director, Global Clinical Supply Chain Planning, Takeda

    Session Details:

    Enhancing team performance to encourage growth and overall efficiency

    2025-11-05, 2:30 PM

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    Shilpa Thakor
    Associate Director, Global Clinical Supply Chain Planning, Takeda

    Session Details:

    Enhancing team performance to encourage growth and overall efficiency

    2025-11-05, 2:30 PM

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    Umar Hayat
    Vice President, CMC and Supply Chain, Union Therapeutics

    Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). He played a pivotal role in the development and commercialization of Veltassa® (USA and EU), a treatment for hyperkalemia, Intermezzo® for MOTN insomnia, Kerydin® for onychomycosis, and Eucrisa® for atopic dermatitis. Dr. Hayat is managing partner of Revive Pharm USA. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. He received M.Sc. Chemistry degree from Punjab University, Institute of Chemistry

    Session Details:

    What are the top risks in a supply chain and how can I mitigate them effectively?

    2025-11-05, 12:00 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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    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:

    KEYNOTE PANEL: Navigating evolving regulations to ease the impact on clinical trial supply

    2025-11-04, 8:30 AM

    Session Details:

    Creating a foolproof contingency plan by evaluating potential risk

    2025-11-04, 4:00 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.

    Session Details:

    Enhancing team performance to encourage growth and overall efficiency

    2025-11-05, 2:30 PM

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    Plan Your Visit

    Venue

    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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