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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  • 2023 Agenda
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Featured Speakers

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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 of the Ukrainian Association for Clinical Research, Managing Director Ukraine at FutureMeds

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

    Company Website

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

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    Company Information

    1MED, is the leading European MedTech specialized solutions provider,
    offering end-to-end development expertise within the medical device, novel technology and combination products fields.

    Founded in 2014, with headquarter in Agno, Switzerland, and employing 100+ professionals across the Europe, 1MED’s mission is to support all the MedTech organizations in facing the complexity associated with the development of innovative medical devices in compliance with MDR.

    Such support may include providing preclinical support, regulatory advice, clinical study management, post marketing support, digital solutions and quality management systems across the clinical research continuum with a cross-functional approach which led to win the certification and certification maintenance of more than 500 different medical devices within the last 5 years.

    Company Website

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

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    Company Information

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

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

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    Company Information

    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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    Company Information

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

    Company Website

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

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    Company Information

    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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    Company Information

    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 - https://www.iconplc.com/sectors/biotech

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    Company Information

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

    Company Website

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

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    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 complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest and Iasi, Romania, and Tokyo, Japan. The company’s Net Promoter Score (NPS) consistently exceeds the technology industry average, contributing to the company being selected by trial sponsors and CROs to support more than 1,000 trials across 80 countries.

    Company Website

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

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    Company Information

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

    Company Website

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

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    Company Information

    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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    Company Information

    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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    Company Information

    At Viedoc, we design engaging software that modernizes clinical research so that necessary treatments can reach the people who need them faster. We believe in life and science, in people, and in our collective power to change the world and build a healthier future. That unmatched driving force is what pushes us to innovate, accelerate and improve every aspect of modern clinical studies.

    Company Website

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

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    Company Information

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

    Company Website

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

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    Company Information

    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

      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

      Benoît Marchal
      Founder & CEO, PicAps (Patient in control, anonymity privacy secure)

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

      Speakers

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

      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
      • 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

      Ivanna Rosendal
      Senior Director, IT Business Partner, Ascendis Pharma

      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

      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

      Karl McEvoy
      Product Director, Decentralised Trial Technology at YPrime
      Paul Margerison
      Director, User Experience & Design, YPrime

      1:15 PM

      Lunch and networking

      2:15 PM

      Utilizing Data Mesh technologies for data analysis in clinical trials

      • Bullets to come
      • Bullets to come

      Speakers

      Mateusz Zabolski
      Head of Technology – Biosamples, AstraZeneca

      2:45 PM

      Tech Showcase – eClinical Solutions; Tech Showcase – Clario

      Tech Showcase – eClinical Solutions 

      Running Up That Hill: Accelerate Cycle Times & Reach Patients Faster with elluminate

      Operational oversight within outsourced models has become increasingly complex for teams who are tasked with managing trials amid a rapidly changing landscape of partners, technologies, and global regulations. Data proliferation along with dwindling resources has made it a top priority for clinical development teams to look to technology to improve cycle times and the overall experiences of data managers, medical monitors, and clinical operations leaders.

      This presentation will highlight how the elluminate Clinical Data Cloud and Biometrics Services can reshape your data architecture by automating data flows to keep up with the pace of data evolution and speed time to insights

       

      Learn how elluminate and eClinical’s Biometrics Services deliver:

       

      • Operational insights across numerous data sources that provides definitive answers and analytics on enrollment, protocol compliance and safety
      • Improved study oversight with a holistic view of risk across all data sources
      • 50 out-of-the-box visualizations to support supports cross-study analysis for deeper insights with self-service access to clinical and operational analytics
      • Increased productivity across data management, medical monitoring, clinical operations, clinical programming and statistical analysis roles

       

       Jason Konn, Solution Consultant, eClinical Solutions 

      Tech Showcase – Clario

      Tech Showcase – eClinical Solutions 

      Running Up That Hill: Accelerate Cycle Times & Reach Patients Faster with elluminate

      Operational oversight within outsourced models has become increasingly complex for teams who are tasked with managing trials amid a rapidly changing landscape of partners, technologies, and global regulations. Data proliferation along with dwindling resources has made it a top priority for clinical development teams to look to technology to improve cycle times and the overall experiences of data managers, medical monitors, and clinical operations leaders.

      This presentation will highlight how the elluminate Clinical Data Cloud and Biometrics Services can reshape your data architecture by automating data flows to keep up with the pace of data evolution and speed time to insights

       

      Learn how elluminate and eClinical’s Biometrics Services deliver:

       

      • Operational insights across numerous data sources that provides definitive answers and analytics on enrollment, protocol compliance and safety
      • Improved study oversight with a holistic view of risk across all data sources
      • 50 out-of-the-box visualizations to support supports cross-study analysis for deeper insights with self-service access to clinical and operational analytics
      • Increased productivity across data management, medical monitoring, clinical operations, clinical programming and statistical analysis roles

       

       Jason Konn, Solution Consultant, 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?
      • 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

      Smruthi Panyam
      Director, Clinical Data Informatics, BeiGene

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

      Speakers

      Laura Jiménez Robledo
      Clinical Project and Innovation Manager, Novo Nordisk

      Stream B: Clinical Technology & Innovation

      Speakers

      Priya Ravisekara
      Senior Pharma Analyst, GlobalData Plc

      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
      • 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

      John Zibert
      Chief Medical Officer, Coegin Pharma AB
      Priya Ravisekara
      Senior Pharma Analyst, GlobalData Plc
      Stephen Lutsch
      Senior Director Clinical Trial Digital Innovation, Genmab

      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.
      • 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

      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

      Xavi Jofre
      Digital Transformation Director, Barcelona Health Hub

      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

      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

      Kevin Landells
      Vice President, Business Head of IRT, IQVIA Technologies
      Karen Maduschke
      Senior Director and GM, Patient Consent, IQVIA Technologies

      1:15 PM

      Lunch and networking

      2:15 PM

      Delving into Digital Health in Oncology clinical trials

      Speakers

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

      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
      • 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

      Dr. Claudia Hesselmann
      Founder & CEO, ARENSIA Exploratory Medicine

      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?
      • 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

      John Zibert
      Chief Medical Officer, Coegin Pharma AB

      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
      • 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

      Begona Nafria Escalera
      Patient Engagement & Research Coordinator, Sant Joan de Deu Barcelona Hospital
      Joana Claverol
      Clinical Research Director, Sant Joan de Deu Barcelona Hospital

      4:45 PM

      Innovation to Strengthen Patient Accessibility to High Impact Medicines

      Utilizing Patient Experience Data to Maximize Value in a Time of Narrowing Margins

      Utilizing Patient Experience Data to Maximize Value in a Time of Narrowing Margins

      Speakers

      Adam Levy
      Senior Director, Business Development, 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
      • 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

      Stephen Lutsch
      Senior Director Clinical Trial Digital Innovation, Genmab

      5:55 PM

      Chair’s Summary & Drinks Reception

      7:45 AM

      Conference Registration and refreshments

      8:20 AM

      Chair’s opening remarks

      Speakers

      Robert S. Greene
      President, Hunger and Thirst Foundation

      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
      • 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

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

      9 AM

      Remote Strategies Around the World: DCT Regulations & Clinical Trials Optimization

      Accelerating advancements in medicine, device, and diagnostic development wouldn’t be possible without significant innovations in remote and decentralized technologies. In order to keep pace with technological capabilities, as well as offer flexibility to reduce burden for clinical trial stakeholders, regulatory adaptation and reform should help propel optimization in the industry. Join this session to learn about the end-to-end clinical trial process and discover how innovations in clinical trials, namely remote operations and management strategies, are shaping necessary adaptations in regulatory frameworks.

       

      Accelerating advancements in medicine, device, and diagnostic development wouldn’t be possible without significant innovations in remote and decentralized technologies. In order to keep pace with technological capabilities, as well as offer flexibility to reduce burden for clinical trial stakeholders, regulatory adaptation and reform should help propel optimization in the industry. Join this session to learn about the end-to-end clinical trial process and discover how innovations in clinical trials, namely remote operations and management strategies, are shaping necessary adaptations in regulatory frameworks.

       

      Speakers

      Joseph Lovett
      Solution Specialist, Patient Cloud, Medidata Solutions, a Dassault Systèmes company
      Fiona Maini BSc. MSc.
      Senior Director - Global Compliance and Strategy Medidata Solutions a Dassault Systèmes Company

      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

      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

      Robert S. Greene
      President, Hunger and Thirst Foundation

      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

      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

      Gilyana Borlikova
      Data Science Manager, ICON plc

      10:30 AM

      Morning refreshments and networking

      Stream A: Outsourcing & Clinical Operations

      Speakers

      Robert S. Greene
      President, Hunger and Thirst Foundation

      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?
      • 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

      Robert S. Greene
      President, Hunger and Thirst Foundation
      Sonja Weiser
      Senior Director Clinical Operations, Insmed
      Roman Fishchuk
      Head of Clinical Trials Department, Central City Clinical Hospital, Ukraine
      Ivan Vyshnivetskyy
      President of the Ukrainian Association for Clinical Research, Managing Director Ukraine at FutureMeds

      11:45 AM

      Optimizing Cell-based Gene Therapy Programs Through the Continued Evolution

      • Lessons across therapeutic areas
      • Driving success in either unexplored settings or in saturated market settings
      • Context-dependent stakeholder engagement
      • Lessons across therapeutic areas
      • Driving success in either unexplored settings or in saturated market settings
      • Context-dependent stakeholder engagement

      Speakers

      Amy Raymond
      Therapeutic Strategy Lead, Gene Therapy Think Tank, 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!
      • 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

      Leveraging local relationships for best in-country solutions to accelerate global drug development

      • Partnering with a CRO to access European infrastructure, in depth local knowledge, site relationships and diverse patient populations
      • Strategies to fast-track clinical trial start-up and patient recruitment timelines
      • Are you ready for EU CTR? Challenges and lessons learned
      • Partnering with a CRO to access European infrastructure, in depth local knowledge, site relationships and diverse patient populations
      • Strategies to fast-track clinical trial start-up and patient recruitment timelines
      • Are you ready for EU CTR? Challenges and lessons learned

      Speakers

      David Chia
      Senior Business Development Manager, Novotech
      Diana Filipescu
      Business Development Manager, 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

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

      Speakers

      Mariusz Olejniczak
      CEO, WPD Pharmaceuticals

      2:45 PM

      Controlling Drug Supply Risk by Enabling Complex Protocols Through Modern RTSM Support

      In today's clinical trial landscape, oversight and risk management are essential for ensuring patient safety and regulatory compliance. However, controlling these risks is not without its challenges. From demand/supply planning issues to forecasting inaccuracies, drug supply management can be a daunting task, especially with rising complexity in the protocol development process. So, how can we best enable this rising protocol complexity while controlling end-to-end drug supply risk for your studies?

      Join this session to explore how these challenges can be addressed through modern Randomization and Trial Supply Management (RTSM) software. We will examine how advanced RTSM systems can be implemented for complex protocols without the need for lengthy implementation timelines. We will also discuss how modern RTSM forecasting/resupply algorithms can work to control drug supply risks in complex protocols. Finally, we'll consider how modern RTSM systems can combine the features highlighted above with providing flexible and prompt post go-live support through extensive self-service trial management capabilities

      In today's clinical trial landscape, oversight and risk management are essential for ensuring patient safety and regulatory compliance. However, controlling these risks is not without its challenges. From demand/supply planning issues to forecasting inaccuracies, drug supply management can be a daunting task, especially with rising complexity in the protocol development process. So, how can we best enable this rising protocol complexity while controlling end-to-end drug supply risk for your studies?

      Join this session to explore how these challenges can be addressed through modern Randomization and Trial Supply Management (RTSM) software. We will examine how advanced RTSM systems can be implemented for complex protocols without the need for lengthy implementation timelines. We will also discuss how modern RTSM forecasting/resupply algorithms can work to control drug supply risks in complex protocols. Finally, we'll consider how modern RTSM systems can combine the features highlighted above with providing flexible and prompt post go-live support through extensive self-service trial management capabilities

      Speakers

      Benjamin Etschmann
      Senior Forecasting Services Lead, 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
      • 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
      • 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

      Ivan Vyshnivetskyy
      President of the Ukrainian Association for Clinical Research, Managing Director Ukraine at FutureMeds

      4:45 PM

      IND Versus CTA Submissions: Is Your Drug Development Program Ready to Take on Both?

      Submitting an Investigational New Drug Application (IND) in the US and a Clinical Trial Application (CTA) in the EU are important milestones in new drug development, marking the transition from bench research to clinical studies in human participants. Successful IND and CTA submissions require careful planning and strict compliance with regulatory requirements, which can be especially challenging for first-time applicants.

      This presentation will cover:

      • An introduction to the IND, including the document structure, optimal data to include, and timeline considerations
      • Key differences in the IND and CTA submission process, and how to leverage similarities in your drug development program
      • The impact of the new, centralized EU trial regulation in global drug regulations

       

      Submitting an Investigational New Drug Application (IND) in the US and a Clinical Trial Application (CTA) in the EU are important milestones in new drug development, marking the transition from bench research to clinical studies in human participants. Successful IND and CTA submissions require careful planning and strict compliance with regulatory requirements, which can be especially challenging for first-time applicants.

      This presentation will cover:

      • An introduction to the IND, including the document structure, optimal data to include, and timeline considerations
      • Key differences in the IND and CTA submission process, and how to leverage similarities in your drug development program
      • The impact of the new, centralized EU trial regulation in global drug regulations

       

      Speakers

      Federica Martini, Ph.D.
      Associate Director, Regulatory Affairs, Premier Consulting

      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
      • 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

      Lidya Domínguez
      Clinical Research Director, Sermes CRO
      Raquel Reviejo
      EU Regional Submission Lead, MSD

      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

      Priya Ravisekara
      Senior Pharma Analyst, GlobalData Plc

      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

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

      Speakers

      James Rudge
      Technical Director, Trajan Scientific and Medical

      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
      • 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

      Marcel Besier
      Director of Services Delivery, Europe

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

      Speakers

      Stefania Alvino
      Head of Digital Innovation, Daiichi Sankyo

      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

       

      • 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

      Edyta Korzuch
      Senior Director Hematology/Oncology Unit, TFS HealthScience

      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
      • 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

      Domenico Merante
      Therapeutic Area Clinical Lead Nephrology, Rare and Orphan Diseases, CSL Vifor
      Henrik Schou
      Global Head Evidence Generation, CSL Vifor

      12:15 PM

      Embedding patient recruitment into healthcare systems

      As the UK’s leading health tech supplier, we're connecting study sponsors and clinical research organisations with our vast network of healthcare professionals and patients to source quality clinical trial candidates at speed. Join this session to learn more about our Recruit solution, including:

      • How we’re enabling primary care organisations to get involved in patient recruitment for clinical trials
      • How we’re empowering participants to take part in clinical research by contacting them through trusted sources
      • How we’re making it easier for study sites to review and contact potentially eligible participants

      As the UK’s leading health tech supplier, we're connecting study sponsors and clinical research organisations with our vast network of healthcare professionals and patients to source quality clinical trial candidates at speed. Join this session to learn more about our Recruit solution, including:

      • How we’re enabling primary care organisations to get involved in patient recruitment for clinical trials
      • How we’re empowering participants to take part in clinical research by contacting them through trusted sources
      • How we’re making it easier for study sites to review and contact potentially eligible participants

      Speakers

      Mihad Mohamed
      Product Director – Research and Life Sciences, 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
      • Outlining the specific digital transformation goals and requirements
      • Overcoming operational challenges associated with medium-sized medical device companies
      • Journey to successful clinical digitalization

      Speakers

      Bálint Feher
      Senior Clinical Research Manager, Geistlich Pharma AG

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

      Speakers

      Jay Smith
      Head of Product, Trial Interactive, TransPerfect

      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

      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

      Elena Carzana
      Vendors Alliance Manager DM&Stat, Chiesi Farmaceutici
      Anna Pugnetti
      Global Clinical and RWE Outsourcing Manager, Chiesi Farmaceutici
      Patryk Mikucki
      Global Head of Country Operations, Alexion
      Lars Tranberg Pettersson
      Chief Information Officer, Ascendis Pharma
      Orlando Vergara
      Pharmaceutical and Healthcare Expert, Universidad Autónoma del Perú

      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

      Werner Gladdines
      VP, Clinical Development Operations, Immunic Therapeutics

      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?

      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

      Werner Gladdines
      VP, Clinical Development Operations, Immunic Therapeutics
      Michael Zörer
      Head of Clinical Operations, VarmX
      Sonja Weiser
      Senior Director Clinical Operations, Insmed

      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?

      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

      Enrico Perfler
      Founder, 1Med

      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
      • 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

      Werner Gladdines
      VP, Clinical Development Operations, Immunic Therapeutics
      Marco Salami
      Head of Clinical & RWE Outsourcing Management, Chiesi Farmaceutici

      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?
      • 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

      Ana Moreno
      Director Global Clinical Operations, APICES

      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
      • 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

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

      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?
      • 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

      Esther Mahillo
      Vice President, Operational Strategy, Precision For Medicine

      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
      • 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

      Silvia Perez Torres
      Director, Clinical Quality Compliance, AstraZeneca

      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?
      • 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

      Harry Yeates
      Strategy Director, Langland

      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
      • 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

      Priya Ravisekara
      Senior Pharma Analyst, GlobalData Plc

      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: Communication & Innovation: Defining innovation in clinical trials

      Host: Laura Jiménez Robledo, Clinical Project and Innovation Manager, Novo Nordisk

      Think Tank 4: Fighting the System: A Provocative Discussion on Challenging the Flaws and Injustices of the Clinical Trials Industry for Better Results

      Host: Ivan Vyshnivetskyy, - President of the Ukrainian Association for Clinical Research, Managing Director Ukraine at FutureMeds

       

      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: Communication & Innovation: Defining innovation in clinical trials

      Host: Laura Jiménez Robledo, Clinical Project and Innovation Manager, Novo Nordisk

      Think Tank 4: Fighting the System: A Provocative Discussion on Challenging the Flaws and Injustices of the Clinical Trials Industry for Better Results

      Host: Ivan Vyshnivetskyy, - President of the Ukrainian Association for Clinical Research, Managing Director Ukraine at FutureMeds

       

      Speakers

      Elena Carzana
      Vendors Alliance Manager DM&Stat, Chiesi Farmaceutici
      Anna Pugnetti
      Global Clinical and RWE Outsourcing Manager, Chiesi Farmaceutici
      Patryk Mikucki
      Global Head of Country Operations, Alexion
      Lars Tranberg Pettersson
      Chief Information Officer, Ascendis Pharma
      Orlando Vergara
      Pharmaceutical and Healthcare Expert, Universidad Autónoma del Perú

      4:15 PM

      End of Event

      2023 Speakers

      Select a speaker to learn more

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      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:

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

      Session Details:

      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

      A 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
      Founder & CEO, PicAps (Patient in control, anonymity privacy secure)

      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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      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 of the Ukrainian Association for Clinical Research, Managing Director Ukraine at FutureMeds

      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
      Senior Director, IT Business Partner, 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 Ravisekara
      Senior Pharma Analyst, GlobalData Plc

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

      Session Details:

      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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      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

      Laura is a Clinical Research Professional. She started in Novo Nordisk in 2013 as CRA and since 2020 she's exploring and defining Clinical Innovation as Clinical Innovation Manager.

      In her current position, she's leading the Innovation Strategy in her department - Clinical Operations in France, Portugal and Spain and additionally, driving the change and bringing innovation in Region Europe.

      Her superpowers: communication, innovation and collaboration.

      Session Details:

      Communication & Innovation: Defining innovation in clinical trials

      2023-05-03, 4:15 PM

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      Joana Claverol
      Clinical Research Director, 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
      Senior Director Clinical Trial Digital Innovation, Genmab

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

      Session Details:

      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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      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
      Global Head Evidence Generation, CSL Vifor

      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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      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
      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 & CEO, ARENSIA Exploratory Medicine

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

       

      Session Details:

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

      2023-05-03, 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, MSD

      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
      Clinical Project & GCP Compliance Leader, Noucor

      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

      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
      Founder, 1Med

      With a Master of Science in Biomedical Engineering, Enrico Perfler boasts 20 years of professional experience specializing in medical device technology. His profound knowledge and innovative approach have significantly shaped the landscape of this field.

      In 2014, Enrico founded 1MED SA, an innovative international company that provides regulatory support, digital solutions, and comprehensive CRO services to the medical device and pharmaceutical industry, with a particular emphasis on IVD and medical products. Under his leadership, 1MED SA has successfully overseen the development and regulatory approval of over 500 medical devices in Europe, solidifying his status as a prominent figure in the MedTech sector.

      Beyond his remarkable entrepreneurial achievements, Enrico serves as a contract professor of "Regulatory Affairs" at the Faculty of Engineering, University of Pavia. His expertise is further highlighted by his participation in the ISO/TC 194 technical committee for the biological evaluation of medical devices, and in national esteemed standardization groups, including UNI and ABHI. This involvement not only showcases his commitment to advancing industry standards but also underlines his influential role in shaping the future of medical device regulation and safety.

      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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      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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      Benjamin Etschmann
      Senior Forecasting Services Lead, 4G Clinical,

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

      Session Details:

      Controlling Drug Supply Risk by Enabling Complex Protocols Through Modern RTSM Support

      2023-05-03, 2:45 PM

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      Paul Margerison
      Director, User Experience & Design, YPrime

      Paul Margerison is Director, User Experience & Design at YPrime. In this role, he brings user-centred methods into the design of software for healthcare applications. Paul spent part of his career at the UK's National Health Service improving benchmarking tools for the management of local healthcare resources. For ten years he has worked in the clinical trials industry with a mission to bring to it the benefits of design thinking. Paul's team focuses development efforts on the places that bring clarity, confidence, and even delight, to patients and when site staff uses the tools of their trade.

      Session Details:

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

      2023-05-03, 12:45 PM

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      Amy Raymond
      Therapeutic Strategy Lead, Gene Therapy Think Tank, Worldwide Clinical Trials

      Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. Her clinical development experience spans all therapeutic areas and all stages of the clinical development lifecycle, from natural history studies through registrational global trials, and Long-Term Follow Up and Post Marketing surveillances.

      In addition to her grasp of the unique dynamics of developing novel treatments for rare and complex diseases, Amy also leverages her combination of training and experience leading the Cell and Gene Therapy Hub at Worldwide Clinical Trials. This experience includes gene therapy, cell therapy, gene-modified cell therapy, and gene editing treatments for oncology and rare disease patient communities. Her experiences in academia, biotech, and CROs confirm that meeting the needs of all stakeholders – payers, regulators, patients, families, and sites – is a critical success factor for efficient development programs.

      Session Details:

      Optimizing Cell-based Gene Therapy Programs Through the Continued Evolution

      2023-05-03, 11:45 AM

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      Jason Konn
      Solution Consultant, eClinical Solutions

      As a Solution Consultant, Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has lead design & development for several products ranging from a Data Management Workbench, Data Integrations, Clinical Operations Platform, Clinical Analytics, and Risk Based Quality Management.  Jason has been in the clinical trials industry for over 15 years and his prior experience includes, global central laboratory, eCOA design, process improvement, and building an automated workforce.

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      Federica Martini, Ph.D.
      Associate Director, Regulatory Affairs, Premier Consulting

      Federica Martini is a regulatory professional with 10+ years of experience in the pharmaceutical and biotech industry and brings an extensive background in cell and gene therapies. Federica first joined the pharma industry in 2012 working in basic and applied research and progressively took on regulatory positions of increasing responsibility and leadership as she moved through various pharma companies and CROs. She has supported pre-approval biologics for allergy, oncology, neurology, ophthalmology, dermatology, pediatric and rare disease indications. Federica has experience in developing EU regulatory strategies, leading cross-functional teams in health authority interactions, and in regulatory applications, including document development to support applications such as Scientific Advice, PRIME, Clinical trial Applications (CTA), Orphan Drug Designations (ODD), Pediatric Investigation Plans (PIP), and Development Safety Updated Reports (DSUR). Federica also supports regulatory activities with the FDA, including participating in FDA meetings, Investigational New Drug [IND] applications and amendments, initial Pediatric Study Plans, ODD, and more.

      Federica holds a Bachelor of Veterinary Medicine from the University of Camerino in Italy, a Master of Medicine in Research and Development from the University Autonoma of Madrid, and a Ph. D. in Veterinary Pharmacology and Toxicology from the University Complutense of Madrid in Spain.

      Session Details:

      IND Versus CTA Submissions: Is Your Drug Development Program Ready to Take on Both?

      2023-05-03, 4:45 PM

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      Alicia Borràs
      Study Coordinator, Digital Health Unit, Strategy Office Més Sant Pau, Hospital de Santa Creu i Sant Pau
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      Joseph Lovett
      Solution Specialist, Patient Cloud, Medidata Solutions, a Dassault Systèmes company

      Joe has worked in the Life Science industries for sixteen years, with eight of those years spent working directly with patient-facing technologies. During Joe’s time working with eClinical technologies, he has worked with a range of trial sponsors in both the public and private sectors, across Europe and the US, assisting in the deployment of a range of technologies to help optimise their clinical studies, including; patient registries, ePRO/eCOA, eConsent and safety solutions.

      Session Details:

      Remote Strategies Around the World: DCT Regulations & Clinical Trials Optimization

      2023-05-03, 9:00 AM

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      Fiona Maini BSc. MSc.
      Senior Director - Global Compliance and Strategy Medidata Solutions a Dassault Systèmes Company

      Fiona has worked within the Life Sciences and Healthcare domain for over 25 years working across GxP areas within the private and public sector environments.

      Fiona is currently a Senior Director at Medidata with a focus on quality management and general regulatory compliance and advocacy on topics within the good clinical practice domain.

      Over the past few years she has been chairing a number of trade association groups on topics such as new technologies in clinical trials, decentrialised clinical trials and a contributor to EU Artificial Intelligence initiatives.

      Prior to Medidata Fiona was a Director at Deloitte, where she led the Deloitte Global Centre for Regulatory Excellence for Life Sciences and provided governance of Deloitte services to the European Medicines Agency and their programmes.

      Fiona has a BSc in Chemistry and Management Science and an MSc in Chemistry

      Session Details:

      Remote Strategies Around the World: DCT Regulations & Clinical Trials Optimization

      2023-05-03, 9:00 AM

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      David Chia
      Senior Business Development Manager, Novotech

      Results-driven senior business development bringing over 18 years of comprehensive achievements in strategic clinical development and operational analysis for biotechnology, pharma and life sciences companies. Recognized for the ability to influence business inflection drivers, develop efficient data strategies and align synergies across multiple stakeholders, which result in increased productivity and value creation.

      Expertise in creating and maintaining successful strategic alliance partnerships between service providers and biopharma sponsors. Highly experienced in all aspects of clinical development both on the business and operation.

      Session Details:

      Leveraging local relationships for best in-country solutions to accelerate global drug development

      2023-05-03, 12:45 PM

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      Adam Levy
      Senior Director, Business Development, THREAD

      Following his degrees in Biomedical Science and Pharmaceuticals, Adam has worked within the pharma industry for 10 years bringing with him a wealth of experience in Regulatory Affairs, RWE and Digital Health Technologies. By strategizing with Sponsors, he has helped bring successful clinical trials to fruition, maximizing use of patient facing technologies including eCOA, eConsent, Wearables and Telehealth. Adam has a keen interest in Patient Reported Outcomes and endpoint development for evidence-based decision making, utilizing subjective and objective evidence to provide maximum value for all stakeholders in the value chain.

      Session Details:

      Innovation to Strengthen Patient Accessibility to High Impact Medicines

      2023-05-03, 4:45 PM

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      Marcel Besier
      Director of Services Delivery, Europe

      Marcel Besier has spent the last 20 years of his career in professional services and program management teams working with global clients implementing IT solutions.  As Director of Services Delivery, he oversees the professional services team responsible for project management, account management, and IRT services delivery for Suvoda’s customers in Europe. Marcel holds a dual degree in International Business Administration and General Management.

      Session Details:

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

      2023-05-04, 9:45 AM

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      Session Details:

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

      2023-05-04, 9:45 AM

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      Mihad Mohamed
      Product Director – Research and Life Sciences, EMIS

      Mihad is a Product Director for research and life sciences at EMIS. He has spent the last 10 years leading the dvelopment of data driven products for the clinical trials sector. Working with leading academic and commercial research organisations, he managed the development of a suite of data driven products on the EMIS-X Analytics platform. Prior to joining EMIS, he played a pivotal role in developing various modules within the Medidata Clinical Trial Management System (CTMS) catering to global study teams and sites.

      Session Details:

      Embedding patient recruitment into healthcare systems

      2023-05-04, 12:15 PM

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      Diana Filipescu
      Business Development Manager, Novotech

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

      Session Details:

      Leveraging local relationships for best in-country solutions to accelerate global drug development

      2023-05-03, 12:45 PM

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      SPONSORSHIP ENQUIRIES

      Nick McCudden

      Head of OCT Events

      +61 280 978 126

      SPEAKER ENQUIRIES

      Maya Hudson

      Senior Conference Producer

      +44 (0) 204 540 7766

      MARKETING ENQUIRIES

      Moona Popal

      Marketing Manager

      Sponsorship Enquiries

      To enquire about sponsorship opportunities for the conference, please contact:

      Nick McCudden

      Head of OCT Events


      +61 280 978 126

      Speaker Enquiries

      To enquire about speaking opportunities for the conference, please contact:

      Maya Hudson

      Senior Conference Producer


      +44 (0) 204 540 7766