Blake is the VP of Marketing for Florence, a software solutions provider creating platforms to accelerate cures – trusted by more than 6,300 research centers globally to manage their documents and workflows. Blake is focused on advancing research through discovering, developing, and delivering innovative eClinical solutions that drive collaboration and efficiency in Clinical Trials.
Prior to Florence, Blake ran marketing and strategy for other HealthTech vendors, healthcare systems, and NGO health centers globally.
Blake is a graduate of the Georgia Institute of Technology and is passionate about building scalable businesses that make a positive impact on the world. Located in Atlanta, Blake and his wife Kimberly have two young boys.
VP, Industry Relations
Association of Clinical Research Organizations (ACRO), USA
Anina joined the Association of Clinical Research Organizations (ACRO) in 2015. She leads the operation of the CRO Forum, a division of ACRO that was set up for CROs and technology partner organizations to engage with TransCelerate on a number of projects. In her role, she supports the voice of ACRO member companies conducting RBQM to the clinical research industry community – and also with regulators.
CEO & Founder
GlobalCare Clinical Trials, USA
Gail Adinamis is founder and CEO of GlobalCare Clinical Trials, a global patient-centric service organization that conducts study visits at patients’ homes or alternate settings via a global network of ambulant healthcare providers to support traditional, virtual or hybrid studies. Adinamis has 40 years of comprehensive global clinical trials experience including over 12 years of global trials management at Abbott Laboratories and Astellas Pharma US. She established the clinical trials divisions for three national home infusion companies and served as president of those subsidiaries. In 2004, she founded and was President and CEO of an independent ambulant care service company for clinical trials prior to establishing GlobalCare Clinical Trials, LLC in 2010. Adinamis is active in many industry associations and has twice been among INC 5000’s fastest growing private companies, CEO and International Game Changer of the Year, and among the top 50 fastest growing Woman-owned companies in 2018 and 2019.
Penny Allinson, BSc
Assoc. Director, Patient Recruitment Programs
Penny Allinson is Associate Director, Patient Recruitment Programs at Pfizer. She began working in patient recruitment and retention in 2003. Throughout her career she has supported global studies across a wide range of therapeutic areas and has experience from patient recruitment agency and Sponsor sides. She holds a BSc in Biochemistry (Medical) from the University of Surrey, UK.
Nadir Ammour, DDS
Clin. Digital Innovation External Engagement, Global Lead
Sanofi R&D, France
Dr. Nadir Ammour began his career as an oral surgeon in public healthcare moving into clinical development. He is working to bring eHealth/Digital innovation in clinical development to deliver new medicines to patients faster.He led several projects in that space such as the Verkko remote trial, Connected Hospitals Network (EHRs); wearables trials, and on-line patient recruitment.
Nadir is a member of the Executive Committee of the EHR4CR/InSite champion project. He is presently leading an EIT Health consortium project, EHR2EDC aiming at further developing capabilities to conduct trials using EHRs data to automatically prefill an eCRF.
Dr. Ammour held various global positions previously at Wyeth, now at Sanofi. He is graduated in medical informatics, health economics and an MBA from Reims Management School, besides his Doctorate in Medical Dentistry.
Rocío Arce, MD
Site Engagement Manager
Eli Lilly, Spain
Rocío Arce is Site Engagement Manager at Lilly. She has 20 years in clinical research both in commercial and academic research. After starting at Lilly as CRA and covering different positions within clinical operations, she moved to CAIBER (Spanish Clinical Research Network) to build this public network dedicated to academic research. On her way back to Lilly, she has held management positions within Site Activation. In her actual position as Site Engagement Manager she is responsible for clinical operations in Spain with focus on selection and recruitment.
Chief Commercial Officer
As Greenphire’s Chief Commercial Officer, Wayne is responsible for the global commercial strategy of the rapidly growing organization, including the execution of sales and marketing programs. Wayne is a proven strategic sales executive with more than 25 years of commercial experience in technology and life science industries. Prior to joining Greenphire in 2016, Wayne served in numerous senior leadership roles at Advanced Health Media (AHM), a leading global provider of SaaS-based solutions designed to manage compliant interactions with healthcare professionals and organizations for the highly-regulated life sciences industry. During his tenure, Wayne helped establish AHM as the market leader, playing an integral role in the organization’s 1500 percent revenue growth during a four-year period, with continued global expansion thereafter. Earlier in his career, Wayne gained sales leadership and industry experience at Parametric Technology Corporation (PTC) and Brent International. He earned his bachelor’s degree in Chemical Engineering from Drexel University.
Senior Director, Contracts & Compliance
MediNova Research, UK
With a 25-year career in contracting and business development, Wendy is Senior Director, Contracts & Compliance for Medinova Clinical Research with accountability for global contracting 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 14 years ago as a Study Project Manager before setting up and leading central global contract management functions for two 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.
Lisa Becker. PA, MPH
Gemini Solutions, The Netherlands
Lisa began her career in direct patient care and community-based research in the US. After immigrating to the Netherlands in 1989, she joined a young oncology biotech company and launched her industry career. Her cultural sensibilities and bridging capabilities led her to successfully set up and expanded European & Global operations for two US-based biotechnology companies. She has acted as the facilitator between CROs and sponsors due to her strategic thinking and understanding of the key, and often small, details that are essential to success. Over the past 30 years, she held leadership positions with multiple (bio-) pharmaceutical and medical device companies, Clinical Research Organizations, and in academic research. Lisa continues to consult a variety of clients, plying her skills as diplomat and/or dragon slayer, whatever the engagement entails.
Federica Bitonti, BSc
Sr. Director, Clinical Site Operations
Molecular Biologist by Training, Federica joins Pfizer R&D 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). Lastly Federica was appointed Senior Director, Clinical Site Operations for a cluster of countries in the south-est Europe. In such a role she oversees the timely conduction of interventional clinical trials ensuring at the same time data quality and sites’ inspection readiness. Federica has become an expert in re-organizations, mergers and changes in operational models and different types of outsourcing approaches, as Pfizer is a very dynamic company in this regard.
Molly Brock, MS
Sr. Director Global Site Partnerships
PRA Health Sciences, USA
Molly joined PRA as a Sr. Director of Clinical Operations responsible for the eTMF system and enhanced site management. Just this year Molly started a new role heading up Global Site Partnerships. Prior to joining PRA, Molly worked for over 14 years leading clinical research operations at academic medical centers.
Andre’ Beukes, BProc(Law)
Syneos Health, UK
Andre Beukes is a Director in the Investigator Management Solutions Business Unit at Syneos Health. The Syneos health IMS team comprises of more than 200 global professionals who make payments in 41 currencies and 78 countries. Andre joined Syneos Health in 2013 to establish an FSP relationship with one of the major Pharma companies, this relationship flourished over the last 7 years and the portfolio value is now in excess of $ 150m. Before joining Syneos Health, Andre served as a finance manager for 13 years at a private hospital group in the UK. Andre holds a law degree from the University of Johannesburg and he practiced law in South Africa for 5 years before moving to the UK in 1999. Andre lives in a 120-year house/DIY project with his lovely wife, Christine and their dog Lulu.
Business Development Manager
NIHR Clinical Research Network, UK
Theo Christie is a Business Development Manager (Commercial) for the NIHR Clinical Research Network (CRN). Theo 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. Theo 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 Clinical Sciences, Theo has been with the Clinical Research Network since 2013. Before joining the Business Development and Marketing Team, Theo 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 10 therapeutic areas, providing operational support through feasibility, set up and patient recruitme
Mark Connolly, FCCA, MPM
ICON plc, Ireland
Mark heads up the FIRECREST division at ICON as part of ICON’s Site Operations Group. FIRECREST is an industry leading digital solution that provides training, document management, eConsent and other capabilities to more than 100 sponsors including most of top 20 Pharma, supporting more than 22,000 research sites in 118 countries. Mark has previously held senior roles at ICON in the Corporate IT and Finance Teams and serves as an industry advisor to the University of Limerick (Ireland) Master’s Degree in Project Management program. His professional interests include adoption of new technologies in clinical trials and improving the clinical trial experience for sites, patients and study teams.
Prof. Edward Czerwinski, MD, PhD
Krakow Medical Centre, Poland
Professor Edward Czerwinski, founder and head of Krakow Medical Centre since 1996 and Professor of Jagiellonian University being the Head of the Department of Bone and Joint Diseases. He has been a practicing medical doctor in orthopaedics for 46 years as well as an active university lecturer, scientist and community benefactor. In Krakow Medical Centre he supervised 124 trials that have been completed in the fields of: cardiology, bone and joint diseases, endocrinology, dermatology, gastroenterology, hematology, kidney, rheumatology, osteoporosis, neurology, nephrology, pain management. Prof. E.Czerwinski is a member of the international Scientific Advisory Boards of: International Foundation of Osteoporosis, EULAR and EFFORT, 10 boards of scientific international magazines, member of 20 societies, organizer of 21 medical congresses in Poland including World Congress on Osteoporosis in 2018. Author of 502 publications, Impact Factor of 191 and Hirsh index 16.
Nikki Dewick, BSc Hons
Process and Standards Lead, UK, Ireland & Israel
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; and now holds the position of Process and Standards Lead for our Global Site and Study Organisation.
Senior Director, Project Management Office
ICON plc, Ireland
Carina Dollenz, MPharm
Lead Study Manager
Bayer AG, Germany
Carina is a pharmacist by training. Her main experience lies within the pharma industry, but she began her career as a scientist at a hospital. In total she has been working on clinical trials for over 13 years.
For the past 9 years, she has been overseeing the operational aspects of globally conducted multi-centered interventional Phase 1 – Phase 3 studies from start up to close-out mainly in the therapeutic area of oncology, but also in hematology and neurology.
Krzysztof Emanuel, PhD
Alliance Sites Associate Director
Parexel International, Poland
Krzysztof’s scope of responsibilities include managing the relationships with sites strategic for PAREXEL within Site Alliance program by building relations between Sites and PAREXEL teams. To increase overall high customers satisfactions (either Sponsors and Sites) by facilitating processes and overcoming barriers. Krzysztof has 10+ years’ experience in clinical research industry predominantly in Clinical Operations and Global Site Solutions. He has a PhD in cardiovascular science; Postdoctoral Fellow at the University of Oxford, UK; and is an academic lecturer in cardiology for medical postgraduate education.
Zsolt Ember, MD, PhD
PPD AES, Hungary
Zsolt Ember, Enrollment Manager at PPD Accelerated Enrolment Solutions (AES). Graduated as an MD from Semmelweis University Budapest Hungary in 1992. Employed by the same University Medical School as a Lecturer, 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. Has been with PPD AES (formerly Acurian) since 2015, supporting central patient recruitment and retention campaigns in the EMEA region.
Nora Farkasova, LL.B, PhD, PhDr, MSc
Targeted Investigator Network Strategy Implementation Lead
Pfizer, Slovak Republic
Nora Farkasova has more than 18 years of experience in the pharmaceutical industry and has held various local and regional roles in Clinical Operations, Quality Assurance and Site Strategy within Pfizer and GSK. Most recently Nora works at the position of the Targeted Investigator Network Strategy Implementation Lead at Pfizer.
Roman Fishchuk, MD, MSc
CEO, Clinical Trials Unit, Ivano-Frankivsk City
Central City Clinical Hospital, Ukraine
CEO of a clinical trials unit that was founded from scratch in 2017 at a state hospital in Ivano-Frankivsk, Ukraine and now developed into an organization with 15-20 multi-specialty trials running simultaneously with a potential to grow. One of the founders and current Board member of the Ukrainian Association for Clinical Research. Adept ENT doctor and principal investigator in otolaryngology with ability to work in a multidisciplinary team, experience in delivering patient care in both public and private settings with the use of the latest industry equipment and technology, as well as establishing own private practice. Proactive and dedicated to seeking opportunities for cooperation with international specialists. Strong knowledge of Ukrainian medical policy landscape through working with the Ministry of Health of Ukraine on reforming healthcare services. Proven track record of planning and executing projects in medical sphere.
Diana Foster, PhD
Vice President, Strategy and Special Projects
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, MD
Senior Director Clinical Feasibility and Site Alliances, Global Head
Agnieszka Gackowska, MD, graduated from the Medical University in Warsaw and has more than 22 years of experience in the pharmaceutical industry in various roles and positions. Since 2016, Agnieszka has been responsible for leading PAREXEL’s global team of Site Alliance Managers, building and managing relationships with strategic research institutions committed to working collaboratively with PAREXEL to advance clinical trials. In addition she assumed the position of the PAREXEL Global Head of Clinical Feasibility Team in November 2018. Knowing that sites and investigators are vital to clinical trial success, she supports the development of different sites’ management models to decrease work burden on investigators and make new drugs available for patients more quickly. She contributed to many campaigns that built patient awareness of various diseases, treatment and prevention, such as: “Yellow Week” – vaccination against hepatitis A and B; “Mom, you have a choice” – a conjugated vaccine immunization of children; “Daisy Flower” campaign for treatment and prevention of urinary incontinence and atrophic vaginitis; ”Change the possibilities in haemophilia” for children and their relatives who suffer from this disease. Prior to joining PAREXEL, Agnieszka served as head and creator of the Prime and Partner Sites Network program for IQVIA from 2009 to 2016. She also served as Managing Director of the Haemophilia Foundation in Poland from 2006 to 2009 and was the originator and leader of the international School of Menopause for Doctors from 2003 to 2008 and cyclic educational program for doctors “Innovation in Haemostasis.”
Katie is an Account Executive at Bio-Optronics, where she focuses on eClinical 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.
Director, Global Clinical Trial Operations
Laura has a unique role which blends internal and external components. Laura is Merck & Co., Inc.’s assigned leadership to the Oversight Committee of TransCelerate BioPharma Inc. The Oversight Committee is the primary governing body for decisions related to the operational direction of TransCelerate, including project direction and expected outcomes. Laura draws on her experience as Director of Clinical Operations for a busy therapeutic area and Head of Clinical Performance, Analytics and Innovation to provide this perspective. Within Merck, she has responsibility for driving internal engagement with key stakeholders. She facilitates adoption and internalization of TransCelerate solutions in alignment with Merck’s objectives. Finally, she watches for opportunities to match innovative approaches to potential process improvement initiatives or other areas of focus.
Almenia Garvey, MSc
Director, Health Care Alliances
Clinical Research Service
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.
Malgorzata Gerjatowicz-Osmanska, MD, MBA
Managing Director, Innovation & Development Team
Dr Małgorzata Gerjatowicz-Osmańska is a graduate of the Jagiellonian University Medical College, Cracow University of Economics and Teesside University, where she gained a Master in Business Administration. Dr. Gerjatowicz-Osmanska has 25 years overall experience in pharmaceutical industry. She started her professional experience in pharmaceutical sales and marketing (MerckSharpDohme, Servier). After 12 years in the industry she decided to capitalize her expertise in clinical research domain and developed a research site. Malopolskie Centrum Medyczne (MCM) successfully pioneered a unique model of dedicated onco-hematology unit on the top of other medical specialties and joined the elite class research sites in Poland which is highly valuated by global Pharmaceutical and CRO companies. In late 2018, MCM became a part of Pratia Site Network where Malgorzata holds the roles of Managing Director at Pratia Research Center in Cracow and Innovation & Development Team Lead supporting Pratia International readiness for digitally enabled and virtual studies globally.
Melynda Geurts, MS
Senior Vice President, Business Operations
Total Clinical Trial Management, USA
Melynda Geurts’ career has focused on advancing education within the healthcare industry for the past 23 years. Since 1998, Melynda has shifted her focus on educating the public about participating in clinical trials through global programs. She currently serves as the Senior Vice President of Site & Patient Engagement for Total Clinical Trial Management (TCTM). Melynda will focus on TCTM’s commitment to strengthening relationships with research sites and Investigators as well as maintaining the company’s track record of meeting 100 percent of enrollment targets on all completed studies. Melynda is invited often to present and train worldwide at industry conferences and has contributed to the industry’s overall body of literature through her writing contributions. Melynda holds a M.S. in Healthcare Administration and a B.B.A. in Marketing.
Marcin Gondek, MS
Marcin has over 10 years of experience in Site Management Organizations, and is currently CFO of FutureMeds, a growing European SMO. Previously, as CFO of Synexus, he negotiated contracts for a network of over 100 Research Sites located in US, Europe, UK and Africa. Marcin closely worked both with Pharma and CRO’s on budget grits and payment terms.
Vladimir Goranov, MSc
Director of IRN and Member of the Business Development Functional Group
International Research Network Ltd, Bulgaria
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 bids and proposals.
Clare Grace, PhD
Vice President, Site and Patient Assess
Syneos Health, UK
As Vice President, Site and Patient Access, Clare Grace develops and executes long-term strategies to drive our vision of creating stronger connections with high-performance sites and targeted patient populations. She serves as a key advocate 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.
Clare brings two decades of strategic global leadership expertise to her role, including a unique blend of academic, pharmaceutical, biotech and CRO industry experience. She joined INC Research from PPD where she held several senior leadership roles, including most recently Senior Director and Head of Global Site Intelligence. 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.
Medidata Solutions, UK
With over 25 years experience in the industry, Michelle has been involved in all stages of drug development and has worked with numerous life sciences companies of all sizes. She has a genuine, personal interest in better, faster, smarter drug development and has spent her career bringing innovative new technologies and optimized processes to client’s to enable them to achieve this. For the last 7 years, Michelle has spent a large proportion of time in the RBM/ RBQM space, helping Sponsors implement effective, practical solutions to comply with ICH E6 R2 and emerging standards such as ICH E8 (R1).
Senior Realization Project Manager, Product Development Industry Collaborations, PD Clinical Operations (PDG)
Jenny Hahn is a Clinical Operations Leader with over 20 years of experience in clinical development across all Phases. Although the majority of her work the last 10 years has been focused on oncology research, she has broad therapeutic area experience including rheumatology, endocrinology, ophthalmology, gastroenterology, and hematology. She started her career as a research assistant at a university hospital ordering records which came in bound volumes, data entering 4 part NCR CRFs and blinding imaging films with a sharpie for submission to the sponsors. In the intervening years, she has been a CRA, a Project Manager at a CRO, a Global Study Lead and an Operations Program Leader. She is currently on a rotation as a Senior Realization Project Manager at Genentech within Product Development Industry Collaborations.
Bert Hartog, MSc, PhD
Sr. Director, Clinical Innovation
Janssen Pharmaceutica, Belgium
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.
Emil Hoeck, MSc
Director of Business Development
Based in Europe, Emil Hoeck joined VirTrial in 2019 and expanded the company’s global presence to reflect their unique international capabilities in the decentralized clinical trial space. In his position at VirTrial, Emil leverages a wide-ranging experience in clinical research, from study coordinator at a dedicated research site, to the CRO world where has he worked in Project Management, Quality Assurance and Strategic Relationships in both small and top 3 CROs. Through comprehensive knowledge of patient needs, technology adoption at clinical research sites and the intricate ecosystem of strategic CRO and Vendor solutions, Emil helps VirTrial’s clients efficiently implement decentralized clinical trials at all stakeholder levels.
Hans Christian Hoeck, MD, PhD
President & CEO
Trialcare Research, Switzerland
Dr. Hoeck is the President and CEO of Trialcare Research. He has extensive senior clinical experience both as a clinician, scientist and has served as Principal Investigator on numerous studies from Phase I-IV. He has worked as a senior executive in the biopharmaceutical industry for over 15 years and has been supporting SCRS from the early beginning. Dr. Hoeck currently serves on the SCRS Leadership council.
Dr. Hoeck founded Trialcare Research with the purpose to bridge critical gaps between science and patient care. This includes a vision to share accumulated knowledge from the biopharmaceutical industry with highly specialized colleagues within Ophthalmology with the overall objective for their patients to have access to the newest and best therapies.
Dr. Hoeck holds MD degree from the University of Southern Denmark. He is a board-certified specialist in Internal Medicine, Endocrinology & Diabetes and holds a PhD in Medicine from the University of Copenhagen.
Tanja Hoffman, CIPP/E
TNJ Life Sciences Consultancy, The Netherlands
All-round pharmaceutical professional with 30+ years’ global experience in Biotech, Pharmaceutical and CRO business in: Clinical Operations (phase 1-4), Medical Affairs, Regulatory Affairs, Business Development and Corporate Affairs. Passionate to drive results that truly impact patients’ health and well-being through leading and/or participating in multidisciplinary initiatives.
Excellent networker with strong entrepreneurial drive, establishing strategic alliances and partnerships. Successful leader in the development and implementation of innovative financial and operational business strategies for pharmaceutical companies, biotech, start-ups and (niche) CRO’s.
Yordanka Ilieva-Borisova, MPharm, MSc
Manager Site Support
International Research Network Ltd, Bulgaria
Yordanka Ilieva-Borisova has more than 7 years of experience in Clinical Research , mainly focused on early phase clinical development and site management: Site selection, patient recruitment, feasibility studies and full service project management. Yordanka is currently responsible for the supervision of all aspects of site support activities in IRN, being involved in many of them on an operational level, guaranteeing smooth process of site selection and start-up, study recruitment and overall trial conduct.
Radoslaw Jadczak, MD, MBA
Director, Strategic Site Solutions, Early Phase
IQVIA RDS, Poland
Dr. Jadczak is responsible for leading the European Early Phase Oncology Network of sites dedicated to Phase I/II solid tumor and hematology trials. He has used his expertise in drug development strategy, knowledge of clinical research methods and understanding of medical science and the therapeutic landscape to shape design and delivery strategies for oncology studies and programs that meet the needs and expectations of Sponsors. He has provided therapeutic strategy input for many cancer indications and trial designs across Phase FIH to IIIb, including adaptive designs, basket studies and biosimilar interchangeability. Dr. Jadczak is responsible for leading the European Early Phase Oncology Network of sites dedicated to Phase I/II solid tumor and hematology trials.
Radoslaw Janiak, MD
Chief Executive Officer
Dr Radoslaw Janiak graduated from Medical University in Warsaw and started his career as internal medicine doctor in Praski Hospital in Warsaw. In 2003 he opened one of the first Dedicated Research Site in Poland which was later acquired by Synexus. During his career in Synexus he supervised site operation in Europe, Africa, India and US as Executive VP and COO. After merge with Radiant Research in US Radoslaw hold the position of President and COO of Synexus Sites within Accelerated Enrollment Solution a Division of PPD.
Since January 2020 he holds the position of CEO for Futuremeds, fully dedicated Research Site Network in Europe with operations in Poland, Hungary and Ukraine.
Janusz Kabata, MD, PhD, MBA
Janusz Kabata MD, PhD, MBA is a healthcare professional with 40 years of academic and executive experience in public and private healthcare sectors in Europe, and 30 years of experience in various aspects of clinical trial management, including managing central laboratory services and home-care services for global clinical trials. He is founder of GP4research, company that develops European network of local Health Care Providers ready to support Decentralized Clinical Trials. Prior to GP4research, he co-founded GlobalCare Clinical Trials Ltd, and developed the network of home care service providers in Europe and Asia. He established Synevo Central Lab. He is a specialist in public health and laboratory medicine. He was Associate Professor at Gdansk Medical University, Poland and Visiting Professor at Hematology Department at Basel University, Switzerland. He has been an invited speaker at several clinical research industry conferences and scientific meetings in laboratory medicine and hematology. With his wife, he manages GP practice in Gdańsk, Poland.
Solomon Kamal-Uddin, MBBs, BMedSc
Medical Director, European Strategy for Paediatrics and Rate Disease
Solomon graduated from St Bartholomew’s and Royal London Medical School in 2005. Whilst there he also completed a BMedSci in Molecular Therapeutics. He formally pursued an interest in Paediatric Emergency medicine (PEM), gaining a training number and working at Emergency departments within the London Deanery. He has a Dual Accreditation CCT in Paediatrics with Sub Speciality training in Emergency Medicine.
Solomon has worked for 3 years as a NHS Consultant in PEM at Watford General Hospital. There he played an active role with the team, helping to develop the Paediatric Emergency Department Service and its identity. This involved being a mentor, clinical and educational supervisor to junior doctors and nurses as well as having key roles in governance structure such as managing clinical incidences, establishing local guidelines, being Paediatric Trauma lead, Paediatric Emergency Audit lead and site Principal Investigator for a number of national trials.
In Solomon’s current role he works at the IQVIA Paediatric and Rare Disease Centre of Excellence in a Europe based Strategy role. His passionate aim is to make site identification, trial design, recruitment and research outcome more patient and investigator orientated. The hope is to achieve this in an industry role by strengthening relationships, reducing family burden and working more proactively with investigators to increase the chances of getting a positive result for all involved.
Solomon is also proud to be part of Medics.Academy as a senior clinical fellow, where he is helping to educate the present and next generation of clinicians; utilising the electronic platform. Most importantly he is he proud father of 3 girls, the youngest of which has a rare disease.
GCP Auditor/CR Trainer
Trial & Eric, The Netherlands
Trial & Eric is a unique and innovative company, delivering unique training, methodologies and driving a passion for learning in different ways. Eric brings his story and experience to the table and delivers his message in a way that people remember long after they hear it. Founded with a passion to share his unique style and sense of humour with the world, Eric delivers his messages passionately and makes people sit up and listen to his story. He engages his audience quickly and involves them in his storytelling process. People listen because they feel involved in his message. Eric places a human side to his message, creating a connection on a personal level. As a keynote speaker, he brings his passion to life on stage. Learning retention is a priority, and Eric’s innovative methodologies make learning fun and memorable. He brings his years of experience in the industry, combined with the latest learning methods to the classroom, and creates a unique style known as the “Eric Experience” Training doesn’t have to be stale when you combine experience, enthusiasm and passion with a side of humour. Trial & Eric delivers you all this and more.”
Maria Kuthning, MSc pharm.med.
Executive Global Clinical Operations
Faculty of Medicine, University of Duisburg-Essen, Germany
Maria is a Senior Executive in pharmaceutical industry with advanced knowledge in Pharmaceutical Medicine, Global Clinical Operations and Medical Affairs. She has long lasting experience in general and operative management of global clinical trials based on European and global standard, line manager in matrix organizations. Maria is an expert in ICH-GCP and risk management. She is internationally agile with in-depth understanding of drug development programs.
Maria oversees CROs of outsourced international clinical projects in several therapeutic areas phase II-IV, IITs, NIS focused on oncology, hematology and infectiology. She is a driver of change management, global initiatives and implementation of an IT project on a global level.
Maria is an experienced strategic leader and line manager of global and matrixed teams driving and steering change management, globalization and digitalization. She is a Keynote Speaker, academic lecturer in Pharmaceutical Medicine. Scientific publication in ethical & legal topics of medicine. Maria enjoys working with people to achieve ambitious goals to deliver science-based innovation.
Michał Kwiatek, MD
Managing Director, Investigator
Examen by Pratia, Poland
Doctor specializing in oncohematology, co-founder of the EXAMEN clinical research center, which at the beginning of 2020 was included in PRATIA – the largest Polish network of clinical research centers. An active clinical investigator as well as a person managing the center from 2016. As a doctor, his main therapeutic areas are lymphomas and leukemia, as the managing director of the center, he focuses mainly on team building and effective recruitment and retention of patients.
Martin Lachs, PhD
VP, Project Management, Oncology & Cell Therapeutics
ICON Clinical Research, UK
With over 28 years’ experience in clinical development, Martin has worked across a number of therapeutic areas whilst specializing in oncology. Martin is based in the UK.
Martin heads up ICON’s Oncology and Cell Therapeutics Project Management Group, lending operational and indication expertise across a group of over 260 international project management staff globally, dedicated to oncology and cell therapy drug development.
After completing a PhD thesis (cell biology, breast cancer) at the University of Manchester in the UK, Martin’s career has spanned laboratory research in large bio-pharma, clinical development in CROs and Imaging Core Labs. Martin has held Project Management Professional Certification (PMP), from the Project Management Institute (PMI) for 19 years.
Maria Leitao, MBA
Regional Site Advocate
Maria developed her career in multinational setting with responsibilities of Project and Multidisciplinary Team management. She’s had relevant experience in 2 different settings Europe and Latin America, both in pharma and CRO environment. Maria has handled all sort of activities Clinical Research related in the last 20 years.
Maria is currently a Regional Site Advocate, which is a strategic role that acts as a critical interface between the company and Clinical Research sites for all operational issues. She currently is serving as a professional, competent and reputable company representative in direct interaction with clinical trial investigators and academic institutions on all activities related to study execution. Maria is a key decision maker in country and site selection. Additionally, she is Partnering with local and global interdisciplinary teams.
Previously as Clinical Operations Manager in a CRO Maria was responsible for a business unit within a partnership with all its particular aspects for Portugal and Spain, managing a team of 25. Active participation in global initiatives within the partnership.
Maria started her career as CRA in pharma and ended up as country Head of Clinical Operations. She moved to a different country and role.
Senior Manager Clinical Feasibilty
Emmanuelle is a Senior Manager of European Clinical Feasibility Leaders at Parexel (France). She has gained experience in feasibility following 13 years spent as a senior Clinical Feasibility Leader at Parexel. Under this role, she was in charge of managing large worldwide site feasibility surveys. Prior to this, she had spent 6 years as a Clinical Research Associate at Laboratoires Genévrier allowing Emmanuelle to closely interact with investigators, to understand and answer their needs in the most appropriate way.
SVP, Site Operation
Experienced Operational and Commercial leader with a demonstrated history of working in the pharmaceuticals and CRO industry. Skilled in Clinical System Implementation and Integration, Project Management, Clinical Data Management and Business Process Improvement.
Ritva Lindgren, MHA
Lead Study Manager
Bayer Oy, Finland
Ritva has worked in the clinical research field more than 20 years in various roles; Study nurse, CRA, SCRA, lead CRA, Project manager, Study lead Monitor, Study manager. Main interest is in the oncology studies and currently working in FIH study in prostate cancer.
Assoc. Director, Strategic Account Lead Global Clinical
Karl is a certified financial advisor and trained economist. After a short time in the financial sector he moved to health care sector and started at a public German sick fund. Since 2015 he is working JnJ’s pharmaceutical company Janssen in Germany. Over the time he changed roles with increasing responsibility. In his current role he oversees the strategic customer relationship management of the clinical operations team in Germany and Switzerland.
Karen Maduschke, MA
Director of Client Engagement
IQVIA Technologies, Germany
Karen is recognized as a global expert in electronic informed consent for the healthcare industry. She has been involved with this innovative technology from its earliest inception and has been instrumental in driving the rapid growth of IQVIA’s eConsent business. Recently, Karen has led the adoption of consent authoring with IQVIA’s pioneering Clinical Document Architect software. Karen’s post graduate education is in health and intercultural communication and she has more than 25 years of experience in the field. She is a fierce advocate for patient-centricity in clinical trials and improved transparency in the informed consent process.
Robin Marcus, RN, MSN
Chief Strategy Officer
GlobalCare Clinical Trials, USA
Robin Marcus is Chief Strategy Officer with GlobalCare Clinical Trials. Over the past 25 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.
Fiona Maini, MSc
Principal Global Strategy and Compliance
Medidata Solutions, UK
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.
Karen McIntyre, MSc
Senior Director, Global Lead Catalyst Program
Karen has 28 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 is also an active member of NREC in Scotland.
Laura Meloni, PhD, MSc
Director, EU Data Networks
Marieke Meulemans, MSc
GCP Central B.V., The Netherlands
With over 15 years of experience in the clinical research world, Marieke Meulemans founded GCP Central in 2012 and is the driving force behind the company’s powerful vision. She is changing the face of Good Clinical Practice (GCP) training by liberating clinical research professionals and organizations to learn about rules and regulations differently, revolutionizing the boring and mandatory side of GCP training and taking it to the future. Marieke pioneered a continuous learning focused regulatory e-learning platform that changes the way we learn about compliance in the clinical research industry, following her own mission to put GCP knowledge at users’ fingertips and make it a core part of everyday practice.
Vice President of Global Engagement
Society of Clinical Research Site (SCRS), USA
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.
Vladmir Misik, PhD
Founder & Managing Partner
Vlado has more than 30 year’s experience in biomedical R&D, including scientist at National Cancer Institute NIH, Bethesda, Maryland; >17 years with Quintiles: where he served in multiple roles including VP for CEEMENA, and Head of Global Operations Center, India; founder of LongTaal clinical trial informatics company), founder of VIARES (Vienna academy for clinical research). Joined SanaClis, a boutique full service award-winning European CRO , as an independent board member in 2017, and served as a CEO from April 2018. Vlado is author of > 60 research articles and book chapters in peer-reviewed journals: his current research focus is on various aspects of globalization of industry clinical trials; since 2014 served as editorial board member at Applied Clinical Research, Clinical Trials and Regulatory Affairs journal.
Joyce Moore, PhD, MBA
Director, Patient Recruitment Services
ICON Clinical Research, UK
Joyce started her career as a research scientist and then transitioned to the biopharmaceutical industry where she has worked for the last 20 years within the CRO industry across a number of functions. For the last fifteen years she has specialising in Patient Engagement and has a keen interest in insuring the patient voice is an input both into study design and into the patient recruitment and retention strategies and tactics being deployed for individual studies and programmes. Joyce has worked for the last 9 years at ICON where she is a Director of Patient Recruitment Services and is Patient Engagement SME in ICON’s rare disease team. She lives and works in Glasgow, UK.
Victor Moreno, MD, PhD
Director of Clinical Research
Victor Moreno, MD, PhD is the Director of Clinical Research at START-Madrid-FJD. He obtained the Medical Degree by the Univerisity Complutense of Madrid in 2004 and completed his specialized formation in Medical Oncology at Hospital Universitario La Paz during 2005 and 2009. During 2008-2010 he obtained the Master Degree in Molecular Oncology by the CNIO (Spanish National Cancer Research Centre, Madrid). He obtained his PhD Doctorate, with European Mention and highest commendation in 2013 for his translational research in rectal cancer.
After finishing the residency period he obtained the Excellent Resident Grant, awarded to complete his training in Phase 1 oncology clinical trials in the Drug Development Unit of the Royal Marsden Hospital (Sutton, UK) during 2010-2011.After the completion of the Fellowship, he returned to a Consultant position in Medical Oncology to the Hospital Universitario La Paz where he was member of the Neuro-Oncology and Gastrointestinal Tumors section and coordinator of the Oncology Phase I Unit. In 2013 he joined the initiated the Phase 1 program in the new center START-Madrid-Fundación Jimenez Diaz (FJD) as Clinical Researcher dedicated exclusively to early clinical trials and drug development with special focus on targeted therapies, cancer immunotherapy and adoptive cell therapy. His team has been actively involved in development of modified TCR for solid tumors including MAGE A10, MAGE-A4 and NY-ESO as well as TILs for different solid tumors. He has published more than 40 articles in main journals such as The New England Journal of Medicine, Nature, Journal of Clinical Oncology and Lancet Oncology among others.
Sergii Myronenko, MD
Kiev Clinical Research Forum, Ukraine
Dr. Sergii Myronenko is a Chairman of Kiev Clinical Research Forum, an international platform for the clinical research industry based in Kiev, Ukraine; Head of International Affairs at UACRP (Ukrainian Association of Clinical Research Professionals – UACRP); key founder and CEO of PharmaSich CRO, Life Sciences consultancy headquartered in Kiev, Ukraine.
Ildikó Nagy, JD
PRA Health Sciences, Hungary
Ildiko is Associate Director of Global Study Start up of PRA responsible for the delivery of Clinical Trial Agreements in Central and Eastern Europe. As a bar qualified lawyer, she also oversees the coordination of legal reviews with Sponsors for CTA’s and serves as a coordinator of changes in regulatory, transparency, privacy, and other laws and regulations as they impact CTA negotiations and delivery. In this capacity she also monitors budget development and negotiation for compliance with Anti-Bribery and Corruption compliance for PRA. Prior to joining PRA 10 years ago, she gained two years experience in a law practice in Hungary. Assigned to the leadership and delivery for strategic Biotech and Pharma clients, Ildi has a unique global perspective on Contract and Budget delivery, Site and Sponsor relationships, and industry developments.
Miriam Noel, BScNH
SIBAmed Studienzentrum GmbH, Germany
Miriam’s educational background as a registered dietitian lead 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. Miriam has been a member of SCRS since 2017.
Patryk Ogórek, MD
CEO & Founder
Doctor, innovative businessman, programmer. Thanks to these 3 elements and holistic approach to the healthcare system I’m trying to propagate progressive solutions for patients, doctors and non-medical staff changing the old-fashioned way of work. As an owner of clinical research network in Poland, fan of big data analysis and inferring I’m developing Aurero ecosystem which is integral system dedicated for medical units and clinical research sites. Thanks to thousands of doctors working every day in Aurero and hundreds of thousands of patients getting care with our system we are developing telemedical tools which will give us ability to spread easy-accessed doctors all over the world. So besides amazing world travels and best TV-seriel, I’m open to talk with you about newest solutions, I believe together we can make something great!
Society of Clinical Research Sites (SCRS), USA
Casey Orvin is President of the Society for Clinical Research Sites (SCRS). With nearly 20 years of experience working with the site community, Orvin previously served as Executive Vice President of Business Development for Synexus, and Vice President of Marketing and Sponsor Recruitment for Clinical Research Advantage. Orvin is a champion for clinical research sites with experience creating outreach programs, developing key partnerships, and generating study opportunities for hundreds of clinical research sites globally. He is an active community member and dedicated volunteer in the Phoenix area where he lives with his wife and three children.
Guillermo Ortiz, BBA
Fundacion Estudios Clinicos, Argentina
Guillermo is an experienced General Manager with a demonstrated history of working in the medical practice industry. Skilled in Marketing Management, Negotiation, Business Planning, Entrepreneurship, and International Business. Strong sales professional with a Bachelor of Business Administration (BBA) focused in Business/Managerial Economics from Universidad Austral, Rosario.
Marina Palombini, MBA
Director, Clinical Trial Site Experience
Marina is Director of Clinical Trial Site Experience and is responsible for the development of communications and solutions aimed at building trusted relationships with the investigators and site staff that Pfizer partners with. She is an experienced global marketer who had led brands across the product lifecycle – from early development to post-patent. At Pfizer, she has held diverse roles including global and regional marketing, alliance management and customer insights. Prior to Pfizer, she worked at Deloitte and Tilia, now Newell Brands. Marina graduated from UC Santa Barbara with a BA in Business Economics and earned her MBA at Columbia Business School.
Ângela Papa, PharmD, MSc
Director, Clinical Management
Ângela Papa is a Director of Clinical Management at PPD, holding a PharmD and a MSc in Public Health and with > 15 years’ experience, with a strong interest and experience in the implementation, at regional level, of the RBM methodology and ICH-GCP E6 R2.
Christine Phillips, CSci, MSc, PhD, FRSB
Sr. Director, Strategic Site Solutions
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; focused 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 18 months old.
Dorota Pokłońska, MD
Executive Director, SSU
Over 25 years of experience in clinical research in various operational and executive roles, in Study Start-up, Clinical Monitoring, Project Management, Patient Recruitment, Engagement & Retention in CRO environment. Creative leader and innovator, focused on process improvements, time and process waste elimination (Lean Six Sigma, Kaizen), active dialogue and partnership with sites and patients. Conference speaker, lecturer for patient’s associations, promotor of patient’s education. Since Jan 2019 responsible globally for Study Start Up team at Clinipace.
Dr. Warner Prevoo
OLVG, Amsterdam, The Netherlands
Warner Prevoo is in daily life an interventional radiologist treating cancer patients. And then out of the blue he becomes a cancer patient himself. He struggles how to be a real patient and at the same time stay the doctor he was before. He tells about his new insights of the relationship between doctors and patients. They should team up. Doctors should not be empathetic in an artificial manner. Patients should ask their doctor how they will live. Not how long. After having worked as an interventional radiologist for 16 years, Warner Prevoo found himself on the other end of the spectrum: Warner, being slightly disturbed about a persistent cough, cycled to the hospital where he had a CT-scan performed. Never would he have dared to think that this scan would radically change his life. The verdict? Advanced lung cancer. He was no longer the doctor, but the patient. Now, as a practicing doctor, Warner has come to understand patients better than ever. The preconceived idea that doctors are immortal no longer holds.
Amanda Rangel, MS, CCRC
VP of Business Development
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.
Lilette Riva, BSc
Global Site Partnership Manager, Europe
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.
SVP, Digital R&D Strategy
Dr. MaryAnne Rizk has 20+ years of experience transforming the way the biopharmaceutical industry manages digital health to improve patient outcomes. Dr. Rizk has globally lead Oracle’s and Medidata’s CRO partner market strategy and building eClinical outsourcing alliances for over 90+ organizations from global pharma to emerging biotech/medtech firms. Prior to joining software SaaS firms, MaryAnne found her patient-driven mission working at Merck for nearly a decade, where she led both clinical and commercial outsourced global technology initiatives. Effective in building enterprise clinical outsourcing collaborations, MaryAnne enables organizations to leverage innovative SaaS cloud-based platform technologies to accelerate drug/device development among lifescience stakeholders: Pharma, Emerging Bio, MedTech, CROs.
David Rosenbaum, MSc
Rosenbaum Consulting, Bulgaria
David has an MSc, Regulations and Standards in Medicine with extensive experience in Clinical Operations. He is a strategic problem-solver for Country Selection, Feasibility and Vendor Management to Biotech companies. David is a trusted partner to Site Management Organizations and independent sites across the European Union.
David has an MSc, Regulations and Standards in Medicine with extensive experience in Clinical Operations. He is a strategic problem-solver for Country Selection, Feasibility and Vendor Management to Biotech companies. David is a trusted partner to Site Management Organizations and independent sites across the European Union.
Macarena Sahores, PhD
Associate Director, Central Monitoring Services
Syneos Health, UK
Macarena Sahores is an Associate Director of Clinical Operations within the Central Monitoring team at Syneos Health. Her area of focus is Central Risk Management, with a Client oversight role for Integrated Quality Risk Management (IQRM).
Associate Director, SMO Liaison
Parexel International, Germany
Claudia has over 15 years of experience working in the pharmaceutical industry at the site, sponsor and CRO level. She started her clinical research career as scientific researcher in pain management, became a site manager, developed into a global project manager in oncology after which she moved into feasibility and site selection. – Currently Claudia works with Parexel’s global SMO and site network partners to deliver new treatment options to patients.
Oriol Serra Ortiz, MS, MBA
Head Site Intelligence & Selection
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.
Piotr Sawicki, MSc
Head of Clinical Trials
Medical Center CMP, Poland
Piotr Sawicki is an enthusiast of modern solutions in patient engagement and recruitment underpin by patient profiling and understanding of patients needs. From 2019, Piotr has been Head of Clinical Trials Department in Medical Center CMP where he is responsible for managing clinical trails and patient recruitment across 13 own clinical sites. Previously, linked with Synexus in role of Head of Patient Engagement for Central and Easter Europe.
Piotr is responsible for patient recruitment and retention in Poland, Bulgaria, Ukraine, Czech Republic and Hungary. He started his career in clinical research industry in Poland in late 90’s in well-known private clinical research unit – Osteomed which was sold to Synexus in 2012. In 2002 he initiated Clinical Research Centre – 56 bed unit dedicated to Phase I and pharmacokinetic studies. In 2007 CRC was sold to Lambda – first Indian CRO entered European market.
Helena Sigal, MD
Sigal SMS GmbH, Germany
SIGAL SMS was founded by Dr. Helena Sigal, who started her career in clinical research more than 15 years ago as an investigator. In 2008, Helena was appointed as Director Clinical Operations, responsible for leading 9 German research sites and established further sites across Europe. Following acquisition by Synexus, Helena continued growth in Germany, leading a team of 70 clinical researchers.
Five years ago, Helena established her own SMO, determined to share her knowledge and expertise with private physicians across Germany to establish a network of fully supported clinical research sites alongside successful medical practices. Today, Helena Sigal leads a young, successful and highly motivated team, which works proactively, creatively and solution-oriented which she is very proud of. The network currently includes around 30 study sites in Germany and new ones are constantly being added.
Lucie Špatenková, MSc, Mgr.
Clinical Research Center, Czech Republic
Lucie is on a mission to build Clinical Research Center – the first Site Management Organization (SMO) in the Czech Republic. She is developing a team of professional clinical study coordinators who increase the work efficiency of physicians and patient comfort. Concurrently she is forming a network of selected physicians from various medical fields in order to ensure high quality elaboration and execution of clinical studies. Educated as biologist & chemist, trained as monitor & project manager of complex commercial and EC granted clinical trials, she can provide her clients with vast know-how of CRO processes as well as with her experience to standardize, automate and digitalize internal processes of the SMOs.
Wojciech Szczepanik, PhD, MBA
Executive Director, International Site Network
Pratia S.A., Poland
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, later Central & Eastern Europe and finally EMEA. Recently Wojciech joined Pratia, where as Executive Director of the International Site Network he expands the range of Pratia’s operations globally.
Nikola Tchakinsky, MD, MBA
General Manager Site Augmentation and Patient Solutions
International Research Network Ltd ,Bulgaria
Nikola Tchakinsky is a Medical Doctor. He does have over 17 years’ experience in Clinical Research as Clinical Project Manager, Project Lead, CRA LM and Regional Head of FSP department serving as a key account of 3 biggest FSP providers in the region. Nikola has long experience in Rheumatology, Oconology, Hematology and CNS trials. Since the beginning of 2020 he joined IRN, spin-off of Comac Medical as a part of its leadership team.
Svitlana Tonkovyd, MD
Director, Clinical Site Operations
Svitlana has over 15 years of experience working in clinical research. She graduated in medicine at Medical University, Ukraine, undertook postgraduate training in Oncology and is a certified Medical Oncologist. She began her career in research as an Investigator at Oncological Hospital managing adult studies in solid tumors. She joined Quintiles in 2006 where she took on roles of increasing leadership from CRA to Clinical Team Leader. She later joined Wyeth Poland where held the role of Medical Monitor across all phases in Oncology and Onco-Hematology. Svitlana transitioned into Pfizer in 2010 taking on line management responsibilities for medical monitoring, continuing medical oversight activities in Oncological studies for EE countries. Most recently, she has served as a Director, Clinical Site Operations responsible for several European countries.
Rianne Tooten, BSc
Clinical Research Professional
Rianne Tooten, The Netherlands
“The medical device world can be complicated if it is not 100% clear which path to take.” Rianne Tooten is a company that offers trainings, consultancy and guidance on the practical implementation of the Medical Device Regulation and ISO14155, the international standard for clinical investigation of medical devices for human subjects. Rianne Tooten brings more than 10 years of experience in clinical research with medical devices. It is her mission to transfer her knowledge and experience to help professionals to find practical solutions on the implementation of the legislation and regulation, by translating it into their daily practice. All trainings and tailor-made programs that Rianne Tooten offers are personal, practical and directly applicable. Her motto is: “In reality not everything is black and white.”
Senior Solutions Specialist
Medidata Solutions, USA
Michael is a member of Medidata’s Mobile Health team and is a subject matter expert in electronic informed consent and virtual trials. Over the last decade Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world to pioneer the use of electronic informed consent and virtual trials. His 30-year career in medical research includes 8 years with the US government conducting and supporting surgical research and 22 years working in the commercial sector to provide technology solutions that improve and support preclinical and clinical research. Michael has been a participant in two clinical trials…but had to consent on paper because eConsent had not been invented yet! Michael is a decorated veteran of the United States Navy and resides in Austin, Texas where he is an elected public official, serving his local community.
Michaela Vančová, Ing, MPH, CRCP
Clinical Operations Director
Slovak Research Center, Slovakia
Michaela Vančová is a chemical engineer (analytic chemistry) with additional masters degree in public health. She has 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 founding Slovak Research Center, where she is the president and co-founder and working as Clinical Operations Director. Previous companies: Icon, KCR, Octapharma, Boehringer Ingelheim.
Isabelle Van der Haegen
Country Head Clinical Operations
Since 1990, Isabelle has been involved in the planning and execution of clinical trials within Europe in all phases of drug development and in multiple Therapeutic Areas among oncology, immunology, hematology, cardiology, nephrology, infectious disease, neurology. In her current function she leads the Country Clinical Operations team in Belgium, Netherlands and Portugal, being part of the Region Europe West.
At Roche, Isabelle is an active member of the EU Clinical Trial Regulation (CTR) readiness team aiming to prepare the whole organization to be ready for the implementation of CTR. She is a Fellow at the University of Brussels. The Fellowship program supports the students for tomorrow’s knowledge and stimulates innovation, entrepreneurship and openness to the world and breaks down walls between academia and society, the business community and policy makers. Isabelle is searching for hope for the patient and their loved ones is my personal drive to excel.
Vivienne van de Walle, MD, PhD, CPI
Director & PI
PT&R, The Netherlands
Viviënne 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 as thought leader and in consulting, education, management, and executive functions at CROs, pharma and trade organizations i.e. ACRP, SCRS, TransCelerate and NVFG. With her PT&R-team she was also the proud winner of the inaugural SPRIA EU. She started her research career 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.
Sandra Vingerhoedt, MS
Clinical Project Manager
Bayer AG, Belgium
Sandra lives in Belgium and has a master degree in Biomedical Sciences. She has been working in the pharmaceutical industry since graduating, for 17 years now. Her main area of interest and activity has been oncology and she has been involved in all study stages ph I to ph IV. Sandra has worked closely with sites in Belgium as a CRA, later on a more global level as Study Manager and have been part of various working groups touching on various operational aspects of clinical studies, eg data management, eCRF, site startup, … Currently she is overseeing multiple studies as Clinical Program Manager.
In this role Sandra ensures operational alignment across multiple studies within a program, have budget accountability, provide support for the teams where needed and ensure operational feasibility is taken into consideration in long term planning.
Léon van Wouwe, MSc (Medical Biology)
Director, Site & Patient Networks
Léon brings many years of experience from working in Clinical Development Operations in several organizations including Celgene, AstraZeneca, Roche, Merck KGaA and also some smaller biotech companies. He also worked across a range of TA’s but especially in oncology and autoimmune diseases. Léon aims to inspire and engage people & teams and brings a strong cross functional focus as well as an innovative approach to running clinical studies and developing new treatment options for patients. Currently working at Clinerion as Site & Patient Network Director, Léon’s main focus is on building clinical research networks globally, offering practical support in the form of digital technologies to clinical trial sites, and helps to bring together clinical research sites, pharmaceutical sponsors, CROs, other health service providers and healthcare policymakers in a bid to reimagine clinical research and accelerate patient access to new treatment options.
Ivan Vyshnyvetskyy, MD, PhD
Ukrainian Association for Clinical Research, Ukraine
Ivan Vyshnyvetskyy has graduated from Donetsk National Medical University (Ukraine) where he gained a Ph.D. degree in Cardiology and Associate Professorship in Internal Medicine. He also worked as Head of Clinical Trial Administration Unit at Donetsk National Medical University until 2014. Ivan has been conducted dozens of sponsored clinical trials as a Principal Investigator with 16 years of experience. In 2014 he commenced a dedicated multi-specialty clinical research site, based on a medium-sized public hospital in a rural region of Ukraine, from scratch. Ivan and his team have developed their business to a small Site Service Organization, which supports the operations of brand new sites in different therapeutic areas. Since 2018 he has also been heading the Ukrainian Association for Clinical Research – a fast-growing professional community of clinical research professionals with ambitious aims of doubling the number of clinical trials conducted in Ukraine.
Vice President, Commercial Operations
Trifecta Clinical, USA
Rick Ward is Vice President of Commercial Operations at Trifecta – a leading global clinical technology solutions provider, producing more than 350 live, on-demand and web-based Investigator meetings each year in 87 countries. Prior to joining Trifecta, Rick has driven commercial growth strategies and led business development efforts for various CRO and niche service organizations supporting the Clinical Trial industry. Rick has over 20 years of business development experience, in both direct sales and sales management roles. Rick graduated with a degree in Marketing from the Pennsylvania State University and is a member of the Hammond Society, having served on Penn State’s Smeal College of Business Alumni Society Board of Directors from 1999 through 2013. Rick is also one of the founding members and former President of the Smeal Business Club of Philadelphia.
Łukasz Wiech, MD, MBA
Accelerated Enrollment Solutions, Poland
Łukasz is a Physician, Public Health Specialist with 10 years of experience in coordinating sites and trials and opening new clinical trial sites. His field of expertise lays in site issues, including feasibility, quality, human resources management, operational management. Łukasz has experience as an Investigator in various Therapeutic Areas, as well as a Manager with a proven record of building and managing diverse teams, experienced in effective matrix cross-functional organizations. He also works as a Lecturer and Postgraduate Program Manager with over 1100 successful alumni in the field of clinical trials management and healthcare management. Łukasz enjoys delivering practical business knowledge, using various educational methods.
David Wright, MBA, MSc
Head of Clinical Operations Western Europe
Johnson & Johnson- Janssen, UK
David has 25 years of experience across a variety of product development and international clinical operations roles at pharmaceutical, biotech and medical device companies. He started his career in the cardiac medical devices industry in Sydney, with Telectronics Pacing Systems, working in software development and later field technical support for pre-clinical and then clinical research projects in Europe. In the early 2000’s David moved to the pharmaceutical industry, holding a variety of European and global clinical operations leadership roles at Amgen, a US biotech company. David joined Janssen in 2016 and is currently Head of Clinical Operations for the Western Europe cluster (France, Germany, Italy, UK, Spain, Portugal, Belgium, The Netherlands & Israel). He is accountable for late development trial planning & delivery across the cluster, optimizing productivity by building synergies across the region, and leading the long-term strategy for excellence in trial execution. David is based in the UK.