14th Annual Outsourcing in Clinical Trials Europe 2024

Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 7th-8th May 2024!

7 - 8

May

2024
  • Hyatt Regency Barcelona Tower, Barcelona, Spain
  • Complimentary
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Featured Speakers

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Estrella Garcia​

Senior Director Global Clinical Operations, Almirall

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

 

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

 

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

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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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    Why attend?

    Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 7th-8th May 2024!

    For the 14th 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 2024. We can’t wait to see you there!

    WHAT TO EXPECT FOR 2024?

    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
    Expand All

    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

    EHDS Challenges: Data Access vs Data Privacy. Would the simplest not be to ask the patients themselves?

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

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

    Speakers

    11:45 AM

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

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

    Speakers

    12:15 PM

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

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

    Speakers

    12:45 PM

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

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

     

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

    Speakers

    1:15 PM

    Lunch and networking

    2:15 PM

    Utilizing Data Mesh technologies for data analysis in clinical trials

    • Bullets to come

    Speakers

    2:45 PM

    Tech Showcase – eClinical Solutions; Tech Showcase – Clario

    Tech Showcase – eClinical Solutions 

    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?

    Speakers

    3:45 PM

    Afternoon refreshments and networking

    4:15 PM

    Communication & Innovation: Defining innovation in clinical trials

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

    Speakers

    Stream B: Clinical Technology & Innovation

    Speakers

    11 AM

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

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

    Speakers

    11:45 AM

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

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

    Speakers

    12:15 PM

    Clinical Validation Center for Digital Health Solutions: generating evidence on the impact of digital tools through clinical trials

    • Generating evidence of the impact on health of digital tools
    • Improving patients’ experience and medication adherence after heart transplant using a multilevel mHealth intervention: The mHeart randomized clinical trial

    Speakers

    12:45 PM

    Simplifying site & patient engagement technology strategies through integration & automation

    Technology strategies that reduce effort, cost & support sustainability goals

     

    • Sites just want to get the job done

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

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

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

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

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

    Speakers

    1:15 PM

    Lunch and networking

    2:15 PM

    Delving into Digital Health in Oncology clinical trials

    Speakers

    2:45 PM

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

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

    Speakers

    3:15 PM

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

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

    Speakers

    3:45 PM

    Afternoon refreshments and networking

    4:15 PM

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

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

    Speakers

    4:45 PM

    Innovation to Strengthen Patient Accessibility to High Impact Medicines

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

    Obtaining Marketing Authorisation through Regulatory Approval and specific defined pathways in key geographies is a necessary step in the lifecycle of drug development and patient access to new medicines. However, convincing regulators of a product's safety and efficacy to obtain Marketing Authorisation is only one part of the value chain.

    As biopharma looks to plan for the needs of complex healthcare ecosystems, there is increasing demand for evidence generation to demonstrate the required value, harmonise needs of multiple stakeholders, and continue listening to the patient voice from early on in drug development, through authorisation and beyond. A robust demonstration of clinical differentiation is required, as well as the importance to leverage real world data for evidence generation.

    In this session, we will discuss the intrinsic need to understand and capture Patient Experience Data through Patient Centered Outcomes Research (PCOR) and innovative technology, from the beginning of the lifecycle of drug development all the way through to prospective data collection in a real world setting.

     

    Speakers

    5:15 PM

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

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

    Speakers

    5:55 PM

    Chair’s Summary & Drinks Reception

    7:45 AM

    Conference Registration and refreshments

    8:20 AM

    Chair’s opening remarks

    Speakers

    8:30 AM

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

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

    Speakers

    9 AM

    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.

     

    Speakers

    9:30 AM

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

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

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

    Speakers

    10 AM

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

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

     

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

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

    Speakers

    10:30 AM

    Morning refreshments and networking

    Stream A: Outsourcing & Clinical Operations

    Speakers

    11 AM

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

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

    Speakers

    11:45 AM

    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

    Speakers

    12:15 PM

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

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

    Speakers

    12:45 PM

    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

    Speakers

    1:15 PM

    Lunch and networking

    2:15 PM

    Call for research in creative climate in organization in clinical development

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

    Speakers

    2:45 PM

    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

    Speakers

    3:15 PM

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

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

    Speakers

    3:45 PM

    Afternoon refreshments and networking

    4:15 PM

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

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

    Speakers

    4:45 PM

    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

     

    Speakers

    5:15 PM

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

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

    Speakers

    5:55 PM

    Chair’s Summary & Drinks Reception

    Streams

    Stream one

    Stream A: Outsourcing & Clinical Operations

    Stream two

    Stream B: Clinical Technology & Innovation

    Stream B: Clinical Technology & Innovation

    Speakers

    9 AM

    WORKSHOP Introducing The Patient Centric Sample Interest Group

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

    Speakers

    9:45 AM

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

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

    Speakers

    10:15 AM

    The metaverse in Pharma it could be a possible solution?

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

    Speakers

    10:45 AM

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

     

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

    Speakers

    11:15 AM

    Morning refreshments and networking

    11:45 AM

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

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

    Speakers

    12:15 PM

    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

    Speakers

    12:45 PM

    Case study: Clinical digitalization roadmap for medical device companies

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

    Speakers

    1:15 PM

    Lunch and networking and Apple Prize draw

    2:15 PM

    Practical use cases to improve clinical site efficiency with technology

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

    Speakers

    3:15 PM

    INTERACTIVE THINK TANKS

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

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

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

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

    Think Tank 2: Building strategic partnerships with CROs

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

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

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

    Think Tank 3: TBC TOPIC

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

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

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

    Speakers

    4:15 PM

    End of Event

    8:10 AM

    Registration and refreshments

    8:45 AM

    Chair’s opening remarks

    Stream A: Outsourcing & Clinical Operations

    Speakers

    9 AM

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

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

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

    Speakers

    9:45 AM

    EU MDR: how attractive is Europe for innovation?

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

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

    Speakers

    10:15 AM

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

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

    Speakers

    10:45 AM

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

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

    Speakers

    11:15 AM

    Morning refreshments and networking

    11:45 AM

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

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

    Speakers

    12:15 PM

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

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

    Speakers

    12:45 PM

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

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

    Speakers

    1:15 PM

    Lunch and networking and Apple Prize draw

    2:15 PM

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

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

    Speakers

    2:45 PM

    The current impact and future of Decentralized Clinical Trials

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

    Speakers

    3:15 PM

    INTERACTIVE THINK TANKS

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

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

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

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

    Think Tank 2: Building strategic partnerships with CROs

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

    Think Tank 3: 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

    4:15 PM

    End of Event

    2023 Speakers

    Select a speaker to learn more

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    Daniel McVeigh
    Director, Clinical Project Lead, Alexion

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

    Session Details:

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

    2023-05-03, 3:15 PM

    Session Details:

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

    2023-05-04, 9:00 AM

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    Werner Gladdines
    VP, Clinical Development Operations, Immunic Therapeutics

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

     

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

    Session Details:

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

    2023-05-04, 10:15 AM

    Session Details:

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

    2023-05-04, 9:00 AM

    Session Details:

    Stream A: Outsourcing & Clinical Operations

    2023-05-04, 8:50 AM

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    Mariusz Olejniczak
    CEO, WPD Pharmaceuticals

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

    Session Details:

    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

    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:

    EHDS Challenges: Data Access vs Data Privacy. Would the simplest not be to ask the patients themselves?

    2023-05-03, 11:00 AM

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    Estrella Garcia
    Senior Director Global Clinical Operations, Almirall

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

     

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

     

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

    Session Details:

    INTERACTIVE THINK TANKS

    2023-05-04, 3:15 PM

    Session Details:

    INTERACTIVE THINK TANKS

    2023-05-04, 3:15 PM

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

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

    Session Details:

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

    2023-05-03, 11:00 AM

    Session Details:

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

    2023-05-03, 8:30 AM

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    Silvia Perez Torres
    Director, Clinical Quality Compliance, AstraZeneca

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

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

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

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

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

    Session Details:

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

    2023-05-04, 12:45 PM

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    Ivan Vyshnivetskyy
    President 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 Nair
    Senior Analyst, GlobalData

    Session Details:

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

    2023-05-03, 11:00 AM

    Session Details:

    The current impact and future of Decentralized Clinical Trials

    2023-05-04, 2:45 PM

    Session Details:

    Stream B: Clinical Technology & Innovation

    2023-05-04, 8:50 AM

    Session Details:

    Stream B: Clinical Technology & Innovation

    2023-05-03, 10:45 AM

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    Roel van der Heijde
    Facilitator & Trainer, Patient Experience Association

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

    He is a driven and experienced trainer and facilitator in:

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

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

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

    Session Details:

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

    2023-05-03, 9:30 AM

    Session Details:

    Stream C: Clinical Data; Strategy & Planning

    2023-05-03, 10:45 AM

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

    Session Details:

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

    2023-05-04, 10:15 AM

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    Anna Pugnetti
    Global Clinical and RWE Outsourcing Manager, Chiesi Farmaceutici

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

    Session Details:

    INTERACTIVE THINK TANKS

    2023-05-04, 3:15 PM

    Session Details:

    INTERACTIVE THINK TANKS

    2023-05-04, 3:15 PM

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    Elena Carzana
    Vendors Alliance Manager DM&Stat, Chiesi Farmaceutici

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

    Session Details:

    INTERACTIVE THINK TANKS

    2023-05-04, 3:15 PM

    Session Details:

    INTERACTIVE THINK TANKS

    2023-05-04, 3:15 PM

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    Smruthi Panyam
    Director, Clinical Data Informatics, BeiGene

    Session Details:

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

    2023-05-03, 3:15 PM

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    Laura Jiménez Robledo
    Clinical Project and Innovation Manager, Novo Nordisk

    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 Unit Manager, Sant Joan de Deu Barcelona Hospital

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

    Session Details:

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

    2023-05-03, 4:15 PM

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    Stephen Lutsch
    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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    Mateusz Zabolski
    Head of Technology – Biosamples, AstraZeneca

    Session Details:

    Utilizing Data Mesh technologies for data analysis in clinical trials

    2023-05-03, 2:15 PM

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

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

    Session Details:

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

    2023-05-04, 11:45 AM

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    Henrik Schou
    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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    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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    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)

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

    2023-05-03, 5:15 PM

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    Lidya Domínguez
    Clinical Research Director, Sermes CRO

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

    Session Details:

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

    2023-05-03, 5:15 PM

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    Jay Smith
    Head of Product, Trial Interactive, TransPerfect

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

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

    Session Details:

    Practical use cases to improve clinical site efficiency with technology

    2023-05-04, 2:15 PM

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    Dr. Claudia Hesselmann
    Founder and CEO, Arensia

    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).

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    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.

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    INTERACTIVE THINK TANKS

    2023-05-04, 3:15 PM

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    INTERACTIVE THINK TANKS

    2023-05-04, 3:15 PM

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    Laia Casas Papiol
    Clinical Project Leader, Noucor Health

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

     

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    Harry Yeates
    Strategy Director, Langland

    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.

     

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    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.

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

    2023-05-04, 12:15 PM

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    Enrico Perfler
    CEO, 1MED SA

    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.

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    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.

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    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

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    INTERACTIVE THINK TANKS

    2023-05-04, 3:15 PM

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    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 deep understanding of the unique dynamics of developing novel treatments for rare and complex diseases, Dr. Raymond also leverages her combination of training and experience leading the Gene Therapy Think Tank at Worldwide Clinical Trials. This experience includes in vivo viral- vectored gene therapies, ex-vivo viral vectored and gene edited treatments for oncology and non-oncology patient communities, and RNA medicine modalities. 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. Dr. Raymond completed her doctoral training in molecular biology at University of California San Diego and post-doctoral training in molecular biology at Memorial Sloan-Kettering in New York City, New York, USA.

    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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