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11th Annual Clinical Trial Supply Nordics 2023

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

24 - 25

October

2023

Clarion Hotel & Congress Copenhagen Airport, Denmark
Complimentary

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Sonia Ben Hamida

Head of Special Cargo, International Air Transport Association (IATA)

As Head of Special Cargo at the International Air Transport Association (IATA), Dr Sonia Ben Hamida leads the development of the special cargo agenda, delivering standards, business processes, and solutions for the air cargo supply chain related to the transport of live animals, perishables, and temperature-sensitive cargo, and all other special cargo. Prior to joining IATA, Sonia held several roles in France where she spent 8 years driving innovation in the aerospace industry. Then she joined academia in 2019 as a lecturer and researcher at EPFL, the Swiss Federal Institute of Technology in Lausanne, and UNIGE, the University of Geneva. Over the past 12 years, I have built a strong expertise in project management, innovation, design, and business and systems modeling. Sonia holds an engineering degree in Aviation and Computer Science from the French Civil Aviation University - ENAC (France) and a PhD in Innovation from CentraleSupélec (France).

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Linda Collstedt

Senior Clinical Supply Program Lead, AstraZeneca

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Tanja Villumsen

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

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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

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Jasmin Hellwig

Associate Director Vendor Relationship Management, MSD

Jasmin Hellwig graduated from the Applied Institute of Science in Muttenz, Switzerland, 2005 in Chemistry and joined Inovalab AG the same year as Study Director. In her various roles, including Business Development, Deputy of the General Management and Deputy of Test Facility Management, she enjoyed facilitating success by supporting processes, which meet high quality and business need. Since 2010 Jasmin is part of the Global Clinical Supplies department of MSD, former Schering Plough. She started as Project Lead coordinating packaging of clinical supplies and supporting integration projects. In September 2014, Jasmin joined the Comparator Sourcing and Planning group, supporting Clinical Trials by purchasing comparators on time from various sources. Since 2020, she fosters the Relationship Management group.

Besides various hobbies she cultivates, particularly horses and singing, she graduated as MSc in Management from the Lorange Business School, Zurich, Switzerland, in 2015.

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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 35,000 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 2,300 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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Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

Company Website

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

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ARENSIA Exploratory Medicine, a German-based company, is a leader in “first-in-patient” Phase IB and II/Proof-of-Concept clinical trials across a wide range of disease areas. With 14 proprietary research clinics and cutting-edge Phase I infrastructure, ARENSIA accelerates the early detection of efficacy signals for new therapies at an unparalleled speed. Its streamlined, highly efficient approach reduces patient recruitment time and costs by over 50% compared to conventional trial sites, which are often overcrowded and understaffed. This exceptional performance has resulted in a 93% repeat business rate and robust growth through collaborations with top pharmaceutical companies, biotechs, and global CROs. Headquartered in Düsseldorf, ARENSIA operates with a team of 600 professionals across 8 countries.

Company Website

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

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Clario is a leading provider of endpoint data solutions that generate high-quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac solutions, 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 2012.

Company Website

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

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Flex Databases platform is a secure, unified and compliant system for clinical trials. Our platform consists of 13 modules that cover every aspect of clinical trials, from project startup to pharmacovigilance. We offer both single modules and a unified solution to maintain all processes – you can cover all existing software needs with only one vendor.

Company Website

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

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Company Website

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

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Suvoda is a global clinical trial technology company specializing in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest and Iasi, Romania, and Tokyo, Japan. The company’s Net Promoter Score (NPS) consistently exceeds the technology industry average, contributing to the company being selected by trial sponsors and CROs to support more than 1,000 trials across 80 countries.

Company Website

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

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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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At Viedoc, we design engaging software that modernizes clinical research so that necessary treatments can reach the people who need them faster. We believe in life and science, in people, and in our collective power to change the world and build a healthier future. That unmatched driving force is what pushes us to innovate, accelerate and improve every aspect of modern clinical studies.

Company Website

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

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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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eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

Company Website

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

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Company Website

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

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

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

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

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

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

Company Website

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

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Barrington James are a Global specialist recruitment consultancy working across the Healthcare sector. Our structure, with separate divisions and dedicated consultants for the markets we serve ensures a thorough, professional and intelligent approach in both permanent and interim solutions. Our tailored methodologies include Contingency database search and executive search.

Company Website

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

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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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BSI Life Sciences offers smart eClinical software for CTMS, eTMF and more. BSI makes life science software for people – and has done so for over 25 years. BSI’s software solution is made in Switzerland, Germany, USA and anywhere else clients need to be, and focused on being innovative and user-friendly. They focus on staying ahead of the industry trends and delivering a functional, compliant, and leading edge eClinical solution. This way, BSI helps its customers continuously optimize and accelerate the clinical development process. And that’s what they love! www.bsi-lifesciences.com

Company Website

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

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Caidya is a multi-therapeutic clinical research organization (CRO) serving innovators worldwide. Focused on delivery excellence and an elevated customer experience, Caidya offers a wide range of clinical services and vast therapeutic expertise, supporting its partners from pre-IND strategy, through clinical development to submission and post-marketing surveillance. Caidya leverages industry-leading and proprietary clinical technology to ensure trial transparency and data-driven decision-making. Formed in 2021 following the merger of leading CROs, dMed and Clinipace, Caidya has nearly 1,800 employees in 30+ countries throughout the world.

Company Website

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

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Clinical ink is the global life science company bringing data, technology, and patient-centric research together. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, and digital biomarkers advancements (including use of Continuous Glucose Monitoring for detection of hypoglycemia), support the next generation of clinical trials and ultimately the clinical management of patients.

Company Website

To learn more, please visit our website - https://url.uk.m.mimecastprotect.com/s/PEWUCjY26Sx7YvltWfYImAmLe?domain=clinicalink.com/

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A world leader in the design and manufacture of high-performance temperature-controlled packaging systems for the transport of pharmaceutical products, EMBALL’ISO is now an expert of turnkey Reuse, Reverse Logistics and Rental solutions.

EMBALL’ISO’s worldwide presence across 4 continents, with 8 production sites (Brazil, China, France, Germany, India, Singapore, UK and the US), 14 Services Centre and collection points in more than 80 countries helps you reuse isothermal packaging while saving time and money.

We supply systems capable of carrying a single vial to airfreight pallet shippers available flat packed or fully assembled in new and innovative Logistics Business models.

EMBALL’ISO delivers quality everywhere, just like you.

Company Website

To learn more, please visit our website - www.emballiso.com/en/

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 2023?

200+ Attendees	30+ Exhibitors	30+ Speakers
200+ Attendees	30+ Exhibitors
30+ Speakers

Testimonials

It was very interesting, both the presentations and the meeting opportunities.

IBSA Institut Biochimique SA

A great networking opportunity.

Medigene AG

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Agenda

24 Oct 2023
25 Oct 2023

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Streams

Stream one

CLINICAL TRIAL SUPPLY

7:30 AM

Registration and refreshments

8:15 AM

Chairperson’s opening remarks

Speakers

Catherine Longworth

Editor in Chief, Healthcare, GlobalData

8:30 AM

Choosing the right CMO and making it your partner to manufacture your product

Importance of a network design to act strategically and not tactically
Considerations when selecting your CMO, what can jeopardize the relationship and to be considered at selection
Defining clear expectations to maximise and harmonise relationships between sponsor and CMO: how to turn business relation into partnership

Speakers

Pierre-Gaultier Delheid

Head of Clinical Vendor Management, UCB Pharma

9 AM

Real-world AI in IRT: From ChatGPT to Large Language Models

The integration of AI into Interactive Response Technology (IRT) has become more than a trend; it's a transformational shift that’s reshaping patient randomization and trial supply management.

Crawl - Introduction to AI in IRT:
ChatGPT in Action: Explore the initial steps of AI integration, using ChatGPT to aid in writing specifications and supply predictions
Demystifying LLMs: An introductory overview of Large Language Models and their potential in IRT
Walk - Advanced Techniques with ChatGPT Plus:
Templates and Automation: Learn how to utilize templates in ChatGPT, streamline repetitive tasks and enhance efficiency
Run - Next-Level AI Integration:
Advanced Applications: Delve into more complex use cases, exploring how advanced AI models can further optimize IRT processes
Security, Data Strategy, and UX: Address essential technical considerations for success
Fly - Enterprise Adoption of LLMs:
Preparing Your Organization: Strategies to equip your organization for the full-scale adoption of LLMs in the context of IRT/RTSM
Future Roadmaps: Explore potential and strategic roadmaps for LLMs within the industry

Speakers

Bryan Clayton

Chief Commercial Officer, Endpoint Clinical

9:30 AM

Sharing updates to IATA Temperature Control Regulations and best practice for temperature-controlled airfreight global logistics for clinical trials

Providing an update on latest changes to IATA Temperature Control Regulations
Discussing Time and Temperature Sensitive labelling and packaging
Reviewing the acceptance checklist for time sensitive shipments
Highlighting best practice and lessons learned for the sponsor perspective

Speakers

Sonia Ben Hamida

Head of Special Cargo, International Air Transport Association (IATA)

10 AM

Tackling Trial Supply Shortages with Advanced RTSM/IRT

Medication supply shortages have become a widespread industry concern. Good RTSM/IRT design can prevent shortages from jeopardizing clinical trial study goals.

In this session we will cover how a robust interactive response technology (IRT) system can address drug supply issues and outline the actions that can be taken to manage both expected and emergency drug shortages.

Planning – supply simulation can assist with planning manufacturing campaigns and optimal supply chains, especially if supplies are limited
Designing – advanced supply management options can ensure the challenge of limited stock is prioritized
Adapting – RTSM settings can be quickly adapted to manage unforeseen situations during trial execution, such as delayed batch manufacture

Speakers

Patricia Rayner

Associate Director, Project & Program Management, CALYX

10:30 AM

Morning Refreshments & Networking

11 AM

Patient centricity: a supply chain perspective

Looking at patient centricity from an internal and external label and packaging perspective
Considerations for supply chain and patient centricity
Handling challenges and highlighting success factors

Speakers

Jasmin Hellwig

Associate Director Vendor Relationship Management, MSD

11:30 AM

Optimizing Trial Success with RTSM Resupply Strategies for Seamless Supply Continuity

The trend to personalized treatments drives more and more complex drug combination research with approved commercial standard of care drugs. The need for expensive co-medication and comparator supplies is continuously increasing and with global commercial drug supply shortages, the sponsors are more and more challenged to design the supply chain effectively to ensure supplies while managing supply shortages and minimizing scrap.

As a critical system ensuring supply within clinical trials, RTSM resupply considerations and capabilities ensure correct supply continuity in trials. Protocol designs dictates the requirements for investigational drug, co-medication and comparator demand to properly assess the efficacy of a new medicinal product. As such, the proper provisioning of all study drugs requires supply oversight and management of costly product.

Please join a panel discussion featuring 4G Clinical and Inceptua as they discuss trends and challenges in supply management of these distinct but not dissimilar supply chains. Topics will include:

Challenges in site resupply logic facing supply teams as clinical trials evolve
Blinding considerations for sites with low enrollment considerations
Methodology underlying the definition and maintenance of trigger and buffer resupply values
Comparing short term inventory management system (RTSM) and long-term solutions (Demand & Supply solutions) and their criticality to success

Speakers

Libbi Rickenbacher

Senior Director Product Strategy and Partnerships, 4G Clinical

Benjamin Etschmann

Senior Forecasting Services Lead, 4G Clinical,

Jan Pieter Kappelle

VP of Clinical Services at Inceptua

12 PM

Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

Future supply chain considerations since the impact of challenges provoked by regulatory changes, Covid-19, Brexit and the Russia-Ukraine conflict
Improving supply chain sourcing and waste reduction
Opportunities to enhance supply chain and processes through data driven technologies

Speakers

Pernille Hemmingsen

Chief Technology Officer, Adcendo

Julian De Garcia

Head of Development and Clinical Planning, UCB

Catherine Longworth

Editor in Chief, Healthcare, GlobalData

12:30 PM

Accelerated performance of complex exploratory patient studies: Practical insights from investigational site

Global Challenges & Industry Trends
Research Clinics dedicated to early patient trials
Key elements to consider when planning a phase IB/IIA Patient Trial
Case Studies

Speakers

Dr. Claudia Hesselmann

Founder & CEO, ARENSIA Exploratory Medicine

1 PM

Lunch and networking

2 PM

Considerations for setting up trial supplies for stem cell based advanced therapy medicinal products

Differences between ATIMPS and conventional trial supplies
Complying with labelling regulations
Services and equipment considerations for ultra cold supply chain

Speakers

Tanja Villumsen

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

Sofie Dalsgaard Seiersen

Clinical Supply Coordinator Cell Therapy, Novo Nordisk

2:30 PM

Considering disruption and uncertainty when forecasting in supply chain to pre-plan effectively

Creating your forecasting and demand planning strategy with uncertainty in mind
Ensuring budget flexibility to overcome unexpected disruptions
Communicating with your clinical operations team for demand planning regarding uncertainty of patient enrolment
Considering technology to assist with forecasting and demand planning

Speakers

Linda Collstedt

Senior Clinical Supply Program Lead, AstraZeneca

3 PM

Afternoon refreshments and networking

3:30 PM

Panel Discussion: Enhancing supply chain relationships with internal teams and external vendors to improve supply chain efficiency

Considerations between clinical operations and clinical supply to ensure study success
Working closely with the regulatory team to understand roadmaps and overcome challenges
Collaborating effectively with vendors to improve communications and oversight

Speakers

Catherine Longworth

Editor in Chief, Healthcare, GlobalData

Jasmin Hellwig

Associate Director Vendor Relationship Management, MSD

Linda Collstedt

Senior Clinical Supply Program Lead, AstraZeneca

4 PM

Seamless Digital Collaboration: Uniting Vendors and Sponsors via eSystems for Transparency and Compliance

• Real-life practice: scenarios with multiple stakeholders – CROs, sponsors, inspectors, and vendors – access, roles, compliance
• Digital Collaboration: communication obstacles, fragmented workflows and data discrepancies among vendors, sponsors, and eSystems
• Demonstrating compliance: digital tools to meet industry regulations and standards
• Transparency: establishing trust, accountability, and fostering effective collaboration
• Adaptability: modern eSystems should integrate for smoother collaboration and efficiency

Speakers

Evgenia Michalcuk-Vrablik

Global Director of Growth, Flex Databases

4:30 PM

Planning and executing clinical trial supply lifecycle from a small biopharma perspective

Efficient use of available IMP considering study design, shipment, labelling, stability
Updates during study for stability, impact on labelling, shipment etc.
QP release, shipment to sites, including differences between US and EU
Preparation and administration considering regulations and available in-use study data

Speakers

Susan Suchdev

Chief Operating Officer, Annexin Pharmaceuticals