12th Annual Clinical Trial Supply Nordics 2024

The annual meeting place for pharmaceutical, biotechnology, and medical device communities in the Nordics to network and discuss strategies for supply chain success in clinical trials

1 - 2

October

2024
  • Clarion Hotel & Congress Copenhagen Airport, Denmark
  • Complimentary
  • Why attend?
  • Agenda
  • Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Why partner?
  • Resources
  • Contact Us
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2024 Sponsors Included:

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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 Website

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

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Company Information

Linical is a global speciality CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With more than 900 employees Linical directly covers more than 20 countries and all key markets in Asia-Pacific, Japan, Europe and N. America via its own offices.

Company Website

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

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Company Information

ARENSIA Exploratory Medicine, a German company, specializes in “first-in-patient” Phase IB and II/PROOF-OF-CONCEPT clinical trials spanning various patient populations. Equipped with 14 proprietary research clinics and advanced Phase I infrastructure, ARENSIA exceptionally accelerates the detection of initial efficacy signals for novel compounds at an unrivalled speed. ARENSIA’s streamlined approach significantly slashes patient recruitment time and costs by at least 50%, as opposed to overcrowded and understaffed conventional trial sites. The company’s remarkable efficiency is underscored by its 93% repeat business rate, propelling its growth and collaborations with leading pharmaceutical companies, biotechs, and global CROs. H3.eadquartered in Düsseldorf, ARENSIA operates with a workforce of over 450 employees across 8 countries.

Company Website

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

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Company Information

KLIFO is a leading international drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies to advance their drug development projects. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement.

We offer multidisciplinary consulting and operational solutions spanning all areas of clinical research, clinical trial supply, QA, CMC development, regulatory affairs, pharmacovigilance, and the development of pharmaceutical and biotech products and medical devices.

Company Website

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

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Company Information

Since 1997, Clinigen has offered market-leading clinical trial supplies and biological sample management services to meet the most complex clinical supply challenges. Part of Clinigen Group’s global supply chain facility and depot network, we deliver tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.

Company Website

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

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Company Website

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

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Company Information

Lexano aims to address the healthcare inequality that exists due to the high medication costs and different accessibility.

We believe that everyone should have access to essential medications. For 20 years we strive to help patients, doctors, and the staff of clinical trial organizations to get the medicines they need through wide partnerships and timely delivery.

Let’s connect and discuss how we can make a difference together!

Company Website

To learn more, please visit our website - http://lexano.eu/en/

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Company Information

Founded in 1997, Ergomed is a full service, global Phase I-IV clinical development and trial management service partner with leading expertise in developing oncology and rare disease drugs.  Our portfolio includes experience working with novel therapies, early phase development, immunotherapy, and adaptive trial designs. Ergomed embodies a patient-centric approach to recruitment and retention with access to global patients in vital geographical areas.  Ergomed’s proven delivery record, expertise, and true partnership means our sponsors can trust us to deliver their oncology trials whatever the challenge. We also offer an industry-leading suite of specialist pharmacovigilance (PV) solutions under the PrimeVigilance brand.

Ergomed has supported and managed clinical development, trial management, pharmacovigilance, and medical information services for over 300 clients in more than 100 countries.

We deliver a complete solution for oncology trials of all sizes and complexity. For more information about Ergomed, please visit: www.ergomedcro.com

Company Website

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

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Company Information

Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 34,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,200 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

Company Website

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

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Company Information

Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

Company Website

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

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Company Information

TFS HealthScience is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Bringing together nearly 700 professionals, we deliver tailored clinical research services in more than 40 countries. TFS supports customers with comprehensive solutions including full clinical development services, strategic and flexible resourcing. In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. Our mission is to bring treatments to patients faster. For more information, please visit www.tfscro.com.

Company Website

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

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Company Information

Climedo offers a digital platform for hybrid clinical trials and observational studies. Its modular and secure solutions include electronic data capture (EDC), eCOA/ePRO and Telemedicine. This enables pharma and medtech companies to validate their medical innovations more efficiently in the post-market phase and to capture data in decentralized, real-world settings.

Company Website

To learn more, please visit our website - www.climedo.de

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Company Information

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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Company Information

Clario is a leading healthcare research and technology company that generates high quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries.  Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2019.

Company Website

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

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Company Information

PPD clinical research business of Thermo Fisher Scientific, provides clinical development and analytical services that enhance customer innovation and productivity. Utilizing patient-centered strategies and data analytics, we cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, patient recruitment, investigator sites and comprehensive laboratory service. To learn more, visit thermofisher.com/ppd

Company Website

To learn more, please visit our website - thermofisher.com/ppd

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Company Information

Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

Company Website

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

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Company Information

Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

Company Website

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

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Company Information

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

 

Company Website

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

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    Why attend?

    This is the unmissable event that the pharmaceutical, biotechnology, and medical device communities need to come together and discuss strategies for operational success in clinical trials. Combining our OCT, CTS and Medical Devices events, this is the perfect platform for professionals from across a range of clinical trial functions to meet, network, and hear about latest developments.

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    WHAT TO EXPECT FOR 2024?

    200+

    Attendees

    		30+

    Exhibitors

    		30+

    Speakers
    200+

    Attendees

    		30+

    Exhibitors
    30+

    Speakers

    Testimonials

    See What It's All About

    Agenda

    • 1 Oct 2024
    • 2 Oct 2024
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    Streams

    Stream one

    CLINICAL TRIAL SUPPLY

    7:30 AM

    Registration and refreshments

    8:15 AM

    Chairperson’s opening remarks

    Speakers

    Fiona Barry
    Editor-in-Chief and Director of PharmSource, GlobalData

    8:30 AM

    Updates from the International Air Transport Association (IATA) on professionalization of temperature-controlled airfreight global logistics

    • Overview of current air cargo professional programs focused on specialization of temperature-controlled air cargo management
    • Insights into ongoing efforts to professionalize the industry across different regions
    • How training programs are integrated into audit and certification programs to airfreight operators (airlines, ground handlers, freight forwarders etc)
    • Difference between regulated and non-regulated training

    Speakers

    Francisco Rizzuto
    Senior Manager Cargo & Logistics Training, IATA

    9 AM

    Adapting to change: Global trends, European insights, and vendor relationships in modern clinical trials

    • In recent years, the clinical trial landscape has undergone significant transformations driven by global events, evolving trial designs, intricate supply chains, innovative dosing schemes, and a heightened focus on patient-centric approaches
    • This session will present feedback from European pharma companies, offering a regional perspective on these trends and challenges. Topics discussed will explore the most impactful changes and trends shaping clinical study protocols globally.
    • The session will also explore how vendor and partner relationships have adapted to these changes, highlighting key considerations for onboarding eClinical technology vendors and maintaining trust in these partnerships. An expert panel discussion will further elaborate on these topics, providing diverse viewpoints and practical strategies for navigating the evolving
      clinical trial environment.

    Speakers

    Libbi Rickenbacher
    Senior Director Product Strategy and Partnerships, 4G Clinical
    Gemma Lofts
    Director Clinical Supply Chain, Bicycle Therapeutics
    Jonathan Pritchard
    Senior Commercial Operations Manager, 4G Clinical

    9:30 AM

    AAV CTM CDMO partnering evaluation through DOE feasibility studies, combining sustainability, quality and general performance

    • Pre-selection through identification of CDMO exclusion criteria
    • Finding synergies (for the process) through cooperation with academia and suitable grants
    • The RfP- how to enable the comparison of apples with apples
    • The ideal process and risk assessment

    Speakers

    Sebastian Bauer
    CMC Director, CombiGene AB

    10 AM

    Protocol optimization: How a transformational relationship with your CRO can increase your development programs’ chances of success

    • Maximizing the opportunity for strategic input and design feedback from your CRO throughout the outsourcing process
    • Overview of the typical areas where your CRO can guide and facilitate study optimization
    • Examples of where CRO experience has transformed study design and operations, to sponsor advantage

    Speakers

    Rich Bennett
    Senior Director, Therapeutic Strategy Lead, Neuroscience, Worldwide Clinical Trials

    10:30 AM

    Morning Refreshments & Networking

    11 AM

    Fireside Chat: Using IRT as a tool to simplify supply planning and management

    • Identifying key characteristics of IRT required for different study types
    • Handling dispensing protocols, calculating dosage, predicting demand and inventory management
    • Controlling dispensing logistics to track your product during shipment and patient distribution to maintain control over your clinical study
    • Managing documentation including returns, reconciliation and accountability for drug

    Speakers

    Nina Munsterhjelm
    Senior IRT and Medication Manager, Bayer

    11:30 AM

    Revolutionizing Patient Engagement in Clinical Trials: The Power of Gamification

    Are high dropout rates and patient disengagement slowing down your clinical trials and driving up costs? This session will introduce you to gamification as a proven solution to keep patients motivated, reduce dropout rates, and improve compliance. By enhancing engagement, you’ll discover how gamification can lead to faster, more efficient trials—and substantial cost savings.

     

    In this session, you will:

    • Get actionable insights on integrating gamification into your trials. Learn practical strategies to boost patient engagement while ensuring accurate data collection.
    • Explore real-world success stories. Discover how increased patient retention translated into shorter trial timelines, lower costs, and better trial outcomes.
    • See how gamification drives efficiency and savings. Understand how engaging patients more effectively can streamline your trials, reduce time to market, and significantly lower costs.

    Speakers

    Christer Nilsson
    Chief Executive Officer, Replior

    12 PM

    Panel discussion: Preparing for and mitigating against risk in clinical supply chain to avoid delays

    • Creating a risk management plan for clinical supply chain
    • Considerations for security risk management
    • Preparing for unexpected and natural disasters
    • Monitoring temperature control risk management

     

    Speakers

    Fiona Barry
    Editor-in-Chief and Director of PharmSource, GlobalData
    Pernille Hemmingsen
    Chief Technology Officer, Adcendo
    Thomas Thoma
    Head Managed Access Programs, CTS/GHT/SR, Teva Pharmaceuticals
    Francisco Rizzuto
    Senior Manager Cargo & Logistics Training, IATA

    12:30 PM

    Innovative solutions for complex clinical trial supply chains

    The landscape of clinical trials is rapidly evolving, driven by technological advancements and a shift toward patient-centric methodologies. This transition is marked by a growing emphasis on decentralization and personalized healthcare, resulting in more accessible and tailored clinical experiences for patients. Hybrid models that blend traditional site-based methods with decentralized strategies are increasingly being adopted to meet these demands and operational innovations are being developed to address the unique challenges presented by new therapeutic modalities.

    This presentation will explore the profound impact of these developments on clinical trial supply chains and trial planning, highlighting how the integration of cutting-edge technologies and innovative strategies can significantly improve operational efficiency and elevate the patient experience.

    Discussion topics:

    • The changing clinical trial landscape and the potential for faster delivery of life-saving drugs to patients
    • The role of smart technologies, deep learning, and artificial intelligence in streamlining clinical trial supply chains
    • The impact of decentralized and hybrid trial models on patient accessibility and convenience
    • The adoption of direct-to-patient digital capabilities and real-time track and trace systems for end-to-end visibility
    • The use of AI and historical data for proactive and predictive analytics to enhance trial planning accuracy and efficiency

    Speakers

    Julia Fields
    Sr. Product Manager, Thermo Fisher Scientific

    1 PM

    Lunch and networking

    2 PM

    Overcoming global supply shortages: urgent actions for sustainable CTS procurement needed

    • Highlighting challenges and impacts of rising global supply shortages
    • Realising urgent need to increase sustainability and life cycle of drug products to avoid limiting innovation due to shortages
    • Overcoming shortages to keep your trial on track

    Speakers

    Thomas Thoma
    Head Managed Access Programs, CTS/GHT/SR, Teva Pharmaceuticals

    2:30 PM

    Ensuring success: Essential sponsor oversight strategies for confirming your clinical study is on track

    • Why it is so important to have proper oversight over study conduct
    • How to make it smooth and effective
    • Which aspects of the trial should have your special attention
    • How CRO can support with keeping oversight on the proper level

    Speakers

    Monika Martyka
    Director Clinical Operations, TFS HealthScience

    3 PM

    Product handling activities in ATMP clinical trials: considerations and strategies for trial supplies

    • Planning and scheduling considerations
    • Understanding the requirements and importance of chain of identity and chain of custody within cell therapy trials
    • Vetting critical partners and identifying technology tracking systems to assist with cell therapy supply

    Speakers

    Tanja Villumsen
    Clinical Supply Specialist, Stem Cell R&D, Novo Nordisk
    Johanne Press Wegeberg
    Specialist Cell Therapy, Novo Nordisk

    3:30 PM

    Afternoon refreshments, networking and prize draw

    4 PM

    Navigating the new landscape of geopolitics and supply chain disruption: A critical look at key macro themes in healthcare

    • Considering recent key geopolitical trends’ impact on the future of healthcare and pharma
    • Investigating the cause of recurring supply chain disruptions
    • Learning how to build supply chain resilience

    Speakers

    Carolina Pinto
    Analyst, GlobalData

    4:30 PM

    Empowering patients to overcome challenges in orphan drug development

    • Orphan drug market: Illustrate the unique challenges of developing a drug for rare diseases
    • Patient-focused drug development: Designing patient-centered clinical trials
    • Operational considerations: Endpoint selection; reducing the burden of participation; cost; sites; patient concierge services
    • Collaboration: Focus on the need for collaboration in this space: sponsors, CROs, patients, patient advocacy groups, investigators, vendors

    Speakers

    Scott Schliebner
    Vice President Drug Development Consulting, Novotech

    5 PM

    Panel Discussion: Forging strong relationships between clinical supply and other stakeholders to work better together

    • Collaborating early with clinical operations to align needs and outcomes
    • Considering tools and processes to assist with cross functional interaction
    • Liaising with quality assurance to enable faster compliance and reduce delays

     

    Speakers

    Fiona Barry
    Editor-in-Chief and Director of PharmSource, GlobalData
    Pernille Hemmingsen
    Chief Technology Officer, Adcendo
    Gemma Lofts
    Director Clinical Supply Chain, Bicycle Therapeutics
    Maria Contino
    Candidates and Assets Supply Lead, UCB

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    Fiona Barry
    Editor-in-Chief and Director of PharmSource, GlobalData

    5:30 PM

    END OF DAY 1 AND NETWORKING DRINKS SPONOSRED BY FORTREA

    Streams

    Stream one

    CLINICAL TRIALS TECHNOLOGY & INNOVATION

    8:15 AM

    Registration and Refreshments

    8:45 AM

    Chairperson’s Opening Remarks

    Speakers

    Libbi Rickenbacher
    Senior Director Product Strategy and Partnerships, 4G Clinical

    9 AM

    Case Study: Real world example of Artificial Intelligence in clinical development – PoC to Production

    • Understanding regulation and preparing compliance
    • Driving innovation and technology into processes through use of generative AI
    • Implementing AI for practical use with valuable return on investment

    Speakers

    Stephen Lutsch
    Senior Director Clinical Trial Digital Innovation, Genmab

    9:30 AM

    AI in Risk Based (Quality) Monitoring

    Regulatory bodies are promoting Risk Based (Quality) Monitoring as a best practice in clinical trials to correct data quality issues as early as possible in the trial lifecycle.  Since this involves the identification of specific patterns in large datasets, artificial intelligence can support us in doing this efficiently.

    • How can AI find specific patterns that humans might miss
    • Interactions between AI and humans in RB(Q)M
    • Real life examples in respiratory

    Speakers

    Benoit Cuyvers
    Upstream AI Product Manager, Clario

    10 AM

    Case Study: Accelerating innovation through digital health technology solutions

    • Driving true benefits for clinical research through digital health technology
    • Learnings from barriers created by integration of digital health
    • Improving processes and focusing on delivering digital health as a tool

    Speakers

    Magnus Jörntén-Karlsson
    Head of Digital Patient & Site Technology, Evinova at AstraZeneca

    10:30 AM

    Morning Refreshments & Networking

    11 AM

    Expert Conversation: Strategic Considerations for End-to-End Development of Fit-For-Purpose Digital Measures of Health

    • Strategies for sourcing components from a scattered ecosystem
    • How to develop meaningful, human-centric measures
    • Pitfalls and opportunities for analytical and clinical validation
    • Novel solutions and digital pathways for scalable regulatory qualification
    • Maximizing value: how to repurpose and extend solutions across use cases in R&D and healthcare

    Speakers

    Kai Langel
    CEO, DEEP Measures
    Teske Valk
    Lead Medical Project Manager, Novo Nordisk

    11:30 AM

    The new age of R&D procurement: clinical business operations transformed

    • We will examine the high cost of doing nothing
    • What is the status quo and can technology help?
    • Vendor management - tackling one of the biggest challenges
    • The role that AI can play
    • What you can gain by embracing technology

    Speakers

    Anca Copaescu
    Chief Executive Officer, Strategikon Pharma

    12 PM

    Transforming clinical trials: ideas from leading industry professionals

    • Assessing outcomes from over 70 interviews with life science industry pioneers
    • Reviewing what clinical professionals wish would be different in the life sciences industry
    • Suggesting next steps towards further evolving clinical trials

    Speakers

    Ivanna Rosendal
    Senior Director, IT Business Partner, Ascendis Pharma

    12:30 PM

    Lunch and networking

    1:30 PM

    Maintaining control and oversight of data in outsourced trials

    • Considering, generally and specifically, data collected with eDiary, CGM and other external sources
    • Assessing risks when outsourcing trials
    • Acting accordingly to manage and mitigate risks
    • Maintaining right level of oversight

    Speakers

    Ane Jensen
    Principal Data Manager, Zealand Pharma

    2 PM

    Panel Discussion: Considering existing and emerging technology to assist with clinical trials

    • Digitalization: what can we digitalize to improve systems and processes
    • AI: what can we implement to save time and resource
    • Systems: what technology and systems are available and emerging to assist in clinical trials and data management

    Moderator: Libbi Rickenbacher, Senior Director of Product Strategy & Partnerships, 4G Clinical
    Panelists:
    Stephen Lutsch, Senior Director Clinical Trial Digital Innovation, Genmab
    Ane Jensen, Principal Data Manager, Zealand Pharma

    Speakers

    Libbi Rickenbacher
    Senior Director Product Strategy and Partnerships, 4G Clinical
    Stephen Lutsch
    Senior Director Clinical Trial Digital Innovation, Genmab
    Ane Jensen
    Principal Data Manager, Zealand Pharma
    Richard Gray
    Managing Partner, Medidata, Dassault Systemes

    2:30 PM

    Afternoon refreshments, networking and prize draw

    3 PM

    ROUNDTABLE SESSIONS

    During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

    Roundtable 1
    Mitigating risk in clinical supply chain
    Pernille Hemmingsen, Chief Technology Officer, Adcendo

    Roundtable 2
    Engaging with CROs: defining deliverables and agreements
    Asger Dahlgaard, VP of Quality Assurance and Regulatory Affairs, BioPorto Diagnostics A/S

    Roundtable 3
    Considering DCT trial design and impact on both the patient and company
    John Zibert, Chief Medical Officer, Coegin Pharma

    Speakers

    Pernille Hemmingsen
    Chief Technology Officer, Adcendo
    Asger Dahlgaard
    VP of Quality Assurance and Regulatory Affairs, BioPorto Diagnostics A/S
    John Zibert
    Chief Medical Officer, Coegin Pharma

    4 PM

    End of conference

    Speakers

    Helen Johansen Blanco
    Chief Operating Officer, Node Pharma AS

    Speakers

    Select a speaker to learn more

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    Pernille Hemmingsen
    Chief Technology Officer, Adcendo

    Pernille Hemmingsen has more than a decade of experience in the development of pharmaceutical products. With a background in biophysical chemistry and chemical engineering, she is particularly interested in the development of robust manufacturing methods and solid quality to enable the best patient experience and convenience. This interest has led to the development of products ranging from cancer targeting liposomes and antibody drug conjugates to tamper resistant tablets and enhanced diabetes formulations at companies including Genmab and Novo Nordisk. Currently, Pernille Hemmingsen is responsible for the chemistry, manufacturing and control at Adcendo, taking to role as CTO. This work particularly includes establishing an efficient supply chain that encompasses elements from both biologics and small molecules. Pernille holds a Ph.D. from the Department of Chemistry at the Technical University of Denmark and an executive Master of Business Administration from Copenhagen Business School.

    Session Details:

    Panel Discussion: Forging strong relationships between clinical supply and other stakeholders to work better together

    2024-10-01, 5:00 PM

    Session Details:

    Panel discussion: Preparing for and mitigating against risk in clinical supply chain to avoid delays

    2024-10-01, 12:00 PM

    Session Details:

    ROUNDTABLE SESSIONS

    2024-10-02, 3:00 PM

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    Ivanna Rosendal
    Senior Director, IT Business Partner, Ascendis Pharma

    Session Details:

    Transforming clinical trials: ideas from leading industry professionals

    2024-10-02, 12:00 PM

    View In Agenda

    Social Links:

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    Magnus Jörntén-Karlsson
    Head of Digital Patient & Site Technology, Evinova at AstraZeneca

    Session Details:

    Case Study: Accelerating innovation through digital health technology solutions

    2024-10-02, 10:00 AM

    View In Agenda
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    Nina Munsterhjelm
    Senior IRT and Medication Manager, Bayer

    Session Details:

    Fireside Chat: Using IRT as a tool to simplify supply planning and management

    2024-10-01, 11:00 AM

    View In Agenda
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    Sebastian Bauer
    CMC Director, CombiGene AB

    Director CMC since 2023.
    Education and experience: Sebastian Bauer holds a PhD in chemistry (analytical biochemistry) at University of Constance, Germany (1995-1999). After a PostDoc (Vaccine research at Karolinska Insitute) he has been working in pharmaceutical industry for the last 22 years. Initially (2001-2011) in different positions in biologics pharmaceutical development (Biovitrum/Sobi). Later (2011-2023) in different positions (Project manager, Head of Development in a Recipharm/SHL JV and recently as PMO director)  in the CDMO industry for Recipharm.

    Session Details:

    AAV CTM CDMO partnering evaluation through DOE feasibility studies, combining sustainability, quality and general performance

    2024-10-01, 9:30 AM

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    Stephen Lutsch
    Senior Director Clinical Trial Digital Innovation, Genmab

    In my position as Senior Director - Clinical Trial Digital Innovation at Genmab, I lead a team driving AI adoption within clinical operations, decentralized clinical trials and digital innovation in drug development. Previously, I have been working to bring the best disruptive innovation into normal clinical operations at LEO Pharma to help improve and accelerate their clinical trials. Furthermore, I am trying to solve some of the toughest challenges related to scaling digitalization, data, and automation to generate competitive advantages across business units. One aspect is driving the necessary foundational components around a scalable GxP data platform, machine learning opportunities as well as automating digital processes with robotics process automation. Besides leading the necessary change internally, focus is on a design-thinking approach where we put the patient and site at the center. I have an ambition towards “delighting” patients, investigators, and sponsors by solving the real-world challenges they face by leveraging both qualitative interviews and observation, as well as quantitative methods to reveal actionable insights

    Session Details:

    Case Study: Real world example of Artificial Intelligence in clinical development – PoC to Production

    2024-10-02, 9:00 AM

    Session Details:

    Panel Discussion: Considering existing and emerging technology to assist with clinical trials

    2024-10-02, 2:00 PM

    View In Agenda
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    Fiona Barry
    Editor-in-Chief and Director of PharmSource, GlobalData

    Experienced healthcare editor with a demonstrated history of B2B journalism covering drug development, manufacturing, and the pharma industry. Skilled in editing, news writing, KOL interviews and financial journalism. Special focus on pharmaceutical manufacturing, clinical trials, rare disease and women's healthcare. Bilingual Glasgow/London-based English and French-speaking media professional with a Master of Arts (M.A.) in English from the University of Bristol.

    Session Details:

    Chairperson’s closing remarks

    2024-10-01, 5:30 PM

    Session Details:

    Panel Discussion: Forging strong relationships between clinical supply and other stakeholders to work better together

    2024-10-01, 5:00 PM

    Session Details:

    Panel discussion: Preparing for and mitigating against risk in clinical supply chain to avoid delays

    2024-10-01, 12:00 PM

    Session Details:

    Chairperson’s opening remarks

    2024-10-01, 8:15 AM

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    Carolina Pinto
    Analyst, GlobalData

    Session Details:

    Navigating the new landscape of geopolitics and supply chain disruption: A critical look at key macro themes in healthcare

    2024-10-01, 4:00 PM

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    Tanja Villumsen
    Clinical Supply Specialist, Stem Cell R&D, Novo Nordisk

    Session Details:

    Product handling activities in ATMP clinical trials: considerations and strategies for trial supplies

    2024-10-01, 3:00 PM

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    Ane Jensen
    Principal Data Manager, Zealand Pharma

    Ane H. Jensen (MA)

    Passionate about new technology and their ability to change the way we conduct clinical trials. Has worked at different positions in Novo Nordisk between 2008 and 2020. Since 2020 employed at Zealand Pharma. Previous experiences include RTSM, training, process improvements, logistics, clinical trials supplies and eLearning development.

    Session Details:

    Maintaining control and oversight of data in outsourced trials

    2024-10-02, 1:30 PM

    Session Details:

    Panel Discussion: Considering existing and emerging technology to assist with clinical trials

    2024-10-02, 2:00 PM

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    Thomas Thoma
    Head Managed Access Programs, CTS/GHT/SR, Teva Pharmaceuticals

    Three University degrees at the University of Augsburg 5 years of Supply Chain Management responsibilities in automotive electronics industry 12 years of Management responsibilities in multiple roles (SCM, IT, Sales) in the pharma industry Since 2014 Head of Clinical Trial Supply (Sales) of Teva Europe. Offering Teva widest pipeline of pharmaceuticals, placebos and manufacturing for clinical trial purposes. Since 2017 Head of Global Health Tendering of Teva Global. Offering Teva widest pipeline to NGOs, GOs and UN related organizations. Married and father of three beautiful kids

    Session Details:

    Overcoming global supply shortages: urgent actions for sustainable CTS procurement needed

    2024-10-01, 2:00 PM

    Session Details:

    Panel discussion: Preparing for and mitigating against risk in clinical supply chain to avoid delays

    2024-10-01, 12:00 PM

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    Francisco Rizzuto
    Senior Manager Cargo & Logistics Training, IATA

    Francisco is an Economic Analyst, MBA and a certified Non-Executive Director (NED), member of UK`s Non-Executive Directors Association, with 30 years of experience in International Air Freight Logistics specialized in Temperature Controlled management Air Cargo operations for pharmaceuticals.

    He joined IATA in 2014 as Regional Cargo Manager for the EU, UK, Turkiye, Israel, Ukraine and Russia & CIS countries. Currently responsible for the global Air Cargo Training department. He also has been acting as Instructor and Validator for the CEIV Pharma Certification program since 2014 as well as Consultant for pharma temperature control projects at airports in Europe, US, Canada, Latin America, and South Africa for Airlines, Ground Handling Companies, Logistics Operators, Freight Forwarding Companies and Trucking Companies.

    Session Details:

    Updates from the International Air Transport Association (IATA) on professionalization of temperature-controlled airfreight global logistics

    2024-10-01, 8:30 AM

    Session Details:

    Panel discussion: Preparing for and mitigating against risk in clinical supply chain to avoid delays

    2024-10-01, 12:00 PM

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    Libbi Rickenbacher
    Senior Director Product Strategy and Partnerships, 4G Clinical

    As Senior Director of Product Strategy & Partnerships, Libbi plays a pivotal role in steering 4G’s success by overseeing two critical domains: product strategy and partnerships management. Within the realm of product strategy, Libbi is dedicated to ensuring that 4G’s product portfolio not only meets but exceeds customer expectations while remaining at the forefront of dynamic market trends. In addition, staying close to market trends allows for Libbi to engage and forge impactful partnerships with organisations that align harmoniously with our business objectives.

    Session Details:

    Adapting to change: Global trends, European insights, and vendor relationships in modern clinical trials

    2024-10-01, 9:00 AM

    Session Details:

    Chairperson’s Opening Remarks

    2024-10-02, 8:45 AM

    Session Details:

    Panel Discussion: Considering existing and emerging technology to assist with clinical trials

    2024-10-02, 2:00 PM

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    Kai Langel
    CEO, DEEP Measures

    Session Details:

    Expert Conversation: Strategic Considerations for End-to-End Development of Fit-For-Purpose Digital Measures of Health

    2024-10-02, 11:00 AM

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    Teske Valk
    Lead Medical Project Manager, Novo Nordisk

    Session Details:

    Expert Conversation: Strategic Considerations for End-to-End Development of Fit-For-Purpose Digital Measures of Health

    2024-10-02, 11:00 AM

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    Asger Dahlgaard
    VP of Quality Assurance and Regulatory Affairs, BioPorto Diagnostics A/S

    Session Details:

    ROUNDTABLE SESSIONS

    2024-10-02, 3:00 PM

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    Benoit Cuyvers
    Upstream AI Product Manager, Clario

    Benoit Cuyvers is the Upstream AI (Artificial Intelligence) Product Manager for Clario, recently joining the team from the ArtiQ acquisition. (Leuven, Belgium). The acquisition advances our respiratory solutions portfolio, combining Clario’s deep scientific expertise with ArtiQ’s innovative artificial intelligence capabilities. Benoit led the efforts on the ArtiQ AI-enabled Risk Based Monitoring system, from concept to solution and will continue these endeavors in his role at Clario. With his background in Bioscience Engineering and his past experience as a digital health expert at Siemens, Benoit is able to apply learnings from other medical and technical fields to the field of AI in respiratory research & medicine.

    Session Details:

    AI in Risk Based (Quality) Monitoring

    2024-10-02, 9:30 AM

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    Jonathan Pritchard
    Senior Commercial Operations Manager, 4G Clinical

    Throughout his career, Jonathan has developed a robust expertise in sales and operations, navigating diverse sectors such as Medical Devices, Biostatistics, and Contract Research Organizations (CROs). Currently, Jonathan specializes in the Randomization and Trial Supply Management (RTSM) space, supporting the commercial team in his role as Senior Commercial Operations Manager and leveraging his extensive background to drive operational excellence and commercial success at 4G Clinical. Jonathan's dedication to advancing clinical research has been instrumental in enhancing the efficacy and efficiency of clinical trials, ultimately contributing to the development of innovative medical solutions.

    Session Details:

    Adapting to change: Global trends, European insights, and vendor relationships in modern clinical trials

    2024-10-01, 9:00 AM

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    Gemma Lofts
    Director Clinical Supply Chain, Bicycle Therapeutics

    Gemma Lofts is an accomplished Clinical Supply Chain professional with over 12 years of experience working in oncology, respiratory, cell and gene and controlled drugs. Gemma is currently the Director of Clinical Supply Chain at Bicycle Therapeutics, where she has set up end-to-end processes to support the expansion of their oncology platform from phase 1 into global phase 2/3 registrational trials. As a small biotech moving to mid-size with a fully outsourced model, this included the selection and set up of new vendors and procedures to ensure best practice and compliance.

    Session Details:

    Adapting to change: Global trends, European insights, and vendor relationships in modern clinical trials

    2024-10-01, 9:00 AM

    Session Details:

    Panel Discussion: Forging strong relationships between clinical supply and other stakeholders to work better together

    2024-10-01, 5:00 PM

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    Julia Fields
    Sr. Product Manager, Thermo Fisher Scientific

    Julia Field is a Sr. Product Manager in the Clinical Trials Division at Thermo Fisher Scientific supporting clinical labels and packaging with a focus on clinical supply technology and innovation. Julia has a background in biological sciences and has previously worked in the Biologicals and Chemicals and Bioproduction Divisions at Thermo Fisher Scientific since 2016,  as well as previous experience in clinical diagnostics and devices.

    Session Details:

    Innovative solutions for complex clinical trial supply chains

    2024-10-01, 12:30 PM

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    Christer Nilsson
    Chief Executive Officer, Replior

    Christer Nilsson is a dynamic entrepreneur and the CEO of Replior, bringing over 30 years of leadership experience in IT, Finance, and Life Sciences. Throughout his career, he has successfully launched and managed several businesses with a strong focus on innovation and customer satisfaction. At Replior, Mr. Nilsson is committed to a transparent and honest approach, ensuring that clients' needs are at the heart of every decision. He leads the integration of cutting-edge digital endpoints, sensor technology, and gamification strategies into clinical research solutions, aimed at reducing patient dropout and increasing compliance. Under his leadership, Replior is pioneering a more patient-centric and effective model for clinical trials.

    Session Details:

    Revolutionizing Patient Engagement in Clinical Trials: The Power of Gamification

    2024-10-01, 11:30 AM

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    Maria Contino
    Candidates and Assets Supply Lead, UCB

    Session Details:

    Panel Discussion: Forging strong relationships between clinical supply and other stakeholders to work better together

    2024-10-01, 5:00 PM

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    Johanne Press Wegeberg
    Specialist Cell Therapy, Novo Nordisk

    Session Details:

    Product handling activities in ATMP clinical trials: considerations and strategies for trial supplies

    2024-10-01, 3:00 PM

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    Rich Bennett
    Senior Director, Therapeutic Strategy Lead, Neuroscience, Worldwide Clinical Trials

    Richard Bennett is Senior Director and Therapeutic Strategy Lead in the Neuroscience franchise at Worldwide Clinical Trials. With two decades in the industry, he has advanced through the traditional clinical operations roles such as clinical research associate and clinical trial manager and has spent many years as a leader of clinical development programs in both the larger pharma and biotech setting. He has worked on neuromuscular disorders, rare diseases, critical care, pain and palliative care, dermatology, and epidemiology programs. His direct experience working with large pharma and small and emerging biotech firms has given him a deep understanding of the needs of our sponsors

    Session Details:

    Protocol optimization: How a transformational relationship with your CRO can increase your development programs’ chances of success

    2024-10-01, 10:00 AM

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    Scott Schliebner
    Vice President Drug Development Consulting, Novotech

    Scott is a strategic and innovative drug development executive with 30 years experience across the biopharma, CRO, and non-profit sectors.  Passionate about ensuring the patient voice is incorporated into drug development, Scott is focused on patient-focused innovations that reduce the burden of clinical trial.  With a particular focus on rare diseases, Scott has built partnerships and collaborations that have led to the acceleration of drug development for rare disease patients.  He received a Master’s Degree in Public Health in Biostatistics from the University of Utah School of Medicine and completed a Graduate Research Fellowship at The National Institutes of Health/NINDS.

    Session Details:

    Empowering patients to overcome challenges in orphan drug development

    2024-10-01, 4:30 PM

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    Monika Martyka
    Director Clinical Operations, TFS HealthScience

    Monika Martyka has over 14 years of experience in clinical research and currently serves as Director of Clinical Operations at TFS HealthScience. She leads complex clinical projects, overseeing cross-functional teams, optimizing clinical processes, and ensuring alignment with regulatory standards. Monika excels in managing the intricacies of clinical trials, including protocol development, patient recruitment, and compliance, while driving operational efficiency to meet critical milestones.

    Her expertise in both clinical and operational management has made her a key player in advancing healthcare through rigorous research methodologies. Dedicated to fostering collaboration and innovation, Monika is committed to the successful delivery of high-impact clinical trials that contribute to the development of cutting-edge therapies and improve patient outcomes globally.

    Session Details:

    Ensuring success: Essential sponsor oversight strategies for confirming your clinical study is on track

    2024-10-01, 2:30 PM

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    John Zibert
    Chief Medical Officer, Coegin Pharma

    Dr. John Zibert, Chief Medical Officer Coegin Pharma AB, a listed Nordic biotech company with several unique molecular technologies and compounds , where he also serves as CEO of Avexxin Oncology AS and Board Member of Reccura Therapeutics AS. He received his master's in medicine and human biology, and PhD in immunology at the University of Copenhagen, DK and University of Otago, NZ. He has demonstrated a successful history of working in the pharmaceutical and digital healthcare industry in established corporate businesses, and in an incubator co-establishing more than 25 start-ups within digital health and biotech, and several of his own biotech companies. Furthermore, he has an academic footprint of 79 publications in particular within digital health, tumor biology and dermatology. He has a deep experience within execution of drug research and development, Decentralized Clinical Trials, digital healthcare solutions, and leadership.

    Session Details:

    ROUNDTABLE SESSIONS

    2024-10-02, 3:00 PM

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    Anca Copaescu
    Chief Executive Officer, Strategikon Pharma

    Anca Copaescu, our CEO, is the powerhouse behind Strategikon's success and the driving force behind the company's revolutionary Clinical Maestro® platform.

    With over 15 years of experience in the clinical research industry, Anca's expertise in clinical outsourcing and analytics is second to none. As Head of Clinical Outsourcing and Analytics at BioMarin Pharmaceuticals, she managed and advanced the company's global outsourcing, vendor management and clinical analytics functions.

    Her passion for efficiency and innovation led her to relentlessly pursue improvements in clinical study planning, outsourcing, and financial management. And when she couldn't find a technology solution that met her standards, she decided to build a better one - the game-changing Clinical Maestro platform.

    Session Details:

    The new age of R&D procurement: clinical business operations transformed

    2024-10-02, 11:30 AM

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    Advisory Board

    Select a member to learn more

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    Chris Wallace
    Head of Distribution EMEA, Argenx

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

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

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

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

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

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

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

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

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    Paul Hingst
    Supply Chain Consultant, Crinetics Pharmaceuticals

    Paul is an experienced Clinical Supply Chain Professional with a 25-year career in the BioPharmaceutical industry.  His extensive career includes roles at major companies like Amgen and Thermo Fisher Scientific, where he honed his skills and made a significant impact.  He has served in varied roles from basic research and contract manufacturing to client services and account management.  He is a Principal Consultant and Co-Founder of Beacon BioPharm Associates, a clinical supply chain consulting firm, providing variable staffing solutions to small and mid-sized BioPharm clients.  Paul is an industry veteran and respected leader known for his expertise in clinical supply chain.

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    Francesco Santo
    Associate Director, Clinical Supply Lead, Exelixis

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

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

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

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    Arnaud Dourlens
    Head of Clinical Trial Supply, Sanofi

    Arnaud Dourlens is an Arts et Métiers engineer, he began his industrial career in the FMCG sector where he held growing responsibilities. Then he joined the LVMH group where he reorganized new product launches and industrial investments in the Make-up segment in order to adapt to the need for innovation and time to market, thus providing a competitive advantage. He then managed the entire portfolio of industrial launches and investments in Perfumes, Skincare and Make-up for Parfums Christian Dior Group. During his career Arnaud held a wide variety of industrial roles. He joined Sanofi in 2017 as Production Director of a major solid oral form production site (>2.5 billion € turnover). He has been a key player in the development of the continuous improvement mindset and in the transformation of the site through IT projects, investments and activity growth following the acquisition of Boehringer Ingelheim consumer healthcare portfolio. Since the beginning of 2020, he’s been the global head of Sanofi Clinical Supply Chain Operations, managing worldwide clinical supply teams involved in more than 300 clinical studies.

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    Paul Larochelle
    Director Global Clinical Supply Chain Planning, Takeda

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

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

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

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