Speakers

Álmath Máire Spooner, PhD, RPh

Director of Regulatory Policy and Intelligence
AbbVie, Ireland

Álmath is a qualified pharmacist and barrister with a PhD from Trinity College Dublin and postgraduate qualifications in statistics, law and pharmaceutical medicine. Álmath has extensive experience in healthcare product regulation and policy with 12 years experience at the Irish Health Products Regulatory authority. Álmath was the first Vice Chair of EMA's PRAC and served from 2012-2018. Álmath was called to the Bar of Ireland in 2018 and practiced in Commercial Law prior to joining AbbVie's Global Regulatory Policy and Intelligence team as Director in 2020. At AbbVie, Álmath is the global policy lead for Patient Focused Drug Development and Pharmacovigilance and European lead for RWE, Digital Health and clinical pharmacology.

Daniel Millar, MBA

Senior Director, Strategic Business Transformation
Janssen Research & Development, United States

Daniel Millar leads Strategic Business Transformation in Quantitative Sciences at Janssen R&D. He is an advocate for utilizing quantitative innovation to advance patient-centric R&D while simultaneously delivering transformational efficiencies. Daniel is a founding leader and champion for multi-stakeholder engagement in the recently launched Innovative Medicines Initiative (IMI) public-private partnership for Integrated Research Platforms. Daniel obtained a MBA from the University of Chicago Booth School of Business and a BA in Mathematics from the University of Pennsylvania. He lives in Manhattan and enjoys traveling. His current “country number” is 115.

Elke Stahl, PhD

Senior Expert, Clinical Trials Department
Federal Institute For Drugs and Medical Devices (BfArM), Germany

Dr. Elke Stahl, Clinical Trial Unit BfArM, Germany. Clinical Trials Senior Expert. CoChair of the Clinical Trial Facilitation Group (CTFG) till 2022. Involved in EMA’s EU CTIS groups as BfArM’s representative, National Contact Point for the CTR in Germany, representative in European Commissions CT working groups. Prior BfArM 10 years experiences as a pharmacokineticist at Bayer HealthCare AG, Germany, in early research up to candidate selection. PostDoc at Hoffmann-La Roche Inc and University of North Carolina (UNC). Ph.D. in pharmacology and licenced pharmacist.

Jesper Kjær, MS

Co-Chair, EMA/HMA Big Data Steering Group; Director of Data Analytics Centre
Danish Medicines Agency (DKMA), Denmark

Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past. Currently active in development of FHIR for clinical research and use of AI/ML in life science.

Patrick Brady, PharmD

Head Regulatory Policy & Intelligence
Bayer AG / Research & Development, Pharmaceuticals, Germany

Dr. Patrick Brady is Vice President, Regulatory Affairs at Bayer. In this role, he leads Bayer’s global regulatory policy and intelligence activities. He has more than 10 years of experience in Regulatory Affairs. Prior to joining Bayer, Patrick led international science and regulatory advocacy efforts across the pharmaceutical industry while working for the U.S. industry trade association, PhRMA. Dr. Brady completed his Doctor of Pharmacy degree at the University of Kansas in May 2003.

Joyce Swart

Clinical Disclosure Lead
Alcon Research, LLC, United States

Joyce Swart is the Clinical Disclosure Lead at Alcon Research, LLC, a major eye care device company operating in the global marketplace. For over 10 years she has been responsible for understanding disclosure requirements specific to medical device trials, developing disclosure practices and processes for companywide implementation, and overseeing the registration of medical device trials on ClinicalTrials.gov and other public registries. She is also skilled in registering drug studies and posting results on ClinicalTrials.gov and EudraCT. Joyce received her B.S. from Rutgers University, New Brunswick, New Jersey.

Nick Sykes, MS

Senior Director, Global Regulatory Affairs
Pfizer Inc, United Kingdom

Currently working in Europe and International regulatory policy and strategy group in Pfizer. Been working for Pfizer since 1998. My main focus - lead a small team providing regulatory policy and strategy to Pfizer organisation particularly regulation of clinical trials. Previous employment includes SmithKline Beecham, Scrip and Cambridge Antibody Technology

Ruediger Pankow, DrSc

Principal Consultant, Regulatory Affairs
Parexel International, Germany

Ruediger Pankow is currently Principal Consultant Regulatory Affairs at Parexel, where he has 15 years CRO experience in global management of clinical trial applications and regulatory consulting with specific expertise on the EU Clinical Trials Regulation. Representing ACRO for the EU Scientific and Regulatory Committee he has been continuously involved since 2016 in various European Medicines Agency (EMA) stakeholder activities for the EU Clinical Trial Information System (CTIS) development, since 2019 as sponsor product owner for the EMA CTIS delivery model and as expert for CTIS training modules.

Fia Westerholm, DVM, MSc

Programme Assurance Manager
European Medicines Agency, Netherlands

Programme Assurance Manager in the Clinical Trials Information System (CTIS) programme managed by the European Medicines Agency to enable implementation of the Clinical Trials Regulation (CTR). Educational background and degrees in veterinary medicine, toxicology and social sciences. More than 20 years of experience alternating between private and public sector in the area of medicines, including in research and development, assessment and regulation of medicines as well as management at EU & national level. At EMA since 2005.

François Houyez

Treatment Information and Access Director, Health Policy Advisor
European Organisation for Rare Diseases (EURORDIS), France

François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also represents Eurordis at the European Medicines Agency.

Peter Richard Arlett, MD, FFPM, FRCP

Head Data Analytics and Methods Task Force
European Medicines Agency, Netherlands

Dr Peter Arlett - Head, Data Analytics and Methods Task Force, European Medicines Agency. Education: Medical Degree, University College London 1991; Member, Royal College of Physicians (MRCP) of London 1994; Fellow of the Faculty of Pharmaceutical Medicine (FFPM) of the Royal College of Physicians of London 2007; Fellow of the Royal College of Physicians of Edinburg 2017; Honorary Professor, London School of Hygiene and Tropic Medicine (2020). Career to date: Head of Pharmacovigilance and Epidemiology Department, EMA 2008 – 2020; Principal Administrator, Pharmaceuticals Unit, European Commission 2003-2008; UK MHRA 1996-2003; Hospital Physician, Oxford and London, UK NHS 1991-1996.

Scott Feiner

Senior Manager, Clinical Records Management, Strategic Clinical Operations
AbbVie, United States

Scott has over a decade of experience with clinical trial disclosure, initially working for smaller sponsors as a one-person clinical trial disclosure department, to later operating in larger organizations, serving as an expert in summary results reporting and clinical document redaction/anonymization for public disclosure. As part of implementation planning for the EU Clinical Trials Regulation, Scott is AbbVie’s representative in the EMA CTIS sponsor master trainer programme.

Jerome De Barros, MS

Policy Officer - Digital Health
European Commission, Belgium

Dominique Hamerlijnck, MBA

Patient Expert
Atini, Netherlands

Dominique Hamerlijnck has a Masters in Philosophy, specialised in ethics and a Masters in Business Administration. Dominique is one of the European Patients’ Academy on Therapeutic Innovation (EUPATI) fellows. Next to her professional life for the past 25 years Dominique is also working as a patient expert especially in the field of severe asthma. She has been involved in many Dutch and EU projects in a patient advisory capacity. She is the patient co-chair for a European Respiratory Society Clinical Research Cooperation on severe asthma. She is a member different patient advisory groups and has been successful in getting the patient voice heard in health technology development.

Xavier Kurz, MD, PhD, MSc

Head of Data Analytics Workstream
European Medicines Agency, Netherlands

Xavier Kurz graduated in 1982 as a Medical Doctor at the University of Liege, Belgium. He specialised in Tropical Medicine and worked for several years in public health projects in Africa and Asia. He obtained a MSc (1991) and a PhD (1997) in Epidemiology and Biostatistics at McGill University, Montreal, Canada. He then joined the Department of Pharmacology of the University of Liege and the Belgian Centre for Pharmacovigilance (Ministry of Health) as scientific expert. He joined the European Medicines Agency (EMA) on 1st September 2005. He is currently leading the Data Analytics team within the Data Analysis and Methods Task Force.

Karen A Noonan, MA

Senior Vice President, Global Regulatory Policy
Association of Clinical Research Organizations (ACRO), United States

Karen joined the Association of Clinical Research Organizations (ACRO) in 2014. Founded in 2002, ACRO represents the world’s leading clinical research and technology organizations. In her role as Senior Vice President of Global Regulatory Policy, she leads ACRO’s global regulatory advocacy. Karen has an MA in political science, and a BA in French.

Laura Pioppo

Scientific Administrator, CTIS expert
European Medicines Agency, Netherlands

Laura qualified as pharmacist before joining the EMA in 2009 in the Compliance and Inspection Department where she was responsible for the coordination and follow up of GCP and Pharmacovigilance inspections requested by CHMP. Since 2017 she has been working on the development of the Clinical Trial Information system (CTIS), defining and testing the system functionalities in collaboration with the MS and sponsors product owners and the European Commission.

Cecile Spiertz, MSc

Senior Director, External Innovation Clinical Trial Platforms
Janssen, Netherlands

Cecile Spiertz is a senior director at J&J, Head External Innovation, Clinical Trial Platforms and current project lead for the IMI Project EU-PEARL. She has a strong operational track record in successful delivery of global clinical development programs for Janssen Immunology R&D in her most recent positions as Global Operations Head and Strategy&Operations Lead for the Immunology clinical development organisation. She brings > 25 years of experience in phase 1, 2, 3 of drug development in various scientific and operational leadership roles, in different companies and is highly skilled in leading global cross-functional teams and innovation projects.

Solange Corriol-Rohou, DrMed, MD, PhD

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
AstraZeneca , France

Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchise. Over the past 20 years, moving from the French Medicines Agency/EMA and academia to the pharmaceutical industry, she has gained strategic experience in drug development. She is quite active within EFPIA, ICH and IMI, and passionate about pediatric drug development.

Bert Hartog, PhD, MSc

Senior Director, Clinical Innovation, R&D Development
Janssen Pharmaceutica, Netherlands

Bert is an experienced Senior Director and Innovation Leader. He leads transformational innovation projects that have the goal to shape the future of clinical trial execution, improve the clinical trial experience and position Janssen as a role model in patient-centered clinical research. Bert is an international industry expert in Clinical Research and Digital Health. He graduated in Biomedicine and obtained a PhD in Medicine from Utrecht University. His main focus is developing capabilities for digital health solutions in clinical trials, including harmonization of digital outcome measures and technologies for patient engagement and remote monitoring.

Pall Jonsson, PhD, MS

Programme Director - Data and RWE
National Institute for Health and Care Excellence (NICE), United Kingdom

Dr Jonsson is Programme Director at the National Institute for Health and Care Excellence (NICE) where he heads up Data and Analytics. His team has a strategic role in ensuring NICE is at the forefront of harnessing new and emerging opportunities for using real world data to inform NICE’s guidance to the health and care sectors. Before joining the Data and Analytics team, he was Associate Director for Science Policy and Research, responsible for NICE’s portfolio of international research projects in areas such as big data and real-world evidence. Dr Jonsson has a PhD in bioinformatics from the University College London. Before joining NICE, he worked in academia, biotech and the pharmaceutical industry.

Jonathan Mackinnon, PhD

Associate Director, Medical Writing Services
Parexel, Spain

Dr. Jonathan Mackinnon is an Associate Director of Medical Writing Services at Parexel and a subject matter expert for protocol development. As part of this role, he regularly consults with clients and medical writers on protocol development and plays an active role in addressing ongoing protocol-related challenges within the industry, including decentralized clinical trials, complex innovative designs, and EU-CTR. He also teaches postgraduate courses in Protocol Development and Trial Design at the London School of Hygiene and Tropical Medicine.

Bhausaheb S. Patil, MPharm

Head Business Operations - Decentralized Clinical Trials
IQVIA, United Kingdom

Bhausaheb Patil has over 25 years of experience in the clinical research industry, having held various local and global roles to promote patient safety, data integrity and regulatory compliance to bring new medicines to patients faster and more safely. Bhausaheb has worked in a variety of functions such as clinical monitoring, clinical operations, project and resource management, and risk-based monitoring approaches. He is a seasoned manager at mid-to-senior levels within the clinical research industry.

Gerhard Schlueter, DrSc, MSc

Head of Strategic and Technical Operations, Regulatory Affairs
Bayer AG, Germany

Currently Head of Strategic & Technical Operations within Regulatory Affairs at Bayer Pharma leading a global team focusing on submission, labeling, outsourcing, quality management, and RIM activities. Before that Gerd directed the global Regulatory Strategy teams for oncology, hematology, and ophthalmology at Bayer. He was member of the DIA Euro organizing committees for the meetings 2018 in Glasgow and 2020 in Brussels.

Patrice Verpillat, DrMed, MD, PhD, MPH

Head of Global Epidemiology
Merck Healthcare KGaA, Germany

Dr. Patrice Verpillat is a medical doctor, specialist in epidemiology, working in the pharmaceutical industry since 2003. He had positions in several international companies, and currently at Merck Healthcare KGaA, always dealing with real-world data (RWD) and non-interventional studies (NIS) in order to bring real-world evidence (RWE) into research, access and life-cycle product management. Dr. Verpillat has published over 60 articles in Medline referenced journals. Since 2014, he is also the efpia Observer to the ENCePP Steering Group, led by the EMA. He is since 2021 one of the Topic Leads to the ICH M14 working group on “Pharmacoepi Studies that Utilize RWD for Safety Assessment”.

Elizabeth Vroom

President
Duchenne Parent Project, Netherlands

Founder and President of the Duchenne Parent Project Netherlands since 1995, Chair and co-founder of the World Duchenne Organization and board member of Eurordis. She is the mother of an adult son with Duchenne MD & orthodontist by training; chair of the Ethics Board & member of the Executive Committee of TREAT-NMD; volunteer for Eurordis; a patient expert for the European Medicines Agency. Involved in several publications regarding Standards of Care and drug development for Duchenne Muscular Dystrophy, concerning development of outcome measures & role of Biomarkers. She is co-author of a handbook on psychosocial aspects of DMD. She participates in several EU funded projects, such as Asterix, Adapt Smart, RD-Connect Vision-DMD & Share4Rare.

Rob Camp

Director, International Patient Collaboration
EUPATI Spain, Spain

Rob has been Communications Coordinator at the European Patients’ Academy (EUPATI), a project on patient education and engagement in the research system, for more than 3 years. He has been part of Eurordis as consultant in patient group growth since 2008 and is working on surveys on patient satisfaction with clinical care. Rob was involved in the US AIDS Treatment Activists Coalition, and in its Drug Development Committee. Previously, at Treatment Action Group (TAG), he was the Antiretroviral Project Director for four years. Rob helped in implementing international patient advocacy and education in Europe. He worked with the European AIDS Treatment Group from 1995 – 2002.

Amos De Jong, MSc

PhD candidate
Utrecht University, Netherlands

Amos de Jong is a PhD student at the Utrecht University, the Netherlands. His thesis work focuses on the regulatory aspects of clinical trial innovation, in particular regarding decentralized clinical trials. The work is embedded within the Innovative Medicines Initiative Trials@Home consortium. Amos completed a BSc and MSc in Biomedical Sciences from the VU University Amsterdam.

Maria Elgaard Sørensen

Special advisor
Danish Medicines Agency, Denmark

Maria Elgaard is a special adviser and project manager at the Danish Medicines Agency and currently in an interim position as team manager in the CT unit. Educational background is M.SC.Pharm and she has been working as an assessor of clinical trials application for several years. As of 2016 she has been increasingly engaged in the CTIS project currently as MSPO and master trainer. Nationally she has been appointed business specialist in both the European and the Danish IT solutions for handling clinical trials and other national systems with interaction to the clinical trials area.

Christine Fletcher, MSc

VP/Head, Speciality and Primary Care Statistics
GlaxoSmithKline, United Kingdom

Chrissie is the VP Speciality & Primary Care Statistics at GSK. Chrissie has worked in the Pharmaceutical Industry for over 30 years and has experience of developing and commercialising new medicines in a variety of therapeutic areas across all phases of clinical development. Chrissie is actively engaged in Statistical societies, Pharmaceutical trade associations and initiatives relating to the Pharmaceutical Industry. She is currently the Chair of the Statisticians in the Pharmaceutical Industry (PSI), the EFPIA lead for the Innovation in Clinical Trials Pillar, a working group in the Clinical Research Expert Group, she is one of the PSI representatives on the EFSPI Council and she is the lead for the EFSPI Statistics Leaders Forum.

Fiona Maini, MS

Principal Global Compliance and Strategy Principal
Medidata a Dassault Systèmes Company, United Kingdom

As a Medidata Global Compliance and Strategy Principal, Fiona’s focus includes evaluation of GxP relevant regulatory changes coupled with the regulatory aspects of technological advancements and geo-political dynamics impacting the Life Sciences and Healthcare industries, specifically within in the clinical research domain. In this role Fiona regularly interacts with authorities on emerging patient centric technologies. Fiona is currently the Chair of the ACRO Decentralised Clinical Trials Working Party in the EU, focused on the end to end process, technology, data and regulatory frameworks for virtual clinical trials. Fiona is also a member of the EU Alliance on Artificial Intelligence. Prior to Medidata Fiona was a Director at Deloitte,

Ana Zanoletty Perez

Programme Manager for ACT EU
European Medicines Agency, Netherlands

Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation procedures. Ana is currently the Programme Manager for the Accelerating Clinical Trials in the EU (ACT EU), a European clinical trials transformation initiative which is co-lead by EC, HMA and EMA.

Guido Grass, MD

Ethic Commission
University of Cologne, Germany

Education 1989-1995 Medicine, University of Cologne, Germany Occupational Carreer Until 2000 Doctoral Thesis on animal models for sepsis research 1998-2002 Research associate (MD) Department for Visceral Surgery, University of Cologne, Germany 2000-2002 Research associate (MD) Department for Surgery II, Biochemical and Experimental Division, University of Cologne 2002-2005 Research associate (MD) Coordinating Center for Clinical Trials Cologne Current Postion Since 2005 Head of the Office of the Ethics Committee of the Medical Faculty of the University of Cologne, Germany Miscellanous Since 2014 Member of the board of the Working Party of Medical Ethics Committees in Germany EC Representive in several EMA working groups

Olga Kholmanskikh Van Criekingen, MD, PhD

Clinical assessor
Federal Agency for Medicines and Health Products, Belgium

Olga Kholmanskikh is a clinical assessor at the Federal Agency for Medicines and Health Products (FAMHP), a Belgian National Competent Authority, since 2012. She is an MD by training and holds PhD in Biomedical and Pharmaceutical Sciences. She leads the Complex Clinical Trials (CCTs) working subgroup at Clinical Trials Coordination Group (CTCG) of the Heads of Medicines Agencies (HMA).

Maria Mavris, PhD

Patient Relations
European Medicines Agency, Netherlands

Maria Mavris first joined EMA as a seconded expert from a patient organisation in 2014 and then as a staff member from 2017. As part of the Public and Stakeholder Engagement department of EMA, her work focuses on involving patients all along the regulatory lifecycle of medicines with a particular focus on committee membership and scientific advice. Maria is also involved in the development of training to support patients’ representatives in EMA’s work, health technology assessment.

Vada A. Perkins, DrSc, MSc

Executive Director, Regulatory Policy and Innovation
Bayer Pharmaceuticals, United States

Vada A. Perkins, Bayer Pharmaceuticals, Executive Director, Regulatory Policy & Innovation, Head Research & Policy-Regions, CAPT (ret) is a former FDA Senior Advisor for Regulatory Science and a recognized global regulatory policy & intelligence expert with regulatory thought leadership in the application of data governance, technology, data standards throughout the product lifecycle . He is active in interactions with national and international stakeholders in promoting technology and innovation (e.g., RWD/RWE) to support international regulatory convergence for medicinal product regulation. He received his degrees from The Johns Hopkins University, University of Southern California, and the University of Maryland.

Mira Zuidgeest, PharmD, PhD, MSc

Associate Professor
University Medical Center Utrecht, Netherlands

Mira Zuidgeest is an Associate Professor at the University Medical Center Utrecht. Trained both as pharmacist and epidemiologist and with a PhD in pharmacoepidemiology in the field of paediatric asthma, her current work focuses on clinical trial innovation, both methodological and operational. She is board member of the GetReal Institute (www.getreal-institute.org) and led the development of a decision-support tool for randomised clinical trials integrated into routine clinical practice (www.getrealtrialtool.eu). As academic lead for the IMI Trials@Home project (www.trialsathome.com), she researches possibilities of centering trials around patients rather than clinical sites by use of innovative technologies (Decentralised Clinical Trials)

Monique Al

Team Coordinator National Clinical Trial Office
Central Committee on Research Involving Human Subjects (CCMO), Netherlands

Monique Al obtained her degree in Human Nutrition at Wageningen University & Research, The Netherlands. Subsequently she received a PhD in Human Biology in September 1994 at the Maastricht University. After that she worked for several nutritional and pharmaceutical companies in the field of clinical research. In 2001 she started as a scientific staff member at the Central Committee on Research Involving Human Subjects (CCMO) in The Netherlands. Currently she is an coordinating advisor specialized in clinical trials and clinical investigations at the CCMO.

Greet Musch, PhD

General Director
FAMHP, Belgium

Mrs Greet Musch obtained a PhD in Pharmaceutical & Biomedical Sciences @ Free University Brussels. She joined the Pharma Industry for 8 years as responsible for all the chemical and pharmaceutical analytical activities related to the development of new innovative drugs . She moved to the Federal Public Health services as senior quality assessor. Since Aug 2004 she was in charge of the R&D department. On Feb 2009 she has been designed as Director-general for the DG Pre-authorisation in the FAMHP.