Speaker Bios
Munther Baara, Senior Director, Development Business Technology, Pfizer
Munther has over 20 years of experience in the pharmaceutical industry. He is currently Sr. Director of Development Business technology at Pfizer, a worldwide pharmaceutical company. Munther is currently the head of Clinical Paradigm within the WRD-BT Development at Pfizer, Munther is spearheading initiatives driving innovation in development operations to align with the paradigm shift in the clinical trials execution model and emerging technologies. Munther Led the Clinical Aggregation Layer (CAL) implementation of a high-profile, large-scale clinical private cloud of clinical and operational data. In addition, he has extensive experience in application and system strategies, best practices, and standards that work for clinical and enterprise architecture, information management, workflow/process automation and integration of both home-grown and commercial applications across mixed platforms.
Aji Barot, Vice President, Pharma (EMEA), Medisafe® Medication Management Platform
https://www.linkedin.com/in/aji-barot-88078111
Professor Dr. Dorothee Bartels, Chief Digital Science Officer, BI X GmbH, Boehringer Ingelheim
Dorothee B. Bartels is Chief Digital Science Officer BI X, BI X is the digital lab of Boehringer Ingelheim. Prior to this role she was Corporate Head of Global Epidemiology at Boehringer Ingelheim for ten years. She holds a Professorship of Epidemiology and Public Health at Hannover Medical School and is Adjunct Professor at McGill University, where she lectures in the course of Advanced Pharmacoepidemiology. She also lectures in the Advanced Pharmacoepidemiology course at Harvard School of Public Health. Her research is focused on secondary data use and data linkages, on innovative approaches (e.g. digital epidemiology) and new strategies for faster drug developments and approvals.
Adam Baumgart, Head, Risk-Based Quality Management, AstraZeneca
Experienced project, line and department manager with 26 years clinical research experience in a variety of pharmaceutical and contract research companies. This includes; Risk-Based Monitoring (RBM) strategy & implementation, management of full-service pharmaceutical projects and internal process excellence & transformation initiatives, department leadership and line management and Electronic Data Collection (EDC) strategy and deployment.
Andree Beckerling, PhD, CEO, Clariness
Dr. Andree Beckerling, Specialist for Pharmaceutical Medicine, MD, PhD, MBA, CEO, CLARINESS Joined Clariness in 2019. >20 years of experience in CRO industry. Served as CEO, CMO and multiple other executive and senior roles. More than 20 years of experience in management and hands on supervision of numerous clinical trials in all major therapeutic areas across the globe, focus on Europe, North America and Asia-Pacific.
Bob Brindle, Venture Lead, Life Sciences, Cognizant
Bob began his career in Data Management and progressed to Head of Technology for Clinical Operations at AstraZeneca, gaining extensive expertise in clinical trial process and technology projects across a 20-year span. He now leads the development of Cognizant Protocol Creator, working with clinical trial leaders and protocol authors to simplify a complex and critical process and enable digital adoption in the life sciences industry. Bob earned a degree in Biochemistry from Cambridge University.
Lukasz Bojarski, Associate Director, Central Monitoring, AstraZeneca Pharmaceuticals, Inc.
Lukasz has received his PhD in biochemistry from Nencki Institute of Polish Academy of Sciences and after enjoying a career in academia he joined pharma industry in 2009. Initially he was involved in preclinical development programes at Celon Pharma SA, where he led several drug discovery projects in psychiatric and metabolic diseases. Some of these projects are now continued in clinical development phase.
Later on Lukasz transitioned to clinical monitoring roles at Quintiles Inc. (now IQVIA) and then at Covance to eventually join Centralized Monitoring Team at AstraZeneca in 2016. Now Lukasz is leading the Centralized Monitoring group, which guides study teams through study de-risking exercise and identification of areas that are critical to study quality. In study execution phase the team led by Lukasz performs continuous central monitoring of study data in search of risk signals at study, country and site levels.
Richard Butterworth, Senior Director, Alliance Management, Global Clinical Operations, Merck KGaA
For more than 25 years, Rich has worked in Life Sciences and Healthcare, building and leading teams in business development, operations, product and partnership management in the Pharma and CRO industry. Rich has spent the majority of his career creating new global partnerships, building and growing high-value businesses, encouraging and translating strategic vision into successful operational delivery and driving success through enhanced trust and confidence between partners.
Elspeth Carnan, Vice President Supplier Performance Management, Global Clinical Operations, EMD Serono
A global bio pharmaceutical industry executive with a PhD and a strong technical background in clinical operations, adept at driving strategic transformation of the clinical trial execution platform, with over 27 years of both domestic and international accountability. Intuitive leadership and communication skills in partnering with senior management teams on executing a focused alignment of strategic and tactical initiatives. Strategic problem solver with a demonstrated track record of proven clinical operational leadership grounded in lean sigma principles of innovation and operational effectiveness.
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.
Sinead Collinge, Industry Operations Manager, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre
Sinead Collinge is a Business Development Manager (Commercial) for the NIHR Clinical Research Network (CRN). Sinead facilitates key discussions between industry and the Clinical Research Network and is a point of contact for the life sciences companies engaging with the Clinical Research Network. Sinead is able to provide advice to companies on how they are able to tap into the Clinical Research Network study support services to ensure clinical studies are set up efficiently and recruit to time and target. With a degree in Biomedical Sciences, Sinead has been with the Clinical Research Network since 2015. Alongside her role within the Business Development and Marketing Team, Sinead works as an Industry Operations Manager. Sinead’s role is to establish and enable the implementation of the NIHR CRN Life Sciences and Business Development and Marketing Strategy at a local level within one of the Local Clinical Research Networks (LCRN). Sinead Collinge Business Development and Marketing Manager (commercial) Operational support through feasibility, set up and patient recruitment.
Larissa Comis, Product Lead, Shared Investigator Platform, Life Sciences Products & Platforms, Cognizant
Larissa drives adoption of the Shared Investigator Platform across the clinical ecosystem. With extensive experience in clinical trial informatics and technology, especially in oncology, Larissa led strategy and products for Medidata, Thompson Reuters, and Eviti (now NantHealth). She helped transform the Coalition of Cancer Cooperative Groups into a national leader in cancer-trial matching services and patient advocacy during her nine-year tenure. Larissa earned her Masters in Journalism from Temple University.
Matt Cooper, PhD, Director, Business Development & Marketing, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre
The National Institute for Health Research Clinical Research Network is the research delivery arm of the NHS. It invests some £300m each year into an infrastructure of specially-trained clinical research professionals across England, to support rapid study set-up and patient identification/recruitment into clinical research studies, academic and commercial. In recent years, the Network has placed a particular focus on its support for the commercial life-sciences industry, which has resulted in year-on-year improvements in patient recruitment numbers and delivery times for industry studies. In 2017/18 the NIHR CRN supported the recruitment of over 725,000 participants into clinical research studies, 50,112 of these were patients recruited into commercial contract clinical trials. As the Business Development & Marketing Director at the Clinical Research Network Coordinating Centre since 2014 Matt brings a wealth of experience to the post, having been part of the Network structure for many years. More recently Matt has also taken on the responsibility for the Research Delivery Directorate at the Coordinating Centre. In a previous role he was a member of the leadership team for the Network’s Cancer Specialty and before that worked in the Clinical Research Group of AstraZeneca for a number of years.
Nurcan Coskun, Ph.D., 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.
Anthony Costello, Vice President, Mobile Health, Medidata
Anthony Costello is Vice President of Mobile Health at Medidata. After beginning his career at Genentech, he has gone on to co-found several clinical trials technology start-up companies. Over his career, Anthony has focused on disruptive and innovative technology that can simplify clinical trials for patients, sites, and sponsors. He is a frequent author and presenter on topics related to the efficient use of technology in clinical research.
Jessica Cordes, Head, Clinical Operations, Medigene AG
Jessica Cordes studied Molecular Life Science in Luebeck and started her business career for 2 years at the Central Lab MDS Pharma Services as project manager. She moved then to GlaxoSmithKline where she worked as country project leader for 4 years. In 2013, she moved to MorphoSys, working for four years in an international role as clinical trial leader. 2017 she moved to Medigene headquarter as clinical trial manager and is now leading the Clinical Operations group since 2018.
Jonathan Crowther, PhD, Site Intelligence Lead, Study Optimization, Global Product Development, Pfizer Inc.
As a Site Intelligence Lead based in Brussels, Belgium, Jonathan plays a role in developing country and site strategies across Pfizer's clinical research portfolio and provides functional support to the Site Intelligence & Selection team in data analytics, data management and continuous improvement activities. Jonathan’s interests lie in leveraging internal and external datasets to provide data driven approaches to clinical research strategies and deliver better medicines to patients. Jonathan holds a BSc in Biopharmaceutical Science from Dundalk Institute of Technology, an MSc in Bioinformatics from Dublin City University and a PhD from KU Leuven.
Matt Cooper, PhD, Director, Business Development & Marketing, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre
The National Institute for Health Research Clinical Research Network is the research delivery arm of the NHS. It invests some £300m each year into an infrastructure of specially-trained clinical research professionals across England, to support rapid study set-up and patient identification/recruitment into clinical research studies, academic and commercial. In recent years, the Network has placed a focus on its support for the commercial life-sciences industry, which has resulted in year-on-year improvements in patient recruitment numbers and delivery times for industry studies. In 2017/18 the NIHR CRN supported the recruitment of over 725,000 participants into clinical research studies, 50,112 of these were patients recruited into commercial contract clinical trials. As the Business Development & Marketing Director at the Clinical Research Network Coordinating Centre since 2014 Matt brings a wealth of experience to the post, having been part of the Network structure for many years. More recently Matt has also taken on the responsibility for the Research Delivery Directorate at the Coordinating Centre. In a previous role he was a member of the leadership team for the Network’s Cancer Specialty and before that worked in the Clinical Research Group of AstraZeneca for several years.
Esteban Czwan, Senior Vice President, Clinical Trials Business Area, SOPHiA GENETICS
Before joining SOPHiA GENETICS in 2015, Esteban Czwan worked for Roche Diagnostics where he was responsible for next-generation sequencing support and third-party analytical solutions. Esteban did his doctoral work at the German Cancer Research Center in Heidelberg developing predictive models of tumor progression and therapy response. Esteban obtained his master’s degree in Bioinformatics from Cardiff University and his bachelor’s degree in Computer Science from the University of Illinois at Springfield.
Ronald Dorenbos, PhD, Associate Director, Materials and Innovation, Takeda Pharmaceuticals
Ronald is Associate Director at Takeda’s Materials & Innovation team and part of the digital strategy group for neuroscience. During his appointment at the Life Science division of PA Consulting Group, a British Consulting firm, he led projects for some of the world’s top 10 pharmaceutical companies around strategy, commercialization and digital health. At his company BioFrontline he provides management, strategy and commercial advice to life science companies around the world. Ronald received MAs in Biotechnology and Molecular Biology and after obtaining a PhD in Pharmaceutical Biology spent six years at Harvard to study Parkinson’s, Schizophrenia and the genetics of aggressive behavior before making the transition to industry. Ronald is a keen follower of developments in the field of Artificial Intelligence (AI) and regularly invited as speaker to present on topics related to pharma, healthcare and AI.
Jennifer Duff, Global Life Sciences Operations Lead, Accenture
Managing Director and Global Lead for Accenture Life Sciences Operations practice. Jennifer has over 20 years of experience in the life sciences industry and over 15 years of experience in business process outsourcing. She is responsible for shaping the innovation agenda at our most strategic clients, and works extensively in the delivery of Clinical Data Management Services.
Chibby Ebhogiaye, Head, Feasibility Services, Solution Adoption Center, IQVIA
Chibby Ebhogiaye is the Head of Feasibility Services for IQVIA Clinical Technologies with a focus on delivering technology enabled services for site identification, site feasibility and selection, contract management and budget negotiation. Chibby is passionate about driving innovation through the delivery of effective and efficient solutions to make a difference in the conduct of clinical trials.
Mark Evans, Managing Director, Havas Lynx Faze
https://www.linkedin.com/in/evansmark/
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.
Anthony Fuller, Global Head, Sourcing, Mitsubishi Tanabe
He is based at their New Jersey office. Prior to joining Mitsubishi, Anthony worked at Eli Lilly and Bristol-Myers Squibb, following some years spent on the supplier side. In his tenure with Mitsubishi, Anthony has developed what was a largely administrative vendor management department into a strategic function supporting end to end sourcing activities. He re-organized the US team on a category basis and focused their work on high-touch, high value projects. More recently, Anthony was asked to create a global Sourcing function for Mitsubishi, aligning people and processes worldwide. Anthony is a graduate of the Universities of Oxford, Sheffield and Northumbria, with postgraduate studies in business, politics and commercial law. He holds Six Sigma Greenbelt certification, CPSM from the Institute for Supply Management, and MCIPS. He lives with his family near Princeton, New Jersey.
Agustín Gómez de la Cámara, MD, PhD, Professor, Department of Medicine, Hospital 12 de Octubre
Agustín Gómez de la Cámara MD, PhD, Senior Scientist; acamara@h12o.es Head of the Central Unit of Clinical Research and Clinical Trials. Biomedical Research Institute Hospital 12 de Octubre. Madrid. Spain; Associated Proffesor and Director PhD teaching program on Biomedicine Research. Universidad Complutense Madrid. Coordinator of the Methodology Department of the Spanish Clinical Research Network and Senior Researcher of the Biomedical Network Consortium of Epidemiology and Public Health. Health Policy and Interventions Evaluation Area. CIBERESP. Carlos III National Research Institute. Ministry of Science and Innovation. Principal investigator of a large body of research projects, including EHD2DC and InSite projects, and Science Citation Index included author articles. RG Score 40.99; h-index 28. His professional activity focuses in Biomedical research teaching and clinical research (clinical trials), epidemiological field (Predictive models, RWD prevalent chronic diseases) and in the permanent promotion and development of scientific knowledge R&D&I, in the clinical rounds.
Shaleen (Sheli) Gupta, President, EMEA Operations, Hu-manity
Sheli relocated to the UK from NJ, USA in the Summer of 2018 to establish and run the EMEA (Europe, Middle East & Africa) operations of Hu-manity.co, the company championing the 31st Human Right for individuals to own their data as property. To date, his most successful venture has been Software Associates International (SAI), which Sheli co-founded in 1994 as a 2 person basement-based consulting firm growing it to a highly successful 180 person sales and marketing software company servicing the US Pharmaceutical Industry, including major clients such as Johnson & Johnson, Roche, Abbott Labs, and Eli Lilly.
Other ventures have included Semantelli, a social media monitoring company, using proprietary healthcare focused software, which was acquired by a global healthcare company. Sheli was born in Nairobi, Kenya and has travelled extensively as a result of his passion for travel and exploring new cultures. He enjoys golf, is fluent in English & Punjabi, and a little rusty in French, Spanish & Swahili! He completed his secondary education as a boarding student at Kimbolton School, Cambridgeshire UK, followed by his B.Sc. in Computer & Electronic Engineering at King’s College, University of London. He is now based in Kimbolton, England.
Valentin Hamy, PhD, Data Analytics Leader, Digital Biomarkers, GSK Associate Fellow, Biostatistics, R&D, GlaxoSmithKline
Valentin works as data analytics leader in digital biomarkers within the biostatistics group in GSK R&D. As such, he is responsible for the development and integration of analysis solutions, including machine learning models, specific to complex data acquired using different types of sensor technologies (e.g. accelerometers, imaging) and devices (e.g. wearables, mobile phones). His work covers applications across a number of therapeutic areas such as immuno-inflammatory, neuroscience or respiratory, focusing on the derivation of meaningful and clinically relevant parameters to design novel endpoints based on innovative technologies. Before joining GSK, Valentin worked in academic research and completed a PhD in medical image computing at University College London. His area of interest was motion correction in Magnetic Resonance Imaging time-series data.
Bert Hartog, PhD, Senior Director, Clinical Innovation, Janssen Pharmaceutica N.V.
Bert is an experienced Senior Director and Innovation Leader. He leads transformational innovation projects that have the goal to shape the future of clinical trial execution, and position Janssen as a role model in patient-centered clinical research. Bert is an industry expert in Global Clinical Operations and Digital Health. He graduated in Biomedicine and obtained a PhD in Medicine from Utrecht University. He worked in Clinical Operations-, QA- and IT-management before joining Janssen’s Clinical Innovation team in 2015. His main focus today is developing capabilities for digital health in clinical trials, including digital outcome measures and technologies for remote patient monitoring.
Ana Herradon, Associate Director, Site Monitoring Manager and Regional Clinical Operations, Iberia, Bristol-Myers Squibb
https://www.linkedin.com/in/ana-herrad%C3%B3n-v%C3%ADrseda-b981a126/
Greg Hersch, PhD, Head, Innovation, Global Development Operation, Novartis
https://www.linkedin.com/in/greg-hersch-2250a91a/
Teresa Hines, Associate Director, Clinical Management, Otsuka Pharmaceutical Development & Commercialization
Teresa Hines is an Associate Director within the Clinical Management Department at Otsuka Pharmaceutical Development Corporation, Inc. (OPDC). In this role, she acts as a strategic alliance manager for several of OPDCs CROs and drives the integration of emerging technologies into day to day operations. Teresa has nearly 20 years of experience in the pharmaceutical industry, and before joining OPDC nearly 7 years ago, has worked previously at Novartis, Wyeth and Pfizer. She holds a Bachelor’s degree in Environmental Science from the Pennsylvania State University.
Keir Hodge, Global Studies Leader, Global Clinical Operations, Hoffman La Roche
An experienced clinical trial professional, Keir has been working for Hoffman La Roche for the last 15 years with expertise in clinical trial databases and for the last 7 years as a leader of late stage global clinical trials in clinical operations. Keir joined the Transcelerate initiative ‘’Clinical Research Access’’ three years ago to support in closing the gap between the willingness of the public to participate in clinical research and the limited clinical trial information available to the public on platforms such as clinical trial registries.
Daoying Hu, MBA, PhD, Associate Director, Strategic Feasibility, UCB BioSciences
Daoying 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.
Adama Ibrahim, Associate Director, Clinical Operations, Biogen
An innovation, multi award-winning Clinical Operations and Consulting Expert with extensive experience and skills gained from international global assignments. A blockchain advocate and patient engagement thought leader with over 17 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 and DIA Patient Engagement Voluntary Community Leadership. Far-reaching and varied knowledge across a broad range of Phase I, II, III and IV trials including Immunology, Neurology, IBD, Rare Disease and Gene Therapy. Experience across creation and execution of successful strategies for trials protocols and CRO oversight, patient and site feasibility, technologies such as eCOA and IVRS, optimal drug packaging and administration concepts, mapping the patient journey, planning and executing effective global site and patient engagement campaigns using direct to patient methods, leading and coaching remote and complex global teams. Founder of a non-profit called Emerging Markets Quality Trials (EMQT) that aims to advance technology enabled clinical trials using AI and blockchain in emerging markets.
Paul Michael Johnson, MSHS, MBA Candidate, Director Global Clinical Operations, Kiniksa Pharmaceuticals
Paul Michael Johnson has 20 years of proven success in bio-pharmaceutical corporate leadership, including product development, operations and corporate development. He joined Amgen in 2006 where he led efforts to design process and deploy the company’s global inaugural risk-based model and RBM technology tool, Spotfire. During his tenure at Amgen he drove site issue escalation, design of RBM data level review and important protocol deviation initiatives aimed at optimization of operations. In 2016 he moved into the biopharma startup arena where he utilizes his expertise to direct the design and buildout of process and technology platforms which optimize clinical research performance and quality. Paul is a veteran Naval and Marine Corps combat medic, and his education includes: a Masters in Leadership and Management from George Washington University, a post-graduate certificate in clinical research design and management from University of California San Diego, and he is currently attending Kenan-Flagler School of Business in a global immersion MBA program. Paul is also an Airline Transport Pilot. His passion for flying allows him to share a unique multidimensional and interdisciplinary perspective to directing and maintaining oversight of clinical research programs.
Koen Kas, MD, Founder & CEO, Healthskouts; Partner, HealthStartup.eu
Koen Kas is a healthcare futurist, entrepreneur, professor of molecular oncology, acclaimed international keynote speaker, and author of Sick No More and Your Guide to Delight. He is founding CEO of HealthSkouts and partner at HealthStartup.eu, a social network of novel health start-ups. His team combines real world data, collected via biomarker and sensor measurements, with design and business model innovations into novel, delightful experiences redefining health, helping shape a new breed of digital health companies. Kas is a professor of oncology at Ghent University in Belgium, and chairs the scientific committee of the European Cancer Prevention Organization. He is an ambassador for Health House. He serves on the advisory board of seven pioneering healthcare companies and a digital health investor. He is a juror of the Prix Galien. He is an editor of the mHealth journal and the European Journal of Cancer Prevention. Kas was CSO Oncology at Thrombogenics, where he spun out Oncurious, testing a novel drug for pediatric brain cancer. Before this, he was founder and CSO of Pronota, building a protein biomarker discovery platform and pipeline of four diagnostic programs. Prior to that, he was the director of drug discovery at Galapagos. Previously he set up and directed the cancer drug discovery program at Tibotec (now Johnson & Johnson). He started his career elucidating the molecular basis of two types of cancers.
Marcy Kravet, Head, Operational Design Center (ODC), Global Clinical Operations, Merck KGaA
Marcy has been in the pharma industry for more than 20 years. She has honed her operational expertise through roles in Pharmaceutical Sales, Clinical Research Site operations, Sponsor Global Clinical Operations, Medical Affairs Scientific Publications, and Early Clinical Development operations. Throughout her career, Marcy has had multiple opportunities to craft new roles and build new organizations aimed at streamlining and simplifying operations in order to better serve patients. Marcy joined EMD Serono (Merck KGaA) in October 2018 and is building out the Operational Design Center within Global Clinical Operations. This capability will provide operational design scenarios for the organization to make decisions based on data and ultimately make our clinical trials accessible to more patients. Marcy has an MBA from DePaul University and a BS in Marketing from the University of Connecticut.
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Andy Lawton was most recently at Boehringer-Ingelheim for 28 years ago. 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.
Jeff Lee, President, eCOA and Patient Engagement, CRF Bracket
Jeff joined CRF Bracket in 2017, following the acquisition of his company, mProve Health, which he founded in 2010. As CEO of mProve Health, a leading provider of mobile technologies for patient recruitment, engagement, and data collection in clinical research studies, Jeff grew the company globally. Today, its applications are used by 18 of the top 20 pharmaceutical companies, 15,000 clinical research sites in over 60 countries, and they are translated in over 50 languages.
Tine Lewi, PhD, MBA, Scientific Director, Janssen R&D/Clinical Innovation
Tine has led projects in the area of (real world) data and insight generation for healthcare over the past 15 years. She has worked for several years in the area of solution development and has a strong interest in novel trial designs and methods to optimize trials, such as virtual or remote trials. She is actively involved in developing new data science capabilities for lifesciences R&D and has a passion for disease interception and the initiatives around “a world without diseases“. Tine has a background in medical informatics and applied economics. She completed a PhD on patient insights and health communication for disease prevention.
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.
Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine
Marina Malikova, Ph.D., MSci, MA, CCRA, RAC Executive Director, Surgical Translational Research: Operations and Compliance. Dr. Malikova has over 14 years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology. Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration. She also holds a master’s degree in Clinical Investigation, Certification in Project Management from Boston University and board certified in Regulatory Affairs (RAC). In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, strategic planning, and macro-management of research programs. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.
Denis McMillan, Vice President, Solutions Consulting – CROps, Strategic Feasibility, Parexel
https://uk.linkedin.com/in/denis-mcmillan-5b9bba78
Janet Munro, General Manager Digital Endpoints, Data and Digital – GDD, Novartis
https://www.linkedin.com/in/janet-munro-79017918/
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).
Amy Neubauer, Director, Data Quality Oversight, Alkermes, Inc.
https://www.linkedin.com/in/amy-neubauer-86a3858
Nicole Noyens, Director, Janssen Clinical Innovation, Janssen at J&J
Nicole Noyens is a Director of the Clinical Innovation department at Janssen. She has more than 30 years of experience in pharmaceutical companies, where she held various leading positions in IT, data management, portfolio and budget management, and change organisational management. Since 2017, Nicole joined the Janssen Clinical Innovation team to apply her expertise in information technology, project management and change leadership to deliver transformational innovation projects that will shape the future of clinical development operations at Janssen. In her current role, Nicole is leading several workstreams in the transformational Integrated Smart Trial and Engagement Program (iSTEP). This program is using disruptive partnerships (technology, software, partners) and is looking at impact of personalized patient engagement and automated real-time data collection on patients, sites and company via smart phones, smart blisters and scanning devices Nicole obtained a Masters in Mathematics from Leuven University.
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.
Raj Pallapothu, mHealth Global Business Lead, Bayer Pharmaceuticals; mHealth Global Advocate
Raj Pallapothu is Global Business Lead for mHealth Connected Platform at Bayer Pharma USA. He has responsibility in designing, developing and commercialize world’s first data source agnostic mHealth ecosystem in supporting next generation Clinical trials whilst setting up transformative business processes, compliance framework – by leveraging advanced Platform technologies, Data Science & Analytic tools. Raj is a trained Medical Doctor from Australia & Health Care Entrepreneur with close to 2 decades of experience in Strategies & Partnerships, Technologies and Product Management. Prior joining Bayer, he had the pleasure of working with tens of Global Enterprises in the space of Consumer Health Care, Device manufacturing, Precision Health, Tele-Medicine, Wireless technology firms along with Startup’s and Venture Capitalist firms. Raj visited 5000+ Hospitals & Specialty Clinics in various countries like USA, Canada, Brazil, Kenya, South Africa, India, China, Taiwan, South Korea, Singapore, UK, France, Germany, Switzerland, Australia etc, and participated in multiple international Government’s led missions.
Mishal Patel, PhD, Head of Health Informatics, AstraZeneca
Mishal read Chemistry and then specialized in Computational Chemistry during his PhD, where he utilized advanced computing and modelling techniques to investigate protein dynamics. After a brief sabbatical in investment banking, Mishal returned to research at the Institute of Cancer Research, in the Computational Biology and Chemogenomic group before moving to the clinical world at the Royal Surrey County Hospital pioneering application of AI to breast mammographic images to modernise breast screening. Currently Mishal works as head of Health Informatics at AstraZeneca, where his team focus is better leverage Real world data to aid better decision making in drug development.
Marc Philipp, MBA, Partner, Managing Director, Pharma & Life Sciences, Accenture GmbH
Marc is a Partner/ Managing Director at Accenture Strategy out of the Berlin office and leads the firm’s Biopharma R&D Strategy Consulting Practice in Europe. Marc advises senior executives across Drug Research and Development with a focus on strategy optimization and competitive agility, growth through innovation, data & analytics-powered operating model transformation and productivity improvement. Besides his advisory experience, he brings hands-on experience from work in Clinical Drug Development as the head of R&D Operations at CHARITÉ BERLIN, a leading European Academic Clinical Research Center. Marc holds an MBA in Corporate Finance from international studies in Germany, Singapore and California as well as a Master in Pharma Intellectual Property, Patent and Antitrust Law from studies in Germany and Washington D.C.
Anja Pietsch-Ottinger, Resource Manager, Bayer AG, Clinical Operations
Anja Pietsch-Ottinger is Resource Manager in Clinical Operations.
In this role Anja focuses on the planning of internal and external FTE resources for the clinical functions. She is responsible for driving the continued development of the Resource Estimation Tool keeping it in line with an ever-changing environment for clinical studies. She also provides direct support to the clinical functions, be it FTE reporting, analysis as well as financial management.
Anja joined Bayer in 2006.
Mariya Pinskaya, Principal Consultant, Areva Consulting
https://www.linkedin.com/in/mariya-pinskaya-85558910/
Gareth Powell, Business Operations, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre
Gareth Powell is a Business Development Officer for the NIHR Clinical Research Network (CRN). Gareth facilitates key discussions between industry and the Clinical Research Network and is a point of contact for the life sciences companies engaging with the Clinical Research Network. Gareth is able to provide advice to companies on how they are able to tap into the Clinical Research Network study support services to ensure clinical studies are set up efficiently and recruit to time and target. Gareth has been with the Clinical Research Network since 2009. Before joining the Business Development and Marketing Team, Gareth previously worked within the Research Delivery Directorate of the Clinical Research Network. He was responsible for supporting interactions between the life sciences industry and NIHR National Specialty Groups across 7 therapeutic areas, providing operational support through feasibility, set up and patient recruitment.
Céline Quix, Site Manager, Clinical Innovation, Global Clinicical Operations, Janssen R&D
Céline Quix is a Site Manager and specializes in using the RWD/EHR platforms for site identification and eChart review. Céline brings along 5 years of experience in global clinical operations where she was working as a site manager monitoring clinical trials in oncology and hematology in several hospitals across Belgium and the Netherlands. She has joined The Hospital Network team within Janssen Clinical Innovation in October 2018 to 1) Support RWD platform awareness and participate in cross sponsor pre-competitive collaborations to enhance clinical research, and 2) Enhance the Hospital Network for the EHR/RWD platforms by improving site experiences and reporting on value cases. She has a MSc in Biochemistry and Biotechnology.
Camilla Ramdeen, PhD, Director, Strategic Feasibility, Integrated Solutions, PAREXEL International
Camilla Ramdeen PhD, Director, Strategic Feasibility, has led the global Strategic Feasibility team at PAREXEL since 2015 and has 12 years of CRO-based clinical research experience in Feasibility and strategy, Study Start Up leadership, Project Management, Investigator relationships and patient recruitment roles. Prior to joining the industry, she worked as an oncology Dietitian and academic researcher at the Royal Marsden Hospital in London.
Thorsten Ruppert, MD, Senior Manager, Research, Development and Innovation, Association of Research-Based Pharmaceutical Companies (vfa)
Dr. Thorsten Ruppert is senior manager for research, development and innovation in the Association of Research-Based Pharmaceutical Companies - vfa. In 1999 he received a doctorate in biochemistry at the Free University in Berlin. Also in 1999 he joined NOXXON Pharma AG as a scientist in the Department of Research & Development. From there he moved internally in the clinical research department and in 2002 he became Director of Scientific Marketing, Division of Business Development. In 2004 he joined the vfa, where as Senior Manager Research, Development & Innovation he is responsible for a clinical trials, personalized medicine and biobanking
Bettina Ryll, MD, PhD, Founder, Melanoma Patient Network Europe
Dr. Ryll holds a medical degree from the Free University of Berlin, Germany, and a PhD in Biomedical Sciences from University College London, UK. After losing her husband to Melanoma, she founded the Melanoma Patient Network Europe and developed a special interest in patient-centric clinical research, innovative trial designs and novel drug development concepts, such as MAPPS (medicines' adaptive pathways to patients). Lately, she focuses on patient-relevant outcomes and sustainable healthcare models ensuring access to innovation for patients. Dr. Ryll is involved in numerous initiatives promoting evidence-based advocacy. She is fascinated by the enormous potential and capacity of patient networks to both educate and support patients as well as to capture data at the primary data source, the patients themselves, to generate evidence at a granularity level non-accessible to outsiders. Between 2015 and 2018, Dr. Ryll chaired the ESMO-PAWG, the first time this position was held by a non-oncologist and was instrumental behind the development of the advocacy track at annual ESMO conferences.
Marco Salami, Head, Clinical Outsourcing, Chiesi
Marco has over 20 years of experience in outsourcing, clinical operations and line management in the pharma industry and CROs. He is currently holding a position with Chiesi Farmaceutici as Head of Clinical Outsourcing with responsibility over Corporate Phase I-IV Clinical Trials.
Sara Sandbach, PhD, Director, Clinical Operations, MedImmune
https://www.linkedin.com/in/sara-sandbach-b174291b/
Andreas Sashegyi, PhD, Senior Research Advisor, Biometrics, Eli Lilly and Company
Andreas Sashegyi obtained a PhD in Biostatistics from the University of Waterloo in Canada in 1998, and joined Eli Lilly and Company later that year. Over his two decades with Lilly he has held various positions across numerous therapeutic areas, focusing on late-stage development of compounds within the endocrine, cardiovascular, auto-immune and oncology spaces. He also spent six years as an advisor of Lilly’s Decision Sciences group, consulting within R&D on major investment and portfolio management decisions. Dr. Sashegyi is currently senior research advisor and therapeutic area lead for statistics, for Lilly Oncology.
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.
Claire Sears, Director, Product Communications, IQVIA Technologies
Claire Sears joined (IQVIA Technologies) DrugDev early in 2013, where she is currently Director, Product Communications for the Data Solutions team, leading communications and training activities for the TransCelerate Investigator Registry, and for Investigator Databank. With a background in academia and a PhD in Cardiovascular Physiology, Claire also leads the thought leadership program for Data Solutions. Based in the UK, before joining DrugDev, Claire spent 8 years at AstraZeneca in medical affairs.
Oriol Serra, MBA, Head of Site Intelligence & Site Selection, Study Optimization, Global Product Development, Pfizer Inc.
As functional Head for Site Intelligence & Site Selection based in La Jolla, CA. Oriol provides leadership, strategic direction and oversight to effectively deliver country & site feasibility globally. Oriol´s main interest is shifting the paradigm in the Feasibility & Design Optimization of clinical programs to accelerate the development of innovative drugs for patients in need. 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.
Bella Sessoms, MPH, Director, Portfolio Sourcing Management, Portfolio Sourcing and Relationship Management, Astellas Pharma Global Development
Bella Sessoms is the Director of Portfolio Sourcing Management at Astellas Pharma Development, where she leads the sourcing and contracting activities for the Development organization. Prior to joining Astellas, Bella spent more than 15 years in various roles within the healthcare industry. The last ten years were in roles of increasing responsibility at a global Contact Research Organization. Over her career, Bella has had the opportunity to collaborate on a global basis with CROs, biotech companies and some of the largest pharmaceutical companies.
Venkat Sethuraman, Associate Principal, ZS
https://www.linkedin.com/in/venkat-sethuraman-695251b/
Nadia Sissani, Director, Global Key Accounts, Commercial Operations, Marken LLP
https://www.linkedin.com/in/nadia-sissani-01670a151/
Fabian Somers, Senior Clinical Program Director, UCBNarinder Chopra, Director, Feasibility, Enrollment & Retention Optimisation, Global Clinical Operations, Biogen
https://www.linkedin.com/in/fabiansomers/
Catherine Stewart, PhD, PMP, Executive Director, Clinical Sciences, Protocol Deviations, Pfizer
Catherine is a PhD and PMP-accredited drug development professional, with 25 years broad-ranging big pharma experience. In her current role, she is responsible for the line management of Clinical Scientists, and associated clinical process improvements at Pfizer. She is currently the Business Process Owner for Protocol Deviations, and is proud to be co-lead of the TransCelerate PD Initiative. She has previously worked as a clinical project director (10 years) and as a study clinician (10 years), and has participated in two successful regulatory submissions.
Mark Summers, President, Patient Engagement, WCG
https://www.linkedin.com/in/mark-summers-a89208/
Yiwen Sun, Associate Manager, Clinical Risk Management at Samumed, LLC
Yiwen started her professional journey in clinical research just as the industry was adapting to a risk-based approach to trial management. She has the unique experience of growing alongside RBM and is an advocate for its adoption at Samumed. Over the past 2 years, Yiwen actively participated in this transition and gained first-hand experience evolving from a traditional CRA into a central monitor. She is an integral part of the RBM team that continues to lead the company towards its risk-based trial management goals. Yiwen graduated from UCSD as a Bioengineer in 2011 and has been with Samumed since 2013.
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.
Marija Todorovic, Hospital Engagement Lead/RWD, Clinical Innovation, Global Clinical Operations, Janssen R&D
Marija Todorovic (mtodorov@its.jnj.com), MSc Pharm, is Hospital Engagement Lead/RWD at Janssen R&D Clinical Innovation. Marija holds a MSc Pharm degree from Pharmacy Faculty in Belgrade, Serbia and she has also specialized in Pharmacoeconomics and Pharmaceutical Legislation. She is currently finishing her PhD in Pharmacology. Marija brings along over 13 years of experience in clinical research operations, and for the last 8 years she was responsible for the global coordination of clinical trial management activities within Janssen. She was involved in several strategic enterprise-wide initiatives and served as subject matter expert evaluating novel technology solutions to support site selection and site activation. She co-leads the work package on hospital engagement within the eIT funded EHR2EDC project.
Ryanne van Huijkelom, Manager, Risk Management-Central Monitoring, Janssen
Ryanne has over 20 years of experience in the pharmaceutical and medical devices industries at Johnson & Johnson in Risk-Based monitoring, trial management, monitoring and sales consulting. She became fully dedicated to Risk-Based Monitoring in 2015 when she joined Janssen’s Risk Management - Central Monitoring department, where she currently is deployed as a manager. Ryanne has been involved in the development of RBM methodology for Early Development & Clinical Pharmacology studies, has led late phase Oncology study teams in the implementation of RBM and most recently is now involved in the implementation of RBM for J&J Consumer Self-Care clinical studies.
Michael Walega, MS, Head, Centralized Monitoring, Global Data Management and Centralized Monitoring, Bristol-Myers Squibb
Michael Walega is Head of Centralized Monitoring at BMS. In this capacity, he is responsible for providing protocol teams with actionable insights to achieve higher quality, ensure that monitoring processes are aligned to ICH E6 (R2), and champion risk-based approaches to monitoring clinical trials. He was previously at Covance, where he led the team responsible for development and growth of Covance’s Risk-Based Monitoring (RBM) solutions, processes, and operational delivery. Additionally, he also led the Late Stage Biostatistics and Programming groups and the Process Excellence team. Mr. Walega is a qualified Biostatistician and a Six Sigma Master Black Belt.
Rikke Winther, Independent Outsourcing Professional
Rikke Winther has more than 20 years’ experience in R&D outsourcing experience across both Pharma and CROs and has a broad experience of working in a variety of roles related to outsourcing of drug development activities – with particular interest and 20+ years of specialty in clinical outsourcing she has for the last 5 years been a steering committee member of PCMG (Pharmaceutical Contract Management Group).
Marion Wolfs, Director, Risk Management-Central Monitoring, Janssen
Marion Wolfs is Director, Risk Management-Central Monitoring (RM-CM) within the Integrated Data Analytics and Reporting (IDAR) organization from Janssen Pharmaceutical Companies of JnJ. In this role she is responsible for the oversight, execution, and management of the Analytical Risk-Based Monitoring (ARBM) processes at Janssen. She also is the RBM CRO Engagement lead for TransCelerate. Marion joined the pharmaceutical industry in 2007 and worked in various clinical operations roles until joining the Risk Management-Central Monitoring Group in October 2014. Marion holds a Master of Science degree in Biomedical Sciences from the Maastricht University and an International Certificate in Enterprise Risk Management from IRM.
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.