12th Annual Outsourcing in Clinical Trials Nordics 2024

The annual meeting place for pharmaceutical, biotechnology, and medical device communities in the Nordics to network and discuss strategies for operational success in clinical trials

1 - 2

October

2024
  • Clarion Hotel & Congress Copenhagen Airport, Denmark
  • Complimentary
  • Why attend?
  • Agenda
  • 2023 Speakers
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  • Event Gallery
  • Sponsors
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Why attend?

WHAT TO EXPECT FOR 2024?

200+

Attendees

30+

Exhibitors

30+

Speakers

200+

Attendees

30+

Exhibitors

30+

Speakers

See What It's All About

Agenda

  • 1 Oct 2024
  • 2 Oct 2024
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Streams

Stream one

OUTSOURCING IN CLINICAL TRIALS & CLINICAL OPERATIONS

Stream two

CLINICAL TRIALS TECHNOLOGY & INNOVATION

8:45 AM

Chairperson’s Opening Remarks

Speakers

Helen Johansen Blanco
Vice President of Operations, Cytovation ASA

9:30 AM

The importance of scientific validation and data integrity when using accessibility features

  • Background on FDA recommendation for accessible features and designs to help increase clinical trial inclusivity such as frequently requested zoom in/zoom out functionality
  • Importance for patients who may have visual impairments, hearing, motor & dexterity, or cognitive difficulties that may impact inclusivity of these patients into clinical trials
  • Significance of deploying these functionalities where the drug under study may cause visual impairment such as certain oncology treatments or population under study, eg older adults, may have one or more impairments.
  • Results of an industry-first clinical study on the ePRO instrument equivalence across accessibility features and patient communication modality preferences.

Speakers

Bryan McDowell
VP, eCOA Science & Consulting, Clario

10 AM

Integrating diversity in clinical trials to increase drug safety and health equity

This interactive session will cover diversity and inequalities in clinical trials; why we have underrepresentation and why it’s vital we improve this now. Roel will give a short overview on the
challenges and will then open the discussion to the audience:
• How can we improve engagement by paying more of a focus on race and socioeconomic disparities?
• Highlighting the impact on your trial if all groups aren’t adequately represented – ask ourselves why not
• Brainstorming solutions: What actions can we take now to get groups interested in participating in trials?
• Advice on how best to reach out to patients to understand their needs
• Informing patients efficiently and translating the trial into a language they understand

Speakers

Roel van der Heijde
Facilitator & Trainer, Roel Rotterdam & Patient Experience Association

10:30 AM

Morning Refreshments & Networking

11 AM

Considering sustainability in clinical trials to improve ESG responsibilities

  • Improving planning and running of clinical trials to better meet the Agenda 2030 and the UN SDG with perspective from social and environmental impact
  • Considering the EU Green Deal and Sustainability Initiative to prepare for EU Corporate Sustainability Reporting Directive (CSRD) and European Sustainability Reporting Standard (ESRS)
  • Looking at the status of planet health, quick win actions to do now and long term focuses for future

Speakers

Anna Arnsvik
ESG Sustainability Lead and Nordic Head Neuroscience, Novartis

11:30 AM

Panel discussion: Recognising and further integrating patient centricity and patient perspectives into clinical trials

• Omitting exclusion: improving engagement through focus on diversity and inclusion
• Actively involving patients in ICF and protocol writing
• Listening to the patient’s voice. Reflecting on what is good for the patient and the right level of choice for the patient
• Highlighting societal changes, the everyday clinic and how these two aspects feed into the trial situation

Speakers

Helen Johansen Blanco
Vice President of Operations, Cytovation ASA
Christoffer Johansen
Head, CASTLE - Cancer Late Effect Research, Center for Surgery and Cancer, Rigshospitalet
Roel van der Heijde
Facilitator & Trainer, Roel Rotterdam & Patient Experience Association
Tanmay Jain
Sr. Director, Trial Design Solutions, Medidata AI

12 PM

Lunch and networking

1 PM

Clinical trial outsourcing and oversight activities – impact analysis of upcoming changes to ICH GCP

• Reviewing relevant sections of draft guideline
• Discussing impact for sponsor organisations

Speakers

Matilda Hugerth
Head of Clinical Development, Xinnate

1:30 PM

Assessing vendor categories to improve governance and accountabilities across clinical trial activities

• Realising the need for diverse internal governance models for different types of vendors based on risk assessment
• Ascertaining the right governance level, expectations and accountability for each type of supplier
• Assessing and identifying ‘grey zone’ vendors in scope for GCP compliance

Speakers

Caroline Sandstroem
Head of Global Clinical Quality, Ferring Pharmaceuticals

2 PM

Afternoon refreshments, networking and prize draw

2:30 PM

ROUNDTABLE SESSIONS

During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

Roundtable 1
Overcoming challenges in clinical supply resourcing
Pernille Hemmingsen, Chief Technology Officer, Adcendo

Roundtable 2
Discussing the role and inclusion of patient relatives in trial reporting and data
Christoffer Johansen, Head, CASTLE - Cancer Late Effect Research, Center for Surgery and Cancer,
Rigshospitalet

Roundtable 3
Considering how to make your clinical trials more environmental and social sustainable

Anna Arnsvik, ESG Sustainability Lead and Nordic Head Neuroscience, Novartis

Speakers

Pernille Hemmingsen
Chief Technology Officer, Adcendo
Christoffer Johansen
Head, CASTLE - Cancer Late Effect Research, Center for Surgery and Cancer, Rigshospitalet
Anna Arnsvik
ESG Sustainability Lead and Nordic Head Neuroscience, Novartis

4 PM

Chairperson’s closing remarks

Speakers

Helen Johansen Blanco
Vice President of Operations, Cytovation ASA

8:45 AM

Chairperson’s opening remarks

Speakers

Catherine Longworth
Editor, Medical Device Network, GlobalData

9 AM

Evolving use of AI and Big Data clinical trials to streamline processes and reduce costs

• Identifying risks and rewards • Reviewing cost savings through use of AI and big data
• Evaluating benefits of using automation and ML technologies to enhance conduction and management of trials
• Highlighting successes of implementing AI and machine learning tools through case study examples

Speakers

Stephen Lutsch
Senior Director Clinical Trial Digital Innovation, Genmab

9:30 AM

Digitalization in clinical trials, a 360 view

  • Presenting on how to digitalize clinical trials in e.g. endpoints, and study designs
  • Highlighting the possibilities that digital trials bring, whilst moving away from the common brick-and-mortar sites
  • Discussing the rigorous standards and scientific integrity required by regulators, whether a regular brick-and-mortar trial or a digital trial
  • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more
  • Major points to consider in designing digital trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind

Speakers

Sverre Bengtsson
Co-Founder, Viedoc

10 AM

Implementing digital health technologies into clinical trials

  • What is Digital Health?
  • How can Digital Health Technologies be used in Clinical Development?
  • Challenges and opportunities
  • Process for selection and implementation

 

Speakers

Viktorija Terebaite
Head of Digital Health Technologies, Lundbeck

10:30 AM

Morning Refreshments & Networking

11 AM

Utilising blockchain technology to improve digital supply chain

• Highlighting benefits of blockchain technology to increase visibility and efficiency in supply
chain
• Considering risks and challenges of blockchain
• Sharing successes and lessons learnt

Speakers

Alexandru Popa
Associate Director, Blockchain for Digital Supply Chain, MSD

11:30 AM

Exploring data management tools and technologies that can assist throughout end-to-end clinical trials

• Discussing technologies and tools available for each stage of the clinical trial
• Outlining the risks and rewards of data management tools and technologies
• Providing case study examples of successes and lessons learnt

Speakers

Alastair Clewlow
Senior Director Data Management Statistical Programming and Digital Solutions, Lundbeck

12 PM

Lunch and networking

1 PM

Fireside Chat: Innovation in clinical trials – a sanity check

Participants who have completed the ATRIUM CPH course “Driving Decentralised Clinical Trials” will
discuss their thoughts on decentralising and using digital health technologies in clinical development.
Which direction are they setting for their organisations, and how will they work with investigators, regulators and vendors moving forward

Speakers

John Zibert
Chief Medical Officer, Coegin Pharma AB
Morten Lind Jensen
VP Of Medical Science, UNION Therapeutics
Christian Born Djurhuus
MD PhD

1:30 PM

Virtual clinical trials and medical devices

• What are they
• Advantages
• Recent Trends
• Likely future trends

Speakers

Andrew Thompson
Director of Therapy Research & Analysis, Medical Devices, GlobalData

2 PM

Afternoon refreshments, networking and prize draw

Streams

Stream one

OUTSOURCING IN CLINICAL TRIALS & CLINICAL OPERATIONS

8:15 AM

Registration and Refreshments

9 AM

Considering the future of DCTs vs hybrid trials, sharing new learnings and pitfalls to avoid

• Considerations for planning and deciding if to run a DCT
• Reviewing the advantages of DCTs from taking the trial to boosting patient recruitment
• Analysing the benefits and constraints of DCTs based on practical experiences
• Sharing learnings from an inspection of an interventional DCT
• Predicting if the future is hybrid trials as they are more realistic and practical compared to full DCTs

Speakers

John Zibert
Chief Medical Officer, Coegin Pharma AB

7:30 AM

Registration and refreshments

8:15 AM

Chairperson’s opening remarks

Speakers

Helen Johansen Blanco
Vice President of Operations, Cytovation ASA

9 AM

Clinical Trial Information System (CTIS) Unveiled: Helping Biotech/Pharma to Streamline Regulatory processes in EU

  • Success stories and lessons learned in CTIS implementation
  • Real-world insights: case studies that unravel the CTIS landscape

Speakers

Diana Filipescu
Business Development Manager, Novotech

9:30 AM

A sponsor perspective on regulatory life with CTIS

• Highlighting the challenges seen so far
• Suggesting ways to work around these challenges
• Proposing thoughts on ways of working with clinical CROs in the future

Speakers

Ann Christine Korsgaard
Vie President Regulatory Affairs, AFYX Therapeutics
Ivana Glatzova
Regulatory Affairs Manager, AFYX Therapeutics

10 AM

Using past trial data to increase the probability of regulatory and technical success

Insights generated from patient-level historical clinical trial (HCT) data have demonstrated meaningful improvements in optimizing protocols, selecting patient subpopulations, and predicting the likelihood of adverse events. This session will explore key ways HCT data helps sponsors, including:

  • How AI and modeling can help you design trial protocols that help predict and mitigate key risks or patient safety events
  • Understanding and selecting patient subpopulations most likely to positively respond to your therapy
  • Using commonly collected lab markers from trial participants and benchmarking against past trial data to predict and mitigate severe adverse events
  • How to generate compelling evidence for market access conversations

Speakers

Tanmay Jain
Sr. Director, Trial Design Solutions, Medidata AI

10:30 AM

Morning Refreshments & Networking

11 AM

Maintaining financial oversight of clinical studies and development to optimise cost savings

• Creating a cost optimized study set-up to work more financially effectively
• Reviewing selection processes and negotiations
• Contracting best practice
• Management and closure of study budget

Speakers

Helen Johansen Blanco
Vice President of Operations, Cytovation ASA

11:30 AM

Delivering oncology studies – challenges and considerations

This session will highlight the trends we have seen over the last 6 months in oncology and describe some of the new developments and issues we have seen and the ways Worldwide are addressing them. The main themes will be based around:
• Project Optimus (FDA requirements for taking 2 doses into phase II)
• Design trends (more push into BOIN)
• Cohort management considerations (especially in CGT studies)
• Treatment modalities (immune-oncology, bi-specific antibodies – biomarkers)

Speakers

Matt Cooper
Executive Director, Therapeutic Strategy Lead, Oncology, Worldwide Clinical Trials

12 PM

Exploring outsourcing models to assess and determine a successful outsourcing strategy

• Reviewing outsourcing models from full outsourcing to functional outsourcing to hybrid outsourcing
• Determining the best outsourcing model: pros and cons and assessment tips to consider
• Operating model: Finding the best service provider fit to address the needs of your company

Speakers

Morten Bang Norgaard
Director Outsourcing, Alligator Bioscience

12:30 PM

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

  • Global Challenges & Industry Trends
  • Research Clinics dedicated to early patient trials
  • Key elements to consider when planning a phase IB/IIA Patient Trial
  • Case Studies

Speakers

Dr. Claudia Hesselmann
Founder and CEO, ARENSIA Exploratory Medicine

1 PM

Lunch and networking

2 PM

Decoding the CRO Choice: An Inside Look at a Biotech’s Modern CRO Selection for Enhanced Clinical Outcomes in Neuroscience

In this session, attendees can expect to:
• Gain a first-hand understanding of the decision-making process behind a biotech's CRO selection, specifically focused on neuroscience
• Uncover the key factors that influence successful CRO collaborations and drive positive clinical outcomes
• Get a glimpse into the evolving landscape of neuroscience research and how CRO collaborations are adapting to modern challenges
• Learn about TFS HealthScience's tailored strategies for enhanced clinical outcomes in neuroscience research

Speakers

Sebastian Turek
Executive Director Internal Medicine & Neuroscience, TFS HealthScience

2:30 PM

Building a flexible and efficient clinical operation organization through a strategic partnership

• Operational challenges running trials globally in medium sized pharma
• Why invest in a strategic partnership between sponsor and CRO?
• Experiences and learnings from both sponsor and CRO
• Site impact and initial reactions
• When honeymoon is over, and the devil is in the details

Speakers

Niels Hoejsgaard Joergensen
Senior Director, Head of Global Site Management, Leo Pharma
Nina Holst
Executive Director Strategic Alliance Management, ICON Strategic Solutions

3 PM

Afternoon refreshments and networking

3:30 PM

Sourcing the right vendor and agreeing clear terms that suit both parties to ensure a successful partnership

• Considerations and best practice for assessing and selecting vendors
• Understanding the budget and scope before signing a contract
• Planning techniques to limit changes once contracts are in place

Speakers

Rikke Winther
Outsourcing Specialist, Camurus AB

4 PM

Seamless Digital Collaboration: Uniting Vendors and Sponsors via eSystems for Transparency and Compliance

• Real-life practice: scenarios with multiple stakeholders – CROs, sponsors, inspectors, and vendors – access, roles, compliance
• Digital Collaboration: communication obstacles, fragmented workflows and data discrepancies among vendors, sponsors, and eSystems
• Demonstrating compliance: digital tools to meet industry regulations and standards
• Transparency: establishing trust, accountability, and fostering effective collaboration
• Adaptability: modern eSystems should integrate for smoother collaboration and efficiency

Speakers

Evgenia Michalcuk-Vrablik
Global Director of Growth, Flex Databases

4:30 PM

Panel Discussion: Reversing the conversation – what the clinical trial industry really wants from its service providers

We’ve all heard pitches from vendor companies telling us what they can do for us, but now it’s time to
reverse the conversation! Hear from the trial industry as they discuss the services they would like to see
from their solution providers, including:
• What they like to see in an outsourced partner organization
• What they would like a partner to know about them / how they work
• What things do they need a partner to do and what they don’t need!
• What things can be best done in house?

Speakers

Lisa Hellstrom
Clinical Program Director, Camurus AB
Ane Jensen
Principal Data Manager, Zealand Pharma
Andreas Cederholm
Senior Corporate Counsel, LEO Pharma
Helen Johansen Blanco
Vice President of Operations, Cytovation ASA

5 PM

Chairperson’s closing remarks

Speakers

Helen Johansen Blanco
Vice President of Operations, Cytovation ASA

END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY FORTREA

2023 Speakers

Select a speaker to learn more

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Svend Ladefoged Nielsen
Clinical Trial Assessor, Danish Medicines Agency

Svend is a trained pharmacist and has been working as a regulatory clinical trial assessor for the past 4 years. He participates in the EU Clinical Trials and Coordination Groups (CTCG) assessors round-table. Furthermore, he has been a board member at the Danish Society of Good Clinical Practice for the past 1.5 years.

 

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Alastair Clewlow
Senior Director Data Management Statistical Programming and Digital Solutions, Lundbeck

Alastair Clewlow is Senior Director for Clinical Data Management, Statistical Programming and Digital solutions at Lundbeck. He has over 25 years of experience in the pharmaceutical and IT Industry, having held positions in Data Management and Clinical Operations at LEO Pharma, Product Strategy and Development in the Oracle Health Sciences Global Business Unit before joining Lundbeck. He graduated from the University of Portsmouth with a BSc (Hons) in molecular biology.

Session Details:

Exploring data management tools and technologies that can assist throughout end-to-end clinical trials

2023-10-25, 11:30 AM

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Caroline Sandstroem
Head of Global Clinical Quality, Ferring Pharmaceuticals

Dr. Caroline Sandström received her PhD in Medical Science from Lund University, Sweden in 2008. She has then worked for Novo Nordisk A/S, Denmark for several years as a pharmacologist driving and executing pharmacological plans supporting pre-clinical projects.

Her interest and enthusiasm for project management, continuous improvement, streamlining initiatives and training was then later beneficially used when she moved into the compliance area managing global improvement and training initiatives within R&D Quality Management System (QMS) including Clinical. For example, she was the project manager for implementing the effective use of Root Cause Analysis in Clinical Development activities but also being highly involved in initiatives related to Quality Culture.  Ferring Pharmaceuticals A/S in Copenhagen, DK. On a daily basis she was involved in discussing, driving compliance and improvement initiatives within both Non-Clinical, Clinical and Pharmacovigilance related activities. She has taken a very active role in contributing to a collaborative and transparent organization where sharing learnings are a main focus area.

From beginning of May 2022, she moved into the position of being Head of the Global Clinical Quality Department being responsible for the QA support of global key stakeholder areas such as Clinical Development, Regulatory Affairs, Pharmacovigilance and Discovery. Her scientifically driven problem-solving skills are used for implementing global cross-functional initiatives, and for supporting and strengthening the harmonization and quality mindset in the organization.

Session Details:

Assessing vendor categories to improve governance and accountabilities across clinical trial activities

2023-10-25, 1:30 PM

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Helen Johansen Blanco
Vice President of Operations, Cytovation ASA

Helén Johansen Blanco has 23 years of clinical development experience, managing Phase I to III clinical trials leading to the successful launch of several oncology products, as Revlimid, Xofigo and a Herceptin biosimilar. She has experience in project management and financial oversight 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, Oncoinvent, Cantargia and Celgene. Currently she holds a position as Vice President of Operations at Cytovation, a small medium sized Norwegian biotech company. She holds a MSc in Biophysics and medical technology and a MBA.

Session Details:

Chairperson’s Opening Remarks

2023-10-25, 8:45 AM

Session Details:

Maintaining financial oversight of clinical studies and development to optimise cost savings

2023-10-24, 11:00 AM

Session Details:

Chairperson’s closing remarks

2023-10-24, 5:00 PM

Session Details:

Chairperson’s closing remarks

2023-10-25, 4:00 PM

Session Details:

Panel Discussion: Reversing the conversation – what the clinical trial industry really wants from its service providers

2023-10-24, 4:30 PM

Session Details:

Chairperson’s opening remarks

2023-10-24, 8:15 AM

Session Details:

Panel discussion: Recognising and further integrating patient centricity and patient perspectives into clinical trials

2023-10-25, 11:30 AM

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Andrew Thompson
Director of Therapy Research & Analysis, Medical Devices, GlobalData

Andrew Thompson is the Director of Therapy and Analysis at GlobalData Healthcare, responsible for data collection and forecasting within the Medical Devices portfolio. Andrew is passionate about developing innovative approaches to the world of medical devices industry research. Andrew joined the team in 2012, following 20 years working within the academic and industry sectors, developing a specialty in advanced diagnostics for infectious disease. With multiple patents in molecular detection technologies, publications’ covering a breadth of topics and leading product development teams, Andrew has established a strong reputation within molecular diagnostics. Having worked on the frontline, Andrew can share a global understanding of the medical device industry, with both a highly developed understanding of the technologies, new and emerging, and of the business dynamics fueling medical device usage in healthcare.

Responsible for the content and direction of global medical device portfolios, GlobalData forward-looking approach generates stimulating analysis and reports, to explore what these changes mean for GlobalData’s clients and their customers.

Session Details:

Virtual clinical trials and medical devices

2023-10-25, 1:30 PM

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John Zibert
Chief Medical Officer, Coegin Pharma AB

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

Session Details:

Considering the future of DCTs vs hybrid trials, sharing new learnings and pitfalls to avoid

2024-10-02, 9:00 AM

Session Details:

Fireside Chat: Innovation in clinical trials – a sanity check

2023-10-25, 1:00 PM

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Christoffer Johansen
Head, CASTLE - Cancer Late Effect Research, Center for Surgery and Cancer, Rigshospitalet

Session Details:

ROUNDTABLE SESSIONS

2023-10-25, 2:30 PM

Session Details:

Panel discussion: Recognising and further integrating patient centricity and patient perspectives into clinical trials

2023-10-25, 11:30 AM

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Viktorija Terebaite
Head of Digital Health Technologies, Lundbeck

Viktorija Terebaite is professional in the field of Digital Health, boasting four years of direct experience in integrating digital tools into clinical trials and heading Digital Health Technologies team in Lundbeck. Viktorija has a unique perspective on digital health innovation, having been involved not just in the academic and clinical realms, but also in the commercial technology sector where she worked on a development of a software product used by over 60 million people globally.

Session Details:

Implementing digital health technologies into clinical trials

2023-10-25, 10:00 AM

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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.

Session Details:

Fireside Chat: Innovation in clinical trials – a sanity check

2023-10-25, 1:00 PM

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Rikke Winther
Outsourcing Specialist, Camurus AB

Rikke Winther has worked in the CRO and Pharmaceutical industry for the past 30 years and has experience from Clinical R&D, Business Development and Contract/Outsourcing Management. She built up and headed up Lundbeck group of Outsourcing & Contracts Management R&D for 19 years and has for the past 4 years worked as an clinical outsourcing specialist for smaller biopharma and covers CRO selection processes as well as contractual, operational and relationship related activities with clinical CROs.

She has in earlier part of her career within bio-analytical research and clinical development in hospital settings as well as project management and business development management at a clinical CRO in Europe and Asia.

Rikke is a former member of the Steering Committee member of the Pharmaceutical Contract Management Group (PCMG) for many years and is a contributing author of the book: “Outsourcing Clinical Development, Gower Publishing Limited”.

 

Session Details:

Sourcing the right vendor and agreeing clear terms that suit both parties to ensure a successful partnership

2023-10-24, 3:30 PM

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Niels Hoejsgaard Joergensen
Senior Director, Head of Global Site Management, Leo Pharma

Session Details:

Building a flexible and efficient clinical operation organization through a strategic partnership

2023-10-24, 2:30 PM

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Stephen Lutsch
Senior Director Clinical Trial Digital Innovation, Genmab

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

Session Details:

Evolving use of AI and Big Data clinical trials to streamline processes and reduce costs

2023-10-25, 9:00 AM

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Catherine Longworth
Editor, Medical Device Network, GlobalData

Catherine Longworth is the Editor for Medical Device Network, covering developments across the medical technology and health tech industry. An experienced writer, Catherine has covered the industry since 2016 and holds a background in biomedical science and journalism. Her previous experience includes reporting for Medtech Insight (Citeline, formerly Informa Pharma Intelligence) and Bioworld (Clarivate).

Session Details:

Chairperson’s opening remarks

2023-10-25, 8:45 AM

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Matilda Hugerth
Head of Clinical Development, Xinnate

Matilda Hugerth (born 1975) holds a Master of Pharmaceutical Science from the Uppsala University and is a registered pharmacist. She has more than 20 years drug of development experience from various roles in both large and small pharmaceutical companies including Lundbeck, UCB, Novartis, Abliva and Amniotics. Matilda Hugerth’s expertise includes clinical development strategies with experience from all clinical phases in the areas of regulatory, project management, clinical operations, clinical quality assurance, and medical affairs.  Matilda Hugerth is a member of the European Federation of GCP Audit working party and is on the steering committee of Medicon Village’s Regulatory Affairs Network.

Session Details:

Clinical trial outsourcing and oversight activities – impact analysis of upcoming changes to ICH GCP

2023-10-25, 1:00 PM

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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.

Session Details:

ROUNDTABLE SESSIONS

2023-10-25, 2:30 PM

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Roel van der Heijde
Facilitator & Trainer, Roel Rotterdam & Patient Experience Association

Roels inspiration: “Be the change you wish to see in the world” - Ghandi

Roel van der Heijde lives in Rotterdam, The Netherlands. He has a MA in International Business, is an international acknowledged NLP trainer, executive team coach and a certified death and grief counsellor.

He is a driven and experienced trainer and facilitator in:

  • - Patient Fear Reduction (for all caregivers);
  • - Team Collaboration;
  • - Vulnerability & Leadership;
  • - Discrimination & Inclusion.

Roels motivation: “Acknowledgement and recognition of the fears and emotions of our patients are the basis for excellent patient experience and patient safety”.

“Working with Groups I experience as thoroughly fascinating and inspiring. In interaction with groups I am every time amazed by the enormous potential of practical knowledge and direct experience that lies hidden in groups and that is so easily overlooked. Herein lies the basis for excellent vulnerable leadership.

Session Details:

Panel discussion: Recognising and further integrating patient centricity and patient perspectives into clinical trials

2023-10-25, 11:30 AM

Session Details:

Integrating diversity in clinical trials to increase drug safety and health equity

2023-10-25, 10:00 AM

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Morten Bang Norgaard
Director Outsourcing, Alligator Bioscience

Specialist with outsourcing experience from all aspects of the value chain, from preclinical work and drug manufacturing through to late-stage clinical development activities and post-marketing non-interventional studies. Morten holds over 20 years of industry experience from a number of small- and mid-sized pharma and biotech companies and for the past decade he has been working in GCP and GMP environments with primary focus on handling of outsourcing activities for phase 1-3 clinical program development activities. Morten’s primary roles have included contract negotiation and -execution, as well as vendor management within outsourcing settings, international project- and relationship management as well as follow-up and evaluation of global collaborations within all phases of clinical development.

Session Details:

Exploring outsourcing models to assess and determine a successful outsourcing strategy

2023-10-24, 12:00 PM

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Ann Christine Korsgaard
Vie President Regulatory Affairs, AFYX Therapeutics

Session Details:

A sponsor perspective on regulatory life with CTIS

2023-10-24, 9:30 AM

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Ane Jensen
Principal Data Manager, Zealand Pharma

Ane H. Jensen (MA)

Passionate about new technology and their ability to change the way we conduct clinical trials. Has worked at different positions in Novo Nordisk between 2008 and 2020. Since 2020 employed at Zealand Pharma. Previous experiences include RTSM, training, process improvements, logistics, clinical trials supplies and eLearning development.

Session Details:

Panel Discussion: Reversing the conversation – what the clinical trial industry really wants from its service providers

2023-10-24, 4:30 PM

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Alexandru Popa
Associate Director, Blockchain for Digital Supply Chain, MSD

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Utilising blockchain technology to improve digital supply chain

2023-10-25, 11:00 AM

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Lisa Hellstrom
Clinical Program Director, Camurus AB

Lisa holds a M.Sc degree in Pharmacy from Uppsala University and has more than 20 years of experience within Clinical Operations, currently working as a Clinical Program Director at Camurus AB in Lund, Sweden. Here she is responsible for the Clinical Development of one of the products in pipeline, currently in Phase 3 in neuroendocrine tumors. She is also partof the Clinical Development management team and responsible for a group of Clinical Trial Managers working on various programs. Prior to joining Camurus in 2019, Lisa worked 10 years at Lundbeck HQ within CNS diseases.

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Panel Discussion: Reversing the conversation – what the clinical trial industry really wants from its service providers

2023-10-24, 4:30 PM

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Dr. Claudia Hesselmann
Founder and CEO, ARENSIA Exploratory Medicine

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

Session Details:

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

2023-10-24, 12:30 PM

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Matt Cooper
Executive Director, Therapeutic Strategy Lead, Oncology, Worldwide Clinical Trials

Matt Cooper is the Executive Director, Therapeutic Strategy Lead, Oncology and has 25 years of experience in the life science industry conducting clinical trials across all phases. His experience spans roles at sponsors, sites, and the NHS, and he has extensive experience in site management and expanded use of oncology therapies. He is passionate about building effective relationships between industry stakeholders to drive innovation and patient access.

Session Details:

Delivering oncology studies – challenges and considerations

2023-10-24, 11:30 AM

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Bryan McDowell
VP, eCOA Science & Consulting, Clario

In his role as VP, eCOA Science & Consulting, Bryan McDowell brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug & device development programs. Bryan is a thought leader and recognized strategist & visionary and continues to influence, drive and deliver on the pharma-wide industry necessity for smarter drug & device development and life cycle management.

Session Details:

The importance of scientific validation and data integrity when using accessibility features

2023-10-25, 9:30 AM

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Nina Holst
Executive Director Strategic Alliance Management, ICON Strategic Solutions

Nina Holst, Executive Director, is responsible for Strategic Alliance Management of global oversight, delivery, and continuing improvement of appointed ICON Strategic Solutions (ISS) established programs. Nina has the strategic program oversight of the LEO FSP (Functional Service Provision) program delivery.

Nina has more than 20 years’ experience from the sourcing and recruitment industry with the last 15 years focused on the Life Science and CRO industry. With her commercial background, she brings predominantly the strength in developing global business models together with successful clients and passionate teams. Through her executive leadership sha has implemented regional, and global business units, growing, and delivering strategic resourcing business to success through strategic alliance partnerships.

ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services. Through combined functional, operational, and talent expertise, ICON offers FSP models that provide cost-savings, clinical expertise and significantly improve business performance.

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Building a flexible and efficient clinical operation organization through a strategic partnership

2023-10-24, 2:30 PM

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Sebastian Turek
Executive Director Internal Medicine & Neuroscience, TFS HealthScience

With 15 years in the pharmaceutical research industry, Sebastian has gained comprehensive experience in both clinical and project management. He has worked in various roles, from CRA to Executive Director, specializing in neurodegenerative disorders, particularly Alzheimer's and Parkinson's. His leadership has been instrumental in screening over 10,000 subjects in studies related to these conditions.

Beyond neurology, Sebastian's background includes work in psychiatry, oncology, ophthalmology, cardiology, and other internal medicine areas. He has managed studies globally, covering Europe, North and Latin Americas, Asia—including challenging markets like China and Japan—and Australia.

Sebastian holds a PharmD degree in pharmacy from Wroclaw Medical University, Poland.

Session Details:

Decoding the CRO Choice: An Inside Look at a Biotech’s Modern CRO Selection for Enhanced Clinical Outcomes in Neuroscience

2023-10-24, 2:00 PM

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Sonia Ben Hamida
Head of Special 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).

Social Links:

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Pierre-Gaultier Delheid
Head of Clinical Vendor Management, UCB Pharma

As Head of Clinical Vendor Management at UCB, Pierre-Gaultier Delheid leads the vendor strategy aiming to design and manage a strong external vendor network. He makes a point of honor to build sustainable and strong alliances to overcome clinical challenges in a flexibility, agile, reliable, green and cost-efficient way. In close collaboration with other UCB business units, he drives a culture of partnership to change the game to a better outcome.

Engineer by background, his experience in bio-pharma industry in CDMO as well as in Sponsor companies and his business DNA gained during an international EMBA (Hult, US/UK) led him to build strong expertise in the field of operation and business optimization as well as building strong partnerships.

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Jasmin Hellwig
Associate Director Vendor Relationship Management, MSD

Jasmin Hellwig graduated from the Applied Institute of Science in Muttenz, Switzerland, 2005 in Chemistry and joined Inovalab AG the same year as Study Director. In her various roles, including Business Development, Deputy of the General Management and Deputy of Test Facility Management, she enjoyed facilitating success by supporting processes, which meet high quality and business need. Since 2010 Jasmin is part of the Global Clinical Supplies department of MSD, former Schering Plough. She started as Project Lead coordinating packaging of clinical supplies and supporting integration projects. In September 2014, Jasmin joined the Comparator Sourcing and Planning group, supporting Clinical Trials by purchasing comparators on time from various sources. Since 2020, she fosters the Relationship Management group.

Besides various hobbies she cultivates, particularly horses and singing, she graduated as MSc in Management from the Lorange Business School, Zurich, Switzerland, in 2015.

 

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Tanja Villumsen
Clinical Supply Specialist, Stem Cell R&D, Novo Nordisk
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Linda Collstedt
Senior Clinical Supply Program Lead, AstraZeneca
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Susan Suchdev
Chief Operating Officer, Annexin Pharmaceuticals
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Ivana Glatzova
Regulatory Affairs Manager, AFYX Therapeutics

Session Details:

A sponsor perspective on regulatory life with CTIS

2023-10-24, 9:30 AM

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Anna Arnsvik
ESG Sustainability Lead and Nordic Head Neuroscience, Novartis

Anna Arnsvik, an ESG Sustainability Lead, boasts a three-decade life science career within company as Novartis, UCB and Kabi-Pharmacia. Her fusion of innovation and sustainable business strategies has helped her to become an international certified ESG ISB® Advisor. Anna's influence extends to roles in the JUC Sustainability and ESG network, MIAN Minds AB, and various volunteering endeavors

Session Details:

ROUNDTABLE SESSIONS

2023-10-25, 2:30 PM

Session Details:

Considering sustainability in clinical trials to improve ESG responsibilities

2023-10-25, 11:00 AM

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Andreas Cederholm
Senior Corporate Counsel, LEO Pharma

Session Details:

Panel Discussion: Reversing the conversation – what the clinical trial industry really wants from its service providers

2023-10-24, 4:30 PM

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Tanmay Jain
Sr. Director, Trial Design Solutions, Medidata AI

Tanmay is a Senior Director at Medidata Acorn AI. He has 10+ years of experience advising Biopharmas and Biotechs on data and analytics across R&D, medical affairs, and commercial functions. He is passionate about getting life-saving and innovative medicines to patients faster by running more efficient clinical trials. At Medidata, Tanmay co-leads clinical data and analytics solutions and focuses on using Medidata’s database of past clinical trials to solve complex problems in clinical development. Prior to joining Medidata Acorn AI, Tanmay was a management consultant at McKinsey and Company where he co-led the advanced analytics practice in North America. 

Session Details:

Using past trial data to increase the probability of regulatory and technical success

2023-10-24, 10:00 AM

Session Details:

Panel discussion: Recognising and further integrating patient centricity and patient perspectives into clinical trials

2023-10-25, 11:30 AM

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

As Senior Director of Product Strategy & Partnerships, Libbi plays a pivotal role in steering 4G’s success by overseeing two critical domains: product strategy and partnerships management. Within the realm of product strategy, Libbi is dedicated to ensuring that 4G’s product portfolio not only meets but exceeds customer expectations while remaining at the forefront of dynamic market trends. In addition, staying close to market trends allows for Libbi to engage and forge impactful partnerships with organisations that align harmoniously with our business objectives.

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Benjamin Etschmann
Senior Forecasting Services Lead, 4G Clinical,

Benjamin has spent more than 10 years in clinical trial supply management in various roles, including operational trial supply logistics management and trial supply setup management. However, his primary focus has been in IVRS/IRT/RTSM management and demand forecasting using dedicated stochastic simulation tools. In his current role, he consults clients and internal teams on probabilistic site and depot demand forecasting in IVRS/IRT/RTSM.

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Jan Pieter Kappelle
VP of Clinical Services at Inceptua

Jan Pieter (JP) Kappelle, VP of Clinical Services at Inceptua, is a Supply Chain Executive with 30 years of industry experience, of which 15 years were spent leading clinical trial supplies departments in global pharmaceutical and biotech companies.

Trained as an Electronic and Quality Engineer, JP has a strong financial background and brings a methodical, analytical and process-oriented approach to his work. Coupled with his MBA and MSc in Supply Chain Management, JP has the unique ability to switch between strategic and operational discussions.

JP also serves as the Global Clinical Supplies Group (GCSG) Master of Ceremony where he connects clinical supply professionals for the purposes of education,
knowledge sharing and the development of industry best practices.

 

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Diana Filipescu
Business Development Manager, Novotech

Diana Filipescu is from Bucharest, România. Diana has a regulatory background, with 11 years of experience in clinical trials. She worked in Regulatory for almost 8 years and then transitioned from Regulatory Line Manager to Business Development Manager. She has earned two BSc., one in Management and the other one in Law. In addition, she also has a MSc. in Health Management. She is very passionate about finding new ways to improve the healthcare industry by ensuring compliance with all applicable laws and regulations. Her goal is to make sure that all medical products are safe for consumers.

Session Details:

Clinical Trial Information System (CTIS) Unveiled: Helping Biotech/Pharma to Streamline Regulatory processes in EU

2023-10-24, 9:00 AM

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Evgenia Michalcuk-Vrablik
Global Director of Growth, Flex Databases

Evgenia holds several degrees in International Economics and MBA in Digital Transformation, she is in top management of eSystem provider Flex Databases, one of the leading European software providers for Life Sciences.

She has been in clinical research for 15+ years, 8 years in the company management, participated in digitalization of 60+ companies 15 to 50 000 employees in the US, Europe, and Asia.

Session Details:

Seamless Digital Collaboration: Uniting Vendors and Sponsors via eSystems for Transparency and Compliance

2023-10-24, 4:00 PM

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Sverre Bengtsson
Co-Founder, Viedoc

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:

Digitalization in clinical trials, a 360 view

2023-10-25, 9:30 AM

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