12th Annual Outsourcing in Clinical Trials Nordics 2024

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

1 - 2

October

2024
  • 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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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

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Morten Pedersen​

VP, Head of Clinical Operations, Lundbeck

Morten completed his Master’s degree in Biotechnology at National University of Ireland, Galway, in 1997, specializing in Pharmacology. He joined Lundbeck in August 2020 as VP, Head of Clinical Operations.

Career to date Morten started at a CRO in 1997 as a CRA on an Epilepsy study.  In the subsequent years he worked in CRO’s, consultancy and big Pharma taking on roles within Project Management, Program Oversight, Innovation and Strategic Partnerships.  He joined Pfizer in 2003 and has a wide range of project management experience delivering projects across multiple therapeutic areas. From 2007 to 2011 he held a leadership role in Pfizer’s Clinical Study Management group providing Operational Oversight in various outsourcing models.  As Group Lead of Emerging Markets and Established Products Business Units he managed a team of Program Directors in a variety of Therapy Areas from Phase II to Late Phase and Non-Interventional trials. From late 2011 Morten joined an Innovation technology CRO in the role of Senior Director and Head of Strategic Partnerships with the aim of improving Clinical Trial efficiencies and supporting Trial Sites. In August 2016 he joined InVentiv Health as VP, Head of Program Delivery in Neuroscience, before the group merged with INC to become Syneos Health.

 

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Helen Johansen Blanco​

Chief Operating Officer, Node Pharma A/S

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Magnus Jörntén-Karlsson​

Head of Digital Patient & Site Technology, Evinova at AstraZeneca

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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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    2024 Sponsors Included:

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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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    Company Information

    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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    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

    ARENSIA Exploratory Medicine, a German company, specializes in “first-in-patient” Phase IB and II/PROOF-OF-CONCEPT clinical trials spanning various patient populations. Equipped with 14 proprietary research clinics and advanced Phase I infrastructure, ARENSIA exceptionally accelerates the detection of initial efficacy signals for novel compounds at an unrivalled speed. ARENSIA’s streamlined approach significantly slashes patient recruitment time and costs by at least 50%, as opposed to overcrowded and understaffed conventional trial sites. The company’s remarkable efficiency is underscored by its 93% repeat business rate, propelling its growth and collaborations with leading pharmaceutical companies, biotechs, and global CROs. H3.eadquartered in Düsseldorf, ARENSIA operates with a workforce of over 450 employees across 8 countries.

    Company Website

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

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    Company Information

    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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    Company Information

    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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    Company Information

    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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    Company Information

    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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    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 33,000 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 2,200+ customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster.

    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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    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

    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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    Company Information

    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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    Company Information

    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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    Company Information

    PPD clinical research business of Thermo Fisher Scientific, provides clinical development and analytical services that enhance customer innovation and productivity. Utilizing patient-centered strategies and data analytics, we cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, patient recruitment, investigator sites and comprehensive laboratory service. To learn more, visit thermofisher.com/ppd

    Company Website

    To learn more , please visit our website - thermofisher.com/ppd

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    Company Information

    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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    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

    Myonex is a global complete clinical trial solutions provider. For over 30 years, we have been the leading global clinical trial supply company and we have expanded our service portfolio to offer complete solutions around clinical trials for our partners. You might have known us as Myoderm as we have recently changed our name – but not our high-quality services as the complete clinical trial supply partner. We at Myonex add value to our clients by helping them always be prepared for what is next in their clinical trials.

    Our goal each day, every day is to make sure our partners have whatever they need when and where they need it to execute a successful clinical trial, while also minimizing delays, unnecessary costs, and surprises.

    With 2,000 annual trials and projects, around 200 active clients and global access to source drugs in over 60 countries, Myonex is your complete partner around clinical trials around the globe – reliable, trusted and by your side.

    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.

       

      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 2024?

      200+

      Attendees

      		30+

      Exhibitors

      		30+

      Speakers
      200+

      Attendees

      		30+

      Exhibitors
      30+

      Speakers

      Testimonials

      See What It's All About

      Agenda

      • 1 Oct 2024
      • 2 Oct 2024
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      Streams

      Stream one

      OUTSOURCING IN CLINICAL TRIALS & CLINICAL OPERATIONS

      7:30 AM

      Registration and refreshments

      8:15 AM

      Chairperson’s opening remarks

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S

      8:30 AM

      Sharing latest updates to the Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS)

      • Providing latest updates: what’s new from the EU regulatory framework?
      • Learning from previous submissions: tips and tricks

      Speakers

      Lene Grejs Petersen
      Senior Advisor, Danish Medicines Agency

      9 AM

      Reserved for Medidata

      9:30 AM

      Building an Outsourcing Strategy for your clinical trials

      • Initiation: landscaping and defining the project
      • Strategy development: analyses and stakeholder management
      • Implementation: selecting vendors, training and alignment
      • Maintenance: KPIs and governance
      • Tips and tricks to consider

      Speakers

      Rikke Winther
      Outsourcing Specialist, Camurus AB

      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 A/S

      9 AM

      Navigating through the jungle of regulatory requirements for combination trials

      • Overview of the COMBINE project created to analyse challenges and find solutions for combined studies
      • Reviewing key regulatory factors within CTR, MDR and IVD to ensure compliance
      • Best practice for streamlining your submissions to optimise approvals for parallel submissions

      Speakers

      Ditte Zerlang Andersen
      Senior EU Project Lead, Senior Adviser, Danish Medicines Agency

      9:30 AM

      Reserved for CMIC

      10 AM

      Improving sustainability: Healthcare transition into a Net Zero world

      • Healthcare sector’s responsibility and action to address the climate crisis as accelerator for the health crisis
      • Methodology and available tools to assess carbon footprint of clinical trials
      • Clinical best-practices to save significant natural and financial resources

      Speakers

      Morten Pedersen
      VP, Head of Clinical Operations, Lundbeck

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Re-evaluating your study if things go wrong in clinical trial: to stay or change?

      • Pro-actively preparing for the worst up front
      • Considerations for changing or re-assessing sites
      • Assessing, selecting and switching vendors: benefits and challenges
      • Case study example: success and lessons learnt

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S

      11:30 AM

      Reserved for Viedoc

      12 PM

      Case Study: Successfully outsourcing a trial from a small to mid-size biotech perspective

      • Selecting vendors suitable for smaller companies
      • Managing the trial and oversight with a small biotech team and limited resource
      • Overcoming hurdles and sharing best practice to successfully outsource trial

      Speakers

      Stina Westergaard Frederiksen
      Senior Director and Head of Clinical Operations, Y-mAbs Therapeutics A/S

      12:30 PM

      Lunch and networking

      1:30 PM

      PI overview of patient safety when carrying out digital elements and decentralized clinical trials

      • Outlining role of the Principal Investigator in digital and decentralized clinical trials
      • Considering key strategies for ensuring patient safety and maintaining regulatory compliance
      • Sharing examples of benefits and challenges of digital integration

      Speakers

      John Zibert
      Chief Medical Officer, Coegin Pharma

      2 PM

      Fireside Chat: How to de-risk a clinical development program?

      • Value of obtaining early feedback from Key Opinion Leaders and Regulators
      • Risk assessment at the trial level
      • Trial oversight matrix implemented with all vendors and subcontractors

      Speakers

      Anna Polak
      Head of Clinical Trials, Cyxone

      2:30 PM

      Afternoon refreshments, networking and prize draw

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

      Roundtable 1
      Mitigating risk in clinical supply chain
      Pernille Hemmingsen, Chief Technology Officer, Adcendo

      Roundtable 2
      Increasing patient enrolment and engagement in clinical trials

      Roundtable 3
      Considering DCT trial design and impact on both the patient and company

      4 PM

      End of conference

      8:45 AM

      Chairperson’s opening remarks

      Speakers

      Libbi Rickenbacher
      Senior Director Product Strategy and Partnerships, 4G Clinical

      9 AM

      Case Study: Real world example of Artificial Intelligence in clinical development – PoC to Production

      • Understanding regulation and preparing compliance
      • Driving innovation and technology into processes through use of generative AI
      • Implementing AI for practical use with valuable return on investment

      Speakers

      Stephen Lutsch
      Senior Director Clinical Trial Digital Innovation, Genmab

      9:30 AM

      Reserved for event sponsor

      10 AM

      Case Study: Accelerating innovation through digital health technology solutions

      • Driving true benefits for clinical research through digital health technology
      • Learnings from barriers created by integration of digital health
      • Improving processes and focusing on delivering digital health as a tool

      Speakers

      Magnus Jörntén-Karlsson
      Head of Digital Patient & Site Technology, Evinova at AstraZeneca

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Expert Conversation: Strategic Considerations for End-to-End Development of Fit-For-Purpose Digital Measures of Health

      • Strategies for sourcing components from a scattered ecosystem
      • How to develop meaningful, human-centric measures
      • Pitfalls and opportunities for analytical and clinical validation
      • Novel solutions and digital pathways for scalable regulatory qualification
      • Maximizing value: how to repurpose and extend solutions across use cases in R&D and healthcare

      Speakers

      Kai Langel
      CEO, DEEP Measures

      11:30 AM

      Reserved for event sponsor

      12 PM

      Transforming clinical trials: ideas from leading industry professionals

      • Assessing outcomes from over 70 interviews with life science industry pioneers
      • Reviewing what clinical professionals wish would be different in the life sciences industry
      • Suggesting next steps towards further evolving clinical trials

      Speakers

      Ivanna Rosendal
      Senior Director, IT Business Partner, Ascendis Pharma

      12:30 PM

      Lunch and networking

      1:30 PM

      Maintaining control and oversight of data in outsourced trials

      • Considering, generally and specifically, data collected with eDiary, CGM and other external sources
      • Assessing risks when outsourcing trials
      • Acting accordingly to manage and mitigate risks
      • Maintaining right level of oversight

      Speakers

      Ane Jensen
      Principal Data Manager, Zealand Pharma

      2 PM

      Panel Discussion: Considering existing and emerging technology to assist with clinical trials

      • Digitalization: what can we digitalize to improve systems and processes
      • AI: what can we implement to save time and resource
      • Systems: what technology and systems are available and emerging to assist in clinical trials and data management

       

      Speakers

      Libbi Rickenbacher
      Senior Director Product Strategy and Partnerships, 4G Clinical
      Stephen Lutsch
      Senior Director Clinical Trial Digital Innovation, Genmab
      Ane Jensen
      Principal Data Manager, Zealand Pharma

      2:30 PM

      Afternoon refreshments, networking and prize draw

      10 AM

      Reserved for Worldwide Clinical Trials

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Creating functional partnerships between sponsors and CROs in a volatile world

      • Integrating vendors and silos into your own organization
      • Considering where vendor management ends and vendor oversight starts?
      • Creating the right framework for a long-lasting partnership

      Speakers

      Lars Rosendal
      Former Head of Global Clinical Operations, LEO Pharma

      11:30 AM

      Why so slow? Insider insights from the clinic floor to speed up the startup and execution of proof-of-concept patient trials

      How to:

      • Harness regulatory dynamics for strategic advantages.
      • Obtain feasibility figures true to delivery.
      • Employ innovative study designs to expedite the development program.
      • Customize efficient patient recruitment tactics!

      Speakers

      Dr. Claudia Hesselmann
      Founder and CEO, ARENSIA Exploratory Medicine

      12 PM

      Panel Discussion: Focusing on the patient: diversity, engagement and safety

      • Increasing patient engagement and involvement
      • Improving diversity in clinical trials
      • Considering sites and patient safety

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S

      12:30 PM

      Reserved for Langland

      1 PM

      Lunch and networking

      2 PM

      Clinical trial outsourcing: a customer perspective

      • Clinical trial outsourcing strategies
      • Sponsor company expectations and CRO selection
      • Clinical trial oversight – considerations for finding the right balance between efficiency and safety

      Speakers

      Christopher Burton
      Chief Medical Officer, Reponex Pharmaceuticals A/S

      2:30 PM

      Reserved for TFS Healthscience

      3 PM

      Clinical Trial Investigations: Looking at the trends and landscape for 2023 and what we can learn from them

      • Overview of global clinical trials for 2023
      • Assessing key sponsors, top interventions and looking at the trial landscape for 2023
      • Looking at key obstacles for terminated trials and evaluation of completed trials which have achieved endpoint status

      Speakers

      Priya Nair
      Senior Analyst, GlobalData

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      Developing neuroimaging and CNS drug: preparing for clinical trial

      • Sharing insights on collaborations with clinical CROs on previous clinical studies
      • Preparing for a clinical trial with a University Hospital in Denmark
      • Choosing and developing the right trial design

      Speakers

      Christine Ryan
      Chief Operating Officer, Gabather

      4:30 PM

      Reserved for Climedo

      5 PM

      Panel Discussion: Defining effective governance structures and oversight models

      • Creating an efficient governance structure to suit the study
      • Communicating and monitoring the framework
      • Evaluating needs and wants of both sponsor and vendor companies
      • Sharing best practice for governance oversight

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S
      Caroline Sandstroem
      Head of Global Clinical Quality, Ferring Pharmaceuticals
      Anna Polak
      Head of Clinical Trials, Cyxone
      Caroline Verheggen
      Head of Clinical Operations. Estetra
      Sara Thuresson
      Head of Clinical Operations, Guard Therapeutics

      5:30 PM

      Chairperson’s closing remarks

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S

      END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY FORTREA

      Speakers

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      Ivanna Rosendal
      Senior Director, IT Business Partner, Ascendis Pharma

      Session Details:

      Transforming clinical trials: ideas from leading industry professionals

      2024-10-02, 12:00 PM

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      Social Links:

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      Magnus Jörntén-Karlsson
      Head of Digital Patient & Site Technology, Evinova at AstraZeneca

      Session Details:

      Case Study: Accelerating innovation through digital health technology solutions

      2024-10-02, 10:00 AM

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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:

      Building an Outsourcing Strategy for your clinical trials

      2024-10-01, 9:30 AM

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      John Zibert
      Chief Medical Officer, Coegin Pharma

      Dr. John Zibert, Chief Medical Officer Coegin Pharma AB, a listed Nordic biotech company with several unique molecular technologies and compounds , where he also serves as CEO of Avexxin Oncology AS and Board Member of Reccura Therapeutics AS. He received his master's in medicine and human biology, and PhD in immunology at the University of Copenhagen, DK and University of Otago, NZ. He has demonstrated a successful history of working in the pharmaceutical and digital healthcare industry in established corporate businesses, and in an incubator co-establishing more than 25 start-ups within digital health and biotech, and several of his own biotech companies. Furthermore, he has an academic footprint of 79 publications in particular within digital health, tumor biology and dermatology. He has a deep experience within execution of drug research and development, Decentralized Clinical Trials, digital healthcare solutions, and leadership.

      Session Details:

      PI overview of patient safety when carrying out digital elements and decentralized clinical trials

      2024-10-02, 1:30 PM

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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:

      Sharing latest updates to the Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS)

      2024-10-01, 8:30 AM

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      Ditte Zerlang Andersen
      Senior EU Project Lead, Senior Adviser, Danish Medicines Agency

      Session Details:

      Navigating through the jungle of regulatory requirements for combination trials

      2024-10-02, 9:00 AM

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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:

      Panel Discussion: Defining effective governance structures and oversight models

      2024-10-01, 5:00 PM

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      Christine Ryan
      Chief Operating Officer, Gabather

      Dr Christine Natasha Ryan holds a PhD in Neuroscience from the University of Cambridge, Cambridge, UK and an MBA from Stockholm School of Economics. Following a post-doc at the Brain Research Institute, St. Hans Hospital, Roskilde, Denmark, Dr Ryan remained in Scandinavia moving to Sweden to work at Astra, which then became AstraZeneca, holding line management and competitive intelligence roles. Dr Ryan has engaged in preclinical research at blue chip companies such as AstraZeneca, smaller pharmaceutical companies, CROs and biotechs, working at Karo Bio AB, and Cerca Insights among others. Dr Ryan joined Gabather AB as Principal Scientist in 2017, becoming VP Operations in 2018. She is currently COO.

      Session Details:

      Developing neuroimaging and CNS drug: preparing for clinical trial

      2024-10-01, 4:00 PM

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      Stephen Lutsch
      Senior Director Clinical Trial Digital Innovation, Genmab

      In my position as Senior Director - Clinical Trial Digital Innovation at Genmab, I lead a team driving AI adoption within clinical operations, decentralized clinical trials and digital innovation in drug development. Previously, I have been working to bring the best disruptive innovation into normal clinical operations at LEO Pharma to help improve and accelerate their clinical trials. Furthermore, I am trying to solve some of the toughest challenges related to scaling digitalization, data, and automation to generate competitive advantages across business units. One aspect is driving the necessary foundational components around a scalable GxP data platform, machine learning opportunities as well as automating digital processes with robotics process automation. Besides leading the necessary change internally, focus is on a design-thinking approach where we put the patient and site at the center. I have an ambition towards “delighting” patients, investigators, and sponsors by solving the real-world challenges they face by leveraging both qualitative interviews and observation, as well as quantitative methods to reveal actionable insights

      Session Details:

      Case Study: Real world example of Artificial Intelligence in clinical development – PoC to Production

      2024-10-02, 9:00 AM

      Session Details:

      Panel Discussion: Considering existing and emerging technology to assist with clinical trials

      2024-10-02, 2:00 PM

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      Priya Nair
      Senior Analyst, GlobalData

      Session Details:

      Clinical Trial Investigations: Looking at the trends and landscape for 2023 and what we can learn from them

      2024-10-01, 3:00 PM

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      Lars Rosendal
      Former Head of Global Clinical Operations, LEO Pharma

      Session Details:

      Creating functional partnerships between sponsors and CROs in a volatile world

      2024-10-01, 11:00 AM

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      Morten Pedersen
      VP, Head of Clinical Operations, Lundbeck

      Morten completed his Master’s degree in Biotechnology at National University of Ireland, Galway, in 1997, specializing in Pharmacology. He joined Lundbeck in August 2020 as VP, Head of Clinical Operations.

      Career to date Morten started at a CRO in 1997 as a CRA on an Epilepsy study.  In the subsequent years he worked in CRO’s, consultancy and big Pharma taking on roles within Project Management, Program Oversight, Innovation and Strategic Partnerships.  He joined Pfizer in 2003 and has a wide range of project management experience delivering projects across multiple therapeutic areas. From 2007 to 2011 he held a leadership role in Pfizer’s Clinical Study Management group providing Operational Oversight in various outsourcing models.  As Group Lead of Emerging Markets and Established Products Business Units he managed a team of Program Directors in a variety of Therapy Areas from Phase II to Late Phase and Non-Interventional trials. From late 2011 Morten joined an Innovation technology CRO in the role of Senior Director and Head of Strategic Partnerships with the aim of improving Clinical Trial efficiencies and supporting Trial Sites. In August 2016 he joined InVentiv Health as VP, Head of Program Delivery in Neuroscience, before the group merged with INC to become Syneos Health.

       

      Session Details:

      Improving sustainability: Healthcare transition into a Net Zero world

      2024-10-02, 10:00 AM

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      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S

      Helén Johansen Blanco has 20+ years of clinical development experience, managing Phase I to III clinical trials leading to the successful launch of several oncology products. She has experience in project management 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 and Celgene, in addition to smaller and larger CROs such as Smerud and Covance. Currently she holds a position as Head of Clinical Operations at Oncoinvent, a small medium sized biotech company located in Norway. She holds a MSc in Biophysics and medical technology from Norwegian Technology and Science University and is currently writing her thesis for a Master in Business Administration.

      Session Details:

      Chairperson’s Opening Remarks

      2024-10-02, 8:45 AM

      Session Details:

      Panel Discussion: Focusing on the patient: diversity, engagement and safety

      2024-10-01, 12:00 PM

      Session Details:

      Chairperson’s closing remarks

      2024-10-01, 5:30 PM

      Session Details:

      Re-evaluating your study if things go wrong in clinical trial: to stay or change?

      2024-10-02, 11:00 AM

      Session Details:

      Panel Discussion: Defining effective governance structures and oversight models

      2024-10-01, 5:00 PM

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      Christopher Burton
      Chief Medical Officer, Reponex Pharmaceuticals A/S

      Session Details:

      Clinical trial outsourcing: a customer perspective

      2024-10-01, 2:00 PM

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      Stina Westergaard Frederiksen
      Senior Director and Head of Clinical Operations, Y-mAbs Therapeutics A/S

      Session Details:

      Case Study: Successfully outsourcing a trial from a small to mid-size biotech perspective

      2024-10-02, 12:00 PM

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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:

      Maintaining control and oversight of data in outsourced trials

      2024-10-02, 1:30 PM

      Session Details:

      Panel Discussion: Considering existing and emerging technology to assist with clinical trials

      2024-10-02, 2:00 PM

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      Anna Polak
      Head of Clinical Trials, Cyxone

      Session Details:

      Panel Discussion: Defining effective governance structures and oversight models

      2024-10-01, 5:00 PM

      Session Details:

      Fireside Chat: How to de-risk a clinical development program?

      2024-10-02, 2:00 PM

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      Dr. Claudia Hesselmann
      Founder and CEO, ARENSIA Exploratory Medicine

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

      Session Details:

      Why so slow? Insider insights from the clinic floor to speed up the startup and execution of proof-of-concept patient trials

      2024-10-01, 11:30 AM

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      Caroline Verheggen
      Head of Clinical Operations. Estetra

      Session Details:

      Panel Discussion: Defining effective governance structures and oversight models

      2024-10-01, 5:00 PM

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      Sara Thuresson
      Head of Clinical Operations, Guard Therapeutics

      Session Details:

      Panel Discussion: Defining effective governance structures and oversight models

      2024-10-01, 5:00 PM

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