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.

  • Clarion Hotel & Congress Copenhagen Airport
  • Complimentary
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Why attend?

WHAT TO EXPECT FOR 2023?

300+

Attendees

30+

Exhibitors

30+

Speakers

300+

Attendees

30+

Exhibitors

30+

Speakers

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

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

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

12 PM

Diversity in Finding New Medicines

12:30 PM

Lunch and networking

12:30 PM

Lunch and networking

12:30 PM

Navigating Complexity Through the Lens of the End-User

2 PM

Temperature Controlled Airfreight Global Logistics for Clinical Trials

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

2:30 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

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 PM

Afternoon refreshments and networking

3:30 PM

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

3:30 PM

Afternoon refreshments and networking

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

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?

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:

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 PM

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

2:30 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

Afternoon refreshments and networking

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

3:30 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?

3:30 PM

Afternoon refreshments and networking

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

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KASPER BENDIX JOHNSEN
Special Advisor Ethics Committee,, Danish National Centre For Ethics EUPATI
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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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Francisco Rizzuto
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DR. CLAUDIA HESSELMANN
Founder And CEO, ARENSIA Exploratory Medicine GmbH

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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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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Svetlana Rojkon Oestergaard
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HELÉN JOHANSEN BLANCO
Senior Clinical Director, Clinical Development, Cantargia

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.

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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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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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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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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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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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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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BRITTA CLAESSON
Supply Chain Study Design Specialist, AstraZeneca
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SONIA BEN HAMIDA, PHD
Head Of Special Cargo, International Air Transport Association (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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ANTOINE REMIOT
Clinical Supply Optimization - Director Solutions Engineering, N-SIDE

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

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Dorte X. Gram
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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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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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LENE LAURSEN
Deputy Director General, Medtech Denmark - Medicoindustrien
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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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HEGE EDVARDSEN
Senior Manager Of Research, Development And Innovation, LMI / The Norwegian Pharma Industry Association
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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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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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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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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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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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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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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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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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ODD VIKING HÖGLUND
CEO And Associate Professor Of Surgery, Resorbable Devices AB And Swedish University Of Agricultural Sciences (SLU)
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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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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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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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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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PRIYA NAIR
Senior Analyst, GlobalData
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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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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.

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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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IRENE RASMUSSEN
Director Clinical Operations Support, LEO Pharma
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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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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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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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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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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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Nick McCudden

Head of OCT Events


+61 280 978 126

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Maya Hudson

Senior Conference Producer


+44 (0) 204 540 7766