Speaker Bios, SCOPE Europe 2018

Victoria Abbott-Fleming, Patient, Founder, Burning Nights CRPS
Victoria Abbott-Fleming: A lawyer and founder of Burning Nights CRPS, who was diagnosed with Complex Regional Pain Syndrome (CRPS) and had her 2 legs amputated. Since then she is fighting for patient empowerment and better awareness. https://www.burningnightscrps.org/ourstory/our-founder/

Gail Adinamis, CEO & Founder, GlobalCare Clinical Trials
Over 35 years of comprehensive phase I-IV clinical trials experience including over 12 years of global clinical trials management at Abbott Laboratories and Astellas Pharma US. She founded the business model for centrally managed homecare services for clinical trials in 1992.

Nadir Ammour,DMD, MBA, Innovation Domain Leader, Patients and Sites, R&D/Clinical Science & Operations, Sanofi
Nadir is a medical dentist, and worked first, in public healthcare. He holds a university degree in health economics and medical informatics. He served in global positions at Wyeth, and now at Sanofi, in clinical operations, leading projects in clinical development, and clinical technologies. Since few years, he is involved in real world data-driven clinical trial and healthcare digital solutions and services. He is actively engaged in bringing innovation in clinical development and led projects in remote trial (Verkko), wearables trials, digital endpoints trials and recently in EHRs driven clinical trials. He is a member of the Executive Committee of the EHR4CR champion project. Nadir is presently leading a consortium project EHR2EDC aiming at further developing capabilities to conduct trials using EHRs data directly.

Artem Andrianov, CEO, Cyntegrity
Artem Andrianov, PhD, serves as CEO for Cyntegrity. He graduated with degrees in engineering, and executive MBA. 15+ year of experience in data quality projects, RBM and biostatistics for pharmaceutical industry. Special expertise in: Spirometry, ECG, Oncology, ePROs, clinical data management.

Scott Askin, Digital Solutions Director, Digital Development, Novartis
Scott Askin, a Digital Solutions Director with Novartis, leads the company’s digital agenda in the areas of eSource (electronic Source) and electronic Informed Consent (eICF/eConsent), in addition to consulting on other key digital programs within Novartis. Scott has been leading digital projects for over 5 years and is working with strategic partners to drive the adoption of novel technologies across the company and industry. Scott brings with him over 18 years of industry experience and is currently based in Basel Switzerland.

Graham Belgrave, Senior Vice President, Head, European Operations, Advanced Clinical
A graduate of Warwick University, Graham Belgrave has over 33 years of experience successfully leading pharmaceutical development across Clinical Operations (phases I-IV), Outsourcing & Contract Management, Project, Program and Vendor Management. Mr. Belgrave has held senior management roles overseeing clinical operations, outsourcing, and vendor management for global top pharma and biotech companies. Most recently, he served as COO at a mid-sized CRO in the UK.

Bob Brindle, Venture Leader, Cognizant Protocol Creator, Cognizant
Bob Brindle has 20+ years' experience in the pharmaceutical industry and extensive background in clinical trials process and technology improvement projects.  Today, he focuses on solving the issues he previously observed in his career in the industry. Now leading the development of Protocol Creator, he primarily works with clinical trials leaders and protocol authors finding ways to simplify this complex and critical process and enabling digital adoption in the life sciences industry.

Divya Chadha Manek, PhD, Head, Business Development, National Institute for Health Research (NIHR) Clinical Research Network
Divya has worked for the NIHR CRN for the past nine years. She has hands experience of delivering clinical research from both a site-level and national perspective. Divya’s current role is to maintain strategic relationships with global and UK life sciences companies. Within this role, Divya provides advice and works collaboratively with companies to optimize how companies utilize government-funded support services to ensure clinical studies are set up quickly and efficiently and recruit to time and target. Divya also leads on keeping the NIHR CRN abreast of study delivery innovations. In doing so she helps to ensure that the services we provide continually evolve meet the needs of the life sciences industry. Divya has a degree in Clinical Psychology, a Masters in Clinical Research and is currently undertaking a Ph.D. in Dementia Care.

Narinder Chopra, Director, Feasibility, Enrollment & Retention Optimisation, Global Clinical Operations, Biogen
With over 23 years of experience in the pharmaceutical industry, Narinder has played multiple roles from the bench to the bedside. Narinder started his career in the laboratories for 3 years before moving into clinical research in 1996. Narinder has developed his career through several clinical research roles over 20+ years, working on UK, regional and global programs; and organisational leadership. His roles have included CRA, study and program leader, regional leadership, phase alignment management and, recruitment and retention. Narinder has had the pleasure of learning from working with approx. 9 different companies over the years. Narinder currently leads the Feasibility, Retention & Optimisation (FERO) team at Biogen looking to bring patients to the centre of research in all disease areas where Biogen are active. Narinder ensures he balances this work priorities with time with family, friends and hobbies.

Joana Claverol, Clinical Research Unit Manager, Sant Joan de Deu Barcelona Children's Hospital, Research Foundation Barcelona Children's Hospital
Joana Claverol , is the Clinical Research Unit Manager at Barcelona Children’s Hospital, Spain, where she leads the clinical trials office since 2012 and coordinates the European Network of Young Scientific Advisors (eYPAGnet). The Clinical Research Unit is a reference unit for pediatric patients nationally and internationally, specializing in innovative treatments for highly complex patients with rare pediatric diseases. She has more than 13 years of experience in medical and clinical research in the pharmaceutical and biotechnology industry, with special knowledge and experience in drug development and clinical trial design, and all regulatory and methodological aspects related to clinical research.

David Cocker, CSO, Ta-scan Business Intelligence Systems, MDC Partners
David J. Cocker is a Biomedical Engineer and active in clinical research for 30 years. David is a committed innovator with a keen interest in leveraging digital technology for clinical trial risk mitigation and product stewardship. As th Chief Scientific Officer of MDCPartners, he is leading the development for ta-Scan clinical buisness intelligence systems. Prior to MDC, he has held Principal positions in leading European clinical laboratories. Marketing Manager of Boehringer Ingelheim's institute Bioscientia, Founder and Managing Director of CRL-Medinet The Netherlands, General Manager of Quintiles European laboratory services UK and Managing Director of Clinical Research Laboratory. As a volunteer he has assisted in strategy and advocacy of many industry associations and societies: He serves as a Member of the European Steering Committee of the Drug Information Association. He serves as a Consultative Member on the United Nations committee of experts on dangerous goods and a consultant to the World health Organization on Bio-safety affairs. He is a long-standing business executive in the contract research community and a committed industry volunteer. He is a founding Member of the European Bio-safety Association, EBSA, secretary from 1996 to 1997and President from 1999 to 2000. Mr. Cocker has achieved sporting Olympic distinction and competed in the 1984 Los Angeles Olympic Games in the sport of Fencing.

Nurcan Coskun, PhD, Global Risk Based Monitoring Program and Technology Solutions Manager, Medtronic
I have 20 years of clinical research experience, contributing in roles such as Clinical Research Manager and Clinical Research Associates Supervisor, Global Clinical Operations Oncology Group Leader, Project Leader, Clinical Monitoring Manager and recently as Global Risk Based Monitoring and Technology Solutions Manager. After obtaining my M.Sc. and Ph.D. degrees on Cancer Epidemiology, completed my Master degree on Medical Informatics at Erasmus University, Rotterdam in the Netherlands. During my studies, I worked as Researcher in the field of Cancer Epidemiology especially in Registries and conducted clinical trials as data manager and statistician. I contributed in the activities of SOP writing, trainings, publications, leading task forces on different topics and presenting at congresses and meetings. My current focus is on Risk Based Approach to Clinical Trials. With collaboration with other authors one whitepaper published on RBM in Medical Device companies and attend the conferences as speaker on the subject.

Jonathan Crowther, PhD, Associate Director, Site Intelligence & Feasibility Lead, Clinical Development & Operations, Pfizer N.V./S.A.
As a Site Intelligence Lead (SIL) at Pfizer, Jonathan has a dynamic cross-functional role to support various study teams in assessing and implementing site intelligence. As a strategic analyst in clinical intelligence Jonathan combined his experience in data mining and analytics to provide innovative approaches and accelerate Site/KOL selection and study optimization. Digital transformation has been a fundamental part of Jonathan’s experience with many of his projects to date focusing on making robust data driven decisions in clinical research.    

Ana Diaz, PhD, Project Officer, Alzheimer Europe
Ana Diaz PhD, is a sociologist and senior social worker and has worked for several years in different services for people with dementia. She currently works for Alzheimer Europe as Project Officer. As part of her role in AE, she facilitates the involvement of people with dementia in various activities and projects of AE and leads AE’s work in the PARADIGM project. She has a particular interest in and has published articles on the topic of Patient and Public Involvement (PPI), quality of life and dementia.

Eric Delente, President, Patient Solutions Business Unit, DrugDev
Eric has more than 20 years of experience leading technical and creative teams in the design and implementation of numerous award-winning online science, healthcare and clinical research web applications – most recently by leading SecureConsent (acquired by DrugDev), the industry’s definitive e-consent solution. His professional focus has consistently centered on the academic, medical and scientific communities, and he has delivered applications, web portals and back-office tools for clients as diverse as The New York Academy of Sciences, Wolters Kluwer, Elsevier, Swets, The American College of Physicians, The National Cancer Institute, The European Society of Cardiology, The Food and Drug Administration, The Aircraft Owners and Pilots Association, The American Red Cross and many of the top 20 Pharmaceutical companies. Eric’s profound understanding of the Science and Healthcare sectors, academic sectors, online publishing, coupled with his track record of developing complex but intuitive electronic data-driven applications makes him uniquely qualified to lead these technical teams. Previously, Eric was the director of Electronic Publishing at Multimedia Software, LLC in Frederick MD where he landed after leaving NYC, where he owned and operated one of the first all-digital audio/video facilities in the world. There he led the production of program promotion materials for MTV, Nickelodeon and several other Viacom-owned networks.  As an engineer, violinist and composer, Eric has recorded and performed with Lenny Kravitz, Vanessa Paradis,  Daddy-O, Scott Ambush (Spyro Gyra), Scotty Hard and many others.

Keith Dorricott, Ambassador, Metrics Champion Consortium; Director, DMPI Ltd.
Keith Dorricott is Director, DMPI Ltd. and an Ambassador for the Metrics Champion Consortium. He has a background in manufacturing from Kodak Ltd. He has worked in quality, metrics, process improvement and operational roles over 11 years for two major CROs. He is a Master Black Belt in Lean Sigma and is an expert in root cause analysis. He acts as facilitator for a number of MCC work groups – Vendor Oversight, Site Selection & Start-Up, Trial Master File - and has worked with MCC member organizations to develop tools such as the Cost of Poor Quality Estimator and the Protocol Operational Complexity Scoring Tool.

Nils Drews, MD, CMO, Clariness
Nils Drews is Chief Medical Officer of Clariness, bringing extensive leadership experience in clinical research oversight as well as electronic data capture and digital data processing. In his current role, Nils serves as Clariness’ medical expert, providing guidance for patient identification, recruitment and retention strategies, study feasibility and site selection. Prior to co-founding Clariness in 2005, Nils served as managing director for Deltavista, provider of international risk management solutions. Previously, he served as Chief Executive Officer of Varigon, a service provider of electronic data capture for clinical research. Past significant clinical research experience includes participation in the European Network for Understanding Mechanisms of Severe Asthma (ENFUMOSA). Nils is a graduate of the University of Hamburg, where he earned a medical degree, and the University of Lubeck.

Ana Esther Garcia Cadenas, Consultant Investigator Platforms, Clinical Information Process Automation, Eli Lilly and Company
Ana currently works as a regional Clinical Information Process Automation (CIPA) Consultant. She leads the adoption and supports study onboarding of investigator platforms (e.g. Shared Investigator Platform (SIP)) with clinical trial sites and Lilly staff. In this role, she serves as the primary business point of contact and leads the transformation from existing (to new) business processes and technologies within the EMEA region. Ana has been working for Lilly for the past 12 years having different roles in the Clinical Operations organization, spending the last 5 years as Regional Clinical Operations Manager covering several countries across Europe. During this period, she has been instrumental in the deployment and adoption of IT systems used by the Clinical Operations organization. Ana’s background is in Pharmacy and she obtained her PhD in Pharmaceutical Chemistry from University of Salamanca (Spain) in collaboration with King’s College London (UK). 

Sophie Evett, PhD, Director, Feasibility Lead, Clinical Development & Operations, Global Product Development, Pfizer
Sophie is Director, Feasibility Lead within the Pfizer Study Optimisation group. She holds a Bachelor degree in Biological Sciences and a PhD in Molecular Biochemistry from the University of Reading, UK. Having worked for CROs since graduating, Sophie joined Pfizer in 2011 and has had various roles within the UK and now global groups.

Charlotte French, Principal, CAF Consulting LLC; Former Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, Astellas
Charlotte's most recent role was the Executive Director, Portfolio Relationship & Sourcing Management at Astellas Pharma Global Development, leading the global sourcing activities for Medical & Development. In this role she led the Service Provider Relationship Management team together with the Outsourcing/Contracts. Charlotte also led the implementation of a tripartite Sourcing Strategy for the Development organization. Prior to joining Astellas in May 2017, Charlotte was Senior Director, Contracting and Outsourcing within Global Clinical Operations at EMD Serono. In this role she led the team of Contract/Outsourcing Managers responsible for supporting the commercial aspects across both the Regional and Global Clinical Operations portfolio. Prior to her transition to Pharma, Charlotte had more than 15 years in the healthcare industry during which time she has led a number of different business functions within CRO sector at ‘top three’ CRO’s, including Finance & Administration, Global Bids and Contracts and Global Management Services. One of her key strengths is the ability to assess opportunities for improvement and then work across multiple functions to develop and measure process improvement initiatives. This was demonstrated during her tenure in the non-governmental environment for a period of three years during which she provided support and leadership on contract/grant management to ensure audit readiness for a number of country assignments in African and Asian countries, including a move to Ghana to lead a regional program for Neglected Tropical Diseases.

Tess Gilbert, Associate Director, Consultative Services, IQVIA TechnologiesTess Gilbert is a pharmaceutical industry subject matter expert with over 16 years of experience in clinical planning, protocol and study development and execution, and clinical development consulting.  She holds a master’s degree in the psychology of organizational development and has a passion for effective change management.  After beginning her clinical research career as a research technician at IU School of Medicine, Riley Children’s Hospital, Autism Clinic, Tess joined Eli Lilly and Company as a Clinical Development Associate.  While at Lilly, Tess enjoyed several roles in various therapeutic areas, including neuroscience, diabetes, oncology, bone-muscle-joint, and auto immune disorders.  She also led teams through the protocol design and operational feasibility processes as both a Clinical Trial Project Manager and as a Clinical Development Consultant on the Lilly Design team.  At IQVIA, Tess shares her knowledge and experience in clinical drug development, organizational change management, and the CTOS Technology Suite, with potential and existing customers through thought leadership, training, and demonstrations.

Susan Griffing, Vice President, Global Head Country Clinical Operations, Roche
Biography coming…

Bert Hartog, PhD, Senior Director, Clinical Innovation, Janssen Pharmaceutica N.V. v
Bert is currently Senior Director and Innovation Leader at Janssen Pharmaceutica. He leads transformational innovation projects that have the goal to shape the future of clinical trial execution, and position Janssen as a role model in patient-centered clinical research. Bert is an industry expert in Global Clinical Operations, Digital Health and related functions. He holds an MSc in Biomedicine and PhD in Medicine, both from Utrecht University, and started building experience as CRA with Eli Lilly in the Netherlands. Following successful stints in international QA and IT management roles he took on Janssen’s clinical operations in the Benelux and Nordic countries, before joining Janssen’s Clinical Innovation team in 2015. He has developed a keen eye for bringing structure into complex environments, finding a healthy balance between need for process and individuals’ accountability. One constant in his career is his drive to exploit technology to bring efficiencies into clinical research and provide patients a better experience. His main focus today is to develop capabilities for digital health in clinical trials, including digital outcome measures and technologies for remote patient monitoring.

Kyle Holen, MD, Head, Development Design Center, AbbVieTrained as a medical oncologist at Columbia University and Memorial Sloan-Kettering Cancer Center, Kyle began his career treating patients with GI tumors at the University of Wisconsin. There, his research interests included early phase trials and novel therapies for GI and neuroendocrine tumors. His educational responsibilities included leading the UW medical oncology fellowship program. He left academia to pursue drug development at AbbVie in 2009 and has since had roles as medical director, senior medical director, senior project lead, and executive medical director. He is currently the head of the Development Design Center, a center that assists clinical teams with their programs and trials using big data/predictive analytics and innovative strategies.

Daoying Hu, MBA, PhD, Associate Director, Strategic Feasibility, UCB BioSciencesDaoying Hu has over a decade clinical research experience in combined Pharmaceutical and CRO industry. She developed her career through several functional roles including research, project management, site network management, and clinical data solutions. She focused on clinical planning and analytics in the recent years, and strengthened her data expertise during her tenure at IQVIA Global Feasibility group. Currently Daoying heads Strategic Feasibility team at UCB, which supports the company’s entire clinical portfolio.

Andy Lawton, Director and Consultant, Risk Based Approach Ltd.
Andy Lawton was most recently at Boehringer-Ingelheim for 28 years. At BI Andy was responsible for managing the statistics, data management and programming groups with BIs UK operation. The group has specialised in the management of large scale trials and the implementation of risk based approaches within them. His experience covers over 33 years in clinical trials, but he also has extensive experience in the areas of computing, statistics, Data Management, RDE and system design. Andy was a founding Committee Member of ACDM and aided in the initiation of CDISC with the provision of the business model. Before joining BI, Andy worked as a statistician in the NHS and in computing in a geophysical exploration company.

Dipak Kalra, PhD, President, The European Institute for Innovation through Health Data
Professor Dipak Kalra, PhD, FRCGP, FBCS, is President of the European Institute for Innovation through Health Data. He plays a leading international role in research and development of electronic health record interoperability standards, data and privacy protection, interoperability business models and the reuse of EHRs for research. He has led multiple European projects in these areas, including Horizon 2020 and the IMI programme alongside pharma companies, hospitals and ICT companies. Dipak is Clinical Professor of Health Informatics at University College London, visiting professor at the University of Gent, and a member of standards bodies including CEN, ISO and HL7.

Beenu Kapoor, Shared Investigator Platform (SIP) - Market Leader, Cognizant Technology Solutions
Beenu has more than 20 years of experience in the Life Sciences industry working for Pharma, Biotech and CROs. She has worked and consulted in transforming Clinical Trial Management and Operations. She earned an Executive MBA in Finance from Rutgers Business School and a MS in Computer Application from Delhi University, India.

Michael Keens, COO, Firma Clinical
Mr. Keens serves as Chief Operating Officer for Firma Clinical Research, a niche CRO focused in Remote Patient Visits and Data Management.  Mr. Keens has extensive experience within the industry, including roles in Clinical Operations, Project Management, Consulting, and Business Development across both large global and growing CROs. Mr. Keens earned his undergraduate degree in Biology/Psychology from James Madison University, and his Master’s degree in Public Health from The University of Virginia.

Gergely Kokas, PharmD, Director, Regional Head (EU North & South), Global Study Operations, Site Management, Amgen
Gergely Kokas was graduated in 1999 as a Pharm D. and subsequently completed his Board certification studies in 2005 on Pharmacology, and Pharmacy management at Semmelweis University in Hungary. In 2010 he completed the MBA curriculum at Budapest University of Technology also in Hungary. Gergely has 5 years of experience in hospital and retail pharmacy and 14 years of experience in clinical trials both in international CROs and pharma side. Since joined the world of clinical trials he held various positions starting in CROs as a CRA, Clinical Team Leader with worldwide responsibilities in phase II-IV multinational clinical trials. He joined the pharma industry with Amgen in 2008 and held various roles with increased responsibilities in clinical operations form local project management through head of local Clinical Operations in multiple countries to Regional responsibilities across Europe, Africa and Middle East. Currently Gergely is a Process improvement Director focusing on Study Start up. Since 2013 Gergely involved in various internal and external projects covering the areas of operational design of clinical trials, Study start-up & Site selection, Risk Based Monitoring and eConsent currently representing Amgen in Trancelerate Biopharma Consortium for eConsent and Shared Investigator Platform. Gergely was member of the Hungarian National Rowing Team until 2004 participating at World Championships and Olympic Games. In addition, of his native Hungarian, Gergely is fluent in English and speaks conversational level in Italian.

Christopher Komelasky, Senior Director, Strategic Feasibility, Site and Patient Access, PPD
Chris Komelasky leads a portfolio of strategic data, technology and process improvement initiatives helping to move PPD towards data-driven decision making. Chris has extensive experience as a management consultant and healthcare executive in the areas of strategy, operations, data analytics, commercialization and business transformation. Chris holds a B.S. in Systems Engineering from the University of Virginia and an MBA from Duke University’s the Fuqua School of Business.

Robert Kroes, Project Manager, Clinical Dermatology and Pain Global Medical Affairs, Eli Lilly and Company
Robert Kroes has a B.Sc. in Microbiology from Aberdeen University, Scotland and a M.Sc. in Medical Biology from the Rijks Universiteit Leiden, Netherlands. Robert Kroes has worked in numerous (management) positions in Lilly over the last 25 years in both sales and medical. Prior to his current role, Robert lead the European efforts with regards to Clinical Open Innovation, with the main goal to improve the patient experience throughout the Clinical Trial Process. In his current role Robert is responsible for the global medical affairs project management (Dermatology) of Lilly.

Kai Langel, Director, Clinical Innovation, Janssen
Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal remote clinical trial platform. Through his involvement in technical, operational and scientific roles, he has gained an in-depth understanding of all aspects of the patient journey in clinical trials from recruitment and engagement through data capture. Kai is a Director in the Janssen Clinical Innovation group, working within the digital health team delivering scalable solutions for digital transformation of clinical trials. In his role, Kai leads digital health innovation projects, focusing on decentralized and remote trial methods, remote patient monitoring and digital data capture and endpoints.

Martine Lewi, PhD, MBA, Scientific Director, Global R&D, Clinical Innovation, Janssen
Tine Lewi is a Scientific Director at Janssen Global R&D/Clinical Innovation. For over 15 years, she led projects in the area of data and insight generation for healthcare. Tine currently leads the Hospital Network within Janssen R&D, covering a number of novel solutions within the real world data portfolio. She is active in developing data science capabilities within Janssen R&D and has a passion for disease interception and various initiatives around “a world without disease”. Tine has a background in medical informatics and applied economics. She completed a PhD on patient insights and health communication for disease prevention.

April Lewis, Head, Global Offerings and Marketing, Clinical Trial Optimization Solutions (CTOS), IQVIA
April currently serves as the Head of Global Offerings and Marketing for IQVIA’s Clinical Trial Optimization Solutions portfolio. She serves on the CTOS executive team where she contributes to the strategic vision for IQVIA’s Planning and Design offerings. She is responsible for leading the strategic development of a portfolio of SaaS technology products that address critical business needs for clinical trial Sponsors and Contract Research Organizations worldwide. April was a member of the IQVIA integration team with a focus on the integration of best in class global data and SaaS technology into IQVIA’s world class service offerings. She was honored as a Healthcare Businesswoman’s Association Rising Star nominee in 2014 and 2017. April joined IQVIA in 2009 bringing her experience in data management, clinical operations, pharmaceutical consulting and site selection with various Sponsor and CRO organizations. April holds an M.S. in Organizational Development and Psychology.

Terrie Livingston, PharmD, Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen; Trial Volunteer/Patient
Terrie Livingston is the Senior Director, US Medical, Head of Real-world Outcomes, Innovative Partnerships & Insights at Biogen. Dr. Livingston has over 18 years of Managed Care expertise and 14 years of Pharmaceutical/Life Sciences experience. She was a Managing Partner and Vice President of Pharmacy Operations and Business Development for eBioCare, a Specialty Pharmacy in California. She has held various positions with increasing responsibility within the pharmaceutical industry ranging from field roles to development and leadership/management as a Functional Head at Pharmacia, Novartis and most recently Biogen. Currently she is the Head of Innovation and External Partnerships in US Medical at Biogen. Dr. Livingston received her doctorate in Pharmacy from the University of California, San Francisco (UCSF) as well as completion of a general and specialty residency from UCSF. In her current role, Terrie is responsible for strategic engagement and partnerships across all key stakeholders in healthcare that include providers, payers, advocacy organizations, professional societies and healthcare policy makers that focus on collaborations and partnerships that provide innovative solutions to healthcare. Through these partnerships, the goal is real-world data generation across the healthcare ecosystem and to create a framework to continuously engage on innovative initiatives that enable sustainable change to improve patient outcomes and the patient experience. Terrie has M.S. She understands firsthand the experience of other patients living with the disease -- and the challenges of managing a chronic condition while also managing the demands of work and life.

Stephen Lock, Head of Business Intelligence, NIHR (National Institute for Health Research)
Stephen Lock is an improvement expert with twenty years experience in the healthcare and IT industries. Over the last ten years, working in research networks, he has developed many innovative and award-winning ways of delivering clinical research to patients, including a pioneering use of social media marketing to help enroll patients into studies. Currently working as Head of Business Intelligence for NIHR CRN CC, where he has a national role in reporting and analysing research activity, Stephen is also member of the Accelerating Digital Programme, which aims to find digital ways to improve clinical research. Previous roles have seen him working as a network manager in the NIHR, leading turnaround projects for the NHS and developing user interfaces for Hewlett-Packard France. Stephen has also helped to establish a temporary English school on an island in Lake Titicaca, Peru, and served as a national ambassador for Sue Ryder (an end of life charity), speaking on their behalf in parliament and at national political conferences. When he's not working, Stephen likes to be running over a fell or cycling across a dale.

Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC
Robert Loll has more than 25 years of healthcare and sales management experience, assisting pharmaceutical, biotechnology, and medical device companies with patient enrollment solutions for global research studies. Robert is also an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP) an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

Suzanne Lukac, Senior Account Director, CluePoints; Director, Risk-Based Monitoring Implementation, MSD
Suzanne Lukac has nearly 20 years experience in the pharmaceutical industry. She is currently Senior Account Director at CluePoints, working consultatively with clients to lay the foundation for successful Risk-Based Monitoring implementation. Prior to joining CluePoints, she was the Project Director for Merck’s RBM Implementation Initiative and was the Co-Lead of the TransCelerate RBM Implementation and Facilitation Team (RIFT). Suzanne’s RBM experience includes assisting clinical teams in implementing Quality by Design (QbD), guiding teams through risk assessment and mitigation exercises to formulate study Quality Plans and advising on the incorporation of RBM methodology into clinical trials through people and process development. Suzanne has also held roles in quality management, clinical research in both Early and Late Stage development as a Protocol Lead and has also worked as a Medical Writer. Suzanne holds a BS in Biology from Temple University.

Marcin Makowski, Head, Risk Based Monitoring & Standards, UCB
Marcin Makowski, MD, PhD graduated from the Faculty of Medicine at Warsaw Medical University. After a successful scientific career in the fields of in immunology and experimental cancer therapy he moved to the pharmaceutical industry and worked for AstraZeneca (AZ) for 11 years. During that time, he took on various roles within Clinical Operations: monitor, local study team leader, study physician, and line manager. Since 2011, Marcin Makowski’s focus was on new monitoring approaches in clinical trials. He worked on one of the first industry implementations of Medidata’s Targeted Source Data Verification (TSDV) module. More recently, Marcin established and led AZ’s Centralized Monitoring group within the Risk-Based Monitoring (RBM) framework. He co-led the TransCelerate working group that prepared the framework paper on predefined Quality Tolerance Limits (QTLs). Currently, Marcin Makowski is the head of the Risk Based Monitoring and Standards group at UCB.

Miguel Angel Mayer, MD, PhD, Research Programme on Biomedical Informatics (GRIB), Hospital del Mar Medical Research Institute (IMIM), Universitat Pompeu Fabra (UPF)
Miguel-Angel Mayer is an MD, specialist in Family and Community Medicine, MPH and PhD in Biomedical Informatics. He is an Associate Professor and academic coordinator of Biomedical Informatics at the Pompeu Fabra University (UPF), and Senior Researcher at the Research Programme on Biomedical Informatics (GRIB) of the Hospital del Mar Medical Research Institute (IMIM) in Barcelona. He worked for more than 10 years as a clinician in an Internal Medicine department and in Primary Care settings in the Spanish National Healthcare System. Since 2001 he has participated in and is involved in several European projects under different programs such as the Public Health General Directorate, Internet Safer Action Plan, FP7, H2020 and the Innovative Medicines Initiative (IMI), working on several research topics such as the quality labelling and assessment of health information on the Internet, ICT educational activities for the general public in Healthcare and biomedical informatics applications in EHR, standards and reuse of clinical information for research.

Asmaa Mrabti, Study Risks and RBM Expert, Trial Operations, Sanofi
Asmaa has a Master’s Degree in Project Management of Clinical Trials from the Pharmacy school of Montpellier University. She started her career as Clinical Trials Manager and has over 8 years’ experience within Trial Operations group at Sanofi. She has worked across multiple therapeutic areas and clinical studies phases; with increasing responsibilities. In the last few years she specialized in the management of Outcome Megatrials. Most recently she has transitioned to the role of transversal study risks and risked based monitoring and is responsible for the implementation and improvement of the RBM process at Sanofi.

Bryan McDowell, Global Program Lead, Executive Director Digital Development, Novartis
Bryan McDowell, a Digital Development Global Program Lead with Novartis, continues to influence, drive and deliver on industry’s need for smarter, better, faster drug development and clinical trial execution. Beyond his responsibilities to provide leadership for the assessment, testing, and implementation of new technologies and methodologies into clinical trials and programs, Bryan is a thought leader and proponent for initiatives to integrate multiple technologies onto a single platform/device while continuing to push and leverage technologies that not only engage and involve patients in trials but, via decentralized trial settings, also vastly expands the reach and access of trials to more patients while in turn giving more patients access to trials and novel therapies. Bryan brings with him over 20 years of clinical trial experience and is also based in Basel Switzerland.

Begonya Nafra, Clinical Research Unit, Sant Joan de Deu Barcelona Children's Hospital, Research Foundation Barcelona Children's Hospital
Ms. Begonya Nafría (F), MsC, Patient Engagement in Research Coordinator at Institut de Recerca Sant Joan de Déu and Fundació Sant Joan de Déu. Experience in coordinating and managing projects in clinical research on rare diseases. Coordinator of YPAG (Young Persons’ Advisory Group)-KIDS Barcelona and RareCommons platform. Ms. Nafría is the Coordinator of eYPAGnet (European YPAG network – accredited by EnprEMA), Member of the Course Committee of Eupati (European Patients' Academy on Therapeutic Innovation) and Chair of the Educational Committee of ICAN (International Children Advisory Network).

Brendan O’Neill, Senior Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer
Brendan is the Sr. Director of Pfizer’s Patient Recruitment Team. Brendan has 15 years of patient recruitment experience from the CRO and Sponsor sides. He has his BS in Pharmaceutical Marketing and Masters in Clinical Trials Sciences.

Bola Oyegunwa, Director, Strategic Planning, Research & Development Solutions Business, IQVIA
Bola Oyegunwa is a Director of Strategic Planning for IQVIA’s Research and Development Solutions Business. He is also the Program Manager for IQVIATM innovative and patient centric Virtual Trial solutions that enables patients to participate in clinical trials from the comfort of their homes. He has key experience re-engineering and optimizing traditional delivery models for virtual trial execution. Prior to joining IQVIA, Bola was a Management Consultant at a Healthcare M&A Advisory Firm and an Associate at a Private Equity Firm. Bola holds a Masters in Molecular Genetics, Ph.D in Immunology and a MBA all from North Carolina State University.

Pepa Polavieja, Senior Research Scientist, Consultant Quality & Operations, Statistical Sciences, Lilly S.A.
Pepa Polavieja is a biostatistician with 22 years of experience in the pharmaceutical industry, working across early and late stage and many therapeutic areas, performing varying roles. In the last 15 years, Pepa has been working for Lilly, having different roles in the Global Statistics and Sciences organization. She was a group leader for the European group neurosciences team, driving the statistical activities around launch preparation, most recently she is in a global role as a consultant in quality operations, leading the implementation of improvement initiatives for the Biometrics organization. In the last year, she has led the TransCelerate workstream focused on developing a Common Statistical Analysis Plan template, highly connected with the Common Protocol Template. Outside work Pepa enjoys her big family of four kids, travelling around the world, cooking, reading, going to see live bands and, of course, dancing with their music.

Ashley Polhemus, Innovation Specialist, Global Innovation Center, Merck and Company
Ashley currently works as an Innovation Specialist at Merck’s IT Global Innovation Center in Prague. While she leads projects in many facets of the company, she primarily focuses on experimenting with clinical and patient-facing technologies. Her primary goals are to understand the opportunities and shortcomings of technologies in this space, and to identify the most effective way to integrate promising technologies into clinical trials and studies. Before joining Merck, Ashley worked with a series of medtech start-up companies and social entrepreneurship projects. In those roles, she led efforts in landscaping, biological and technical research, product development, and clinical trial design. Ashley’s background is in biomedical engineering and medical device design, and she received her master’s degree in biomedical engineering and medtech entrepreneurship from Johns Hopkins University.

Lorraine Rusch, PhD, President, High Point Clinical Trials Center
Dr. Rusch is an executive level business development professional and drug development scientist specializing in early clinical development services as President at High Point Clinical Trial Center. Her specialized background allows her to provide a consultative service tailored to the needs of biotechnology and pharma clients. Dr. Rusch earned her Ph.D. in Laboratory Medicine and Bioanalytical Chemistry from the Cleveland Clinic Foundation/Cleveland State University Consortium. She has significant drug development expertise in the biotechnology industry as well as operational expertise in early clinical development contract research organizational leadership. Dr. Rusch provided preclinical, clinical pharmacology and metabolism expertise on many pre-IND drug development teams, including Merck’s Zolinza™ program, a first-in-class histone deacetyylase inhibitor (HDAC) currently approved for the treatment of cutaneous T-cell lymphoma and under study for additional indications. Dr. Rusch’s current interest is the creation of viable strategies for clients focused in achieving Proof of Concept (POC) in Phase I/IIa by use of adaptive clinical trials involving both healthy normal subjects and patient populations.

Richard Scaife, Chair, Pharmaceutical Contract Management Group (PCMG)
Richard worked as an Intensive Care Unit Nurse in the UK and Saudi Arabia, managed a British Aerospace Medical Centre in Saudi, returning to the UK in 1990 to join Ciba-Geigy in Pharma sales roles, Sales Management and ultimately CNS portfolio Brand Management. He moved to the CRO sector in 1997 with Covance, then Fisher Clinical Services in Health Economics/Reimbursement and Marketing roles, then leading a BD and Proposals unit at Quintiles before joining Daiichi-Sankyo in 2005. The following thirteen years in clinical development outsourcing (moving to Mitsubishi Tanabe Pharma in 2009 to become Global Outsourcing Lead) have included EU and global level achievements ranging from creating a new outsourcing and contracts function, negotiating global CRO agreements whilst building long-term, effective, CRO working relationships. Since January 2017 Richard has been working on a freelance basis with financial, pharma and biotech companies on a broad range of clinical outsourcing projects whilst continuing his role as Committee Chair for the PCMG since 2013, having joined this Pharma outsourcing association in 2006.

Oriol Serra Ortiz, MS, MBA, Senior Director, Head Site Intelligence & Selection, Study Optimization, Clinical Development & Operations, Pfizer
A leader in Strategic Planning and Optimization of R&D Portfolios. As functional Head for Site Intelligence & Site Selection based in La Jolla, CA, Oriol provides leadership, strategic direction and oversight to effectively deliver country and site feasibility globally. Oriol´s interest in Protocol and Site Optimization started early in his career, since then as a change agent he has Led multiple cross-portfolio / cross-functional strategic projects in all the organizations he has worked with, innovating about the engagement of key stakeholders and utilization of data to predictably deliver clinical trials. Oriol holds a Bachelor in Biological Sciences from the Fairleigh Dickinson University, MS Clinical Trials Management from the International University Barcelona and an Executive MBA from University of California San Diego-Rady School of Management.

Silke Strommenger, MD, Head, Feasibility Analytics & Planning, Bayer
Dr. Silke Strommenger is the Head of Feasibility Analytics & Planning at Bayer. Silke Strommenger received the licence to practice medicine from Freie Universität Berlin and a doctoral degree from the Medical University Bonn. Silke has over 20 years of experience in pharmaceutical industries in Clinical Development and Medical Affairs, working in different pharmaceutical companies such as Daiichi Sankyo, Organon. In 2007 Silke joined Bayer as Global Clinical Leader and has lead development of several compounds. Since 2011 she is Head of Feasibility and Analytics within Bayer supporting global Phase I-III studies in data driven feasibility assessments.

Mats Sundgren, PhD, Director Health Informatics, AstraZeneca
Dr Sundgren brings in expertise and services for using various external health data for supporting the clinical trial process across all AZ therapeutic areas. Relevant to this domain knowledge, Dr Sundgren led the AZ coordinated IMI (Innovative Medicine Initiative) EHR4CR private public research project 2011-2016, including 10 pharma companies and 25 academic partners. The EHR4CR project aimed to build a robust and scalable platform that will unlock data from hospital EHR systems, in full compliance with the ethical, regulatory and data protection policies and requirements across Europe and beyond. He is also member of the board of directors of the newly established European Institute for Innovation through Health Data, and holds a research fellow role at the University of Chalmers and the IT University of Gothenburg.

Shawn Tedman, Head, Trial Optimization Offerings, CTOS, IQVIA
Shawn Tedman is Head of Trial Optimization Product Offerings within the Clinical Trial Optimization Solutions (CTOS) group at IQVIA. Shawn’s background is largely in clinical operations – as a clinical monitor, project manager, and auditor. His particular area of interest has long been the optimization of site/country selection strategies as well as enrollment modeling to inform strategic operational planning. In his current role at IQVIA, Shawn leads the team directing the content and roadmap for the industry-leading CTOS Trial Optimization suite of products – including StudyOptimizer, SiteOptimizer, and Enrollment Benchmarks.

Anne Tinggaard, E-Trial System Specialist, Novo Nordisk
Anne is a E-trials System Specialist in the clinical IT area of Novo Nordisk. Her role is to identify technologies and applications hereof that can benefit Novo Nordisk's voyage to digitize trials and align to a future-oriented methodology with electronic devices. She acts as an advisory for the internal teams, to ensure a link between new technologies and the clinical projects' goals. Anne has a background in the pharma-IT space, with 6 years working for a life-science technology provider, NNIT, where she managed application teams for pharmacovigilance, clinical, regulatory and quality. Industry experience includes a number of years in various roles, in Ferring pharmaceuticals and Novo Nordisk.

Jean-David Zeitoun, CMO, Inato
Jean-David Zeitoun is an MD, specialized in hepatology and gastroenterology (PhD in clinical epidemiology). His research focuses on drug regulation, safety, pharmaceutical R&D, health economics, therapeutic innovation. He is the author of approximately 100 scientific articles, more than 40 of which were published in international journals. He is an advisor for health industries, directly through consulting firms, public affairs firms or international lawyer offices. He is co-founder and CMO of Inato, a startup involved in clinical trials.

Sara Zembrodt, Associate Business Systems Director, Design Offerings, IQVIA Technologies
Sara Zembrodt joined Quintiles (now IQVIA) in 2013 to support Design. In this role, Sara has been integral to establishing the business analysis team and the processes utilized for demand and requirements elicitation and management. Prior to joining IQVIA, Sara served the Design team as a consultant, working primarily with Predictive Analytics and Dashboard. Sara’s primary consulting role was as a business analyst consultant working with clients to establish and refine business processes and elicit and document product and process requirement; working in industries as varied as Pharmaceutical Clinical Planning and Design, Compliance Quality and Manufacturing Support, Cohort Default Management, Industrial Automation Programming Tools, Online Marketplaces, and Futures and Options Trading. She also worked as a Quality Assurance Engineer for Eli Lilly and Company ensuring compliance of validation and qualification efforts for automated and IT systems in parenteral manufacturing.

Maya Zlatanova, FindMeCure Foundation
A health tech entrepreneur with 10 years of experience in the clinical research industry. Developed training on regulations and how to improve the clinical research industry for the United Nations, the NHS, and the pharmaceutical companies. In the last few years, passionate patient advocate heading FindMeCure and the Patient Empowerment Initiative with focus on solving the biggest problems within patient recruitment and engagement.