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

Barcelona, Spain
Complimentary

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Estrella Garcia

Senior Director Global Clinical Operations, Almirall

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

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

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

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Marco Salami

Head of Clinical & RWE Outsourcing Management, Chiesi Farmaceutici

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Domenico Merante

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

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

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Xavi Jofre

Digital Transformation Director, Barcelona Health Hub

I live between a fuzzy and a techie world!

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

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

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Caoimhe Vallely-Gilroy

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

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

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

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Ivan Vyshnivetskyy

President 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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Company Information

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

Company Website

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

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

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

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

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

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

Company Website

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

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

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

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

Company Website

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

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

Company Website

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

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

Company Website

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

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

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

Company Website

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

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

Company Website

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

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

Company Website

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

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Novotech is internationally recognized as the leading Asia Pacific centred Biotech Contract Research Organization (CRO) with global execution capabilities.

Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 3000 staff globally and 34 office locations.”

About Novotech- The Asia Pacific Centred Global Biotech CRO | Novotech CRO (novotech-cro.com)

Company Website

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

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

Company Website

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

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

Company Website

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

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

Company Website

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

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

-Dermatology, Immunology and Inflammatory Diseases

-Hematology and Oncology

-Ophthalmology

-Internal Medicine including Neurology & Respiratory

-Pediatrics, Rare Diseases and Orphan Drugs

-Real World Evidence

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

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

Company Website

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

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

Company Website

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

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

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

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

Company Website

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

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

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

Company Website

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

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Why attend?

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

For the 14^th 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

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Streams

Stream one

Stream A: Outsourcing & Clinical Operations

Stream two

Stream B: Clinical Technology & Innovation

Stream three

Stream C: Clinical Data; Strategy & Planning

Speakers

Roel van der Heijde

Facilitator & Trainer, Patient Experience Association

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

Benoît Marchal

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

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

Neil Vivian

Senior Director of Business Solutions and Product Manager, Anju Software

12:15 PM

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

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

Speakers

Ivanna Rosendal

Director, Global Process Governance, Ascendis Pharma

12:45 PM

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

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

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

Speakers

Karl McEvoy

Product Director, Decentralised Trial Technology at YPrime

Paul Margerison

Director, User Experience & Design, YPrime

1:15 PM

Lunch and networking

2:15 PM

Utilizing Data Mesh technologies for data analysis in clinical trials

Bullets to come

Speakers

Mateusz Zabolski

Head of Technology – Biosamples, AstraZeneca

2:45 PM

Tech Showcase – eClinical Solutions; Tech Showcase – Clario

Tech Showcase – eClinical Solutions

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

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

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

Learn how elluminate and eClinical’s Biometrics Services deliver:

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

Jason Konn, Solution Consultant, eClinical Solutions

Tech Showcase – Clario

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

Smruthi Panyam

Director, Clinical Data Informatics, BeiGene

3:45 PM

Afternoon refreshments and networking

4:15 PM

Communication & Innovation: Defining innovation in clinical trials

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

Speakers

Laura Jiménez Robledo

Clinical Project and Innovation Manager, Novo Nordisk

Stream B: Clinical Technology & Innovation

Speakers

Priya Nair

Senior Analyst, GlobalData

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

John Zibert

Chief Medical Officer, Coegin Pharma AB

Priya Nair

Senior Analyst, GlobalData

Stephen Lutsch

Senior Director Clinical Trial Digital Innovation, Genmab

11:45 AM

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

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

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

Alicia Borràs

Study Coordinator, Digital Health Unit, Strategy Office Més Sant Pau, Hospital de Santa Creu i Sant Pau

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

Kevin Landells

Vice President, Business Head of IRT, IQVIA Technologies

Karen Maduschke

Senior Director and GM, Patient Consent, IQVIA Technologies

1:15 PM

Lunch and networking

2:15 PM

Delving into Digital Health in Oncology clinical trials

Speakers

Caoimhe Vallely-Gilroy

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

2:45 PM

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

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

Speakers

Dr. Claudia Hesselmann

Founder And CEO, ARENSIA Exploratory Medicine GmbH

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

John Zibert

Chief Medical Officer, Coegin Pharma AB

3:45 PM

Afternoon refreshments and networking

4:15 PM

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

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

Speakers

Begona Nafria Escalera

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

Joana Claverol

Clinical Research Unit Manager, Sant Joan de Deu Barcelona Hospital

4:45 PM

Innovation to Strengthen Patient Accessibility to High Impact Medicines

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

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

Adam Levy

Senior Director, Business Development, THREAD

5:15 PM

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

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

Speakers

Stephen Lutsch

Senior Director Clinical Trial Digital Innovation, Genmab

5:55 PM

Chair’s Summary & Drinks Reception

7:45 AM

Conference Registration and refreshments

8:20 AM

Chair’s opening remarks

Speakers

Robert S. Greene

President, Hunger and Thirst Foundation

8:30 AM

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

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

Speakers

Roman Fishchuk

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

9 AM

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

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

Speakers

Joseph Lovett

Solution Specialist, Patient Cloud, Medidata Solutions, a Dassault Systèmes company

Fiona Maini

Senior Director - Global Compliance and Strategy Medidata Solutions a Dassault Systèmes Company

9:30 AM

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

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

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

Speakers

Robert S. Greene

President, Hunger and Thirst Foundation

Roel van der Heijde

Facilitator & Trainer, Patient Experience Association

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

Gilyana Borlikova

Data Science Manager, ICON plc

10:30 AM

Morning refreshments and networking

Stream A: Outsourcing & Clinical Operations

Speakers

Robert S. Greene

President, Hunger and Thirst Foundation

11 AM

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

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

Speakers

Robert S. Greene

President, Hunger and Thirst Foundation

Sonja Weiser

Senior Director Clinical Operations, Insmed

Roman Fishchuk

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

Ivan Vyshnivetskyy

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

11:45 AM

Optimizing Cell-based Gene Therapy Programs Through the Continued Evolution

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

Speakers

Amy Raymond

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

12:15 PM

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

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

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

David Chia

Senior Business Development Manager In Business Development United Kingdom, Novotech

1:15 PM

Lunch and networking

2:15 PM

Call for research in creative climate in organization in clinical development

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

Speakers

Mariusz Olejniczak

CEO, WPD Pharmaceuticals

2:45 PM

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

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

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

Speakers

Benjamin Etschmann

Senior Forecasting Services Lead, 4G Clinical,

3:15 PM

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

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

Speakers

Daniel McVeigh

Director, Clinical Project Lead, Alexion

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

Ivan Vyshnivetskyy

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

4:45 PM

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

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

This presentation will cover:

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

Speakers

Federica Martini, Ph.D.

Associate Director, Regulatory Affairs, Premier Consulting

5:15 PM

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

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

Speakers

Lidya Domínguez

Clinical Research Director, Sermes CRO

Raquel Reviejo

EU Regional Submission Lead, MSD

5:55 PM

Chair’s Summary & Drinks Reception

Streams

Stream one

Stream A: Outsourcing & Clinical Operations

Stream two

Stream B: Clinical Technology & Innovation

Speakers

Priya Nair

Senior Analyst, GlobalData

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

James Rudge

Technical Director, Trajan Scientific and Medical

9:45 AM

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

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

Speakers

Marcel Besier

Director of Services Delivery, Europe

Daniela Duffett

Solutions Consultant, Suvoda

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

Stefania Alvino

Head of Digital Innovation, Daiichi Sankyo

10:45 AM

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

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

Speakers

Edyta Korzuch

Senior Director Hematology/Oncology Unit, TFS HealthScience

11:15 AM

Morning refreshments and networking

11:45 AM

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

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

Speakers

Domenico Merante

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

Henrik Schou

Global Head Evidence Generation, CSL Vifor

12:15 PM

Embedding patient recruitment into healthcare systems

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

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

Speakers

Mihad Mohamed

Head of Product Management – Research and Life Sciences, EMIS

12:45 PM

Case study: Clinical digitalization roadmap for medical device companies

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

Speakers

Bálint Feher

Senior Clinical Research Manager, Geistlich Pharma AG

1:15 PM

Lunch and networking and Apple Prize draw

2:15 PM

Practical use cases to improve clinical site efficiency with technology

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

Speakers

Jay Smith

Head of Product, Trial Interactive, TransPerfect

3:15 PM

INTERACTIVE THINK TANKS

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

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

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

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

Think Tank 2: Building strategic partnerships with CROs

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

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

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

Think Tank 3: TBC TOPIC

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

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

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

Speakers

Estrella Garcia

Senior Director Global Clinical Operations, Almirall

Elena Carzana

Vendors Alliance Manager DM&Stat, Chiesi Farmaceutici

Anna Pugnetti

Global Clinical and RWE Outsourcing Manager, Chiesi Farmaceutici

Patryk Mikucki

Global Head of Country Operations, Alexion

Lars Tranberg Pettersson

Chief Information Officer, Ascendis Pharma

Orlando Vergara

Pharmaceutical and Healthcare Expert, Universidad Autónoma del Perú

4:15 PM

End of Event

8:10 AM

Registration and refreshments

8:45 AM

Chair’s opening remarks

Stream A: Outsourcing & Clinical Operations

Speakers

Werner Gladdines

VP, Clinical Development Operations, Immunic Therapeutics

9 AM

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

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

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

Speakers

Daniel McVeigh

Director, Clinical Project Lead, Alexion

Werner Gladdines

VP, Clinical Development Operations, Immunic Therapeutics

Michael Zörer

Head of Clinical Operations, VarmX

Sonja Weiser

Senior Director Clinical Operations, Insmed

9:45 AM

EU MDR: how attractive is Europe for innovation?

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

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

Speakers

Enrico Perfler

CEO, 1MED SA

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

Werner Gladdines

VP, Clinical Development Operations, Immunic Therapeutics

Marco Salami

Head of Clinical & RWE Outsourcing Management, Chiesi Farmaceutici

10:45 AM

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

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

Speakers

Ana Moreno

Director Global Clinical Operations, APICES

11:15 AM

Morning refreshments and networking

11:45 AM

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

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

Speakers

Kateryna Orlovska

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

12:15 PM

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

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

Speakers

Esther Mahillo

Vice President, Operational Strategy, Precision For Medicine

12:45 PM

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

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

Speakers

Silvia Perez Torres

Director, Clinical Quality Compliance, AstraZeneca

1:15 PM

Lunch and networking and Apple Prize draw

2:15 PM

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

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

Speakers

Harry Yeates

Strategy Director, Langland

2:45 PM

The current impact and future of Decentralized Clinical Trials

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

Speakers

Priya Nair

Senior Analyst, GlobalData

3:15 PM

INTERACTIVE THINK TANKS

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

Estrella Garcia

Senior Director Global Clinical Operations, Almirall

Elena Carzana

Vendors Alliance Manager DM&Stat, Chiesi Farmaceutici

Anna Pugnetti

Global Clinical and RWE Outsourcing Manager, Chiesi Farmaceutici

Patryk Mikucki

Global Head of Country Operations, Alexion

Lars Tranberg Pettersson

Chief Information Officer, Ascendis Pharma

Orlando Vergara

Pharmaceutical and Healthcare Expert, Universidad Autónoma del Perú

4:15 PM

End of Event

2023 Speakers

Select a speaker to learn more

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

Session Details:

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

2023-05-03, 11:00 AM

Session Details:

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

2023-05-03, 3:15 PM

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Sonja Weiser

Senior Director Clinical Operations, Insmed

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

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

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

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

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

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

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

Session Details:

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

2023-05-03, 11:00 AM

Session Details:

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

2023-05-04, 9:00 AM

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Benoît Marchal

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

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

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

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

Session Details:

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

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

Session Details:

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

2023-05-03, 11:00 AM

Session Details:

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

2023-05-03, 4:15 PM

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Ivanna Rosendal

Director, Global Process Governance, Ascendis Pharma

Session Details:

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

2023-05-03, 12:15 PM

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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

Previous to my position as Senior Director Clinical Trial Digital Innovation at Genmab, I have been working to bring the best disruptive innovation into normal clinical operations at LEO Pharma to help improve and accelerate our clinical trials. Furthermore, I am trying to solve some of the toughest challenges related to scaling digitalisation, data, and automation to generate competitive advantages across business units. One aspect is driving the necessary foundational components around a scalable GxP data platform, machine learning opportunities as well as automating digital processes with robotics process automation.

Specifically, the team I led received approval for the first fully decentralised and hybrid interventional clinical trial for LEO Pharma with the goal of accelerating the ambition to design hybrid DCTs as default. Besides driving the necessary change internally, we focused on a design-thinking approach where we put the patient and site at the center. I have an ambition towards “delighting” patients, investigators, and sponsors by solving the real-world challenges they face by leveraging both qualitative interviews and observation, as well as, quantitative methods to reveal actionable insights.

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

Session Details:

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

2023-05-03, 11:00 AM

Session Details:

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

2023-05-03, 5:15 PM

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Mateusz Zabolski

Head of Technology – Biosamples, AstraZeneca

Session Details:

Utilizing Data Mesh technologies for data analysis in clinical trials

2023-05-03, 2:15 PM

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Domenico Merante

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

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!

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Bálint Feher

Senior Clinical Research Manager, Geistlich Pharma AG

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

Session Details:

Case study: Clinical digitalization roadmap for medical device companies

2023-05-04, 12:45 PM

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James Rudge

Technical Director, Trajan Scientific and Medical

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

Session Details:

WORKSHOP Introducing The Patient Centric Sample Interest Group

2023-05-04, 9:00 AM

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Begona Nafria Escalera

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

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

Session Details:

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

2023-05-03, 4:15 PM

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Raquel Reviejo

EU Regional Submission Lead, MSD

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

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

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

Session Details:

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

2023-05-03, 5:15 PM

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Lidya Domínguez

Clinical Research Director, Sermes CRO

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

Session Details:

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

2023-05-03, 5:15 PM

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Jay Smith

Head of Product, Trial Interactive, TransPerfect

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

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

Session Details:

Practical use cases to improve clinical site efficiency with technology

2023-05-04, 2:15 PM

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Dr. Claudia Hesselmann

Founder And CEO, ARENSIA Exploratory Medicine GmbH

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

Session Details:

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

2023-05-03, 2:45 PM

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Ana Moreno

Director Global Clinical Operations, APICES

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

Session Details:

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

2023-05-04, 10:45 AM

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Karl McEvoy

Product Director, Decentralised Trial Technology at YPrime

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

Session Details:

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

2023-05-03, 12:45 PM

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Michael Zörer

Head of Clinical Operations, VarmX

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

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

Session Details:

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

2023-05-04, 9:00 AM

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Stefania Alvino

Head of Digital Innovation, Daiichi Sankyo

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

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

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

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

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

Session Details:

The metaverse in Pharma it could be a possible solution?

2023-05-04, 10:15 AM

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Kateryna Orlovska

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

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

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

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

Session Details:

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

2023-05-04, 11:45 AM

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Caoimhe Vallely-Gilroy

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

Session Details:

Delving into Digital Health in Oncology clinical trials

2023-05-03, 2:15 PM

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Orlando Vergara

Pharmaceutical and Healthcare Expert, Universidad Autónoma del Perú

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

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

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

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

Session Details:

INTERACTIVE THINK TANKS

2023-05-04, 3:15 PM

Session Details:

INTERACTIVE THINK TANKS

2023-05-04, 3:15 PM

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Laia Casas Papiol

Clinical Project Leader, Noucor Health

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

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Harry Yeates

Strategy Director, Langland

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

Session Details:

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

2023-05-04, 2:15 PM

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Neil Vivian

Senior Director of Business Solutions and Product Manager, Anju Software

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

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

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

Session Details:

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

2023-05-03, 11:45 AM

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Edyta Korzuch

Senior Director Hematology/Oncology Unit, TFS HealthScience

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

Session Details:

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

2023-05-04, 10:45 AM

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Esther Mahillo

Vice President, Operational Strategy, Precision For Medicine

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

Session Details:

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

2023-05-04, 12:15 PM

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Enrico Perfler

CEO, 1MED SA

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

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

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

Session Details:

EU MDR: how attractive is Europe for innovation?

2023-05-04, 9:45 AM

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Gilyana Borlikova

Data Science Manager, ICON plc

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

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

Session Details:

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

2023-05-03, 10:00 AM

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Lars Tranberg Pettersson

Chief Information Officer, Ascendis Pharma

Session Details:

INTERACTIVE THINK TANKS

2023-05-04, 3:15 PM

Session Details:

INTERACTIVE THINK TANKS

2023-05-04, 3:15 PM

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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 Etschmann, Senior Forecasting Services Lead at 4G Clinical, has more than 10 years of experience in clinical supply with a focus on RTSM technologies and demand forecasting using stochastic simulation tools. Benjamin is a qualified veterinary surgeon and therefore has a deep comprehension of the medical context which is at the heart of each drug development endeavor. With a Ph.D. in veterinary virology, he also appreciates the complexity and cost associated with the production of biologicals and is therefore focused on finding the optimal balance between risk and cost in each clinical trial.

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

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

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

Company Website

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

Technology Spotlight Sponsor

Drinks Sponsor

EXHIBITORS

Company Information

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

Company Website

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

Company Information

Specialty Script Rx was founded by a team of pharmacists and industry leaders since incorporated in 2011, however, we have held strong presence in the pharma industry for well over three decades through a number of ventures – all of which following the mission to support the demand of US FDA pharmaceuticals in order to accelerate clinical research, thus, determined to further science as a whole. Holding a large presence both domestically and internationally as the trusted provider of items such as limited distribution, orphan, specialty drugs & brand, generic items to sites, including, yet not limited to CRO(s), R&D institutions, BioTech firms, Hospitals and clinics. Specialty Script Rx offers rather competitive pricing and wide access when it comes to RLDs, comparator sourcing and finished dose form items in demand both within the US and overseas. Specifically, we handle a wide array of lines within the oncological, neurological and Rheumatological -amongst many others.

Company Website

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