Outsourcing in Clinical Trials & Clinical Trial Supply Nordics 2023

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.

24 - 25

October

2023
  • Clarion Hotel & Congress Copenhagen Airport
  • Complimentary
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FLAVIA CHRISTINA LADWIG ROBLES​

BSc.Pharm, Patient Advocate

Having had a normal weight in childhood, obesity entered my life when I had my child in 1993. I gained a total of 40 kg over the next 14 years despite diet monitoring, physical exercise and obesity medication available back in time. No matter what I did I couldn’t stop putting on weight… I was almost 100 kg in 2007 and the consequences of so much weight were so clear: pain in lower back, ankles and knees, fat in my liver but even more scary – high blood sugar levels. I was a single mother and my only concern was that my health would deteriorate so badly that I’d leave my kid an orphan. As nothing less invasive seemed to help me in losing my body weight, I decided to have bariatric surgery. Although I’m having a normal weight for the last 11 years, I still struggle every day to keep it in control. Today I use my story to advocate for the cause of defeating Obesity together with my scientific background. I am a pharmacist contributing that better and effective drug treatment for losing weight is available to an affordable cost to all people in need of it. The collaborative relationship between patients living with a chronic disease and pharma is a win-win situation. Patient experiences, perception and opinions are heard by the companies behind new therapeutic options that hopefully will bring more quality to patients' life. This close dialogue helps to educate and raise the awareness of the burden caused by these diseases both on an individual and society perspective. The potential products can show exciting results in the laboratory and animals but only patients have the actual experience in their disease control. By giving the patients the opportunity of sharing their feedback from beginning of a product development the companies are able to make available better treatment options that meet patients' expectations on a faster fashion.

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Sonia Ben Hamida​

PhD, Head of Special Cargo Operations, Safety and Security – Cargo, IATA

As Head of Special Cargo at the International Air Transport Association (IATA), Dr Sonia Ben Hamida leads the development of the special cargo agenda, delivering standards, business processes, and solutions for the air cargo supply chain related to the transport of live animals, perishables, and temperature-sensitive cargo, and all other special cargo. Prior to joining IATA, Sonia held several roles in France where she spent 8 years driving innovation in the aerospace industry. Then she joined academia in 2019 as a lecturer and researcher at EPFL, the Swiss Federal Institute of Technology in Lausanne, and UNIGE, the University of Geneva. Over the past 12 years, I have built a strong expertise in project management, innovation, design, and business and systems modeling. Sonia holds an engineering degree in Aviation and Computer Science from the French Civil Aviation University - ENAC (France) and a PhD in Innovation from CentraleSupélec (France).

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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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John Zibert​

Chief Medical Officer, Coegin Pharma AB

Dr. John Zibert is Chief Medical Officer at LEO Innovation Lab, LEO Pharma’s independent innovation unit, where he leads a decentralized clinical trials unit, Studies&Me, working to personalize treatment development. Dr. Zibert has a history of more than seven year with LEO Pharma where he has held a number of positions as medical director for Region Europe, Medical advisor, Project leader and scientist. Dr. Zibert has senior experience with pharmaceutical drug development for various skin diseases, for which he contributed to the launch of two new products. He holds a B.Sc. in microbiology, M.Sc. in Human biology and a Ph.D. in medicine. John Zibert has been carrying out International clinical research on skin diseases and cancers for over a decade, with several publications in high-tier peer-reviewed journals. Prior to his scientific work, Dr. Zibert spent seven years in the Danish armed forces’ health and sports sector, and as a paramedic.

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Aakarsh Shard​

Director, Change Management Office, Novo Nordisk

Heading up a change management office at Novo Nordisk to support digitalization, decentralized trials and new ways of working across the clinical drug development landscape. Has over 15 years of experience driving change across companies like AP Moller Maersk, Grundfos, GN Store Nord and Leo Pharma including supply chain and HR transformations, M&A, ERP deployment and organizational redesign.

 

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STEFAN KNOLD​

IT QA Business Partner, LEO Pharma

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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

    Novotech is an Australia based clinical CRO operating across Asia and South Africa. Headquartered in Sydney since 1996, Novotech has come to be recognised as the CRO of choice for many US and European biotechnology firms in the Asia Pacific. Our full service offering includes clinical program management, biometrics services and regulatory affairs.

    Company Website

    To learn more , please visit our website - http://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) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, we build solution-driven teams working for a healthier future. Bringing together nearly 700 professionals, TFS delivers tailored clinical research services in more than 40 countries. TFS  demonstrates  scientific  and  medical  competence  across populations and therapeutics, with industry-leading capabilities in:

     

    -Dermatology, Immunology and Inflammatory Diseases

    -Hematology and Oncology

    -Ophthalmology

    -Internal Medicine including Neurology & Respiratory

    -Pediatrics, Rare Diseases and Orphan Drugs

    -Real World Evidence​

    Detailed information about TFS, and its business offerings can be obtained through

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    Viedoc designs engaging software for the life science industry. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. www.viedoc.com

    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 Website

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

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    Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

    Company Website

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

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    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 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.

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      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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      7:30 AM

      Registration and refreshments

      8:15 AM

      Chairperson’s opening remarks

      8:30 AM

      Highlights of the Clinical Trial Regulation experiences since 31 January 2022. Presented by the Danish Medicines Agency

      • Focusing on the regulatory landscape and Clinical Trial Information Systems (CTIS) for good clinical practice.
      • An update on the National Decentralised Clinical Trial Guidance

      9 AM

      Developing a More Complete Picture of the Patient Experience Through an Integrated Approach to eCOA and Sensors

      • The last five years have seen a proliferation of technologies intended for capturing data directly from patients in life science research, (e.g., ePRO, sensors, and live video visits.) This data, often collected during DCT and hybrid trials, is meaningful in understanding patient reported data; however, it is subjective by nature.  Objective data is often considered the gold standard; yet, it does not capture patient perceptions of outcomes.  A more complete data set is obtained when both subjective and objective data sets are combined and drives better insights into the full patient experience.

      • Benefits to uniting continuous objective technology acquired data with subjective clinical outcomes data

      • Keys to creating a sustainable approach to DCTs that leads to greater flexibility and better clinical insights

      • Enhancing value demonstration through real world effectiveness

      • How to get started, benefits of a pilot study

      9:30 AM

      The Patient’s Perspective: ‘Why are patient’s voices so important in clinical development?’

      • Discussing the personal experiences of the patient
      • Defining ‘patient centricity’
      • Regulatory situation in support of patient-centered development
      • What are the benefits of using multi-stakeholder approaches

      10 AM

      Decentralized clinical trials and hybrid trials: what you need to understand to run these successfully

      • Key learnings from running DCT/hybrid trials so far
      • Points to consider designing your coming clinical trials using DCT processes and technologies
      • The building blocks in your DCT/hybrid trials

      10:30 AM

      Morning Refreshments & Networking

      10:45 AM

      OUTSOURCING IN CLINICAL TRIALS

      • Chair: Helen Blanco, Senior Clinical Director, Clinical Development, Cantargia

      11 AM

      Panel Discussion Solutions to fully adapt to the future of Decentralised Clinical Trials to ensure patient engagement and overall DCT success

      • Expanding geographic reach and providing access to diverse populations and difficult-to reach candidates.
      • Minimising patient burden to reduce the risk of failure and lessen the costs associated with this loss
      • Engaging with sites at the early stages to determine the best approach for an upcoming trial and how to format superlative protocols

      11 AM

      Political challenges beyond our control: How pharma and biotech companies in the Nordic region can mitigate against this

      • Analysing the conflict’s impact on clinical trials in the Nordic region
      • Logistical challenges: The inability to send anything to Russia or take samples from Ukraine
      • Assessing future trial design from a more resilient perspective

      11:30 AM

      Improving ways of working in the study design phase to reduce waste and cost of drugs

      • Discover how some often-overlooked parameters can have a significant impact on IMP waste and supply risk
      • How AstraZeneca is working with trial design by promoting cross-department collaboration
      • Through case studies, learn how trial design optimization reduces drug waste, costs and carbon footprint
      • Tips and tricks on how to make this a reality in your organization

      11:30 AM

      Next evolution of operational considerations in rare disease trials

      • As the industry continues to change rapidly, are you prepared for what’s coming next? Join Derek Ansel as he explores emerging trends, such as

      • New recommendations to mitigate risk and find patients faster

      • Changing relationships between sponsors and CROs; and how to flip traditional thinking to encourage innovationp

      • How emphasis on diversity, genetic and ethnic, will impact operational considerations moving forward

      11:30 AM

      The Evolution of Clinical Development in AsiaPacific

      • Novotech update – expansion of our global capabilities and footprint
      • Acceleration of Clinical Development in the fastest growing region
      • Technologies – evolution of the DCT landscape in APAC

      • Niklas Lindberg, Senior Business Development Manager, Novotech

      12 PM

      Diversity in Finding New Medicines

      12:30 PM

      Navigating Complexity Through the Lens of the End-User

      12:30 PM

      Lunch and networking

      12:30 PM

      Lunch and networking

      2 PM

      Decentralized clinical trials in ethical committees

      • Ethical opportunities and challenges in decentralized clinical trials (DCT)
      • Educating members of ethical committees and researchers in DCTs
      • DCTs and trust between investigator and participant

      2 PM

      Temperature Controlled Airfreight Global Logistics for Clinical Trials

      2:30 PM

      Employing Flexibility in Oncology Clinical Trial Designs to Facilitate Patient-Focused Drug Development

      • There is a strong regulatory push for patient-focused drug development (PFDD), demonstrated by the new FDA PFDD Guidance Series and the Core Patient-Reported Outcomes in Cancer Clinical Trials Guidance.

      • This presents a real opportunity to optimise clinical trial design towards reducing participant and site burden. As a result, the industry is now focused on their respective journeys during study design. .

      • Traditionally, oncology trials have been site-based, with lengthy, complex, and burdensome visits for all parties.. Additionally, studies have not included a standard set of PRO domains, creating high levels of missing data.

      • Employing flexible but standardised approaches to data capture in studies can help solve this.

      • For example, capturing patient experience endpoints remotely complements objective endpoints, demonstrating greater treatment benefits . It also enhances the treatment’s valuation, such as its impact on symptoms, functioning, side-effects, and health-related quality of life.

      • Join us to learn  how eConsent, ePRO, wearables, and televisits can reduce burden on participants and sites to maximise the chance of success in oncology clinical trials. You’ll receive:

      • An outline of the recommended PRO strategy from the FDA

      • Knowledge of what domains should be measured in oncology trials to enable full realization of a treatment’s value and facilitate comparison across studies

      • An understanding on how PROs can be captured outside clinical settings

      3 PM

      Afternoon refreshments and networking

      3 PM

      How to optimize collaboration with patient advocacy organizations

      • The TRIFOUR trial: collaborating with GEICAM, the Spanish Breast Cancer Organization, in a multi-site, randomized phase 1b/II study
      • The Precision Promise trial: a randomized, phase II/III platform trial conducted in the USA in collaboration with PanCAN, the Pancreatic Cancer Action Network
      • Two Case Studies presented by Helén Johansen Blanco, MSc, MBA, Senior Clinical Director, Clinical Development, Cantargia

      3:30 PM

      Afternoon refreshments and networking

      3:30 PM

      Building CRO Relationships. What are the critical factors to consider when procuring from a CRO?

      4 PM

      Great expectations and how to meet them – connected devices and ePRO in clinical trials

      • Digitalization and use of device data has endless opportunities to change the way we run trials
      • Understanding your data collection is key – but how do we achieve the level of knowledge needed?
      • Avoid expensive mistakes that undermine your trial outcome

      4 PM

      ATIMP Clinical supply for early-stage clinical trials

      4:30 PM

      How to prepare for successful recruitment in Clinical Trials

      • Novo Nordisk
      • Global Trial Planning
      • Data-driven Site Identification
      • CARS: The why, what and how
      • Takeaway

      4:30 PM

      Making Clinical Supply More Effective: IRT as a tool to Manage Your Trial Supply Chain with Flexibility, Visibility and Control

      • Uncover how clinical trials can leverage a flexible IRT to improve supply chain efficiency and help you control unforeseen circumstances. In this presentation, we will discuss:
      • Challenges to optimizing your clinical supply chains
      • Leveraging technology to create real-time visibility and streamline drug supply management
      • How trials are using flexible IRT to gain control over their supply chains

      5 PM

      Chairperson’s closing remarks

      5 PM

      FIRESIDE CHAT: Focusing on Technology & Innovation to ensure worldwide leadership in the field.

      • Analysing the possible implications if we do not move forward with technology in good time; Will innovations get lost from Europe and be developed elsewhere? Will we fall behind the rest of the world, Eastern countries, and the US? This would be a catastrophe for the clinical landscapes in the Nordic region and for the whole of the EU.

      5:30 PM

      Chairperson’s closing remarks

      8:15 AM

      Registration and Refreshments

      8:50 AM

      Chairperson’s Opening Remarks

      9 AM

      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 Decentralised Clinical Trials; a discussion on transforming clinical trial development 

      • Ulla Holm Hansen, Director Clinical Operation, Symphogen

      • Roundtable 2 Real World Data; an ‘ocean of data, but a desert for analysis’

      • Nigel Hughes, Scientific Director, Observational Health Data Analytics/Epidemiology

      • Johnson & Johnson, Office of the Chief Medical Officer

      • Roundtable 3 Clinical Supply Chain; purchasing, planning and logistics to ensure consistent success 

      • Pernille Hemmingsen, Chief Technology Officer, Adcendo

      • Roundtable 4 Implementing effective vendor management tools to avoid the failure of clinical trials

      • Heike Schön, Managing Director and Shareholder, Lumis Life Science Consulting GmbH

      • Roundtable 5 Discussion on the higher plan of how regulators govern clinical trials and manage the rapid changes within the area, including what expectations the clinical trial ecosystem has for their regulators. Furthermore, discussions on how to strengthen the collaboration in the clinical trial ecosystem and what the clinical trial ecosystem would like to see from the governing bodies such as the DKMA, and vice versa.

      • Frederik Grell Norgaard, Head of Clinical Trials Unit (interim), Danish Medicines Agency

      • Roundtable 6 Reserved for N-SIDE

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Real World Data and Real-World Evidence post COVID-19; responding to the systemic information dementia in healthcare

      • The information dementia at the heart of healthcare provision, clinical and R&D
      • An overview of opportunities and challenges in working with RWD/RWE in Development/Post-authorisation
      • Initiatives addressing Europe being an ‘ocean of data, but a desert for analysis’
      • Johnson & Johnson
      • Office of the Chief Medical Officer

      11 AM

      Medical Device Testing Panel Discussion: Best practices within medical device clinical trials in order to stay compliant

      • The fear of not fulfilling or complying with requirements, understanding the changing global medical device landscape
      • Enabling small and medium enterprises to fulfil requirements
      • Finding specially trained couriers who can deliver medication and other medical supplies and equipment safely and legally

      11:30 AM

      Session Reserved for Event Sponsor

      12 PM

      Innovation & Creativity vs Reimbursement; Clinical trials as part of the innovation ecosystem – what elements affect our possibility to attract clinical trials

      • Recognising if regulations can help to stimulate new ideas, cut investment risk, and build consumer confidence in new innovations.
      • Implementing innovative solutions – does delayed reimbursement effect our ability to attract innovation development to the Nordics
      • Examining the relationship between innovation, creativity, and regulations
      • What are our selling points as a region?

      12 PM

      Optimising your partnership strategy to turn your medical devices into reality

      • Developing a medical device in an academic setting: what partnership options are available?
      • Combining resources in academia with resources in the start-up industry
      • Exploiting scientific marketing to compliment your clinical evidence

      12:30 PM

      Data-Driven Operations and Oversight with elluminate

      • Operational oversight within outsourced models has become increasingly complex for teams who are tasked with managing trials amid a rapidly changing landscape of partners, technologies, and global regulations. The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. Learn how elluminate delivers:

      • Operational analytics including enrollment, protocol compliance and safety

      • Risk-based analyses and insights with elluminate RBQM

      • Operational knowledge for data-driven development with elluminate CTMS

      • Centralized issue management across roles in operations, data and medical review

      • Sample tracking, data forecasting and financial performance indicators

      12:45 PM

      Lunch and networking

      1 PM

      Lunch and networking

      1:30 PM

      Case Study: Considerations on sponsor oversight of vendor computerized systems applied in clinical trials From a Clinical Operations point of view – experiences post a European Authority GCP inspection looking into:

      1:30 PM

      EU Medical Device Regulation: Classification as a Key to Regulatory Strategy

      • Regulations and how the manufacturer can adhere to them – MDR (medical device regulation)
      • Analysing combination products, ongoing discussions and recent guidelines published from European commission. Is there too much room for interpretation making it too challenging to implement?

      2 PM

      Case study: Patient engagement and adherence in Decentralised clinical trials; an introduction to the DTaP study completed by Huma, Bayer, and Stanford University

      2 PM

      Defining Medical Device practice to push your product to market; based on real-life product launches, I will highlight how we push a Medical Device to market.

      • Define different target groups.
      • Change to a new procedure at the Hospital – what consequences will follow
      • Next step? Implementation

      2:30 PM

      The power of hybrid clinical trials, learnings and future considerations, from a sponsor’s perspective.

      2:30 PM

      The movement towards decentralized clinical trials

      • The impact of COVID-19 on the future of clinical trials and the main concern for primary sponsors and CRO’s during the COVID-19 pandemic
      • The movement towards DCT’s and why sponsors are incorporating digital elements into clinical trials and the challenges around this
      • How AI can aid decentralized trials and real-life case studies

      3 PM

      Supply Chain Panel: Ensuring the highest level of collaboration between clinical trial supply and clinical operations

      • Ascertaining how clinical supply can get a seat at the table with clinical operations to streamline capabilities
      • Discovering how teams can collaborate and how technology can enable this
      • Sourcing raw materials in order to produce products
      • Overcoming logistical challenges within supply chain
      • Discussing how to provide products to patient

      3 PM

      Afternoon refreshments and networking

      3:30 PM

      Afternoon refreshments and networking

      3:30 PM

      Building CRO Relationships. What are the critical factors to consider when procuring from a CRO?

      • Establishing common ground with your CRO
      • Ascertaining the critical factors to think about when you collaborate with a CRO
      • Exploring how the concept of Co-development between Pharma & CRO is working best
      • Overcoming the differences between Pharma & CRO business models to work in harmony
      • Underlining the factors which could be limiting what choice you make?

      4 PM

      The Pursuit of Success: Driving your drug from the lab to the patient

      4:30 PM

      Accelerated performance of complex exploratory patient studies: practical insights from investigational site

      5 PM

      Lessons Learnt from Phase I Clinical Trials: Real World Experience

      5:30 PM

      Drinks Reception

      2022 Speakers

      Select a speaker to learn more

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      FREDERIK GRELL NØRGAARD
      Clinical Trials Assessor, Danish Medicines Agency

      Frederik Grell Nørgaard is Project Manager for decentralised trials at the Clinical Trial Unit, Danish Medicines Agency (DKMA). Frederik is working as a regulatory assessor and coordinator of clinical trials applications and runs several Danish initiatives such as the dialogue forum for decentralised trials (DCT). He is also the co-author and coordinator of the Danish DCT guidance. Frederik is a member of several workgroups within the Clinical Trials Facilitation and Coordination Group (CTFG) being involved in development of DCT guidance and a Q&A regarding the IVDR-CTR interface. Frederik has a background as Master in Pharmacy.

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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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      Britta Claesson
      Supply Chain Study Design Specialist, AstraZeneca
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      Priya Nair
      Senior Analyst, GlobalData
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      KASPER BENDIX JOHNSEN
      Special Advisor Ethics Committee,, Danish National Centre For Ethics EUPATI
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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.

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      Ulla Holm Hansen
      Director Clinical Operation, Symphogen

      I am director of IND & Phase I (which includes clinical operation) in Symphogen/Servier (Symphogen was acquired by Servier in 2020)

      I have worked several years in a CRO and the industry as CRA, Senior CRA and PM before joining Symphogen in 2010, where I am now heading the IND & Phase I entity which includes clinical operation but also the responsibility of facilitating new compounds (mAb) when received a go to be explored in FIH to FPFV. Symphogen develops mAb within oncology.

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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.

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      Nigel Hughes
      Scientific Director, Observational Health Data Analytics/Epidemiology, Johnson & Johnson

      Nigel Hughes has a thirty-six year career spanning the NHS in the UK (16 years), NGOs and patient organisations (10 years) and within the pharmaceutical industry (18 years). He has worked clinically in HIV and viral hepatitis, liver disease, and in sales & marketing, medical affairs, market access and health economics, R&D, precision medicine, advanced diagnostics, health IT and Real World Data/Real World Medicine. His experience covers clinical, education, as an advisor, consulting, communications and lobbying over the years. He is currently the Project Lead for the IMI2 European Health Data & Evidence Network (EHDEN), and was Platform Co-Lead for the IMI1 European Medical Information Framework (EMIF), as well as consulting on numerous projects and programmes in the domain of RWD/RWE.

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      CHRISTIAN FRIIS
      MSC. PHARM,Strategic Trial Planning Manager, Global Trial Planning, Novo Nordisk

      Christian Friis – (Strategic Trial Planning Manager) brings more than 20 years of experience from the industry. Christian has worked in Regulatory, as CRA in a CRO and as International Trial Manager in Biotech for close to eight years. In 2010 Christian joined Ferring where he has had several roles with increasing responsibilities and latest he progressed into the role as Clinical Project Leader, in Global Clinical Operations. In 2021 Christian joined Global Trial Planning at Novo Nordisk and he is responsible for country allocation of the haemophilia trial portfolio.

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      ODD VIKING HÖGLUND
      CEO And Associate Professor Of Surgery, Resorbable Devices AB And Swedish University Of Agricultural Sciences (SLU)
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      Ane Jensen
      Senior 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.

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      Hege Edvardsen
      Senior Manager Of Research, Development And Innovation, LMI / The Norwegian Pharma Industry Association
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      Dr. Tatiana Borer
      MD, Vice President, Head Of Haematology, Swedish Orphan Biovitrum AB

      Born in Moscow. Graduated in Russian State Medical University 1991-1997 followed by 3 years of Postgraduate specialisation in Neurology.

      MD degree in Neurology.

      Joined Pharmaceutical industry in 2000, having 7 years different regionals roles in Sales & Marketing.

      From 2007, relocation to Denmark, Nycomed HQs, different roles in R&D.

      From 2010 based in Switzerland, starting in Takeda, as CNS Franchise Head, then Head of Portfolio strategy and Business excellence.

      Executed 4 Global launches over the last 5 years in rare diseases, haemoonclology and CNS.

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      John Zibert
      Chief Medical Officer, Coegin Pharma AB
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      FLAVIA CHRISTINA LADWIG ROBLES
      BSc.Pharm, Patient Advocate

      Having had a normal weight in childhood, obesity entered my life when I had my child in 1993. I gained a total of 40 kg over the next 14 years despite diet monitoring, physical exercise and obesity medication available back in time. No matter what I did I couldn’t stop putting on weight… I was almost 100 kg in 2007 and the consequences of so much weight were so clear: pain in lower back, ankles and knees, fat in my liver but even more scary – high blood sugar levels. I was a single mother and my only concern was that my health would deteriorate so badly that I’d leave my kid an orphan. As nothing less invasive seemed to help me in losing my body weight, I decided to have bariatric surgery. Although I’m having a normal weight for the last 11 years, I still struggle every day to keep it in control. Today I use my story to advocate for the cause of defeating Obesity together with my scientific background. I am a pharmacist contributing that better and effective drug treatment for losing weight is available to an affordable cost to all people in need of it. The collaborative relationship between patients living with a chronic disease and pharma is a win-win situation. Patient experiences, perception and opinions are heard by the companies behind new therapeutic options that hopefully will bring more quality to patients' life. This close dialogue helps to educate and raise the awareness of the burden caused by these diseases both on an individual and society perspective. The potential products can show exciting results in the laboratory and animals but only patients have the actual experience in their disease control. By giving the patients the opportunity of sharing their feedback from beginning of a product development the companies are able to make available better treatment options that meet patients' expectations on a faster fashion.

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      Christine Ryan
      Vice President Operations, 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.

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      Irene Rasmussen
      Director Clinical Operations Support, LEO Pharma

      Session Details:

      OUTSOURCING IN CLINICAL TRIALS

      2022-10-26, 12:00 AM

      View In Agenda
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      Svetlana Oestergaard
      Regulatory Affairs Specialist, Phillips-Medisize

      I have a MSc as physician biophysist from Moscow Medical University (1995), MSc in biochemistry from the University of Copenhagen (2002) and PhD from the Faculty of Pharmaceutical Science at the University of Copenhagen (2011).

      I have 20 years of experience in the medical industry and consultancy. During my career I hold diverse positions: as a Scientist in the R&D department in the in-vitro diagnostics company, Regulatory Affairs Specialist at medical device company, QA audit in pharmaceutical company.

      In the period of 2018-2022, I have worked as Technical Assessor and Auditor at the Notified Body (Presafe, DNV), where I got a lot of experience in assessing compliance of technical documentation for medical devices related to Medical Device Directive and (EU) Medical Device Regulation and providing recommendation for CE certification.

      Today I work as a Regulatory Affairs Specialist at Phillips-Medisize, a medical device company with a strong expertise in design and development of drug delivery devices.

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      May-Britt Bonum
      Product Manager Medical Device, Viatris ApS

      I have more than 20 years of experience in sales and marketing from Life Science. In recent years, my focus has been on Medical Devices - both B2B and B2C. I am responsible for strategy, commercialization and execution. I have extensive knowledge of Regional and Municipal decision-making processes, including EU tenders. My strength is the understanding from the interaction between customers, products, government agencies and suppliers.

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      Niklas Lindberg
      Senior Business Development Manager, Sweden,, Novotech

      Niklas Lindberg specializes in business development in the biotech industry. Niklas has over 30 years of experience in international business development and has worked in several countries and with focus on knowledge driven decision making and development plans. Niklas has experience from clinical development in Biotech, MedTech and big pharma developing their R&D pipelines and strategies. Niklas joined Novotech 2022.

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      Dr. Claudia Hesselmann
      Founder And CEO, ARENSIA Exploratory Medicine GmbH

      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.

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      Adama Ibrahim
      VP, Digital Strategy And Change Management, Digital Science And Innovation, R&ED, Novo Nordisk

      A UK top 100 influential tech leader passionate about diversity and inclusion practices. Innovation award winning pharma industry advisory consultant, founder, disruptor, passionate operational strategy expert, blockchain advocate, technology enabled clinical trials and patient engagement thought leader with over 20 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON, Biogen and Novartis). As a part of R&D transformation led the strategy and implemented hybrid decentralized trials into the clinical development operating model at Biogen. Part of DIA Patient Engagement Voluntary Community Leadership team. Driver for change through identifying unmet customer needs, digital strategies, implementation and expansion of disruptive digital platform technologies across drug development and commercial lifecycles. Experience across various therapeutic areas and phases of trials in drug development including leading all phases of global clinical trials, developing electrophysiological clinical endpoints, creation and execution of successful strategies for research protocols and CRO oversight, patient and site feasibility, expertise in technologies such as eCOA, eConsent, telemedicine and IRT, creation of optimal drug packaging and administration concepts, mapping the patient journey, planning and executing effective global site and patient engagement campaigns using direct to patient methods, leading and coaching remote and complex global teams.

      Awards:
      • Financial Times 2019 Top 100 UK influential BAME tech leader
      • Founder of award winning Not-for-Profit to advance Clinical Trials in Emerging Markets in 2018
      • Women Innovation Network UK Co-Lead (2016 Honorary Mention for Diversity and Inclusion Award)
      • Sunday Times UK ‘Rising Stars in Healthcare’ award in 2018
      • Innovation award winner on clinical endpoints in 2014
      • Nigerian diplomats wives award for donation of medical supplies in 2003

      Notable Achievements include:
      • BBC Radio interview in 2020 on STEM activities and careers
      • Implemented lay language summary and end of study patient surveys
      • MBA dissertation titled ‘Implementing Patient Engagement at a Biotechnology Company’
      • Conducted management consulting visit in Chile and various global consulting assignments
      • Keynote speaker and chair at various international conferences
      • Setting up mentoring programs and leadership workshops
      • Trustee for a youth charity in London

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      Lene Laursen
      Deputy Director General, Medtech Denmark - Medicoindustrien
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      Sonia Ben Hamida, PhD
      PhD, Head of Special Cargo Operations, Safety and Security – Cargo, IATA

      As Head of Special Cargo at the International Air Transport Association (IATA), Dr Sonia Ben Hamida leads the development of the special cargo agenda, delivering standards, business processes, and solutions for the air cargo supply chain related to the transport of live animals, perishables, and temperature-sensitive cargo, and all other special cargo. Prior to joining IATA, Sonia held several roles in France where she spent 8 years driving innovation in the aerospace industry. Then she joined academia in 2019 as a lecturer and researcher at EPFL, the Swiss Federal Institute of Technology in Lausanne, and UNIGE, the University of Geneva. Over the past 12 years, I have built a strong expertise in project management, innovation, design, and business and systems modeling. Sonia holds an engineering degree in Aviation and Computer Science from the French Civil Aviation University - ENAC (France) and a PhD in Innovation from CentraleSupélec (France).

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      Aakarsh Shard
      Director, Change Management Office, Novo Nordisk

      Heading up a change management office at Novo Nordisk to support digitalization, decentralized trials and new ways of working across the clinical drug development landscape. Has over 15 years of experience driving change across companies like AP Moller Maersk, Grundfos, GN Store Nord and Leo Pharma including supply chain and HR transformations, M&A, ERP deployment and organizational redesign.

       

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      Sverre Bengtsson
      Co-Founder, Viedoc Technologies

      Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used.

       

      Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

      Session Details:

      Session Reserved for PCI Pharma Services

      2022-10-25, 2:30 PM

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      Kevin Machado Gamboa
      Data Science Engineer From The Sensor Cloud , Medidata

      Kevin has 4 years of experience in industry, research and medical environments. In these fields he has been developing innovative projects in medical software technology and AI. He is a Biomedical Engineer by training and holds an MSc in Artificial Intelligence from Essex University in the UK. He is committed to contributing to the development of gold-standard techniques for real-world data collection from sensors, digital biomarker discovery, preventive medicine and AI applications in healthcare.

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      Derek Ansel
      Executive Director, Therapeutic Strategy Lead, Rare Diseases, Worldwide Clinical Trials

      Derek Ansel is Executive Director, Therapeutic Strategy Lead, Rare Disease at Worldwide Clinical Trials.  Mr. Ansel has worked in clinical research for more than a decade with a focus almost exclusively in rare and pediatric diseases, including non-malignant hematology, autoimmune diseases, metabolic disorders, movement disorders, and other genetic conditions. At Worldwide, he leads and supports corporate initiatives within rare and pediatric diseases and maintains relationships with over 60 patient-focused advocacy organizations. He holds a master’s degree in Pharmacology and Toxicology from Michigan State University and is pursuing a master’s degree in Genetic Counseling from Bay Path University.

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      Antoine Remiot
      Clinical Supply Optimization - Director Solutions Engineering, N-SIDE

      Antoine Remiot is N-SIDE's Director of Solutions Engineering. Over the past years, Antoine has been sharing his enthusiasm about lean clinical supply chain management, waste reduction and sustainability with various pharma partners. Meeting new people from both large and small pharma, understanding their challenges and optimizing complex supply strategies are really what drives him.

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      Achilleas Zaras
      Solutions Consultant, EClinical Solutions

      Achilleas has 12+ years of experience in software industry involving software demonstrations, managing a team of 15+ developers, hands-on coding in Microsoft .Net platform and Business Intelligence Suites like QlikSense. He has enjoyed a progressive career in diverse roles including responsibilities of a Sales Engineer, Team Manager, Software Engineer and Business Intelligence Analyst in various industries like Banking, Retail and now the Pharmaceutical industry with eClinical Solutions.

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      Florence Mowlem
      Director, ECoa, Medable

      Dr Florence Mowlem is Medable’s Subject Matter Expert on digitising the capture of Clinical Outcome Assessments (COAs) in clinical trials, ensuring optimal solutions for clients that meet the scientific needs of their studies. She contributes expertise on solution design for all eCOA types (ePROs, eClinROs, eObsROs, ePerfOs, eDiaries) and advises around project complexities, to ensure adherence with the protocol requirements, that industry best practices are followed, and regulatory considerations accounted for. Flo is an active member of industry consortium (C-PATH eCOA, DIA), has presented at international conferences, and has numerous peer-reviewed publications.

      Flo has an MSc and PhD in Social, Genetic, & Developmental Psychiatry from the Institute of Psychiatry, Psychology, & Neuroscience (King’s College London), where her research focused on sex differences in the diagnosis and treatment of Attention Deficit Hyperactivity Disorder (ADHD), and the psychometric evaluation and validation of a new patient-reported measure for use in adult ADHD.

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      Libbi Rickenbacher
      Director Of Strategy, 4G Clinical

      Libbi Rickenbacher, Director of Strategy, has over 15 years of experience in the field of life sciences, and is an e-clinical RTSM solutions subject matter expert. Her experience lies at building and managing accounts, clients, and strategic initiatives. Has a proven record of success in conceptualizing and delivering client focused solutions, standards, and providing oversight and guidance to both internal and external teams. Holds BA in both Neuroscience and Psychology and a Doctorate (PhD) in Neuroscience

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      HEIKE SCHÖN
      Managing Director, Lumis International GmbH

      Heike is the Shareholder and Co-Founder of Lumis International, Lumis Life Science Consulting and the newly founded UK branch Lumis International Limited. She has more than 25 years of experience in leadership positions in international clinical research and drug development. She has profound knowledge of the clinical drug development processes and regulatory requirements from first in human to market access. She is experienced in developing strategies and concepts for biopharmaceutical and medical device companies covering clinical operations, clinical research, outsourcing, vendor management and oversight management.

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      ALEXIS DAVIN
      Clinical Supply Optimization - Solutions Engineer, N-SIDE

      Alexis Davin is a clinical optimization specialist at N-SIDE and a volunteer at the GCSG. His experience in clinical supply expanded quickly by solving day-to-day supply challenges of biopharma companies. He is passionate about how digitalization can improve the clinical supply industry and, ultimately, impact patients’ health. Alexis is also supporting the development of new digital solutions to solve supply chain issues in clinical trials, which offers him a strategic view on industry trends and internal processes.

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      JAN TALTS
      COO And CTO, Amniotics

      Jan Talts has extensive R&D and management experience from academia, the biotech industry, and the health care sector. He earned his PhD in Animal Physiology at Uppsala University working with extracellular matrix molecules in development and disease and has since then held positions as Associate Professor at Lund University Medical Faculty, Associate Professor and Section Leader for Anatomy and Cell Biology at the Royal Veterinary and Agricultural University, Copenhagen, Chief Medical Staff, Clinical Pathology, Lund University Hospital, and Senior Scientist, Project Manager and ECA certified QA Manager at the Swedish Regenerative Medicine Company Xintela AB. During the last years, he has been with Amniotics AB, first as Senior Scientist, then Chief Quality Officer and now Chief Operating Officer. He is the inventor on several patents and has published articles in international journals such as Cell, Molecular Cell, EMBO J, and PNAS. Jan Talts is well familiarized with most aspects of Advanced Therapy Medicinal Product (ATMP) development and have hands on experience within the preclinical, CMC, and regulatory fields.

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      Daniela Duffett
      Solutions Consultant, Suvoda

      Daniela Duffett is the European Solutions Consultant at Suvoda, based out of our Barcelona office. She consults with clients and prospects, delivering presentations and demonstrations, while acting as a Subject Matter Expert on Suvoda’s solutions. She started at Suvoda three years ago on the Project Management side of our Services Delivery organisation, so can impart her hands-on delivery experience & knowledge.

       

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      MIGUEL LECUMBERRI
      Head Of Legal Affairs & Compliance, PILA PHARMA

      I am an international business lawyer with an important corporate and transactional practice within the LifeSciences industry, mainly dealing with clinical R&D, finance, manufacture and logistics. I am from Spain but trained and with practice in the US, Latin America and, more recently, in the Nordics. I developed a deep expertise on: (i) Trading, infrastructure, public bidding processes; (ii) M&A, patent licensing, tax strategies; (iii) Foreign trade, customs, international business practices; (iv) Intellectual Property, IP monetization, technology transfer; and (v) implementation of strategies for small biotechs to become global. Currently I am the Head of Legal Affairs & Compliance at Pila Pharma AB in Sweden.

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      ARRASH YASSAEE
      Global Clinical Director, Huma

      Arrash is an academic paediatrician at Imperial College, and is Huma's Global Clinical Director. His previous national roles included working at the Department of Health and NHS England/Improvement. His healthcare experience includes some of the largest healthcare projects to date, including the 7-day hospital services programme and a range of other national initiatives.

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      DENNIS VELASQUEZ
      VP, Commercial, DCT, Huma

      A trained scientist with more than 15 years of international experience and expertise working in the pharmaceutical and biotech industries, Dennis joined Huma earlier in 2022 with the mission to build and lead the Decentralised Clinical Trials’ (DCT) team in EMEA. Working on a daily basis with Sponsors and CROs, helping them build efficient ecosystems for their clinical trials, assessing the implementation of a decentralized / hybrid trials’ strategy is what drives Dennis. It is about making a significant impact on research and access to research and cures. Prior to Huma, Dennis was at Medable, ERT, BioClinica, Oracle, and he started his career at Thomson Reuters. A native from Colombia, Dennis is a professional scuba rescue driver who can be found training at the gym and walking / cycling to the office on a daily basis. “I am passionate about delivering everything I am involved in to the highest standards. I believe it is paramount to fulfil my promises all the time and in the best possible way.’

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      Francisco Rizzuto
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      Dorte X. Gram
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      Svetlana Rojkon Oestergaard
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      Plan Your Visit

      Venue

      Clarion Hotel & Congress Copenhagen Airport

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

      Accommodation

      Scandic Copenhagen

      Booking code to be used: BARE241022 (valid until 24.09.22)

      The rooms can only be booked on www.scandichotels.com for the dates 24-26.10.2022

      The price is:

      1 person, per room, per day 1345 DKK

      2 persons, per room, per day 1445 DKK

      Cancellation deadline for the rooms is: 14.10.2022  at 18.00 (6pm) ,https://www.scandichotels.com/

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