13th Annual Outsourcing in Clinical Trials Nordics 2025

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

21 - 22

October

2025
  • Clarion Hotel & Congress Copenhagen Airport, Denmark
  • Complimentary
  • Why attend?
  • Agenda
  • OCT Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Why partner?
  • Contact Us
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2025 Sponsors Included:

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Company Information

ARENSIA Exploratory Medicine, a German-based company, is a leader in “first-in-patient” Phase IB and II/Proof-of-Concept clinical trials across a wide range of disease areas. With 14 proprietary research clinics and cutting-edge Phase I infrastructure, ARENSIA accelerates the early detection of efficacy signals for new therapies at an unparalleled speed. Its streamlined, highly efficient approach reduces patient recruitment time and costs by over 50% compared to conventional trial sites, which are often overcrowded and understaffed. This exceptional performance has resulted in a 93% repeat business rate and robust growth through collaborations with top pharmaceutical companies, biotechs, and global CROs. Headquartered in Düsseldorf, ARENSIA operates with a team of 600 professionals across 8 countries.

Company Website

To learn more, please visit our website - http://www.arensia-em.com/

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Company Information

Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 35,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,300 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

Company Website

To learn more, please visit our website - https://www.medidata.com

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Company Information

Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

Company Website

To learn more, please visit our website - https://www.fortrea.com/

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Company Information

TFS HealthScience is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Bringing together nearly 700 professionals, we deliver tailored clinical research services in more than 40 countries. TFS supports customers with comprehensive solutions including full clinical development services, strategic and flexible resourcing. In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. Our mission is to bring treatments to patients faster. For more information, please visit www.tfscro.com.

Company Website

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

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Company Information

Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

Company Website

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

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    Why attend?

    This is the unmissable event that the pharmaceutical, biotechnology, and medical device communities need to come together and discuss strategies for operational success in clinical trials. Combining our OCT, CTS and Medical Devices events, this is the perfect platform for professionals from across a range of clinical trial functions to meet, network, and hear about latest developments

     

    WHAT TO EXPECT FOR 2025?

    200+

    Attendees

    		30+

    Exhibitors

    		30+

    Speakers
    200+

    Attendees

    		30+

    Exhibitors
    30+

    Speakers

    Testimonials

    See What It's All About

    Agenda

    • 21 Oct 2025
    • 22 Oct 2025
    Expand All

    Streams

    Stream one

    OUTSOURCING IN CLINICAL TRIALS & CLINICAL OPERATIONS

    7:30 AM

    Registration and refreshments

    8:15 AM

    Chairperson’s opening remarks

    Speakers

    8:30 AM

    Making the EU more attractive for clinical trials: how can we achieve this?

    • Sharing issues and feedback collated regarding difficulties of trials in EU
    • Discussing potential solutions to improve the appeal of running trials in EU
    • Looking at how and when these solutions could be implemented

    Speakers

    Lene Grejs Petersen
    Senior Adviser, Danish Medicines Agency

    9 AM

    Reserved for Replior

    9:30 AM

    Panel Discussion: Discussing patient centric initiatives to enhance patient engagement in clinical trials

    • Considering touchpoints of when and how we can reach patients
    • Collating patient input early to incorporate their perspective in protocols and trial design
    • Utilizing digitalization and technology in patient communications

    Speakers

    Helen Johansen Blanco
    Chief Operating Officer, Node Pharma
    Catharina Östberg
    Head of Site Management Nordics, Bayer
    Lill-Brith Wium von Arx
    RWE Lead Northern European Hub, Eli Lilly and Company
    Merete Schmiegelow
    Patient Advocate

    10 AM

    Reserved for ARENSIA

    10:30 AM

    Morning Refreshments & Networking

    11 AM

    Patient Perspective: Considering patient engagement in medicines R&D, approvals and life cycle

    From a patient advocate perspective, Merete will discuss the why, what, when and how of patient engagement

    Speakers

    Merete Schmiegelow
    Patient Advocate

    11:30 AM

    Reserved for Fortrea

    12 PM

    Outsourcing of pharmacovigilance: risks and implications on the global PV system

    • Global and local PV set-up
    • Vendor interactions and mutual agreement on expectations
    • Potential impact on continued safety surveillance and risk management
    • Compliance risks to PV system

    Speakers

    Kira Hammershoi
    Director EU/UK QPPV, LEO Pharma

    12:30 PM

    Reserved for Novotech

    1 PM

    Lunch and networking

    2 PM

    Implementing FDA’s Project Optimus and reviewing the impact on trials

    • Selecting the right dose in line with FDA guidance
    • Sharing implementation methods within study designs and protocols
    • Highlighting challenges and successes

    Speakers

    Karin Nordbladh
    Director Clinical Operations, Alligator Bioscience

    2:30 PM

    Reserved for TFS

    3 PM

    Panel Discussion: Navigating updated GCP guidelines: ICH E6 (R3)

    • Highlighting the key changes in ICH E6 (R3) and their practical implications for clinical trial conduct
    • Exploring approaches to implementing new guidelines in diverse trial settings
    • Analysing challenges, opportunities, and interpretations associated with ICH E6 (R3)

    3:30 PM

    Afternoon refreshments, networking and prize draw

    4 PM

    Beyond the spreadsheet: a practical model to align budget, milestones & cash flow

    • Track budgets in sync with timelines using a simple Excel-based model
    • Forecast cash flow and spot issues early — no finance degree needed
    • Boost transparency between sponsors and vendors, reduce surprises

    Speakers

    Cornelia Baumgartner
    Head of Clinical Operations, T-CURX

    4:30 PM

    Reserved for Syneos Health

    5 PM

    Sharing latest updates on SweTrial initiative to enhance clinical trials in Sweden

    • Creating a national partnership to enhance conditions for clinical trials
    • Collaborating between healthcare sector, academia, and the pharmaceutical industry to make Sweden more competitive in conducting clinical trials
    • Streamlining clinical study systems to improve efficiency and accessibility of clinical trials

    Speakers

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    Helen Johansen Blanco
    Chief Operating Officer, Node Pharma

    END OF DAY 1 AND NETWORKING DRINKS

    Streams

    Stream one

    OUTSOURCING IN CLINICAL TRIALS & CLINICAL OPERATIONS

    Stream two

    CLINICAL TRIALS TECHNOLOGY & INNOVATION

    8:15 AM

    Registration and refreshments

    8:30 AM

    Chairperson’s Opening Remarks

    Speakers

    Helen Johansen Blanco
    Chief Operating Officer, Node Pharma

    8:45 AM

    Unravelling regulatory complexity of combined studies – update from the COMBINE programme

    • Overview of the COMBINE programme and ongoing projects
    • Framework of the COMBINE ‘All in One coordination’ pilot procedure to optimise

    Speakers

    Päivi Susanna Worsøe
    Project Manager and Special Adviser in Clinical Trials, Danish Medicines Agency

    9:15 AM

    Transforming Sponsor-CRO Partnerships

    This interactive session will delve into the challenges and opportunities in creating good sponsor CRO partnerships, with a focus on building stronger stakeholder relationships, enhancing transparency, and managing teams effectively through shared values, objectives and KPI's

    Speakers

    Claudia Krag
    Director Clinical Operations, Novo Nordisk
    Nicholas Alp
    Chief Medical Officer, Clinical ink

    9:45 AM

    Negotiation skills during CRO and vendor selection process

    • Paying for what you need and not more
    • Ensuring that you are discussing with the right-fit-partner from the start
    • Assessing contract set-ups: milestone payments vs hourly rate, including bonus/penalty fees or opting for fixed price
    • Setting up the study from the beginning, minimizing cost

    Speakers

    Helen Johansen Blanco
    Chief Operating Officer, Node Pharma

    10:15 AM

    Morning Refreshments & Networking

    10:45 AM

    Clinical trials in Japan experience: from vendor selection to J-NDA approval

    • Selecting a CRO in Japan
    • Discussing PMDA negotiations, regulatory landscape and inspection readiness
    • Sharing challenges and benefits of conducting trials in Japan
    • Overcoming initial doubts and providing lessons learned from partnerships between sponsor and CRO in Japan

    Speakers

    Lisbet Groes
    Associate Director Clinical Operations, Ascendis Pharma

    11:15 AM

    From setback to success: The art of clinical trial rescue

    In the complex world of clinical research, even meticulously planned trials can face unexpected hurdles that threaten to derail progress and encounter obstacles beyond the capabilities of a small-scale Clinical Research Organization (CRO). When studies falter, a well-executed rescue strategy with an experienced global CRO becomes crucial. Drawing from Parexel's extensive rescue-trial experience, this presentation unveils the blueprint for successful clinical trial transitions, focusing on four key phases:

    • Strategic Initiation & Planning - establishing a robust framework and standardized processes
    • Comprehensive Preparation & Due Diligence - ensuring stakeholder alignment on transition plans and timelines - Conducting thorough documentation review and gap analysis
    • Adaptive Execution & Transfer - How to operationalize a study transfer - Anticipating challenges and employing agile governance for real-time course corrections
    • Effective Closure & Delivery - defining clear transition thresholds and success metrics  - Ensuring continuity and maintaining data integrity throughout the process

    Speakers

    Suzanne McNally
    Executive Director in Portfolio Management, Parexel

    11:45 AM

    Panel Discussion: Choosing an outsourcing model: FSO vs FSP vs inhouse

    • Weighing up pros and cons of different outsourcing models: which is best for your trial?
    • When is mixing and matching better than fully outsourcing or keeping trials fully in house?
    • Developing an outsourcing strategy with limited resources
    • Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?
    • How do strategic alliances impact this decision?

    Speakers

    Helen Johansen Blanco
    Chief Operating Officer, Node Pharma
    Elisabeth Ahlmann-Ohlsen
    Director Quality Assurance, Hemispherian AS
    Cornelia Baumgartner
    Head of Clinical Operations, T-CURX

    12:30 PM

    Lunch and networking

    1:30 PM

    Preparing for close of study and commercialisation as a small biotech: submitting an NDA

    • Planning ahead: aligning clinical trial timelines with regulatory expectations
    • Discussing challenges in data readiness and submissions and how to overcome them
    • Considering pricing, reimbursement and scaling up production strategies
    • Transitioning from clinical trial to market: best practice tips
      Session reserved

    2 PM

    Reserved for Biorce

    2:30 PM

    Sharing insights on ethical considerations for clinical trials

    • Looking at informed consent: requirements and challenges
    • Balancing risks with anticipated benefits
    • Considering diversity and accessibility
    • Complying with regulatory ethical review processes

    Speakers

    Elisabeth Ahlmann-Ohlsen
    Director Quality Assurance, Hemispherian AS

    3 PM

    Afternoon refreshments, networking and prize draw

    3:30 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 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

    Roundtable 1
    Progressing your planning as a small biotech whilst in funding mode
    Judi Simonsen, CEO and Co-Founder, MERODZ

    Roundtable 2
    Selecting and managing sites: key considerations
    Catharina Östberg, Head of Site Management Nordics, Bayer

    Roundtable 3
    Considering sustainability throughout the clinical supply chain: where can we improve?
    Kamal Amin, Head of Supply Chain Management, Galderma

    4:30 PM

    End of conference

    8:30 AM

    Chairperson’s opening remarks

    Speakers

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

    8:45 AM

    Transforming clinical data management with AI: challenges, solutions, and ROI

    • Tapping into the unprecedented opportunities the integration of Artificial Intelligence (AI) offers in the rapidly evolving landscape of clinical research
    • Implementing AI tools to enhance the efficiency, accuracy, and compliance of clinical data management
    • Exploring the dual role of AI: Generating and reviewing clinical documents, addressing the critical challenges and proposing a robust framework for implementation

    Speakers

    Jonathan Crowther
    Former Head of Predictive Analytics, Pfizer

    9:15 AM

    Reserved for event sponsor

    9:45 AM

    Improving clinical supply chain with digital display labelling

    • Enhancing real-time data visibility and accuracy
    • Streamlining compliance and regulatory adherence
    • Boosting flexibility and efficiency in clinical supply management

    Speakers

    Alexander Debets
    Lead Clinical Supply Innovation, Former MSD

    10:15 AM

    Morning Refreshments & Networking

    10:45 AM

    Discussing importance and benefits of data-enabled clinical trial recruitment

    • Considering types of data that can be utilized to assist with patient recruitment challenges
    • Incorporating data findings into development of eligibility criteria
    • Using secondary health data to identify sites and patient cohorts
    • Complying with ethical and regulatory requirements of data usage

    Speakers

    Lill-Brith Wium von Arx
    RWE Lead Northern European Hub, Eli Lilly and Company
    Hanne Joergensen
    Clinical Trial Lead Northern European Hub, Eli Lilly and Company

    11:15 AM

    Transform procurement: Harnessing AI for strategic sourcing

    In the rapidly evolving landscape of procurement, staying ahead of the curve is more critical than ever.

    This session will explore the transformative role of Artificial Intelligence (AI) in revolutionizing clinical business operations. Attendees will gain insights into how AI is reshaping strategic sourcing, vendor management, and cost optimization, enabling organizations to achieve unprecedented levels of efficiency and agility.

    Through real-world use cases we’ll delve into AI-driven tools that enhance decision-making, streamline workflows, and predict study cost with unparalleled accuracy. Whether you’re an outsourcing manager, a clinical operations or R&D finance professional, this session will equip you with the knowledge and strategies needed to harness the power of AI for smarter, more effective procurement leveraging Clinical Maestro powerful engine.

    Speakers

    Anca Copaescu
    Chief Executive Officer, Strategikon Pharma

    11:30 AM

    Reserved for event sponsor (tech spotlight)

    11:45 AM

    Panel Discussion: Clinical trial innovation: insights into new technology and strategy

    • Incorporating digitalization and new technologies into your clinical trials
    • platforms: improving communication and efficiency among stakeholders
    • Success stories, transformative case studies and key takeaways

    Speakers

    Alexander Debets
    Lead Clinical Supply Innovation, Former MSD
    Tankred Ott
    Senior Data Scientist – AI & Analytics CoE, Novo Nordisk
    Dr. Claudia Hesselmann
    PhD – Founder & CEO, ARENSIA Exploratory Medicine PhD，创始人兼 CEO, ARENSIA Exploratory Medicine

    12:30 PM

    Lunch and networking

    1:30 PM

    Lessons learned from implementing Digital Health Technologies into clinical trials

    • Examples from integrating DHTs, such as wearable devices, into clinical trials
    • Device burden and patient-related factors
    • Challenges faced by sites during DHT implementation

    Speakers

    Charlotte Sauter
    Principal Digital Health Scientist, Lundbeck

    2 PM

    Reserved for event sponsor

    2:30 PM

    Session TBC

    Speakers

    Tankred Ott
    Senior Data Scientist – AI & Analytics CoE, Novo Nordisk

    Speakers

    Select a speaker to learn more

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    Karin Nordbladh
    Director Clinical Operations, Alligator Bioscience

    Karin has a MSc in Pharmacy and Pharmaceutical Biosciences from Uppsala University in Sweden.  She is passionate about drug development that aims to meet unmet medical needs. Karin has 19 years of experience in life science industry and has worked for Astra Zenica, McNeil AB, a Johnson&Johnson company, and currently works at Alligator Bioscience AB since 4 years as Dir ClinOps. Alligator is a company specialized in immune oncology drug development.

    Session Details:

    Implementing FDA’s Project Optimus and reviewing the impact on trials

    2025-10-21, 2:00 PM

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    Dr. Claudia Hesselmann
    PhD – Founder & CEO, ARENSIA Exploratory Medicine PhD，创始人兼 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:

    Panel Discussion: Clinical trial innovation: insights into new technology and strategy

    2025-10-22, 11:45 AM

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    Lisbet Groes
    Associate Director Clinical Operations, Ascendis Pharma

    Lisbet Groes, Ph.D., e*MMBS, is Associate Director, Clinical Operations at Ascendis Pharma. With over 25 years in clinical development, she brings deep expertise in global trial execution, including leading Phase III programs in Japan. Lisbet has hands-on experience with CRO selection, PMDA interactions, trial execution, and inspection readiness. She is known for her strategic mindset, cross-cultural collaboration, and ability to foster high-performing sponsor-CRO partnerships.

    Session Details:

    Clinical trials in Japan experience: from vendor selection to J-NDA approval

    2025-10-22, 10:45 AM

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    Catharina Östberg
    Head of Site Management Nordics, Bayer

    Session Details:

    Panel Discussion: Discussing patient centric initiatives to enhance patient engagement in clinical trials

    2025-10-21, 9:30 AM

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    Luiz Barberini
    Head of External Manufacturing, Latin America, Bayer
    • Over 25 years’ experience in Logistics, Supply Chain, Procurement and Demand Planning areas.
      Solid knowledge and experience in the whole S&OP process and its KPI´s inter-relationships with stakeholders
    • Demand Planning process management - pre-S&OP, with Sales, Marketing, Trade Marketing, Industrial Planning and Finance and customized tool design for such process
    • Management skills: experience with multidisciplinary and international teams (Brazil / Latin America / US).
    • Experience in S&OP, 3PL and Supply Chain Organization projects' implementation
    • Strong experience with Pharmaceutical and Consumer companies and Brazilian distribution model / 3PL contracts
    • Solid team management skills, as well as Customer Service relationship and management
    • Teacher for major Post Graduation Schools - Demand Planning and Procurement/Negotiation areas

    CSCP & CPIM APICS. Logistics & Supply Chain driven strategy. Distribution & Logistics, Demand Planning, S&OP, Procurement and Export experiences, focusing on Business necessities through effective leadership.

    Working as External Manufacturing Operations Manager Latin America at Bayer, in charge for external partners for CHC Division. Previously as Relationship Associated Director at Merck , Logistics Manager at Takeda/Nycomed Pharma, focusing on demand management, planning and distribution activities. Also has worked as Pfizer´s Logistic Manager and EFD´s Supply Chain Manager. Souza Cruz´s Procurement Manager and Rhodia's Logistic Supervisor.

    Specialties: Logistics, Supply Chain, Materials, Procurement , Services, Negotiation, 3PL contracts, S&OP, Demand Planning

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    Nicholas Alp
    Chief Medical Officer, Clinical ink

    Session Details:

    Transforming Sponsor-CRO Partnerships

    2025-10-22, 9:15 AM

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    Lene Grejs Petersen
    Senior Adviser, Danish Medicines Agency

    Session Details:

    Making the EU more attractive for clinical trials: how can we achieve this?

    2025-10-21, 8:30 AM

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    Päivi Susanna Worsøe
    Project Manager and Special Adviser in Clinical Trials, Danish Medicines Agency

    Session Details:

    Unravelling regulatory complexity of combined studies – update from the COMBINE programme

    2025-10-22, 8:45 AM

    View In Agenda
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    Lill-Brith Wium von Arx
    RWE Lead Northern European Hub, Eli Lilly and Company

    Session Details:

    Panel Discussion: Discussing patient centric initiatives to enhance patient engagement in clinical trials

    2025-10-21, 9:30 AM

    Session Details:

    Discussing importance and benefits of data-enabled clinical trial recruitment

    2025-10-22, 10:45 AM

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    Hanne Joergensen
    Clinical Trial Lead Northern European Hub, Eli Lilly and Company

    Session Details:

    Discussing importance and benefits of data-enabled clinical trial recruitment

    2025-10-22, 10:45 AM

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    Nagaraja “Sri” Srivatsan
    CEO, Endpoint Clinical

    Srivatsan has over thirty years of experience in growing businesses in the Digital, Data, AI, Analytics, IT, Product and Operations management areas across several industry verticals.

    Currently, Srivatsan serves as the CEO of Endpoint Clinical, a global leader in Randomization and Trial Supply Management (RTSM). He is spearheading the next phase of growth, strengthening Endpoint’s position as a trusted partner in accelerating clinical trials and bringing innovative treatments to patients. Additionally, he advises companies, helping them unlock exponential growth opportunities.

    Previously as Chief Digital Officer for R&DS Technologies, IQVIA he was responsible for driving growth and leading product development and operations of R&DS Technologies.

    Prior to that, as Chief Growth Officer for EXL he oversaw the Sales & Marketing, Consulting and Strategy functions helping EXL become a Strategic digital transformation partner to its customers.

    Before that, as Venture partner, he grew Cognizant’s foray into Digital & Platforms. He identified, incubated and grew innovative digitally enabled ventures across the Healthcare & Life Sciences value chain. In addition, he significantly grew the new markets portfolio for Cognizant by penetrating the Government & Energy & Utilities sector globally. He was a member of the Executive Leadership Team.

    Early on, He was responsible for growing Cognizant’s Life Sciences business unit to be a Tier one provider. He has worked with the many of the top 50 global Life Sciences organizations providing them comprehensive end-to-end consulting, analytics, business process and IT solutions. He has provided strategic leadership in helping life sciences organizations leverage technology and the global delivery model to effectively transform their businesses.

    Srivatsan was recognized as the top 100 most inspiring people in the life sciences industry award by PharmaVOICE publication and has been regularly quoted in national and global magazines on digital, Automation, Analytics, AI, healthcare & life sciences related topics. He has been a speaker in various seminars, webcasts and conferences on Healthcare and Life sciences domain, Business Transformation, Business & Technology/Outsourcing, Enterprise Integration and Digital Transformation topics.

    Srivatsan holds a Bachelors in Electrical Engineering from B.I.T.S. in India and a Masters degree in Electrical Engineering & Computer Science from Northwestern University. He also completed graduate studies in Telecommunications Policy and Management at Northwestern University.

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    Kamal Amin
    Head of Clinical Supplies Management, Galderma

    Kamal is a trained Chemist who decided to pursue a career in supply chain management and quality. In this role, he was tasked to supervise commercial and clinical trial products. Kamal has worked in the pharmaceutical and device industries for over 15 years in different size organisations ranging from large multinational to small virtual companies. He is currently leading a global team at Galderma to develop an integrated clinical supply chain organisation within the company.

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    Sonnika Lamont
    Senior Analyst, GlobalData

    Sonnika Lamont, MRes, is a Clinical Trials Senior Analyst at GlobalData, where her primary responsibilities include the review and update of clinical trial information presented on GlobalData’s Trials Intelligence Platform, the production of analytical reports and insights, testing database releases, and providing comprehensive conference coverage. She has a firm understanding of all aspects of clinical research, and the drug development process. Prior to joining GlobalData, Sonnika worked as a Clinical Trials Research Assistant at University College London’s Cancer Institute. Sonnika holds a Master of Research in Drug Design with a concentration in rare diseases from University College London, and a Bachelor of Science in Biochemistry from Nottingham Trent University.

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    Elisabeth Ahlmann-Ohlsen
    Director Quality Assurance, Hemispherian AS

    Session Details:

    Sharing insights on ethical considerations for clinical trials

    2025-10-22, 2:30 PM

    Session Details:

    Panel Discussion: Choosing an outsourcing model: FSO vs FSP vs inhouse

    2025-10-22, 11:45 AM

    View In Agenda
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    Kira Hammershoi
    Director EU/UK QPPV, LEO Pharma

    Session Details:

    Outsourcing of pharmacovigilance: risks and implications on the global PV system

    2025-10-21, 12:00 PM

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    Malene Gantzhorn Pedersen
    Senior Clinical Supply Specialist, Lundbeck

    Malene holds a MSc in Pharmacy from the Faculty of Pharmaceutical Sciences in Copenhagen. With over 17 years of experience in clinical supply management at Lundbeck, she has developed a deep expertise in vendor management, project management, and process optimization. Currently serving as a Senior Clinical Supply Specialist, she leads strategic initiatives and global collaborations to enhance clinical supply processes.

    In addition to her extensive professional experience, she is an ICF certified Coach from Mindjuice Academy, specializing in powerful communication, systemic thinking, and personal leadership. She holds a Master Coach certification in Team Coaching and Leadership, equipping her with the skills to transform team dynamics and inspire collective success.

    Malene is passionate about enhancing team collaboration across organizational barriers to improve clinical trials, project progress, and ultimately benefit patients with unmet needs.

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    Charlotte Sauter
    Principal Digital Health Scientist, Lundbeck

    Charlotte Sauter is a dedicated professional in digital health. As a Principal Digital Health Scientist at Lundbeck, she brings more than four years of experience in evaluating and implementing Digital Health Technologies, including wearable devices, into clinical trials. Before joining Lundbeck, Charlotte worked as a Research Associate at NTU Singapore, focusing on digital health within the field of population health science. She holds a Bachelor’s degree in Health Economics and a Master’s degree in Global Health.

    Session Details:

    Lessons learned from implementing Digital Health Technologies into clinical trials

    2025-10-22, 1:30 PM

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    Judi Simonsen
    CEO and Co-Founder, MERODZ
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    Alexander Debets
    Lead Clinical Supply Innovation, Former MSD

    Dr. Alexander Debets has and more than 20 years of experience in analytical and pharmaceutical R&D, and currently chairs the Clinical Supply Chain Council, a cross-functional and cross-divisional decision-making body for the integrated clinical supply chain.

    He previously worked for Organon and Schering-Plough. He held several roles of increasing responsibility in Analytical Development, Pharmaceutical Development and Clinical Supply Operations in the Netherlands. He was site head of development manufacturing sites in Germany and in Switzerland, which involved the transition of a site from research and development into commercial.

    His educational background includes a Doctor in Chemistry, and a Master’s Degree in Analytical Chemistry and Toxicology from the Free University of Amsterdam, the Netherlands.
    He was chairman of several committees and councils, including global harmonization steering committees for Analytical Chemistry, Manufacturing and Control (CMC) processes, Quality and international Procurement Improvements. He was board-member of the Analytical Section of the Royal Dutch Chemical Society and president of the Analytical Lab Managers Association.

    Session Details:

    Panel Discussion: Clinical trial innovation: insights into new technology and strategy

    2025-10-22, 11:45 AM

    Session Details:

    Improving clinical supply chain with digital display labelling

    2025-10-22, 9:45 AM

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    Andrea Salmen
    Chief Operating Officer, NEOGAP Therapeutics AB
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    Helen Johansen Blanco
    Chief Operating Officer, Node Pharma

    Helén Johansen Blanco has 24 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 AstraZeneca and Mylan, as well as small, medium to large sized biotechnology companies as Nordic Nanovector, Oncoinvent, Cantargia, Cytovation and Celgene. Currently she holds a position as Chief Operating Officer at Node Pharma AS, a small medium sized Norwegian biotech company. She holds a Diploma Engineer/MSc degree in Biophysics and medical technology and a MBA.

    Session Details:

    Chairperson’s Opening Remarks

    2025-10-22, 8:30 AM

    Session Details:

    Chairperson’s closing remarks

    2025-10-21, 5:30 PM

    Session Details:

    Panel Discussion: Discussing patient centric initiatives to enhance patient engagement in clinical trials

    2025-10-21, 9:30 AM

    Session Details:

    Negotiation skills during CRO and vendor selection process

    2025-10-22, 9:45 AM

    Session Details:

    Panel Discussion: Choosing an outsourcing model: FSO vs FSP vs inhouse

    2025-10-22, 11:45 AM

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    Claudia Krag
    Director Clinical Operations, Novo Nordisk

    Session Details:

    Transforming Sponsor-CRO Partnerships

    2025-10-22, 9:15 AM

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    Tine Bülow
    Supply Chain Project Manager, Novo Nordisk

    Tine Bülow is a Biomedical Engineer with over 12 years of experience in clinical systems. Her current focus is on the integration of clinical systems, particularly in temperature management, which is complemented by 8 years of expertise in IRT (Interactive Response Technology) systems and 4 years of dedicated work with temperature control systems.

    Tine specializes in ensuring optimal temperature management throughout the product lifecycle—from the packaging of shipments to transportation—ultimately ensuring seamless delivery to patients participating in clinical trials. She is committed to enhancing the integrity and reliability of clinical trial supplies through effective temperature control solutions.

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    Tankred Ott
    Senior Data Scientist – AI & Analytics CoE, Novo Nordisk

    Session Details:

    Session TBC

    2025-10-22, 2:30 PM

    Session Details:

    Panel Discussion: Clinical trial innovation: insights into new technology and strategy

    2025-10-22, 11:45 AM

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    Suzanne McNally
    Executive Director in Portfolio Management, Parexel

    Suzanne McNally is an Executive Director in Portfolio Management with over 20 years of leadership experience in clinical trial management. She holds a BA (Hons) in Nursing and brings strong financial acumen, innovation, and a proven track record in overseeing multi-therapeutic, global Phase I-IV drug trials. Suzanne has clinical research experience in oncology, neurology, ophthalmology, GI, general medicine, and infectious diseases, managing complex global projects with high quality.

    As a proactive leader, Suzanne excels in navigating challenging operational complexities and site dynamics, providing innovative solutions to meet tight timelines and budgets. She is a certified PMP, Lean Six Sigma, and a member of the global Women in Leadership alumni.

    Session Details:

    From setback to success: The art of clinical trial rescue

    2025-10-22, 11:15 AM

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    Merete Schmiegelow
    Patient Advocate

    Session Details:

    Panel Discussion: Discussing patient centric initiatives to enhance patient engagement in clinical trials

    2025-10-21, 9:30 AM

    Session Details:

    Patient Perspective: Considering patient engagement in medicines R&D, approvals and life cycle

    2025-10-21, 11:00 AM

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    Jonathan Crowther
    Former Head of Predictive Analytics, Pfizer

    With a keen eye for Strategic Vision, Jonathan has been at the forefront of advancing analytical capabilities, particularly in site intelligence, operational metrics, and quality indicators. With a prowess in Digital Transformation has been instrumental in the on-time delivery and precision of a diverse suite of predictive models, leveraging ML/AI and Generative AI technologies.

    Session Details:

    Transforming clinical data management with AI: challenges, solutions, and ROI

    2025-10-22, 8:45 AM

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    Arnaud Dourlens
    Global Head of Clinical Supply Chain Operations, Sanofi

    Arnaud Dourlens is an Arts et Métiers engineer, he began his industrial career in the FMCG sector where he held growing responsibilities. Then he joined the LVMH group where he reorganized new product launches and industrial investments in the Make-up segment in order to adapt to the need for innovation and time to market, thus providing a competitive advantage. He then managed the entire portfolio of industrial launches and investments in Perfumes, Skincare and Make-up for Parfums Christian Dior Group.

    During his career Arnaud held a wide variety of industrial roles. He joined Sanofi in 2017 as Production Director of a major solid oral form production site (>2.5 billion € turnover). He has been a key player in the development of the continuous improvement mindset and in the transformation of the site through IT projects, investments and activity growth following the acquisition of Boehringer Ingelheim consumer healthcare portfolio.

    Since the beginning of 2020, he’s been the global head of Sanofi Clinical Supply Chain Operations, managing worldwide clinical supply teams involved in more than 300 clinical studies.

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    Anca Copaescu
    Chief Executive Officer, Strategikon Pharma

    Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side.  She is currently the Founder and CEO of Strategikon Pharma, developer of Clinical MaestroTM, the industry’s only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. She also had several leadership positions with PharmaNet Development Group (now Syneos Health), ICON Clinical Research and eMetagen Corporation.

    Session Details:

    Transform procurement: Harnessing AI for strategic sourcing

    2025-10-22, 11:15 AM

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    Gunilla Andrew-Nielsen
    Head of Clinical Trials, Swedish Medical Products Agency

    Gunilla Andrew-Nielsen has held her current position as Head of Clinical Trial and Special Permission at the MPA in Sweden during seven years. Since the early 1990s, she has held various positions within global R&D in the pharma industry including project and training management and later as Director of Quality Assurance.

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    Cornelia Baumgartner
    Head of Clinical Operations, T-CURX

    Session Details:

    Panel Discussion: Choosing an outsourcing model: FSO vs FSP vs inhouse

    2025-10-22, 11:45 AM

    Session Details:

    Beyond the spreadsheet: a practical model to align budget, milestones & cash flow

    2025-10-21, 4:00 PM

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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.

    Session Details:

    Chairperson’s opening remarks

    2025-10-22, 8:30 AM

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    OCT Advisory Board

    Select a member to learn more

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    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

     

    Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

     

    Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

     

    Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

     

    Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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    Kathleen Cohen
    Vice President, Clinical Development, Marinus Pharmaceuticals

    Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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    THOMAS M TREMBLAY
    Vice President Of Clinical Development, Trefoil Therapeutics, Inc

    Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

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    Bao Dinh
    Global Development Business Operation, Takeda

    With over 15 years of experience in Clinical Data Management, Bao leads business strategy and vendor operations for Takeda’s Clinical Data Management, Clinical Data Engineering, and Clinical Data Standards groups, driving organizational growth, managing global FSP partnerships, and enhancing cross-functional collaboration. As a member of the 2024–2025 OCT Advisory Board, Bao brings expertise in clinical outsourcing, strategic vendor partnerships, and RFP process optimization, providing a fresh vision for the organization.

    Beyond professional achievements, Bao is dedicated to fostering collaboration and investing in the local community. As a partner of The Town FC and a Silicon Valley angel investor, Bao champions ventures that advance sustainable growth, youth enrichment, and innovation in technology.’

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