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11th Annual Outsourcing in Clinical Trials Nordics 2023

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

24 - 25

October

2023

Clarion Hotel & Congress Copenhagen Airport, Denmark
Complimentary

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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.

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Caroline Sandstroem

Head of Global Clinical Quality, Ferring Pharmaceuticals

Dr. Caroline Sandström received her PhD in Medical Science from Lund University, Sweden in 2008. She has then worked for Novo Nordisk A/S, Denmark for several years as a pharmacologist driving and executing pharmacological plans supporting pre-clinical projects.

Her interest and enthusiasm for project management, continuous improvement, streamlining initiatives and training was then later beneficially used when she moved into the compliance area managing global improvement and training initiatives within R&D Quality Management System (QMS) including Clinical. For example, she was the project manager for implementing the effective use of Root Cause Analysis in Clinical Development activities but also being highly involved in initiatives related to Quality Culture. Ferring Pharmaceuticals A/S in Copenhagen, DK. On a daily basis she was involved in discussing, driving compliance and improvement initiatives within both Non-Clinical, Clinical and Pharmacovigilance related activities. She has taken a very active role in contributing to a collaborative and transparent organization where sharing learnings are a main focus area.

From beginning of May 2022, she moved into the position of being Head of the Global Clinical Quality Department being responsible for the QA support of global key stakeholder areas such as Clinical Development, Regulatory Affairs, Pharmacovigilance and Discovery. Her scientifically driven problem-solving skills are used for implementing global cross-functional initiatives, and for supporting and strengthening the harmonization and quality mindset in the organization.

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Niels Hoejsgaard Joergensen

Senior Director, Head of Global Site Management, Leo Pharma

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Helen Johansen Blanco

Chief Operating Officer, Node Pharma AS

Helén Johansen Blanco has 24 years of clinical development experience, managing Phase I to III clinical trials leading to the successful launch of several oncology products, as Revlimid, Xofigo and a Herceptin biosimilar. She has experience in project management and financial oversight of large global clinical trials conducted in all continents of the world, mainly within oncology, but also therapeutic areas as cardiovascular and gastrointestinal. Mrs. Blanco has previously worked for large international pharma companies such as AstraZeneca and Mylan, as well as small, medium to large sized biotechnology companies as Nordic Nanovector, Oncoinvent, Cantargia, Cytovation and Celgene. Currently she holds a position as Chief Operating Officer at Node Pharma AS, a small medium sized Norwegian biotech company. She holds a Diploma Engineer/MSc degree in Biophysics and medical technology and a MBA.

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John Zibert

Chief Medical Officer, Coegin Pharma AB

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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Svend Ladefoged Nielsen

Clinical Trial Assessor, Danish Medicines Agency

Svend is a trained pharmacist and has been working as a regulatory clinical trial assessor for the past 4 years. He participates in the EU Clinical Trials and Coordination Groups (CTCG) assessors round-table. Furthermore, he has been a board member at the Danish Society of Good Clinical Practice for the past 1.5 years.

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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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Company Information

Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase.

Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, the Asia-Pacific Contract Research Organization Company of the Year Award since 2006.

The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice.

For more information or to speak to an expert team member visit www.Novotech-CRO.com

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 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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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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NULL

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/

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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 2023?

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

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Agenda

24 Oct 2023
25 Oct 2023

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Streams

Stream one

OUTSOURCING IN CLINICAL TRIALS & CLINICAL OPERATIONS

Stream two

CLINICAL TRIALS TECHNOLOGY & INNOVATION

8:15 AM

Registration and Refreshments

8:45 AM

Chairperson’s Opening Remarks

Speakers

Helen Johansen Blanco

Chief Operating Officer, Node Pharma AS

9 AM

Considering the future of DCTs vs hybrid trials, sharing new learnings and pitfalls to avoid

• Considerations for planning and deciding if to run a DCT
• Reviewing the advantages of DCTs from taking the trial to boosting patient recruitment
• Analysing the benefits and constraints of DCTs based on practical experiences
• Sharing learnings from an inspection of an interventional DCT
• Predicting if the future is hybrid trials as they are more realistic and practical compared to full DCTs

Speakers

John Zibert

Chief Medical Officer, Coegin Pharma AB

9:30 AM

The importance of scientific validation and data integrity when using accessibility features

Background on FDA recommendation for accessible features and designs to help increase clinical trial inclusivity such as frequently requested zoom in/zoom out functionality
Importance for patients who may have visual impairments, hearing, motor & dexterity, or cognitive difficulties that may impact inclusivity of these patients into clinical trials
Significance of deploying these functionalities where the drug under study may cause visual impairment such as certain oncology treatments or population under study, eg older adults, may have one or more impairments.
Results of an industry-first clinical study on the ePRO instrument equivalence across accessibility features and patient communication modality preferences.

Speakers

Bryan McDowell

VP, eCOA Science & Consulting, Clario

10 AM

Integrating diversity in clinical trials to increase drug safety and health equity

This interactive session will cover diversity and inequalities in clinical trials; why we have underrepresentation and why it’s vital we improve this now. Roel will give a short overview on the
challenges and will then open the discussion to the audience:
• How can we improve engagement by paying more of a focus on race and socioeconomic disparities?
• Highlighting the impact on your trial if all groups aren’t adequately represented – ask ourselves why not
• Brainstorming solutions: What actions can we take now to get groups interested in participating in trials?
• Advice on how best to reach out to patients to understand their needs
• Informing patients efficiently and translating the trial into a language they understand

Speakers

Roel van der Heijde

Facilitator & Trainer, Roel Rotterdam & Patient Experience Association

10:30 AM

Morning Refreshments & Networking

11 AM

Considering sustainability in clinical trials to improve ESG responsibilities

Improving planning and running of clinical trials to better meet the Agenda 2030 and the UN SDG with perspective from social and environmental impact
Considering the EU Green Deal and Sustainability Initiative to prepare for EU Corporate Sustainability Reporting Directive (CSRD) and European Sustainability Reporting Standard (ESRS)
Looking at the status of planet health, quick win actions to do now and long term focuses for future

Speakers

Anna Arnsvik

ESG Sustainability Lead and Nordic Head Neuroscience, Novartis

11:30 AM

Panel discussion: Recognising and further integrating patient centricity and patient perspectives into clinical trials

• Omitting exclusion: improving engagement through focus on diversity and inclusion
• Actively involving patients in ICF and protocol writing
• Listening to the patient’s voice. Reflecting on what is good for the patient and the right level of choice for the patient
• Highlighting societal changes, the everyday clinic and how these two aspects feed into the trial situation

Speakers

Helen Johansen Blanco

Chief Operating Officer, Node Pharma AS

Christoffer Johansen

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

Roel van der Heijde

Facilitator & Trainer, Roel Rotterdam & Patient Experience Association

Tanmay Jain

Sr. Director, Trial Design Solutions, Medidata AI

12 PM

Lunch and networking

1 PM

Clinical trial outsourcing and oversight activities – impact analysis of upcoming changes to ICH GCP

• Reviewing relevant sections of draft guideline
• Discussing impact for sponsor organisations

Speakers

Matilda Hugerth

Head of Clinical Development, Xinnate

1:30 PM

Assessing vendor categories to improve governance and accountabilities across clinical trial activities

• Realising the need for diverse internal governance models for different types of vendors based on risk assessment
• Ascertaining the right governance level, expectations and accountability for each type of supplier
• Assessing and identifying ‘grey zone’ vendors in scope for GCP compliance

Speakers

Caroline Sandstroem

Head of Global Clinical Quality, Ferring Pharmaceuticals

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

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