2017 Faculty

Todd Albin, MBA, CCRP
Senior Director, Site Enrollment Optimization
Acurian

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.

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

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.

Munther Baara, MS
Head of New Clinical Paradigm
Pfizer

Munther Baara has over 20 years of experience in the pharmaceutical industry. He is currently Sr. Director of Development Business technology at Pfizer, a worldwide pharmaceutical company. Munther is currently the head of New Clinical Paradigm within the GPD-BT Development at Pfizer, Munther is spearheading initiatives driving innovation in development operations to align with the paradigm shift in the clinical trials execution model and emerging technologies.

Christophe Berthoux, DVM, MBA
Chief Executive Officer
Synexus

Dr. Christophe Berthoux has been CEO at Synexus since 2010. Prior to joining Synexus, he spent 20 years with Charles River where he was most recently Executive Vice President Global Sales and Marketing and Chief Commercial Officer. Dr Berthoux has extensive experience in the international clinical trials sector and has worked both in the United States and Europe. Before launching his career in the field of clinical research, Dr. Berthoux trained as a veterinary practitioner.

Yordanka Borisova, MPharm
Manager, Site Support
COMAC Medical

Yordanka Borisovais the Manager, Site Support in Early Phase Clinical Development Division at Comac Medical Ltd. She us a Master of Pharmacy specializing in Clinical Pharmacy.
Yordanka has more than 4 years’ experience in Early Phase Clinical Development, mainly focused on full-service Project management of Early Phase Studies, including BA/BE; Site management, Patient Recruitment and Feasibility studies. Her main duties within the division include supervision of all aspects of site support activities, guaranteeing smooth process of recruitment potential assessment and site selection proposal, supervision over maintenance of the referral network, and project management. She is also a member of the functional Business Development Group.

Simon Bracewell
Site Relationship & Operations Lead, UK & Ireland
Merck Serono

Simon Bracewell is an experienced Clinical Research Professional, specialising in the management of site relationships and the operational oversight of outsourced clinical trials on both a local and international level. He has previously worked in both global trial management and clinical monitoring in all phases and across multiple therapeutic areas.

Jerome Chiaro
Vice President, Clinical Site Operations
StudyKik

Jerome Chiaro is Vice President of Clinical Site Operations at StudyKIK and regularly presents workshops for a non-profit, SCORE in Orange County, CA. Previous to the clinical trial industry, Jerome was a social media consultant for businesses across the nation and he has published multiple e-books and video training series' on the topic of social media marketing.

Kyle Cunningham
Vice President of Product Innovation
Greenphire

​As Vice President of Product Management, Kyle leads the strategic direction of product development, ensuring that Greenphire solutions are constantly evolving to address client needs. He works closely with sales and IT to understand the evolving clinical trial landscape and works to identify how to align the product roadmap to ensure the Company stays ahead of the curve.
Kyle has more than two decades of experience in product strategy, product and project management, relationship management and operations management. Prior to joining Greenphire, Kyle worked for SEI Investments company, where he focused on product and service strategy for international investment processing and management.

Kyle holds a Bachelor of Science degree in Business from Kutztown University. In his free time, Kyle enjoys hiking with his wife and daughter.

Franco Davi, MBA
Senior Clinical Program Leader, gRED Clinical Operations
Genentech

Franco joined Genentech in 2013 as a Clinical Trial Manager in gRED Clinical Operations. Since then he has proven himself to be a leader in our organization and has made contributions through his active participation in initiatives and other non-molecule projects and events.
Franco started his career in the pharmaceutical industry as a project specialist at Quintiles and then went on to hold leadership roles in Clinical Project Management at Quintiles, Perrigo, Pfizer and Novartis. Franco holds two degrees from Hofstra University -- a Bachelors in Biology and an MBA in International Business.

Emer Doherty
Senior Director Clinical Risk Management
ICON

Emer Doherty has a wealth of experience in clinical research spanning over 25 years, mostly in the Pharmaceutical and CRO industry. In the early part of her career she worked for 5 years as a study site coordinator, before moving to work in Project Management for a large pharma company. More recently, Emer moved to a role in Clinical Risk Management at ICON and is ICON’s leading expert in the global cross-functional implementation of the changes to ICH E6 R2.

Zsolt Ember, MD, PhD
Site Strategy Consultant
Acurian

Zsolt Ember, MD, PhD graduated with an MD from Semmelweis University in Budapest.
He taught medical and dental students and conducted basic research between 1992 and 2002 and has been with PPD for 13 years. His current position is a Principal CRA.
Dr. Ember has been with Acurian as a Site Strategy Consultant for one-and-a-half years to support their central recruitment and retention campaigns in Europe.

Diana Foster, PhD
Vice President, Strategy & Development
Society for Clinical Research Sites

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.

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

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.

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

Martin Gibson serves as Clinical Director at the NIHR Clinical Research Network for Greater Manchester, Associate Director for Industry (Clinical Research Networks), Chief Executive Officer at Northwest EHealth, and as a Consultant Physician (Diabetes and Endocrinology) for the Salford Royal NHS Foundation Trust.

His areas of interest include:
• The processes by which insulin resistance and glucose intolerance predispose individuals to vascular disease focusing on the role of the insulin-like growth factor (IGF) system.
• The development novel interventions across primary and secondary care to measure and optimise vascular risk reduction utilizing district-wide electronic patient information systems to target and monitor intervention programmes. This includes the ongoing development of a proactive contact-centre based diabetes management and prevention systems.
•Use of electronic clinical information systems to support improved healthcare and clinical research including the development of large scale 'real world' studies.

Dr. Gibson's specialties include Diabetes, Lipid Disorders, Clinical Trials, Clinical Data Systems, and Patient Self-Management.

Clare Grace, PhD
Vice President, Site and Patient Access
INC Research

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 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 INC Research 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.

Lucy Hampshire, MSc
Director, Medicines Quality Organisation International
Lilly

Lucy has worked in the pharmaceutical industry since 2001 and is a Quality Director in the Medicines Quality Organisation division of Eli Lilly and Company Limited. Lucy leads a team providing country level quality oversight for activities relating to medical, regulatory and safety across Europe. Lucy started her career in industry in pharmacovigilance before moving into a quality oversight role. Lucy provides leadership and expertise in medical and pharmacovigilance quality systems, ensuring the update of processes impacted by EU GvP and GCP. Lucy has a vast experience in GvP inspections and since the beginning of 2015 took on quality oversight responsibilities for clinical activities, hosting a recent MHRA Sponsor and Site GCP inspection as well as providing leadership for other European GCP inspections. Lucy has a particular interest in compilation and maintenance of the Sponsor Trial Master File.

Lucy has a BSc in Biological Sciences (Microbiology) and obtained an MSc Clinical Microbiology from Barts and The London School of Medicine and Dentistry. Lucy previously trained as a clinical scientist researching antimicrobial resistance before moving into the pharmaceutical industry.

Wendy Ingham
Group HR Director
Synexus

Wendy joined Synexus in November 2011. She previously held HR leadership positions in the logistics sector and business consultancy. Her early career was in health care in the UK and the Middle East.
Her mission for people management in Synexus is to build an HR service which is a true partner to the operational business with a fully engaged workforce committed to delivering both exemplary service to patients and to profitability, where everyone goes “that extra mile” : Great company, Great people, Great jobs, Great rewards.
Wendy graduated from the University of Lancaster, is a Fellow of the Chartered Institute of Personnel and Development and of the Institute of Directors. For relaxation, Wendy sings soprano with a number of international choirs, describing herself as more “enthusiastic than talented”.

Summer Iverson, MSHS, CCRA
Associate Director, Global Clinical Trial Execution
Pfizer

Summer Iverson has over 17 years of experience in the pharmaceutical industry in study monitoring and study management and holds a Master of Science in Health Sciences, Clinical Research Administration degree from George Washington University. She is currently the Investigator Site Process Lead within Global Clinical Trial Execution at Pfizer, a worldwide pharmaceutical company. Summer is leading the business process implementation at Pfizer for the TransCelerate Shared Investigator Platform (SIP) and represents Pfizer on the TransCelerate Site Qualification and Training (SQT) workstream.

Jackie Kent
Senior Director, Product Delivery Supply Planning & Systems
Lilly

Jackie Kent joined Eli Lilly and Company in 1990, within the IT organization. Jackie held a variety of positions within IT both technical and leadership before moving into Lilly Research Labs, supporting global clinical development in 2001. Presently, Jackie is responsible for the organization that provides services to study team to support Clinical Development planning, protocol optimization, feasibility and enrollment planning across all therapeutic areas. Jackie is also the lead for the TransCelerate Investigator Platform.

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

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.

Hanna Kuśmierek, MSc
Clinical Trials Managing Director
Centrum Badan Klinicznych PI-House

Member of the Board of the site and Clinical Research Director responsible for overall performance of the site with 5 years of experience as a study coordinator in many different trials. Certified Clinical Research Coordinator (CCRC ACRP) since last year.
The site which is Centrum Badan Klinicznych PI-House sp. z o.o. located in Gdansk, Poland is a dedicated research center focused on ambulatory clinical trials of various indications.

Alistair Macdonald, MSc
Chief Executive Officer
INC Research

Alistair Macdonald joined INC in 2002 and has held a variety of senior leadership positions. Prior to CEO, he served as President and COO overseeing global operations. He also served as President, Clinical Development Services; Executive Vice President, Oncology; Executive Vice President, Strategic Development; Executive Vice President, Global Services; Head of Global Business Development and Marketing; and Senior Vice President, Biometrics.

Outside of INC, Mr. Macdonald has been the Vice President, U.S., Operations for Datatrial; Manager, Operations Consulting at Bovis Lend Lease Pharmaceuticals and held senior positions at Novartis Pharmaceuticals including Project Manager, Production Manager and Tablet Coating/Printing Team Leader. He started his career as a Hydrocarbon Logging Engineer at Geoservices International.

Mr. Macdonald earned a diploma from the Institute of Directors (IoD), a professional organization that certifies top business executives. He earned a Bachelor of Science in Applied Geology from Plymouth Polytechnic and a Master of Science in Environmental Diagnostics from Cranfield University.

Robin Marcus, RN, BSN
Senior Vice President
GlobalCare Clinical Trials

Robin Marcus is a Senior Vice President 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.

Ken McFarlane
Managing, Principal Engagement Consultant
Medidata

Ken McFarlane is a principal engagement consultant at Medidata with over 14 years of experience in the leadership, management and monitoring of all phases of clinical trials. Ken spent most of his clinical career as a monitor, project manager and director, working closely with large and mid-sized pharma customers. Ken has experience in organizational design, enhancing business processes and implementing efficiency models.

Paul Mitchel
Global Marketing Director
Acurian

Paul Mitchel is an expert in direct response marketing across all media with proven ability to deliver marketing and business growth. He has over 19 years’ experience working with blue chip and market leading brands, planning and implementing award winning direct marketing strategies, and effectively developing and managing operational delivery to achieve outstanding ROI

Kate O'Brien
Senior Research Nurse
Albany House Medical Centre

Kate O'Brien has worked in Primary Care research since 1999. Her practice practice conducts phase 2-4 industry trials, plus academic studies and has been awarded leadership site status for the second year for the East Midlands South Yorkshire Research Network.
Kate's role includes assessing trial feasibility, liaising with Sponsors and co-ordinating all trial requirements, plus the daily management of studies covering a wide range of conditions.

Francesca Panzeri
Director, Managed Site Network
Site & Patient Networks EMEA
QuintilesIMS

In the CRO environment for nearly 20 years, with QuintilesIMS Francesca Panzeri is a pioneer in designing and implementing a Partnering Strategy with selected high performing sites in the delivery of Clinical trials and related activities - locally in Italy and then regionally across Europe. In her current role as a Director of Managed Site Networks, she is supporting QuintilesIMS’ vision of further developing innovative cooperation with selected sites and Networks in key Therapeutic Areas in EMEA, thereby facilitating improved efficiency and quality in clinical research thus leading to improved delivery for customers and better access to treatments for the patients.

Ângela Papa, MSc, PharmD
Director, Clinical Management
PPD

Ângela Papa has worked at PPD for the last 13 years, having started in Madrid, Spain, with the last 7 as Country Manager in Portugal. She graduated in Pharmacy Sciences from Lisbon University (Portugal) and has a MSc in Public Health from Miguel Hernandez University (Spain) with a thesis on gender bias in clinical trials. While at PPD, Ângela has developed some work with Eastern Europe countries and more recently has been involved as the Clinical representative in PPD’s group for the ICH-GCP E6 Revision 2 adaptation and has been sitting in the Risk Based Monitoring and Remote Monitoring Leadership and Action Council.

Christine Pierre
President
Society for Clinical Research Sites

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.

Claire Sears, PhD
Director, Data Solutions
DrugDev

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.

Oriol Serra, MS, MBA
Director, Feasibility & Patient Recruitment, Europe
Pfizer

Oriol Serra is a leader in Development Operations with 11+ year’s global experience in strategic planning & execution of clinical programs both at CRO and Sponsor, and a MBA Graduate from the University Of California San Diego. In his role of Director of Feasibility at Pfizer, Oriol provides strategic direction in the planning & execution of clinical programs to enable the predictable delivery of portfolio and oversees the relationship with CROs to ensure optimization of services. Oriol has spent half of his career in the US and half in Europe and currently resides in the province of Barcelona.

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

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
Head of Drug Development Unit
Sarah Cannon Research Institute

With extensive operational and commercial experience across all phases of drug development within the Pharmaceutical and CRO industries, Matt has overall responsibility for the day-to-day management of the Sarah Cannon Research UK Drug Development Unit. Matt received his degree in Molecular Biology from The University of Manchester in 1994 and joined what was then SmithKline Beecham working on the clinical development of a novel cytotoxic agent. Immediately before joining Sarah Cannon Research Institute UK he managed the global Commercial Operations teams for Worldwide Clinical Trials, a mid-sized, full service CRO.

Wojciech Szczepanik, PhD, MBA, MSc
Managing Director, Central Europe
Synexus

Wojciech joined Synexus in 2009 as a Site Director of the Wroclaw site. His previous experience was monitoring as CRA and academic. In his further role of Director of Operations he expanded the sites network in Poland. Wojciech was promoted in 2015 to the current role of a Managing Director of the Central European region and now he has full responsibility for Poland and Hungary. He is excited to be part of the growth of Synexus.

Marcus Thornton
Global Lead, Payments
Medidata

Marcus Thornton is the Global Lead, Payments at Medidata Solutions, based in the London office. Marcus came to Medidata with two decades of experience in the life science industry. He worked at two biotechnology companies in the 1990s and established a life sciences communications company working with Large Pharma, which he merged with an international e-solutions consultancy in Europe. At SEQUUS Pharmaceuticals, Marcus was responsible for global payment administration (outside of the US) and maintained internal payment systems to directly support site management and accounting functions. Prior to joining Medidata, Marcus co-founded Clinical Force, to realize his vision of innovating the development of clinical trial management systems.

Jeff Wagner, MS
Advisor, Clinical Development Information & Optimization
Lilly

Jeff Wagner is an Advisor for the Shared Investigator Platform (SIP) at Eli Lilly and Company. He has been a TransCelerate SIP core team member since its inception, contributing to the development of the platform and is responsible for SIP implementation at Lilly.

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

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.

Petra Westphal
Site Relationship and Operations Lead
Merck Serono

Petra Westphal joined Merck in 2011 as a Clinical Research Liaison and is since then working in various positions, always supporting relationship with investigational sites and providing oversight on clinical trials.
Prior to Merck, she spent more than 10 years building up a clinical trial center at huge university hospital and working at a CRO.