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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
Download Agenda
Contact Us

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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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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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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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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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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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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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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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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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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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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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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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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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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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Thermo Fisher Scientific provides industry-leading pharma services for drug development, clinical trial logistics, and commercial manufacturing through Patheon™ brand. We partner with customers in the pharmaceutical, biotech, and life sciences industries as their trusted CDMO. Our services include API, biologics, cell therapy, viral vectors, formulation, clinical trials solutions, logistics services, and commercial manufacturing, and packaging.

Company Website

To learn more, please visit our website - https://www.patheon.com/us/en/our-capabilities/clinical-trial-services.html

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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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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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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

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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