The Association of Clinical Research Professionals

ACRP Board of Trustees

John Neal, ACRP Board

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 and 2018 Vice Chair of ACRP’s Board of Trustees.

Paul Evans, ACRP Board of Trustees, Member

VICE 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.

Kathryn Kimmel, CCRC, CCRA, ACRP-CP, FACRP, a senior clinical research associate with PRA Health Sciences and 2018 ACRP Board Chair

IMMEDIATE PAST CHAIR
Kathryn L. Kimmel, CCRC, CCRA, FACRP, ACRP-CP decided to explore opportunities in clinical research after working 15 years in a hospital based laboratory. In the 22 years Kathryn has been in the clinical research field, she has worked as a CRC, a director of a multi-therapeutic clinic based research department, a CRA and a Regional Manager of CRAs. Kathryn has also served as Chair for the Phlebotomy exam for NCA, and a committee member and Chair of the ACRP Global CCRC Exam Committee. Kathryn has served as a Board member and Chair of the Academy Board of Trustees and ABoT Liaison to the Academy Board. She has also served at Chair of the ACRP Governance Committee and member of the ACRP Nominating Committee. Kathryn has been active with ACRP at the local level, was a charter member and served as President and Program Chair of the Inland Northwest Chapter (now disbanded). Kathryn has maintained her ACRP certifications for both CRC (20 years) and CRA (13 years) and is very passionate about certification and the value it brings to the industry. Kathryn is currently a Senior Clinical Research Associate with PRA Health Sciences. She served as ACRP’s 2017 Vice Chair and 2018 Chair of the Board of Trustees.

Erika Stevens

TREASURER
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. Ms. Stevens 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. Ms. Stevens is the immediate past president of the Association of Clinical Research Professionals (ACRP) New York Metropolitan Chapter. Ms. Stevens served as chair, for two terms, of the editorial advisory board for Clinical Researcher, the peer reviewed journal publication for Association of Clinical Research Professionals (ACRP). Ms. Stevens is the treasurer of the Associate Board of Trustees. Erika serves on the MAGI advisory board and is a director for Brightpoint Health. She is also 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. Ms. Stevens 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.

Guy Iannuzzi, ACRP Board of Trustees, Public Member

PUBLIC MEMBER
Guy Iannuzzi, CEO, Mentus
is a marketing executive with over 45 years of experience in marketing biotech and high technologies. He and Mentus have become proficient in translating technology innovation into commercial success in a wide range of industries and markets – useful in helping fund 150 IPOs. Guy founded Mentus in 1981, to market high technology and biotech for companies and institutions such as the DOD, DOE, NIH, the NSF (He was a founding director of San Diego’s Biocom). Leveraging a national reputation for developing creative promotional platforms for innovation, Mentus provides marketing and investor communications for emerging technology and FORTUNE 500 companies. Guy’s four decades of corporate marketing includes being general manager of Marina Advertising, the marketing division of Revell in Los Angeles. He has held creative and marketing positions with the Summa Corporation, the Getty Oil Corporation, Lockheed Electronics and Young & Rubicam. He has also marketed high technology in Europe, Latin America and the Middle East. Versed in marketing and finance issues in a wide range of industries, Guy is able to motivate management teams to achieve extraordinary results in challenging environments and disparate cultures via seminars and workshops on market positioning and messaging. He also makes numerous presentations on best practices for marketing innovative technologies and market positioning. Currently, Guy is involved in promoting the San Diego transformation as a biotech and high tech cluster around the world. He is also developing and implementing medical tourism programs for destinations across the United States.

Anne Blanchard

Anne Blanchard, CCRA is CEO and Quality Assurance for a regional Contract Research Organization (CRO) operating in Latin America, leading numerous projects ongoing in Argentina, Brazil, Chile, Mexico and Colombia since November 2008. 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 is also Editor of the Barnett International “GCP Question and Answer Guide” (Section for Latin America) yearly since 2012. 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. She is also presently a member of the board within The Association of International CROs, AICROS, where she manages Latin America. Since 2005, Anne is also president of Fundacion Dra. Cecilia Grierson, a regional non-for-profit organization dedicated to inform the community in general about the process for participation in research and education to clinical research professionals about regulations and research administration, in addition to educating on the life and legacy of Cecilia Grierson, Anne’s great-Aunt and the first woman to become a Physician in Argentina in 1889.

Jennifer Byrne

Jennifer Byrne was most recently the Chief Executive Officer of PMG Research, Inc. (PMG). There, she led their expansion from a single center site to a network of integrated research site partnerships throughout the United States. During her tenure, Jennifer and her team transformed PMG into a healthcare institution partner of choice and market leader, conducting over 7,500 clinical trials with 150,000+ trial participants for the development of hundreds of compounds and medical devices. Under her leadership, PMG transitioned to a private equity partner with Frontier Capital, and subsequently to ICON plc. Recently, Jennifer was recognized as a CenterWatch Top 25 Innovator and is the recipient of the ACRP’s 2018 Innovation in Clinical Research Award. She currently serves as Board Chair for Greater Gift (501c3), and as a Board Member for ACRP and The Hospice Foundation. Additionally, she is an Advisory Board member to CISCRP, Wake Forest Institute of Regenerative Medicine, Dioko Fund, and NC 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 at DrugDev, a technology company with a suite of investigator-facing solutions, Elisa is responsible for DrugDev’s platform solutions that are used by individual pharmaceutical companies and CROs, and industry
collaborations including the Investigator Databank and TransCelerate Investigator Registry. Prior to DrugDev, 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 regular “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.

Glenda Guest, ACRP Board

Glenda Guest, CCRA, RQAP-GCP, TIACR 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. 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.

David Morin, ACRP Board, Academy Board of Trustees

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.

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 engaged in obsessive-compulsive disorder research 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, Sub-Investigator, and Senior Project Manager before moving to her current role. Dr. Senn holds her Ph.D. in Psychology and has Masters 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.