Outsourcing in Clinical Trials Europe 2023

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

3 - 4

May

2023
  • Hyatt Regency Barcelona Tower, Spain
  • Complimentary
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Why attend?

WHAT TO EXPECT FOR 2023?

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

250+

Attendees

20+

Exhibitors

25+

Speakers

85%

Attendees at Director+ level

250+

Attendees

20+

Exhibitors

25+

Speakers

85%

Attendees at Director+ level

See What It's All About

2023 Agenda

  • 3 May 2023
  • 4 May 2023
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Streams

Stream one

Stream A: Outsourcing & Clinical Operations

Stream two

Stream B: Clinical Technology & Innovation

Stream three

Stream C: Clinical Data; Strategy & Planning

Stream C: Clinical Data; Strategy & Planning

Speakers

11 AM

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

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

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

Speakers

11:45 AM

Session Reserved for Event Sponsor

12:15 PM

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

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

Speakers

12:45 PM

Session Reserved for Event Sponsor

1:15 PM

Lunch and networking

2:15 PM

Utilizing Data Mesh technologies for data analysis in clinical trials

Speakers

2:45 PM

Session Reserved for Event Sponsor

3:15 PM

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

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

Speakers

3:45 PM

Afternoon refreshments and networking

4:15 PM

Communication & Innovation: Defining innovation in clinical trials

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

Speakers

Stream B: Clinical Technology & Innovation

Speakers

11 AM

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

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

Speakers

11:45 AM

Session Reserved for Event Sponsor

12:15 PM

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

How does digital transformation happen?

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

Speakers

12:45 PM

Session Reserved for Event Sponsor

1:15 PM

Lunch and networking

2:15 PM

Delving into Digital Health in Oncology clinical trials

Speakers

2:45 PM

Session Reserved for Event Sponsor

3:15 PM

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

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

Speakers

3:45 PM

Afternoon refreshments and networking

4:15 PM

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

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

Speakers

4:45 PM

Session Reserved for Event Sponsor

5:15 PM

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

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

Speakers

5:45 PM

Chair’s Summary & Drinks Reception

7:45 AM

Conference Registration and refreshments

8:20 AM

Chair’s opening remarks

Speakers

8:30 AM

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

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

Speakers

9 AM

Session Reserved for Medidata

9:30 AM

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

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

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

Speakers

10 AM

Session Reserved for Featured Sponsor

10:30 AM

Morning refreshments and networking

Stream A: Outsourcing & Clinical Operations

Speakers

11 AM

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

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

Speakers

11:45 AM

Session Reserved for Event Sponsor

12:15 PM

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

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

Speakers

12:45 PM

Session Reserved for Event Sponsor

1:15 PM

Lunch and networking

2:15 PM

Call for research in creative climate in organization in clinical development

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

Speakers

2:45 PM

Session Reserved for Event Sponsor

3:15 PM

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

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

Speakers

3:45 PM

Afternoon refreshments and networking

4:15 PM

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

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

Speakers

4:45 PM

Session Reserved for Event Sponsor

5:15 PM

CLOSING KEYNOTE Can the new EU Clinical Trial Regulation revolutionize clinical trial processes across Europe, creating a more streamlined application?

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

  • Benefits of submitting through same portal for all ethics committees/authorities
  • The advantages for biopharma companies of standardized timelines
  • Understanding the new trial authorisation process for regulatory and ethical approval
  • Overview of major new requirements, such as risk-based evaluations and informed consent
  • Update since January 2023

Speakers

5:45 PM

Chair’s Summary & Drinks Reception

Streams

Stream one

Stream A: Outsourcing & Clinical Operations

Stream two

Stream B: Clinical Technology & Innovation

Stream B: Clinical Technology & Innovation

Speakers

9 AM

WORKSHOP Introducing The Patient Centric Sample Interest Group

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

Speakers

9:45 AM

Session Reserved for YPrime

Speakers

10:15 AM

The metaverse in Pharma it could be a possible solution?

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

Speakers

10:45 AM

Session Reserved for Event Sponsor

11:15 AM

Morning refreshments and networking

11:45 AM

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

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

Speakers

12:15 PM

Session Reserved for Event Sponsor

12:45 PM

Case study: Clinical digitalization roadmap for medical device companies

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

Speakers

1:15 PM

Lunch and networking and Apple Prize draw

2:15 PM

Practical use cases to improve clinical site efficiency with technology

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

Speakers

2:45 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: Working with Patient Advocacy Groups & overcoming barriers with patient engagement
Host:

Speakers

3:45 PM

End of Event

8:10 AM

Registration and refreshments

8:45 AM

Chair’s opening remarks

Stream A: Outsourcing & Clinical Operations

Speakers

9 AM

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

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

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

Speakers

9:45 AM

Session Reserved for Event Sponsor

10:15 AM

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

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

Speakers

10:45 AM

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

11:15 AM

Morning refreshments and networking

11:45 AM

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

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

Speakers

12:15 PM

Session Reserved for Event Sponsor

12:45 PM

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

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

Speakers

1:15 PM

Lunch and networking and Apple Prize draw

2:15 PM

Session Reserved for Event Sponsor

2:45 PM

The current impact and future of Decentralized Clinical Trials

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

Speakers

3:15 PM

TBC TOPIC – Choosing a CRO as a small to mid-sized biotech company: factors to consider

  • Balancing the benefits of working with a small CRO vs a large global CRO: which is better equipped to handle the needs of a smaller biotech?
  • How important is it to choose a CRO with experience in your therapeutic area?
  • Working with multiple vendors: is this the best option for smaller sponsor companies?

Speakers

3:45 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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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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Mariusz Olejniczak
CEO, WPD Pharmaceuticals

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

Session Details:

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

2023-05-04, 11:30 AM

Session Details:

Call for research in creative climate in organization in clinical development

2023-05-03, 2:15 PM

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Robert S. Greene
President, Hunger and Thirst Foundation

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

Session Details:

Chair’s opening remarks

2023-05-03, 8:20 AM

Session Details:

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

2023-05-03, 11:00 AM

Session Details:

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

2023-05-03, 9:30 AM

Session Details:

Stream A: Outsourcing & Clinical Operations

2023-05-03, 10:45 AM

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John Zibert
Chief Medical Officer, Coegin Pharma AB

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

Session Details:

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

2023-05-03, 11:00 AM

Session Details:

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

2023-05-03, 3:15 PM

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Sonja Weiser
Senior Director Clinical Operations, Insmed

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

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

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

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

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

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

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

Session Details:

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

2023-05-03, 11:00 AM

Session Details:

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

2023-05-04, 9:00 AM

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

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

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

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

Session Details:

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

2023-05-03, 11:00 AM

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Estrella Garcia
Senior Director Global Clinical Operations, Almirall

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

 

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

 

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

Session Details:

INTERACTIVE THINK TANKS

2023-05-04, 2:45 PM

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

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

Session Details:

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

2023-05-03, 11:00 AM

Session Details:

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

2023-05-03, 8:30 AM

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Silvia Perez Torres
Director, Clinical Quality Compliance, AstraZeneca

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

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

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

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

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

Session Details:

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

2023-05-04, 12:45 PM

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Ivan Vyshnivetskyy
President, Ukrainian Association for Clinical Research

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

 

Session Details:

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

2023-05-03, 11:00 AM

Session Details:

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

2023-05-03, 4:15 PM

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Ivanna Rosendal
Director, Global Process Governance, Ascendis Pharma

Session Details:

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

2023-05-03, 12:15 PM

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Priya Nair
Senior Analyst, GlobalData

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

2023-05-03, 11:00 AM

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The current impact and future of Decentralized Clinical Trials

2023-05-04, 2:45 PM

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Stream B: Clinical Technology & Innovation

2023-05-04, 8:50 AM

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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. 

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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

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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

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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.

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INTERACTIVE THINK TANKS

2023-05-04, 2:45 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.

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INTERACTIVE THINK TANKS

2023-05-04, 2:45 PM

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Smruthi Panyam
Director, Clinical Data Informatics, BeiGene

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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

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Communication & Innovation: Defining innovation in clinical trials

2023-05-03, 4:15 PM

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Jelena Mihajlović
Clinical Operations Program Lead, Immunic Therapeutics

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TBC TOPIC – Choosing a CRO as a small to mid-sized biotech company: factors to consider

2023-05-04, 3:15 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.

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

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

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

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

Session Details:

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

2023-05-03, 11:00 AM

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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

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Utilizing Data Mesh technologies for data analysis in clinical trials

2023-05-03, 2:15 PM

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

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

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

2023-05-04, 11:45 AM

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

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

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

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

2023-05-04, 11:45 AM

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Xavi Jofre
Digital Transformation Director, Barcelona Health Hub

I live between a fuzzy and a techie world!

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

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

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

2023-05-03, 12:15 PM

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Bálint Feher
Senior Clinical Research Manager, Geistlich Pharma AG

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

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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).

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

2023-05-03, 4:15 PM

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Asta Selin
EU Regional Submission Lead, MSD

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CLOSING KEYNOTE Can the new EU Clinical Trial Regulation revolutionize clinical trial processes across Europe, creating a more streamlined application?

2023-05-03, 5:15 PM

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Lidya Domínguez
Clinical Research Manager, 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.

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CLOSING KEYNOTE Can the new EU Clinical Trial Regulation revolutionize clinical trial processes across Europe, creating a more streamlined application?

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.

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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.

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

2023-05-04, 10:45 AM

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