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
  • OCT Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Why partner?
  • Contact Us
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Featured Speakers

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Lene Grejs Petersen​

Senior Advisor, Danish Medicines Agency

Lene Grejs Petersen is Senior Adviser at the Danish Medicines Agency, Clinical Trial Unit. Lene is member of the Clinical Trials Coordinating and Facilitation Group (CTCG) member since 2008 and is the Danish representative Clinical Trials Advisory Group (CTAG) since 2022. Lene has been an employee at the Danish Medicines Agency since 2000 and she has been involved in the implementation of the EU Clinical Trials Regulation and works as a regulatory assessor and coordinator of clinical trials. Lene has a background as Master in Pharmacy.

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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

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Morten Pedersen​

VP, Head of Clinical Operations, Lundbeck

Morten completed his Master’s degree in Biotechnology at National University of Ireland, Galway, in 1997, specializing in Pharmacology. He joined Lundbeck in August 2020 as VP, Head of Clinical Operations.

Career to date Morten started at a CRO in 1997 as a CRA on an Epilepsy study.  In the subsequent years he worked in CRO’s, consultancy and big Pharma taking on roles within Project Management, Program Oversight, Innovation and Strategic Partnerships.  He joined Pfizer in 2003 and has a wide range of project management experience delivering projects across multiple therapeutic areas. From 2007 to 2011 he held a leadership role in Pfizer’s Clinical Study Management group providing Operational Oversight in various outsourcing models.  As Group Lead of Emerging Markets and Established Products Business Units he managed a team of Program Directors in a variety of Therapy Areas from Phase II to Late Phase and Non-Interventional trials. From late 2011 Morten joined an Innovation technology CRO in the role of Senior Director and Head of Strategic Partnerships with the aim of improving Clinical Trial efficiencies and supporting Trial Sites. In August 2016 he joined InVentiv Health as VP, Head of Program Delivery in Neuroscience, before the group merged with INC to become Syneos Health.

 

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Helen Johansen Blanco​

Chief Operating Officer, Node Pharma A/S

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.

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Magnus Jörntén-Karlsson​

Head of Digital Patient & Site Technology, Evinova at AstraZeneca

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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.

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Joachim Lovin​

DCT Specialist, Novo Nordisk

Joachim Lövin has worked in the pharmaceutical industry for over 20 years across various therapeutic areas and organizations. During this time, Joachim has worked in different roles spanning over Data Management, Project Management, Process Development, Senior Business Analyst and Clinical Operations. In his current role as DCT Specialist, Joachim focuses on supporting trials including competence development of Clinical Operations, identifying opportunities, and operationalising Decentralised Clinical Trial Elements across Novo Nordisk. Joachim is the Workstream Lead for the Modernizing Clinical Trial Conduct workstream for TransCelerate Biopharma, and a member of the eClinical Forums Trial of the Future. All of Joachim’s work is aligned with his passion to improve patient experience and accelerating clinical trials.

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    2024 Sponsors Included:

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    Company Information

    Simply sourcing comparators – we offer a unique blend of small company flexibility and speed, backed with the large-scale buying power of the Orifarm Group, which is one of the largest pharmaceutical suppliers in Europe. With over €1.4B products sold in 2021 and more than 4,000 unique product lines sourced on a monthly basis, we have unparalleled access to “out of market” and manufacturer direct buying capability, both in the US and Europe.

    Company website: www.Orifarm-CTS.com

    Company Website

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

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    Company Website

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

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    Company Information

    Linical is a global speciality CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With more than 900 employees Linical directly covers more than 20 countries and all key markets in Asia-Pacific, Japan, Europe and N. America via its own offices.

    Company Website

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

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    Company Information

    ARENSIA Exploratory Medicine, a German company, specializes in “first-in-patient” Phase IB and II/PROOF-OF-CONCEPT clinical trials spanning various patient populations. Equipped with 14 proprietary research clinics and advanced Phase I infrastructure, ARENSIA exceptionally accelerates the detection of initial efficacy signals for novel compounds at an unrivalled speed. ARENSIA’s streamlined approach significantly slashes patient recruitment time and costs by at least 50%, as opposed to overcrowded and understaffed conventional trial sites. The company’s remarkable efficiency is underscored by its 93% repeat business rate, propelling its growth and collaborations with leading pharmaceutical companies, biotechs, and global CROs. H3.eadquartered in Düsseldorf, ARENSIA operates with a workforce of over 450 employees across 8 countries.

    Company Website

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

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    Company Information

    KLIFO is a leading international drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies to advance their drug development projects. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement.

    We offer multidisciplinary consulting and operational solutions spanning all areas of clinical research, clinical trial supply, QA, CMC development, regulatory affairs, pharmacovigilance, and the development of pharmaceutical and biotech products and medical devices.

    Company Website

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

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    Company Information

    Since 1997, Clinigen has offered market-leading clinical trial supplies and biological sample management services to meet the most complex clinical supply challenges. Part of Clinigen Group’s global supply chain facility and depot network, we deliver tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.

    Company Website

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

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    Company Website

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

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    Company Information

    Lexano aims to address the healthcare inequality that exists due to the high medication costs and different accessibility.

    We believe that everyone should have access to essential medications. For 20 years we strive to help patients, doctors, and the staff of clinical trial organizations to get the medicines they need through wide partnerships and timely delivery.

    Let’s connect and discuss how we can make a difference together!

    Company Website

    To learn more, please visit our website - http://lexano.eu/en/

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    Company Information

    Founded in 1997, Ergomed is a full service, global Phase I-IV clinical development and trial management service partner with leading expertise in developing oncology and rare disease drugs.  Our portfolio includes experience working with novel therapies, early phase development, immunotherapy, and adaptive trial designs. Ergomed embodies a patient-centric approach to recruitment and retention with access to global patients in vital geographical areas.  Ergomed’s proven delivery record, expertise, and true partnership means our sponsors can trust us to deliver their oncology trials whatever the challenge. We also offer an industry-leading suite of specialist pharmacovigilance (PV) solutions under the PrimeVigilance brand.

    Ergomed has supported and managed clinical development, trial management, pharmacovigilance, and medical information services for over 300 clients in more than 100 countries.

    We deliver a complete solution for oncology trials of all sizes and complexity. For more information about Ergomed, please visit: www.ergomedcro.com

    Company Website

    To learn more, please visit our website - www.ergomedcro.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 34,000 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 2,200 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

    Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

    Company Website

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

    Climedo offers a digital platform for hybrid clinical trials and observational studies. Its modular and secure solutions include electronic data capture (EDC), eCOA/ePRO and Telemedicine. This enables pharma and medtech companies to validate their medical innovations more efficiently in the post-market phase and to capture data in decentralized, real-world settings.

    Company Website

    To learn more, please visit our website - www.climedo.de

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    Company Information

    4G Clinical is a leader in randomization and trial supply management (RTSM) for the global life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) and integrated supply forecasting. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia. For more information, please visit www.4gclinical.com

    Company Website:http://www.4gclinical.com/

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    Company Information

    Clario is a leading healthcare research and technology company that generates high quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries.  Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2019.

    Company Website

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

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    Company Information

    PPD clinical research business of Thermo Fisher Scientific, provides clinical development and analytical services that enhance customer innovation and productivity. Utilizing patient-centered strategies and data analytics, we cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, patient recruitment, investigator sites and comprehensive laboratory service. To learn more, visit thermofisher.com/ppd

    Company Website

    To learn more, please visit our website - thermofisher.com/ppd

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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

    Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

    Company Website

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

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    Company Information

    Myonex provides tailored services and solutions to advance medicine through clinical to commercial stages with tailored drug sourcing and ancillary supply, to packaging, labeling, and distribution. With ten global locations, we offer flexible, efficient, and cost-effective support for clients across the pharmaceutical and biotech sectors.

     

    Company Website

    To learn more, please visit our website - www.myonex.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.

       

      Clinical Trial Outsourcing and Clinical Trial Procurement Nordics 2023 is an event for online casino players not to be missed. The online casino https://gamblizard.ca/casinos/galaxyno-bonus/ communities with bonuses of biotechnologists, pharmacists and medical devices should come together to discuss strategies for successful clinical trials. Combining our OCT, CTS and Medical Devices events, this is the perfect platform for online casino professionals and clinical trials.

      WHAT TO EXPECT FOR 2024?

      200+

      Attendees

      		30+

      Exhibitors

      		30+

      Speakers
      200+

      Attendees

      		30+

      Exhibitors
      30+

      Speakers

      Testimonials

      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

      7:30 AM

      Registration and refreshments

      8:15 AM

      Chairperson’s opening remarks

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S

      8:30 AM

      Sharing latest updates to the Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS)

      • Providing latest updates: what’s new from the EU regulatory framework?
      • Learning from previous submissions: tips and tricks

      Speakers

      Lene Grejs Petersen
      Senior Advisor, Danish Medicines Agency

      9 AM

      A new paradigm for clinical innovation

      The clinical research industry is at an inflection point. Advancements in technology have created the opportunity to transform clinical trial outcomes, but to make this ambition a reality, we must now rethink how we engage with patients.

      Today, we often treat patient relationships as transactional, de-identified numbers on individual clinical trials. We need a new way of thinking about patients. A more longitudinal way, with greater pre-trial engagement and post-trial follow-up, and across multiple studies and healthcare experiences.

      We also need to change how we look at patient data, widening the lens to understand patients’ health and research journeys across a broad ecosystem of data sources. But how do we execute this paradigm shift when we’re also under pressure to accelerate timelines, reduce risk, lower costs, and improve quality?

      In this presentation, we’ll explore:

      • Industry drivers of this clinical research evolution
      • Challenges faced & the value of change
      • Reasons to believe - Improving trial experiences for patients, sites, CROs, & sponsors

      Speakers

      Richard Gray
      Managing Partner, Medidata, Dassault Systemes

      9:30 AM

      Building an Outsourcing Strategy for your clinical trials

      • Initiation: landscaping and defining the project
      • Strategy development: analyses and stakeholder management
      • Implementation: selecting vendors, training and alignment
      • Maintenance: KPIs and governance
      • Tips and tricks to consider

      Speakers

      Rikke Winther
      Outsourcing Specialist, Camurus AB

      Streams

      Stream one

      OUTSOURCING IN CLINICAL TRIALS & CLINICAL OPERATIONS

      Stream two

      CLINICAL TRIALS TECHNOLOGY & INNOVATION

      8:15 AM

      Registration and refreshments

      8:45 AM

      Chairperson’s Opening Remarks

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S

      9 AM

      Navigating through the jungle of regulatory requirements for combination trials

      • Overview of the COMBINE project created to analyse challenges and find solutions for combined studies
      • Reviewing key regulatory factors within CTR, MDR and IVD to ensure compliance
      • Best practice for streamlining your submissions to optimise approvals for parallel submissions

      Speakers

      Ditte Zerlang Andersen
      Senior EU Project Lead, Senior Adviser, Danish Medicines Agency

      9:30 AM

      Asia Pacific clinical trials: opportunities and regulatory updates

      • Advantages in running clinical trials in the APAC region
      • Key country differences and regulatory updates
      • How to overcome challenges to ensure clinical trial success

      Speakers

      Kento Nakamura
      Strategy and Corporate Development, CMIC

      10 AM

      Improving sustainability: Healthcare transition into a Net Zero world

      • Healthcare sector’s responsibility and action to address the climate crisis as accelerator for the health crisis
      • Methodology and available tools to assess carbon footprint of clinical trials
      • Clinical best-practices to save significant natural and financial resources

      Speakers

      Morten Pedersen
      VP, Head of Clinical Operations, Lundbeck

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Re-evaluating your study if things go wrong in clinical trial: to stay or change?

      • Pro-actively preparing for the worst up front
      • Considerations for changing or re-assessing sites
      • Assessing, selecting and switching vendors: benefits and challenges
      • Case study example: success and lessons learnt

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S

      11:30 AM

      Reserved for Viedoc

      Speakers

      Lina Gaggi
      Product Manager, Viedoc

      12 PM

      Implementing decentralised clinical trial (DCT) elements: a sponsor experience

      • Reviewing current state and future direction of decentralized clinical trials post-COVID-19 through sponsor survey results
      • Providing greater understanding of innovative modern solutions that could help support more effective patient engagement and choice
      • Discussing best practices and barriers experienced when implementing DCT elements as part of global trials
      • Sharing learnings to inform of modern patient centric ways of working for industry and regulators and available tools to support this

      Speakers

      Joachim Lovin
      DCT Specialist, Novo Nordisk

      12:30 PM

      Lunch and networking

      1:30 PM

      PI overview of patient safety when carrying out digital elements and decentralized clinical trials

      • Outlining role of the Principal Investigator in digital and decentralized clinical trials
      • Considering key strategies for ensuring patient safety and maintaining regulatory compliance
      • Sharing examples of benefits and challenges of digital integration

      Speakers

      John Zibert
      Chief Medical Officer, Coegin Pharma

      2 PM

      Fireside Chat: How to de-risk a clinical development program?

      • Value of obtaining early feedback from Key Opinion Leaders and Regulators
      • Risk assessment at the trial level
      • Trial oversight matrix implemented with all vendors and subcontractors

      Speakers

      Anna Polak-Andersen
      Head of Clinical Development, Entero Target

      2:30 PM

      Afternoon refreshments, networking and prize draw

      3 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
      Mitigating risk in clinical supply chain
      Pernille Hemmingsen, Chief Technology Officer, Adcendo

      Roundtable 2
      Engaging with CROs: defining deliverables and agreements
      Asger Dahlgaard, VP of Quality Assurance and Regulatory Affairs, BioPorto Diagnostics A/S

      Roundtable 3
      Considering DCT trial design and impact on both the patient and company

      Speakers

      Pernille Hemmingsen
      Chief Technology Officer, Adcendo
      Asger Dahlgaard
      VP of Quality Assurance and Regulatory Affairs, BioPorto Diagnostics A/S

      4 PM

      End of conference

      8:45 AM

      Chairperson’s opening remarks

      Speakers

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

      9 AM

      Case Study: Real world example of Artificial Intelligence in clinical development – PoC to Production

      • Understanding regulation and preparing compliance
      • Driving innovation and technology into processes through use of generative AI
      • Implementing AI for practical use with valuable return on investment

      Speakers

      Stephen Lutsch
      Senior Director Clinical Trial Digital Innovation, Genmab

      9:30 AM

      Reserved for event sponsor

      10 AM

      Case Study: Accelerating innovation through digital health technology solutions

      • Driving true benefits for clinical research through digital health technology
      • Learnings from barriers created by integration of digital health
      • Improving processes and focusing on delivering digital health as a tool

      Speakers

      Magnus Jörntén-Karlsson
      Head of Digital Patient & Site Technology, Evinova at AstraZeneca

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Expert Conversation: Strategic Considerations for End-to-End Development of Fit-For-Purpose Digital Measures of Health

      • Strategies for sourcing components from a scattered ecosystem
      • How to develop meaningful, human-centric measures
      • Pitfalls and opportunities for analytical and clinical validation
      • Novel solutions and digital pathways for scalable regulatory qualification
      • Maximizing value: how to repurpose and extend solutions across use cases in R&D and healthcare

      Speakers

      Kai Langel
      CEO, DEEP Measures
      Teske Valk
      Lead Medical Project Manager, Novo Nordisk

      11:30 AM

      The new age of R&D procurement: clinical business operations transformed

      • We will examine the high cost of doing nothing
      • What is the status quo and can technology help?
      • Vendor management - tackling one of the biggest challenges
      • The role that AI can play
      • What you can gain by embracing technology

      Speakers

      Anca Copaescu
      Chief Executive Officer, Strategikon Pharma

      12 PM

      Transforming clinical trials: ideas from leading industry professionals

      • Assessing outcomes from over 70 interviews with life science industry pioneers
      • Reviewing what clinical professionals wish would be different in the life sciences industry
      • Suggesting next steps towards further evolving clinical trials

      Speakers

      Ivanna Rosendal
      Senior Director, IT Business Partner, Ascendis Pharma

      12:30 PM

      Lunch and networking

      1:30 PM

      Maintaining control and oversight of data in outsourced trials

      • Considering, generally and specifically, data collected with eDiary, CGM and other external sources
      • Assessing risks when outsourcing trials
      • Acting accordingly to manage and mitigate risks
      • Maintaining right level of oversight

      Speakers

      Ane Jensen
      Principal Data Manager, Zealand Pharma

      2 PM

      Panel Discussion: Considering existing and emerging technology to assist with clinical trials

      • Digitalization: what can we digitalize to improve systems and processes
      • AI: what can we implement to save time and resource
      • Systems: what technology and systems are available and emerging to assist in clinical trials and data management

       

      Speakers

      Libbi Rickenbacher
      Senior Director Product Strategy and Partnerships, 4G Clinical
      Stephen Lutsch
      Senior Director Clinical Trial Digital Innovation, Genmab
      Ane Jensen
      Principal Data Manager, Zealand Pharma

      2:30 PM

      Afternoon refreshments, networking and prize draw

      10 AM

      Protocol optimization: How a transformational relationship with your CRO can increase your development programs’ chances of success

      • Maximizing the opportunity for strategic input and design feedback from your CRO throughout the outsourcing process
      • Overview of the typical areas where your CRO can guide and facilitate study optimization
      • Examples of where CRO experience has transformed study design and operations, to sponsor advantage

      Speakers

      Rich Bennett
      Senior Director, Therapeutic Strategy Lead, Neuroscience, Worldwide Clinical Trials

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Creating functional partnerships between sponsors and CROs in a volatile world

      • Integrating vendors and silos into your own organization
      • Considering where vendor management ends and vendor oversight starts?
      • Creating the right framework for a long-lasting partnership

      Speakers

      Lars Rosendal
      Chief Development Officer, UNION Therapeutics

      11:30 AM

      Why so slow? Insider insights from the clinic floor to speed up the startup and execution of proof-of-concept patient trials

      How to:

      • Harness regulatory dynamics for strategic advantages.
      • Obtain feasibility figures true to delivery.
      • Employ innovative study designs to expedite the development program.
      • Customize efficient patient recruitment tactics!

      Speakers

      Dr. Claudia Hesselmann
      Founder and CEO, ARENSIA Exploratory Medicine

      12 PM

      Panel Discussion: Defining effective governance structures and oversight models

      • Creating an efficient governance structure to suit the study
      • Communicating and monitoring the framework
      • Evaluating needs and wants of both sponsor and vendor companies
      • Sharing best practice for governance oversight

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S
      Caroline Sandstroem
      Head of Global Clinical Quality, Ferring Pharmaceuticals
      Anna Polak-Andersen
      Head of Clinical Development, Entero Target
      Lien Verheggen
      Head of Clinical Operations. Estetra (a wholly owned subsidiary of Gedeon Richter Plc)
      Sara Thuresson
      Head of Clinical Operations, Guard Therapeutics

      12:30 PM

      Lessons in chemistry: The art of site engagement

      Clinical trials follow a formula, but their success is about more than science. How can sponsors maximise their communications opportunities to stimulate and maintain the passion and proactivity that are key to the success of their study, among site staff with competing priorities, who may feel they’ve seen it all before

      Speakers

      Chloe Gower-Page
      Senior Account Director, Site Engagement, Clinical Trial Experience, Langland

      1 PM

      Lunch and networking

      2 PM

      Clinical trial outsourcing: a customer perspective

      • Clinical trial outsourcing strategies
      • Sponsor company expectations and CRO selection
      • Clinical trial oversight – considerations for finding the right balance between efficiency and safety

      Speakers

      Christopher Burton
      Chief Medical Officer, Reponex Pharmaceuticals A/S

      2:30 PM

      Ensuring success: Essential sponsor oversight strategies for confirming your clinical study is on track

      • Why it is so important to have proper oversight over study conduct
      • How to make it smooth and effective
      • Which aspects of the trial should have your special attention
      • How CRO can support with keeping oversight on the proper level

      Speakers

      Monika Martyka
      Director Clinical Operations, TFS HealthScience

      3 PM

      Clinical Trial Investigations: Looking at the trends and landscape for 2023 and what we can learn from them

      • Overview of global clinical trials for 2023
      • Assessing key sponsors, top interventions and looking at the trial landscape for 2023
      • Looking at key obstacles for terminated trials and evaluation of completed trials which have achieved endpoint status

      Speakers

      Priya Ravisekara
      Senior Analyst, GlobalData

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      Developing neuroimaging and CNS drug: preparing for clinical trial

      • Sharing insights on collaborations with clinical CROs on previous clinical studies
      • Preparing for a clinical trial with a University Hospital in Denmark
      • Choosing and developing the right trial design

      Speakers

      Christine Ryan
      Chief Operating Officer, Gabather

      4:30 PM

      Empowering patients to overcome challenges in orphan drug development

      • Orphan drug market: Illustrate the unique challenges of developing a drug for rare diseases
      • Patient-focused drug development: Designing patient-centered clinical trials
      • Operational considerations: Endpoint selection; reducing the burden of participation; cost; sites; patient concierge services
      • Collaboration: Focus on the need for collaboration in this space: sponsors, CRO (Clinical Research Organizations), patients, patient advocacy groups, investigators, vendors

      Speakers

      Scott Schliebner
      Vice President Drug Development Consulting, Novotech

      5 PM

      Panel Discussion: Focusing on the patient: diversity, engagement and safety

      • Increasing patient engagement and involvement
      • Improving diversity in clinical trials
      • Considering sites and patient safety

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S
      Révérien Uwacu
      Clinical Trial Supply Management Consultant at UCB
      Dr. Claudia Hesselmann
      Founder and CEO, ARENSIA Exploratory Medicine

      5:30 PM

      Chairperson’s closing remarks

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S

      END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY FORTREA

      Speakers

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      Ivanna Rosendal
      Senior Director, IT Business Partner, Ascendis Pharma

      Session Details:

      Transforming clinical trials: ideas from leading industry professionals

      2024-10-02, 12:00 PM

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      Magnus Jörntén-Karlsson
      Head of Digital Patient & Site Technology, Evinova at AstraZeneca

      Session Details:

      Case Study: Accelerating innovation through digital health technology solutions

      2024-10-02, 10:00 AM

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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 5 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:

      Building an Outsourcing Strategy for your clinical trials

      2024-10-01, 9:30 AM

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      John Zibert
      Chief Medical Officer, Coegin Pharma

      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:

      PI overview of patient safety when carrying out digital elements and decentralized clinical trials

      2024-10-02, 1:30 PM

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      Lene Grejs Petersen
      Senior Advisor, Danish Medicines Agency

      Lene Grejs Petersen is Senior Adviser at the Danish Medicines Agency, Clinical Trial Unit. Lene is member of the Clinical Trials Coordinating and Facilitation Group (CTCG) member since 2008 and is the Danish representative Clinical Trials Advisory Group (CTAG) since 2022. Lene has been an employee at the Danish Medicines Agency since 2000 and she has been involved in the implementation of the EU Clinical Trials Regulation and works as a regulatory assessor and coordinator of clinical trials. Lene has a background as Master in Pharmacy.

      Session Details:

      Sharing latest updates to the Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS)

      2024-10-01, 8:30 AM

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      Ditte Zerlang Andersen
      Senior EU Project Lead, Senior Adviser, Danish Medicines Agency

      Ditte Zerlang Andersen joined the Danish Medicines Agency (DKMA) in 2015 as a clinical trial assessor. She now leads strategic projects in our national and EU regulatory landscape as a senior strategy project lead. Ditte recently led the work of the EU ‘COMBINE’ project analysing the interface between clinical trials and the device and in vitro diagnostic area. Prior joining DKMA, Ditte worked 5 years in the pharmaceutical industry and have a PhD in neuroscience.

      Session Details:

      Navigating through the jungle of regulatory requirements for combination trials

      2024-10-02, 9:00 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:

      Panel Discussion: Defining effective governance structures and oversight models

      2024-10-01, 12:00 PM

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      Christine Ryan
      Chief Operating Officer, Gabather

      Dr Christine Natasha Ryan holds a PhD in Neuroscience from the University of Cambridge, Cambridge, UK and an MBA from Stockholm School of Economics. Following a post-doc at the Brain Research Institute, St. Hans Hospital, Roskilde, Denmark, Dr Ryan remained in Scandinavia moving to Sweden to work at Astra, which then became AstraZeneca, holding line management and competitive intelligence roles. Dr Ryan has engaged in preclinical research at blue chip companies such as AstraZeneca, smaller pharmaceutical companies, CROs and biotechs, working at Karo Bio AB, and Cerca Insights among others. Dr Ryan joined Gabather AB as Principal Scientist in 2017, becoming VP Operations in 2018. She is currently COO.

      Session Details:

      Developing neuroimaging and CNS drug: preparing for clinical trial

      2024-10-01, 4:00 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:

      Case Study: Real world example of Artificial Intelligence in clinical development – PoC to Production

      2024-10-02, 9:00 AM

      Session Details:

      Panel Discussion: Considering existing and emerging technology to assist with clinical trials

      2024-10-02, 2:00 PM

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      Priya Ravisekara
      Senior Analyst, GlobalData

      Priya Ravisekara, MSc,is a senior analyst at GlobalData in London, UK, where her primary responsibilities include producing analytical reports, improving and maintaining database functionality through quality assurance testing, updating and monitoring Global Data’s Clinical Trials Intelligence Database, and answering queries directly from clients. Priya holds a Masters in Clinical Drug Development from Barts and The London School of Medicine and Dentistry, and a Bachelor of Science in Biochemistry from Brunel University, London.​

      Session Details:

      Clinical Trial Investigations: Looking at the trends and landscape for 2023 and what we can learn from them

      2024-10-01, 3:00 PM

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      Lars Rosendal
      Chief Development Officer, UNION Therapeutics

      Session Details:

      Creating functional partnerships between sponsors and CROs in a volatile world

      2024-10-01, 11:00 AM

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      Morten Pedersen
      VP, Head of Clinical Operations, Lundbeck

      Morten completed his Master’s degree in Biotechnology at National University of Ireland, Galway, in 1997, specializing in Pharmacology. He joined Lundbeck in August 2020 as VP, Head of Clinical Operations.

      Career to date Morten started at a CRO in 1997 as a CRA on an Epilepsy study.  In the subsequent years he worked in CRO’s, consultancy and big Pharma taking on roles within Project Management, Program Oversight, Innovation and Strategic Partnerships.  He joined Pfizer in 2003 and has a wide range of project management experience delivering projects across multiple therapeutic areas. From 2007 to 2011 he held a leadership role in Pfizer’s Clinical Study Management group providing Operational Oversight in various outsourcing models.  As Group Lead of Emerging Markets and Established Products Business Units he managed a team of Program Directors in a variety of Therapy Areas from Phase II to Late Phase and Non-Interventional trials. From late 2011 Morten joined an Innovation technology CRO in the role of Senior Director and Head of Strategic Partnerships with the aim of improving Clinical Trial efficiencies and supporting Trial Sites. In August 2016 he joined InVentiv Health as VP, Head of Program Delivery in Neuroscience, before the group merged with INC to become Syneos Health.

       

      Session Details:

      Improving sustainability: Healthcare transition into a Net Zero world

      2024-10-02, 10:00 AM

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      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S

      Helén Johansen Blanco has 20+ years of clinical development experience, managing Phase I to III clinical trials leading to the successful launch of several oncology products. She has experience in project management of large global clinical trials conducted in all continents of the world, mainly within oncology, but also therapeutic areas as cardiovascular and gastrointestinal. Mrs. Blanco has previously worked for large international pharma companies such as Astra Zeneca and Mylan, as well as small, medium to large sized biotechnology companies as Nordic Nanovector and Celgene, in addition to smaller and larger CROs such as Smerud and Covance. Currently she holds a position as Head of Clinical Operations at Oncoinvent, a small medium sized biotech company located in Norway. She holds a MSc in Biophysics and medical technology from Norwegian Technology and Science University and is currently writing her thesis for a Master in Business Administration.

      Session Details:

      Chairperson’s Opening Remarks

      2024-10-02, 8:45 AM

      Session Details:

      Panel Discussion: Focusing on the patient: diversity, engagement and safety

      2024-10-01, 5:00 PM

      Session Details:

      Chairperson’s closing remarks

      2024-10-01, 5:30 PM

      Session Details:

      Re-evaluating your study if things go wrong in clinical trial: to stay or change?

      2024-10-02, 11:00 AM

      Session Details:

      Panel Discussion: Defining effective governance structures and oversight models

      2024-10-01, 12:00 PM

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      Christopher Burton
      Chief Medical Officer, Reponex Pharmaceuticals A/S

      Session Details:

      Clinical trial outsourcing: a customer perspective

      2024-10-01, 2:00 PM

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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:

      Maintaining control and oversight of data in outsourced trials

      2024-10-02, 1:30 PM

      Session Details:

      Panel Discussion: Considering existing and emerging technology to assist with clinical trials

      2024-10-02, 2:00 PM

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      Anna Polak-Andersen
      Head of Clinical Development, Entero Target

      Session Details:

      Panel Discussion: Defining effective governance structures and oversight models

      2024-10-01, 12:00 PM

      Session Details:

      Fireside Chat: How to de-risk a clinical development program?

      2024-10-02, 2:00 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:

      Panel Discussion: Focusing on the patient: diversity, engagement and safety

      2024-10-01, 5:00 PM

      Session Details:

      Why so slow? Insider insights from the clinic floor to speed up the startup and execution of proof-of-concept patient trials

      2024-10-01, 11:30 AM

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      Lien Verheggen
      Head of Clinical Operations. Estetra (a wholly owned subsidiary of Gedeon Richter Plc)

      Session Details:

      Panel Discussion: Defining effective governance structures and oversight models

      2024-10-01, 12:00 PM

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      Sara Thuresson
      Head of Clinical Operations, Guard Therapeutics

      Session Details:

      Panel Discussion: Defining effective governance structures and oversight models

      2024-10-01, 12:00 PM

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      Joachim Lovin
      DCT Specialist, Novo Nordisk

      Joachim Lövin has worked in the pharmaceutical industry for over 20 years across various therapeutic areas and organizations. During this time, Joachim has worked in different roles spanning over Data Management, Project Management, Process Development, Senior Business Analyst and Clinical Operations. In his current role as DCT Specialist, Joachim focuses on supporting trials including competence development of Clinical Operations, identifying opportunities, and operationalising Decentralised Clinical Trial Elements across Novo Nordisk. Joachim is the Workstream Lead for the Modernizing Clinical Trial Conduct workstream for TransCelerate Biopharma, and a member of the eClinical Forums Trial of the Future. All of Joachim’s work is aligned with his passion to improve patient experience and accelerating clinical trials.

      Session Details:

      Implementing decentralised clinical trial (DCT) elements: a sponsor experience

      2024-10-02, 12:00 PM

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      Anca Copaescu
      Chief Executive Officer, Strategikon Pharma

      Anca Copaescu, our CEO, is the powerhouse behind Strategikon's success and the driving force behind the company's revolutionary Clinical Maestro® platform.

      With over 15 years of experience in the clinical research industry, Anca's expertise in clinical outsourcing and analytics is second to none. As Head of Clinical Outsourcing and Analytics at BioMarin Pharmaceuticals, she managed and advanced the company's global outsourcing, vendor management and clinical analytics functions.

      Her passion for efficiency and innovation led her to relentlessly pursue improvements in clinical study planning, outsourcing, and financial management. And when she couldn't find a technology solution that met her standards, she decided to build a better one - the game-changing Clinical Maestro platform.

      Session Details:

      The new age of R&D procurement: clinical business operations transformed

      2024-10-02, 11:30 AM

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      Kento Nakamura
      Strategy and Corporate Development, CMIC

      Kento Nakamura is a global professional having worked both in the Western and Eastern healthcare landscapes. He has been in various roles, contributing significantly to drug development, market access, and pharmaceutical marketing.

      At CMIC, Japan and South Korea’s first CRO, Kento wears multiple hats including helping formulate corporate strategy, creating mutually beneficial partnerships with other companies, and taking initiative to create business development opportunities.

      During his tenure at KM Pharmaceutical Consulting, a boutique drug development consulting firm, Kento co-pioneered the market access perspective on drug development, resulting in key additional endpoints in an ongoing phase 2 study. He also played a crucial role in developing the global drug safety plan, ensuring compliance with reporting requirements across multiple continents.

      Kento holds an MPH in Health Management from Harvard University and a BS in Biology from Tufts University. He is fluent in English and proficient in Japanese. In his free time, Kento enjoys playing tennis, watching football, visiting contemporary art museums, and traveling around the world.

      Session Details:

      Asia Pacific clinical trials: opportunities and regulatory updates

      2024-10-02, 9:30 AM

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      Asger Dahlgaard
      VP of Quality Assurance and Regulatory Affairs, BioPorto Diagnostics A/S

      Session Details:

      ROUNDTABLE SESSIONS

      2024-10-02, 3:00 PM

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      Scott Schliebner
      Vice President Drug Development Consulting, Novotech

      Scott is a strategic and innovative drug development executive with 30 years experience across the biopharma, CRO, and non-profit sectors.  Passionate about ensuring the patient voice is incorporated into drug development, Scott is focused on patient-focused innovations that reduce the burden of clinical trial.  With a particular focus on rare diseases, Scott has built partnerships and collaborations that have led to the acceleration of drug development for rare disease patients.  He received a Master’s Degree in Public Health in Biostatistics from the University of Utah School of Medicine and completed a Graduate Research Fellowship at The National Institutes of Health/NINDS.

      Session Details:

      Empowering patients to overcome challenges in orphan drug development

      2024-10-01, 4:30 PM

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      Teske Valk
      Lead Medical Project Manager, Novo Nordisk

      Session Details:

      Expert Conversation: Strategic Considerations for End-to-End Development of Fit-For-Purpose Digital Measures of Health

      2024-10-02, 11:00 AM

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      Kai Langel
      CEO, DEEP Measures

      Session Details:

      Expert Conversation: Strategic Considerations for End-to-End Development of Fit-For-Purpose Digital Measures of Health

      2024-10-02, 11:00 AM

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      Rich Bennett
      Senior Director, Therapeutic Strategy Lead, Neuroscience, Worldwide Clinical Trials

      Richard Bennett is Senior Director and Therapeutic Strategy Lead in the Neuroscience franchise at Worldwide Clinical Trials. With two decades in the industry, he has advanced through the traditional clinical operations roles such as clinical research associate and clinical trial manager and has spent many years as a leader of clinical development programs in both the larger pharma and biotech setting. He has worked on neuromuscular disorders, rare diseases, critical care, pain and palliative care, dermatology, and epidemiology programs. His direct experience working with large pharma and small and emerging biotech firms has given him a deep understanding of the needs of our sponsors

      Session Details:

      Protocol optimization: How a transformational relationship with your CRO can increase your development programs’ chances of success

      2024-10-01, 10:00 AM

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      Richard Gray
      Managing Partner, Medidata, Dassault Systemes

      Richard Gray is a Managing Partner at Dassault Life Sciences, engaged across the full portfolio including the market leading Medidata brand. He has been serving the life sciences & healthcare industry for over 30 years, inspired by the opportunity to accelerate productivity across the value chain and improve outcomes for patients.

      With a background in process optimization, data, and technology, he has enabled many European and US sponsors to uplift their capabilities, and in his current role he is driving innovation in areas including early-stage research and discovery, through preclinical and clinical, out to manufacturing, supply chain and commercialisation.

      Richard believes that data [strategy] holds the key to accelerating the value of technology, creating the opportunity to connect physical and digital worlds to advance virtual twin experiences, enabling the promise of AI to be democratized, and fueling in silico approaches that will revolutionise the science of tomorrow.

      Session Details:

      A new paradigm for clinical innovation

      2024-10-01, 9:00 AM

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      Monika Martyka
      Director Clinical Operations, TFS HealthScience

      Monika Martyka has over 14 years of experience in clinical research and currently serves as Director of Clinical Operations at TFS HealthScience. She leads complex clinical projects, overseeing cross-functional teams, optimizing clinical processes, and ensuring alignment with regulatory standards. Monika excels in managing the intricacies of clinical trials, including protocol development, patient recruitment, and compliance, while driving operational efficiency to meet critical milestones.

      Her expertise in both clinical and operational management has made her a key player in advancing healthcare through rigorous research methodologies. Dedicated to fostering collaboration and innovation, Monika is committed to the successful delivery of high-impact clinical trials that contribute to the development of cutting-edge therapies and improve patient outcomes globally.

      Session Details:

      Ensuring success: Essential sponsor oversight strategies for confirming your clinical study is on track

      2024-10-01, 2:30 PM

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      Lina Gaggi
      Product Manager, Viedoc

      Lina Gaggi, Product Manager, has over 10 years' experience in computer engineering developing and delivering the products that customers want. With a keen eye for user needs, she knows how to find the right solution that reduces complexity and makes software enjoyable. Focusing on the life science industry at this stage in her career, she’s a dedicated product manager that can distill the big picture in order to find robust solutions for small tasks, that in the end deliver value to customers.

      Session Details:

      Reserved for Viedoc

      2024-10-02, 11:30 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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      Behtash Bahador
      Director, Health Literacy, CISCRP

      Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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