Outsourcing in Clinical Trials & Clinical Trial Supply Nordics 2022

Biography: 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: Highlights of the Clinical Trial Regulation experiences since 31 January 2022. Presented by the Danish Medicines Agency 25-10-2022, 8:30 am View In Agenda

Biography: 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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Biography: 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 25-10-2022, 8:15 am OUTSOURCING IN CLINICAL TRIALS 25-10-2022, Panel Discussion Solutions to fully adapt to the future of Decentralised Clinical Trials to ensure patient engagement and overall DCT success 25-10-2022, 12:00 pm How to optimize collaboration with patient advocacy organizations 25-10-2022, 3:00 pm Chairperson’s closing remarks 25-10-2022, 5:30 pm Chairperson’s opening remarks 26-10-2022, 8:45 am OUTSOURCING IN CLINICAL TRIALS 26-10-2022, Chairperson’s closing remarks 26-10-2022, 5:00 pm View In Agenda

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Session Details: CLINICAL TRIAL SUPPLY 25-10-2022, The movement towards decentralized clinical trials 25-10-2022, 4:00 pm MEDICAL DEVICES 26-10-2022, View In Agenda

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Session Details: Improving ways of working in the study design phase in order to reduce waste and cost of drugs 25-10-2022, 12:00 pm Supply Chain Panel: Ensuring the highest level of collaboration between clinical trial supply and clinical operations 25-10-2022, 3:00 pm View In Agenda

Biography: Francisco (52) is a certified Non-Executive Director, Economic Analyst & MBA with 28 years of experience in International Trade & Air Freight Transportation, specialized on Temperature Controlled Shipments of Pharmaceuticals. Currently, at the International Air Transport Association (IATA) holding the position of Cargo Specialist Manager for the EU, UK, Turkey, Ukraine, Israel, Russia & CIS countries being responsible for delivering IATA’s Cargo Agenda in the Region and supporting the air cargo industry adoption and implementation of IATA´s global certification program for the proper air transportation of pharmaceuticals: being Instructor for the IATA’s Diploma of Air Cargo Transportation of Pharmaceuticals including courses of Temperature Control Risk Management, Temperature Control Air Cargo Operations, Audit and Quality for Temperature Controlled Shipments with more than 350 trained industry professionals globally. Additionally acting also as IATA`s Auditor & Consultant on pharma temperature control projects at Airports in Europe, US, Canada, Latin America and South Africa for Airlines, Airports´ Handling & Ramp Operators, Freight Forwarding Companies and Trucking Companies. Before joining IATA, Francisco owned and managed his own company for 15 years dedicated to Freight Forwarding, Customs Brokerage and Int´l Trade Consulting, and worked for companies like Panalpina and UPS (Supply Chain).

Session Details: Political challenges beyond our control: How pharma and biotech companies in the Nordic region can mitigate against this 25-10-2022, 11:00 am Airfreight Temperature Controlled Global Logistics for Clinical Trials 25-10-2022, 2:00 pm View In Agenda

Biography: Morten Lind Jensen is VP of Medical Science at UNION Therapeutics A/S. Prior to working at UNION, Morten has 9 years of experience as medical specialist, project manager and line manager from Novo Nordisk, where he worked across the internal Novo Nordisk portfolio and established external collaboration projects within new ways of doing clinical trials and using digital data. Prior to joining the pharmaceutical industry, Morten did his Ph.D. within the research space of medical education, and on how to optimize learning outcomes during the training of professionals. He has also worked clinically as a medical doctor within radiology and surgery. Morten is an MD from University of Copenhagen, Denmark.

Session Details: Panel Discussion Solutions to fully adapt to the future of Decentralised Clinical Trials to ensure patient engagement and overall DCT success 25-10-2022, 12:00 pm View In Agenda

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Session Details: Panel Discussion Solutions to fully adapt to the future of Decentralised Clinical Trials to ensure patient engagement and overall DCT success 25-10-2022, 12:00 pm Decentralized clinical trials in ethical committees 25-10-2022, 2:00 pm View In Agenda

Biography: 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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Session Details: FIRESIDE CHAT: Focusing on Technology & Innovation to ensure worldwide leadership in the field. 25-10-2022, 5:00 pm View In Agenda

Biography: 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.

Session Details: Real World Data and Real-World Evidence post COVID-19; responding to the systemic information dementia in healthcare 26-10-2022, 11:00 am View In Agenda

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Session Details: Medical Device Testing Panel Discussion: Best practices within medical device clinical trials in order to stay compliant 26-10-2022, 11:00 am Optimising your partnership strategy to turn your medical devices into reality 26-10-2022, 12:00 pm View In Agenda

Biography: 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.

Session Details: How to ensure successful recruitment in Clinical Trials? 26-10-2022, 4:00 pm View In Agenda

Biography: 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: Great expectations and how to meet them – connected devices and ePRO in clinical trials 26-10-2022, 3:30 pm View In Agenda

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Session Details: Political challenges beyond our control: How pharma and biotech companies in the Nordic region can mitigate against this 25-10-2022, 11:00 am Panel Discussion Solutions to fully adapt to the future of Decentralised Clinical Trials to ensure patient engagement and overall DCT success 25-10-2022, 12:00 pm Innovation & Creativity vs Reimbursement; Clinical trials as part of the innovation ecosystem – what elements affect our possibility to attract clinical trials 26-10-2022, 12:00 pm View In Agenda

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Session Details: Political challenges beyond our control: How pharma and biotech companies in the Nordic region can mitigate against this 25-10-2022, 11:00 am The Pursuit of Success: Driving your drug from the lab to the patient 25-10-2022, 4:00 pm View In Agenda

Biography: Dorte X. Gram (Danish, born 1969) is the founder and Chief Executive Officer (CEO) of Pila Pharma. She is XENIA PHARMA’s representative in PILA PHARMA’s Board of Directors. Dorte X. Gram is the inventor of the principle of treating diabetes and obesity with TRPV1 antagonists – a discovery-by-surprise during her PhD studies at Novo Nordisk, Denmark. In 2008, she acquired the rights to the invention from Novo Nordisk, Denmark, had use-patents issued via her mother-company XENIA PHARMA, Denmark and, in 2014, founded PILA PHARMA in Sweden as a subsidiary. Besides her innovative and entrepreneurial drive, Dorte X. Gram provides experience to PILA PHARMA in diabetes project management and planning including preclinical and clinical pharmacology, toxicology and regulatory affairs. She further has an extensive network in diabetes and runs PILA as a virtual company with a basic focus on target product profile, lean project management and engagement of her various professional contacts and other experts. Dorte X Gram graduated as veterinarian (DVM) in 1996 and was awarded the PhD title in 2003. She has profound experience from the life-science industry, whereof more than 10 years were in Diabetes Research & Development at Novo Nordisk A/S, Denmark working with various project teams within the diabetes and obesity research areas with small molecules and peptides including insulin- and GLP-1- analogues. She is the author of several scientific publications with a focus on TRPV1 in diabetes or anti-diabetic agents as well as of patents related to TRPV1 in diabetes and to basal insulin analogues. Dorte X. Gram is an expert in Pharmacology and Toxicology and previously, she has worked as Teaching and Scientific Assistant  at the University of Copenhagen, Denmark (1996-1999), PhD Student, Research Scientist and Clinical Pharmacologist at Novo Nordisk, Denmark (1999-2009), Associate Professor of Pharmacology at the University of Copenhagen, Denmark (2009-2010), External lecturer of Pharmacology & Toxicology, Roskilde University, Denmark (2010-2014), as Senior Toxicologist and Business Area Manager, Dept. of Human Health and Safety, DHI, Denmark (2010-2011), Senior Consultant and CEO of XENIA PHARMA, Denmark (2011-present) and CEO of PILA PHARMA, Sweden (2014-present).

Session Details: Building CRO Relationships. What are the critical factors to consider when procuring from a CRO? 26-10-2022, 3:30 pm View In Agenda

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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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Session Details: The Patient's Perspective: ‘Why are patient's voices so important in clinical development?’ 25-10-2022, 9:30 am View In Agenda

Biography: Mats has more than 35 years of experience in the pharmaceutical industry (Discovery, Development, IT, Marketing, Patents and Clinical Science). He is integration lead for implementing EHR driven services in AstraZeneca. On behalf of AstraZeneca, he was the Coordinator of the European IMI EHR4CR project during 2011-15 (35 partners, incl. 10 pharma companies) aiming to R&D the concept of scalable federated EHR services. Mats provide health analytics support strategic support on Pragmatic Clinical Trials RWD enabled services. Mats previous lead for AZ engagement in the EIT Health sponsored project EHR2EDC with European HCOs together with Janssens and Sanofi. He is on the board of Directors of the European Institute for Innovation through Health Data , i-HD and a member of TriNetX Advisory Board, and is author of +50 publications and books in science and economics (innovation management, clinical science, medical informatics, eHealth and business modelling).

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Biography: 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: Political challenges beyond our control: How pharma and biotech companies in the Nordic region can mitigate against this 25-10-2022, 11:00 am Lessons Learnt from Phase I Clinical Trials: Real World Experience 25-10-2022, 5:00 pm View In Agenda

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Session Details: 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: 26-10-2022, 1:30 pm View In Agenda

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Session Details: Medical Device Testing Panel Discussion: Best practices within medical device clinical trials in order to stay compliant 26-10-2022, 11:00 am EU Medical Device Regulation: Classification as a Key to Regulatory Strategy 26-10-2022, 1:30 pm View In Agenda

Biography: 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.

Session Details: Medical Device Testing Panel Discussion: Best practices within medical device clinical trials in order to stay compliant 26-10-2022, 11:00 am Defining Medical Device practice to push your product to market’ 26-10-2022, 2:30 pm View In Agenda

Biography: 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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Biography: 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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Biography: 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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Biography: 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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Session Details: Diversity in Finding New Medicines 25-10-2022, 11:00 am View In Agenda