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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Featured Speakers

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Lene Grejs Petersen​

Senior Advisor, Danish Medicines Agency

Lene Grejs Petersen is Senior Adviser at the Danish Medicines Agency, Clinical Trial Unit. Lene is member of the Clinical Trials Coordinating and Facilitation Group (CTCG) member since 2008 and is the Danish representative of the EU Commission’s expert group concerning clinical trials (CTEG) since 2001. Lene has been an employee at the Danish Medicines Agency since 2000 and she has been involved in the implementation of the EU Clinical Trials Regulation into Danish legislation and works as a regulatory assessor and coordinator of clinical trials. Lene has a background as Master in Pharmacy.

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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​

Vice President of Operations, Cytovation ASA

Helén Johansen Blanco has 23 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 Astra Zeneca and Mylan, as well as small, medium to large sized biotechnology companies as Nordic Nanovector, Oncoinvent, Cantargia and Celgene. Currently she holds a position as Vice President of Operations at Cytovation, a small medium sized Norwegian biotech company. She holds a MSc 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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    2023 Sponsors Included:

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    Company Information

    Medidata is leading the digital transformation of life science, with the world’s most used platform for clinical development, commercial, and real-world data. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/

    Company Website

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

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    Company Information

    Established in 1997, Novotech is a global CRO recognized for its partnership with sponsors in clinical trial development and management. The Company offers a comprehensive suite of services, including laboratories, Phase I facilities, drug development consulting, and regulatory expertise, Novotech has executed over 5,000 clinical projects, spanning Phase I to Phase IV trials and bioequivalence studies.

    With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech supports clinical trials across Asia Pacific, the United States, and Europe. Leveraging a vast global footprint, deep relationships, and a robust operational framework, Novotech enables small to medium-sized biotech, biopharma, and pharma sponsors to accelerate the speed and scope of their clinical development endeavours.

    Discover more at www.novotech-cro.com

    Company Website

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

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    Company Information

    To support the acceleration of drug development, over the last 12 years, ARENSIA Exploratory Medicine GmbH (www.arensia-em.com) has built up its own research clinics, with full Phase I infrastructure, entirely dedicated to the performance of sophisticated FIRST-in-PATIENT Phase IB, IIA and PROOF OF CONCEPT clinical trials with novel compounds. ARENSIA’s outstanding recruitment performance across numerous disease areas substantially reduces the overall number of sites and countries for any early-phase patient trial. ARENSIA’s speed and data quality provide our Partners/Sponsors with a strategic advantage across the entire lifecycle of a project, as they can progress their novel compounds much faster to later phases of research. ARENSIA is trusted by Leading Pharmaceutical and Biotechnology organizations worldwide. ARENSIA is based with its headquarters in Düsseldorf, Germany, and operates with 400+ talented employees in 7 countries

    Company Website

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

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    Company Information

    In 2021, ERT and Bioclinica merged to become Clario creating the broadest endpoint technology platform in the industry and enhancing our scientific expertise. With this expertise, global scale and the broadest endpoint technology platform, Clario will continue to lead the way in clinical trial technology that will transform patients’ lives.

    Company Website

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

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    Company Information

    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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    Company Information

    Suvoda is a global clinical trial technology company specializing in highly complex, life-sustaining studies in therapeutic areas like oncology, CNS, and rare disease. Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through IRT, eConsent, and eCOA solutions delivered on a single platform.

    Company Website

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

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    Company Information

    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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    Company Information

    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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    Company Information

    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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    Company Information

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

    Company Website

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

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    Company Information

    NULL

    Company Website

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

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    Company Information

    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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    Company Information

    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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    Company Information

    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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    Company Information

    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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    Company Information

    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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    Company Information

    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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    Company Information

    Clinical ink is the global life science company that brings data, technology, and patient science together.

    Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials.

    By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience.

    Company Website

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

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    Company Information

    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.

      Clinical Trial Outsourcing and Clinical Trial Procurement Nordics 2023 is an event for online casino players not to be missed. The online casino https://gamblizard.ca/casinos/galaxyno-bonus/ communities with bonuses of biotechnologists, pharmacists and medical devices should come together to discuss strategies for successful clinical trials. Combining our OCT, CTS and Medical Devices events, this is the perfect platform for online casino professionals and clinical trials.

      WHAT TO EXPECT FOR 2023?

      200+

      Attendees

      		30+

      Exhibitors

      		30+

      Speakers
      200+

      Attendees

      		30+

      Exhibitors
      30+

      Speakers

      Testimonials

      See What It's All About

      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

      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

      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

      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

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Incorporating social listening in clinical trials to increase patient centricity and recruitment

      • Why social listening matters and how it can benefit clinical trials
      • Considering social listening tools, applications and remote measuring options
      • How to incorporate social listening into clinical trial design and patient recruitment

      Speakers

      11:30 AM

      Reserved for session sponsor

      12 PM

      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

      12:30 PM

      Lunch and networking

      1:30 PM

      Maintaining financial oversight of clinical studies and development to optimise cost savings

      • Creating a cost optimized study set-up to work more financially effectively
      • Reviewing selection processes and negotiations
      • Contracting best practice
      • Management and closure of study budget

      Speakers

      2 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

      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

      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

      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-toend 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

      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

      7:30 AM

      Registration and refreshments

      8:15 AM

      Chairperson’s opening remarks

      8:30 AM

      Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS): where are we now and what have we learnt?

      • Sharing updates within CTR and CTIS and where we are at now since its launch
      • Focusing on lessons learnt and best practice from submissions so far
      • Highlighting challenges and benefits from user experiences and questions from sponsor
      perspective

      Speakers

      9 AM

      Reserved for Novotech

      9:30 AM

      A sponsor perspective on regulatory life with CTIS

      • Highlighting the challenges seen so far
      • Suggesting ways to work around these challenges
      • Proposing thoughts on ways of working with clinical CROs in the future

      Speakers

      10 AM

      Reserved for Medidata

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      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

      11:30 AM

      Reserved for Worldwide Clinical Trials

      Speakers

      12 PM

      Exploring outsourcing models to assess and determine a successful outsourcing strategy

      • Reviewing outsourcing models from full outsourcing to functional outsourcing to hybrid outsourcing
      • Determining the best outsourcing model: pros and cons and assessment tips to consider
      • Operating model: Finding the best service provider fit to address the needs of your company

      Speakers

      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

      1 PM

      Lunch and networking

      2 PM

      Navigating through the jungle of regulatory requirements for combination trials

      • Reviewing key regulatory factors within CTR, MDR and IVD to ensure compliance
      • Best practice for ensuring all requirements are considered in parallel for submissions

      Speakers

      2:30 PM

      Reserved for TFS HealthScience

      Speakers

      3 PM

      Building a flexible and efficient clinical operation organization through a strategic partnership

      • Operational challenges running trials globally in medium sized pharma
      • Why invest in a strategic partnership between sponsor and CRO?
      • Experiences and learnings from both sponsor and CRO
      • Site impact and initial reactions
      • When honeymoon is over, and the devil is in the details

      Speakers

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      Sourcing the right vendor and agreeing clear terms that suit both parties to ensure a successful partnership

      • Considerations and best practice for assessing and selecting vendors
      • Understanding the budget and scope before signing a contract
      • Planning techniques to limit changes once contracts are in place

      Speakers

      4:30 PM

      Reserved for Flex Databases

      5 PM

      Panel Discussion: Reversing the conversation – what the clinical trial industry really wants from its service providers

      We’ve all heard pitches from vendor companies telling us what they can do for us, but now it’s time to
      reverse the conversation! Hear from the trial industry as they discuss the services they would like to see
      from their solution providers, including:
      • What they like to see in an outsourced partner organization
      • What they would like a partner to know about them / how they work
      • What things do they need a partner to do and what they don’t need!
      • What things can be best done in house?

      Speakers

      5:30 PM

      Chairperson’s closing remarks

      5:30 PM

      Chairperson’s closing remarks

      Speakers

      Select a speaker to learn more

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      Lene Grejs Petersen
      Senior Advisor, Danish Medicines Agency

      Lene Grejs Petersen is Senior Adviser at the Danish Medicines Agency, Clinical Trial Unit. Lene is member of the Clinical Trials Coordinating and Facilitation Group (CTCG) member since 2008 and is the Danish representative of the EU Commission’s expert group concerning clinical trials (CTEG) since 2001. Lene has been an employee at the Danish Medicines Agency since 2000 and she has been involved in the implementation of the EU Clinical Trials Regulation into Danish legislation and works as a regulatory assessor and coordinator of clinical trials. Lene has a background as Master in Pharmacy.

      Session Details:

      Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS): where are we now and what have we learnt?

      2023-10-24, 8:30 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.

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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.

      Session Details:

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

      2023-10-25, 2:00 PM

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      Helen Johansen Blanco
      Vice President of Operations, Cytovation ASA

      Helén Johansen Blanco has 23 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 Astra Zeneca and Mylan, as well as small, medium to large sized biotechnology companies as Nordic Nanovector, Oncoinvent, Cantargia and Celgene. Currently she holds a position as Vice President of Operations at Cytovation, a small medium sized Norwegian biotech company. She holds a MSc in Biophysics and medical technology and a MBA.

      Session Details:

      Chairperson’s Opening Remarks

      2023-10-25, 8:45 AM

      Session Details:

      Chairperson’s closing remarks

      2023-10-25, 4:30 PM

      Session Details:

      Maintaining financial oversight of clinical studies and development to optimise cost savings

      2023-10-25, 1:30 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 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.

      Session Details:

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

      2023-10-25, 9:00 AM

      Session Details:

      Fireside Chat: Innovation in clinical trials – a sanity check

      2023-10-25, 1:30 PM

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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

      Session Details:

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

      2023-10-25, 12:00 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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      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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      Rikke Winther
      Outsourcing Specialist, Camurus AB

      Rikke Winther has worked in the CRO and Pharmaceutical industry for the past 30 years and has experience from Clinical R&D, Business Development and Contract/Outsourcing Management. She built up and headed up Lundbeck group of Outsourcing & Contracts Management R&D for 19 years and has for the past 4 years worked as an clinical outsourcing specialist for smaller biopharma and covers CRO selection processes as well as contractual, operational and relationship related activities with clinical CROs.

      She has in earlier part of her career within bio-analytical research and clinical development in hospital settings as well as project management and business development management at a clinical CRO in Europe and Asia.

      Rikke is a former member of the Steering Committee member of the Pharmaceutical Contract Management Group (PCMG) for many years and is a contributing author of the book: “Outsourcing Clinical Development, Gower Publishing Limited”.

       

      Session Details:

      Sourcing the right vendor and agreeing clear terms that suit both parties to ensure a successful partnership

      2023-10-24, 4:00 PM

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      Niels Hoejsgaard Joergensen
      Senior Director, Head of Global Site Management, Leo Pharma

      Session Details:

      Building a flexible and efficient clinical operation organization through a strategic partnership

      2023-10-24, 3:00 PM

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      Frederik Grell Norgaard
      Head of Clinical Trials Unit (interim)

      Session Details:

      Navigating through the jungle of regulatory requirements for combination trials

      2023-10-24, 2:00 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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      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

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      Ivanna Rosendal
      Senior Director, IT Business Partner, Ascendis Pharma

      Session Details:

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

      2023-10-25, 12:00 PM

      Session Details:

      Incorporating social listening in clinical trials to increase patient centricity and recruitment

      2023-10-25, 11:00 AM

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      Social Links:

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      Matilda Hugerth
      Former Director Clinical and Regulatory Affairs

      Matilda Hugerth holds a Master of Pharmaceutical Science from the Uppsala University and is a registered pharmacist. She has more than 20 years drug of development experience from various roles in both large and small pharmaceutical companies including Lundbeck, UCB, Novartis and Abliva. Matilda’s expertise includes clinical development strategies with experience from all clinical phases in the areas of regulatory, project management, clinical operations, clinical quality assurance, and medical affairs. She is the author of four scientific articles. Matilda is a member of the European Federation of GCP Audit working party and is on the steering committee of Medicon Village’s Regulatory Affairs Network.

      Session Details:

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

      2023-10-24, 11:00 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:

      ROUNDTABLE SESSIONS

      2023-10-25, 3:00 PM

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      Roel van der Heijde
      Facilitator & Trainer, Roel Rotterdam & Patient Experience Association

      Roels inspiration: “Be the change you wish to see in the world” - Ghandi

      Roel van der Heijde lives in Rotterdam, The Netherlands. He has a MA in International Business, is an international acknowledged NLP trainer, executive team coach and a certified death and grief counsellor.

      He is a driven and experienced trainer and facilitator in:

      • - Patient Fear Reduction (for all caregivers);
      • - Team Collaboration;
      • - Vulnerability & Leadership;
      • - Discrimination & Inclusion.

      Roels motivation: “Acknowledgement and recognition of the fears and emotions of our patients are the basis for excellent patient experience and patient safety”.

      “Working with Groups I experience as thoroughly fascinating and inspiring. In interaction with groups I am every time amazed by the enormous potential of practical knowledge and direct experience that lies hidden in groups and that is so easily overlooked. Herein lies the basis for excellent vulnerable leadership.

      Session Details:

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

      2023-10-25, 12:00 PM

      Session Details:

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

      2023-10-25, 10:00 AM

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      Morten Bang Norgaard
      Director Outsourcing, Alligator Bioscience

      Specialist with outsourcing experience from all aspects of the value chain, from preclinical work and drug manufacturing through to late-stage clinical development activities and post-marketing non-interventional studies. Morten holds over 20 years of industry experience from a number of small- and mid-sized pharma and biotech companies and for the past decade he has been working in GCP and GMP environments with primary focus on handling of outsourcing activities for phase 1-3 clinical program development activities. Morten’s primary roles have included contract negotiation and -execution, as well as vendor management within outsourcing settings, international project- and relationship management as well as follow-up and evaluation of global collaborations within all phases of clinical development.

      Session Details:

      Exploring outsourcing models to assess and determine a successful outsourcing strategy

      2023-10-24, 12:00 PM

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      Ann Christine Korsgaard
      Vie President Regulatory Affairs, AFYX Therapeutics

      Session Details:

      A sponsor perspective on regulatory life with CTIS

      2023-10-24, 9:30 AM

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      Ane Jensen
      Principal Data Manager, Zealand Pharma

      Ane H. Jensen (MA)

      Passionate about new technology and their ability to change the way we conduct clinical trials. Has worked at different positions in Novo Nordisk between 2008 and 2020. Since 2020 employed at Zealand Pharma. Previous experiences include RTSM, training, process improvements, logistics, clinical trials supplies and eLearning development.

      Session Details:

      Panel Discussion: Reversing the conversation – what the clinical trial industry really wants from its service providers

      2023-10-24, 5:00 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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      Lisa Hellstrom
      Clinical Program Director, Camurus AB

      Session Details:

      Panel Discussion: Reversing the conversation – what the clinical trial industry really wants from its service providers

      2023-10-24, 5:00 PM

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      Dr. Claudia Hesselmann
      Founder and CEO, Arensia

      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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      Matt Cooper
      Executive Director, Therapeutic Strategy Lead, Oncology, Worldwide Clinical Trials

      Matt Cooper is the Executive Director, Therapeutic Strategy Lead, Oncology and has 25 years of experience in the life science industry conducting clinical trials across all phases. His experience spans roles at sponsors, sites, and the NHS, and he has extensive experience in site management and expanded use of oncology therapies. He is passionate about building effective relationships between industry stakeholders to drive innovation and patient access.

      Session Details:

      Reserved for Worldwide Clinical Trials

      2023-10-24, 11:30 AM

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      Bryan McDowell
      VP, eCOA Science & Consulting, Clario

      In his role as VP, eCOA Science & Consulting, Bryan McDowell brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug & device development programs. Bryan is a thought leader and recognized strategist & visionary and continues to influence, drive and deliver on the pharma-wide industry necessity for smarter drug & device development and life cycle management.

      Session Details:

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

      2023-10-25, 9:30 AM

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      Nina Holst
      Executive Director Strategic Alliance Management, ICON Strategic Solutions

      Nina Holst, Executive Director, is responsible for Strategic Alliance Management of global oversight, delivery, and continuing improvement of appointed ICON Strategic Solutions (ISS) established programs. Nina has the strategic program oversight of the LEO FSP (Functional Service Provision) program delivery.

      Nina has more than 20 years’ experience from the sourcing and recruitment industry with the last 15 years focused on the Life Science and CRO industry. With her commercial background, she brings predominantly the strength in developing global business models together with successful clients and passionate teams. Through her executive leadership sha has implemented regional, and global business units, growing, and delivering strategic resourcing business to success through strategic alliance partnerships.

      ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services. Through combined functional, operational, and talent expertise, ICON offers FSP models that provide cost-savings, clinical expertise and significantly improve business performance.

      Session Details:

      Building a flexible and efficient clinical operation organization through a strategic partnership

      2023-10-24, 3:00 PM

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      Sebastian Turek
      Executive Director Internal Medicine & Neuroscience, TFS HealthScience

      Session Details:

      Reserved for TFS HealthScience

      2023-10-24, 2:30 PM

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