2018 Faculty

With a 24-year career in contracting and business development, Wendy is Senior Director, Contracts & Compliance for Medinova Clinical Research with accountability for global contracting, group insurance and corporate compliance. Wendy works across network partners, Sponsors, CROs and vendors and is part of the team who assess new study opportunities from a value and risk perspective. She started her career in clinical research 13 years ago as a Study Project Manager before setting up and leading central global contract management functions for Site Management Organisations. Wendy is deeply passionate about recognising and promoting the value of investigator sites and patients as the two critical components of the clinical research supply chain.

Dr. Bergtholdt is managing partner and principal investigator at emovis GmbH, a dedicated research site, located in Berlin, Germany. Her study site is specialized in conducting clinical phase II and III in various indications. Since 2012 she and her staff are supporting home care visits in clinical trials in several European countries. Dr. Bergtholdt started studying medicine in 1987 at the Free University of Berlin, Germany and became MD in 1994. From 1994 – 2001 she used to work in different psychiatric wards as junior house officer, followed by a professorship for Social Psychiatry at the University of Applied Sciences Stendal. In 2001 she founded emovis GmbH and became CEO and PI of emovis.

Molecular Biologist by Training, Federica joins Pfizer Research and Development Unit in 1992 as a CRA at first. She then moved to positions of greater responsibility over the course of the years (local project manager, CRA Line manager, Vendor Manager, Head of Clinical Operations). In the last several years Federica was appointed Director of Clinical Site Management for a cluster of countries in the south-est Europe. In such a role she is in charge of the timely conduction of interventional clinical trials ensuring at the same time data quality and sites’ inspection readiness. Even if she stayed in Pfizer for all her career, Federica has become an expert in re-organisations, mergers and changes in operational models and different types of outsourcing models, as Pfizer is a very dynamic company in this sense.

​Brandusa Bittel is a Medical Doctor who graduated the University of Medicine and Pharmacy "Carol Davila” from Bucharest, Romania in 1998. After a few years of probation in the ICU specialty in 2003, she started working in the Clinical Research field as a CRA, then as a SCRA. Her employers were GSK and Pharm-Olam until 2008 when she became an entrepreneur, starting her first company in Clinical Research. Work experience: Clinical Project Manager specialized in phase I/explorative trials, GCP trainer and Junior CRA trainer. Scala Clinical Research was created by Brandusa Bittel in 2012 and became the most important Site Management Organization in Romania, running 3 sites (in both private and public health sectors), including a new clinical unit that will be dedicated to phase I and biosimilars/bioequivalence trials. Scala’s team is composed of highly skilled pharmacists as site coordinators and experienced Financial and Management directors.

​Dr. Borislav Borissov graduated medicine with distinction at the Higher Medical Institute - Sofia, Bulgaria in 1990 and until 1998 he worked as an assistant at the Department of Anaesthesiology and Intensive Care, the Medical Institute – Sofia. Specializes in University clinics in France and the UK. Results of his research work in these centers have been published in leading world publications. From 1998 to 2004 he was the director of the Bulgarian Drug Agency (BDA). Since 2004 he has been engaged in international consultancy in the field of drug regulation and health technology assessment. He runs an international medical center for clinical trials. He is a member of the International Society for Pharmacoeconomics, ISPOR since 1998. He holds PhD degree in Medicine (1997), Master's degrees in Business Administration (2002) and Medical Care & Health Management (2015) and DSc. (2018).

​Rachael Buck has over 15 years experience in the clinical trial industry with significant involvement of developing successful Programme Management teams as well as Patient Engagement teams in Site Management Organisations. She also has extensive experience in the CRO industry as a Global Site Relationship Manager and developing site networks. She currently works for Medinova research who are one of the world’s largest site networks putting quality and patients at the heart of clinical research.

​Following completion of a PhD in Cardiovascular Pharmacology at the University of Strathclyde, Steven worked as a Medical Writer before joining NHS Greater Glasgow and Clyde as a Research Co-ordinator. More recently, Steven was the NHS Research Scotland Industry Liaison Manager and worked to support the development of the commercial research portfolio across the NHS in Scotland. Steven has recently joined the Strategic Site Collaborations team at PPD and manages site relationships across the UK. Steven has experience in representing sites in Scotland at both national and international meetings and is a strong advocate for initiatives that streamline and simplify the research process for sites.

​Innovative life sciences and healthcare strategist with proven record of successfully launching new solutions to market globally. History of driving value for all stakeholders including pharmaceutical and biotechnology companies, CROs, physicians, payers, patients. Deep expertise in clinical trials solutions with a focus on oncology. Implemented strategies that have driven double-digit revenue growth year on year for multiple businesses.

​Michelle's early research career started in basic research in academia and then she transitioned to clinical research when she joined the Pharmaceutical Industry. She has worked for nearly 25 years in the industry being at Roche for the past 15 years. She has worked across a number of therapeutic areas and has been in Oncology for the last 7 years. She has extensive experience of delivering global studies across all phases of Clinical Trials whether they are in or outsourced and worked with a number of Alliances in the clinical setting. With the increasingly complexity of clinical trials, Michelle is very passionate about partnering with investigational sites to offer clinical trial options to patients.

Over 30 years experience in Research and Development at GSK of which over 25 were in Clinical Pharmacology Operations. Since January 2014, have been the leader of the Content sub-team of the Transcelerate Common Protocol Template (CPT). Still a core member of this team which is working on further improvements to the CPT to lay the foundations for downstream re-use of data into documents such as the Statistical Analysis Plan(SAP) and Clinical Study Report(CSR )as well as disclosure to agencies and potentially automated review tools.

Bill Byrom has worked in the Pharmaceutical Industry for 28 years. Combining practical experience of roles within clinical development with a keen interest in leveraging technology, Bill is a key strategic thinker helping to shape the direction and application of eClinical solutions. Bill is a thought leader in patient-facing technologies including electronic patient-reported outcome solutions, the use of wearables and connected devices, and new novel technology-derived endpoints.

Assist in country & site selection process by working alongside study teams and site intelligence specialists. Identification, acquisition and analysis of internal & external intelligence sources to provide optimized country and site feasibility. Enhancing data driven decision making to meet the organizational goals and objectives. SME for public data trial intelligence tools and data.

​Professor Edward Czerwinski is the founder and head of Krakow Medical Centre since 1996. He has supervised 118 trials being PI in 31. Professor of Jagiellonian University, member of 10 boards of scientific international magazines, member of 21 societies, organizer of 21 congresses in Poland. 502 publications, Impact Factor of 191.

Nikki holds an honours degree in Human Biology. She started her Clinical Research career in 1994 as a PASS CRA with Sandoz. She then joined Pharmacia which later became Pfizer. She has enjoyed a variety of roles with ever increasing responsibility from CRA through Project Manager, Programme Manager, Monitoring Manager, Head of Monitoring UK, Director of Clinical Site Management for UK, and Ireland to her most recent position of Process and Standards Lead.

Diane started her career as a pharmacologist at Smith Kline & French, before switching to Clinical Development in a CRO in 1988. She then spent 12 years taking roles of increasing responsibility and geographical scope, before moving to Pharma in 2000. During her time at UCB she has led global clinical development programs, set up and managed a global in-house monitoring team, as well as spending 3 years outside clinical operations in the strategic role of Global Project Leader leading global cross functional teams to develop new drug candidates from research to clinical POC. In 2014 she returned to Clinical Operations to head up UCB’s Outsourcing Contracts & Strategic Partnering department, where she was responsible for continuing to develop and implement the global clinical outsourcing strategy and the management /oversight of UCB’s Strategic Partnering relationships. In July this year she was appointed Head of Program Delivery, where she provides expertise and leadership of a team to drive &
oversee clinical studies from study concept to submission, and is also accountable
for the provision of strategic and on-site feasibility assessments In addition, Diane also represents UCB on the Integrated Leadership Team of TransCelerate.

Brian is currently managing Global Engagement for TransCelerate BioPharma – leading efforts to engage both global membership and industry stakeholders to raise awareness of TransCelerate and its solutions. Brian began his career as a communications professional more than a decade ago, working within a hospital system to lead marketing and communications efforts for new practices, treatments, and physicians within the hospital. Since then, Brian has a proven record of success in the design and hands-on management of brand marketing, employee relations, and public relations campaigns across varying industries with a focus on patient-oriented health care. Brian brings his strong background and proven abilities to all professional challenges and has been commended for his ability to collaborate with key partners.

Sylvia has long-term pharmaceutical industry experience and expertise. She focuses on conducting clinical studies in various positions with proven team management and project management skills in an international working environment. She is a business leader in a project developing a new process setup and infrastructure for data review after data entry as the interface between business requirements and technical/process implementation.

Annabel Elliott is a Senior Director of Quality for the MeDiNova group where she has accountability for compliance across the global organisation including the quality management system, operational compliance team, internal audit programme and management of client audits and regulatory inspections. Initially training as a microbiologist within a pharmaceutical manufacturing business, Annabel moved on to various quality management roles within other organisations and now has over 30 years’ experience within the pharmaceutical industry both in GMP and GCP functions. For the last 15 years Annabel has worked within the clinical research sector gaining significant experience particularly within site management organisations, most recently at MeDiNova where she is supporting its strategic plans for international growth with the implementation of the highest quality standards.

Zsolt graduated as an MD from Semmelweis University Budapest Hungary in 1992. Employed by the same
University Medical School as a Lecturer, his main duties included teaching undergraduate and graduate
students as well as medical research activities. PhD degree in Clinical Sciences was obtained in 2003.
Joined PPD as a CRA and has filled various CRA and Manager positions since 2004. Zsolt has been
working for Acurian a PPD Company since 2015, supporting their central recruitment and retention
campaigns in the EMEA region.

Marie Emms has 20 years of experience in healthcare communications, spanning PR, medical education and clinical trial recruitment support. She has spent the past 15 years focused solely in patient recruitment, supporting pharma, biotech and CRO clients. She specializes in the development and execution of strategic integrated communications programs to support sites and their patients through the clinical trial journey, from initial awareness, consent through to compliance and adherence. Marie has worked on a wide variety of therapeutic areas across neonatal, pediatric, adult and geriatric studies.

Matyas Faluvegi is an Internal Medicine Specialist and Clinical Pharmacologist. He has been in the pharmaceutical industry since 2004, worked as Consulting Medical Director of Synexus Hungary between 2010- 2012. Mátyás joined AstraZeneca Sweden as Patient Safety Physician in 2014. After his secondment as Country Head SMM Nordics, currently he is the Country Head of SMM Hungary.

Nora Farkasova has more than 17 years of experience in the pharmaceutical industry and has held various roles in Clinical Operations and Quality Assurance within Pfizer and GSK. Since 2012 Nora has worked at the position of senior Investigator Site Development & Support Lead, since 2016 as the Director of Clinical Site Management for Hungary / Romania and most recently as the Targeted Investigator Network Strategy Implementation Lead at Pfizer.

Diana Foster, PhD, is the Vice President of Strategy and Development for the Society for Clinical Research Sites and is responsible for building relationships with industry that help amplify the voice of the clinical research site. She is a recognized expert in the intricacies of site management and an innovator in the use of strategic marketing tactics. Diana has designed and facilitated site management and patient recruitment trainings across the globe.

Agnieszka Gackowska, the professional with over 20 years of experience of working in pharmaceutical industry in both areas of product development: clinical research and market access. Graduated as a Medical Doctor in Poland and interested mostly in therapeutic areas of haemostatic disorders, vaccines and women’s health. Successful in preparation of launches of many pharmaceutical products and in the development of several marketing campaigns directed to doctors, nurses, pharmacists and patients. Over 12 years of teams’ management experience on country, regional and global levels. Her recent interests are focused on effective methods of customer service relationships and communication among investigators, health care managers, doctors, patients and representatives of pharmaceutical business to support development of R&D centres and increase patients’ awareness about clinical trials and access to modern solutions in medicine. Currently work in PAREXEL CRO as the Global Head of Site Alliance Program.

Katie is an Account Executive at Bio-Optronics, where she focuses on Clinical Research Software Applications. In her current role, Katie works with prospective clients within the Life Sciences industry to provide SaaS solutions to accommodate regulatory compliance and enhance clinical research operations. Before starting at Bio-Optronics, Katie was a Technical Account Representative at MediSked, LLC, a SaaS solutions provider to human service agencies, oversight entities and managed care organizations. Katie graduated from the State University of New York at Buffalo with a joint BA degree in Communication and Psychology.

Almenia Garvey is the Director of Site Alliances at ICON plc. ICON is a full service CRO that offers a range of services to assist the pharmaceutical, biotech and medical device industries in bringing new products to market. Almenia has over 20 years of experience in Minority recruitment, site selection strategy, investigator identification and investigator relationship management.

She graduated from Medical School at Jagiellonian University in Krakow, Poland, and from Master of Business Administration Programme at both Krakow Economic University and Teesside University. After 12 years of experience in big pharma sales and marketing (in MerckSharpDohme and Servier) she joined the clinical trials society, and within the next 12 years, she developed a small research site (Malopolskie Centrum Medyczne, MCM) into one of the most significant independent Research Centers in Poland. In late 2018, MCM became a part of Pratia Inc., the greatest Polish SMO. Małgorzata is holding the position of the Managing Director at Pratia MCM Research Center and is responsible for innovations within the whole company structure. She is also an active member of the GCPpl, a Polish clinical trial society, as well as a lecturer in postgraduate studies in clinical trials management.

Martin Gibson is Chief Executive of Northwest EHealth, Research and Informatics Director of the Greater Manchester AHSN and Director of the NIHR Clinical Research for Greater Manchester. He is a consultant physician specialising in diabetes and lipid disorders at Salford Royal NHS Foundation Trust where he was formerly R&D Director of both the acute and primary care Trusts. Martin is an active clinical trialist and has had a long-term interest in the use of electronic clinical data systems to improve healthcare and facilitate research. NWEH specialises in developing supported easy-to- use software tools for clinicians, scientists and managers to undertake research, audit, commissioning and care.

Vladimir Goranov, M.Sc., Director of IRN, gained experience in accounting and finance in manufacturing and trading companies where he was responsible for financial management and reporting activities. Mr. Goranov holds a MSc. Degree in Finance and Accounting from the University of National and World Economy, Sofia, Bulgaria and has specialized in Corporate Finance Management. Mr. Goranov is a member of the Business Development functional group within the company and responsible for the preparation of Comac Medical bids and proposals.

As Vice President, Site and Patient Access, Clare Grace develops and executes long-term strategies to drive the vision of creating stronger connections with high-performance sites and Patients. She serves as a key advocate in the organization for sites and patients through several core focus areas, including developing strategic relationships with patient advocacy organizations and site management organizations, implementing new and innovative approaches to working with sites, and streamlining operational functions to drive delivery, quality and efficiency whilst ensuring a patient centered approach across the organization. Clare brings two decades of strategic global leadership expertise to her role, including a unique blend of academic, pharmaceutical, biotech and CRO industry experience. Clare holds a PhD in Molecular Oncology from the University Of Manchester Institute Of Science and Technology and a bachelor’s degree in applied biochemistry from Liverpool John Moores University.

Andreas Grund (MSc, PhD) works since 1997 in the clinical research area. He worked in different positions in the areas Clinical Monitoring, Quality Assurance, Project Management and Training. In 2004 the CRO “GCP-Service International” was founded by Andreas Grund in Bremen (Germany). He developed a critical view for inefficient processes in clinical studies why he invented in 2009 an online based quality risk management tool (QCTMS). Since 2013 he is president of the “Association of International CROs (AICROS)”.

Sonia Houston Pichardo is the EU lead for Digital Health at Boehringer Ingelheim Pharmaceuticals. Prior to this role, she worked mainly at Contract Research Organizations (CROs) from Clinical Research Associate to Senior Project Manager. Her role within Digital Health is to serve the needs of patients by creating a digital footprint and platform to engage and enrich patient’s clinical trial experience. “It is my hope that as we expand and further build our capabilities, we will allieviate many pain points for sites allowing for better communication, recruitment and quality measures within clinical trials.”

A Senior Director with over 20 years of experience in CRO and Sponsor environments in Clinical Operations, Study Start-Up and Project Management disciplines. Stephen’s current role is with the Site Partnerships team within Covance, where he is responsible for establishing key strategic partnerships with a number of clinical research sites, networks and SMOs across the EMEA region. The aim of his role is to develop and maintain relationships with groups committed to a long-term collaborative partnership with Covance, ensuring all suitable study opportunities are provided to these partners and then working with them to ensure the studies can be executed effectively. The role involves the routine sharing of performance metrics and development of targeted initiatives to help support sites in their conduct of studies.

Dr Hayley Jewell is Site Engagement Director for Eli Lilly & Company responsible for clinical trial delivery in the EMEA region. She has over 20 years clinical research experience across phase 1-IV.

Srinivas Karri is a Senior Director of Cloud Strategy for clinical data warehousing applications at Oracle Corporation. In this leadership role he has responsibility for bringing to market new and innovative cloud services and technology platforms for managing clinical data. He currently works with many of the top 50 global pharmaceutical companies to identify new opportunities for streamlining clinical data acquisition, data management and visualisation in a safe, secure and regulatory compliant manner. Prior to his role at Oracle, he worked for Roche, having global responsibility for clinical applications. Additionally he has held various roles associated with clinical data and clinical supply chains as part of a career spanning over 20 years in the pharmaceutical industry and software development. Srinivas has a degree in Chemical Engineering, a Masters of Sciences in Process Systems Engineering from Imperial College London and has conducted research at University College London in the area of Decision Making Under Uncertainty for the Business of Biopharmaceutical Drug Development.

Dr Karoon have been working in various aspect of drug development for the past 15 years. After getting a PhD in neuroscience from UCL, she moved to MHRA and started a long and varied carrier for 12 years in the regulatory agency, critically appraising various types of regulatory dossiers and submissions. As a Clinical/Scientific Assessor she specialized in paediatric legislation, PIPs, Rewards and Art 45/6. Moving to the industry as a European Regulatory Lead in Amgen for 2 years, before joining PAREXEL as a Principal Consultant. In the last year she has focused on Brexit and its implication for the sector and patients alike. She has been advising Pharma companies that are PAREXEL clients on their Brexit planning, writing articles in Pharma media and presenting on the Brexit regulatory issues in Pharma /regulatory conferences including DIA & RAPS.

Jackie Kent is serving as SVP, head of product at Medidata Solutions. Kent is responsible for strategy, development and go-to-market for Medidata Cloud, the industry’s leading unified, cloud platform accelerating the science and business of research. For over 30 years, Kent has led the development of innovative, transformative capabilities that have revolutionized clinical research across therapeutic areas. She has extensive experience in building, modernizing and managing clinical operations, including clinical development processes, complex IT strategies, and system solutions. Prior to joining Medidata, Jackie Kent spent 28 years as a senior executive at Eli Lilly, where she started with technical IT and moved into various leadership roles. She developed a comprehensive knowledge of information technology, clinical trial design and execution, as well as CT supply planning. Kent had accountability for the IT systems that supported these teams, including the Clinical Trial MRP system (SAP) and the Lilly IRT system.

Eric brings 20 years of experience in quality improvement through clinical research training and GCP auditing. Eric Klaver has trained on six continents, from the United States to China, from Mexico to Australia, from Brazil to Korea, from Israel to Malawi, the Gabon and Kenya and all over the European continent. Eric has performed GCP audits throughout the EU, Eastern Europe and Israel. Eric’s focus has always been purely on quality improvement within the conduct of clinical trials, aiming to increase trial subject protection and supporting credible trial results for customers worldwide. Whether it is through training or through auditing, the aim is to find where structural improvements can decrease risks and increase quality.

Regional Director, In Country Clinical Operations, Europe, Russia, Middle East, Africa. Microbiologist with experience in pharmaceutical industry since 1985 & international clinical research since 1986 working in GSK and legacy companies (Beecham Pharmaceuticals, Glaxo, Glaxo Wellcome ) as well as Serono. Has held roles both in Head Office and Local Operating Companies in UK & Norway, been involved in all aspects of phase I-IV clinical research (including study design, study management, site management, data management), regulatory inspections, working with external stakeholders & partners. Current role includes driving strategy, study delivery and quality across the Region. Areas of interest also include use of data & digital solutions as well as patient centric approaches in clinical research.

Kim Kundert is an experienced research executive and currently VP of Clinical Operations for Virtrial. Prior to Virtrial, she served as the SVP of Operations for Radiant Research/Synexus, the largest site network in the world. Kundert was responsible for overseeing operations and performance of 84 research sites across the US. In her 19 years at Radiant, Kundert helped develop a platform of standardization across the network sites and had some hand in approximately 10,000 trials. Kundert has served on pharmaceutical advisory boards and CRO planning committees to provide input on protocol development and enrollment strategies from a site’s perspective. Kundert is a winner of two Stevie Awards for women in Business- Best Executive in Service Businesses in 2011, Silver Stevie for Female Executive of the Year in 2012. Kundert graduated Summa Cum Laude from Arizona State University with a bachelor’s degree in Nursing.

Experienced international information security and governance consultant and software engineer with a demonstrated history of working in the health and research sectors. Skilled in Computer Science, Information Privacy and Security, GDPR, Digital Ethics, Software Development, Lecturing and Course Development. Strong research professional with a Doctor of Philosophy (Ph.D.) focused in Medical Informatics from UCL.

Karen is currently Director of Client Engagement for DrugDev Patient Solutions at IQVIA. Her expertise in electronic informed consent systems for the global healthcare industry evolves from a background in health and intercultural communication merged with over 25 years of industry experience, focused mostly on digital communication in multinational settings. She is a fierce advocate for patient-centricity in clinical trials and improved transparency in the informed consent process. Karen holds a Master of Arts in Communication from Michigan State University and has completed four years of doctoral research in cross-cultural physician-patient communication.

Fiona’s role includes the evaluation of good clinical practice regulatory relevant changes impacting stakeholders managing clinical trials, with a key focus on regulatory aspects of technological advancements and geo-political dynamics. Specifically, impact of the EU Clinical Trial Regulation, ICH GCP revisions, impact of Brexit on the clinical trial ecosystem, advances in global data standardisation, use of robotics, artificial intelligence and regulatory adoption of mobile health applications within clinical trials. Most recently Fiona has been leading a global project interfacing with regulatory authorities with respect to the regulatory aspects of emerging patient centric technologies. Prior to Medidata Fiona was a Director at Deloitte leading the Global Centre for Regulatory Excellence in Life Sciences, Regulatory Brexit Advisory Lead for Life Sciences and a Director overseeing Deloitte consulting services to the European Medicines Agency. Fiona has a MSc in Chemistry and BSc in Chemistry and Management Science.

Robin Marcus is Chief Strategy Officer with GlobalCare Clinical Trials. Over the past 28 years Robin has become known as an innovative healthcare executive focused on operationalizing new products and services. Her talents have been leveraged with companies of all sizes including Caremark, Mediware, Home Healthcare Laboratory of America, and Integrity Health Care. She began her professional career as a an Oncology and Bone Marrow Transplant Nurse in San Francisco after receiving her BA from University of California San Diego and her BSN from The University of San Francisco.

Karen has 27 years' experience in a clinical research organization (CRO) and Site Management Organisation (SMO) in a variety of positions. From Study Site coordinator to Head of a Site Management Organization. Karen brings extensive experience in variety of therapeutic areas including cardiovascular and metabolic disorder, women’s health, neuroscience and infectious diseases in phase II through phase IV clinical trials. With a special interest in site support Karen has been involved in the development of Site Support Management tools with the goal to improve quality, transparency and compliance across investigative sites since 2005. Karen was also an active member of NREC from 2013 until 2016.

Dan Milam is the vice president of Global Engagement for the Society for Clinical Research Sites (SCRS). With over twenty years of experience working in the pharmaceutical, CRO, and site sectors, Dan has an intimate understanding of the needs of the industry as a whole and is adept at facilitating and building strong alliances. His focus is on expanding SCRS’ global footprint and the inclusion of all industry stakeholders in SCRS initiatives with the goal to foster sustainability for clinical research sites.

Matt Miller is President at StudyKIK and has been a leader in the use of digital and social media campaigns for patient recruitment on a single site and multi-site level with experience at a major CRO. Matt has developed cutting edge techniques to patient recruitment using social media for various therapeutic areas and disease states.

Christina Mueller holds a PhD in Biomedical Science from the University of Gent, Belgium as a continuation of her undergrad degree in Molecular Biology at the University of St. Andreas, Scotland. She has practical experiences in fundamental research for medication development, in particular antagonistic Nanobody(R) development for interleukins in auto-immune diseases. During the last 3 years, Christina has been instrumental in building and expanding the InSite network as part of the core team at Custodix. Next to her role of leading the team for the InSite network expansion in Europe, she is also involved in RWD services.

Dr. Sergii Myronenko is a key founder and CEO of PharmaSich CRO headquartered in Ukraine; Chairman of Kiev Clinical Research Forum. He is focused on clinical operations in Central & Eastern Europe, patient enrollment & retention, site optimization and the models of collaboration between niche CROs.

Miriam’s educational background as a registered dietitian led her to work both in Canada and England until a move to Germany 9 years ago introduced her to
clinical trials. She is currently the Center Manager at an independent clinical trial site in Leipzig where she works on increasing patient recruitment and awareness of clinical trial research.

Brendan is currently the Sr. Director of Patient Recruitment Programs at Pfizer. He has spent the past 20 years in various clinical operations roles and spent the past 15 years focusing on site selection and patient recruitment planning on the CRO and Sponsor side. He hold his BS in Pharmaceutical Marketing and MS in Clinical Trial Sciences.

Jiri Paseka is the Chief Medical Officer at GCP-Service International, a European CRO based in Bremen, Germany. He regularly gives lectures and trainings in the field of clinical research and is a co-author of the textbook “Monitoring, audit and inspection of clinical trials”. Dr. Paseka is a member of the Board of Czech Association of Pharmaceutical Medicine and since 2013 he also serves as Vice-President of AICROS (the Association of International Contract Research Organizations). Before joining the CRO business he gained his experience in Janssen-Cilag, a pharmaceutical division of Johnson and Johnson. Later he founded LCR, a CRO covering Central Europe which was besides the clinical trials of pharmaceutical focused on emerging needs of Medical Device manufacturers. Recently LCR merged with GCP-Service International.

An experienced clinical development professional with almost 20 years international industry experience gained from both CRO and pharmaceutical companies. Working predominantly in clinical operations, leading global clinical trials or programmes in multiple therapeutic areas from inception to marketing authorization. Currently leading a team to deliver studies within the UK.

Christine first joined industry in 1990 where she worked for first GSK (5 years) then Pfizer (15 years); moving to join Quintiles for 2 years. Christine left to take up the first Deputy Director of Research & Development post created within NHS Scotland and essentially had oversight, as a sponsor, of all academic studies (357 active studies) within a large NHS board partnering with University of Edinburgh, Scotland, UK Christine has degrees in Biology and Biochemistry and is a Fellow of the Royal Society of Biology Christine returned to industry in 2013 and to IQVIA in October 2017 where she works as part of Next Generation Clinical Operations team; focussed onsite identification within Europe, Middle east and Africa. Christine is married; has 4 sons, 2 are married and recently a new member of the clan has arrived a new granddaughter who is just 6 months old.

Ben is the Head of the Feasibility, Recruitment and Mobile Health division at Covance. He has over 20 years operational experience across Pharma, CRO and SMOs, where his roles have often focused on the site and patient aspects of the clinical trial process. Through this he has gained a keen interest in both site and patient centricity, and the application of different tools and techniques to better enable sites and patients to participate in clinical trials.

Amanda has spent 15 years in the clinical research industry serving a variety of functions including clinical research coordinator, patient recruitment and engagement specialist, business development, and head of operations for a US based site network. Most recently, Amanda served as Sr. Director, Global Business Development for Synexus, the largest site network in the world. Amanda is now fortunate to help lead VirTrial's integration of telehealth into the clinical research industry.

Denise Reyes joined TransCelerate BioPharma Inc in 2016, as the Sites Subcommittee Program Director. Since 2005, Denise held various positions supporting global clinical development. Presently, Denise is responsible for the delivery of initiatives geared toward enhancing the site’s clinical trial experience, including leading the delivery of the Shared Investigator Platform.

Biologist by training, since 1996, Lilette has been involved in clinical research, starting as a CRA.
Lilette joined Sanofi in 2002 as Clinical Project Leader. In the following years, she was responsible of setting up and managing different clinical trials, from phase I to phase IV, and observational studies, in various therapeutic areas both at local and international level. Starting from 2015 she covers the position of Global Site Partnership Manager for the European Region. In her role she develops an investigator site partnership strategy towards site optimization and performance.

Joel is a global patient engagement leader within Syneos Health’s Site & Patient Access group. He is responsible for helping sponsors and sites formulate and execute successful recruitment and retention strategies across early and late phase clinical trials. Joel began his forage into clinical trials at a research site in the UK, with a focus on recruitment into respiratory and allergy studies as well as the recruitment of healthy volunteers for early phase. Prior to joining Syneos Health, Joel set and up lead EU patient and physician services at a global CRO.

Jess joined GSK in late 2018 as Director of Study Start-Up Leads. Her previous experience at Roche and Novartis in global and local study management led to her leading the UK study start-up team at Roche before moving to GSK in late 2018 to start a new team of global Study Start-Up Leads who will collaborate with central study teams to reduce study start-up cycle times and optimize trial design and delivery.

Industry professional with experience in the CRO, SMO and Innovative Patient recruitment field. MSc. In Regulations and Standards in Medicine led by Military Medical Academy.

Sam Russell is a Regional Site Advocate with Vertex Pharmaceuticals. As a Regional Site Advocate, Sam supports clinical trial sites on operational issues, identifies trends across the Vertex clinical trial portfolio and supports centres with study specific issues. She also is a member of the Clinical Trial allocation Committee at Vertex, representing sites across the UK, Ireland and the Nordic Countries. Previous to her current position, she has been involved in delivery of medical projects for Vertex and prior to that worked for GlaxoSmithKline in Sales Management, Training, Disruptive Technologies and Innovation. She is a Certified Associate in Project Management and is experienced in accelerated delivery programmes.

Piotr Sawicki – Head of Patient Engagement for Central and Easter Europe in Synexus. Responsible for patient engagement and recruitment in Poland, Bulgaria, Ukraine, Czech Republic and Hungary. Started career in clinical research industry in Poland in late 90’s in well-known private clinical research unit – Osteomed In 2002 he initiated Clinical Research Centre – 56 bed unit dedicated to Phase I and pharmacokinetic studies. In 2007 unit was sold to Lambda Therapeutic Research – first Indian CRO operating in Europe. Piotr continue his carrier in developing ideas for patient recruitment using traditional media and new methods with use of on line and social media. In 2012 Osteomed join hands with Synexus where Piotr was responsible for patient
recruitment in Poland and currently in Central and Eastern Europe region.

Pharmaceutical industry experience from site, sponsor and CRO perspective – 7 years at a German investigational and Key Opinion Leader (KOL) site as Study Coordinator and Research Manager, 4 years as a Global Project Manager and Clinical Trial Manager at a biotech company, 5 years as Clinical Feasibility Leader at PAREXEL in Site Selection and currently engaging with global SMOs to achieve the most efficient study set-up.

Graduated with a MSc in Health Sciences from Maastricht University before joining the Clinical Trials Industry as a CRA. Having worked in both small and large CROs experience has been gained in a variety of Therapeutic Areas including Medical Devices. Experienced in all aspects of Site Management from Set-up to Closeout including Regulatory processed, contract & budget negotiation. Currently a Clinical Operations Manager with PRA Health Sciences responsible for recruitment, training and management of a Clinical Operational team and delivery of clinical studies across the UK and Ireland.

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.

Helena Sigal, MD started her professional carrier as a medical doctor and investigator. Growing very fast in the clinical research field, she has overtaken the positions of Director Clinical Operations or Head of Operations Germany with the International Dedicated Research Centers Company. After years of experience, she decided to set up her own company - SMO in Germany - to support the sites to become more professional.

Lucie Spatenkova is a managing director in Clinical Research Center -SMO in Czech Republic, who is helping investigators to conduct and manage clinical trials. Before starting own business, Lucie worked 11 years as a CRA and clinical project manager. Lucie gained experience in several different roles and projects within different companies, culture and teams.

Fifteen years of Clinical Research experience in Clinical Team and Project Management, Functional Management and Process Management with a focus on Adaptive Trial Monitoring and Management.

Wojciech started his adventure with drug development choosing the Biomedicinal Chemistry department at the University of Wroclaw as his PhD studies location. After completing the PhD degree he joined AstraZeneca where he learned the rules and regulations around the clinical trials as a CRA and later as a Local Study Delivery Team Leader. In 2009 he joined Synexus as a Site Manager, where he developed his expertise in the business by managing the Dedicated Research Site. He later became a Director of Operations taking the responsibility for all the Synexus sites in Poland. He developed the network in Poland and was further given the role of the regional Managing Director of the Central Europe where he expands the Synexus Business in Poland, Hungary and recently Italy.

MD based on education, have been working in clinical research area since 2006. Currently leading site management organization in Russia and responsible for running phase I-IV trials.

Paula worked for NHS for 27 years as a Senior Manager, developing strategic growth of academic and clinical research portfolios. Initially at Great Ormond Street Hospital, from 1990 through to 2009 in clinical genetics, respiratory, cardiology and from 2006, as the Network Lead for the Medicines for Children Clinical Research Network. Relocating to the South West, Paula worked in oncology as the Clinical Research Manager and latterly as the Industry Operations Manager/Business Intelligence Lead for the South West Peninsula Clinical Research Network. Paula left the NHS in 2017 and joined TriNetX as Director, Clinical Account Management (EMEA). TriNetX offers a unique and innovative healthcare data analytics platform supporting the growth (and breadth) of research opportunities; harnessing data to develop protocols, feasibility and delivery of research across therapeutic areas.

I am a chemical engineer (analytic chemistry) with additional masters degree in public health. I have 13 years of experience in clinical research in different positions - from CRA, LCRA to international PM in both CROs and big Pharma companies up to finding Slovak research center, where I am the President and co-founder and working at position of Clinical Operations Director. Previous companies: Icon, KCR, Octapharma, Boehringer Ingelheim.

Vivienne van de Walle studied medicine both at the University of Maastricht and at the University of Oxford. In 2004 she successfully defended her thesis for her PhD and in 2011, she passed the CPI exam. She has always combined clinical research with patient care and has been a full time investigator at independent clinical research sites. She co-founded and owns the independent research site PT&R (www.ptr.nu) since 2006. Her entrepreneurship is reflected by her skills in consulting, education, management, leadership and executive functions at CROs, Farma and trade organizations i.e. ACRP, SCRS, TransCelerate and NVFG. She started her carrier as a participant in a clinical trial. As a result, Vivienne has a unique perspective of the various sides of the table in clinical research and is eager to share her many years of experience.

Dr. Wolff has more than 25 years of experience in the health and life sciences industries as a scientist and analyst working in the US and Europe. He joined SAS in 2005 and is an Advisory Industry Consultant and Chief Health Analytics Strategist for the SAS Global IoT Division. Mark is recognized as an accomplished practitioner and thought leader in the development and application of advanced and predictive analytics to complex problems in health and life sciences. Current work focuses on methods and application of Machine Learning to real time sensor/IoT data in support of outcomes and safety research, and the development of intelligent, decision support systems.

20 years in preclinical and clinical biopharmaceutical product development and 10 years with IQVIA within operational oversight and strategic alliances. Part of European Strategic Site Solutions leadership team with a wide ranging remit to deliver solutions which better engage patients and clinical research sites to drive healthcare forward. Leads the strategic alliances with IQVIA’s external clinical site networks and the development of IQVIA’s support model for Academic and Investigator-initiated Research (AIR). Focus on developing commercial and non-commercial collaborations to enhance our ability to bring new therapies to our patients through innovation. Extensive Analytical Chemistry, Central Lab and CRO experience within the global market. Bachelor of Science, Chemistry with IT and Instrumentation from Glasgow Caledonian University. Living in Glasgow and office-based at the IQVIA facility in Livingston.