Future of Evidence and Smart Health Conference
Thomas Brookland, MSc
- Personalised Healthcare Policy Strategy Leader
- F. Hoffmann-La Roche Ltd., Switzerland
Thomas (Tom) Brookland has worked in industry for the last 15 years, combining interests in both regulatory science and policy research. He joined Hoffmann La Roche in 2008 and in this time has held multiple roles including regulatory product development lead for the development and licensing of molecules across different therapeutic areas, in addition to global and EU focused policy roles in the innovation space specifically focused on Personalised Healthcare and data/evidence related topics.
Adrian Cassidy, PhD, MSc
- Global Head of RWE and Data Science
- Novartis, Switzerland
Adrian Cassidy started his epidemiology career in academia where he lead risk-prediction research at the University of Liverpool and MD Anderson Cancer Center. Adrian moved from academia to industry in 2010 to realize an ambition to help develop innovative medicines. An accomplished leader, Adrian has an exceptional track record of building and leading data/analytics/informatics platforms and developing high value data/digital transformation strategies at GSK Vaccines, Roche, and Novartis. Adrian currently serves as Vice President and Global Head of RWE and Data Science to advance Real World Data/Science/Evidence applications and solutions across the product lifecycle to help reimagine medicine and improve the lives of patients.
Michael Lees, MA
- Chief Operating Officer and Head of Market Access Strategy
- PHMR Ltd, United Kingdom
Michael is the Chief Operating Officer and Head of Market Access Strategy at PHMR. In this role, he is responsible for ensuring that the research delivered matches the strategic needs of our clients. Michael has extensive experience in the development of health economic models and indirect treatment comparisons, utility measurement and health valuation, strategies for collection and use of real-world data, and the development of dossiers to support HTA submission. He also has substantial experience in working with different stakeholders, including through the use of early scientific advice through HTA agencies, to lead the development of integrated evidence plans and allow for access needs to be incorporated from early in development.
Solène Thieffry, MSc
- Global RWE Policy Lead
- UCB, Belgium
Solène is the Global RWE Policy Lead for UCB in Brussels, Belgium. In this role, she is leading and coordinating the external engagement strategy that aims to advance acceptance of RWE by healthcare decision-makers from early clinical development through to in-market treatment options. Within this role, she is actively involved in different activities such as the IMI EHDEN project. Prior to this, she held various positions in access, pricing and health economics and outcomes research in Global Market Access mostly focusing on neurology solutions for patients.
Emma Du Four, MBA
- Head of International Regulatory Policy
- Abbvie, United Kingdom
Emma Du Four has extensive global experience in the biopharmaceutical industry, encompassing product development, clinical trials, real world evidence, paediatric medicines, biotherapeutics, devices, pharmacovigilance, policy and strategy development. Emma currently serves as Head of International Regulatory Policy at AbbVie and she is Chair of the EFPIA Regulatory Affairs & Operations working group. Emma holds an Honours degree in BioChemistry, an MBA and is a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA)
Cécile Mathilde Ollivier, MS
- OCM Director - Regulatory Science Europe
- Critical Path Institute (C-Path), Netherlands
Senior health engineer with 15 years of global drug development experience in children & rare diseases. Recently joined C-Path as scientific director, previously Chief Innovation Officer for Aparito a medtech company for 2 years and scientific officer in the Paediatric division of Science & Innovation at EMA for 12 years where Cecile has been leading the EMA extrapolation strategy and was an expert for the ICH E11(R)1 guideline.
Virginia Acha, PhD, MSc
- Global Lead, Global Regulatory Policy
- MSD, United Kingdom
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She recently joined MSD to lead regulatory policy efforts for innovation that will lead to better treatment for patients in Europe, the Middle East, Africa and Asia. In particular, she is supporting work on science policy, regulatory innovation and integrated evidence generation. Before joining MSD, Ginny was the senior spokesman for the industry in the UK for research, medical and innovation policy. She was responsible for ABPI’s work on BREXIT for the life sciences sector. Previously, Ginny worked for Amgen and Pfizer.
- Senior Director Epidemiology & Evidence Excellence, AstraZeneca AB
- Adj Researcher Karolinska Institute, Dept Epidemiology and Biostatistics, Sweden
Claudia Cabrera graduated from Tulane University School of Public Health with a master’s degree in international public health and a concentration in Epidemiology and Biostatistics in 1994. She completed her doctorate degree in Epidemiology at the Nordic School of Public Health and Sahlgrenska Academy, Göteborg University. She also holds a Licentiate in Medical Science. Claudia has worked in the Pharmaceutical Industry for the past 14 years across all therapy areas and patient safety, lately she has focused on the build of large global studies related to respiratory disease. Her most recent position is in Real World Science and Digital.
Alison Cave, PhD
- Chief Safety Officer
- Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Dr Cave joined Innovate UK in October 2019 as the ISCF Challenge Director for Data to Early Diagnosis and Precision Medicine and Accelerating Detection of Disease. She holds a BA Honours degree and PhD from the University of London, has over 15 years of cardiovascular academic research experience gained in both the US and UK and has authored multiple articles. Prior to joining Innovate UK she was a Principal Scientific Administrator at the European Medicines Agency and co-chaired the HMA-EMA Joint Big Data taskforce, leading on the development of new strategic approaches to better utilise real world data and more broadly big data to facilitate evidence generation across the medicines product life cycle. From 2013-16 she was Head of Cellular
Adama Ibrahim, MBA
- Director, Digital Solutions (Technology and Platforms)
- Novartis Pharma AG, Switzerland
UK top 100 technology influencer in 2019, operational strategy collaborator, blockchain advocate, eCOA and patient engagement thought leader with over 19 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). An R&D transformation change champion. DIA Patient Engagement Voluntary Community Leadership team. Experience across various therapeutic areas and broad range of Phase I, II, III and IV trials including Neurology, IBD, Rare Disease and Gene Therapy. Hybrid virtual trials leader.
Niels Buch Leander, PhD
- Global Head of Regulatory Affairs
- NNIT, Denmark
Dr. Niels Buch Leander is Global Head of Regulatory Affairs at NNIT. He has 12 years of R&D IT project experience and hence extensive experience with regulatory data standards and digital transformation. He advises global pharmaceutical and medtech companies on their digital transformation strategy. He is a member of EMA SPOR Task Force.
- Global Business Development Director & Group Head of Real World Evidence
- Carenity - EvidentIQ, France
Carine Odouard is the Global Business Development Director and Head of RWE at Carenity, The Patient Insights’ Company (EvidentIQ Group). Before joining Carenity, Carine spent 15 years working in the Pharma Industry. She began her career in Marketing working for AstraZeneca and Baxter in various therapeutics areas. She then held responsibilities in commercial strategy and market access to finally join Roche as Commercial Head within the Market Access Team focusing her efforts to ensure a better access to innovation for patients. Driven by the desire to make patient-centricity come true she joined Carenity to facilitate real-life patients' studies.
Frank Petavy, MS
- Head of Methodology
- European Medicines Agency, Netherlands
- Director, Global Commercial Development
- Market Access Transformation, United Kingdom
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.
- Seconded National Expert
- European Medicines Agency, Netherlands
Theodor studied statistics at the Dortmund University of Technology and at the University of Auckland. He joined the Institute of Biostatistics at Hannover Medical School in 2009 where his main areas of work were consulting, teaching and clinical trials. He also served as a deputy member for the Ethics Committee at Hannover Medical School and completed a PhD in Biostatistics. Theodor works as a Seconded National Expert at the EMA since September 2020.
Licinio Kustra Mano
- Strategic Advisor for EU Cross-Border eHealth Services
- European Commission, Belgium
Rodrigo Palacios, MBA
- Policy Lead - Technology and Data, Regulatory Policy
- F. Hoffmann-La Roche, Switzerland
Rodrigo Palacios is an Associate Director in Regulatory Policy at Roche. He is responsible for advancing global policy on data and technology in the regulatory domain. These topics include Cloud Submissions, Data Standardisation (e.g. IDMP), structured data submissions, eCTD and Regulatory Information Management. Rodrigo represents Roche in EFPIA and PhRMA in Regulatory Technology expert groups. He is a member of the Accumulus Consortium Leadership Team and co-chairs its EU subcommittee. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.
Andrew Raven, MSc
- Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB
- Health Canada, Canada
Andrew Raven joined Health Canada in 2004. He holds a Bachelor of Science in Molecular Biology and Genetics and a Master of Science in Mathematics and Statistics both from the University of Guelph. He has worked as a biostatistician, senior biostatistician, and manager in the Biostatistics and Epidemiology Unit within the Therapeutic Products Directorate. He has been manager of the Biostatistics and Epidemiology Unit for 3 years.
Cormac Sammon, PhD
- Chief Epidemiologist and Head of RWE
- PHMR, United Kingdom
- Pathfinder for Patients and Caregivers, Teacher, CEO/Founder
- CysticFibrosis.com, United States
- Chief Product Officer
- Owkin & Coordinator of the MELLODDY project, France
Mathieu Galtier, PhD - Owkin Chief Product Officer. Mathieu graduated from ENS and Mines ParisTech and completed his PhD in Machine Learning applied to Neuroscience at Oxford and Inria. He started his career at Rythm, a neurotech startup, where he directed research and algorithms and led the Morpheo project. He is devoted to deploying AI in a responsible way. He now leads Owkin’s Connect business unit and serves as the Company’s Chief Product Officer.
- Professor & Senior physician, Department of Clinical Neuroscience
- Karolinska Institutet, Sweden
Lada Leyens, PhD, MSc
- Regulatory Program Director
- F. Hoffmann-La Roche Ltd., Switzerland
Lada Leyens has a background in human genetics, health economics and personalised medicine. She has worked at Health Authorities for over 8 years, mainly in the approval of clinical trials and as a GCP inspector at Swissmedic. At EMA she was in the specialised disciplines office working in the centralised procedure and with the PKWP and PGWP. At Roche, Lada is the Regulatory Lead for digital health programs and the Regulatory Shaping Lead on Clinical Trial Innovation. In this role she is working to increase the use of innovations in our drug development programs and their acceptance by HAs. Lada is passionate about leveraging innovative technologies to make drug development more efficient and bringing innovative drugs faster to patients.
Susant Mallick, MBA
- Leader and Evangelist, Healthcare and Life Sciences,
- Amazon Web Services, Netherlands
Susant Mallick is leading Amazon AWS HCLS professional services for EMEA region. He comes up with 21+yrs of Pharma and IT background on building disruptive solutions/products in Clinical and Regulatory space. He is technology evangelist on cutting edge technology like (Artificial Intelligence, Machine Learning, IoT, Cloud etc) and an industry leading speakers across geographies. He has been working with various customers & partners in pharma & healthcare to drive digital transformation in Clinical & Regulatory landscape. He was instrumental in implementing/building many Regulatory solutions using advanced technology. Innovation & Digital Transformation in Healthcare & Life Sciences are two key focus areas for him in AWS.
- Global Medical Research Head Excellence
- Takeda, Switzerland
- Seconded National Expert (Data Analytics and Methods Task Force)
- European Medicines Agency, Netherlands
Marcia holds a master’s degree in Mathematics and a Ph.D. in Biostatistics. In 2015, she started working at the Institute of Medical Statistics at the RWTH Aachen University Hospital. Her main responsibilities included teaching and consulting on the design and analysis of observational studies. Marcia joined the Data Analytics and Methods Task Force at the European Medicines Agency as Seconded National Expert in August 2020.
Sebastian Schneeweiss, DrSc, MD
- Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology
- Harvard Medical School and Brigham and Women's Hospital, United States
Dr. Schneeweiss's research focuses on assessing the effectiveness and safety of biopharmaceuticals in clinical practice. He has developed analytic methods to improve the accuracy of estimating causal treatment effects of new drugs using complex digital healthcare databases. His work is published in >500 articles and is used for regulatory and coverage decision making around the globe. He is funded by NIH, PCORI, IMI, and FDA where he is also a voting consultant. He is Principal Investigator of the FDA Sentinel Innovation Center and co-leads the RCT-DUPLICATE initiative to understand when and how real-world evidence studies can reach causal conclusions.
Babak Boroojerdi, DrMed, MBA
- Global Program Physician, Rare Disease Organization
- UCB Biosciences, Germany
Babak Boroojerdi, MD, PhD, MBA is a neurologist and a movement disorders specialist who has been involved in the field of Parkinson’s Disease (PD) and movement disorders through his academic and industry career in the last 25+ years in Germany, US and UK. Babak has conducted numerous studies in the field of PD with a special interest in wearable technologies. He has been a member of the Critical Path Parkinson for several years and has been serving as industry co-director of the Modeling & Simulation team in the last years. He is currently representing UCB at a new IMI project (IDEA-FAST).
Elizabeth Garry, PhD, MPH
- Senior Principal Scientist
- Aetion, Inc., United States
Dr. Garry is an epidemiologist with over 15 years of pharmacoepidemiology and academic research experience. She holds a doctorate in epidemiology with a concentration in pharmacoepidemiology from UNC Chapel Hill and an MPH from Tufts University School of Medicine with a dual concentration in biostatistics and epidemiology. She has been with Aetion for over 7 years, providing scientific oversight and support of both client- and Aetion-driven research activities, primarily related to use of RWE for decision-making, including the RCT-DUPLICATE collaboration with Brigham and Women’s Hospital and the FDA.
Niels Gronning, MSc
- Senior Specialist
- Microsoft, Denmark
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more recently the implementation and impact assessment of ISO IDMP.
Yusuf Henriques, MPH
- Founder and CEO
- IndyGeneUS AI, United States
Yusuf Henriques is the Founder & Chief Executive Officer (CEO) of IndyGeneUS AI. (pronounced indigenous) IndyGeneUS is a genomics company creating the world’s largest block-chain encrypted repository of indigenous and diasporic African clinical data for disease prevention and detection, drug discovery and development, clinical disease management, and precision health equity. As CEO, he leads strategic direction and partnerships as well as investor relations. Prior to IndyGeneUS, Henriques founded TruGenomix Health Inc., an emerging precision genomics behavioral health company harnessing the power of genomics to improve risk prediction and diagnosis of Post-Traumatic Stress Disorder (PTSD).
Angela Ibald-Mulli, DrPH, MBA, MPH, MS
- Integrated Evidence Generation Lead Thrombosis
- Bayer Pharmaceuticals, Germany
Dr. Ibald-Mulli is a trained Epidemiologist and holds a Doctorate degree in Environmental Epidemiology as well as Master’s Degrees in Public Health , Nutrition and Business Administration. Dr Ibald-Mulli has been working in the biopharmaceutical industry for the past 18 years in various roles including clinical development, post marketing research, business operations and most recently in real world evidence generation. Angela recently joined Bayer as Integrated Evidence Generation lead for the Thrombosis franchise having previously held a similar position within Sanofi. Prior to embarking on a career in the pharmaceutical Industry Angela worked as a research scientist at the LMU Institute of Epidemiology in Munich.
- Chairman and Founder, Foundation 29; Scientific Director
- Dravet Syndrome European Federation, Spain
Julian Isla is the Chief Scientific Officer of the European Dravet Syndrome Federation, an European organization of patients with Dravet Syndrome. Julian Isla founded Dravet Syndrome Foundation seven years ago. Dravet Syndrome Foundation is committed to find new treatment for Dravet Syndrome, an epileptic encephalopathy having long lasting seizures refractory to treatment as severe developmental delay as main symptoms. Julian is the father of Sergio, a young boy six years old who has Dravet Syndrome. Julian is software engineer by training and he works for Microsoft as full time employee. Julian is also member of the Orphan Drug Committee at European Medicines Agency
Jesper Kjær, MS
- Head of Danish Medicines Agency’s 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.
Amr Makady, PharmD, PhD, MSc
- Health Economics and Market Access Manager
- Johnson & Johnson, Netherlands
Amr is a pharmacist by training, having completed his PharmD degree in Egypt before moving to the Netherlands to pursue his Master’s studies at Utrecht University in the field of pharmaceutical policy. Recently, Amr completed his PhD degree at Utrecht University whereby his thesis focused on the use of Real-World Evidence (RWE) in HTA practice. Amr worked as a pharmacoeconomic assessor and policy advisor at the Dutch National Health Care Institute (ZIN) and was involved in a number of international projects related to RWE generation and use in decision-making, including: IMI-GetReal I/II, IMI-ROADMAP, EUnetHTA JA3 and NEWDIGS. Currenly Amr works as a market access manager at Janssen Pharmaceuticals in the Netherlands.
Irene Nunes, PhD
- VP, Head of Regulatory Affairs
- Flatiron Health, United States
Baris Erdogan, PhD
- Clinerion Ltd, Switzerland
Baris Erdogan is the Chief Executive Officer of Clinerion. He studied computer engineering and holds M.Sc. and Ph.D. in educational technology. He practiced data mining techniques in various sectors including healthcare. He lectures on the topics of software development, database management, medical informatics, and project management. His expertise and experience include the management of innovative Medical Informatics projects and implementation of end-to-end Healthcare IT enterprise information systems, both in the public and private sectors.
Marcus Grobe-Einsler, DrMed
- German Center for Neurodegenerative Diseases (DZNE), Germany
Tadeusz Lewandowski, MS
- NEST Business Lead
- F. Hoffmann-La Roche AG, Switzerland
Sean Manion, PhD
- Chief Scientific Officer
- ConsenSys Health, United States
Sean Manion, PhD is a neuroscientist with two decades of federal brain research and leadership experience. He is the Chief Scientific Officer of ConsenSys Health, a start-up focused on the application of emerging technology (blockchain, decentralized machine learning, and privacy-preserving encryption) in healthcare and life sciences. He completed his doctoral and post-doctoral work as a civilian at Uniformed Services University of the Health Sciences looking at pre-clinical models of post-traumatic stress disorder (1999-2009). He continued work with the Military Health System as Deputy Chief of Staff and later Research Activities Chief for the Defense and Veterans Brain Injury Center (2009-2017).
Gustavo Mendes Lima Santos, MPharm
- General Manager of Medicines and Biological Products
- ANVISA, Brazil
General Manager of Medicines and Biological Products at ANVISA, Brazil. Responsible for the management of drug and biological product registration submission evaluation teams, authorization to conduct clinical trials in Brazil, and certification of bioequivalence centers. I have been working at ANVISA, Brazil since 2003 mostly with bioequivalence / biowaiver studies and clinical trial evaluations. I'm a pharmacist with specialization in public health, I also holds a Master of Toxicology.
Jim Nasr, MBA
- Founder and Chief Executive Officer
- ACOER and Ex-CDC, United States
Prior to Acoer, Jim was the Vice President of Technology for Certara and was the Chief Software Architect at the US Centers for Disease Control (CDC). Jim led a number of modernizations of CDC’s public health systems, through implementation of interoperable software, data as a service, blockchain and open source software. Jim has more than twenty years of experience in the technology industry, with over a decade as a founder and CEO of Armedia. With Jim’s expertise, Armedia grew from inception to over 100 employees, and a 5-time Inc. 5000 awardee. Jim is on the board of many technology organizations and the Architecture Lead for PhUSE Blockchain Working Group. He has an MBA from the University of Connecticut.
Ian Rentsch, JD
- Vice President, Growth and Strategic Partnerships
- Aetion , Germany
Ian Rentsch has over 25 years’ experience in Multinational Corporate Affairs, Outsourcing Management & Clinical Research Development working in large multinational companies including large biopharma and Contract Research Organizations Globally and in Emerging Markets. Most recent roles include General Executive Management, Leadership of regional clinical teams, Business Operations and Strategic Business Development in the Contract Research Industry & Clinical Technology.
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.
Mathew Rose, MD, MS, MSc
- Founder and Chief Executive Officer
- SAAVHA Inc., United States
Dr. Rose is a Physician, Entrepreneur, and Blockchain Specialist, who strives to use cutting-edge technology to simplify secure user experiences that increase patient engagement and drive better health outcomes. He has more than 9 years working on Translational Medicine and Phase I/II clinical research projects. Since authoring one of the first 75 whitepapers on creating U.S. hospital interoperability through blockchain technology for the ONC/NIST 2016 inaugural workshop, he has spoken at various conferences on the subject matter. Dr. Rose has been mentioned in Forbes, CoinDesk, The Parallax, and participates on several committees to help create standards for blockchain's technology in healthcare and clinical research.