Advancing Patient Science Workshop
Sara Torgal, MPharm
- Senior Manager, Scientific Programs
- DIA, Switzerland
Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for communicating with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific topics and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East region. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.
Thomas Morel, DrSc
- Director, Patient-Centred Outcomes Research
- UCB Biopharma, Belgium
Thomas Morel (DrSc) is Director for Patient-Centred Outcomes Research, Global Clinical Development at UCB. Through his role, Thomas ensures that the patient perspective is at the very heart of drug development by promoting the use in clinical trials of PROs and of clinical outcome assessments that are meaningful to patients. Thomas is also Research Fellow at KU Leuven (Belgium) where he conducts academic research on rare diseases, and a member of the Therapies Scientific Committee of the International Rare Diseases Research Consortium (IRDiRC).
Thomas Metcalfe, MBA
- Data Policy Leader, Personalised Healthcare
- F. Hoffmann-La Roche, Switzerland
Tom Metcalfe graduated in Biochem from King's in London and has an MBA from the Open University. He currently works as a Data Policy Leader in Roche Pharma's Personalised Healthcare Centre of Excellence. Prior to that he worked for Roche as a Strategic Innovation Leader in Global Development from 2015 to 2018. He served as CEO of Oncotest GmbH, a CRO providing preclinical profiling services in Oncology from 2011 to 2104 and worked for Roche Pharma and Diagnostics in a variety of roles from 1993 to 2011 including as Head of the Personalised Healthcare Portfolio and the Roche Biomarker Program.
- Global Program Regulatory Director, Innovation
- Novartis Pharma AG, Switzerland
Currently working in the area of Regulatory Innovation for Novartis, Scott has nearly 20 years of pharma industry experience from both the CRO world and within Pharma, in roles focusing on Data Management, Data Standards and Digital Innovation. Prior to joining Regulatory Affairs, Scott led several of Novartis’s innovation projects. Since his transition into Regulatory Affairs, Scott continues to advise digital program teams internally and collaborates in several cross industry initiatives externally. Scott has a BSc in Computing and Management Sciences and is based in Basel, Switzerland.
Nathalie Bere, MPH
- Patient Engagement
- European Medicines Agency, Netherlands
Nathalie Bere has a BSc in Psychology and a Master in Public Health. Nathalie has been working with European Medicines Agency (EMA)since 1998 and is currently responsible for its engagement with patients and consumers. Patients bring specific knowledge and expertise from their real-life experience of the condition and its treatment to the scientific discussions, and their contributions lead to better regulatory outcomes. Over the years, Nathalie has tested and implemented methods for the inclusion of the patient’s voice in all aspects of the medicines regulatory lifecycle and she continues to further strengthen these interactions and ensure they are fit for purpose in an evolving health landscape.
Mark Perrott, PhD
- Managing Patner
- Axian Consulting ltd., United Kingdom
Mark is Head of Development Consulting and leads a team of Benefit-Risk and Risk Minimisation professionals. He has a >20 year pharma career has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI, Foresight, PopeWoodhead and Huron). He is now focusing on the opportunities presented by new benefit-risk management approaches to improve development decision-making and enhance the interactions of industry and customers to maximise B-R balance. From January 2021, Mark and the existing team of benefit:risk and digital design and development colleagues will be starting-up a new company called Axian Consulting which will further develop the focus on the use of digital to enhance patient safety.
- Executive Director Global Regulatory Policy
- MSD`, Netherlands
Aimad Torqui is Director of Global Regulatory Policy at MSD. Previous employment. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory policy.
Tom Willgoss, PhD, MSc
- Head of Late Stage Portfolio and Com., Patient Centered Outcomes Research
- Roche Products Ltd, United Kingdom
Tom is the Head of Clinical Outcomes Assessment (COA) Strategy and Execution for Roche's Patient-Centered Outcomes Research (PCOR) team. His role is focused on optimizing the development of the company's pipeline through patient-focused outcomes. Prior to joining Roche, Tom worked in academia, clinical practice and consultancy, in roles focused on the development and validation of patient-focused outcomes.
Christina Akerman, DrMed, MD
- Affiliate Faculty at the Dell Medical School at the University of Texas at Austi
- Affiliate Faculty At the Dell Medical School At the University of Texas At Austi, Sweden
Christina A°kerman, MD, PhD, Executive MBA, is Senior Advisor for EIT Health and Chair of EIT Health High Value Care Forum Advisory Board, Affiliate Faculty at the Dell Medical School at the University of Texas at Austin, and on the Steering Committee of the Coalition for Health, Ethics and Society at the European Policy Center. Until August 2018, she was the President of the International Consortium for Health Outcomes Measurement. She has also served as Director General for the Medical Products Agency in Sweden, been a Member of the Board of the European Medicines Agency and President of AstraZeneca Philippines.
Michelle Campbell, PhD
- Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER
- FDA, United States
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a reviewer on the Clinical Outcome Assessments (COA) Staff and Scientific Coordinator of the COA Qualification Program in OND. Dr. Campbell’s focus is in patient-focused drug development and the use of patient experience data in the regulatory setting.
Stephany Chantal Jones
- PV Process Leader
- F. Hoffmann-La Roche AG, Switzerland
D.K.Theo Raynor, PhD, MPharm
- Professor of Pharmacy Practice
- University of Leeds, United Kingdom
A hospital pharmacist before becoming inaugural Professor of Pharmacy at Leeds, Theo has 35 years of research improving patient information and ‘user testing’ the information with lay people. This led to forming the spin-out company Luto Research, a leading provider of user testing services. Synergies between the University and Luto underpin recent work, notably how best to present benefit and harm information. Currently he is working in policy and practice on making the new clinical trial ‘layperson summaries’ fit-for-purpose. He has a Lifetime Achievement Award from Fédération Internationale Pharmaceutique.
Josh Rose, MBA
- Vice President, Global Head, Virtual Trial Solutions
- IQVIA, United States
As Vice President and Global Head of Strategy for the R&D Solutions business unit at IQVIA, Josh Rose is responsible for building the overarching strategy for the clinical development business, establishing and governing strategic initiatives, and leading the identification of acquisition candidates. He focuses specifically on bringing to market new solutions that drive growth and differentiation across the company. He also leads the Virtual Trial service business within the R&DS business unit.
- Patient Representative
- Sarcoma UK, United Kingdom
Melanie Jane Calvert, PhD
- Professor of Outcomes Methodology, Director of the Centre for PROs Research
- University of Birmingham, United Kingdom
Melanie Calvert, PhD, is Professor of Outcomes Methodology at the University of Birmingham UK. She is Director of the Centre for Patient Reported Outcomes (PROs) Research (www.birmingham.ac.uk/cpror) which aims to optimise the use of PROs in clinical trials and routine care, to improve service delivery, enhance patient care and outcomes and ensure that the patient perspective is at the heart of health research and healthcare decision-making. She has led the development of international guidance for PROs including SPIRIT-PRO and CONSORT-PRO and is a member of the SISAQOL and PROTEUS Consortia.
Francesco Pignatti, MD
- Head of Oncology and Hematology
- European Medicines Agency, Netherlands
- Senior Neurology Registrar & Clinical Research Fellow
- University of Dundee, United Kingdom
Evelien is a Clinical Neurologist in training who works for NHS Tayside, Scotland. She is currently in post as a Clinical Research Fellow at MEMO Research – Medicines Monitoring Unit & Hypertension Research Centre, University of Dundee. MEMO runs several large-scale randomised clinical trials, including decentralised trials looking at drug safety and efficacy. Trials include FAST, ALL-HEART and the TIME Study.
- Chair of the Department of Psychosomatic Medicine
- Charité – Universitätsmedizin, Germany
Elizabeth Scanlan, PhD, MSc
- Scientific Communication Officer, Stakeholders and Communication Division
- European Medicines Agency, Netherlands
Elizabeth Scanlan joined the European Medicines Agency in 2016 where she is a Scientific Communication Officer, with a focus on communication of information on safe and effective use of medicines to patients and healthcare professionals. Prior to joining EMA, she worked in communication roles in the biotechnology industry and not-for-profit sector. Elizabeth holds a PhD in molecular biology from Trinity College Dublin.
Meredith Smith, PhD, MPA, FISPE
- Director, Risk Management, Global Drug Safety, Research and Development
- Alexion Pharmaceuticals, United States
Meredith Smith is Risk Management Director at Alexion, Inc. where she leads a team responsible for medicinal product benefit-risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience in the pharmaceutical industry. She has served on numerous FDA expert panels, on CIOMS Working Groups VIII, IX and XI, and IMI-PREFER. Currently, she is the Pharmacovigilance Track Chair for the 2021 DIA Annual Meeting Planning Committee. Recently, she led the effort to develop the RIMES Statement, a set of quality reporting guidelines for risk minimization evaluation studies.
Sabrina Conti, LLM
- Policy and Regulatory Coordinator
- Medicines For Europe, Belgium
Sabrina Conti is Senior Policy and Regulatory Affairs Coordinator at Medicines for Europe. In her role she leads the Digital and Telematics working groups and she is involved in the following topics: EU Digital Health, operational excellence, SPOR IDMP, interoperability and ePI. She is also member of the Regulatory and Scientific Affairs Committee within Medicines for Europe and coordinator in several industry inter-associations groups, such as SPOR - IDMP and electronic product information (ePI) cross-industry taskforces. She actively contributed in the latest Industry report on Multilingual package and modernisation of the Variations system.
- Retina International, Ireland
Fabio Lievano, DrMed
- V.P., Safety Science -Medical Safety Evaluation
- AbbVie, United States
Dr. Lievano has extensive experience in medicine, clinical development, risk management, epidemiology, pharmacovigilance at several pharmaceutical companies. Additionally, he worked as a public health expert at WHO European Regional Office and researcher at CDC in Atlanta. He is a physician from Colombia trained in epidemiology at Epidemiology Intelligence Service of the CDC. He manages a large team of scientists (MDs, PhDs, statisticians) in several therapeutic areas mainly Immunology, Oncology and Vaccines. He has authored several papers and abstracts in medical journals and major scientific conferences. In connection with his CDC work he received several awards for distinguished service by the US Secretary of Health and Human Services.
- Deputy CEO
- The Cure Parkinson's Trust, United Kingdom
Daniel O'Connor, DrMed, PhD, MS
- Medical Assessor
- Medicines and Healthcare products Regulatory Agency, United Kingdom
Dan is a Leicester medical graduate with a background in cancer research, histopathology and oncology. His PhD in the field of tumour suppressor genes was awarded from Imperial College London and he holds an MSc in Oncology from the Institute of Cancer Research. He completed higher medical training in the UK in Pharmaceutical Medicine. He joined the Medicines and Healthcare products Regulatory Agency (MHRA) as a Medical Assessor in 2006. He is editor author of the first edition Oxford Specialist Handbook of Pharmaceutical Medicine and he is on the editorial board of the journal Expert Opinion on Orphan Drugs. Dan has special interest in rare diseases, patient engagement and early access.
- Head of Department, Institute for Quality and Efficiency in Health Care
- IQWiG, Germany
- Vice President, Head of Global Labeling
- Bayer Plc, United Kingdom
Deborah has been working in the Pharmaceutical Industry for over 25 years. She began her career in Research before moving into Regulatory Affairs. During her tenure at Bayer Deborah worked in the UK affiliate, as an EU liaison, set up a new global RA department focussing on the RA support for Mature products and headed the International RA department before moving to her current position 9 years ago. She is currently VP and Head of Global Labeling at Bayer.
Megan Heath, PhD
- Head of Clinical Study Units Europe Region
- Sanofi, United Kingdom
Megan Heath is Efpia Lead in the PILOT study within IMI Trials@Home project. Megan has 25 years of operational experience managing all phases of the drug development process. Megan started her career as a phase I research associate at Inveresk Clinical Research, UK before moving through various clinical operations positions in the industry. Megan joined Sanofi in Medical Affairs Clinical Operations and is currently the Head of Clinical Studies Units European Region. Megan graduated with a Bachelor’s degree in Pharmacology from Glasgow University before completing a PhD in Asthma Pharmacology at University of Manchester.
Anthony Humphreys, MPharm
- Head of the Regulatory Science and Innovation Task Force
- European Medicines Agency, Netherlands
He is the Head of the Regulatory Science and Innovation Task Force (TRS). He is responsible for providing leadership in the taskforce and the Agency to enable it’s continuous future proofing through operation of a regulatory science observatory, addressing key scientific and technological trends and their translation through the development of regulatory science strategy, planning and governance.
Pavel Petrov Balabanov, MD, PhD
- Head of Therapies for Neurological and Psychiatric Disorders
- European Medicines Agency, Netherlands
I am a clinical neurologist who before joining the EMA worked as a consultant neurologist at the Clinic of Neurology, University Hospital – Plovdiv, Bulgaria. I have a PhD in Neurology and hold a position of senior teaching professor of neurology at the Department of Neurology, Medical University of Plovdiv. Currently I lead the office for Therapies for Neurological and Psychiatric Disorders at the EMA. In my career at the EMA, I have been involved in the development of the regulatory guidelines for development of new drugs in the field of Multiple sclerosis, Duchenne Muscular Dystrophy (DMD) and Amyotrophic Lateral Sclerosis (ALS).
Cesar Hernandez Garcia
- Head of Department, Department of Medicines for Human Use
- Spanish Agency For Medicines and Medical Devices, Spain
Dr. César Hernández MD, PhD. joined the Spanish Agency for Medicines and Medical Devices as a Head of the Human Medicines Department in 2009. Prior to joining, he was the deputy Medical Director of the Hospital Clínico San Carlos in Madrid for three years. He previously worked as rheumatologist at the same Hospital for 16 years also developing functions as associate professor of Medicine and principal and associate investigator in several research projects financed by public and/or private funds in areas such as basic research, clinical research and health care services. He graduated from medicine and surgery, specialist in Rheumatology in 1987 at the Complutense University of Madrid and received his PhD in 1996 at the same university.
Isaac R Rodriguez-Chavez, MHS, PhD, MS
- Senior Vice President, Scientific and Clinical Affairs, Head, Global COE
- ICON plc, United States
Dr. Isaac R. Rodriguez-Chavez is a biomedical and regulatory leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, Microbiology, and Vaccinology. His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical research (phase I – IV), non-interventional clinical research and post-marketing studies.
- Head, Pharmacotherapeutic Harmonization
- Catalan Health System, Spain
Antoine Regnault, PhD, MS
- Global Lead - Statistics
- Modus Outcomes, France
Antoine is a biostatistician specializing in the analysis of patient-centered outcomes data. Antoine holds a PhD in Applied Statistics from the University Claude Bernard Lyon 1 (France). Over the past 20 years, Antoine developed a combined skillset in psychometrics and statistics that he uses to support pharmaceutical companies with their analysis of patient-centered outcomes data from clinical trials and observational studies in a wide variety of disease areas, including oncology, hematology, neurology and rare diseases. He currently is a member of the Board of Directors of the International Society of Quality of Life (ISOQOL) and has been a member of international research initiatives such as SPIRIT-PRO or NeuroMET-2.
Thomas Keeley, PhD, MSc
- Director, Patient Centred Outcomes
- GlaxoSmithKline, United Kingdom