2018 Faculty

Roberto Aguirre, MD, CPI, CCRP
VP, Global Research Director & Co-Founder
AGA Clinical Trials, USA

Dr. Roberto Aguirre is a certified Principal Investigator, VP, Global Research Director, and Co-Founder of AGA Clinical Trials (Miami, FL) and AGA Clinical (Ecuador), both multi-specialty Phase I-IV Research Centers. He is also a doctor of medicine and surgery in Ecuador and has been involved in over 183 trials since 2005. He spent time as a Clinical Research Coordinator at the University of Miami, Miller School of Medicine from 2005-2006, and CRSF since 2006-2007. Dr. Aguirre has also spent the last 22 + years volunteering as a Diabetes Senior Instructor at the FUNDACION ASISTENCIA DIABETOLOGICA ECUATORIANA where he helps to educate, treat patients and teenagers on how to manage their diabetes diagnosis including; carbohydrate counting, insulin management therapy, as well as psychological support for patients and families after the initial diagnosis. He has a passion and specialty in Clinical Operations and International Business Development.

Todd Albin, MBA, CCRP
Senior Director, Global Site Relations
Acurian, USA

Todd Albin, MBA, CCRP is an experienced clinical research professional who has worked in the late phase site environment for 18 years. He has worked as a study coordinator, site manager/director and regional manager for research sites and site management organizations in Florida, California and Arizona. Todd was also an adjunct faculty instructor for Pima Community College’s Clinical Research Coordinator program where he developed curriculum and taught classes on clinical research site coordination and management, ethics and diversity in clinical research. In 2014, he joined the Global Patient Recruitment and Retention company, Acurian, where he is the Senior Director of Site Enrollment Optimization. Todd is a Certified Clinical Research Professional and received his bachelor’s degree in business from the University of Miami and his Master’s in Business Administration from Florida International University.


Valdo Arnera
General Manager Geneva Office & Scientific Advisor
ERT, Switzerland

A Medical Doctor by training, Valdo has over 30 years of experience in the pharmaceutical industry. After having practiced medicine in various positions, he started his career in the industry as a clinical pharmacologist in a Ciba-Geigy’s daughter company. He then founded the first European Central Clinical Laboratory dedicated to clinical trials, SciCor (now Covance Central Laboratory) in 1992. After that, he joined PHT in 2000, and founded its European affiliate in January 2001. PHT was acquired by ERT in May 2015. Skilled in both science and management, Dr. Arnera currently serves as the General Manager of ERT eCOA European operations. He has also been very involved with DIA and was the co-chair of the DIA 2011 Euromeeting. Valdo's goals are to improve the way clinical trials are performed and, more generally, the way healthcare is delivered.


Scott Askin
Digital Development Director
Novartis, Switzerland

Having been working in the Pharma industry for over 15 years, Scott Askin is digital strategist, intrapeneur and a self-proclaimed master of Data Management. Based in Basel Switzerland, he is a member of the Novartis Digital elite and leads the company’s work in the area of electronic Source (eSource) and electronic Informed Consent (eICF/eConsent). Spending the first years of his career working within a CRO and later moving into Pharma, Scott spent the majority of his working life in Data Management, later moving into Data Standards and more recently into the ever evolving and exciting world that is Digital. Scott has a proven track record of demonstrated success, in taking on and overcoming the “impossible” and bringing new technologies to fruition through identifying, testing and bringing solutions to scale, in close collaboration with internal and external stakeholders. Scott has a BSc (Hons) in Computing and Management Sciences from Sheffield Hallam University in the United Kingdom.


Wendy Baird
Senior Director, Contracts & Compliance
MeDiNova Clinical Research, UK

With a 23 year career in contracting and business development, Wendy is Senior Director, Contracts & Compliance for the Medinova Group with accountability for client, site and vendor contracting, corporate compliance and the global insurance program. She started her career in clinical research 12 years ago as a Study Project Manager before setting up and leading a central global contract management function for a Site Management Organisation. She recently moved to Medinova Clinical Research to support its strategic plans for international growth and continued site network integration.


Andrew Barker
Manager
Medtronic Industry Partnership Programmes (IPP), Switzerland

Andrew is the manager of Medtronic Industry Partnership Programmes (IPP) – a global initiative to bring Medtronic devices into clinical research through partnerships with industry partners. Since it’s inception in 2009 Medtronic IPP has been working mainly with pharmaceutical, biotech, and academic researchers to utilize the data capture functionality of our therapeutic devices to deliver high-quality medical data into trials.  A core service is to retrain trial staff on protocol specific data collection rather than therapy delivery i.e. a site may use continuous glucose monitoring on a daily basis to help diabetic patients but data blinding and subject anonymity requires special attention. Andrew is a polyglot engineer founded on a BSc from Kingston University UK and supported by a broad spectrum of experience over 30 years in diverse fields from medical devices, mHealth to fibre optics.


Andrew Benzie, MD
Head of Patients in Partnerships
GlaxoSmithKline, UK

Dr. Andrew Benzie is head of GSK’s Patients in Partnership programme. His role is to bring distinct enterprise leadership to establishing patient influence in GSK decision making, from early R&D through to marketed products. He leads on driving the process and business culture changes needed to increase patient involvement throughout the business, and across the medicine lifecycle. Andrew has worked extensively with HIV patients to ensure that their voices are heard in respect of their treatment, both in industry and the UK NHS. He joined GSK as Medical Director for ViiV Healthcare UK in 2012, from the NHS where he worked as consultant physician at Guy’s and St Thomas NHS Foundation Trust, London for 8 years, continuing to practice up until May 2016.


Mark. A. Campbell
Vice President, Programme Management
Synexus, UK

Mark Campbell is a seasoned programme and project management leader, with rich and diverse experience in both early stage and global, world class life science organisations. Mark manages the International Project Management team accountable for delivering our international clinical trial program. He has over 16 years’ life sciences experience and holds a BSc (Hons) and M.Sc. in Strategic Project Management from Leeds University where he is a also a guest lecturer. Prior to joining Synexus, Mark held a number of senior leadership and consulting positions for leading and emerging biotech/pharma companies, such as, Amgen, Fresenius Biotech, Quanticate and Johnson and Johnson.


Matt Cooper
Business Development & Marketing Director
NIHR Clinical Research Network, UK

Matt Cooper is Business Development and Marketing Director for the National Institute for Health Research (NIHR) Clinical Research Network. Previously he led the Network’s Cancer Specialty and prior to that has held clinical research roles within AstraZeneca UK, an NHS Foundation Trust and Leeds Institute of Molecular Medicine.


Edward Czerwinski
Director
Krakow Medical Centre, Poland

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


Ian Dalton
Senior Director, Finance
IQVIA, UK

 

Nikki Dewick
Director of Clinical Site Management, UK Cluster
Pfizer, UK & Ireland

Nikki holds an honours degree in Human Biology. She started her Clinical Research career in 1994 as a CRA with Sandoz. She then joined Pharmacia/Pfizer, maintaining a variety of roles throughout the Clinical Research spectrum culminating in her most recent position as Director of Clinical Site Management for UK/Ireland.


Diane Driver
Head Outsourcing Contracts & Strategic Partnerships
UCB, UK

Diane started her career as a pharmacologist at Smith Kline & French, before switching to Clinical Development in a CRO in 1988. She then spent 12 years taking roles of increasing responsibility and geographical scope, before moving to Pharma in 2000. During her time at UCB she has led global clinical development programs, set up and managed a global in-house monitoring team, as well as spending 3 years outside clinical operations in the strategic role of Global Project Leader leading global cross-functional teams to develop new drug candidates from research to clinical POC. In 2014 she returned to Clinical Operations to head up UCB’s Outsourcing Contracts & Strategic Partnering department, where she is responsible for developing and implementing the global clinical outsourcing strategy and the management /oversight of UCB’s Strategic Partnering relationships. In addition, Diane also represents UCB on the Oversight Committee of TransCelerate.


Paul Duffy
Director Clinical Research UK & Ireland
MSD, UK

Paul is a registered General Nurse with a Post Graduate Diploma’s in Medical Ethics and Law and also Medical Research, Biotechnology and Law. Paul joined the pharmaceutical industry following an eight-year career in Accident and Emergency nursing. His clinical experience includes working in a variety of global pharmaceutical and Clinical Research Organisations and small biotechnology companies, including European, USA, and Japanese managed organisations. He joined Schering Plough as Clinical Research Manager UK from Sosei Company, where he had worked as European Clinical Director for 3 years. In 2008 he was appointed Head of Clinical Operations, UK & ROI and was appointed Clinical Research Director for UK & ROI at MSD in January 2010.


Marie Emms
Head, Global Clinical Trial Engagement
Syneos Health, USA

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


David Fauvart, PMP
Associate Director, Clinical Innovation
The Janssen Pharmaceutical Companies of Johnson & Johnson, Belgium

David holds Master degrees in Physical Therapy and Management and is a PMI certified Project Management Professional. After several years working as a Physical Therapist, he joined the pharmaceutical industry in 2003, holding various positions in management and clinical operations at various pharmaceutical companies and clinical research organizations. In his current role at Janssen Clinical Innovation, David is currently leading the roll-out and implementation of eConsent as well as other Digital Health initiatives. David is passionate about technology, innovation and strategy execution.


Agnieszka Gackowska, MD
Senior Director Site Alliance, Global Head
PAREXEL, Poland

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


Almenia Garvey, MSc
Director, Health Care Alliances
Clinical Research Service
ICON plc, France

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.


Andrew Gebbie
Principal Solution Consultant
Medidata Solutions, UK

Andrew Gebbie is a technology specialist with over 25 years experience in the life science industry. Andrew has been with Medidata Solutions for more than 6 years and is currently a Principal Solution Consultant within the Solution Consulting group. Prior to his time with Medidata, Andrew spent 20 years with PPD where he held various roles including Data Manager, Database Builder and Clinical Research Associate. Andrew graduated from Glasgow Caledonian University with a B.Sc. in Applied Biology and is a member of the Institute of Clinical Research. He is based out of Medidata’s EMEA headquarters in Hammersmith, London and lives in Carluke in Lanarkshire, Scotland.


Steven Geller, MD
Medical Director
Centennial Medical Group, an RxTrials site, USA

Steven Geller MD FACP CPI graduated from the Johns Hopkins University School of Medicine in 1985 , and then completed his internal medicine residency at the Johns Hopkins Hospital. Since then he has been in private practice at Centennial Medical Group, where he is currently the Medical Director. He is also a Past President of the Medical Staff at Howard County General Hospital , and a past member of the executive committee of the board of trustees for the Johns Hopkins Medical Institutions. He has been performing clinical research for about 14 years and has been an investigator in approximately 85 studies. He has been a past member of the CPI examination committee for the American College of Research Professionals (ACRP) and a past member of the Leadership Council of the Society of Clinical Research Sites (SCRS).


Prof Martin Gibson, PhD, MB ChB, FRCP
Chief Executive Officer
Northwest EHealth, UK

Martin Gibson serves as clinical director at the NIHR Clinical Research Network for Greater Manchester, associate director for industry (Clinical Research Networks), CEO at Northwest EHealth, and as a consultant physician (Diabetes and Endocrinology) for the Salford Royal NHS Foundation Trust. Dr. Gibson's specialties include Diabetes, Lipid Disorders, Clinical Trials, Clinical Data Systems, and Patient Self-Management.


Gretchen E. Goller, MSW
Global Head, Patient Recruitment & Retention Solutions
ICON plc, USA

Gretchen has amassed over 20 years of clinical research experience, including work at the site, sponsor and CRO level. Gretchen leads the Patient Recruitment and Retention Solutions group at ICON working with a team of strategists to implement recruitment and retention programs on all pertinent ICON studies. Gretchen has a BA from the University of Massachusetts and an MSW from the University of Pennsylvania.


Clare Grace, PhD
Vice President, Site & Patient Access
Syneos Health, UK

Clare brings nearly two decades of strategic global leadership expertise to her role, including a unique blend of academic, pharmaceutical, biotech and CRO industry experience. She joined Syneos Health from PPD where she held several senior leadership roles, including most recently Senior Direct 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.


Rhonda Henry
Vice President, Site Collaborations & Patient Centricity
PPD, USA

As vice president of site collaborations and patient centricity, Rhonda Henry leads PPD’s commitment to building strategic relationships globally with physicians and patients. Rhonda joined PPD in 1991 as a clinical research associate, and has held a variety of positions on both the commercial and operation sides of PPD during her time there. Rhonda has a bachelor’s degree in nursing from the University of North Carolina Wilmington. She completed Lean Six Sigma training from Vanderbilt University, and was a member of the first graduating class of PPD’s Global Leadership Program. She now serves as a mentor for the program. Rhonda is a member of the Association of Strategic Alliance Professionals, the Oncology Nursing Society, an alumni of Women in Leadership, and participates in the AVOCA’s Leadership Advisory Board for Patient Engagement.


Lisa Montague Hieb, JD, CIPP/E, CIPM
Global Privacy & Data Protection Officer
Syneos Health, USA

Lisa Montague Hieb is an attorney with more than 20 years’ experience, the majority of her career spent as internal counsel for companies in the healthcare and life sciences industries. As the Global Privacy and Data Protection Officer for Syneos Health, she focuses on ensuring the company’s compliance with all privacy laws applicable to it as a global CRO and CCO and supporting the organization’s operations as the company cooperates with the privacy compliance needs of its clients. Previously Lisa provided internal legal support across all aspects of the company’s Clinical Division, including Early Phase, Strategic Resourcing, and Contract Research Organization service offerings.


Yordanka Ilieva-Borisova, MSc, MPharm
Manager Site Support
Comac Medical Ltd, Bulgaria

Yordanka Borisovais the manager of site support in the early phase clinical development division at Comac Medical Ltd, with a Master of Pharmacy specializing in Clinical Pharmacy. Yordanka mainly focuses on full-service project management of early phase studies including BA/BE, site management, patient recruitment and feasibility studies. She is also a member of the functional Business Development Group.


Stephen Jasperse
Senior Director, Site Partnerships
Covance, UK

 

Eric Klaver
GCP & QA Trainer
Amsterdam Clinical Research Academy, The Netherlands

Eric brings vast experience in both clinical research and Clinical Research Training. Eric has trained from the United States to China, from Mexico to Australia, from Brazil to Korea, from Israel to Malawi, the Gabon and Kenya and all over the European continent. Eric is currently the trainer of choice for the Free University (VU) Amsterdam, responsible for their clinical research module of their acclaimed masters programme.


Emil Kostov, MPharm
Site Alliance & Support Manager
COMAC Medical Ltd, Bulgaria

More than 5 years in Clinical Research, currently Head of the Site Alliance Network in Comac Medical Ltd, consisting of more than 200 PIs and more than 90 Institutions in 12 countries in Central and Eastern Europe.
Main responsibilities: Site Alliance Network set up and expansion, Supervision of all aspects of Site Support activities; Guaranteeing smooth process of recruitment potential assessment and site selection proposal, as well as during the study conduct; Supervision of all employees within the group.


Alexander Krutin, MD, MSc
Director of Clinical Trial Management
Medpace, UK

Alexander Krutilin has 13 years of drug development experience, and 10 years of project management experience working with Phase I – IV studies. He has expertise in managing complex PK programs with multiple vendors, and a diverse therapeutic research background including work in the fields of Oncology, Hematology, Infectious disease, Metabolic, Urology, CNS and Pediatrics. Alexander is currently focused on Phase I Oncology including large immuno-oncology programs.


Rudi Ladenius, PhD
Regional Site Advocate
Vertex Pharmaceuticals, The Netherlands

Rudi Ladenius (Ph.D.) has been active in clinical development for >25 years at pharmaceutical companies and CROs. He has been involved in site selection focusing on value added solutions for sites and sponsors. In his current role as Regional Site Advocate he maintains relationships with clinical research sites in Central Europe and Middle East for Vertex Pharmaceuticals.


Lorraine Large
Director, Central Monitoring, EAPA, Adaptive Monitoring Leadership Team
PRA Health Sciences, UK

Lorraine has been with PRA for nearly 14 years and has worked in Clinical Operations, Study-Start-Up, Project Management, Functional Management and Process and Change Management. Lorraine currently head’s up Central Monitoring within EAPA for PRA. Lorraine is familiar with regulatory environments worldwide.


Gabriella Laurora
Director of Clinical Team Management
PRA Heath Sciences, Italy

Gabriella Laurora has over 25 years of experience in clinical research from both the Pharma and CRO perspective: starting as a CRA, Gabriella has progressed into project and functional management roles. During these years, Gabriella has focused on patient safety and data quality, introducing new strategies such as Risk Based and Centralized Monitoring.


Matt Lowery, CCRC
Executive Director
CRBDPlus, USA

In his 11 years in clinical research, Matt has worked on both the site and sponsor sides of the industry. He has found his niche in business development and contract/budget negotiation and has been a certified clinical research coordinator through ACRP since 2013.


Paulo Moreiro
Vice President, Global Clinical Operations - External Innovation
EMD Serono, USA

Paulo is a Clinical Development executive with 25+ years of experience in Clinical R&D. He has been with EMD Serono for the last 17 years in diverse positions within Clinical Development, and he presently serves as the Head of Global Clinical Operations External Innovation. In this capacity, Paulo is responsible for Clinical Innovation as well for Patient Centricity in Clinical Development and Operations where he has had a preponderant role in establishing EMD Serono as an industry leader in patient centricity around clinical trials. Paulo is also a Visiting Scholar at Boston College where he teaches at the Essentials of Clinical Research and Project Management Program. Paulo is very active in several industry-wide organizations. He dedicates some of his time to the Steering Committee of the Clinical Trial Transformation Initiative (CTTI). He leads TransCelerate’s Clinical Research Awareness & Access workstream and represents EMD Serono on TransCelerate’s Operations Committee and fulfills the role as the Global Impact Partner of the Society for Clinical Research Sites (SCRS). Paulo also serves on the Advisory Board of a couple of companies that provide services to the Pharma/Biotech industries. Lastly, Paulo was named twice to PharmaVoice’s 100 Most Inspirational Leaders of 2015 and 2017 recognizing his industry leadership around patient centricity.


Heidi Müller
Director Patient Engagement Strategy
The Janssen Pharmaceutical Companies of Johnson & Johnson, Belgium

Heidi Müller, Director Patient Engagement Strategy at the Janssen Pharmaceutical Companies of Johnson & Johnson, is for over 24 years a Clinical Research Professional with passion for Patients, People and Partnerships. She has gained local and global clinical operations experience both at the CRO and pharma side, as well as 8 years of nursing expertise.


Sergii Myronenko, MD
CEO
PharmaSich, Ukraine

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


Alastair Nicholson
Policy Development Lead
HRA Approval, UK

Before joining the HRA in 2014, Alastair was a CLRN Lead Research Management and Governance Manager. Alastair joined the NHS in 2001, as a Trust R&D Coordinator, before moving to the Cancer Research Network in 2006 and the CLRN in 2008.


Christine Phillips, CSci, MSc, PhD, FRCB
Senior Director, Next Generation Clinical Operations
IQVIA, UK

Christine Phillips has 30+ years of experience working in the clinical research industry, including 20 years with the pharmaceutical industry, 5 years with CROs, 3 years in NHS and 2 years in academia/public funding/government. She has worked with phase II-IV clinical research studies, including extended use and data protection. Christine also has experience working with patient & site identification, feasibility & selection, initiation & start up to target, and minimizing zero recruiting sites.


Christine Pierre
President
Society for Clinical Research Sites, USA

Christine Pierre is the President of the Society for Clinical Research Sites (SCRS). She is internationally known for her expertise in clinical research site management and patient recruitment and retention for the clinical trials industry. In addition, she also addresses audiences around the world on issues pertaining to human subject protection, site operations and subject recruitment and retention. Her global reach has included presentations in Australia, Canada, Africa, Israel, and the United States.


Sheuli Porkess, MRCP, FFPM
Interim Executive Director Research, Medical & Innovation
The Association of the British Pharmaceutical Industry, UK

Sheuli Porkess is an experienced Medical Affairs Physician, who is currently the Interim Executive Director of Research, Medical & Innovation at the Association of the British Pharmaceutical Industry. Sheuli’s career began in clinical medicine in the NHS and subsequently has included a number of medical leadership roles at a national, regional and international level, including Medical Director roles in the Netherlands, Nordics and UK. Sheuli was the Global Head of Quality Management for Medicine and Regulatory, for Boehringer Ingelheim in Germany. Sheuli is Director of a medical affairs consultancy, Actaros and the MedicoMarketing Partnership. Sheuli is a Fellow of the Faculty of Pharmaceutical Medicine in the UK and is on the Board of Examiners for the Faculty.


Jennifer Preston
Patient & Public Involvement & Engagement Priority Lead
NIHR Clinical Research Network, UK

Jenny Preston joined the NIHR Clinical Research Network in 2005 to develop and implement a strategy for involving patients in the design and delivery of health research. Jenny leads on projects, such as the Patient Research Ambassador Initiative, which supports patients and researchers to actively promote research in the NHS.


Denise Reyes
Program Director, Sites Subcommittee
TransCelerate BioPharma Inc., USA

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



Claire Sears, PhD
Director, Data Solutions
DrugDev, UK

Claire Sears joined DrugDev in 2013. She leads DrugDev’s communications and training activities for the TransCelerate Investigator Registry and the Investigator Databank, and also leads DrugDev’s thought leadership program for Data Solutions. Claire earned her BA(Hons) and her Doctorate in Cardiovascular Physiology from the University of Oxford.


Helena Sigal, MD
Founder & Owner
SIGAL Site Management & Support, Germany

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


Matt Simmons
Independent Consultant
UK

With extensive operational and commercial experience across all phases and many sectors within the drug development industry, Matt currently works as an independent consultant, advising clients on optimising the clinical trial process.


Craig Stevenson
Area Head Western Europe
Pfizer, UK

Craig started a career in clinical research in 1989 with Glaxo and worked as a CRA, Project Manager and Line Manager in both the UK Country Office and in Global R&D. He spent 2 years as the Clinical Research Manager for Glaxo Wellcome China living in Beijing before becoming a Global Clinical Lead for GSK’s Hepatitis Programmes. Craig joined Pfizer for the first time in 2002 and spent 5 years as the Director of Clinical Research for Pfizer UK. He then spent 18 months as the Head International Clinical Research Operations for Novartis UK before returning to Pfizer as one of the Regional Heads of Clinical Operations for Europe in Oct 2008. Since May 2011, Craig has had a wider responsibility for Clinical Trial Operations in both Western Europe and Eastern Europe, Africa and Mid East as the Area Head for Clinical Trial Execution.


Wojciech Szczepanik, PhD, MBA, MSc
Managing Director, Central Europe
Synexus, 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. He developed the network in Poland and was further given the role of the regional Managing Director of the Central Europe where he expands the Synexus Business in Poland, Hungary and recently Italy.


Vivienne van de Walle, MD, PhD, CPI
Director & Owner
PT&R, The Netherlands

Vivienne van de Walle studied medicine at the University of Maastricht in the Netherlands and did part of her medical training at the University of Oxford in the UK. During her medical training she enjoyed the combination of patient care and clinical research. She received an additional medical science degree for her research in OBGYN, pediatrics and genetics when she graduated. In 2004 she successfully defended her thesis on Auxology for her PhD. She has always combined clinical research with patient care and has been a full time investigator since 1999 at independent clinical research sites. Vivienne co-founded and has co-owned PT&R since 2006 and took over fully in 2013. In 2011, she passed the CPI exam. A member of the nation BROK/GCP examcie, the ACRON, APCR. SCRS and the NVFG (ClinOps Group and Fiagnostiek Magazine), she is active in social media both privately and professionally. Vivienne has been invited to teach at CROs, Pharma companies and at Universities, and she is often asked to consult for CROs and Pharma regarding protocol development, feasibilities, the Company-Site relationship, and social media. As a result, Vivienne has a unique perspective of both sides of the table in clinical research.


Tom Van Paepegem
Clinical Operations Manager
Harmony Clinical Research, Belgium

Tom Van Paepegem is a registered nurse with a degree in medical-social sciences. His career began in clinical research as a trial nurse in 2002. Since then, Tom has held a variety of positions including working as a quality coordinator and clinical quality assurance auditor. In 2010, Tom re-oriented his career to clinical operations. During his 15+ years in the field he has developed a broad set of project operations experience and progressive leadership responsibility. In 2012, together with Jacqueline Hertoghs, Tom co-founded CRO Harmony Clinical Research where he is responsible for clinical operations and staffing.


Gerda van Wijhe, MSc
Head of Clinical Programs
Global ELN Center of Excellence Clinical Research, The Netherlands

Gerda van Wijhe received her master degree in Human Nutrition at Wageningen University in 2002. She joined the clinical trial team in hospital Erasmus MC-Daniel Den Hoed in 2002, where she worked on clinical studies in prevention and treatment of cancer. In 2005, she joined Nutricia Research and has held several positions with the organization since. In 2010 she moved to Singapore to build a new clinical research team in a new R&D centre for Nutricia. After returning to The Netherlands in 2013, she became innovation program leader, leading the gut health program. Last year she transitioned to head of the clinical programs team for early life nutrition.


Elizabeth Vroom
Director
Duchenne Parent Project, The Netherlands

Elizabeth Vroom is the president of the Dutch Duchenne Parent Project and the chair of the worldwide United Parent Projects Muscular Dystrophy (UPPMD). She is a member of the TREAT-NMD Project Ethics Council as well as the TACT committee and is a practising Orthodontist. Elizabeth is invited to speak at many international conferences about DMD and related issues.


Rick Ward
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.