2021 Faculty

André Beukes, BProc(Law)
Director, IMS, Grants
Syneos Health, UK

André 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. André 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, André served as a finance manager for 13 years at a private hospital group in the UK.  André 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.  André lives in a 120-year house/DIY project with his lovely wife, Christine and their dog Lulu.

Bill Byrom, PhD
VP Product Intelligence and Positioning
Signant Health, UK

Bill serves as Vice President of product intelligence and positioning at Signant Health, where he also serves as a principal ePRO scientist. He has worked in the Pharmaceutical industry for 30 years and is the author of over 70 publications and two industry textbooks on electronic patient-reported outcomes (ePRO). His recent scientific work includes the use of wearable technology and bring- your-own-device (BYOD) eCOA in clinical trials. Bill recently served as Vice Director of the C-PATH ePRO Consortium and is an active member of the DIA Study Endpoints Community where he leads a cross-disciplinary group on the use of endpoints derived from wearable devices to support labelling claims and regulatory decision making. Bill provides independent eClinical commentary via LinkedIn and Twitter (@billbyrom).

 

Martine Dehlinger-Kremer, PhD, MS
Vice President of Scientific Affairs, Pediatric Subject Matter Expert
PRA Health Sciences
President, EUCROF, Germany

Dr. Dehlinger-Kremer’s expertise spans more than 30 years in the research industry, including 29 years of experience in global regulatory affairs, medical affairs, and pediatric leadership. Prior to joining PRA Health Sciences, she served in several executive leadership roles at global CROs, and has experience in global drug development in more than 40 countries. She has contributed hands-on to the global development of numerous products, including medicines for children, drugs for orphan diseases and biosimilars.  Her vision and leadership extend to service with a number of professional organizations – she is an observer member of the Coordinating Group of the European Network of Pediatric Research (Enpr-EMA) at the European Medicines Agency, chair of the Pediatric Working Group and also President of the European CRO Federation (EUCROF), serves as chair of the European Forum for Good Clinical Practice (EFGCP) Children’s Medicines Working Party and Board Member of the association, and is active in the International Children’s Advisory Network (iCAN).

In 2015, Dr. Dehlinger-Kremer was named one of PharmaVOICE’s 100 Most Inspiring People in Life Sciences.

Dr. Dehlinger-Kremer earned a Doctorate in Sciences from the J. W. Goethe University in Francfort on the Main, Germany;  a Degree of Advanced Study in Neurophysiology from the University Louis-Pasteur, Strasbourg, France; and a Master of Sciences degree from University Moulin de la Housse in Reims, France.

 

Paul Duffy, RGN
Global Head, Clinical Site Relationship Development
MSD, UK

Brian Egan, MA
Senior Manager, Communications & Engagement
TransCelerate BioPharm, USA

 

 

Brian currently manages communication and engagement efforts for TransCelerate membership, including leadership from 20 pharmaceutical companies. With a focus on raising awareness of solutions globally, Brian oversees the activities of a member network that spans more than 30 countries. Through the course of his career, Brian has focused on communications within healthcare, a passion that began as he worked 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.

Roman Fishchuk, MD, MSc
CEO, Clinical Trials Unit
Central City Clinical Hospital of Ivano-Frankivsk City Council, 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
Society for Clinical Research Sites (SCRS), USA

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.

Ken Getz, MBA
Founder and Board Chair, CISCRP
Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, USA

Ken Getz is the Director and a professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts grant-funded research on pharmaceutical R&D management and execution; protocol design optimization, contract service provider and investigative site management, e-clinical technology and data usage and patient engagement.  He is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise.  A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. He holds a number of board appointments in the private and public sectors and serves on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science.  Ken received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University.  He is the founder of CenterWatch, a leading publisher in the clinical trials industry, and one of several businesses that he has created and sold.

Rick Greenfield
CEO
Realtime Softward Solutions, USA

Rick has nearly 20 years of experience in the Clinical Research industry. He was part owner and helped build one of the largest multi-specialty research sites in the US over a 13 year period. With a lack of truly effective and efficient CTMS systems available, he put his education in Information Systems to work and began the development of RealTime-CTMS, which eventually became the backbone of his site’s operations. RealTime was built from the ground up with the input of all of the key players at the site level to include site managers and stakeholders, Investigators, clinical research coordinators, regulatory compliance specialists, quality control and quality assurance personnel, advertisers and recruiters, clinical research associates (monitors) and more.  It is Rick’s goal to continue to build innovative systems for sites, Sponsor and CROs that will contribute to operational excellence in clinical trials.

Daniel A. Gutierrez, PhD
Customer Solutions Director
Clinerion, Switzerland

Daniel Gutierrez is a physicist and cardiac physiologist by training educated at the EPFL, University of Bern, and ETH Zurich. While working at Roche, his research was key in the development of techniques to study antibody mode-of-action mechanisms during tumour cell killing using the drugs Gazyva, GA201, CEA-TCB and other T-cell bispecific antibodies.

Afterwards Daniel founded his own start-up, GeneLook AG, where he developed a digital health solution in the field of genetics to remotely pre-screen and validate rare disease patients. He developed a platform to enable patients share specific mutations found in their DNA while keeping the rest of their DNA code undisclosed and secure.  

Currently at Clinerion, Daniel is developing new busines models in the field of RWD & RWE access through Electronic Health Records and Clinical imaging to achieve remote patient pre-screening and enable researchers to accelerate and refine site selection and patient enrollment.

Lani Hashimoto
Associate Digital Solutions Director, CARE for the Experience, Data & Digital
Novartis, USA

With operational expertise and extensive industry relationships, Lani has worked across all therapeutic categories in Phases I-IV including rare diseases, medical devices, and incorporating innovative technologies.

Ms. Hashimoto’s perspective is patient-empathetic while encompassing the whole study context from investigator site needs to patient recruitment’s impact on downstream resources and processes. Lani’s expertise also includes feasibility, patient privacy and advocacy initiatives.

Joining Novartis in October 2014, Lani is focused on connecting patients to clinical research. In her current role, Lani supports new indications and programs with early evidence to support decisions, patient engagement facilitation, and patient recruitment strategic planning.

Megan Heath, PhD
Head of CSU
Sanofi, Europe Region

Megan Heath is Efpia Lead in the PILOT study within IMI Trials@Home project. Megan has 25 years of operational experience managing all phases of the drug development process. Megan started her career as a phase I research associate at Inveresk Clinical Research, UK before moving through various clinical operations positions in the industry. Megan joined Sanofi in Medical Affairs Clinical Operations and is currently the Head of Clinical Studies Units European Region. Megan graduated with a Bachelor’s degree in Pharmacology from Glasgow University before completing a PhD in Asthma Pharmacology at University of Manchester.

Emil Hoeck, MSC
Sr. Director, Virtual Trial Solutions
VirTrial, Denmark

I have a background in academic research and a decade of experience in clinical trials from working at Sites and CROs. I have always had passion for technologies that solve real-life issues and in recent years I have been fortunate to work with pharmaceutical companies as they navigate telemedicine, patient engagement, and remote data collection in clinical trials. That being said, I sure am looking forward to when we can all go back to meeting in person!

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.

Radoslaw Janiak, MD, MBA
CEO
FutureMeds

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 dedicated Research Site Network in Europe .

Derek Johnston
Director, Regulatory Intelligence
Covance, UK

Derek Johnston currently holds the position of Director in Covance’s Regulatory Intelligence Office at Covance by Labcorp. In this capacity, Derek leads regulatory interpretation, implementation and communication across Covance by Labcorp, ensuring compliance with current and upcoming regulatory requirements. Prior to joining Covance in 2012, Derek studied traditional medicine prior to joining the pharmaceutical industry in 2004. Starting at Johnson & Johnson he worked across functions gaining familiarity with regulations and requirements pertaining to Good Clinical Practice (GCP), Good Clinical Laboratory Practice, (GCLP), Good Manufacturing Practice (GMP), and Good Pharmacovigilance Practice (GPvP). Previous chair and ongoing member of ACRO’s EU Scientific & Regulatory Committee Derek has the opportunity to meet with regulatory authorities to discuss current interpretations, compliance trends and upcoming changes or initiatives.

Maria- Joao Leitao, MBA
Regional Site Advocate
Vertex, Portugal

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.

Alison Liddy
SVP, Site Operations
ICON, Ireland

Alison has over 17 years of clinical research experience, focused on clinical data operations, clinical system implementations, relationship management and transformational change strategies.  In her current role, Alison leads Site Operations for ICON.   Prior to her current role, Alison was SVP, Global Head of Data Operations and Risk Based Monitoring where she managed a team of 900+ employees.
Her previous roles included VP, Strategic Alliance Management at ICON, where she managed key client accounts as well as the large-scale transition of studies to ICON from a large pharmaceutical client. Subsequently she led all clinical development process, quality and reporting solutions for this function.  Prior to joining ICON, Alison worked within Accenture’s R&D Life Science Practice as a Manager on various system implementation projects and as a Project Manager at Phase Forward/Oracle. She has gained extensive experience in transformational change initiatives for many of the top pharmaceutical companies. Alison holds a B.A. (Mod) Natural Sciences, Chemistry from Trinity College Dublin and a Post Graduate Diploma in Business Studies, Smurfit Graduate School of Business, UCD.

James Lewis
VP
Barrington James, UK

James comes from an esteemed recruitment background having started his career within recruitment almost two decades ago, with the majority of this time spent focused on the contract market. He joined Barrington James in 2012 to use his knowledge and expertise to expand our Contract division as our Global Director. James is a passionate and driven recruiter who is motivated by the fast pace world of contract recruitment.

Splitting his time between the USA and Europe, when not sitting on a plane, James tries to either be a golfer or professional gambler, of which he is not great at either. A massive Liverpool fan James is slowly turning his 2 daughters into football fans and the house from pink to red!

Joachim Lövin
eTrials Senior System Supporter
Novo Nordisk, Denmark

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
Head of DCT Market
Covance, USA

Under pressure to maintain patient safety and trial continuity during the pandemic, what had been a tentative, exploratory adoption curve for decentralized clinical trial (DCT) models quickly transitioned to the beginning of a new normal for patient-centric clinical trial conduct. Because DCT design doesn’t follow the traditional templates, some sponsors and sites felt they were going back to the drawing board with each trial. For this reason, we have introduced a series of pre-packaged solutions that are configurable to the needs of each trial, while streamlining the front end during the design and planning stage. These solutions, combined with our enterprise delivery approach which seamlessly delivers most services from a single vendor, provide efficient startup and coordinated service delivery. By incorporating stakeholder insights from a year of dynamic change, we are transforming the clinical trial experience for patients, sites, and sponsors.

 

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
Syneos, UK

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.

Marieke Meulemans, MSc
CEO 
GCP Central B.V., The Netherlands

Marieke Meulemans founded GCP Central in 2012 and is the driving force behind the company’s powerful vision. She has a Master’s Degree in Health Sciences, and over 15 years of experience in the life science industry. Including her work for top 50 Pharma companies, CROs and training academic hospitals in clinical research, Marieke has strong regulatory knowledge and combines this with her expertise in strategic learning management and innovative online learning methods. It is Marieke’s mission to make GxP knowledge a core part of everyday practice and improving the quality of research. She wants to make yearly GxP training obsolete by pioneering a continuous learning strategy in the life science industry.

She is keen on supporting global initiatives with her expertise and is member of the CTIS Expert Group of EMA, the EUCROF Events and Training Working group and supports various initiatives training Clinical Research Sites in the implementation of the CTR and the use of the CTIS.

 

Karen Noonan, MA
Senior Vice President, Global Regulatory Policy
ACRO, USA

Karen joined ACRO in 2014 and leads ACRO’s global regulatory advocacy — including engagement with European regulators on the EU Clinical Trial Regulation, the General Data Protection Regulation, and clinical trial modernization. Karen has aA in political science, and a BA in French.

Patryk Ogórek, MD
CEO & Founder
Aurero, Poland

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!

 

Casey Orvin
President
Society for 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.

Ângela Papa, PharmD, MSc
Director, Regional Operational Delivery
PPD, Portugal

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.

Scott Palmese, MS
Senior Director, Site Networks Molization Lead
Accellacare (part of ICON, plc)

Scott Palmese is currently Senior Director, Site Networks Mobilization Lead for Accellacare (part of ICON plc).  In his role, he leads a team with the goal of growing and harmonizing operations across the Accellacare network.  Prior to his current role , Scott was Vice President of Site Operations at ClinX, LLC, overseeing several key business functions including business development and site network operations for sister companies ClinEdge, BTC Network, and Guidestar Research.  Before that, Scott was an operations coordinator for one of the largest clinical research sites in the United States.  Scott is a specialist in site operations and has worked in the industry for over 10 years, supporting sites with everything from business development and patient recruitment to financial operations and organizational structure.  Through his extensive site experience, Scott has learned how to operate sites effectively and has spent the better part of his career working with sites to help them grow and streamline their operations.  Scott currently resides in Boston, MA with his wife and when he is not working with sites, you can probably find him at the theme parks in Florida.

Linda Rutgrink, MSc
Regional Trial Manager
Sanofi, The Netherlands

David Rosenbaum, MSc
Managing Director
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.

Claudia Schaub
Associate Director, Strategic Site Network Access, Global Site Solutions
Parexel International, Germany

Claudia has over 16 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 Strategic SMO and site network partners to deliver new treatment options to patients.  

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.

 

Nuno Sousa, Professor
Director of the Clinical Academic Center
Hospital de Braga, Portugal

Nuno Sousa is a Full Professor at the School of Medicine of the University of Minho and its current President. He is a member of several medical education boards, as well as of medical assessment associations (NBME, EuroBMA). He is a Physician, Neuro-Radiologist and the Director of the Clinical Academic Center – Braga (2CA-Braga), at Braga Hospital. He is also the Director of P5 Digital Medical Center Association (ACMP5), based at the School of Medicine of the University of Minho.

Nuno Sousa is a researcher in the field of Neurosciences at the Life and Health Sciences Research Institute (ICVS) of the University of Minho. He has published more than 450 research papers in international journals, having an h-factor of 61 and being cited more than 15000 times. He has supervised several PhD and Master’s students and coordinated numerous research projects, with funding exceeding € 5M in the last 5 years. He received 6 awards for his research accomplishments, of which the Janssen Neuroscience Award and the Ministry of Health Gold Medal in 2011. He is a member of several national and international health and research commissions.

He is Editor-in-Chief of Frontiers in Behavioral Neuroscience and Member of the Editorial Board of the Journal Neurobiology of Stress. Between 2011-2015, he was President of the Portuguese Society of Neurosciences and between 2014-2016 he was President of the Scientific Council for Life Sciences and Health of the Science and Technology Foundation. He is a member of the Executive Board of Bial Foundation.

Nicole Stansbury
Vice President, Central Monitoring Services
Syneos Health, USA

Nicole Stansbury, Vice President, Central Monitoring Services, joined Syneos Health in February 2019.   Nicole has 29 years of experience in the industry beginning as a study coordinator in a multi-therapeutic site followed by 21 years at a large, global CRO where she spent several years as a Clinical Research Associate (CRA) and Project Manager (PM) before moving into leadership roles.  Nicole’s leadership roles included Head of Clinical Management in the Central US where she oversaw Clinical Team Managers (CTMs), CRAs and administrative staff and Head of Global Clinical Performance, a group responsible for clinical metrics, systems, process and quality where Nicole led the development of the risk-based monitoring (RBM) strategy, process and tools.  Nicole has consulted with biotech companies on ICH E6 R2 compliance, conducted risk management training, performed a detailed assessments of EDC, CTMS, RBM and eTMF technologies for a small CRO and completed a risk management and centralized monitoring process assessment for a large pharmaceutical company.

Nicole has a yellow belt in Lean Six Sigma, completed a Global Leadership program, received the 2011 CEO Leadership Excellence Award, met with the FDA in 2014 to share RBM strategy ideas, participated on ACRO’s RBM Forum, presented at numerous industry conferences on RBM and published several articles on RBM and Change Management.

Nicole has a B.S. in Animal Science from Texas A&M University.

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.”

 

Isabelle Van der Haegen
Country Head Clinical Operations
Roche, Belgium

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.

 

Tiffany Valentine, MBA, PMP
Associate Director, Clinical Innovation
BMS, USA

25 years of pharmaceutical experience managing local and global clinical trials, developing and launching digital projects, innovation campaigns, and industry consortia workstreams. ​ Responsible for running and implementing new clinical innovation and digital opportunities to improve BMS Global Clinical Operations productivity and effectiveness, site & patient experience, and engagement in clinical studies, enabling BMS to become an industry leader in light of clinical innovation. ​ Driving the implementation of prototypes, proof of concepts, and pilots that support the delivery of innovative clinical development and clinical operations opportunities.​

Vivienne van de Walle, MD, PhD, CPI
Director & Owner
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.

Ivan Vyshnyvetskyy, MD, PhD
President
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.

Łukasz Więch, MD, MBA
Partnership Manager
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. 

Julia Williams
Operations Programme Leader, Oncology
F. Hoffmann-La Roche, Ltd. 

Julia Williams is an Operations Program Leader in Product Development at Roche. During her nearly 30 year tenure, she has led programs from first indication decisions through NME approval and beyond. She has experience across multiple therapeutic areas with a focus the last 8 years in oncology. As a leader in Global Operations, Julia led the global transformation to Risk Based Monitoring. She is passionate about Patient Experience and transforming clinical trials. 
 
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