PharPoint Research

Arthur L. Holmes, B.A. serves as President and Chief Executive Officer for PharPoint. Mr. Holmes is a seasoned industry professional with nearly 20 years of experience in the pharmaceutical industry, including extensive experience in pharmaceutical consulting and contract services. Prior to PharPoint, he founded Databasics Consulting, Inc., a company specializing in systems implementation and validation for pharmaceutical and biotechnology clients. Mr. Holmes has also held management positions at Quintiles Transnational Corp. and PharmaResearch Inc, subsequently known as Kendle International. In his capacity with these companies he provided leadership in both technical and operational strategies.

Audra G. McRae, B.S. serves as PharPoint’s Chief Operating Officer. Ms. McRae has been a part of clinical research for over 20 years. Her experience includes both laboratory research and various aspects of clinical trial oversight. With extensive CRO industry experience, Ms. McRae has directed large international data management departments, providing integration and process development management for 3 corporate mergers. Active in industry organizations, Ms. McRae is a member of the Society for Clinical Data Management and served on the Board of Directors for the society from 2003 to 2005.

Jennifer A. Elder, Ph.D. serves as Vice President of Biostatistics and Consulting Services for PharPoint. Dr. Elder has performed statistical analyses for clinical trials for 15 years, with 11 of those years being in the CRO industry. Dr. Elder served as the lead statistician on the pivotal studies for two novel compounds in a new class of antiretroviral medications in indications for the treatment of HIV and viral hepatitis. She participated in the completion of several NDA, MAA, sNDA, and IND applications and provided strategic consulting, clinical program development planning, and statistical analysis oversight for over 75 projects. Additionally, her experience includes providing statistical support for several pharmaceutical industry-sponsored pregnancy registries and phase I through IV clinical trials. Prior to her CRO experience, Dr. Elder was an Assistant Professor of Biostatistics and a statistical consultant at the University of North Carolina at Wilmington where she maintains an adjunct affiliation. Dr. Elder has participated in the authorship of many presentations and has been an invited speaker at several industry conferences.

Amy T. Flynt, Ph.D. serves as Director of Biostatistics for PharPoint. Dr. Flynt received her Ph.D. in statistics from North Carolina State University. While completing her degree, she spent three years as an intern in the clinical statistics department at a major pharmaceutical company. Prior to joining PharPoint, she worked in the pharmaceutical industry for over five years where she served as a lead statistician and provided statistical support for phase I through IV clinical trials and pharmaceutical industry-sponsored pregnancy registries. She also has served as a DMC statistician and as a statistical consultant. Her work experience has spanned various therapeutic areas, including: psychiatric disorders, cardiovascular, virology, women’s health, respiratory, pain, and oncology.

Ms. Fallon brings more than 20 years of experience to the clinical research industry. Most recently, she served as COO for an Independent Institutional Review Board in Research Triangle Park (RTP), North Carolina. Prior to this, Ms. Fallon co-founded and served as Senior Vice President of Clinical Research at PharmaResearch Corporation, subsequently known as Kendle. While there, she was instrumental in the development and implementation of the domestic clinical operations for the company. Prior to that, she was a Sr. Clinical Research Scientist at Glaxo where she collaborated on the development, implementation, and reporting of a Phase II-III program for lamivudine (3TC) for the treatment of HIV infection. Along with her colleagues, this pivotal research was published in the New England Journal of Medicine. Previously she served as Assistant Director for Clinical Compliance at a large international contract research organization located in RTP. She has managed multiple national and international protocols in several therapeutic areas, has monitored and audited multiple research sites and has overseen the training department of one of the aforementioned CROs. During the 2007 Healthcare Business Women’s Association’s (HBA) annual luncheon in New York City, Ms. Fallon received the HBA’s Rising Star Award.

Jayme Swinson, MS. received his M.S. in mathematics from the University of North Carolina at Wilmington. He has over 12 years experience of statistical report programming in the CRO industry. While at PharPoint, Mr. Swinson led a data standardization project culminating in the successful submission of data and analyses for an NDA. Over his career, Mr. Swinson served as a lead statistical programmer for a number of phase I-IV clinical trials and integrated ISS/ISE analyses. He has additional experience in the analysis of data from pregnancy registries, including one registry focused on HIV drug exposure during pregnancy and birth defects. His therapeutic experience includes antivirals, pharmacoeconomics, anti-infectives, respiratory, cardiovascular, epidemiology, dermatology, and sleep disorders.

Ms. Hawkins received her B.S. in communications with a minor in marketing from Appalachian State University. She has worked for over 15 years in the CRO industry. She has managed Phase I through IV clinical trials across both EDC and paper platforms. She has a broad therapeutic base and extensive experience including: virology, dermatology, respiratory, cardiovascular, anti-infective and oncology as well as healthy, normal studies.

Ms. Holt has worked in Data Management for over 19 years. She has led Phase I through III clinical trials, as well as multiple global studies and programs. She has worked in various therapeutic areas, including CNS, gastrointestinal, oncology, virology and women’s health. In addition to project oversight, Ms. Holt has maintained responsibility for managing staff and assisting in the training of junior team members. Ms. Holt has extensive experience working with electronic data capture (EDC) including initiating start-up processes and conducting, production and close out activities for numerous clinical trials. She has also conducted multiple paper-based trials using Clintrial and Oracle Clinical.