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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 and CTS 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 2026?

400+

Attendees

30+

Exhibitors

30+

Speakers
400+

Attendees

30+

Exhibitors
30+

Speakers

Testimonials

See What It's All About

Featured Sponsors

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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

Biorce builds AI infrastructure for clinical trials. Our platform, Aika, accelerates how pharmaceutical companies, biotechs, and CROs design and execute clinical research—reducing protocol development time by at least 50% while eliminating costly amendments that delay patient access to life-saving treatments. Built on a foundation of 1 million clinical trials, Aika delivers evidence-based recommendations with complete regulatory transparency. Every decision auditable and defensible before agencies like the FDA and EMA.

Company Website

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

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Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. We work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference.

Company Website

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

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Company Information

S-CLINICA is the leader in advanced clinical supply management, specializing in Supply Forecasting, Cost and Risk Analysis, Production Planning and RTSM on a single-platform solution – ClinVision, designed to streamline trial execution.

With built-in supply demand planning and risk analysis, our system enables sponsors to evaluate multiple scenarios and make data-driven decisions to optimize production and distribution.

By supporting continuous planning and real-time updates, ClinVision ensures that supply strategies align with study needs and adapt seamlessly to changes as they happen.

Our proven technology reduces waste, minimizes risk, and accelerates trial timelines, helping biopharma companies execute clinical studies with greater efficiency and confidence.

Company Website

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

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Company Information

Syneos Health (Nasdaq:SYNH*) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together, we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit SyneosHealth.com. 

Company Website

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

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Company Information

At TRI, we make RBQM work. Deployed on over 450 clinical trials, we understand the challenges and how to overcome them. Our industry-leading RBQM platform, OPRA, is built by operational experts to support Risk Assessment, Risk Management, and Central Monitoring—all in one intuitive system.

With real-world clinical trial experience, our RBQM team provides the guidance you need to meet regulatory requirements (ICH E6/E8) and confidently embed RBQM at the heart of your trials. That’s why leading global players trust TRI.

We’re not called The RBQM Experts for nothing.

Company Website

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

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Company Information

DISTILL is supported by parent company Solverminds Solutions and Technologies, specialized in building Software products, Low code platforms, AI / ML applications and Business Analytics solutions.

DISTILL can support global and local projects from its offices in Europe, US, India, UAE and Singapore.

Company Website

To learn more, please visit our website - www.distill.biz

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Company Information

Coquelle Consulting is a trusted partner supporting biotech and pharmaceutical companies in their clinical development journey. We provide highly skilled clinical trial professionals including Trial Managers, Project Managers, TMF Experts, CRAs, Start up Specialists, Data Managers, Vendor Managers, Biostatisticians, Safety Experts and Medical Advisors. Our consultants integrate seamlessly into client teams, bringing clear communication, a collaborative approach and proven expertise that ensures efficiency and precision.

From emerging biotech innovators to established pharmaceutical leaders, we advance clinical success through seamless execution, reliable delivery, and an uncompromising commitment to quality in every project.

Learn more at coquelle-consulting.com

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Company Information

Evestia Clinical is the specialist CRO for biotech running oncology, rare disease, and neurodegenerative trials. Your program is never a low priority for us. You get direct access to senior leaders from day one. The same team starts and finishes your trial. Your science deserves nothing less.
evestiaclinical.com

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Company Information

HEMEX is a European CRO supporting pharmaceutical, biotech, and MedTech SMEs with clinical development solutions. Headquartered in Basel and operating globally, we manage multinational trials. Our services include clinical operations, regulatory support, quality assurance, BA/BE and PK studies, patient recruitment, and advanced medical imaging

Company Website

To learn more, please visit our website - https://hemex.ch/

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Company Information

Founded in 2017, Collective Minds is a medical imaging platform connecting hospitals, scientists, and doctors, which helps organisations running clinical trials and research generate high-quality evidence faster and more efficiently. Headquartered in Stockholm, Collective Minds is built by a specialised team of 40 experts with deep experience in medical imaging and research operations.

Company Website

To learn more, please visit our website - https://collectiveminds.health/

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Company Information

The CCL Clinical Business Unit is the global specialist of CCL Industries Inc. for products and services in the clinical trials sector. Leveraging over two decades of expertise and operating across various manufacturing sites, we stand poised as your premier partner for clinical trial labeling. With a combined portfolio, worldwide reach, and dedicated local assistance, CCL Clinical emerges as your ultimate destination for excellence in clinical trial labeling services.

Company Website

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

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    Agenda

    • 20 Oct 2026
    • 21 Oct 2026
    Expand All

    8 AM

    Registration and refreshments

    8:20 AM

    Chairperson’s opening remarks

    8:30 AM

    Optimising Combined Study Approvals Across the Clinical Trial and Medical Device Regulatory Frameworks

    Update from COMBINE “all-in-one” Pilot Exploring the coordinated assessment of combined study applications

    • Learnings and experience from the pilot phase 1
    • Framework of the pilot phase 2 and experiences so far

    Speakers

    Paivi Worsoe
    Project Manager, Danish Medicines Agency

    9 AM

    Session reserved for event sponsor

    9:30 AM

    Implementing the New UK Clinical Trial Regulation: What Sponsors Need to Do Differently

    • Understanding how the new UK framework is working in practice 6 months after implementation
    • Identifying key operational changes, including approvals, consent, and trial setup
    • Clarifying how sponsors can take advantage of faster pathways while staying compliant

    Reserved for NIHR

    10 AM

    Session reserved for event sponsor

    10:30 AM

    Morning refreshments and networking break

    11 AM

    PANEL DISCUSSION Debating Ownership and Risk Sharing in Sponsor and Vendor Partnerships

    • Exploring the meaning of risk sharing across roles
    • Supporting balance between procurement and R&D priorities
    • Strengthening partnership models through transparency

    1 x Biopharma panel seat available

    1 x Vendor panel seat available

    Speakers

    Sigrid Schollen
    Clinical Project Lead, Hirundo

    11:30 AM

    Session reserved for event sponsor

    12 PM

    Live from Ukraine: Running Clinical Trials During Disruption and Lessons for Global Studies

    • Understanding how clinical trials continue during war and infrastructure disruption
    • Managing patient safety supply chain and data integrity under extreme conditions
    • Applying lessons from Ukraine to improve resilience and contingency planning

    Speakers

    Ivan Vyshnyvetskyy
    Managing Director, FutureMeds

    12:30 PM

    Session reserved for event sponsor

    1 PM

    Lunch and networking

    2 PM

    FOCUS SESSION + EXPERT COMMENTARY Evaluating China Expansion Strategies for Global Clinical Development

    Understanding when China makes sense, when it doesn’t, and how to build a practical operational pathway

    • Evaluating when China is the right fit for global development strategies
    • Weighing the benefits, risks and timelines of China-linked studies
    • Exploring Australia and other ICH-aligned pathways into the US market
    • Comparing China, Australia and Central & Eastern Europe for trial execution
    • Aligning clinical operations, CMC, manufacturing and quality strategies
    • Sharing practical lessons from sponsors currently assessing China expansion

    2 x Biopharma panel seats available

    1 x Vendor panel seat available

    Speakers

    Kamil Sitarz
    Chief Operating Officer, Ryvu Therapeutics

    3 PM

    Session reserved for event sponsor

    3:30 PM

    Afternoon refreshments and networking

    4 PM

    ASK THE EXPERT SESSION Understanding The Key Criteria Investors Use When Selecting Biotech to Fund

    • Identifying how clinical strategy and data quality impact investment decisions
    • Translating investor expectations into practical changes in trial design and execution
    • Applying these insights to improve funding strategy in a tougher market

    Speakers

    Stephan Christgau
    Founding Partner, Eir Ventures

    4:30 PM

    Session reserved for event sponsor

    5 PM

    STANDUP COMEDY Taking a light-hearted look at the realities of working in clinical trials and life sciences

    Speakers

    Ivanna Rosendal
    Vice President of Business Digitalization, Ascendis

    5:20 PM

    NETWORKING DRINKS

    8:15 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s Opening Remarks

    9 AM

    Session reserved for

    Speakers

    Lene Laursen
    Deputy Director General, Danish Medicines Agency

    9:30 AM

    Session reserved for event sponsor

    10 AM

    PANEL DISCUSSION Choosing Where to Run Clinical Trials in 2027 and Balancing Speed, Quality and Access

    • Comparing timelines and setup across the UK EU and other key regions
    • Understanding trade-offs between speed cost quality and patient access
    • Deciding how to prioritise regions based on trial type and strategy

    1 x Biopharma panel seat available

    1 x Vendor panel seat available

    Speakers

    Lene Laursen
    Deputy Director General, Danish Medicines Agency

    10:30 AM

    Morning refreshments and networking break

    11 AM

    CASE STUDY + CO-PRESENTATION Maintaining Control While Working with CROs and Improving Oversight Without Slowing Trials

    • Defining clear roles and responsibilities between sponsor and CRO to avoid duplication and gaps
    • Identifying what sponsors should actively oversee versus what can be delegated with confidence
    • Setting meaningful KPIs and oversight models that focus on risk rather than excessive monitoring
    • Improving communication and escalation pathways to prevent delays and misalignment
    • Avoiding common mistakes that lead to over-control increased workload and inefficiencies

    Speakers

    Olivia Vu Van
    Clinical Project Manager, IRLAB

    11:30 AM

    Session reserved for event sponsor

    12 PM

    Using National Trial Support Models Effectively and When They Add Value

    • Exploring initiatives like Trial Nation
    • Understanding funding structures
    • Deciding when they add value

    Speakers

    Kirsten Bødker
    Head of Business Relations, Facilitator of Centres for Dementia and Infectious Disease & Immunomodulation, Trial Nation

    12:30 PM

    Lunch and networking

    1:30 PM

    Meaningful Patient Involvement in Rare Disease Trials: From Recruitment to Partnership

    • Insights from the Nordic Patient Empowerment Survey (Nordic Rare Disease Summit 2025) and the Danish Rare Disease Survey (Guldkundeunders gelsen 2025) and their relevance for clinical trial design and patient engagement
    • Building trust and improving communication to support participation in healthcare and clinical research
    • Understanding the practical barriers faced by people living with rare diseases and how they may influence clinical trial participation
    • Moving from consultation to partnership: patient perspectives on involvement and decision-making throughout the research journey
    • Leveraging insights from Nordic patient organisations to better understand patient needs and priorities in rare disease research

    Speakers

    Liselotte Wesley Andersen
    Chairperson, SBONN

    2 PM

    Session reserved for event sponsor

    2:30 PM

    PANEL DISCUSSION What Went Wrong in Clinical Trials and What Should Have Been Done Differently

    • Sharing real examples of decisions that led to delays inefficiencies or trial failure
    • Understanding early warning signs that were missed or ignored
    • Identifying what should have been done differently in hindsight
    • Applying these lessons to improve future trial design and execution

    3 x Biopharma panel seats available

    1 x Vendor panel seat available

    3:30 PM

    Afternoon refreshments and networking

    4 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.

    Navigating communication styles by tailoring approaches for different patient personalities
    Roel van der Heijde, Facilitator & Trainer, Patient Experience Association The Netherlands

    Managing Clinical Trial Budgets in An Unstable Financial World

    Working Better with Investigative Sites

    Working With CROs More Effectively

    5 PM

    End of Conference

    Speakers

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    Laurynas Dailide
    Senior Category Lead, Novo Nordisk
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    Ivan Vyshnyvetskyy
    Managing Director, FutureMeds

    Dr. Ivan Vyshnyvetskyy is a seasoned expert in clinical trials with over 20 years of experience. His expertise spans over 70 clinical trials, including more than 50 as Principal Investigator. As the Managing Director Ukraine, he leads a growing Ukrainian unit of FutureMeds, a top-ranked European professional site network. Dr. Vyshnyvetskyy also serves as the Chair of the Ukrainian Association of Clinical Trials, where he works to enhance cooperation with regulatory bodies, harmonize legislation, and improve clinical trial awareness.  As an Associate Professor at O.O. Bohomolets National Medical University, Dr. Vyshnyvetskyy teaches courses in Research Methodology, Healthcare Management, and Strategic Management.  He holds a PhD in Cardiology from Donetsk National Medical University and a Master of Global Management from American University Kyiv.

    Session Details:

    Live from Ukraine: Running Clinical Trials During Disruption and Lessons for Global Studies

    2026-10-20, 12:00 PM

    View In Agenda
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    Ivanna Rosendal
    Vice President of Business Digitalization, Ascendis

    Session Details:

    STANDUP COMEDY Taking a light-hearted look at the realities of working in clinical trials and life sciences

    2026-10-20, 5:00 PM

    View In Agenda
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    Lene Laursen
    Deputy Director General, Danish Medicines Agency

    Session Details:

    PANEL DISCUSSION Choosing Where to Run Clinical Trials in 2027 and Balancing Speed, Quality and Access

    2026-10-21, 10:00 AM

    Session Details:

    Session reserved for

    2026-10-21, 9:00 AM

    View In Agenda
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    Rasmus Jakobsen
    Senior Manager, Digital Innovation and Execution, Genmab
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    Olivia Vu Van
    Clinical Project Manager, IRLAB

    Session Details:

    CASE STUDY + CO-PRESENTATION Maintaining Control While Working with CROs and Improving Oversight Without Slowing Trials

    2026-10-21, 11:00 AM

    View In Agenda
    Next speaker
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    Kirsten Bødker
    Head of Business Relations, Facilitator of Centres for Dementia and Infectious Disease & Immunomodulation, Trial Nation

    Session Details:

    Using National Trial Support Models Effectively and When They Add Value

    2026-10-21, 12:00 PM

    View In Agenda
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    Roel van der Heijde
    Facilitator & Trainer, Patient Experience Association The Netherlands

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

    He is a driven and experienced trainer and facilitator in:

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

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

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

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    Jens Kanstrup Kjær
    Site Manager, Aarhus University Hospital
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    Kamil Sitarz
    Chief Operating Officer, Ryvu Therapeutics

    Kamil Sitarz is Chief Operating Officer and Management Board Member at Ryvu Therapeutics, a European clinical-stage oncology company advancing a diversified pipeline of innovative therapies. He leads corporate strategy, enterprise governance, capital planning, and cross-functional clinical development execution across a diversified oncology portfolio.

    He has been instrumental in transforming Ryvu into a multi-program clinical-stage organization, embedding disciplined portfolio governance and architecting development pathways designed to enhance execution predictability in complex, high-risk oncology settings. His leadership integrates clinical strategy with capital allocation discipline, ensuring alignment across scientific ambition, regulatory positioning, operational design, and financial planning to drive sustainable enterprise value.

     

    Under his direction, Ryvu has built and scaled a robust clinical development organization capable of delivering international Phase I/II programs across challenging hematologic indications and multi-country site networks. He has also played a key role in establishing and governing strategic clinical collaborations with leading global oncology partners, strengthening Ryvu’s development footprint and reinforcing its credibility within the international biotech ecosystem.

     

    With a PhD in Medical Genetics and an Executive MBA, Kamil combines scientific depth with enterprise-level strategic and operational leadership to advance innovation with rigor, accountability, and long-term growth orientation.

    Session Details:

    FOCUS SESSION + EXPERT COMMENTARY Evaluating China Expansion Strategies for Global Clinical Development

    2026-10-20, 2:00 PM

    View In Agenda
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    Mateusz Zawadzki
    Product Manager Special Cargo Certification, International Air Transport Association
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    Paivi Worsoe
    Project Manager, Danish Medicines Agency

    Session Details:

    Optimising Combined Study Approvals Across the Clinical Trial and Medical Device Regulatory Frameworks

    2026-10-20, 8:30 AM

    View In Agenda
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    Maria Koufali
    Life Sciences Industry Director, National Institute for Health and Care Research (NIHR)

    Maria Koufali, is an experienced senior leader in life sciences research and innovation, bringing over 20 years of cross-sector expertise in working with global pharmaceutical companies, digital health firms, diagnostics developers, and MedTech SMEs. She holds a PhD in Pharmacology and Neuroscience, an MBA (Distinction), and is the first NHS R&D Director nationally to be awarded the Nye Bevan Executive Health Leadership Award. Maria currently leads the UK Vaccine Innovation Pathway at NIHR/DHSC, a nationally mandated clinical trials accelerator. In this role, she has delivered over 20 high-priority commercial trials, expanded partnerships beyond Moderna and BioNTech to include smaller biotech firms and large pharma, and embedded site-readiness models and trial metrics to support faster delivery.

    Maria has built a wide network of trusted relationships across the life sciences sector and has consistently translated strategic ambition into operational delivery, regulatory compliance, and commercial value. Previously, as Managing Director of Research & Innovation at Nottingham University Hospitals NHS Trust, she designed and delivered the Trust’s entire NIHR infrastructure portfolio from the ground up, securing funding and oversight for a £70m suite including a BRC, CRF, BioResource, and the Medical Technologies Innovation Facility (MTIF)—a £23m translational platform that supports SMEs to take digital and MedTech innovations from prototype to trial. Under her leadership, the Trust’s commercial research income rose to over £13m per year. She has successfully navigated and aligned MHRA, HRA and ISO frameworks to support industry delivery at scale. Maria currently serves as Trustee and Chair of the Industry Advisory Board at the BBSRC-funded Quadram Institute, where she shapes translational and commercial strategy. She brings a proven ability to develop national infrastructure, deliver commercial growth, and work across government and industry to accelerate innovation that benefits patients and the UK economy.

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    Annemette Broch
    Chairman of the Board and Founder of DATA for GOOD Foundation, DfG
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    Navid Arshad
    Supply Chain Clinical Trial Study Lead, AstraZeneca
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    Liselotte Wesley Andersen
    Chairperson, SBONN

    Session Details:

    Meaningful Patient Involvement in Rare Disease Trials: From Recruitment to Partnership

    2026-10-21, 1:30 PM

    View In Agenda
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    Sigrid Schollen
    Clinical Project Lead, Hirundo

    Session Details:

    PANEL DISCUSSION Debating Ownership and Risk Sharing in Sponsor and Vendor Partnerships

    2026-10-20, 11:00 AM

    View In Agenda
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    Eleni Tokali
    Analyst, GlobalData

    Eleni Tokali, MPharm, MPH, is a Drug Intelligence Analyst at GlobalData. Her primary responsibilities include managing and maintaining GlobalData’s Drugs Database, analyzing drug pipeline information and producing analytical market insight reports. Additionally, Eleni provides timely client support and performs database quality checks. Prior to joining GlobalData, Eleni worked as a registered pharmacist under the General Pharmaceutical Council (GPhC). Eleni has a firm knowledge of pharmaceutical industry dynamics as well as global public health perspectives. Eleni holds a Master of Pharmacy from the University of Brighton and a Master of Public Health from King's College London.

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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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    Anne Sofie Weigelt Nielsen
    Study Coordinator, Dept. of Hematology, Aarhus University Hospital
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    Ivan Costa Abalo
    Senior Data Manager, Zealand Pharma
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    Stephan Christgau
    Founding Partner, Eir Ventures

    Session Details:

    ASK THE EXPERT SESSION Understanding The Key Criteria Investors Use When Selecting Biotech to Fund

    2026-10-20, 4:00 PM

    View In Agenda
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    OCT Advisory Board

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    Dr Alison McMorn
    Head of Clinical Strategy and Development, LifeArc

    Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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    Behtash Bahador
    Senior Director, Community Engagement & Partnerships, CISCRP

    Behtash Bahador is the Senior Director of Community Engagement & Partnerships 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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    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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    Aditya Kotta
    VP Business Development, Novotech

    Aditya Kotta is the VP of Business Development for Novotech. He has been with the company since 2018. He has 14 years of experience in the clinical trial industry, working in both Clinical Operations and Business Development. He holds degrees in Biomedical Engineering from Johns Hopkins University and Medical Science from Boston University.

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    Martin Rodriguez
    Consumer Safety & Evidence Global Quality & Excellence Head, Opella

    Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

    I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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

    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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    Edwin van Vulpen
    Executive Director and Head of Clinical Business Development Euro-Asia
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