Outsourcing in Clinical Trials & Clinical Trial Supply Nordics 2022

Biography: Helén Johansen Blanco is Senior Clinical Director, Clinical Development at the Swedish biotech company Cantargia AB. She has 21+ years’ experience in clinical research and has worked within Big Pharma as AstraZeneca, the generic company Mylan, larger biotech as Celgene and in large and small CROs, in addition to several Scandinavian biotech companies. The majority of her career is within project/study management of phase I, II and III studies; with a track record of several leading registration trials within oncology, leading to successful marketed drug. Previously, she has worked and lived in Switzerland, Australia, Iceland, Sweden and Norway. Her passions are quality in clinical trials, proactive risk management and financial oversight.

Session Details: Dealing with the unexpected: risk management versus issue management 26-10-2021, 2:00 pm Chairperson’s closing remarks 26-10-2021, 5:00 pm Chairperson’s closing remarks 27-10-2021, 2:30 pm View In Agenda

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Session Details: Codesign transfer: ensuring quality when evaluating designs into production 27-10-2021, 12:00 pm 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.

Session Details: PANEL DISCUSSION: Delivering a successful decentralised trial: considerations and best practice 26-10-2021, 9:30 am View In Agenda

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Session Details: OPENING KEYNOTE PRESENTATION: Understanding the new EU Clinical Trial Regulation 26-10-2021, 8:30 am View In Agenda

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Session Details: Patient insights data in clinical medicines programme: regulatory and market access influence 26-10-2021, 12:00 pm View In Agenda

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Session Details: CASE STUDY: Learnings from managing a clinical trial through the COVID-19 pandemic 26-10-2021, 11:00 am View In Agenda

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Session Details: The interface between drugs and devices: overcoming common challenges 27-10-2021, 11:00 am View In Agenda

Biography: Dr. Svendsen has served as Chief Executive Officer of Forward Pharma since March 2017. Within Forward Pharma, his previous role as Executive Vice President included responsibility for corporate functions, portfolio strategy, regulatory interactions and medical and scientific input across all phases of clinical trials. Prior to joining Forward Pharma in 2015, he held positions of increasing seniority in the Danish pharmaceutical company Novo Nordisk A/S, including roles of Global Medical Director for Victoza® (liraglutide) and for Saxenda® in its regulatory and pre-launch phase for weight management, supporting a successful FDA advisory committee meeting and finally FDA and EMA approval. From 2007 to 2009, he worked as a Medical Analyst in Nordic Biotech Advisors ApS, dealing with due diligence of potential investment opportunities. He is a Medical Doctor from University of Copenhagen in 2003, and additionally completed a PhD in sarcoidosis pathobiology in 2009. He has worked in several countries with a clinical background mainly in internal medicine, and is a recipient of a Young Investigator Award from the Foundation for Sarcoidosis Research in 2009. Dr. Svendsen is an author of 27 publications in international, peer-reviewed journals and >50 abstracts presented at international congresses on pathobiology of sarcoidosis, methods in molecular biology, and medical treatment of diabetes and obesity.

Session Details: Working efficiently and successfully with your CRO 26-10-2021, 4:30 pm View In Agenda

Biography: Jennifer C. Smith is Senior Editor for GlobalData’s investigative, science journalism team based in New York and London. An award-winning healthcare journalist with a deep knowledge of the US and European pharmaceutical, regulatory and pricing/reimbursement sector, Jennifer works closely with other management on editorial strategy and output, mentors and trains junior reporters and is responsible for wide-ranging editorial projects. Her passion for healthcare and science-related news, with a particular focus on government and public and social policy, has led to diverse reporting experience across the US and internationally over the past decade.

Session Details: PANEL DISCUSSION: Delivering a successful decentralised trial: considerations and best practice 26-10-2021, 9:30 am View In Agenda

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Session Details: The role of global standards in the clinical trial supply chain 27-10-2021, 2:00 pm View In Agenda

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Session Details: Financing your clinical trial: how to attract funding through Innovation Fund Denmark 27-10-2021, 1:30 pm View In Agenda

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Session Details: ROUNDTABLE SESSIONS 27-10-2021, 9:00 am View In Agenda

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Session Details: PANEL DISCUSSION: Delivering a successful decentralised trial: considerations and best practice 26-10-2021, 9:30 am Running decentralised trials in Sweden: what do you need to know? 26-10-2021, 11:00 am View In Agenda

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Session Details: PANEL DISCUSSION: Delivering a successful decentralised trial: considerations and best practice 26-10-2021, 9:30 am Revolutionising clinical trials: a decentralised trial case study 26-10-2021, 12:00 pm View In Agenda

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Session Details: Considerations for setting up trial supplies for stem cell based advanced therapy medicinal products 26-10-2021, 1:30 pm View In Agenda

Biography: Chief Operating Officer at OnDosis AB, a Swedish health-tech company developing a new category of prescription regimens, delivered in a connected hand-held device, integrating medicine with flexible dosing. 15+ years of experience from different roles within research and clinical affairs at global medical device companies. Significant experience from development of Class I-III medical devices and drug-device combination products.

Session Details: Rethinking dose finding studies using a connected Dosage Manager - what are the opportunities and risks? 26-10-2021, 3:30 pm View In Agenda

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Session Details: Optimising your partnership strategy to turn your medical devices into reality 27-10-2021, 2:00 pm View In Agenda

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Session Details: Running your clinical supply chain internationally: what regulatory factors do you need to consider to ensure trial success? 26-10-2021, 2:30 pm View In Agenda

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Session Details: ROUNDTABLE SESSIONS 27-10-2021, 9:00 am View In Agenda

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Session Details: The state of play of IVDR: a notified body perspective 27-10-2021, 11:30 am View In Agenda

Biography: From my educational background I am biologist. I have completed my PhD at the Helmholtz Research Centre of Munich in cooperation with the Technical University of Munich in the field of toxicology. After that I gained several years of experience in the pharmaceutical industry with a focus on quality management. Since nearly 4 years, I am working within TÜV SÜD in the sector of Medical Health Services. Currently, I am leading a team of experts and auditors for non-active medical devices and I am responsible for the Article 117 business in the regions DACH & Nordics. Besides these roles, I am Auditor and Senior Product Specialist for non-active medical devices.

Session Details: The future of drug-device combinations under the new regulation MDR (May 2021) and the recently updated Guidance Documents 27-10-2021, 1:30 pm View In Agenda

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Session Details: Clinical investigation requirements before CE marking and Post Market Clinical Follow Up (PMCF) 27-10-2021, 11:00 am View In Agenda

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Session Details: How to put patients at the centre of decentralised clinical trials 26-10-2021, 4:00 pm View In Agenda

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Session Details: Choosing a CRO as a small to medium sized sponsor company: considerations in order to secure the best possible partnership for your trial 27-10-2021, 12:00 pm View In Agenda

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Session Details: ROUNDTABLE SESSIONS 27-10-2021, 9:00 am View In Agenda

Biography: Amaury Jeandrain has a Master’s Degree in Business Engineering with a specialization in supply chain management. After working for a CRO, he joined N-SIDE where he supported the optimization of hundreds of trials from different indications and pharmaceutical companies, providing services ranging from risk-based optimization to clinical trial design and solving drug supply shortage problems. Amaury now leads a group of consultants, focusing on the extension of N-SIDE’s solutions.

Session Details: Clinical supply chain optimization: what about manufacturing? 26-10-2021, 11:30 am ROUNDTABLE SESSIONS 27-10-2021, 9:00 am View In Agenda

Biography: Antoine Remiot has been sharing his enthusiasm and technical advice to various pharma partners, helping them tackle clinical trial supply challenges and solve drug shortage. He truly enjoys complex situations where he can use his skills to solve tricky problems. Antoine has a Master’s Degree in Mechanical Engineering with a focus on optimization. After working for various optimization software companies in the aeronautical market, he joined N-SIDE to focus on new pharma companies

Session Details: Clinical supply chain optimization: what about manufacturing? 26-10-2021, 11:30 am View In Agenda

Biography: Tinna Björk finished her industrial PhD from DTU and Novo Nordisk A/S in 2020, on mathematical modelling for digital therapeutics in type 2 diabetes treatment. Currently she is the technical project leader of an IFD Grand Solutions project, ADAPT-T2D, a collaboration between industry, academia and health clinics.

Session Details: CASE STUDY: Innovation in digital therapeutics at Novo Nordisk 26-10-2021, 4:00 pm View In Agenda

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Working closely and collaboratively with life science partners, Ben is responsible for solution innovation across Medidata’s Acorn AI portfolio. This is focused on using data to optimize clinical trial enrollment, designing more patient centric protocols, and developing Synthetic Control Arms for regulatory submissions. 

Ben holds a Masters degree in Genetics, and prior to joining Medidata was a part of IQVIA designing and project managing joint working collaborations between UK NHS organisations and Pharma in the, focusing on using Real World Data to optimize patient care and address inequities of access to medicines. 

Session Details: Outsourcing towards optimal: how to augment clinical operations with real trial insights 26-10-2021, 9:00 am View In Agenda

Biography: Rasmus Hogreffe, MSc.Med., MBA is considered as a Virtual Clinical Trials expert. His main goal is to improve treatment for patients by making trials better and faster than ever before, using digital and remote innovations.   Rasmus has extensive experience in the pharmaceutical industry and has been involved in more than 60 clinical trials, giving him a broad knowledge regarding every aspect of clinical research.   Furthermore, Rasmus is a serial entrepreneur and has a successful record of starting and selling companies within his broad scope of interests: Digitalization of clinical trials, Patient recruitment, Real World Data, and Health innovation.   In addition, as an external lecturer and supervisor at Aalborg University, Rasmus has developed and given courses and workshops on management of clinical studies on topics such as the development of recruitment and retention strategies, site-optimization, site-selection and patient engagement to sponsors, investigators and study teams at leading medical centers.   His innovative approach within the field of digital health, Patient Recruitment, and Virtual Clinical Trials make him a frequently used chairman and speaker. ................ Specialties: Patient #Recruitment, Patient #engagement, #Study start-up, Site #optimization Project #Management, #Medical #Market #Access, Business #Development, #Marketing, Health Economy, Economy analysis, #HEOR

Session Details: Decentralized Clinical Trials solution: reimagine healthcare outcomes through IoT 26-10-2021, 11:30 am View In Agenda