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ACDM20 Programme

ACDM20 Programme

The Programme for ACDM20 is shown below. There are a small number sessions that we are awaiting confirmation from the speaker and panel members before we can finalise. We will update these as soon as possible. 

Sunday 8th March 2020

As a prelude to ACDM20, the 2020 ACDM Annual Conference, we are taking an optional social and networking trip into the centre of Dublin to visit the Guinness Storehouse. This will take place on the afternoon of Sunday 8th March. 

The Guinness Storehouse is Dublin’s #1 tourist attraction and the place to learn all about Guinness’ rich history. As you walk through each floor you will learn what goes into making a perfect pint of Guinness as well as having the opportunity to “pour” a perfect pint. 

The tour takes about 2 hours and you will see the famous River Liffey and be able to sample a pint of Guinness (soft drink alternatives available) from the world famous Gravity Bar where you have 360 degree views over the city of Dublin and the Wicklow Mountains. 

Registration will be open in the Lobby of Clontarf Castle from 5pm. 

From 7.30pm on the sunday evening we will be holding a networking buffet in the Indigo Lounge at Clontarf Castle. This a great way to meet delegates, speakers and exhibitors before the main start of ACDM20. Drinks for the evening have been sponsored by Phastar.

Monday 9th March 2020

10:00 - 12:00 Registration & Exhibition

10:45 - 11:45 Demonstration Hour

Castor will be providing a one hour live demonstration of their system as well as taking questions and answers.

12:00 - 13:00 Welcome & Plenary Session

Presented by: Ian Slack (Vertex Pharmaceuticals)

What will impact Data Management the most in the next five years? People, Process, Technology or Partnerships?
This presentation aims to deliver a fun perspective of why People and culture are key to the changes we will see over the near future of our industry.

Learning objectives: 
The importance of culture within and outside of DM
Using people in the right way to achieve success
Diversity means ideas and innovation
Presenter Details
Ian Slack 
Director, Clinical Data Management: Vertex Pharmaceuticals

Ian has been in the industry for over 20 years having come from a Laboratory background and accidentally finding Data Management at PAREXEL joining their newly formed dedicated medical coding group in 1999. Apart from Ian’s expertise in medical coding he is an experienced people manager, presenter and trainer and includes process development/optimisation and implementation in his general skillset. Currently Ian works for Vertex Pharmaceuticals out of their London office as a Director in Clinical Data Management leading the European DM team. Additionally, Ian is the Global Manager of Medical Coding and is a Personal Data Privacy Champion (Think GDPR!) for Clinical Operations.

13:00 - 14:00 Lunch & Exhibition

14:00 - 15:30 Plenary Session

Presented by: Maria Craze (Merck Sharp & Dhome Inc. (MSD)) Armand Matejunas (Accenture Life Sciences) Christopher Lamplugh (Merck & Co., Inc. (Kenilworth, New Jersey, U.S.A.)) Catherine Célingant (Pfizer) Mike Jagielski (KCR)

The days of the traditional data manager of the past, manually entering data from a paper CRF into a database and passing that data along for another data manager to manually clean, are LONG GONE. Today, most see the data manager as a processor of the clinical data in an EDC system; turning clinical requirements into specifications, verifying edit checks, running exception reports and listings, etc. to clean the data and manually writing queries to site staff. Then stop and repeat. But I pose that even this role of the data manager is becoming obsolete and is the new definition of the “past” when describing a data manager. The role of the data manager is evolving, and we can catch up and stay ahead, or get lost in the past. Data Managers will have to think more intelligently and handle more complex scenarios as automation takes care of the repeatable and predictable. The Future data manager must be highly skilled in end-to end study design, signal detection, risk management, problem solving and team leadership as well as have a high tolerance for the ambiguous and live and breathe adaptability. We must recruit data managers for their POTENTIAL in these areas, cultivate that potential and develop the data managers for the future. Traditional activity-based learning plans and sequential development plans just do not evolve fast enough. In this session, the panel of CDM experts will provide their perspectives on the past, present and most importantly the future of the data manager. This must be a CONTINUAL EVOLUTION and never again a once and done catch up exercise. Just as the science and technology of clinical trials is evolving so must the data manager.

Learning objectives: 
Educate the audience on the skill set needs for the future CDM
Help CDM managers/leaders in the audience to think about how to evolve their DMs for the future
Address audience questions and concerns around the role of the DM of the future
Presenter Details
Maria Craze 
Executive Director- Global Data Operations: Merck Sharp & Dhome Inc. (MSD)

I have been in the field of Pharmaceutical Clinical Data Management for 17 years. My experience spans from the mail room and data entry/data review to project manager and study designer through process owner/SME, management and now executive leadership. I have years of experience as a traditional data manager, and I myself have had to manage change from a CDM perspective as the industry moved from paper based CDM to electronic. As a CDM subject matter expert I have had great opportunities to explore emerging technologies, risk based approaches as well as automation trends. I have had experience developing and authoring CDM process, training plans and materials for the ever growing CDM groups forming. I have also had the pleasure of training, mentoring and coaching CDMs of multiple skill levels over the last decade. My experience as a Organization Leader at MSD in the area of CDM has afforded me vast and broad opportunities to interact with technology vendors and CROs to be part of shaping the future. Additionally I serve on the board of a global CDM society whose main mission is also to provide leadership, guidance and support for the ever changing CDM community.

Armand Matejunas 
Clinical Data Operations Lead Accenture: Accenture Life Sciences

Armand has been a leader of Data Management organizations at Otsuka America, Purdue Pharma and Shire LLC over the past 20 years. An industry veteran of over 35 years, he has led teams in Data Management, Clinical Data Standards and Clinical Technology support to ensure on time delivery of quality data. In his current role at Accenture, Armand leads the Clinical Data Operations team in Applied Life Sciences Solutions, which delivers data management, data integration and data pooling services to Pharma and Biotech clients. He holds a Masters Degree in Computer Science from New Jersey Institute of Technology and a Bachelors of Computer Science from Stevens Institute of Technology.

Christopher Lamplugh 
Head of Global Data Management and Standards (GDMS): Merck & Co., Inc. (Kenilworth, New Jersey, U.S.A.)

Christopher Lamplugh is Associate Vice President and Head of Global Data Management and Standards (GDMS) at Merck & Co., Inc. (Kenilworth, New Jersey, U.S.A.). GDMS provides Clinical Data Management services for ESD and LSD trials, including data standards, Interactive Response Technology (IRT), Clinical Outcomes Assessment (COA), Pharmacovigilance Case Processing, and other technical business enablement operations. Over his 15-year career at our company, Chris also led the creation, expansion and operationalization of our Data Management Centers (DMCs). Located strategically in centers around the globe, our DMC network provides world class Data Management (DM) deliverables & Pharmacovigilance case process requirements for our company.

Prior to his career at our company, Chris worked for General Electric for 10 years in Sales Management, Sales Force Effectiveness and Quality. He is a certified Six Sigma Black Belt and is active in many industry initiatives and forums within the pharmaceutical industry. He has a BA from Ursinus College and an MBA from Penn State, with coursework in Health Policy from Jefferson University. Chris lives in Philadelphia with his wife and 4 children.

Catherine Célingant 
Oncology Therapeutic Area Lead in the Data Monitoring and Management Organisation: Pfizer

As the Oncology Therapeutic Area Lead in the Data Monitoring and Management (DMM) organization at Pfizer, Catherine Célingant leads a team of Clinical Data Scientists and Data Managers responsible for timely and high-quality data management deliverables supporting the Pfizer Oncology portfolio.

Catherine has over 20 years of experience in Data Management, Clinical Informatics, and Medical Operations. Prior to joining Pfizer, Catherine worked at Millennium: The Takeda Oncology Company, where she successively led the Clinical Data Management and Clinical Systems, Medical Systems Innovative Technologies and Operations, and Medical Business Operations functions. Catherine also worked at Accenture, Wyeth, Genetics Institute, and MTRA (AAI).

Over the years, Catherine has been involved in several PhRMA, eClinical Forum and Transcelerate-sponsored groups working with other bio-pharmaceutical sponsors, regulators and other stakeholders to facilitate the adoption of research-enabling technologies such as EDC, ePRO, and eSource.

Catherine holds a M.A. in Linguistics from Cornell University and an undergraduate degree in Biology from the University of Bordeaux, France.

Mike Jagielski 
President & CEO: KCR

Mike Jagielski is President & CEO of KCR, a contract research organization operating internationally. KCR is a mid-size full service CRO with 500 employees. He plays a significant role in advocating for a patient-centric approach in clinical studies. Mr. Mike Jagielski stepped in as President and CEO of KCR in 2013. He has over 20 years of experience in the global clinical trial operations industry. Prior to joining KCR, Mr. Jagielski worked for Merck&Co for over 13 years, holding managerial positions across many different countries and regions.

Presented by: Tanya du Plessis (Bioforum)

Times are changing, the work-place “looks different”. It looks physically different (what we actually see) and professionally different (how we experience the working environment. With less people being office bound, and more companies expanding their geographic foot prints, the fact that your may have a big team (around you or reporting to you) but not physically with you in the office is a real reality. Additionally, a whole new generation (The millennials) have joined the work force and have brought with them new approaches to career management.

Additionally, the way we work has also changed drastically. Very few companies are hosting data files locally, and even fewer are limiting network access to the office space only. Yet, we see many companies continuously trying to apply aged management plans, and employee engagement strategies, to a work place.

The question how do we change? What should we be focusing on to retain young talent? and keep them talent engaged? How do we reply on our trustworthy management principles and yet apply them differently?

In this session I will speak about how to over come these hurdles and get the most out of the new dynamic work-force and virtual work place, without loosing engagement and team dynamic. I will share experience on methods that worked as well as those that didn’t/don’t, what are the common pit-falls and of course how to plan ahead for change.

Learning objectives: 
Understanding how the work place and work force has changed
Gaining new knowledge on how to adapt to the conditions (Managing young and often virtual talent)
Sharing experience on what works and what does not
Presenter Details
Tanya du Plessis 
VP, Data Strategies and Solutions: Bioforum

Tanya is currently Vice President Data strategies and solutions of Bioforum, she has vast industry experience with over 14 years with IQVIA (legacy Quintiles). Leading various data management operation teams, Tanya has actively lead strategies for customized data delivery solutions focusing on timely quality data. She has driven numerous innovation teams, and her dedication to optimal customer service/delivery is visible through her long standing relationships.
As a certified clinical data manager (CCDM, SCDM), Tanya holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State, as well as her project management professional certification (PMP, PMI).

15:30 - 16:00 Break & Exhibition

16:00 - 17:00 Plenary Session

Presented by: Maria Fiorella Pilotti (IQVIA)

Clinical trials with long-term follow-up stages provide significant estimates of the effect of a drug in a specific population, as well as data about its safety and efficacy. In fact, for hard targets such as cancer treatments, these studies are essential to deliver substantial statistical results, which could lead to increasing patient survival time and quality of life.

As CDMs our primary objective is to provide high-quality data to our sponsors, meaning that it is accurate, reliable and complete. This has become easier by using software applications to review discrepancies and reconcile them, while keeping an audit trail of the records in the databases. However, there can be difficulties reaching goals, due to the number of patients lost to follow-up and lack of protocol adherence following investigational product administration. To increase their patient retention rate, many trials do not specify within their protocols when exactly a subject is officially considered ‘lost to follow-up’. Therefore, the number of subjects enrolled, to which there is no survival or death awareness, grows considerably leading to a potential risk in data quality.

Fortunately, with social media it is becoming easier to get information about the status of subjects. At the moment, over 40% of the World population is consider an active social media user, and by year 2025 this number is expected to be over 45%, accordingly to different sources. This means more resources to find people worldwide and to be aware of what they do and where they are. As still so recent, there is still a gap between social media data, ethics and privacy in terms of a clinical trial. Which is the limit, if any, to locate a subject that is in long-term follow-up and currently not showing up to in-site visits or getting investigator’s phone calls? Is it acceptable to document someone’s well-being by a Facebook picture or a Twitter post? How appropriate is it for a clinical trial to not specify a period in which a patient is ‘lost to follow-up’? How reliable would this data be, as we don’t know for sure who is in the other side of the screen?

For the upcoming years, it would be interesting for the Industry to set multi-disciplinary discussions about the resources available for patient tracking and their impact in data privacy. A review of current regulations should also be addressed for the success of future studies.

Learning objectives: 
Presenter Details
Maria Fiorella Pilotti 
Clinical Data Manager: IQVIA

Born in 1991 in Argentina, Maria Fiorella got her BS Pharmacy Degree from Universidad Nacional del Sur in 2016 and has been working in Clinical Reserch since then. On the last year of University she worked on neurodegenerative diseases at CONICET Argentina, and then jumped into her first role in a CRO has Clinical Trials Assistant. Before joining IQVIA Ireland, where she now performs a role as Data Management Lead since May 2019, she worked for 2 years as Clinical Data Manager in growing team in Buenos Aires.

Presented by: Sheelagh Aird (Phastar)

Key Performance Indicators (KPIs) are values which demonstrate an organisation’s performance, strengths, and opportunities for improvement. Whilst high level KPIs are often used to monitor the health of partnerships between companies, targeted KPIs should be used to focus on the improvement of processes and procedures to ensure the quality and timeliness of key deliverables.

What should be the goal of KPIs? Most KPIs will have levels of expectation assigned – Minimum Level and Target Level. What are we achieving by meeting these levels? Associating KPIs to processes or procedures which are already delivering high levels of efficiency will mostly tell us what we already know – the process/procedure is performing well. Pat on the back! So how do we effectively use KPIs to track process improvements and efficiencies in terms of time and costs? Phastar’s approach stems from our core values and golden roles – Understand, Interpret, Check and Drive.

This session will share some of our tools, techniques and strategies for identifying processes which can be improved. Starting with a ‘no blame’ ethos and implementation of the golden rules, we will discuss measurements in terms of what, when and how including use of KPI data to assist our root cause analysis for process optimisation.

Learning objectives: 
How to target KPIs for effective data management process improvement
Effective measurement of KPIs
Using KPIs for root cause analyses
Presenter Details
Sheelagh Aird 
Head, Clinical Data Operations: Phastar

Sheelagh’s background is in pharmacology, gaining a doctorate in Pharmacokinetics from the University of Bath. She has worked in the pharmaceutical industry for over 25 years, working for large, medium and small CROs, heading up their data management and programming groups. She was the co-owner and Director of a bespoke data management CRO before joining PHASTAR in 2016 to lead their Clinical Data Operations team.

17:00 - 17:30 Annual General Meeting of the ACDM

19:00 - 01:30 Drinks Reception, Conference Dinner & ACDM Awards

Thanks to Phastar, who are our Networking & Conference Dinner Sponsor, we bring to you a night of Irish hospitality and entertainment in Clontarf Castle. We always like to bring the local culture to the evening.  Do you remember ACDM19 Dinner on the canals of Amsterdam? Well ACDM20 Dinner will be in the Castle and will be one to remember. 

Tuesday 10th March 2020

09:15 - 11:05 Plenary Session

Presented by: Aoife Giblin (ICON plc)

With progressive enhancement in Clinical Research technology over recent years, from the deployment of wearable devices to the exploration of artificial intelligence, the role of a Data Manager is once again evolving as we navigate through an increasingly complex environment. Robots can now issue our once manually raised queries directly from data review tools. They have the capability to freeze and lock eCRFs using pre-defined criteria. As we look to automate such traditional data management activities, the DM role does not go away but rather the responsibilities of this role become far more technical in their nature. With any new technology, there is a learning curve for both the vendor and the users, but are we allowing sufficient time and contingency in our planning for delivery?!

In these times where EDC databases can act as eCOA systems with Data Managers creating patient facing screens, we need a shift in our mindset, a willingness to adapt and some thoughtful database design. Our responsibilities are also broadening into the management of multiple data sources and multiple data flows and there is a definite requirement for specific Data Management systems to:

– Manage queries
– Data review
– Discrepancy review
– Listing review
– Managing and loading external data
– Data Mapping to SDTM and other formats

Learning objectives: 
The advantages and challenges of technological advancement in DM.
The opportunities which come with this technological evolution and expansion of the DM role.
How we can work to effectively design eCOA screens in EDC systems, and effectively manage the multiple sources and flow of Third Party Vendor data.
Presenter Details
Aoife Giblin 
Director of Data Management: ICON plc

Joined ICON plc in Apr 2019 as Director of Data Management. Based in Dublin, Ireland. Aoife has over 13 years of CRO DM experience with over 8 years in a DM management position. Aoife has strong technical and process knowledge and has extensive experience across multiple EDC platforms and Therapeutic Areas including Oncology, Neuorology and Rheumatology

Presented by: Jennifer Bradford (PHASTAR)

Despite the hype surrounding consumer-grade wearable technology in healthcare, the role of patient-generated data alongside traditionally collected data on a clinical trial is not fully understood. Ongoing clinical trials that utilise consumer-grade devices, specifically activity trackers, focus on their use as an intervention for example in behavioural studies or as an endpoint measure. There is limited evidence of how data from such devices might be used more generally together with traditionally collected trial data.
Consumer wrist-worn activity trackers continue to gain in popularity and typically measure steps, heart rate, activity and sleep. This rich data source could potentially offer insights into the general health and well-being of individuals on a clinical trial. We performed a feasibility study to look at the data generated from activity trackers and discuss challenges and potential solutions around the data workflow; from data access through to meaningful analysis and interpretation.

Learning objectives: 
Appreciate the potential for different wearables on clinical trials and the sort of data generated
Understand some of the challenges around wearables and clinical trials
Realise ways in which wearable data could be used to provide meaningful insights on a clinical trial
Presenter Details
Jennifer Bradford 
Head of Data Science: PHASTAR

Jennifer Bradford, PhD is Head of Data Science for the CRO PHASTAR. She previously worked for the Advanced Analytics Group at AstraZeneca, leading the development of the REACT clinical trial monitoring tool, which she later customized and delivered to other sponsors as part of Cancer Research UK (CRUK). Within CRUK and in close collaboration with the Christie hospital she worked on EDC, app development and wearables data analytics in the context of clinical trials. She has a degree in Biomedical Sciences from Keele University and a bioinformatics Masters and PhD from Leeds University.

Presented by: Emma Albacar (TFS) Albana Shahini (TFS)

Patient retention represents an important challenge in some therapeutic areas. Some late phase studies, but also clinical trials, may be destined to fail due to a low patient retention. In example, the prevalence of chronic psoriasis in Western industrialized countries is around 2% (>30M people). Most treatments have side effects that may lead patients to withdrawn the treatment, increasing the risk of suffering other concomitant conditions like psoriatic arthritis or cardiovascular diseases. The impact of low patient retention in patient’s quality of life is also something that worries to the clinicians.

This fact has inspired an alliance among Pharmaceutical companies, CROs and EDC vendors for developing apps to improve patient retention. In addition this app collects ePRO data and offers another functionalities and links to specific tools useful for patient condition. There are also reminders for medication in order to make them more compliant and side effect reporting so the sites can plan actions for them.

The app has been developed, validated and placed in production in 6 months since the signature of the contract. Currently, subjects has started to use it and the study is ongoing. The patient retention tool can be accessible for patients from their own mobile phone and for the sites through one portal hosting the EDC, the app and the eConsent with just one single login. Data Managers can also benefit of this single access to the platform and make their job more efficient.

In six month from now, we expect to evaluate the impact of this new tool, re-evaluate the content and continue improving the app on benefit of the patients. During our presentation, we would like to focus not only in the implementation challenges and opportunities for patients but also to analyst the benefits for every role using the tool.

Learning objectives: 
Custom a solution (e-tool) in benefit of the patient, sites and CDMs. How it works? Steps of the development.
Leason learnt from the new tool and acceptance from the patients and sites. Next steps.
How to built up a success relationship between 3 parties (starting from the contract/agreement, followup and succesful product)
Presenter Details
Emma Albacar 
Senior Director Data Management: TFS

Emma has a Degree in Statistics and Master degree in Public Health from the University of Barcelona and a Master degree in Marketing Research from UOC. She has over 19 years’ experience in Clinical Research working mainly in CROs, several therapeutic areas/phases and in different positions (Statistician, SAS programmer, Data Manager and coordinating Data Management activities).

From 2016 Emma is Senior Director of Data Management at TFS and co-ordinates Data Management activities across Europe and US, giving support to the teams in the different study stages. She is also investing time in system implementation and validation, including leadership and support on the development of new Data Management tools. Recently, Emma has been working closely with Data Management team from different companies on the development of a patient retention tool and eConsent.

Albana Shahini 
Senior Clinical Data Manager: TFS

Albana Shahini has been working in the pharmaceutical industry in different positions since 2012. Albana joined the data management department at TFS in 2015 and has during this time been working with small and medium sized companies as well as big pharma as a clinical data manager. In Albana’s position as a data manager she has been involved from project start-up to finalization in different therapeutic areas and phases, working with vendor management; electronic Patient Reported Outcomes, among others. Albana is also involved in the development, implementation and validation of EDC and ePRO systems at TFS, taking a leading role in some of these activities. Lately, Albana has been involved in the development of the eConsent and patient retention tool as the leading CDM from the CRO side.
Albana is educated at Karolinska Institute and Lund University, where she received a Bachelor degree in Biomedical Science (2009) and a Master degree in Biomedicine (2011), respectively.

11:05 - 11:35 Break & Exhibition

11:35 - 12:25 Parallel Sessions

Session A

Presented by: Caroline Halsey (Perficient) Damon Fahimi (Uppsala Monitoring Centre)

WHODrug Koda is an automated coding service custom-built by UMC. The service is specifically designed for increasing the efficiency, consistency and quality of drug coding. Perficient are working with UMC to see how we can enable sponsor’s to efficiently and effectively integrate Koda into their existing medical coding systems and would like to share our experience with the conference.

Learning objectives: 
Gain an understanding of the capabilities of WHODrug Koda
Understand how WHODrug Koda can be integrated into medical coding systems
Presenter Details
Caroline Halsey 
Director, Life Sciences: Perficient

Caroline Halsey has over 20 years’ experience in the clinical trials industry from various angles including data management, project management, cardiac safety services and IT consultancy. Recent responsibilities include enhancing the data management services at Perficient and oversight of the development of a bespoke medical coding system for a major pharma, alongside responsibilities as Director within the Perficient Life Sciences Business Unit.

Damon Fahimi 
Product & Outreach Manager: Uppsala Monitoring Centre

Damon Fahimi is working as a Product & Outreach Manager for WHODrug at Uppsala Monitoring Centre (UMC), the maintenance organisation for WHODrug Global. Damon holds a MSc Pharm degree from Uppsala University, Sweden. He joined the UMC in 2012 and is responsible for making sure that the WHODrug portfolio meets regulatory and user needs.

Presented by: Cliona O’Donovan (Pavilion Health Europe Pte Ltd)

Information on clinical activity in hospitals is collected through a coding process where data on individual episodes of care are summarized and classified using international classification systems such as ICD10 (with some country-specific variants of the classification system). The resulting data are used for a variety of purposes including for funding hospitals and in measures of quality of care. Therefore, data quality is essential.

The conduct of clinical coding audits is an essential component in quality assurance for clinical coding. Audits measure the accuracy of the clinical coding’s representation of the medical record. However clinical coding auditing is very time-consuming, resource-intensive and there are limited numbers of experienced auditors available to conduct audits. This presentation describes our method to balance statistical robustness of clinical coding audit sample sizes with the practicalities of auditing large numbers of medical records.

The approach is based on a disproportionate stratification by stratum method to allow us to examine each hospital individually, because we do not know if hospital size in terms of counts of episodes reflects the complexity of care at that hospital, or if the count of episodes impacts on the chance of errors in coding. In addition to disproportionate stratification, we deliberately bias the episode selection probability to select episodes from across the spread of complexity at the hospital.

In the analysis step we then calculate our findings for each stratum and extrapolate back to that hospital by adjusting for deliberate bias introduced in the sampling.

The result are sample sizes of episodes of care for clinical coding audit that are robust enough to extrapolate to the whole, while small enough to feasibly conduct the audit with limited resources.; facilitating the conduct of clinical coding audits of while maximising the efficient use of auditor resource. This has practical implications in real-life settings.

Learning objectives: 
Demonstrate sampling method that balances statistical robustness with feasibility of examining the sample with limited resources
Awareness of challenges of data quality assurance for routinely collected clinical data compared to prospective clinical trial data
How routinely collected clinical data are used to inform performance including quality of care and funding.
Presenter Details
Cliona O’Donovan 
Senior Statistician, Head of Irish Operations: Pavilion Health Europe Pte Ltd

Cliona heads Pavilion Health Europe’s operations in Ireland. A statistician with a strong background in clinical data management, Cliona is currently leading the implementation of data quality measurement and assessment tools for activity data across all acute public hospitals in Ireland, manages international projects on assessment of data quality in and analyses international activity information to gain insight into quality of care from routinely collected data.

Cliona has lived and worked in Ireland and Australia and has held senior management and technical roles for clinical research organizations and within the public sector. She has over many years of experience in international clinical research data management to ICH-GCP regulatory requirements on large multinational trials; along with 10 years’ experience of routinely collected hospital activity information. Cliona has a particular interest in using business intelligence tools to allow users to draw insights from diverse data sources.

Cliona has a degree in Pharmacology and Biochemistry from University College Cork and an MSc in Epidemiology from the London School of Hygiene and Tropical Medicine. A long-time member of ACDM Training committee, Cliona developed and taught Certificate I and Certificate II courses on clinical data management for the Association for Clinical Data Management.

Session B

Presented by: Sue Huxtable (Covance)

Despite EDC being around for some 15+ years, the data manager is a role that has survived. Whilst the tools have improved, some of the fundamental challenges we face remain very much as they were in the early paper based days. In a world of multiple data sources, is the role of the traditional data manager now moving away from an EDC based environment, to more of a reconciliation and laboratory expert role?
I will give some examples of models we are implementing at Covance, including technology solutions offered.

Learning objectives: 
How todays Lab Data Manager role has evolved
How technology can support the Lab Data Manager
Presenter Details
Sue Huxtable 
Director, Data Management and Standards: Covance

Sue Huxtable has more than 25 years’ experience in the industry, mainly focused on Clinical Data Management and Clinical Programming at several large pharma and CROs. Sue has played a lead role in various initiatives including the implementation of Electronic Data Capture/data management systems and integrations such as ePRO, CTMS and sample management systems. Recently, she led the CDM effort in the roll out of full end-to-end standards. Over the years, she has provided line management to many operational teams, most recently at an ePRO provider, managing the EU operational team. She is now using her industry experience and standards knowledge at Covance, supporting a client partnership as Director, Data Management and Standards

Presented by: Marcus Schwabedissen (QFINITY)

To reduce the overall costs of drugs, pharmaceutical companies need to look for innovations in the pharmaceutical value chain and research and development, especially clinical trials, which represent a great opportunity. It becomes more and more obvious that, in this space, digital transformations like wearables, health apps, and social media are being increasingly adopted by pharma companies and CROs alike, which will, in turn, improve the entire spectrum of patient recruitment, engagement and retention throughout the clinical trials study. In addition, new methods like virtual studies and technologies like artificial intelligence provide opportunities in this context and increase the speed of digital transformation. The presentation should provide an insight into what this development means for clinical trials and trigger discussions about the changed role of humans in future clinical trials and the importance of ethics and culture.

Learning objectives: 
Understand the current status of digital transformation in clinical trials
Get insight in future trends
Recognize value of ethics and culture as catalyst in the context of digital transformation
Presenter Details
Marcus Schwabedissen 
Chief Operating Officer and Senior Executive Consultant: QFINITY

Marcus has been in the life science industry for more than 20 years, and spent most of that time in IT, Computerised System Validation, Risk Management, Quality Management and Quality Assurance. Over the last 20 years he was in charge of different leadership positions, which included Head of Global Technology Quality Management and Head of the QA Computer Technology Auditing Group at PAREXEL. Marcus has a proven history of getting to the heart of matters impacting Quality or Information Security, with clear insight into gaps, threats and remediation solutions. Adept at leading worldwide programs and projects to deploy frameworks, systems, and controls that transform how companies handle risk prevention and mitigation. Recognized for driving continuous improvement at all levels, with a key focus on transformation in project management and systems controls including computerized system validation. In 2017, he joined Q-FINITY, a consulting company for risk-based Quality Management, Quality Assurance, GxP-Compliance and Continuous Improvement of Processes, Data and Computerized System Validation. As Chief Operating Officer he now takes care of the operational belongings of Q-FINITY.

12:25 - 13:25 Lunch & Exhibition

13:25 - 14:30 Panel Session

Presented by: Kevin Kane (PHASTAR) Rob Nichols (uMotif) Richard Young (Veeva) Philippa Waller (SQN Clinical) Robert King (PPD) Jon Wood (AstraZeneca)

A panel of experts sharing their opinions on various questions surrounding the Data Management and the Industry. This session will be interactive with audience participation.

Learning objectives: 
To listen to industry experts sharing their diverse views on the data management in the 2020s.
To see if there is a common understanding of the future from pharma, CRO, software providers and more.
To allow yourself to consider questions relating to the management of clinical data and make interactive decisions
Presenter Details
Kevin Kane 
Founder and CEO: PHASTAR

Kevin started his statistical career in 1990 with Amgen. After 3 years, he moved to Wellcome and stayed in the GSK family of companies for a number of years. Having a variety of positions, including project statistician and technical support allowed him a broad oversight of the clinical trial process. Kevin set up PHASTAR in 2007, and is a Chartered Statistician and was a Board Member for PSI (Statisticians in the Pharmaceutical Industry). He is still actively involved in providing statistical support.

Rob Nichols 
VP Customer Experience: uMotif

As part of high performing management teams in growing companies Rob has applied strong leadership and communication skills to define and convert large-scale strategic objectives into commercially successful outcomes across diverse regions including USA, Japan, India, China and Europe. Rob has repeatedly been part of teams assessing future industry requirements, leading to the driving of novel approaches, resulting in wide scale uptake in a variety of what have become mainstream eClinical offerings – including eDC at Phase Forward, eSource at IQVIA, and Risk Based Approaches at Algorics. Rob has presented at numerous global data management conferences over the last 20 years, including presentations at SCDM, DIA and OCT among others. Rob has also served as chair of the ACDM.

Richard Young 
Vice President, Vault CDMS: Veeva

A veteran of almost 25-years in life sciences, Richard is Vice President, Vault CDMS. Richard is responsible for defining strategy and direction for Vault CDMS, especially with respect to clinical data management. Richard brings Veeva customers both keen executive vision and proven operational experience in data management, eClinical Solutions, and advanced clinical strategies (e.g. adaptive trials, risk based monitoring, strategic technology reviews).

Philippa Waller 
Head of Biometrics: SQN Clinical

Philippa Waller has worked in Data Management for 25 years, all within CROs, and is currently Head of Biometrics at SQN Clinical. With a strong focus on people and processes, Philippa has an excellent track record of building effective and efficient teams, supporting their development of skills and experience while achieving sponsors requirements and business needs.

Robert King 
Snr Dir Global Functional Service Provider, Global Biometrics: PPD

Robert King is a Senior Director responsible for PPD’s Biometrics’ Functional Service Provision strategy. Collaborating with our sponsors to develop customized solutions to deliver resource continuity, increase productivity and drive value to bend the time cost curve.

Robert has 25+ years of experience in clinical development. During the last 15 years he has had global leadership roles in Data Management/Statistics and Clinical Development support functions. In all these roles he has been key driver in developing and implementing corporate strategic direction across clinical development and eClinical technologies as well as significant experience in the FSP marketplace.

Jon Wood 
Alliance Director – Late Phase Data Management: AstraZeneca

Jon started his career in clinical data management in 1989 following a 4 year degree in physiology and a year in post-graduate research. Over his 30 year career, Jon has worked in data management operations across CRO and Pharma/Biotech sectors. He has been developing a focus on strategic partnerships in data management during his tenure with Pfizer and now with AstraZeneca as Alliance Director supporting all late phase data management services. Jon has supported the ACDM in training for more than 20 years and remains passionate about the continuous development opportunities for the profession as technology and processes continue to evolve the data management role.

14:30 - 14:55 Break & Exhibition

14:55 - 16:15 Plenary Session

Presented by: Ashley Howard (Pfizer)

Artificial Intelligence is a present-day buzzword but how can we integrate and apply this advance in technology to our everyday Data Management processes. In this session we will explore how deep learning AI has the potential to transform Clinical Data Management as we know it. How can we leverage machines to not just perform repetitive data cleaning tasks but take on higher complexity activities in tandem with humans?

Learning objectives: 
Understand Artificial Intelligence in relation to applications within Clinical Data Management
Appreciate the complexities and challenges of embedding AI into common DM tasks/activities
• Explore a specific use case of applying AI in the wider context of data cleaning
Presenter Details
Ashley Howard 
Associate Director, Asset Lead: Pfizer

Ashley has over 10 years’ experience in Clinical Data Management both within the CRO and Pharmaceutical industries. Ashley started his career in the late phase Data Management department at PAREXEL working on numerous trials, across multiple therapeutic areas and in a variety of EDC systems. He progressed into a Data Management operational leadership position where he had overall accountability, as an account lead, for the execution of the Data Management strategy on numerous complex Oncology studies.

Ashley joined the Oncology TA team within the Data Monitoring and Management department at Pfizer in 2018. He is currently responsible for and provides oversight of several key pivotal assets. Ashley is an Oracle InForm EDC SME and his putting his knowledge and experience to good use working on a number of internal AI process development initiatives.

Presented by: Kirsten Bulpitt (Cmed)

We are at a time where there are continuing advances in technology, expanding volumes of data from increasingly diverse sources. Factor in new tools and risk-based approaches for the review of data, the role of the Lead DM becomes more challenging than ever before.
Data Managers have typically been heavily involved in the incorporation of data from different sources with an active role in the management of this flow as well as the quality of the data. Given the exponential evolution in data acquisition and the changes in the review and monitoring of data should the Lead DM look to specialize, leading to a multitude of experts focussing on defined areas or should the Lead DM be the “conductor” of this extensive orchestra that is Data Management?
Can we really do it all? Should DM split into separate specialist functions? Or should we be prepared to diversify our understanding to ensure end-to-end control?

Learning objectives: 
understand the shifts in industry
To remain relevant DM will need to evolve
Presenter Details
Kirsten Bulpitt 
Clinical Data Management Director: Cmed

Kirsten is a Clinical Data Management (CDM) Director at Cmed Clinical Research Services. With over 20 years in CDM, Kirsten has a wide breadth and depth of experience both in the Pharma and CRO environments. She has led the development of innovative processes, supported new system implementations and adoption of technical solutions within data management.

16:15 Close of ACDM20

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