Clinical Trial Supply East Coast 2023

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

11 - 12

October

2023
  • Sheraton Valley Forge, King of Prussia, PA, USA
  • Free
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2023 Sponsors Include:

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Company Information

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

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

Company Website

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

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4G Clinical is a leader in randomization and trial supply management (RTSM) for the global life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) and integrated supply forecasting. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia. For more information, please visit www.4gclinical.com

Company Website:http://www.4gclinical.com/

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Abacus Medicine Pharma Services is the new name for the healthcare and pharma services company previously known as Aposave. The company has three service lines: Clinical Trial Solutions (CTS), Commercial Partnerships and Unlicensed Medicines.

The CTS service focuses on comparator sourcing solutions for clinical trials as well as bespoke batch-specific sourcing of pre-clinical samples. We specialize in partnering biosimilar manufacturers, biotechnology and innovative pharma companies

Company Website

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

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Mercalis is an integrated life sciences commercialization partner that provides comprehensive solutions that span the entire healthcare value chain.  The company partners closely with its clients to deliver an end-to-end spectrum of commercial capabilities that work together seamlessly and flexibly.  Backed by proven industry expertise and results-driven technology, Mercalis provides the data and strategic insights, patient support services, and healthcare provider engagement tools to help life sciences companies successfully commercialize new products.  Above all, Mercalis helps navigate the complex life sciences marketplace to accelerate value and enhance patient lives.  Founded in 2000, Mercalis provides commercialization solutions to more than 500 life sciences customers and has provided access and affordability support to millions of patients.  The company is headquartered in Morrisville, North Carolina.  For more information about Mercalis, please visit www.mercalis.com.

Company Website

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

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YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. 

We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster. 

Company Website

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

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Yourway is The Biopharma Services Company changing the landscape of clinical supply chain solutions with a unique, single source model. We are the only truly integrated provider premium courier and clinical packager, supported by a global network of GMP facilities. We have the resources, experience and commitment to make your packaging and shipments faster, and management of trials easier and more efficient. For over 20 years, Yourway has guaranteed speed of delivery with highly customized transport and storage solutions for biopharmaceutical companies, CDMOs and anyone needing to move high value and temperature-sensitive materials around the world. By integrating your clinical packaging seamlessly, we provide unified project management and total visibility.

Company Website

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

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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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AWT Healthcare manufacturers clinical trial labels. We have expanded our product line to include Medical Device Labeling through AWT Labels & Packaging. AWT Healthcare is solely focused on providing the clinical pharmaceutical and custom labels & packaging industry with state-of-the-art solutions at a fair price and competitive timing.

 

For more information please contact Graig Daley – Business Development Manager and Jackson Young – Business Development Associate at sales@citlabels.com.

Company Website

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

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

Company Website

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

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Company Information

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 Website

To learn more , please visit our website - https://www.boostcode.eu

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Brocacef operates throughout the entire pharmaceutical chain, lending us an unique position as a wholesaler in the Dutch pharmaceutical healthcare industry. With expertise in global logistics, sourcing and supply chain experience Brocacef is able to offer a variety of services for clinical trials.

Company Website

To learn more , please visit our website - www.brocacef.nl

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Labels for spirits are unique in their need for high-quality decorations and unique embellishments – no matter the size of the run. CCL Label is committed to delivering excellence in printing and service for all customers whether large or small.

Quality is never sacrificed: state-of-the-art technology and equipment guarantee the highest quality of label production.

Service is priority: CCL offers a strong customer service, building partnerships that last a lifetime.

Company Website

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

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Company Information

Endpoint Clinical is an interactive response technology (IRT) solutions provider that supports the life sciences industry. Our innovative, high-quality randomization and clinical trial management technologies are backed by over a decade of award-winning experience and expertise. Endpoint is headquartered in Wakefield, MA, with offices across the US, EU, and Asia.

Company Website

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

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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 Website

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

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IMP Logistics offers warehousing and logistics services for clinical trials in Russia, Ukraine and Belarus, operating in state-of-the-art licensed facilities. Our integrated range of services includes import of clinical trial materials, storage in temperature controlled areas (ambient,  2-8°C, -15 -25°C, and -80°C), re-labeling , purchasing comparators, distribution to/from sites and arranging destruction of returned materials.

Company Website

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

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The Inceptua Group Group is a dynamic, enterprising, and future-oriented service provider operating within the clinical trial and unlicensed medicines supply chain at an international level.

Our multinational team provide connections to an extensive global network, offering our clients customized solutions ranging from strategic planning and sourcing, clinical manufacturing and global depot solutions, right through to early access to unlicensed medicines.

We are committed to safety, and reliably supporting our clients every step of the way, leaving them safe in the knowledge that every potential obstacle has been considered, and every eventuality planned for.

Our worldwide presence enables us to fulfil these services for the duration of trials, and our expert team work closely with our customers to ensure they receive full support throughout the lifecycle of their project.

Company Website

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

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Company Information

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Company Website

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

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    Why attend?

    We are excited to be hosting the next edition of Clinical Trial Supply East Coast on the 11th and 12th of October 2023 in the 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 Pfizer, 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 some exciting talks covering the latest in IRT systems, some exciting case studies and a talk from the FDA.

    Don’t miss out, join us in King of Prussia on the 11th and 12th of October 2023.

     

    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

    • 11 Oct 2023
    • 12 Oct 2023
    Expand All

    Streams

    Stream one

    Clinical Supply Logistics and Operations

    Stream two

    Clinical Supply Technology and Innovation

    11:15 AM

    PANEL DISCUSSION: Analyzing the opportunities offered by effective use of IRT

    • Key considerations when choosing an IRT vendor: what questions should you be asking?
    • How to leverage your IRT systems effectively to get the most out of your technology
    • Incorporating data-driven technology such as AI and machine learning to maximize efficiency of your IRT systems
    • Understanding the key advantages and disadvantages of new IRT systems
    • Practical takeaways and lessons learned when it comes to using new IRT systems

    Speakers

    11:45 AM

    Re-imagining IRT for modern clinical development

    • The vast majority of clinical studies are being run on technology that is over 10 years old, which limits the ability to innovate and optimally support modern trials
    • IRT can become a driver of innovation and not a constraint when advances in the broader technology landscape are applied to allow for more flexible solutions
    • Deliver scalable, robust, and future-proof IRT solutions by applying lessons learned from other industries
    • Examples include: A.I.-enabled datasets, no-code study deployment, automated excursion reviews, rapid prototyping, reduced (or removed) need for change orders, and ability to adapt to unforeseen challenges

    Speakers

    12:15 PM

    Revolutionizing clinical trial supply chains with Patient-Centric Hybrid Trials (PHTs) and Direct-to-Patient models

    • Designing clinical trials with patient needs at the center by leveraging hybrid trial models for supply chain efficiency and success
    • Investing in patient-centric methodologies to prioritize patient needs and preferences for optimal clinical trial supply chain outcomes
    • Empowering patients for clinical trial supply chain success: personalizing logistics, delivering human content, providing data access, and engaging patients in innovative ways.

    Speakers

    12:45 PM

    Drug supply management: ensure supply safety while generating huge savings

    • Challenges and opportunities in the drug supply chain management
    • Best practices
    • Expected skills in clinical supply
    • Communication framework
    • Success stories

    Speakers

    1:15 PM

    Lunch and networking

    2:30 PM

    CASE STUDY: Implementing an effective IRT system into your clinical trial supply chain

    • Choosing an IRT vendor that works for you: key considerations and factors in supplier choice
    • Overcoming challenges around implementation and use of a new IRT system
    • What do you need from your IRT system: measuring benefits and increased efficiency

    Speakers

    3 PM

    Reserved for event sponsor

    3:30 PM

    CASE STUDY: Digital display labels transforming the clinical supply chain

    • Decreases turnaround timelines, increases flexibility and efficiency of scarce IMP inventory benefiting sponsors and study site personnel
    • Driving enhanced safety, understanding, and compliance for patients and clinical sites, enabled by immediate updates of IMP information and IMP label content
    • Leveraging technology enabling a more robust IMP data management, tracking of contents/changes as required by cGMP for patients, for clinical sites and for health authorities

    Speakers

    4 PM

    Afternoon refreshments and networking

    4:20 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!

    4:30 PM

    INTERACTIVE DISCUSSION SESSION: Overcoming roadblocks in comparator sourcing and vendor management

    • Accessing supply: ensuring your supply chain is robust and planning timelines to avoid delays
    • Managing regulatory hurdles when importing comparators from overseas
    • Working efficiently with vendors when sourcing comparators for your clinical trial
    • What to consider in order to ensure your comparator sourcing processes meet cost and waste targets

    Speakers

    5 PM

    Reserved for event sponsor

    5:30 PM

    Chairperson’s closing remarks and networking drinks

    Speakers

    7:30 AM

    Registration and refreshments

    8:25 AM

    Chairperson’s opening remarks

    Speakers

    8:30 AM

    Revolutionizing clinical trial supply chains with data driven systems

    • How data driven systems in clinical supply chains can lead to enhancing efficiency, accelerating trial timelines, and putting patients first
    • Automating data management for efficient supply chain operations
    • Enhancing and streamlining supply chain operations with AI and other data driven technologies

    Speakers

    9 AM

    Re-imagining planning for a best-in-class supply chain performance

    Planning serves as the brain of the supply chain, orchestrating various activities and KPIs that profoundly impact its overall performance. Waste, cost, risk, shortages, CO2 emissions, bottlenecks, and workload are all outcomes tied to carefully planned operations. But today’s challenges are changing the paradigm of our supply chains. Join our talk to learn:

    • The current challenges that will force us to revolutionize our supply chain
    • How GSK is re-imagining the role of clinical supply planner and its place in enabling an ambitious R&D
    • How planning is increasingly important at all stages of the trial lifecycle
    • At any given time, how to always remain with the optimal supply chain strategy

    Speakers

    9:30 AM

    PANEL DISCUSSION: Navigating uncertainty: strategies for enhancing supply chain security in times of geopolitical and economic instability

    • Assessing site selection in times of geopolitical tensions and uncertainty
    • Managing the impact of high inflation rates on the Medicare Part D Program
    • Enhancing supply chain security by understanding global socio-economic dynamics

    Speakers

    10 AM

    Reserved for 4G Clinical

    10:30 AM

    Morning refreshments and networking

    11:15 AM

    CEIV Pharma: raising the standard of pharmaceutical logistics

    • Risks and potential gaps in cold chain when transporting temperature-sensitive drugs by air
    • How IATA's standards and certification can improve handling of pharmaceutical cargo, ensuring compliance with regulations
    • Benefits of participating in IATA's CEIV Pharma program: how this can help you establish and maintain shipment integrity
    • Engage in the process of a simplified audit solution against clear standard criteria and provide constructive feedback on IATA's proposed solution

    Speakers

    11:45 AM

    Clinical trial logistics: evolving supply models and new therapies highlight emerging trends

    Decentralized trial logistics:

    • The role of DTP in maximizing benefits of DCT
    • Overcoming DTP complexities

    Emergence of cell and gene therapies

    • Unique logistics considerations for CGTs
    • Ensuring quality through technology solutions

    Speakers

    12:15 PM

    Impact of drug pooling and just-in-time manufacturing on the clinical supply chain and related technologies

    Speakers

    12:45 PM

    Reserved for Inceptua

    1:15 PM

    Lunch and networking

    2:30 PM

    Assessing sourcing models to determine the optimal sourcing strategy

    • Overview of different sourcing models
    • Assessing options to determine optimal strategies
    • Working in a wholly outsourcing model: maintaining a strong supplier base

    Speakers

    3 PM

    Innovative processes to better address today’s trial dynamics

    • Supply chain efficiency: why do extra work and spend more money than necessary?
    • Payment process efficient: leverage an existing workflow process that sites use everyday
    • Understanding the total value a vendor can provide
    • Select a vendor that can demonstrate its total value (and make you look good in the eyes of your company)

    Speakers

    3:30 PM

    Enhanced communication methods: building rapport between clinical supply groups and partners

    • Enhancing communication methods and tools to foster effective communication between global clinical supply groups and their partners
    • Building rapport through collaborative efforts to strengthen relationships
    • Establishing feedback mechanisms to provide a continuous loop of communication, allowing for ongoing improvement and increased understanding between stakeholders

    Speakers

    4 PM

    Afternoon refreshments and networking

    4:20 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!

    4:30 PM

    INTERACTIVE DISCUSSION SESSION: Overcoming roadblocks in comparator sourcing and vendor management

    • Accessing supply: ensuring your supply chain is robust and planning timelines to avoid delays
    • Managing regulatory hurdles when importing comparators from overseas
    • Working efficiently with vendors when sourcing comparators for your clinical trial
    • What to consider in order to ensure your comparator sourcing processes meet cost and waste targets

    Speakers

    5 PM

    A toolkit for sourcing commercial medicines for your clinical trials

    • Introduction to Abacus Medicine Pharma Services
    • Expect the unexpected
    • When to take action
    • Tools to minimize the risk of disruption

    Speakers

    5:30 PM

    Chairperson’s closing remarks and networking drinks

    Speakers

    Streams

    Stream one

    Clinical Supply Logistics and Operations

    Stream two

    Clinical Supply Technology and Innovation

    9 AM

    Revolutionizing clinical trial supply management with AI powered IRT forecasting and optimization

    • Improving the efficiency and agility of clinical trial supply management through the use of AI-powered IRT forecasting
    • Optimizing the allocation of clinical trial supplies across sites and reducing waste by using advanced AI algorithms to forecast IRT needs
    • Leveraging real-time data and machine learning to enhance IRT forecasting accuracy and improve supply chain resilience in clinical trials

    Speakers

    9:30 AM

    PANEL DISCUSSION: Considerations when designing a direct-to-patient distribution model for your clinical supply chain

    • Benefits to patients of direct-to-patient models: how can DTP make clinical trials more accessible?
    • Where are the benefits and disadvantages of DTP from a patient perspective?
    • Implementing a DTP strategy that works for your clinical study
    • Understanding how DTP can optimize supply chain flexibility for clinical trials
    • The regulatory environment surrounding DCT and DTP in the US: what you need to be aware of

    Speakers

    9:45 AM

    Revolutionizing clinical trial supply management with AI powered IRT forecasting and optimization

    • Improving the efficiency and agility of clinical trial supply management through the use of AI-powered IRT forecasting
    • Optimizing the allocation of clinical trial supplies across sites and reducing waste by using advanced AI algorithms to forecast IRT needs
    • Leveraging real-time data and machine learning to enhance IRT forecasting accuracy and improve supply chain resilience in clinical trials

    Speakers

    10:15 AM

    Morning refreshments and networking

    11 AM

    Reserved for

    Speakers

    11:30 AM

    PANEL DISCUSSION: Considerations and best practice for working effectively with clinical supply technology vendors and partners

    • The importance of integrated systems with CMOs: how much integration is useful?
    • Considerations when choosing technology partners in order to facilitate a strong partnership
    • Remote communications: best practice for selecting and working with partners when working remotely

    Speakers

    12 PM

    Lunch and networking

    8 AM

    Registration and refreshments

    9 AM

    The improving clinical trials environment in Canada

    • Harnessing unique assets to sustain Canada’s role as a medical research and health innovation hub
    • Raising numerous interesting and difficult policy questions related to Canadian and US collaboration when addressing ‘extraordinary’ needs of rare disease patients
    • Clinical innovation as a means to cultivate supportive conditions for improved care for rare patients in Canada
    • Using scientific knowledge to improve patient impact and system receptivity

    Speakers

    9:30 AM

    PANEL DISCUSSION: Pain points in the clinical supply chain: overcoming common challenges and hurdles to improve efficiency

    • Using technology to mitigate against risk of changing supply and demand
    • Shipping internationally outside of the US: common hurdles and how to overcome these
    • The changing regulatory environment in the US and how to ensure you stay up to date with new regulations

    Speakers

    9:45 AM

    PANEL DISCUSSION: Pain points in the clinical supply chain: overcoming common challenges and hurdles to improve efficiency

    • Using technology to mitigate against risk of changing supply and demand
    • Shipping internationally outside of the US: common hurdles and how to overcome these
    • The changing regulatory environment in the US and how to ensure you stay up to date with new regulations

    Speakers

    10:15 AM

    Morning refreshments and networking

    11 AM

    Driving successful clinical trials with complex supply chains

    • Identifying and implementing continuous improvements in the supply chain: where are the main opportunities for higher efficiency?
    • Understanding additional needs of more complex supply chains and how to meet these
    • Taking advantage of new technology and systems in order to streamline and maximize the efficiency of your clinical supply chain

    Speakers

    11:30 AM

    Ensuring financial sustainability in the pharmaceutical industry: strategies for pricing, reimbursement, and cost containment

    • Evaluating pricing strategies for pharmaceutical products in light of changing market dynamics and reimbursement policies: ensuring financial sustainability for both payers and pharma sponsors
    • Navigating complex policy landscapes and balancing the needs of patients, providers, and payers when determining drug prices and reimbursement rates
    • Mitigating the risk of drug shortages, inflation pressure and economic uncertainty by modifying cost-containment measures and exploring alternative payment models for medicines

    Speakers

    12 PM

    Lunch and networking

    1:15 PM

    Optimizing clinical trial supply chain efficiency through CTPAT/Trade Compliance

    • Ensuring compliance with CBP regulations: a discussion of PHC-CEE, the benefits of joining the CTPAT Trade Compliance (TC) program and how to become eligible
    • Strengthening supply chain security and reducing the risk of delays at the border: understanding the CBP's expectations of importers and how the CTPAT TC program can support you
    • Enhancing the efficiency of clinical trial supply management: how participation in the CTPAT TC program can streamline import processes and lead to timely and cost-effective delivery

    Speakers

    1:45 PM

    Revolutionizing clinical trials with accelerating clinical evidence models: enhancing efficiency, collaboration, and patient access

    • Implementing a novel approach for drug approvals with accelerated approval pathway to streamline processes
    • Enhancing collaboration between the FDA and CMS in developing new payment methods for drugs approved via accelerated approval to promote the completion of confirmatory trials
    • Improving patient access to post-market safety and efficacy data by utilizing the Accelerating Clinical Evidence model, leading to better healthcare outcomes and cost savings

    Speakers

    2:15 PM

    PANEL DISCUSSION: Advancing diversity, equity, and inclusion in clinical trial supply chain management: best practices and future directions

    • Designing for diversity: strategies for inclusive clinical trial supply chain management
    • Increasing vaccine awareness and acceptance through inclusive clinical trials
    • Addressing genetic differences and promoting equity in clinical trial supply management
    • Developing cultural competence in clinical trial supply chain management to ensure equity and inclusion

    Speakers

    3 PM

    Afternoon refreshments and networking

    3:20 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!

    3:30 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.

    ROUNDTABLE 1: Planning for a smooth import/export at the border: considerations when working with CBP

    Mary Zhang, National Account Manager, US Customs and Border Protection

     

    ROUNDTABLE 2: Ensuring regulatory compliance in clinical trial supply: best practices and guidelines

     

    ROUNDTABLE 3: Navigating inflation and economic uncertainty: clinical supply chain considerations

    Milena Izmirlieva, Head of Health Economics and Market Access Research and Analysis, GlobalData

    Speakers

    4:30 PM

    End of Conference

    Speakers

    Select a speaker to learn more

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    Jason Bellman
    Manager, Clinical Supply Chain Systems, Apellis Pharma

    Session Details:

    PANEL DISCUSSION: Analyzing the opportunities offered by effective use of IRT

    2023-10-11, 11:15 AM

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    Susan Marlin
    President and CEO

    Susan Marlin is the President and CEO of Clinical Trials Ontario (CTO), an organization established by the Province of Ontario to make Ontario a preferred location for clinical trials while maintaining the highest ethical standards. Prior to joining CTO she served as the Associate Vice-Principal at Queen’s University. Susan worked with the National Cancer Institute of Canada Clinical Trials Group for many years, coordinating cancer clinical trials and leading the development of the Ethics and Regulatory Office.

    Susan served as President of the Canadian Association of Research Ethics Boards, and as a member of the Canadian Institutes of Health Research (CIHR) Research Integrity Committee, the Ontario Cancer Research Ethics Board, the Tri-Agency Panel on the Responsible Conduct of Research, and the Ontario Government Life Sciences Working Group. She is currently a member of the Life Sciences Ontario Board of Directors and the Management Team for the Ontario SPOR (Strategy for Patient Oriented Research) Support Unit.

    Susan was born and raised in Halifax, Nova Scotia. She holds a BSc (Hons) from Dalhousie University, and an MSc in Community Health and Epidemiology from Queen’s University. She was awarded the Queen’s Elizabeth II Diamond Jubilee medal in 2012 in recognition of her work in support of military and veteran health research.

    Session Details:

    PANEL DISCUSSION: Considerations and best practice for working effectively with clinical supply technology vendors and partners

    2023-10-12, 12:00 PM

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    Gustav Ando
    Vice President, Managing Director, GlobalData

    Session Details:

    Chairs opening remarks

    2023-10-12, 8:50 AM

    Session Details:

    Ensuring financial sustainability in the pharmaceutical industry: strategies for pricing, reimbursement, and cost containment

    2023-10-12, 12:00 PM

    Session Details:

    PANEL DISCUSSION: Pain points in the clinical supply chain: overcoming common challenges and hurdles to improve efficiency

    2023-10-12, 9:45 AM

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    Blake Edward Wilson
    Partner (FDA Regulatory), Hogan Lovells

    Session Details:

    Revolutionizing clinical trials with accelerating clinical evidence models: enhancing efficiency, collaboration, and patient access

    2023-10-12, 1:45 PM

    Session Details:

    PANEL DISCUSSION: Considerations when designing a direct-to-patient distribution model for your clinical supply chain

    2023-10-12, 9:30 AM

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    Dawn Wright
    Director Global Supply Chain, Incyte

    Accomplished leader experienced in clinical trials and CROs looking for an opportunity to grow into a new area by building on knowledge and skills acquired over many years in the industry. Proven track record for managing global teams across multiple sites in the US and UK. Extensive background in planning of clinical study activities and leading matrix teams. Experienced in leading after action reviews and implementing process improvements that address the root cause and improve processes.

    Session Details:

    Impact of drug pooling and just-in-time manufacturing on the clinical supply chain and related technologies

    2023-10-11, 12:15 PM

    Session Details:

    PANEL DISCUSSION: Pain points in the clinical supply chain: overcoming common challenges and hurdles to improve efficiency

    2023-10-12, 9:30 AM

    Session Details:

    PANEL DISCUSSION: Pain points in the clinical supply chain: overcoming common challenges and hurdles to improve efficiency

    2023-10-12, 9:45 AM

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    Ronald Schaefer
    Consulting Head of Certification Programs (CEIV Pharma), IATA

    Ronald Schaefer is Senior Principal, Consulting. He is also the Consulting Head of the Certifications Programs (CEIV Pharma, CEIV Live Animals, CEIV Fresh, CEIV Lithium Battery, CBTA, etc.) at IATA. He was born in Hamburg, Germany, raised in Mexico and educated in the US. After long-term professional assignments in Germany, Spain, Malaysia, Kuwait, Venezuela and Canada, he has been based in Miami for the last 14 years working for IATA. Before joining IATA, Mr. Schaefer accumulated vast experience in the air transport field working as a consultant for Lufthansa Consulting GmbH, Roland Berger Strategy Consultants GmbH and Ferrostaal México. He has worked on corporate restructuring, strategy, post-merger integration, market and competitive analysis, safety, risk management initiatives among others, in the transportation industry on all continents. Throughout his career Ronald has held positions in Mexico, Stuttgart, Kuala Lumpur, Frankfurt, Cologne, New York, Montreal and Miami.

    At IATA he developed in conjunction with the IATA Pharma subject matter expert the CEIV Pharma pre-assessment tools and materials to facilitate successful independent validation of organizations. He also led the initial independent assessment Proof-of-Concept for Singapore Air Terminal Services (SATS) and is now managing the program worldwide. Since its start he has managed ~450 certifications, +1000 assessments and +800 validations.

    He is also jointly responsible for the development and implementation of new CEIV initiatives such as CEIV Live Animal, officially launched in April 2018 and CEIV Fresh launched in 2019. In conjunction with the IATA Live Animal and Perishable expert, he is also developing the pre-/assessment tools for validations of organizations and jointly managing the on-going pilots.

    He holds a Bachelor of Science (B. Sc.) in Business Administration from California State University at Sonoma and Master of Business Administration (MBA) from Georgetown University.

    Session Details:

    CEIV Pharma: raising the standard of pharmaceutical logistics

    2023-10-11, 11:15 AM

    Session Details:

    PANEL DISCUSSION: Pain points in the clinical supply chain: overcoming common challenges and hurdles to improve efficiency

    2023-10-12, 9:30 AM

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    Shawn Gehen
    Clinical Demand Planning Manager (Contractor), Seagen

    Session Details:

    PANEL DISCUSSION: Analyzing the opportunities offered by effective use of IRT

    2023-10-11, 11:15 AM

    Session Details:

    Revolutionizing clinical trial supply management with AI powered IRT forecasting and optimization

    2023-10-12, 9:00 AM

    Session Details:

    Revolutionizing clinical trial supply management with AI powered IRT forecasting and optimization

    2023-10-12, 9:45 AM

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    Kevin Hickman
    Director, Global Logistics, Mirati
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    RAM RAJU
    Former CEO, NYC Health & Hosptials Corporation

    Dr. Ram Raju has a distinguished career over 40 years as a healthcare provider, teacher, researcher and community organizer. In his role at Northwell Health, Dr. Raju set the strategic vision to improve population health by finding ways to meet the needs of its most vulnerable communities, by examining the existing programs aimed at improving the health system's response to the community's needs and working with local organizations to address them. Northwell Health is the largest healthcare provider in the state of New York, is a system with 23 hospitals and 830 outpatient facilities that sees 2 million people every year in the New York metro area and beyond.

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    David Sokoloff
    Sr. Director Global Logistics and Materials Management, Novavax

    David Sokoloff is the Director of Global Logistics & Materials Management for Novavax, Inc. He manages the storage and transportation of Novavax’s products through its global network. David founded For Granted, Inc. in 2006, a nonprofit supporting community driven programming in education, water and sanitation, micro-finance, and child health.

     

    David has managed supply chains for emergency relief efforts across the Globe. He ran operations in the field for several years with Doctors Without Borders, prior to working in Washington, D.C., leading logistics operations for the U.S. Office of Foreign Disaster Assistance. At the onset of the COVID-19 outbreak, David joined Novavax, Inc. He supports their global supply chain to deliver products preventing a broad range of infectious diseases. Novavax produces vaccine candidates in response to both known and emerging disease threats, including the company’s CoVID-19 vaccine.

    Session Details:

    PANEL DISCUSSION: Navigating uncertainty: strategies for enhancing supply chain security in times of geopolitical and economic instability

    2023-10-11, 9:30 AM

    Session Details:

    Revolutionizing clinical trial supply chains with data driven systems

    2023-10-11, 8:30 AM

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    Ginelle Andrews
    Director Commercial Product Sourcing Strategy, Pfizer

    Session Details:

    Assessing sourcing models to determine the optimal sourcing strategy

    2023-10-11, 2:30 PM

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    Lindsey Marshall
    Director, Clinical Drug Supply, Regeneron

    Session Details:

    PANEL DISCUSSION: Pain points in the clinical supply chain: overcoming common challenges and hurdles to improve efficiency

    2023-10-12, 9:30 AM

    Session Details:

    INTERACTIVE DISCUSSION SESSION: Overcoming roadblocks in comparator sourcing and vendor management

    2023-10-11, 4:30 PM

    Session Details:

    INTERACTIVE DISCUSSION SESSION: Overcoming roadblocks in comparator sourcing and vendor management

    2023-10-11, 4:30 PM

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    Jen Horonjeff
    CEO, Savvy Cooperative

    Jen Horonjeff, PhD, is a patient advocate and the Founder & CEO of Savvy Cooperative. She was named one of the 50 Most Daring Entrepreneurs by Entrepreneur Magazine, alongside Elon Musk and Reese Witherspoon, for her work at Savvy, which helps companies equitably gather input and insights from diverse patients. Jen is passionate about patient co-design as she grew up with juvenile idiopathic arthritis, and survived a brain tumor as an adult. She also holds a PhD in Environmental Medicine, and previously worked as a health outcomes researcher, a human factors engineer and user-centered designer, and an advisor to the FDA. Jen serves on the Board of Directors for The Sequoia Project, a non-profit focused on health data exchange, the Advisory Board of Trialbee, a clinical trial recruitment company, and numerous other committees to ensure the patient voice is included.

    Session Details:

    PANEL DISCUSSION: Advancing diversity, equity, and inclusion in clinical trial supply chain management: best practices and future directions

    2023-10-12, 2:15 PM

    Session Details:

    PANEL DISCUSSION: Considerations when designing a direct-to-patient distribution model for your clinical supply chain

    2023-10-12, 9:30 AM

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    Vatsala Sadasivan
    Global Operations Excellence Lead R&D, Sanofi

    Session Details:

    Revolutionizing clinical trial supply chains with Patient-Centric Hybrid Trials (PHTs) and Direct-to-Patient models

    2023-10-11, 12:15 PM

    Session Details:

    PANEL DISCUSSION: Considerations when designing a direct-to-patient distribution model for your clinical supply chain

    2023-10-12, 9:30 AM

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    Paul Larochelle
    Director, Global Clinical Supply Chain, Takeda

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

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    Tyler Wilson
    Global Clinical Supply Chain Fellow, Takeda

    BS Chemistry from University of Minnesota in 2017

    PharmD from University of Minnesota College of Pharmacy in 2022

     

    Started as postdoctoral fellow in global clinical supply chain at Takeda in July 2022

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    Mary Zhang
    National Account Manager, US Customs and Border Protection

    Session Details:

    SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

    2023-10-12, 3:30 PM

    Session Details:

    Optimizing clinical trial supply chain efficiency through CTPAT/Trade Compliance

    2023-10-12, 1:15 PM

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    Simi Nischal
    Senior Director, Digital, Data and Analytics, Clinical Supply Chain, GSK

    Session Details:

    PANEL DISCUSSION: Analyzing the opportunities offered by effective use of IRT

    2023-10-11, 11:15 AM

    Session Details:

    PANEL DISCUSSION: Considerations and best practice for working effectively with clinical supply technology vendors and partners

    2023-10-12, 11:30 AM

    Session Details:

    PANEL DISCUSSION: Considerations and best practice for working effectively with clinical supply technology vendors and partners

    2023-10-12, 12:00 PM

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    Haneen Mazahreh-Boivert
    Senior Director Global Clinical Supply, Boston Pharmaceuticals
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    Francesco Santo
    Associate Director, Global Clinical Supply Chain, HUYABIO International

    Session Details:

    Driving successful clinical trials with complex supply chains

    2023-10-12, 11:00 AM

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    Jennifer Fenwick
    Senior Manager Personalized Supply Chain, World Courier

    Session Details:

    Clinical trial logistics: evolving supply models and new therapies highlight emerging trends

    2023-10-11, 11:45 AM

    Session Details:

    PANEL DISCUSSION: Considerations when designing a direct-to-patient distribution model for your clinical supply chain

    2023-10-12, 9:30 AM

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    Kim Buchanan
    Associate Director Development Quality, Merck

    Experienced quality professional with strong leadership and exceptional background in packaging operations, technology, clinical supplies, commercial products, laboratory, and FDA & EU regulatory agency compliance and inspections. Cross functional roles include 2 interim clinical supply assignments, direct line supervision of Global Quality, Sterile & Biological Operations/Technology and Pharm Laboratory personnel.  Key in the development of Expanded Access Program at her company.

    Session Details:

    CASE STUDY: Digital display labels transforming the clinical supply chain

    2023-10-11, 3:30 PM

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    Ian Hoban
    Business Development Director, Abacus Medicine

    Ian has over 30 years of pharmaceutical industry experience, predominantly within global organisations such as Pfizer and Eli Lilly.  He built his reputation in the commercialisation of numerous brands in a variety of disease areas, and at every stage of the product lifecycle.

    During his career, Ian has worked closely with supply chain, ensuring accurate forecasting, and getting medicines to patients through the implementation of novel approaches.

    Before joining Abacus Medicine Pharma Services Ian worked in senior roles at two leading global clinical solutions companies.  He provided many leading pharmaceutical and biotechnology companies with successful comparator sourcing solutions which helped successfully deliver their pivotal late phase clinical trials.

    Session Details:

    A toolkit for sourcing commercial medicines for your clinical trials

    2023-10-11, 5:00 PM

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    Yves Dethier
    Drug Supply Chain Expert and Business Leader, Boostcode

    Session Details:

    Drug supply management: ensure supply safety while generating huge savings

    2023-10-11, 12:45 PM

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    Milena Izmirlieva
    Head of Health Economics and Market Access Research and Analysis, GlobalData

    Session Details:

    Chairperson’s opening remarks

    2023-10-11, 8:25 AM

    Session Details:

    PANEL DISCUSSION: Navigating uncertainty: strategies for enhancing supply chain security in times of geopolitical and economic instability

    2023-10-11, 9:30 AM

    Session Details:

    SPEAKER HOSTED ROUNDTABLE DISCUSSIONS

    2023-10-12, 3:30 PM

    Session Details:

    PANEL DISCUSSION: Advancing diversity, equity, and inclusion in clinical trial supply chain management: best practices and future directions

    2023-10-12, 2:15 PM

    Session Details:

    Ensuring financial sustainability in the pharmaceutical industry: strategies for pricing, reimbursement, and cost containment

    2023-10-12, 11:30 AM

    Session Details:

    PANEL DISCUSSION: Pain points in the clinical supply chain: overcoming common challenges and hurdles to improve efficiency

    2023-10-12, 9:30 AM

    Session Details:

    Chairperson’s closing remarks and networking drinks

    2023-10-11, 5:30 PM

    Session Details:

    Chairperson’s closing remarks and networking drinks

    2023-10-11, 5:30 PM

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    Linda Nichols
    Director, Study Start Up and Optimization, GSK

    Session Details:

    Re-imagining planning for a best-in-class supply chain performance

    2023-10-11, 9:00 AM

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    Michelle Novak
    Regional Director, Business Development, Inceptua
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    Paul F. Hughes
    Director, Randomization and Trial Supply Management, Janssen

    Session Details:

    CASE STUDY: Implementing an effective IRT system into your clinical trial supply chain

    2023-10-11, 2:30 PM

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    Amaury Jeandrain
    Vice President of Strategy, N-SIDE

    Amaury Jeandrain has a Master’s Degree in Business Engineering with a specialization in supply chain management. After working for a CRO, he joined N-SIDE where he supported the optimization of hundreds of trials from different indications and pharmaceutical companies, providing services ranging from risk-based optimization to clinical trial design and solving drug supply shortage problems. Amaury now leads a group of consultants, focusing on the extension of N-SIDE’s solutions.

    Session Details:

    Re-imagining planning for a best-in-class supply chain performance

    2023-10-11, 9:00 AM

    Session Details:

    PANEL DISCUSSION: Considerations when designing a direct-to-patient distribution model for your clinical supply chain

    2023-10-12, 9:30 AM

    Session Details:

    PANEL DISCUSSION: Considerations and best practice for working effectively with clinical supply technology vendors and partners

    2023-10-12, 11:30 AM

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    Loïc Struyf
    Associate Director, Head of Customer Success, N-Side

    Session Details:

    Re-imagining planning for a best-in-class supply chain performance

    2023-10-11, 9:00 AM

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    Tom Gottschalk
    Senior Director, Business Development, TrialCard

    Tom Gottschalk has worked in the life sciences industry for over 25 years.  His first 10 years were spent as a Pharmaceutical Representative and Product Manager for Bertek Pharmaceuticals, Merck, and GSK.  He then joined RxSolutions as a commercial services account representative before transitioning into a focused clinical role after creating the RxStudy Card offering.  He joined TrialCard in 2019 via its acquisition of RxSolutions.  For over 12 years, Tom has been committed to changing the paradigm of the traditional clinical trial supply process through the RxStudy Card.

    Session Details:

    Innovative processes to better address today’s trial dynamics

    2023-10-11, 3:00 PM

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    Elliot N. Ortiz
    Chief Agriculture Specialist, Area Port of Philadelphia, US Customs and Border Protection

    Session Details:

    Reserved for

    2023-10-12, 11:00 AM

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