The Association of Clinical Research Professionals

ACRP Board of Trustees

Paul Evans

CHAIR
Paul Evans, PhD
has worked in the pharmaceutical industry for over 26 years. He is currently President and CEO of Velocity Clinical Research. Velocity owns and operates investigator sites across multiple therapeutic areas in the US, focused on delivering large patient numbers and timely quality data. He started his career establishing and managing research sites in the UK and was a founder of one of the first European SMOs. He pioneered innovative patient recruitment approaches as he built a site network with a reputation for outstanding delivery. This included the first phase III TV advertising campaigns in the UK and some of the earliest internet based patient outreach programs at the turn of the century. Paul joined the CRO sector in 2005 building global site networks that partnered strategically rather than being selected tactically by the CRO, and continued to work on innovative patient recruitment campaigns in the most challenging environments across all continents. In two of the world’s largest CROs he has led global functions that have included site intelligence, study start-up, feasibility, site contracting, patient recruitment and Investigator payments. Few people have had the opportunity to spend so much of their careers working both on the investigator and sponsor sides of the GCP divide and this breadth of experience gives him a unique insight into the challenges faced by the drug development industry.

Erika Stevens

VICE CHAIR
Erika Stevens, MA leads research transformation advisory and assurance services. In this capacity, she advised cancer centers, life sciences, AMCs, hospitals and health systems process improvement initiatives for productivity, quality and efficiency in operations, cross-functional relationships, administration, manufacturing and compliance. Her regulatory knowledge and quality oversight of the Code of Federal Regulations (CFR) includes, but is not limited to, GMP, GLP and GCP. Erika has over 20 years of research/R&D experience, including over 12 years in research management serving in roles such as Vice President Research, Senior Managing Director, Director Clinical Trials Office, Director of Clinical Research, Interim Executive Director, Clinical Trials Office and Director of Research Operations.  She is a past president of the Association of Clinical Research Professionals (ACRP) New York Metropolitan Chapter. She served as chair, for two terms, of the editorial advisory board for “The Clinical Researcher,” the peer reviewed journal publication for Association of Clinical Research Professionals (ACRP). Currently the Vice Chair of the Association’s Board of Trustees, Erika also serves on the MAGI advisory board and is a director for Brightpoint Health. She is a frequent speaker on research operations and compliance practices at international conferences. Additionally, she is a published author whose work appears in a variety of peer journals including the American Journal of Obstetrics & Gynecology, The Monitor, Clinical Researcher, Regulatory Focus, Applied Clinical Trials, Clinical and Translation Science and the Journal of Mental Health and Aging. Erika holds her B.A. from the University of Vermont, her M.A. from Case Western Reserve University and her M.A. from Temple University. She also holds a Graduate Certificate in Gerontology from Case Western University.

John Neal, ACRP Board

IMMEDIATE PAST CHAIR
John Neal, CPA (inactive), BS, CRCP is Founder and Chairman of PCRS Network, LLC, an international network of quality focused, independent clinical research sites that conduct phase I through IV studies in a broad range of indications. John received his Bachelor of Science degree in Accounting, graduating with honors, from San Diego State University. He became a Certified Public Accountant in the State of California while working with Deloitte & Touche, serving privately held and venture capital backed high-tech, early stage biotech, and pharmaceutical companies. John has held executive positions with several clinical research sites, and provides strategic direction to his clients. He has founded several companies and a not-for-profit organization, and has served on the Board of Directors of numerous companies and organizations. He served on the Board of Directors of the California Chamber of Commerce for fourteen years, and was the Chairman of its Small Business Committee. John served on the committee to reactivate the ACRP Site Interest Group in the Online Community and lead a solutions focused discussion between Sponsors, CROs, and Sites at the 2nd Annual Site Strategy Forum in April 2015. He is a frequent speaker at clinical research conferences, has authored a variety of articles on clinical research financial and management topics (including an article in The Monitor, September 2010), and is a frequent contributor to clinical research forums online. John is an enthusiastic supporter of ACRP and is dedicated to accelerating clinical research through innovation and best practices. John served as the 2017 Treasurer, 2018 Vice Chair, and 2019 Chair of ACRP’s Board of Trustees.

David Morin, ACRP Board, Academy Board of Trustees

TREASURER
David Morin, MD, FACP, CPI, FACRP
has participated as a Principal Investigator in hundreds of studies (Phase I-IV) since 1989. He attained the status of CPI in 2007, ACRP Credentialed Clinical Research Trainer (CCRT) in 2010, and ACRP Fellow in 2017. Dr. Morin received the “Outstanding Physician Leadership in the Profession” award by ACRP/APCR in 2012. He obtained his pharmacy degree and pre-med with High Distinction at the University of Rhode Island, his MD with Honors at the University of Vermont, and completed medical residency training at the University of Virginia in Charlottesville. Dr. Morin is Board certified in Internal Medicine and a Fellow of the American College of Physicians (FACP). In addition to serving as the Director of Research at Holston Medical Group, a large multispecialty practice in East Tennessee, he continues to provide patient care at HMG and as the Director of the High-Risk Disease Prevention program for a fortune 500 company. An author, speaker, an entrepreneur as Founder/CEO of Trike, LLC which developed the SiteOptex® Software System designed to optimize research efficiency and is currently in use at US sites. He has served on the Board of Trustees for ACRP since 2016 and on many related committees. He co-developed the ‘CRC Bootcamp’ and is also an instructor for the ‘Competency Based’ Investigator training program with ACRP. Past activities include serving as a teaching attending for East Tennessee State College of Medicine, employee health director for Bristol Regional Medical Center, medical director of a CRO, and a pharma consultant.

Catherine Shuster

PUBLIC MEMBER
Catherine Shuster, BS, MS, BChE has had a 20+ year career including management and executive positions with both Fortune 500 companies such as IBM and GE as well as midsize entrepreneurial companies. Catherine received both her Bachelor of Science degree, with a biology major and chemistry minor, and her Master of Science degree in genetics from Purdue University. She also completed an Executive Business Program at Stanford. Later she went back to school for a Bachelor of Chemical Engineering. She was the first woman engineer at GE’s Plastics manufacturing site. She spoke at many colleges and universities encouraging women to go into engineering. When Catherine was in college, only 2% of the engineering graduates were women. By the time she was speaking to co-eds there were 20% women in engineering. Catherine thrives in environments where there are opportunities to problem solve. She has captained high-level teams that not only resolved issues but produced outcomes that led to innovations adopted by her employer. In one case the innovation was eventually presented at the UN. Her forte has been the ability to bring together opposing groups to achieve stronger win-win outcomes. Catherine is an avid supporter of ACRP’s mission. Research innovations and clinical trials have impacted her life in a very personal way. As the Board’s public member, she is looking forward to giving back to the research community.

Sergio Armani

Sergio Armani is VP of Business Development North America for Advarra, the premier provider of institutional review board (IRB), institutional biosafety committee (IBC), and research quality and compliance consulting services in North America. Sergio brings a decade of business development leadership experience to his position, and in his role leads the sponsor and contract research organization (CRO) business development team for the U.S. and Canada. Previously, he was a member of the institutions and sponsor/CRO business development teams at Schulman IRB. Additionally, Sergio was the director of business development at Bio-Optronics and VP of business development at Greenphire where he had extensive experience in building relationships with and supporting study teams at both independent and institutional sites. He has had a successful business development career that spans 30 years across both the financial services and clinical research industries. Sergio earned his B.A. is human resource management from Muhlenberg College in Allentown, Pa. and is active in both community and industry non-profit associations including the Greater Philadelphia Chapter of ACRP.

Anne Blanchard

Anne Blanchard, CCRA is Clinical Research Executive Consultant in Latin America and former CEO and Quality Assurance for a regional Contract Research Organization (CRO) for more than 10 years (November 2008-December 2019), leading numerous projects ongoing in Argentina, Brazil, Chile, Mexico, Bolivia, and Colombia. She began her career in Clinical Research in 1997, when she worked for a multi-national CRO in Argentina. Since then Anne has been involved in Clinical Monitoring and Management for both the Biopharmaceutical & Medical Device Industry and Academic Based Research. Anne studied Biology at the University of Buenos Aires and completed her postgraduate in Monitoring of Clinical Trials and Clinical Research in the AMA (Argentine Medical Association) in 2001. Internationally ICH certified as CRA by ACRP in 2004, and past Item Writer for the CCRA exam, Anne was also Editor of the Barnett International “GCP Question and Answer Guide” (Section for Latin America) between 2012 and 2019. Anne has authored several articles in publications such as The Monitor and GCP Journal, presented at several international conferences and also hosted webinars and in person trainings related to the implementation of Clinical Research studies, regulations and oversight for compliance in Latin America. In 2015 she won the Outstanding Leadership in Clinical Research as a CRA Award by ACRP. Anne has also participated in the writing of local regulations in Argentina about Clinical Research and coordinated the writing of National Plans to support overall clinical research activity.  Since 2005, Anne is also president and Executive Director of Fundacion Dra. Cecilia Grierson, a regional non-for-profit organization dedicated to support for academic and Investigator Initiated Research, community awareness about Clinical Research Participation and education about the life of Cecilia Grierson, Anne’s great-aunt and the first woman to become a physician in Argentina in 1889.

Christina Brennan

Christina Brennan, MD, MBA, CCRC has devoted her career to clinical research and currently serves as Northwell Health’s vice president of clinical research. Committed to the advancement of science and medicine, Dr. Brennan has more than 20 years of extensive clinical research experience, including over 15 years in clinical research management roles. She is the immediate past president of the NY Metropolitan Chapter of the Association of Clinical Research Professionals. She is an active member of the Clinical Trial Transformation Initiative (CCTI), with Duke University and the FDA, where she actively sits on some of their committees. She also sits on the oncology advisory board and technology site advocacy group with the Society for Clinical Research Sites (SCRS).  She is also an active member of the Drug Information Agency, the Regulatory Affairs Professional Society, Women in Bio and the American College of Healthcare Executives. She is an adjunct professor for Yeshiva University where she teaches a clinical trials and research management class for the Masters of Science, biotechnology and entrepreneurship program. Dr. Brennan also has authored chapters in textbooks, coauthored many manuscripts and abstracts, and has presented at numerous scientific and research meetings.

Jennifer Byrne

Jennifer Byrne is CEO and Board Chair of Javara Inc, an Integrated Research Organization (IRO) that offers comprehensive clinical research site services, as an integrated offering, within leading healthcare organizations. Her involvement in the clinical research enterprise has been vast including collaborations with hundreds of pharma, device, Contract Research Organizations (CROs), technology, site organizations, and other research service providers while working alongside hundreds of investigators and over 115,000 trial participants.  Prior to co-founding Javara Inc, Jennifer was formerly the CEO of PMG Research, a pre-eminent Site Management Organization, for which nearly 8,000 Phase I-IV clinical trials were conducted during her tenure. In addition to her Board of Trustees role with ACRP, she also serves as Board Chair for Greater Gift, is the Advisory Board Chair for the Wake Forest University Master’s in Clinical Research degree, is the Board Chair for Summit School, and serves in an advisory capacity for CISCRP, The Wake Forest Institute of Regenerative Medicine, The Dioko Fund, and The North Carolina Biotech of the Piedmont Triad. Jennifer is a graduate of Texas A&M University.

Elisa Cascade, MBA has over 25 years of experience in strategy consulting, pharmaceutical clinical research, market research, brand strategy, salesforce deployment, health economics, and pricing. Her industry honors include being named to the PharmaVOICE 100 and the Medicine Maker Power 100 for her innovative approach to furthering clinical research through industry collaboration and standardization of clinical trial technology/processes. As Chief Product Officer for the Trial Design & Site Engagement portfolio at IQVIA Technologies, Elisa is responsible for development and maintenance of site-facing technology solutions that are used by individual pharmaceutical companies and CROs, and industry collaborations including the Investigator Databank and TransCelerate Investigator Registry. Prior to joining DrugDev, an IQVIA Technology company, Elisa was a Vice President at Quintiles where she ran global operations for Quintiles Digital Patient Unit with responsibility for direct-to-patient studies. She also performed strategic consulting for the Lewin Group. Elisa has a substantial track record of publications and presentations across a variety of research topics including writing and disseminating results of the DrugDev Annual Investigator Survey as well as publishing a “Pulse on Technology” column in CenterWatch Monthly. Elisa has an MBA from The Wharton School and a B.S. with High Honors and High Distinction from the University of Michigan.

Deborah Driscoll

Deborah Driscoll has 20+ years of experience in academia and the pharmaceutical industry. She began her career working as a research technician at the Boston VA Medical Center and Boston University. She began her career in industry at Roche as a pharmacology research scientist working in pre-clinical neuroscience research. She transitioned from the laboratory to clinical working as a clinical research associate in oncology and HIV research. Deborah spent several years at Pfizer working in Research and Development, including the role of Vice President of Quality Assurance. She joined Merck as the head of Quality Assurance in July 2015, assuming responsibilities for GCP, GLP, GPvP, CGMP, and Animal Welfare oversight within Merck Research Laboratories. Deborah assumed the leadership role for the TransCelerate BioPharma Inc. Clinical Quality Management System Team (years 2014-2017) working with member companies to develop and advance a clinical quality framework to enable consistent and timely delivery of reliable data that may be used by an organization, its partners, regulators, clinicians, and patients to make informed decisions. Deborah holds a B.S. in Animal Science and an M.S. in Biology.

Glenda Guest, ACRP Board

Glenda Guest, CCRA, RQAP-GCP, TIACR, FACRP has an extensive background in the clinical research industry having worked as a monitor, project manager, data management coordinator, database programmer, quality assurance auditor and senior trainer since joining the clinical research profession in 1997. She is the Vice President of Norwich Clinical Research Associates (NCRA) a full-service clinical contract research organization (CRO) serving the pharmaceutical, medical device and biologics industries since 1994. In 2017 she also started her independent consulting firm Assured of Quality Consulting & Training. Through her extensive experiences in a CRO environment she’s developed a unique perspective not only of the requirements for regulated product development and market approval, but also the insights from collaboration with multiple sponsor companies’ varying approaches to meeting those requirements. Glenda is an active member of the Association of Clinical Research Professionals (ACRP), Model Agreements and Guidelines International (MAGI) and the Society of Quality Assurance (SQA). She has maintained her ACRP Certified Clinical Research Associate (CCRA) status since April of 2002. She has also maintained her status through SQA as a Registered Quality Assurance Professional – Good Clinical Practices (RQAP-GCP) since April 2007. She attained Certified Trainer status (TIACR) via the International Association of Clinical Research in March 2015.

Virginia Nido, MS is an experienced leader with over 25 years of industry experience and strong competencies in drug development, business processes, team systems, and people management. She has a demonstrated ability to lead strategic projects across functions and therapeutic areas. Virginia has a wide breadth of experience in Phase II-IV clinical trials in multiple indications. Virginia is passionate about innovation in clinical research through pre-competitive industry collaborations. Virginia joined Genentech in 2002 and progressed through several roles in Product Development. Virginia did an international rotation in Basel, Switzerland in 2010, facilitating the global roll-out of molecule development teams and governance committees. Virginia is currently the global head of the Industry Collaborations group at Roche and Genentech. Virginia serves on the TransCelerate Operations Committee, the Clinical Trials Transformation Initiative Executive and Steering Committees, the Global Impact Partnership Board of the Society for Clinical Research Sites, and was formerly on the Board of Directors of the Women’s Cancer Resource Center in Oakland, CA. Before joining Genentech she worked at Quintiles, the University of California San Francisco, and the University of Pennsylvania. Virginia holds a BA from Barnard College and an MS from the University of Pennsylvania.

Earnest Prentice, ACRP Board of Trustees, Member

Ernest D. Prentice, PhD is Professor Emeritus in the Department of Genetics, Cell Biology and Anatomy at the University of Nebraska Medical Center (UNMC ). He also currently serves as Senior Consultant for IntegReview IRB .Dr. Prentice is the former Institutional Official for both the UNMC Human Research Protection Program and the UNMC Animal Care and Use Program. Previously he served as the Executive Chair of the UNMC Institutional Review Board (IRB) and, for over 26 years, served as the Co-Chair of the IRB. Dr. Prentice is a frequent contributor to the literature on the ethics and regulation of human research and he is an active speaker at meetings on various aspects of research ethics. He has given hundreds of presentations at conferences across the US and internationally. Dr Prentice is the immediate past-President of the Scientists Center for Animal Welfare. From 2003-2007, he served as the Chair of the HHS Secretary’s Advisory Committee on Human Research Protection. In 2005, PRIM&R presented Dr. Prentice with the Distinguished Service Award and in 2006, the HHS OHRP presented Dr. Prentice with a medallion for Outstanding Achievement in Human Subject Protections.

Christine Senn

Christine Senn, PhD, CCRC, CPI, ACRP-CP is Chief Operations and Implementation Officer at IACT Health, a multi-specialty research management organization with clinical sites throughout the Southeast United States. She started her research career in obsessive-compulsive disorders at Concordia University in Montreal, eating disorders at Douglas Hospital in Montreal, and pediatric oncology at the University of Vermont. Since joining IACT Health in 2007, she has worked as a Clinical Research Coordinator, Site Manager, Quality Assurance chair, Sub-Investigator, and Senior Project Manager before moving to her current role. Dr. Senn holds her Ph.D. in Psychology and has Master’s degrees in both Clinical Psychology and Advertising & Public Relations. She is triple-certified by the Association of Clinical Research Professionals as a Certified Clinical Research Coordinator (CCRC), Certified Principal Investigator (CPI), Certified Professional (ACRP-CP), and is proud to be among the first Fellows of ACRP.

Jim Kremidas, ACRP Board

SECRETARY, NON-VOTING
Jim Kremidas joined ACRP as Executive Director in October 2015. Mr. Kremidas has over 30 years of experience in the health care industry, including positions in the lab, sales, marketing, strategic sourcing, and clinical operations at Eli Lilly and Company, Quintiles, inVentiv Health, and CenterWatch. While at Lilly, he led the development of the first functional area to focus on global enrollment optimization. Kremidas is a founding advisory board member at the Center for Information & Study on Clinical Research Participation and a volunteer for the Clinical Trials Transformation Initiative. Mr. Kremidas serves as non-voting Secretary to ACRP’s Board of Trustees.