Outsourcing in Clinical Trials Europe 2023

Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023!

3 - 4

May

2023
  • Hyatt Regency Barcelona Tower, Spain
  • Complimentary
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Estrella Garcia​

Senior Director Global Clinical Operations, Almirall

Estrella began her ‘scientific odyssey’ at the University of Navarra, Spain, where she gained a PhD in Genetic Toxicology.  Following this, Estrella held at post-doctoral position at ICI (now Astra Zeneca) in Macclesfield, UK. At ICI Estrella’s focus was on novel anti-tumor drugs in the pre-clinical phase. Subsequently Estrella returned to Spain where she joined Almirall as a Clinical Research Scientist. Since then, Estrella has amassed a 30 year career with the company- taking on roles of increasing demand and responsibility, including Head of Allergy Therapeutic Area and Head of Clinical Development Operations- to the role she holds today.

 

Estrella leads her group and is responsible for clinical trials worldwide. Since Almirall do not have affiliates fully involved in clinical development, the company externalizes all clinical trials, with a strategic focus on keeping only core competencies- particularly for pivotal studies- in-house. In this capacity Estrella has worked with dozens of CROs and service providers managing Phase I to Phase IV clinical trials of all sizes, from small single centre studies to global programs involving hundreds of sites and thousands of patients. Her responsibility is covering the selecting, negotiation, contracting, managing and final evaluation of the CROs responsible for the worldwide clinical development, in order to deliver on the agreed timelines, quality and cost.

 

She has been responsible for ensuring Clinical Development for Aclidinium bromide in COPD was performed worldwide from the operational point of view on time, budget and quality, among other development from Almirall.

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Marco Salami​

Head of Clinical & RWE Outsourcing Management, Chiesi Farmaceutici

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Domenico Merante​

Therapeutic Area Clinical Lead Nephrology, Rare and Orphan Diseases, CSL Vifor

Dr Domenico Merante completed his degree in medicine in 1988 at the age of 25 and in 1993 became specialist of endocrinology, diabetes and metabolic diseases, both degrees obtained at the University of Pisa/Italy. Dr Merante is currently Clinical Research Lead TA Orphan/ Nephrology at CSL Vifor in Glattbrugg, Switzerland. He previously worked at Sosei Heptares in 2018-2019 as VP of Clinical Development and at Shionogi as VP and Head of Clinical Science in 2017 and 2018. Between 2007 and 2016 he covered the role of Senior Director of Clinical Development at Daiichi Sankyo Development Ltd, UK heading the European Frontiers/Opportunity Department. Dr Merante had previously worked at GSK Italy, Eli Lilly Italy, Novo Nordisk UK and Laboratori Guidotti Italy in several clinical positions. So far Dr Merante has spent 28 years in drug clinical development working in Italy, UK, US and Switzerland in multiple therapeutic areas. These include diabetes and complications (i.e. macular edema and neuropathic pain), fibromyalgia, endocrinology area (i.e. growth hormone deficiencies, Cushing syndrome), severe hypertension, infectious diseases, hematology and nephrology/orphan and rare diseases. Dr Merante has to date 119 publications amongst full papers, abstracts as either main author or co-author and oral presentations made during scientific or industry-based conferences.

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Xavi Jofre​

Digital Transformation Director, Barcelona Health Hub

I live between a fuzzy and a techie world!

I am focused on business, innovation and strategy management with over fifteen years of experience helping different kind of companies (from multinational to family-owned) and sectors such as new technologies, pharma, banking, trading and media & entertainment.

I am a graduate of Electronic Arts and Digital Design (URL & ESDI), a program for management development (ESADE), and an exchange program in Strategic Innovation and Cross-Cultural Management (HEC). He also holds a Master’s degree in International Business and Relations (ESEI Business School).

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Caoimhe Vallely-Gilroy​

Independent Advisor – HIRANI, former Global Head of Digital Health & Therapeutics at Healthcare Business

Caoimhe Vallely-Gilroy is a passionate advocate of patients’ rights and wishes. She strives to ensure that data from every single patient is appropriately used, never under-appreciated and answers more than one question. As part of her goal to create the optimum operating model of humanity, Caoimhe relentlessly focuses on the connected patient experience and works to promote and power patient autonomy with their own health and health data. 

 

Caoimhe has a background in clinical development, from leading and managing clinical trials, protocol analysis and patient sampling kit design, strategy development and implementation to ethical oversight, and regulatory affairs. She has also led and implemented new technologies and processes in the pharmaceutical industry, including digital biosample management, informed consent databases and biomarker operations strategy.  

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Ivan Vyshnivetskyy​

President, Ukrainian Association for Clinical Research

Graduated from Donetsk National Medical University (Ukraine) where he gained a PhD degree in Cardiology and an Associate Professorship in Internal Medicine. As a physician-investigator, he participated in over 70 clinical trials in various indications, including over 50 as Principal Investigator. Ivan worked as Head of the Clinical Trial Administration Unit at Donetsk Medical University until 2014. Since 2014 he has been working as an Associate Professor of the Healthcare Management Department National Medical University (Kyiv). Since November 2021 Ivan works with FutureMeds, a fast-growing professional clinical research site network, as Managing Director Ukraine. The President of the Ukrainian Association for Clinical Research since 2019.

 

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    2023 Sponsors Include:

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    Company Information

    Medidata is leading the digital transformation of life science, with the world’s most used platform for clinical development, commercial, and real-world data. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/

    Company Website

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

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    Company Information

    1MED is a dynamic and proactive international company providing regulatory support, digital solutions and full-service CRO assistance to the medical device and pharmaceutical industries, concentrating on innovation, continuous improvement, scalability and alignment with regulatory and clinical requirements.

    1MED’s goal is to transform a time-consuming and complex process, such as product approval, into a reliable, more predictable and streamlined process, while still guaranteeing quality and conformity to the applicable regulatory requirements.

    With a unique focus on medical devices and the ability to quickly develop smart and tailor-made solutions, 1MED’s experienced and specialised multidisciplinary team of more than 70 employees is able to meet the increasingly demanding requirements of medical device and in vitro product regulations.

    Thanks to a good and solid relationship with 14 Notified Bodies in the EU, the Swiss-based company has been able to lead more than 500 medical devices to successful CE marking.

    “We are committed to working at your side, designing and implementing highly competitive and affordable strategies precisely because we know, understand and predict your challenges”.

    Company Website

    To learn more , please visit our website - https://www.1med.ch/

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    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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    Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. TrialMaster, IRMS MAX, and TA Scan, the company’s flagship products, lead the way in reducing complexities in the drug and device discovery and commercialization process. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets.

    Company Website

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

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    Company Information

    APICES provides full range of clinical research services improving the quality of investigational products development optimizing the processes and activities of clinical research from project design to the publication of results, with expert project management that avoids and anticipates with contingency plans any possible deviation from the original project goals.

    Company Website

    To learn more , please visit our website - www.apices.es

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    To support the acceleration of drug development, over the last 12 years, ARENSIA Exploratory Medicine GmbH (www.arensia-em.com) has built up its own research clinics, with full Phase I infrastructure, entirely dedicated to the performance of sophisticated FIRST-in-PATIENT Phase IB, IIA and PROOF OF CONCEPT clinical trials with novel compounds. ARENSIA’s outstanding recruitment performance across numerous disease areas substantially reduces the overall number of sites and countries for any early-phase patient trial. ARENSIA’s speed and data quality provide our Partners/Sponsors with a strategic advantage across the entire lifecycle of a project, as they can progress their novel compounds much faster to later phases of research. ARENSIA is trusted by Leading Pharmaceutical and Biotechnology organizations worldwide. ARENSIA is based with its headquarters in Düsseldorf, Germany, and operates with 400+ talented employees in 7 countries

    Company Website

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

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    Company Information

    EMIS Recruit is an integrated solution that connects Research, Life Sciences and healthcare by embedding clinical research recruitment tools directly into the point of care systems.  EMIS recruit gives research organisations clear visibility of clinically relevant patients based on your study protocol. This enables us to provide you with qualified patients that streamline your recruitment process

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    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022.

    Company Website

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

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    IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. Formed through the merger of IMS Health and Quintiles, IQVIA has more than 58,000 employees worldwide. Learn more at www.iqvia.com.

    Company Website

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

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    Company Information

    Langland is a global health communications agency that helps people, sponsors and businesses think further. Combining patient, protocol, disease and media insights with data and technology, our Clinical Trial Experience discipline has delivered recruitment and retention solutions that have enrolled over 350,000 patients for 450 studies across 75 countries.

     

    Company Website

    To learn more , please visit our website - publicislangland.com

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    Company Information

    Novotech is an Australia based clinical CRO operating across Asia and South Africa. Headquartered in Sydney since 1996, Novotech has come to be recognised as the CRO of choice for many US and European biotechnology firms in the Asia Pacific. Our full service offering includes clinical program management, biometrics services and regulatory affairs.

    Company Website

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

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    Company Information

    Precision medicine is in our blood, our cells, our genes, and our name. Precision for Medicine (PFM), the full-service global CRO, is purpose-built to accelerate clinical research and development processes to bring life-changing therapeutics to those who need them most. We integrate clinical operations excellence, laboratory expertise, and advanced data sciences to deliver on the promise of personalized therapy; translating research into real-world results and forever reimaging how to get there.

    Company Website

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

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    Company Information

    Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease.

    Company Website

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

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    Company Information

    Suvoda is a global clinical trial technology company specializing in highly complex, life-sustaining studies in therapeutic areas like oncology, CNS, and rare disease. Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through IRT, eConsent, and eCOA solutions delivered on a single platform.

    Company Website

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

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    TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, we build solution-driven teams working for a healthier future. Bringing together nearly 700 professionals, TFS delivers tailored clinical research services in more than 40 countries. TFS  demonstrates  scientific  and  medical  competence  across populations and therapeutics, with industry-leading capabilities in:

     

    -Dermatology, Immunology and Inflammatory Diseases

    -Hematology and Oncology

    -Ophthalmology

    -Internal Medicine including Neurology & Respiratory

    -Pediatrics, Rare Diseases and Orphan Drugs

    -Real World Evidence​

    Detailed information about TFS, and its business offerings can be obtained through

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    THREAD is a leading provider of a proprietary, decentralized research platform and suite of supporting services used by biopharma, CROs and life science organizations to remotely capture data from participants and sites during, in-between and in lieu of in-clinic visits. THREAD’s platform and supporting services are helping customers to shorten study launch timelines, reduce study budgets with Virtual Visits, and bring studies from the clinic to patients’ homes. THREAD provides key platform features such as eConsent, eCOA/ePRO, sensors, reminders, and telehealth Virtual Visits to support remote data capture, hybrid virtual studies, and fully decentralized studies in key therapeutic areas. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners.

    Company Website

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

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    TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc.), pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact by driving quality, mitigating compliance risk, and enhancing patient engagement.

    Company Website

    To learn more , please visit our website - https://lifesciences.transperfect.com/

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    Viedoc designs engaging software for the life science industry. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. www.viedoc.com

    Company Website

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

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    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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    YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. 

    We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster. 

    Company Website

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

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      Why attend?

      Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the  3rd-4th May 2023!

      For the 13th Annual event, our flagship European clinical show will provide delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials.

      Don’t miss out on our jam-packed, 3-streamed agenda; join us in beautiful Barcelona in May 2023. We can’t wait to see you there!

      WHAT TO EXPECT FOR 2023?

      As this event returns to an in-person format, you can look forward to a networking focused event with industry leading presentations, interactive formats and the most innovative solution providers attending. Hear from industry leading speakers, Learn what is round the corner in terms of future trends and get the latest knowledge on new and upcoming disruptors.

      500+

      Attendees

      		80+

      Exhibitors

      		40+

      Speakers
      500+

      Attendees

      		80+

      Exhibitors
      40+

      Speakers

      Testimonials

      See What It's All About

      2023 Agenda

      • 3 May 2023
      • 4 May 2023
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      Streams

      Stream one

      Stream A: Outsourcing & Clinical Operations

      Stream two

      Stream B: Clinical Technology & Innovation

      Stream three

      Stream C: Clinical Data; Strategy & Planning

      Stream C: Clinical Data; Strategy & Planning

      Speakers

      11 AM

      CASE STUDY Data Access vs Data Privacy. Would the simplest not be to ask the patients themselves?

      In this talk Benoît will introduce PicAps (Patient in Control, Anonymity Privacy Secured) and explore the benefits of a direct anonymous communication with the patients.

      • For what? Clinical trials use cases: Lay summaries, Recruitment, Clinical trial data sharing, long time follow-up, home delivery, continuous monitoring ...
      • How it works: decentralized network of trusted neutral organizations to ensure privacy
      • Regulatory aspect
      • The big picture: access to EHR data

      Speakers

      11:45 AM

      Patient Engagement and eConsent – a historical look at Decentralized Trials and their future with a focus on eConsent

      • Patients will be more empowered
      • Trials will become decentralized
      • Technology will support this decentralization:
        o Wearables
        o Telemedicine
        o eConsent

      Speakers

      12:15 PM

      Exploring how to use data collected through consumer-wearables and integrate them into a clinical trial

      • How to integrate data collected through consumer-wearables into a clinical trial
      • Why consumer-wearables can provide wider access to clinical trials
      • Consumer wearables and data that they can reliably collect
      • Getting data from the wearables to contribute to the clinical trial

      Speakers

      12:45 PM

      The Opportunities and Challenges of Moving to Electronic Capture of Informed Consent

      Technology has revolutionized the process of obtaining a patient’s informed consent to participate in a clinical trial. Benefits of electronic informed consent (eConsent) include increased security, speed of roll-out, and detailed reporting in real time. However, concerns remain about the patient’s experience with the informed consent process while they are being asked to make a serious decision about their own health. In this presentation, we will explore

       

      • The advantages with eConsent for both patients and clinical site staff
      • Potential user experience challenges of consenting on a digital device
      • The design-led approach that YPrime has taken to its new eConsent app

      Speakers

      1:15 PM

      Lunch and networking

      2:15 PM

      Utilizing Data Mesh technologies for data analysis in clinical trials

      • Bullets to come

      Speakers

      2:45 PM

      Tech Showcase – eClinical Solutions; Tech Showcase – Clario

      Tech Showcase – eClinical Solutions 

      Tech Showcase – Clario

      3:15 PM

      The rise of RWE/RWD: Unlocking how to properly utilize real world evidence to improve study design and execution

      • Sharing positive experiences of supplementing clinical trial data with RWD/RWE
      • Navigating RWE to gain metrics on how many patients sites bring in to improve site selection
      • Utilizing RWE in a non-international study to look into desired factors
      • RWE allowing a better understanding of unmet need and unrepresentativeness- how can this benefit physician and patient?
      • Regulatory landscape isn’t giving many clues – what are regulators saying and how should we approach it?

      Speakers

      3:45 PM

      Afternoon refreshments and networking

      4:15 PM

      Communication & Innovation: Defining innovation in clinical trials

      • What is innovation in clinical trials?
      • Why communication is key in our innovation strategy?
      • How do we communicate innovation?

      Speakers

      Stream B: Clinical Technology & Innovation

      Speakers

      11 AM

      PANEL DISCUSSION Key considerations for designing and implementing DCTs; exploring the protocol design

      • Exploring the idea that DCT is not a one-size-fits-all approach
      • Looking to outsource if you lack internal capabilities to operationalize DCT
      • Designing a proactive strategy with patient groups to maximize efficiency and the patient experience
      • Considering a hybrid trial as a more agile design
      • Importance of engaging with regulatory agencies early
      • Using the knowledge of traditional sites – how to work with a combination of physical and remote sites for protocol design
      • Explore user testing and involvement when going digital

      Speakers

      11:45 AM

      Hybrid trials using DCT technology and processes; focus on patients and the sites

      • Highlighting the complexity that Hybrid/DCT brings whilst moving away from the common brick-and-mortar sites.
      • Discussing the rise in regulator concerns in areas such as investigator oversight, and participant’s safety when face to face contact is limited.
      • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more.
      • Major points to consider in designing hybrid/DCT trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind.

      Speakers

      12:15 PM

      Explore how Barcelona Health Hub is pushing forward digital tools in clinical trials

      How does digital transformation happen?

      • Discover how the health ecosystem looks like in 10 years from now
      • Barcelona Health Hub and digital health as a solution
      • How to choose a relevant partner for your clinical validation

      Speakers

      12:45 PM

      Simplifying site & patient engagement technology strategies through integration & automation

      Technology strategies that reduce effort, cost & support sustainability goals

       

      • Sites just want to get the job done

      Reduce the barrier to eClinical technology adoption at sites by offloading burden

      • Not all technology, integration and automation strategies are the same

      Understand how best-in-class technologies, established integrations and seemless automation comes together to make a difference for sites, patients and sponsors

      • How to evaluate technologies partners to maximize impact towards sustainability goals

      How the right technology investments and automations can reduce carbon footprint and optimize the clinical supply chain

      Speakers

      1:15 PM

      Lunch and networking

      2:15 PM

      Delving into Digital Health in Oncology clinical trials

      Speakers

      2:45 PM

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

      • Unique model of dedicated research clinics in Eastern Europe
      • Strategies for fast patient enrollment and retention
      • Operational tips for flawless study conduct
      • Takeaways after operating under unprecedented circumstances / case studies

      Speakers

      3:15 PM

      2023 UPDATE: Sharing practical experiences with Decentralized & Hybrid Trials – is there a future for DCT?

      • Advantages of DCT; from taking the trial to the patient boosting recruitment
      • The benefits and constraints of DCT based on practical experience from running DCT
      • Learnings from an inspection of an interventional DCT -what is the role of the patient?
      • Strategy/Planning: How do you make the decision to run a DCT; what are the considerations?
      • Is the future hybrid trials as they are more realistic and practical compared to full DCT?

      Speakers

      3:45 PM

      Afternoon refreshments and networking

      4:15 PM

      Paediatric-centric clinical trials: A right for children and young people

      • Children’s rights in their involvement in clinical research
      • Why? Who? Where? Involve children and young people
      • Return on the investment and return on the engagement
      • eYPAGnet: European Network of Young Person’s Advisory Groups Network
      • Case study: DCT in paediatric clinical trials

      Speakers

      4:45 PM

      Session Reserved for THREAD

      5:15 PM

      CLOSING KEYNOTE: Decentralized Clinical Trials/Hybrid Trials: Lessons learned and what you need to know to run them successfully

      • Delving into the promise of DCT
      • Laying the innovation and technical foundation for DCT
      • My key learnings from running DCT/hybrid trials
      • Tangible takeaways

      Speakers

      5:55 PM

      Chair’s Summary & Drinks Reception

      7:45 AM

      Conference Registration and refreshments

      8:20 AM

      Chair’s opening remarks

      Speakers

      8:30 AM

      KEYNOTE Disaster Preparedness: How can the clinical trial industry prepare for the unexpected? Using the Ukrainian crisis as a case study

      • Briefly explaining the impact of the war on Ukraine’s/Europe’s clinical trial industry
      • Involving sites with sponsor decisions when developing Decentralized models – what tech and solutions can sites offer?
      • Identifying what protocol changes help sites vs what makes their job harder
      • A message to Ukrainian Pharma offices: Importance of backup plans to ensure data integrity and keep trials moving
      • Mitigation risk plans: Making plans for the future and involving all clinical trial stakeholders
      • New solutions – bringing in a reliable Ukrainian CRO with local knowledge to work directly with trial sponsors

      Speakers

      9 AM

      Leveraging DCT Technology to Pair Objective and Subjective Patient Data for Improved Outcomes

      What does it take to create a more holistic view of the patient journey in clinical trials? Hybrid and decentralizing solutions can bring clinical trials to any patient who is interested and provide more flexible choices for how they participate. By utilizing sensors (objective data) in conjunction with ePROs (subjective data), sponsors and sites can diversify study enrollment, improve patient satisfaction and retention, and increase the generalizability of study findings. Join Joseph Lovett, Solution Specialist at Medidata, for this session to learn more about how you can expand choice for patients in DCTs to benefit both patients and study staff, including what DCT technologies will reduce vs. increase burden.

       

      • Learning Objectives:
      • Learn about the methodology of incorporating technology that benefits all stakeholders
      • Understand the different types of objective and subjective data capture (manual, automated, and direct) in DCTs
      • Discover how to utilize diverse technologies to gather better and more relevant patient data

       

       

      Medidata

       

      9:30 AM

      INTERACTIVE SESSION – The Diversity Conversation – follow up from the 2022 discussion and what we should do for 2023 and beyond

      This session will cover diversity and race inequalities in clinical trials; why we have underrepresentation and why it’s vital we improve. Robert & Roel will give an overview and then open up the discussion to the audience;

      • Exploring what diversity means in clinical trials – what have we done to improve this since the 2022 event?
      • How can we improve engagement by paying more of a focus on race and socioeconomic disparities?
      • Exploring the role of patient advocacy groups in tackling underrepresentation
      • Highlighting the impact on your trial if all groups aren’t adequately represented – ask ourselves why not
      • Brainstorming solutions: What actions can we take now to get groups interested in participating in trials?
      • Audience stories, feedback and strategies moving forward

      Speakers

      10 AM

      Advancements in AI: turning big data into actionable intel for optimal site identification

      Despite advancing technologies, trials still struggle to meet patient enrolment goals. Slow enrolment directly impacts schedule and budget, with each day of delay carrying cripplingly high costs. Successful, timely patient recruitment is directly linked to effective site selection. Conversely, selecting the wrong site can negatively impact recruitment or result in total failure to enroll patients.

       

      Join us to learn how advancements in AI can help the pharma industry identify the best sites for their clinical trials through the harnessing of big data. Topics include:

      • Transitioning from data overload to data driven decision-making
      • The role of Artificial Intelligence in optimizing site identification and selection
      • Expected and unexpected downstream benefits of an AI-enabled site selection strategy

      Speakers

      10:30 AM

      Morning refreshments and networking

      Stream A: Outsourcing & Clinical Operations

      Speakers

      11 AM

      PANEL DISCUSSION Handling prolonged site start-up times and the worldwide site staff shortages crisis

      • Pinpointing the challenges of getting all vendors/systems in place for study start-up –is this beyond the site’s capacity?
      • Encouraging all stakeholders to take time and get involved in budget negotiation to reduce site activation delays
      • With complexity of trials increasing, what affect will this have on site staff training?
      • Importance of easy access to training particularly when site staff is low – can vendors help?
      • Sharing ideas for retaining site staff/physician talent in the industry
      • Could flying study nurses help in the short term?

      Speakers

      11:45 AM

      Session Reserved for Worldwide Clinical Trials

      12:15 PM

      CASE STUDY Stop taking the easy route! Delving into recent societal changes and how Clinical Trials can adapt

      • Appreciating the need to be more inclusive with race but what about other underrepresented groups?
      • Discussing the use of male vs female in ICFs and inclusion/exclusion criteria –impact of not including LGBTQ+
      • Exploring the benefits of updating your ICF to adapt to societal changes and linguistic challenges
      • Best practices for engaging with ethics committees and coming to an agreement on terms
      • Examples of getting wording approved by ethics committee – get hands on today!

      Speakers

      12:45 PM

      Session Reserved for Novotech

      1:15 PM

      Lunch and networking

      2:15 PM

      Call for research in creative climate in organization in clinical development

      Mariusz will explore his research and discovery on how to help CRO and pharma to be more productive

      Speakers

      2:45 PM

      Session Reserved for 4G Clinical

      3:15 PM

      Optimizing oversight & governance: What does oversight mean to you?

      • Best practices and tools for managing supplier governance and ascertaining who is accountable
      • Identifying the criteria to determine level of oversight needed for a vendor
      • Local vendor oversight vs global provider oversight – how would you manage this differently?
      • Strategies for managing CRO governance for small/start-up companies with limited resources or large companies with competing priorities

      Speakers

      3:45 PM

      Afternoon refreshments and networking

      4:15 PM

      Pro et contra of working with Professional Site Networks for sponsors and CROs

      • Does the industry needs professionalization of clinical research sites?
      • The general perception of site networks and site management organizations
      • What benefits can professional site networks provide to sponsors and CROs
      • Risks and drawbacks of working with Professional Site Networks

      Speakers

      4:45 PM

      Session Reserved for Premier Research

      5:15 PM

      CLOSING KEYNOTE Gain a comprehensive overview of the EU Clinical Trial Regulation and changes for trials in the EU

      • Intro to EuCTR and CTIS
      • Experience in CTIS and KPIs: Organization model Sponsor-CRO: Challenges and Success cases
      • Benefits of submitting through the same portal for all sponsors/CROs and the advantages for biopharma companies of standardized timelines
      • Overview of major new requirements, such as transparency rules and regulatory submission packages
      • Understanding the new trial authorization process for regulatory and ethical approval

      Speakers

      5:55 PM

      Chair’s Summary & Drinks Reception

      Streams

      Stream one

      Stream A: Outsourcing & Clinical Operations

      Stream two

      Stream B: Clinical Technology & Innovation

      Stream B: Clinical Technology & Innovation

      Speakers

      9 AM

      WORKSHOP Introducing The Patient Centric Sample Interest Group

      This workshop will explore different approaches and strategies for putting patients at the centre when collecting samples for clinical trials

      Speakers

      9:45 AM

      Practical innovation: Powering IRT for improved patient management and drug logistics in a clinical trials platform

      • Clinical trials today are becoming increasingly complex, and the technology landscape to manage them can be complicated and overwhelming.
      • Seamlessly connecting IRT with eConsent and eCOA in a single platform enhances the user experience, reduces workloads, and drives rapid deployment through centrally shared data and streamlined workflows
      • Explore examples of how interoperable systems increase visibility to patient data, more accurately project supply and resupply needs, and support timely outcomes data collection, all through your IRT

      Speakers

      10:15 AM

      The metaverse in Pharma it could be a possible solution?

      • Explore what’s the metaverse
      • If the pharma industry is ready for the tech
      • What could be an add value for the Customer

      Speakers

      10:45 AM

      Advancing Towards Patient-Centered Measurement Methods by Integrating ePRO in Oncology Trials; Lessons Learned from a Recent Study

       

      • Reviewing the strategy for the provision of the user-friendly platforms
      • Identifying the potential barriers in day-to-day utilization and how they can be overcome
      • Discussing the expectations of PRO in oncology research moving forward

      Speakers

      11:15 AM

      Morning refreshments and networking

      11:45 AM

      Bridging the gap from RCTs through Real World Evidence into clinical practice; exploring how to improve patient focussed disease management

      • Relevance of generating Real World Evidence data in rare ad orphan kidney diseases
      • The urgent need to access main clinical data, including those from still unpublished clinical studies
      • Bridging an existing gap between randomized clinical trials results and clinical practice evidence for people affected by rare and orphan kidney diseases
      • Development of ‘personalized’ treatment algorithms to improve patient-focused outcomes in patients suffering from these diseases

      Speakers

      12:15 PM

      Session Reserved for EMIS

      12:45 PM

      Case study: Clinical digitalization roadmap for medical device companies

      • Outlining the specific digital transformation goals and requirements
      • Overcoming operational challenges associated with medium-sized medical device companies
      • Journey to successful clinical digitalization

      Speakers

      1:15 PM

      Lunch and networking and Apple Prize draw

      2:15 PM

      Practical use cases to improve clinical site efficiency with technology

      • Using technology to work with sites
      • Using machine learning to increase efficiency
      • Leveraging interoperability to streamline operations

      Speakers

      3:15 PM

      INTERACTIVE THINK TANKS

      Interactive think tank sessions offer a unique opportunity to come together to share best practice and develop solutions to challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, think tanks are an interactive way to build your personal network and learn from the experience of others.

      Each think tank session lasts for 30 minutes, and delegates may attend up to 2

      Think Tank 1: What does the clinical trial industry really want from its service providers?

      Host: Estrella Garcia, Senior Director Global Clinical Operations, Almirall

      Think Tank 2: Building strategic partnerships with CROs

      Host: Elena Carzana, Vendors Alliance Manager DM&Stat, Chiesi Farmaceutici & Anna Pugnetti, Global Clinical and RWE Outsourcing Manager, Chiesi Farmaceutici

      Think Tank 3: TBC- Working with Patient Advocacy Groups & overcoming barriers with patient engagement

      Host: Patryk Mikucki, Global Head of Country Operations, Alexion

      Think Tank 3: TBC TOPIC

      Host: Lars Tranberg Pettersson, Chief Information Officer, Ascendis Pharma

      Think Tank 5: Migrating Leadership Perspective: Moving from EGO to ECOSystem mindset

      Host: Orlando Vergara, Pharmaceutical and Healthcare Expert, Universidad Autónoma del Perú

      Speakers

      4:15 PM

      End of Event

      8:10 AM

      Registration and refreshments

      8:45 AM

      Chair’s opening remarks

      Stream A: Outsourcing & Clinical Operations

      Speakers

      9 AM

      PANEL DISCUSSION Reversing the Conversation: What the clinical trial industry really wants from its service providers

      We’ve all had to sit through pitches from vendor companies telling us what they can do for us, but now it’s time to reverse the conversation! Hear from the trial industry as they discuss the services they would like to see from their solution providers, including:

      • What they like to see in an outsourced partner organization
      • What they would like a partner to know about them / how they work
      • What things do they need a partner to do and what they don’t need!
      • What things can be best done in house?

      Speakers

      9:45 AM

      EU MDR: how attractive is Europe for innovation?

      Talking Points: “The aim of the presentation is to highlight MDR positive and negative consequences on the development of new medical devices by answering to the following questions:

      • What are the main regulatory challenges for new medical devices after EU MDR?
      • How MedTech companies are reacting?
      • Is CE-mark still "first choice" by start-ups and SMEs?

      Speakers

      10:15 AM

      FIRESIDE CHAT Establishing strong CRO/sponsor relationships and building trust in a more virtual landscape- What 5 things does our expert speaker say to focus on right now?

      • Oversight with less presence– designing an oversight plan based on KPIs, fewer monitoring visits and more virtual meetings, how to make this work
      • Lessons learned on how to effectively build working relationships remotely
      • Strategies to deliver training and upskill your clinical trial team
      • Handling hard discussions with the site remotely if can’t get there in person
      • Guidance on improving CRO communication channels– keep CROs in the loop and draw on their experience
      • We are all human, we all fail: Ensuring positivity in initial stages and taking responsibility

      Speakers

      10:45 AM

      How to succeed in your Oncology clinical trial from regional-medium CRO’s point of view?

      • What is the added value of the small and medium CROs?
      • Can these CROs successfully manage current changes in technology paradigm?
      • Can we help to optimize enrollment challenge to reduce costs and get results within timelines?

      Speakers

      11:15 AM

      Morning refreshments and networking

      11:45 AM

      Being a Process Manager, when all processes collapse – War in Ukraine, one sponsor’s perspective

      • What is business continuity during the war in Ukraine and how are we ensuring it?
      • Leading people, process, projects
      • Processes adaptation, flexible decisions: remote SDR and SDV implementation, electronic signatures
      • Experience in patients transfers within and outside of Ukraine

      Speakers

      12:15 PM

      Why Patient Participation Isn’t Recovering and Tactics to Drive Change

      • Covid-19 pandemic has changed the paradigm of clinical research, with a rapid uptick in adoption of new technologies and integrated ecosystems, to enable and support decentralized trials, patient recruitment and retention,  or data transference form electronic health records (EHC) into electronic data capture (EDC), among others
      • This new technologically-driven environment requires additional collaboration between Sponsors, Clinical Research Organizations (CRO), investigators and other vendors and providers.
      • In parallel, global analysis shows a trend on decreasing number of subjects participating in clinical trials, as well as recruitment rates
      • Is it time to look into clinical trials from a different angle?

      Speakers

      12:45 PM

      Exploring the role of Quality in vendor oversight and vendor quality agreements

      • How can Quality provide more support to the study team, particularly with vendor oversight?
      • Exploring the importance of quality agreements and vendor communications – how can we add more value with monitoring/safety aspects?
      • Best practices in reporting to ensure patience safety and preventative action
      • How can Quality work more closely with regulatory bodies on reporting issues to ensure GCP?
      • Exploring risk-based quality management strategies

      Speakers

      1:15 PM

      Lunch and networking and Apple Prize draw

      2:15 PM

      Is a clinical trial a customer experience? Insights from consumer research

      • Consumer brands thrive on a sophisticated understanding of the needs and motivations of their customers, and the role the brand plays in their lives.
      • Clinical trials don't typically prioritise such a deep understanding of their end user, but trials don't happen in a vacuum.
      • As people increasingly expect consumer-like personalisation and choice from their healthcare, what can clinical trials learn from thinking of participants as customers?

      Speakers

      2:45 PM

      The current impact and future of Decentralized Clinical Trials

      • The impact of COVID-19 on the future of clinical trials and the main concern for primary sponsors and CRO's during the COVID-19 pandemic
      • The movement towards DCT's and why sponsors are incorporating digital elements into clinical trials and the challenges around this
      • How AI can aid decentralized trials and real-life case studies

      Speakers

      3:15 PM

      INTERACTIVE THINK TANKS

      Interactive think tank sessions offer a unique opportunity to come together to share best practice and develop solutions to challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, think tanks are an interactive way to build your personal network and learn from the experience of others.

      Each think tank session lasts for 30 minutes, and delegates may attend up to 2

      Think Tank 1: What does the clinical trial industry really want from its service providers?

      Host: Estrella Garcia, Senior Director Global Clinical Operations, Almirall

      Think Tank 2: Building strategic partnerships with CROs

      Host: Elena Carzana, Vendors Alliance Manager DM&Stat, Chiesi Farmaceutici & Anna Pugnetti, Global Clinical and RWE Outsourcing Manager, Chiesi Farmaceutici

      Think Tank 3: TBC- Working with Patient Advocacy Groups & overcoming barriers with patient engagement

      Host: Patryk Mikucki, Global Head of Country Operations, Alexion

      Think Tank 3: TBC TOPIC

      Host: Lars Tranberg Pettersson, Chief Information Officer, Ascendis Pharma

      Think Tank 5: Migrating Leadership Perspective: Moving from EGO to ECOSystem mindset

      Host: Orlando Vergara, Pharmaceutical and Healthcare Expert, Universidad Autónoma del Perú

      Speakers

      4:15 PM

      End of Event

      2023 Speakers

      Select a speaker to learn more

      Back
      Daniel McVeigh
      Director, Clinical Project Lead, Alexion

      A Clinical Research Professional with over 12 years’ experience across various settings such as Site, CRO, Small Biotech and Pharma. Expertise in various therapeutic areas from Oncology and Rare/Orphan Disease. Experience from early phase first in human to late phase and Nov Intervention RWE generation and Registries. Focused on Clinical Operations excellence and process improvements for the benefit of the patients we serve. Currently Director, CPL at Alexion, AZ Rare Disease leading a Cross Functional clinical team in the execution of multiple clinical studies and PASS studies.

      Session Details:

      Optimizing oversight & governance: What does oversight mean to you?

      2023-05-03, 3:15 PM

      Session Details:

      PANEL DISCUSSION Reversing the Conversation: What the clinical trial industry really wants from its service providers

      2023-05-04, 9:00 AM

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      Werner Gladdines
      VP, Clinical Development Operations, Immunic Therapeutics

      I am a passionate biotech drug development executive with over 20 years of extensive global clinical operations and clinical sciences experience in oncology, immunology, neurology, gastro-intestinal and metabolic orphan diseases; I have actively contributed to the registration of 3 medicinal products and led multiple investigational products from idea to phase II/III, overseeing all the operational activities. I have an in-depth knowledge of FDA/EMA regulations for GCP’s, GLP’s and GMP’s and experienced in establishing and developing clinical operations, regulatory affairs and quality assurance systems. I have strong management and leadership abilities and have led development operational teams up to 40 FTE, external consultants and global Clinical Research, Lab and Manufacturing Organizations in over 35 international phase I to IV clinical studies.

       

      Special interests: building biotech development teams, operations excellence, innovation in clinical development operations

      Session Details:

      FIRESIDE CHAT Establishing strong CRO/sponsor relationships and building trust in a more virtual landscape- What 5 things does our expert speaker say to focus on right now?

      2023-05-04, 10:15 AM

      Session Details:

      PANEL DISCUSSION Reversing the Conversation: What the clinical trial industry really wants from its service providers

      2023-05-04, 9:00 AM

      Session Details:

      Stream A: Outsourcing & Clinical Operations

      2023-05-04, 8:50 AM

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      Mariusz Olejniczak
      CEO, WPD Pharmaceuticals

      CEO of WPD Pharmaceuticals Inc and WPD Pharmaceuticals Sp. z o.o. Experienced expert in medicinal products, medical devices, supplements and plant protection products R&D at every stage - from planning and scientific advice through supervision to the closure and finalization of the project. A founder of several start-ups in the e-health industry and a member of the board and supervisory board of several R&D companies. Author of the publication „Change of the product development model as an opportunity for the Polish pharmaceutical industry” (in Polish). Member of the editorial committee of the book „Clinical Trials” (in Polish). Lecturer in postgraduate study programs.

      Session Details:

      PANEL DISCUSSION: Trials & tribulations of conducting a clinical trial in Europe throughout the pandemic, tips & tricks for the future

      2023-05-04, 11:30 AM

      Session Details:

      Call for research in creative climate in organization in clinical development

      2023-05-03, 2:15 PM

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      Robert S. Greene
      President, Hunger and Thirst Foundation

      Robert Greene is an experienced patient advocate and speaker. Driven by his passion for a more patient-centered and patient-centric approach within the entire patient pathway, he takes pride in using his experience to educate others on the importance of patient involvement and patient engagement. As a Patient Advocate, consultant, and speaker, his goals include igniting collaboration between the industry, patient organizations, and other stakeholders. His experience with side effects during his chemotherapy treatment in 2012 – 2013 led him to become involved in advocacy work. He wants to be a voice for those who came before him, those dealing with cancer today, and the millions whose lives will be affected by cancer in the future. Robert is the founder and President of the HungerNdThirst Foundation. He is a member of the ASCO Foundation Grants Selection Committee, a GSK Health Advisory Board Member, Data Saves Lives Patient Advisory Board Board Member, Gravitate Health Legal and Ethical Board, and a Rising Tide Review Committee Member. 

      Session Details:

      Chair’s opening remarks

      2023-05-03, 8:20 AM

      Session Details:

      PANEL DISCUSSION Handling prolonged site start-up times and the worldwide site staff shortages crisis

      2023-05-03, 11:00 AM

      Session Details:

      INTERACTIVE SESSION – The Diversity Conversation – follow up from the 2022 discussion and what we should do for 2023 and beyond

      2023-05-03, 9:30 AM

      Session Details:

      Stream A: Outsourcing & Clinical Operations

      2023-05-03, 10:45 AM

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      John Zibert
      Chief Medical Officer, Coegin Pharma AB

      Dr. John Zibert is Chief Medical Officer at LEO Innovation Lab, LEO Pharma’s independent innovation unit, where he leads a decentralized clinical trials unit, Studies&Me, working to personalize treatment development. Dr. Zibert has a history of more than seven year with LEO Pharma where he has held a number of positions as medical director for Region Europe, Medical advisor, Project leader and scientist. Dr. Zibert has senior experience with pharmaceutical drug development for various skin diseases, for which he contributed to the launch of two new products. He holds a B.Sc. in microbiology, M.Sc. in Human biology and a Ph.D. in medicine. John Zibert has been carrying out International clinical research on skin diseases and cancers for over a decade, with several publications in high-tier peer-reviewed journals. Prior to his scientific work, Dr. Zibert spent seven years in the Danish armed forces’ health and sports sector, and as a paramedic.

      Session Details:

      PANEL DISCUSSION Key considerations for designing and implementing DCTs; exploring the protocol design

      2023-05-03, 11:00 AM

      Session Details:

      2023 UPDATE: Sharing practical experiences with Decentralized & Hybrid Trials – is there a future for DCT?

      2023-05-03, 3:15 PM

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      Sonja Weiser
      Senior Director Clinical Operations, Insmed

      Clinical Research Professional (Pharmacist), PhD (Medical School ‐ Pharmacology/Toxicology) and PMP

      (2016) with more than 20 years’ experience in Biotech / Health Care Industry / CRO / Drug Development/ Clinical Research.

      Expertise ranging from Clinical Research/Clinical Operations experience in Pharma, Biotech and CRO

      with focus on Oncology, Immunology, Infectious Disease, Respiratory indications and Rare/Orphan

      indications. Focused on goal achievement, constant striving for improving processes on an international / global level, strong project management background.

      Dedication to people management as the main success factor in clinical research/clinical development – foster open & trustful communication on a global level.

      Strong believer in "Manage by example" as key to success in drug development.

      Session Details:

      PANEL DISCUSSION Handling prolonged site start-up times and the worldwide site staff shortages crisis

      2023-05-03, 11:00 AM

      Session Details:

      PANEL DISCUSSION Reversing the Conversation: What the clinical trial industry really wants from its service providers

      2023-05-04, 9:00 AM

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      Benoît Marchal
      Chief Digital Trust Officer, Partners for Patients, PicAps (NFP)

      Benoît has a Master degree in IT from the University of Compiègne France and has worked 25+ years for the digitalisation of the clinical trials process for start-ups and world leading medical device and pharmaceutical companies. 

      As Chief Digital Trust Officer for Partners for Patients, Benoît aims at proposing disruptive digital approaches to specific challenges in the industry like health data access. 

      As the founder of the PicAps association, Benoît intends to implement one of such propositions: empowering the patients while keeping their anonymity well protected 

      Session Details:

      CASE STUDY Data Access vs Data Privacy. Would the simplest not be to ask the patients themselves?

      2023-05-03, 11:00 AM

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      Estrella Garcia
      Senior Director Global Clinical Operations, Almirall

      Estrella began her ‘scientific odyssey’ at the University of Navarra, Spain, where she gained a PhD in Genetic Toxicology.  Following this, Estrella held at post-doctoral position at ICI (now Astra Zeneca) in Macclesfield, UK. At ICI Estrella’s focus was on novel anti-tumor drugs in the pre-clinical phase. Subsequently Estrella returned to Spain where she joined Almirall as a Clinical Research Scientist. Since then, Estrella has amassed a 30 year career with the company- taking on roles of increasing demand and responsibility, including Head of Allergy Therapeutic Area and Head of Clinical Development Operations- to the role she holds today.

       

      Estrella leads her group and is responsible for clinical trials worldwide. Since Almirall do not have affiliates fully involved in clinical development, the company externalizes all clinical trials, with a strategic focus on keeping only core competencies- particularly for pivotal studies- in-house. In this capacity Estrella has worked with dozens of CROs and service providers managing Phase I to Phase IV clinical trials of all sizes, from small single centre studies to global programs involving hundreds of sites and thousands of patients. Her responsibility is covering the selecting, negotiation, contracting, managing and final evaluation of the CROs responsible for the worldwide clinical development, in order to deliver on the agreed timelines, quality and cost.

       

      She has been responsible for ensuring Clinical Development for Aclidinium bromide in COPD was performed worldwide from the operational point of view on time, budget and quality, among other development from Almirall.

      Session Details:

      INTERACTIVE THINK TANKS

      2023-05-04, 3:15 PM

      Session Details:

      INTERACTIVE THINK TANKS

      2023-05-04, 3:15 PM

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      Roman Fishchuk
      Head of Clinical Trials Department, Central City Clinical Hospital, Ukraine

      CEO of a clinical trials unit that was founded from scratch in 2017 at a state hospital in Ivano-Frankivsk, Ukraine and now developed into an organization with 15-20 multi-specialty trials running simultaneously with a potential to grow. One of the founders and current Board member of the Ukrainian Association for Clinical Research. Adept ENT doctor and principal investigator in otolaryngology with ability to work in a multidisciplinary team, experience in delivering patient care in both public and private settings with the use of the latest industry equipment and technology, as well as establishing own private practice. Proactive and dedicated to seeking opportunities for cooperation with international specialists. Strong knowledge of Ukrainian medical policy landscape through working with the Ministry of Health of Ukraine on reforming healthcare services. Proven track record of planning and executing projects in medical sphere.

      Session Details:

      PANEL DISCUSSION Handling prolonged site start-up times and the worldwide site staff shortages crisis

      2023-05-03, 11:00 AM

      Session Details:

      KEYNOTE Disaster Preparedness: How can the clinical trial industry prepare for the unexpected? Using the Ukrainian crisis as a case study

      2023-05-03, 8:30 AM

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      Silvia Perez Torres
      Director, Clinical Quality Compliance, AstraZeneca

      I have a PH degree in Pharmaceutical sciences by the Barcelona University. I started my career as a researcher in Neurochemical department within the Barcelona Biomedical Research Institute (IIBB), where I developed my PH degree focused on Alzheimer’s disease and Inflammation.

      Once I completed my Ph Degree in Neuroscience, I moved to the clinical industry, working most of my career in Data Management, first in a small CRO company and later in the pharma industry.

      For along almost 12 years, I was managing phase III clinical trials acting as Global Data Manager Lead, coordinating end-to-end data management activities (including SDTM development) mainly outsourced to global CROs. Apart of the oversight of clinical trials, part of my role as an expert in DM was to lead standardization on E2E data and processes.

      On 2018, I completely changed my role and moved to the Quality area. Since then, I’m Director on Clinical Quality Compliance. On this role, I’m providing quality support to Biometrics functions (including DM, Programming and Statistics roles). Among other activities, I’m giving quality related advice and guidance, overseeing quality issues, CAPA implementation and risk management. Coordinating and supporting audit and inspections, as well as preparing teams to be inspection ready at all time.

      Since 2020, I’m Regulatory Considerations Expert Group DMEG Chair on the Association for Clinical Data Management. The aim of the Regulatory Considerations Expert Group looks at providing guidance information on several areas surrounding regulations. The expectations and recommendations on implementation and what data management needs to be prepared for in readiness for inspection.

      Session Details:

      Exploring the role of Quality in vendor oversight and vendor quality agreements

      2023-05-04, 12:45 PM

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      Ivan Vyshnivetskyy
      President, Ukrainian Association for Clinical Research

      Graduated from Donetsk National Medical University (Ukraine) where he gained a PhD degree in Cardiology and an Associate Professorship in Internal Medicine. As a physician-investigator, he participated in over 70 clinical trials in various indications, including over 50 as Principal Investigator. Ivan worked as Head of the Clinical Trial Administration Unit at Donetsk Medical University until 2014. Since 2014 he has been working as an Associate Professor of the Healthcare Management Department National Medical University (Kyiv). Since November 2021 Ivan works with FutureMeds, a fast-growing professional clinical research site network, as Managing Director Ukraine. The President of the Ukrainian Association for Clinical Research since 2019.

       

      Session Details:

      PANEL DISCUSSION Handling prolonged site start-up times and the worldwide site staff shortages crisis

      2023-05-03, 11:00 AM

      Session Details:

      Pro et contra of working with Professional Site Networks for sponsors and CROs

      2023-05-03, 4:15 PM

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      Ivanna Rosendal
      Director, Global Process Governance, Ascendis Pharma

      Session Details:

      Exploring how to use data collected through consumer-wearables and integrate them into a clinical trial

      2023-05-03, 12:15 PM

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      Social Links:

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      Priya Nair
      Senior Analyst, GlobalData

      Session Details:

      PANEL DISCUSSION Key considerations for designing and implementing DCTs; exploring the protocol design

      2023-05-03, 11:00 AM

      Session Details:

      The current impact and future of Decentralized Clinical Trials

      2023-05-04, 2:45 PM

      Session Details:

      Stream B: Clinical Technology & Innovation

      2023-05-04, 8:50 AM

      Session Details:

      Stream B: Clinical Technology & Innovation

      2023-05-03, 10:45 AM

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      Roel van der Heijde
      Facilitator & Trainer, Patient Experience Association

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

      He is a driven and experienced trainer and facilitator in:

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

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

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

      Session Details:

      INTERACTIVE SESSION – The Diversity Conversation – follow up from the 2022 discussion and what we should do for 2023 and beyond

      2023-05-03, 9:30 AM

      Session Details:

      Stream C: Clinical Data; Strategy & Planning

      2023-05-03, 10:45 AM

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      Marco Salami
      Head of Clinical & RWE Outsourcing Management, Chiesi Farmaceutici

      Session Details:

      FIRESIDE CHAT Establishing strong CRO/sponsor relationships and building trust in a more virtual landscape- What 5 things does our expert speaker say to focus on right now?

      2023-05-04, 10:15 AM

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      Anna Pugnetti
      Global Clinical and RWE Outsourcing Manager, Chiesi Farmaceutici

      Anna has a Master degree in International Business from the University of Parma (Italy) and has 6 years of experience in the field of clinical outsourcing. During this time, she has worked across all study phases in respiratory area mainly in particular in developing strategic relationships with some CROs/Clinical Providers in order to ensure efficiency and processes fluidity in terms of budget and contractual negotiation.

      Session Details:

      INTERACTIVE THINK TANKS

      2023-05-04, 3:15 PM

      Session Details:

      INTERACTIVE THINK TANKS

      2023-05-04, 3:15 PM

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      Elena Carzana
      Vendors Alliance Manager DM&Stat, Chiesi Farmaceutici

      Elena has a Master degree in Pharmaceutical Chemistry and Technology from the University of Padua Italy and has 15+ years of experience in the field of clinical development at pharma and medical device companies. During this time, she has worked across all study phases, including large phase III clinical trials and across different therapeutic areas. As Vendors Alliance Manger, Elena shapes the relationships with the strategic vendors from concept through operationalization to maximise their value and efficiency.

      Session Details:

      INTERACTIVE THINK TANKS

      2023-05-04, 3:15 PM

      Session Details:

      INTERACTIVE THINK TANKS

      2023-05-04, 3:15 PM

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      Smruthi Panyam
      Director, Clinical Data Informatics, BeiGene

      Session Details:

      The rise of RWE/RWD: Unlocking how to properly utilize real world evidence to improve study design and execution

      2023-05-03, 3:15 PM

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      Laura Jiménez Robledo
      Clinical Project and Innovation Manager, Novo Nordisk

      Session Details:

      Communication & Innovation: Defining innovation in clinical trials

      2023-05-03, 4:15 PM

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      Joana Claverol
      Clinical Research Unit Manager, Sant Joan de Deu Barcelona Hospital

       Joana Claverol , is the Clinical Research Director at Barcelona Children’s Hospital Sant Joan de Déu, Spain, where she leads the clinical trials office since 2012 and the Patients engagement in research area since 2015. The Clinical Research Unit is a reference unit for pediatric patients nationally and internationally, specializing in innovative treatments for highly complex patients with rare pediatric diseases. She has more than 13 years of experience in medical and clinical research in the pharmaceutical and biotechnology industry, with special knowledge and experience in drug development and clinical trial design, and all regulatory and methodological aspects related to clinical research. She holds a postgraduate in Senior Management Program of Health Institutions by IESE Business School, a Master in Pharmaceutical Marketing by Universitat Pompeu Fabra, a Master of clinical trials at Universitat de Barcelona and a BS Degree in Biological Sciences by Universitat Autonoma de Barcelona.

      Session Details:

      Paediatric-centric clinical trials: A right for children and young people

      2023-05-03, 4:15 PM

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      Stephen Lutsch
      Former Director - Revolutionize Clinical Trials (ReCT), LEO Pharma

      I have been working to bring the best disruptive innovation into normal clinical operations at LEO Pharma to help improve and accelerate our clinical trials. Furthermore, I am trying to solve some of the toughest challenges related to scaling digitalisation, 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. 

      Specifically, the team I led received approval for the first fully decentralised and hybrid interventional clinical trial for LEO Pharma with the goal of accelerating the ambition to design hybrid DCTs as default. Besides driving the necessary change internally, we focused 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.

      Personally, I live in Denmark north of Copenhagen with my lovely wife and three young children. Besides raising the little ones, I love learning new skills and solving problems in my spare time as I am quite curious by nature. Currently, home automation and renovations are catching my limited extra time, though I’m always up for competitive sports or games of pretty much all kinds when possible from poker to basketball or padel tennis. 

      Session Details:

      PANEL DISCUSSION Key considerations for designing and implementing DCTs; exploring the protocol design

      2023-05-03, 11:00 AM

      Session Details:

      CLOSING KEYNOTE: Decentralized Clinical Trials/Hybrid Trials: Lessons learned and what you need to know to run them successfully

      2023-05-03, 5:15 PM

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      Mateusz Zabolski
      Head of Technology – Biosamples, AstraZeneca

      Session Details:

      Utilizing Data Mesh technologies for data analysis in clinical trials

      2023-05-04, 2:45 PM

      Session Details:

      Utilizing Data Mesh technologies for data analysis in clinical trials

      2023-05-03, 2:15 PM

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      Domenico Merante
      Therapeutic Area Clinical Lead Nephrology, Rare and Orphan Diseases, CSL Vifor

      Dr Domenico Merante completed his degree in medicine in 1988 at the age of 25 and in 1993 became specialist of endocrinology, diabetes and metabolic diseases, both degrees obtained at the University of Pisa/Italy. Dr Merante is currently Clinical Research Lead TA Orphan/ Nephrology at CSL Vifor in Glattbrugg, Switzerland. He previously worked at Sosei Heptares in 2018-2019 as VP of Clinical Development and at Shionogi as VP and Head of Clinical Science in 2017 and 2018. Between 2007 and 2016 he covered the role of Senior Director of Clinical Development at Daiichi Sankyo Development Ltd, UK heading the European Frontiers/Opportunity Department. Dr Merante had previously worked at GSK Italy, Eli Lilly Italy, Novo Nordisk UK and Laboratori Guidotti Italy in several clinical positions. So far Dr Merante has spent 28 years in drug clinical development working in Italy, UK, US and Switzerland in multiple therapeutic areas. These include diabetes and complications (i.e. macular edema and neuropathic pain), fibromyalgia, endocrinology area (i.e. growth hormone deficiencies, Cushing syndrome), severe hypertension, infectious diseases, hematology and nephrology/orphan and rare diseases. Dr Merante has to date 119 publications amongst full papers, abstracts as either main author or co-author and oral presentations made during scientific or industry-based conferences.

      Session Details:

      Bridging the gap from RCTs through Real World Evidence into clinical practice; exploring how to improve patient focussed disease management

      2023-05-04, 11:45 AM

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      Henrik Schou
      VP, Global Head Evidence Generation, Vifor Pharma Group

      Henrik Schou is the Global Head Evidence Generation at CSL-VIFOR PHARMA. Henrik has been in the industry for more than 20 years in different geographies and roles, where evidence generation has been an essential piece. Henrik has cradle to grave experience in all aspects of evidence generation, and use to satisfy regulatory, reimbursement and medical affairs objectives.

      Henrik is a Mathematician from University of Aarhus in Denmark, Postgraduate in Health Economics from University of York in the UK. A diploma in Pharmaceutical Medicine from Kings College in London and a Management Diploma from Harvard Business School.

      Session Details:

      Bridging the gap from RCTs through Real World Evidence into clinical practice; exploring how to improve patient focussed disease management

      2023-05-04, 11:45 AM

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      Xavi Jofre
      Digital Transformation Director, Barcelona Health Hub

      I live between a fuzzy and a techie world!

      I am focused on business, innovation and strategy management with over fifteen years of experience helping different kind of companies (from multinational to family-owned) and sectors such as new technologies, pharma, banking, trading and media & entertainment.

      I am a graduate of Electronic Arts and Digital Design (URL & ESDI), a program for management development (ESADE), and an exchange program in Strategic Innovation and Cross-Cultural Management (HEC). He also holds a Master’s degree in International Business and Relations (ESEI Business School).

      Session Details:

      Explore how Barcelona Health Hub is pushing forward digital tools in clinical trials

      2023-05-03, 12:15 PM

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      Bálint Feher
      Senior Clinical Research Manager, Geistlich Pharma AG

      Balint Feher is a senior clinical research manager at Geistlich Pharma AG. He leads eClinical project at Geistlich, supporting the organization to redesign processes and transition to digital arena. He holds PharmD at Semmelweis University, Budapest and double MSc in computer science and biomedical engineering fields. He has 15+ years’ clinical and 5+ years’ IT expertise in pharma and medical devices industries. Balint’s passion lies in the intersection of clinical, regulatory and IT by leading projects where team can solve complex problems needed combined skillset also at project lead’s level.

      Session Details:

      Case study: Clinical digitalization roadmap for medical device companies

      2023-05-04, 12:45 PM

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      James Rudge
      Technical Director, Trajan Scientific and Medical

      James Rudge, PhD, is Technical Director at Neoteryx, the microsampling brand of Trajan Scientific and Medical. He is a co-inventor of the Mitra® device and its patented VAMS® technology. Dr. Rudge has co-published 16 papers on VAMS microsampling with co-authors from around the globe, and he authored a book chapter on VAMS in 2021. Among his recent events and speaking engagements, Dr. Rudge was a vision speaker at the 2021 CPSA (Clinical & Pharmaceutical Solutions through Analysis) USA virtual conference and chaired a session at the Outsourcing Clinical Trials conference UK & Ireland focused on decentralized clinical trials. He is involved in several international research collaborations, including a large European research consortium addressing unmet needs in inflammatory disease.

      Session Details:

      WORKSHOP Introducing The Patient Centric Sample Interest Group

      2023-05-04, 9:00 AM

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      Begona Nafria Escalera
      Patient Engagement & Research Coordinator, Sant Joan de Deu Barcelona Hospital

      She is Patient Engagement in Research Coordinator at Sant Joan de Déu Chidren’s Hospital (Spain). She has long experience in the field of the involvement of patients and families in research initiatives. She has also a personal story as a caregiver and patient advocate because is the sister of a young adult with cerebral palsy. Her areas of expertise are focused in paediatric patients involvement in research and specifically in the field of clinical trials and in health innovation. She is currently a PhD student in the patient involvement in paediatrics field, specifically in a thesis project about the rights of children and young people participating in clinical trials. Other relevant background of her profile is: Fellow of EUPATI (first cohort) and member of its Steering Committee, Coordinator and Founder Member of eYPAGnet (European Young Patients Advisory Group Network – www.eypagnet.eu), Coordinator of Kids Barcelona (YPAG of Sant Joan de Déu Children’s Hospital- www.kidsbarcelona.org), Co-chair of Children’s Medicines Working Party of EFPGCP, volunteer member of the Editorial Board of Center for Information & Study on Clinical Research Participation (CISCRP), member of the Patients and Families working group and Chair of the Cross-Border Access to Paedaitric Clinical Trials of EnprEMA (European Network of Paediatric Research of EMA).,She is Patient Engagement in Research Coordinator at Sant Joan de Déu Chidren’s Hospital (Spain). She has long experience in the field of the involvement of patients and families in research initiatives. She has also a personal story as a caregiver and patient advocate because is the sister of a young adult with cerebral palsy. Her areas of expertise are focused in paediatric patients involvement in research and specifically in the field of clinical trials and in health innovation. She is currently a PhD student in the patient involvement in paediatrics field, specifically in a thesis project about the rights of children and young people participating in clinical trials. Other relevant background of her profile is: Fellow of EUPATI (first cohort) and member of its Steering Committee, Coordinator and Founder Member of eYPAGnet (European Young Patients Advisory Group Network – www.eypagnet.eu), Coordinator of Kids Barcelona (YPAG of Sant Joan de Déu Children’s Hospital- www.kidsbarcelona.org), Co-chair of Children’s Medicines Working Party of EFPGCP, volunteer member of the Editorial Board of Center for Information & Study on Clinical Research Participation (CISCRP), member of the Patients and Families working group and Chair of the Cross-Border Access to Paedaitric Clinical Trials of EnprEMA (European Network of Paediatric Research of EMA).

      Session Details:

      Paediatric-centric clinical trials: A right for children and young people

      2023-05-03, 4:15 PM

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      Raquel Reviejo
      MSD’s EU Regional Submission Lead, MSD

      Raquel Reviejo is an EU Regional Submission Lead at MSD with 13 years experience in clinical research.

      In her current position, Raquel is accountable for the overall management and coordination of the submission activities across EU countries for assigned Clinical Trials. She is also involved in the EU CTR Transition strategy project.

      Raquel received a Bachelor of Pharmacy degree from the Universidad Complutense of Madrid and a master’s degree in monitoring and management of clinical trials (Colegio Oficial de Farmacéuticos de Madrid)

      Session Details:

      CLOSING KEYNOTE Gain a comprehensive overview of the EU Clinical Trial Regulation and changes for trials in the EU

      2023-05-03, 5:15 PM

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      Lidya Domínguez
      Clinical Research Director, Sermes CRO

      Lidya Domínguez’s working years have always been related to clinical research. She graduated in nutrition and human dietic and master’s coursed in project management and several expert courses in Clinical Trials and Regulatory Procedures. She is the Head of the Clinical Research Department at Sermes CRO, an International Contract Research Organization with headquarters in Madrid, Spain. Oncology and cellular and advanced therapies are amongst her main therapeutic experience, but during her large experience in pharma, she has worked with several TAs, such as endocrinology, vaccines, infectious diseases, etc. She is an expert in European Clinical Trial Regulation. She has been involved in the CTIS project from the right beginning, as part of EMA’s 15-people working group since 2017 for the development of this new European clinical trials portal. She has been certified by the EMA as CTIS Master Trainer. Lidya’s team at Sermes CRO achieved the first submission of a clinical trial through CTIS in Spain, in March 2022. Since then, they have never stopped submitting and transitioning clinical trials via CTIS.

      Session Details:

      CLOSING KEYNOTE Gain a comprehensive overview of the EU Clinical Trial Regulation and changes for trials in the EU

      2023-05-03, 5:15 PM

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      Jay Smith
      Head of Product, Trial Interactive, TransPerfect

      Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. He brings over 25 years of product management, consulting, and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment and manufacturing. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. Jay has also created and managed products for eCTD submission publishing and review, enterprise quality management, document management, computer validation, as well as mobile apps for physicians, sales reps, and music and sports fans.

      Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College.

      Session Details:

      Practical use cases to improve clinical site efficiency with technology

      2023-05-04, 2:15 PM

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      Dr. Claudia Hesselmann
      Founder And CEO, ARENSIA Exploratory Medicine GmbH

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

      Session Details:

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

      2023-05-03, 2:45 PM

      Session Details:

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

      2023-05-03, 2:45 PM

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      Ana Moreno
      Director Global Clinical Operations, APICES
      Ana Moreno has a degree in Biology and 21 years of experience in Clinical Research across CRO sector, Big Pharma and Academic Groups. Throughout her career she has supported medical and scientific teams, clinical development programs and operations worldwide for the success of oncology treatments. Ana’s career include ClinOps manager career at Pharma (Gilead Sciences) and CROs (Biometrica and APICES) leading scientific programs and supporting the development of clinical trials in breast, colorectal, lung, liver, pancreas and ovarian cancer among others.

      Session Details:

      How to succeed in your Oncology clinical trial from regional-medium CRO’s point of view?

      2023-05-04, 10:45 AM

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      Karl McEvoy
      Product Director, Decentralised Trial Technology at YPrime

      Dr. Karl McEvoy has over a decade of industry experience in both the vendor and sponsor sides. His clinical trial experience spans from set-up to delivery across all phases in a wide variety of disease and therapeutic areas. Karl has collaborated with the world's top 20 pharmaceutical companies and has extensive experience in patient-centered outcomes research, eCOA strategy, and drug development.

      Session Details:

      The Opportunities and Challenges of Moving to Electronic Capture of Informed Consent

      2023-05-03, 12:45 PM

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      Michael Zörer
      Head of Clinical Operations, VarmX

      Michael is responsible for a team of 11 people and the overall delivery of the conducted studies. The group runs several studies in different indications with a clear focus on rare diseases. In 2016 AOP Orphan received approval for one new product (RAPIBLOC®). In 2019 AOP received the marketing authorization for their first biological (BESREMi®), after completing a series of clinical studies and successfully passing a series of EMA inspections under Michael’s responsibility.

      Before joining AOP Orphan Michael has been operations manager for Haemophilia at Baxter. Michael has many years of experience as a project manager and learned the job in clinical research from scratch starting as CRA at Amgen. Michael received his Ph. D in biochemistry from the University of Vienna. 

      Session Details:

      PANEL DISCUSSION Reversing the Conversation: What the clinical trial industry really wants from its service providers

      2023-05-04, 9:00 AM

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      Stefania Alvino
      Head of Digital Innovation, Daiichi Sankyo

      Stefania is a Digital Orchestrator and Omnichannel Marketing Manager in Daiichi Sankyo Italy, also driver of the  Digital Transformation at European level for the country. She established strong digital marketing, social media and digital strategy experience. In her role, Stefania has developed her ability to translate theory into action in the context of change control and mind process.

      At Daiichi Sankyo Italy, Stefania is responsible for digital & omni-channel strategy, the planning of local and regional initiatives, evaluating the impact of multi-channel marketing and digital strategy to the integration of on-and offline services and initiatives to open up cross-functional opportunities.

      She has gain several awards for innovative projects in the digital and multichannel field and has been a guest speaker at various Italian and international conferences.

      Stefania has over 10 years of pharmaceutical, marketing, communications and digital experience in different company.

      She is also a journalist with several experience in radio, TV and magazines publishing several articles and nowadays she writes articles on innovation and digital transformation topics.

      Session Details:

      The metaverse in Pharma it could be a possible solution?

      2023-05-04, 10:15 AM

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      Kateryna Orlovska
      Country Clinical Quality Management Lead Ukraine, Georgia and CIS, Merck

      Kateryna is an Associate Director, Clinical Quality Management Lead at MSD Ukraine responsible for quality management in trials conducted in Ukraine, Georgia and Moldova. She holds over 15 years of expertise in different roles in clinical trials including 7 years in quality management at MSD.

      She is responsible for variety of duties in process management, quality control and compliance, risk assessment - altogether to ensure business continuity for the conducted studies.

      Kateryna holds BSc in Economic Theory, MA in Health Care Management obtained from Kyiv-Mohyla Academy (Ukraine) and Maastricht University (Netherlands), and has a post-graduate degree in Pharmacy from National Medical University of Bogomolets (Ukraine).

      Session Details:

      Being a Process Manager, when all processes collapse – War in Ukraine, one sponsor’s perspective

      2023-05-04, 11:45 AM

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      Caoimhe Vallely-Gilroy
      Independent Advisor – HIRANI, former Global Head of Digital Health & Therapeutics at Healthcare Business

      Caoimhe Vallely-Gilroy is a passionate advocate of patients’ rights and wishes. She strives to ensure that data from every single patient is appropriately used, never under-appreciated and answers more than one question. As part of her goal to create the optimum operating model of humanity, Caoimhe relentlessly focuses on the connected patient experience and works to promote and power patient autonomy with their own health and health data. 

       

      Caoimhe has a background in clinical development, from leading and managing clinical trials, protocol analysis and patient sampling kit design, strategy development and implementation to ethical oversight, and regulatory affairs. She has also led and implemented new technologies and processes in the pharmaceutical industry, including digital biosample management, informed consent databases and biomarker operations strategy.  

      Session Details:

      Delving into Digital Health in Oncology clinical trials

      2023-05-03, 2:15 PM

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      Orlando Vergara
      Pharmaceutical and Healthcare Expert, Universidad Autónoma del Perú

      Orlando is a curious and innovative person and is passionate about healthcare ecosystem and has over 20 years of experience in the pharma industry.

      Orlando started his career in Merck (MSD) Italy where he has covered different positions from 2000 to 2009. In 2015 was appointed Head of Business Operations and Strategic Projects – Region Europe and in 2017 he moved to Spain to Reimagine Neuroscience.

      Orlando is graduated in Economics from “La Sapienza” University of Rome (Italy) and has obtained a Master in Finance from Pisa University (Italy) and the Advanced Management Program from IESE Business School (Spain). He completed a finance course at Harvard Business School, Boston (USA) and participated in leadership programs during his career.

      Orlando is member of the Advisory Board of the MBA program of Universidad Autonoma del Peru and Ambassador of Barcelona Health Hub. He is mentor in Novatalent, Mujeres en Farma and is speaker in many conferences. He is founder of Novartis NeuroHouse in Spain and Sounds of Leadership. Currently he is developing and fostering “Ecosystem Leaders Mindset” within the organizations.

      Session Details:

      INTERACTIVE THINK TANKS

      2023-05-04, 3:15 PM

      Session Details:

      INTERACTIVE THINK TANKS

      2023-05-04, 3:15 PM

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      Laia Casas Papiol
      Clinical Project Leader, Noucor Health

      Biomedical Scientist with an MSc in Monitoring Clinical trials and Medical Affairs. Have worked in several positions from top to bottom: From study coordinator to RD Project Manager at a Sponsor Company, including CRA. Work through various companies: Pharmaceutical laboratories, CROs and medical device start-ups. Have worldwide experience in clinical trials, and planned, designed, and led clinical projects for EMA and FDA.

       

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      Harry Yeates
      Strategy Director, Langland Advertising & Marketing Ltd

      As strategy lead for Clinical Trial Experience at Langland, Harry focuses on ensuring we understand the motivations and priorities of the people whose experience can make or break a study, so we can devise efficient, effective strategies to recruit, educate and support them. That means prospective participants and their partners and families, but also site staff and physicians, so the study is clearly understood, remains top-of-mind, and appropriate emphasis is placed on key moments, such as consent.

       

      Session Details:

      Is a clinical trial a customer experience? Insights from consumer research

      2023-05-04, 2:15 PM

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      Neil Vivian
      Senior Director of Business Solutions and Product Manager, Anju Software

      Neil Vivian joined Anju in 2019 as Senior Director of Business Solutions and Product Manager. He is responsible for providing technical support to the Business Development group in positioning Anju Solutions and Services to potential and existing clients. His Product Manager role responsibilities include providing guidance and high-level business requirements for new product features based on his industry experience and understanding of new emerging Regulatory Guidance.

      He has over 43 years’ experience in the software industry built from a solid foundation in the Defense Industry, 29 of those focused on Life Sciences.

      He has a BSc in Physics and Engineering Science and MSc in Information Technology.

      Session Details:

      Patient Engagement and eConsent – a historical look at Decentralized Trials and their future with a focus on eConsent

      2023-05-03, 11:45 AM

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      Edyta Korzuch
      Senior Director Hematology/Oncology Unit, TFS HealthScience

      Edyta Korzuch - Edyta is a Sr. Director of Project Management at TFS HealthScience. She has over 20 years of experience in clinical research industry within global and cross-cultural environment where she successfully managed studies from Phase 1 first in human to Phase 3 registrational trials. Her current focus is on innovative solutions for early phase oncology and hematology clinical development. Edyta was educated at Silesian Medical University in Katowice, Poland and Oxford Brookes University, UK. She is based in Paris, France.

      Session Details:

      Advancing Towards Patient-Centered Measurement Methods by Integrating ePRO in Oncology Trials; Lessons Learned from a Recent Study

      2023-05-04, 10:45 AM

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      Esther Mahillo
      Vice President, Operational Strategy, Precision For Medicine

      Dr. Mahillo has 28+ years of experience in the clinical research arena, 25 of them in oncology global trials. Her areas of expertise are inmuno-oncology, including cancer vaccines, advanced therapies, genetically modified organisms and other immuno therapies. She has an in-depth knowledge on oncology networks and advocacy groups, with which she cooperates since 1999. Dr. Mahillo is a professor/magister in several Master programs administered at different Universities (Universidad Alcalá de Henares, Universidad CEU San Pablo, CESIF). She has authored of 3 books, 20 scientific articles, and 24 contributions to scientific congresses. Dr. Mahillo was awarded the first prize of the Spanish Society of Medical Oncology (SEOM) in 2015 for her project “Y Seguiré” (will keep on moving), for the promotion of clinical research. Dr. Mahillo obtained her PhD with a research on the role of multicatalytic proteinase (proteasome) as an oncology intracellular target, research line that ended up with the development of bortezomib, a proteasome inhibitor approved for the treatment of multiple myeloma patients.

      Session Details:

      Why Patient Participation Isn’t Recovering and Tactics to Drive Change

      2023-05-04, 12:15 PM

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      Enrico Perfler
      CEO, 1MED SA

      A biomedical engineer by training, Mr. Perfler has 18 years of professional experience specialising in medical device technology and, with his company, has overseen the development and regulatory approval of over 500 medical devices.

      In 2014, he founded 1MED SA, a dynamic international company providing regulatory support, digital solutions and full-service CRO support to the medical device and pharmaceutical industry with a focus on IVD and medical products.

      Mr. Perfler is also a contract professor of “Regulatory Affairs” at University of Pavia, Faculty of Engineering and an active contributor to the ISO technical committee for the biological evaluation of medical devices.

      Session Details:

      EU MDR: how attractive is Europe for innovation?

      2023-05-04, 9:45 AM

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      Gilyana Borlikova
      Data Science Manager, ICON plc

      A Data Science Manager (Principal Data Scientist) at ICON plc. IT Innovation and Informatics Data Science team, responsible for development and delivery of ML/AI solutions. Gilyana has over 20 years of experience in life sciences and 7 years specifically developing and implementing machine learning algorithms for clinical trials operations.

      Prior to joining ICON, Gilyana spent 15 years working in several leading research-intensive universities, including the UCD Centre for Business Analytics, University College Dublin (Ireland), University of Queensland (Australia) and the University of Sussex (UK). Gilyana holds MSc in Business Analytics and PhD in Neuroscience. She has extensive research experience with 5 peer-reviewed publications in the field of Machine Learning and 15 peer-reviewed journal publications in Biomedical Research.

      Session Details:

      Advancements in AI: turning big data into actionable intel for optimal site identification

      2023-05-03, 10:00 AM

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      Lars Tranberg Pettersson
      Chief Information Officer, Ascendis Pharma

      Session Details:

      INTERACTIVE THINK TANKS

      2023-05-04, 3:15 PM

      Session Details:

      INTERACTIVE THINK TANKS

      2023-05-04, 3:15 PM

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

      Mr. Bennett has worked in clinical development for approximately 20 years and has worked for WCT since September 2021. He began his career in clinical research in a phase 1 clinic and soon after held roles as a Clinical Research Associate on both early and late phase clinical trials with responsibilities for data validation and site management. This solid base experience in ICH-GCP was further supplemented with broad operational knowledge regarding the conduct of clinical trials when he was appointed as a Clinical Trial Manager of Phase I, II and II trials within global programs. Building on this operational grounding, he has latterly (seven years) held positions where he has led cross-functional project teams within clinical research and has been responsible for project strategies, clinical development plans, clinical trial methodologies (concept/design), protocol authorship and the transformation of the scientific endeavor into an operationalized activity. Through being part of R&D leadership teams, he has contributed to business management and the development of operating models and outsourcing strategies. He has been responsible for representing pipeline projects in R&D governance boards and holds experiences throughout the drug development life cycle.

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      Kevin Landells
      Vice President, Business Head of IRT, IQVIA Technologies

      Kevin has over 24+ years of experience in the IRT/ RTSM industry, having worked across many technical and project management leadership roles.  Experienced with developing and leading global teams delivering managed services spanning Operations, Project Management, Client Partnerships and Business Transformation.  Kevin is passionate about improving healthcare and utilizing technology that makes a real difference to patients’ lives.

      Kevin holds a Bachelors’ Degree in Computer Science from Hertfordshire University in the UK.

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      Karen Maduschke
      Senior Director and GM, Patient Consent, IQVIA Technologies

      Karen Maduschke is recognized as a global expert in electronic informed consent for the healthcare industry. She has been involved with this innovative technology from its earliest inception and has been instrumental in driving the dramatic growth of IQVIA’s eConsent business. In the last year, Karen has led the rapid deployment of eConsent for numerous critical COVID19 vaccine and treatment trials. Karen’s post graduate education is in health and intercultural communication and she has more than 25 years of experience in the field. She is a fierce advocate for patient-centricity in clinical trials and improved transparency in the informed consent process. 

      Session Details:

      Simplifying site & patient engagement technology strategies through integration & automation

      2023-05-03, 12:45 PM

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