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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  • Agenda
  • Speakers
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Why attend?

WHAT TO EXPECT FOR 2023?

200+

Attendees

30+

Exhibitors

30+

Speakers

200+

Attendees

30+

Exhibitors

30+

Speakers

See What It's All About

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, Medical Device Network, 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, Medical Device Network, 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 and 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, Medical Device Network, 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

5 PM

Chairperson’s closing remarks

Speakers

Catherine Longworth
Editor, Medical Device Network, GlobalData

END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY FORTREA

Streams

Stream one

CLINICAL TRIALS TECHNOLOGY & INNOVATION

8:15 AM

Registration and Refreshments

8:45 AM

Chairperson’s Opening Remarks

Speakers

Catherine Longworth
Editor, Medical Device Network, GlobalData

9 AM

Evolving use of AI and Big Data clinical trials to streamline processes and reduce costs

  • Identifying risks and rewards
  • Reviewing cost savings through use of AI and big data
  • Evaluating benefits of using automation and ML technologies to enhance conduction and management of trials
  • Highlighting successes of implementing AI and machine learning tools through case study examples

Speakers

Stephen Lutsch
Senior Director Clinical Trial Digital Innovation, Genmab

9:30 AM

Digitalization in clinical trials, a 360 view

  • Presenting on how to digitalize clinical trials in e.g. endpoints, and study designs
  • Highlighting the possibilities that digital trials bring, whilst moving away from the common brick-and-mortar sites
  • Discussing the rigorous standards and scientific integrity required by regulators, whether a regular brick-and-mortar trial or a digital trial
  • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more
  • Major points to consider in designing digital trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind

Speakers

Sverre Bengtsson
Co-Founder, Viedoc

10 AM

Implementing digital health technologies into clinical trials

  • What is Digital Health?
  • How can Digital Health Technologies be used in Clinical Development?
  • Challenges and opportunities
  • Process for selection and implementation

Speakers

Viktorija Terebaite
Head of Digital Health Technologies, Lundbeck

10:30 AM

Morning Refreshments & Networking

11 AM

Utilising blockchain technology to improve digital supply chain

  • Highlighting benefits of blockchain technology to increase visibility and efficiency in supply chain
  • Considering risks and challenges of blockchain
  • Sharing successes and lessons learnt

Speakers

Alexandru Popa
Associate Director, Blockchain for Digital Supply Chain, MSD

11:30 AM

Exploring data management tools and technologies that can assist throughout end-to-end clinical trials

  • Discussing technologies and tools available for each stage of the clinical trial
  • Outlining the risks and rewards of data management tools and technologies
  • Providing case study examples of successes and lessons learnt

Speakers

Alastair Clewlow
Senior Director Data Management Statistical Programming and Digital Solutions, Lundbeck

12 PM

Lunch and networking

1 PM

Fireside Chat: Innovation in clinical trials – a sanity check

Participants who have completed the ATRIUM CPH course “Driving Decentralised Clinical Trials” will discuss their thoughts on decentralising and using digital health technologies in clinical development. Which direction are they setting for their organisations, and how will they work with investigators, regulators and vendors moving forward.

Speakers

John Zibert
Chief Medical Officer, Coegin Pharma AB
Morten Lind Jensen
VP Of Medical Science, UNION Therapeutics
Christian Born Djurhuus
MD PhD

1:30 PM

Virtual clinical trials and medical devices

  • What are they
  • Advantages
  • Recent Trends
  • Likely future trends

Speakers

Andrew Thompson
Director of Therapy Research & Analysis, Medical Devices, GlobalData

2 PM

Afternoon refreshments, networking and prize draw

2:30 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 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

Roundtable 1
Overcoming challenges in clinical supply resourcing
Pernille Hemmingsen, Chief Technology Officer, Adcendo

Roundtable 2
Discussing the role and inclusion of patient relatives in trial reporting and data
Christoffer Johansen, Head, CASTLE - Cancer Late Effect Research, Center for Surgery and Cancer,
Rigshospitalet

Roundtable 3
Considering how to make your clinical trials more environmental and social sustainable

Anna Arnsvik, ESG Sustainability Lead and Nordic Head Neuroscience, Novartis

Speakers

Pernille Hemmingsen
Chief Technology Officer, Adcendo
Christoffer Johansen
Head, CASTLE - Cancer Late Effect Research, Center for Surgery and Cancer, Rigshospitalet
Anna Arnsvik
ESG Sustainability Lead and Nordic Head Neuroscience, Novartis

4 PM

Chairperson’s closing remarks

Speakers

Helen Johansen Blanco
Chief Operating Officer, Node Pharma AS

Speakers

Select a speaker to learn more

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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).

Session Details:

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

2023-10-24, 9:30 AM

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Pierre-Gaultier Delheid
Head of Clinical Vendor Management, UCB Pharma

As Head of Clinical Vendor Management at UCB, Pierre-Gaultier Delheid leads the vendor strategy aiming to design and manage a strong external vendor network. He makes a point of honor to build sustainable and strong alliances to overcome clinical challenges in a flexibility, agile, reliable, green and cost-efficient way. In close collaboration with other UCB business units, he drives a culture of partnership to change the game to a better outcome.

Engineer by background, his experience in bio-pharma industry in CDMO as well as in Sponsor companies and his business DNA gained during an international EMBA (Hult, US/UK) led him to build strong expertise in the field of operation and business optimization as well as building strong partnerships.

Session Details:

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

2023-10-24, 8:30 AM

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

2023-10-24, 12:00 PM

Session Details:

ROUNDTABLE SESSIONS

2023-10-25, 2:30 PM

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

Session Details:

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

2023-10-24, 2:00 PM

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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.

 

Session Details:

Patient centricity: a supply chain perspective

2023-10-24, 11:00 AM

Session Details:

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

2023-10-24, 3:30 PM

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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:

Evolving use of AI and Big Data clinical trials to streamline processes and reduce costs

2023-10-25, 9:00 AM

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Alastair Clewlow
Senior Director Data Management Statistical Programming and Digital Solutions, Lundbeck

Alastair Clewlow is Senior Director for Clinical Data Management, Statistical Programming and Digital solutions at Lundbeck. He has over 25 years of experience in the pharmaceutical and IT Industry, having held positions in Data Management and Clinical Operations at LEO Pharma, Product Strategy and Development in the Oracle Health Sciences Global Business Unit before joining Lundbeck. He graduated from the University of Portsmouth with a BSc (Hons) in molecular biology.

Session Details:

Exploring data management tools and technologies that can assist throughout end-to-end clinical trials

2023-10-25, 11:30 AM

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Andrew Thompson
Director of Therapy Research & Analysis, Medical Devices, GlobalData

Andrew Thompson is the Director of Therapy and Analysis at GlobalData Healthcare, responsible for data collection and forecasting within the Medical Devices portfolio. Andrew is passionate about developing innovative approaches to the world of medical devices industry research. Andrew joined the team in 2012, following 20 years working within the academic and industry sectors, developing a specialty in advanced diagnostics for infectious disease. With multiple patents in molecular detection technologies, publications’ covering a breadth of topics and leading product development teams, Andrew has established a strong reputation within molecular diagnostics. Having worked on the frontline, Andrew can share a global understanding of the medical device industry, with both a highly developed understanding of the technologies, new and emerging, and of the business dynamics fueling medical device usage in healthcare.

Responsible for the content and direction of global medical device portfolios, GlobalData forward-looking approach generates stimulating analysis and reports, to explore what these changes mean for GlobalData’s clients and their customers.

Session Details:

Virtual clinical trials and medical devices

2023-10-25, 1:30 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.

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Morten Lind Jensen
VP Of Medical Science, UNION Therapeutics

Morten Lind Jensen is VP of Medical Science at UNION Therapeutics A/S. Prior to working at UNION, Morten has 9 years of experience as medical specialist, project manager and line manager from Novo Nordisk, where he worked across the internal Novo Nordisk portfolio and established external collaboration projects within new ways of doing clinical trials and using digital data.

Prior to joining the pharmaceutical industry, Morten did his Ph.D. within the research space of medical education, and on how to optimize learning outcomes during the training of professionals. He has also worked clinically as a medical doctor within radiology and surgery.

Morten is an MD from University of Copenhagen, Denmark.

Session Details:

Fireside Chat: Innovation in clinical trials – a sanity check

2023-10-25, 1:00 PM

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Viktorija Terebaite
Head of Digital Health Technologies, Lundbeck

Viktorija Terebaite is professional in the field of Digital Health, boasting four years of direct experience in integrating digital tools into clinical trials and heading Digital Health Technologies team in Lundbeck. Viktorija has a unique perspective on digital health innovation, having been involved not just in the academic and clinical realms, but also in the commercial technology sector where she worked on a development of a software product used by over 60 million people globally.

Session Details:

Implementing digital health technologies into clinical trials

2023-10-25, 10:00 AM

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Christoffer Johansen
Head, CASTLE - Cancer Late Effect Research, Center for Surgery and Cancer, Rigshospitalet

Session Details:

ROUNDTABLE SESSIONS

2023-10-25, 2:30 PM

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Alexandru Popa
Associate Director, Blockchain for Digital Supply Chain, MSD

Session Details:

Utilising blockchain technology to improve digital supply chain

2023-10-25, 11:00 AM

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Linda Collstedt
Senior Clinical Supply Program Lead, AstraZeneca

Session Details:

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

2023-10-24, 2:30 PM

Session Details:

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

2023-10-24, 3:30 PM

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Susan Suchdev
Chief Operating Officer, Annexin Pharmaceuticals

Session Details:

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

2023-10-24, 4:30 PM

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Catherine Longworth
Editor, Medical Device Network, GlobalData

Catherine Longworth is the Editor for Medical Device Network, covering developments across the medical technology and health tech industry. An experienced writer, Catherine has covered the industry since 2016 and holds a background in biomedical science and journalism. Her previous experience includes reporting for Medtech Insight (Citeline, formerly Informa Pharma Intelligence) and Bioworld (Clarivate).

Session Details:

Chairperson’s Opening Remarks

2023-10-25, 8:45 AM

Session Details:

Chairperson’s closing remarks

2023-10-24, 5:00 PM

Session Details:

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

2023-10-24, 12:00 PM

Session Details:

Chairperson’s opening remarks

2023-10-24, 8:15 AM

Session Details:

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

2023-10-24, 3:30 PM

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Julian De Garcia
Head of Development and Clinical Planning, UCB

Session Details:

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

2023-10-24, 12:00 PM

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Bryan Clayton
Chief Commercial Officer, Endpoint Clinical

Bryan Clayton is a seasoned global commercial leader with experience across multiple functions including sales and marketing, operations, and software product design. For over 20 years, he has effectively managed cross-functional teams, created new technology solutions, managed contract negotiations, and driven revenue growth for top life sciences technology and solutions providers. Bryan is a sought-after speaker, writer and contributor to industry events and publications, and possesses a range of skills well-suited to boost commercial success and revenue growth.

Bryan joined endpoint Clinical in 2023 as Chief Commercial Officer to lead commercial strategy and business development operations, and to further strengthen endpoint’s expertise in providing agile, patient centric IRT solutions. In his spare time, Bryan coaching and playing baseball.

Session Details:

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

2023-10-24, 9:00 AM

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Christian Born Djurhuus
MD PhD

Session Details:

Fireside Chat: Innovation in clinical trials – a sanity check

2023-10-25, 1:00 PM

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Sofie Dalsgaard Seiersen
Clinical Supply Coordinator Cell Therapy, Novo Nordisk

Session Details:

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

2023-10-24, 2:00 PM

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Dr. Claudia Hesselmann
Founder and CEO, ARENSIA Exploratory Medicine

Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

Session Details:

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

2023-10-24, 12:30 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:

Optimizing Trial Success with RTSM Resupply Strategies for Seamless Supply Continuity

2023-10-24, 11:30 AM

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Benjamin Etschmann
Senior Forecasting Services Lead, 4G Clinical,

Benjamin has spent more than 10 years in clinical trial supply management in various roles, including operational trial supply logistics management and trial supply setup management. However, his primary focus has been in IVRS/IRT/RTSM management and demand forecasting using dedicated stochastic simulation tools. In his current role, he consults clients and internal teams on probabilistic site and depot demand forecasting in IVRS/IRT/RTSM.

Session Details:

Optimizing Trial Success with RTSM Resupply Strategies for Seamless Supply Continuity

2023-10-24, 11:30 AM

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Jan Pieter Kappelle
VP of Clinical Services at Inceptua

Jan Pieter (JP) Kappelle, VP of Clinical Services at Inceptua, is a Supply Chain Executive with 30 years of industry experience, of which 15 years were spent leading clinical trial supplies departments in global pharmaceutical and biotech companies.

Trained as an Electronic and Quality Engineer, JP has a strong financial background and brings a methodical, analytical and process-oriented approach to his work. Coupled with his MBA and MSc in Supply Chain Management, JP has the unique ability to switch between strategic and operational discussions.

JP also serves as the Global Clinical Supplies Group (GCSG) Master of Ceremony where he connects clinical supply professionals for the purposes of education,
knowledge sharing and the development of industry best practices.

 

Session Details:

Optimizing Trial Success with RTSM Resupply Strategies for Seamless Supply Continuity

2023-10-24, 11:30 AM

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Anna Arnsvik
ESG Sustainability Lead and Nordic Head Neuroscience, Novartis

Anna Arnsvik, an ESG Sustainability Lead, boasts a three-decade life science career within company as Novartis, UCB and Kabi-Pharmacia. Her fusion of innovation and sustainable business strategies has helped her to become an international certified ESG ISB® Advisor. Anna's influence extends to roles in the JUC Sustainability and ESG network, MIAN Minds AB, and various volunteering endeavors

Session Details:

ROUNDTABLE SESSIONS

2023-10-25, 2:30 PM

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Patricia Rayner
Associate Director, Project & Program Management, CALYX

Trish has spent over 14 years helping sponsors to effectively manage their clinical trials and programs with RTSM/IRT solutions & services. She currently holds a leadership role, managing and mentoring a team of RTSM designers. Her focus is on cultivating relationships with clinical trial teams and always on improving the lives of patients.

Session Details:

Tackling Trial Supply Shortages with Advanced RTSM/IRT

2023-10-24, 10:00 AM

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Evgenia Michalcuk-Vrablik
Global Director of Growth, Flex Databases

Evgenia holds several degrees in International Economics and MBA in Digital Transformation, she is in top management of eSystem provider Flex Databases, one of the leading European software providers for Life Sciences.

She has been in clinical research for 15+ years, 8 years in the company management, participated in digitalization of 60+ companies 15 to 50 000 employees in the US, Europe, and Asia.

Session Details:

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

2023-10-24, 4:00 PM

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Sverre Bengtsson
Co-Founder, Viedoc

Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used. Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

Session Details:

Digitalization in clinical trials, a 360 view

2023-10-25, 9:30 AM

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Clarion Hotel & Congress Copenhagen Airport, Kastrup, Denmark, 2770

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