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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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

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

9 AM

Reserved for Featured Sponsor

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

10 AM

Reserved for Featured Sponsor

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

11:30 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. "Real-world AI in IRT: From ChatGPT to Large Language Models" is structured to guide attendees through a four-step journey: Crawl, Walk, Run, and Fly. This progression offers a comprehensive understanding of how to harness AI from the ground up, focusing on Large Language Models (LLMs).

  1. 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
  2. Walk - Advanced Techniques with ChatGPT Plus:
    • Templates and Automation: Learn how to utilize templates in ChatGPT,  streamline repetitive tasks and enhance efficiency
  3. 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.
  4. 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

Endpoint Clinical

Speakers

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
  • Current opportunities to enhance supply chain and processes through data driven technologies
  • New and emerging technologies and concepts for future development

Speakers

12:30 PM

Reserved for CALYX

Speakers

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

2:30 PM

Reserved for 4G Clinical

3 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

3:30 PM

Afternoon refreshments and networking

4 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
  • Uncovering common QA compliance oversights and how to avoid them
  • Aligning early phase vs late phase quality assurance considerations with supply chain protocols to minimise disruptions and supply chain backlogs
  • Collaborating effectively with vendors to improve communications and oversight

Speakers

4:30 PM

Reserved for Session Sponsor

5 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

5:30 PM

Chairperson’s closing remarks

END OF DAY 1 AND NETWORKING DRINKS

Streams

Stream one

CLINICAL TRIALS TECHNOLOGY & INNOVATION

8:15 AM

Registration and Refreshments

8:45 AM

Chairperson’s Opening Remarks

Speakers

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

9:30 AM

Reserved for 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

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

11:30 AM

Reserved for event sponsor

12 PM

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

12:30 PM

Lunch and networking

1:30 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

2 PM

Virtual clinical trials and medical devices

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

Speakers

2:30 PM

Afternoon refreshments and networking

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 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

Roundtable 4

Reserved for event sponsor

Speakers

4:30 PM

Chairperson’s closing remarks

Speakers

Select a speaker to learn more

Back
Sonia Ben Hamida
Head of Special Cargo, 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, 3:00 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

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, 4:00 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, 12:00 PM

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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, 2:00 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:

Fireside Chat: Innovation in clinical trials – a sanity check

2023-10-25, 1:30 PM

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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, 1:30 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, 3:00 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, 3:00 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, 5:00 PM

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Juan Munoz-Pujol
VP of RTSM, CALYX

Session Details:

Reserved for CALYX

2023-10-24, 12:30 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 opening remarks

2023-10-24, 8:15 AM

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Bryan Clayton
Chief Commercial Officer, Endpoint Clinical

Session Details:

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

2023-10-24, 11:30 AM

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Plan Your Visit

Venue

Clarion Hotel & Congress Copenhagen Airport

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

Please use Discount Code 𝗔𝗥𝗘𝟱 when you are booking your hotel.

Accommodation

Clarion Hotel & Congress Copenhagen Airport

Guests can book accommodation only by sending email to reservation.cl.copenhagen.airport@choice.dk Please provide a booking number: 3034GR033377. All changes must be also made via e-mail. Room rate of DKK 1,395 will be including VAT and breakfast per night. Rooms will be available at this rate only until the 2nd October 2023.

Sponsors

Select a sponsor to learn more

FEATURED SPONSORS

SESSION SPONSORS

Drinks Reception Sponsor

EXHIBITORS

CO-SPONSORS

BADGE SPONSOR

Media Centre

MEDIA PARTNERS

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Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Ben Lloyd-Davis

Head of Healthcare Sponsorship

+44 207866 9497

SPEAKER ENQUIRIES

Ruth Atterbury

Portfolio Manager • Communities Production

+44 (0) 204 540 7766

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

SPONSORSHIP ENQUIRIES

To enquire about sponsorship opportunities for the conference, please contact:

Ben Lloyd-Davis

Head of Healthcare Sponsorship


+44 207866 9497

SPEAKER ENQUIRES

To enquire about speaking opportunities for the conference, please contact:

Ruth Atterbury

Portfolio Manager • Communities Production


+44 (0) 204 540 7766