Randy Anderson received his bachelor’s degree in zoology in 1979 from the University of North Carolina at Chapel Hill and his doctorate in biostatistics in 1990 from VCU, where he served as an analyst for the NIH-NINDS Traumatic Coma Data Bank program project. From VCU, he joined the faculty of now-Wake Forest University Medical School, where he was the lead statistician for the planning and implementation of the NIH-NHLBl lnsulin Resistance and Atherosclerosis Study coordinating center. He then worked for another major contract research organization as a program lead statistician and project manager for drug trials evaluating treatments for diabetic neuropathy and diabetic nephropathy. Anderson joined PPD in 1997 as director of biostatistics and currently serves as one of PPD’s leading science experts for diabetes clinical trials and as a leading strategic development scientist for PPD Program Alliance ventures, focusing on clinical development. He has been a key designer of clinical development programs in Type 1 diabetes, Type 2 diabetes, diabetes complications and other indications. He has 26 years of experience as a statistical scientist, focusing on commercial and NIH-funded drug development for products to treat Type 1 or Type 2 diabetes and related complications. Anderson currently serves as the clinical sciences leader for PPD’s preferred provider contract with the Juvenile Diabetes Research Foundation International.
Anderson has served the North Carolina Chapter of the American Statistical Association in every elected officer role, including president in 1998. He served two terms on the ASA Advisory Committee on Continuing Education, and as chair in 2004-05. Anderson served on the board of JDRF’s Eastern North Carolina Chapter from 2001-03, and now serves on the board of JDRF’s Wilmington, N.C., branch. Since 2007, he has served JDRF as an ad hoc member of the Clinical Affairs Working Group, and since 2009 as a member of the JDRF Medical Affairs Committee. In 2010, he was selected by PharmaVoice as one of the 100 most inspiring people in pharmaceuticals development.
Todd Coffey graduated magna cum laude with a B.S. in statistics from Brigham Young University in 2000, received an M.S. in biostatistics from the University of Michigan in 2002 and earned a Ph.D. in biostatistics from VCU in 2005. His dissertation research was in the area of the design and simultaneous analysis of multiple endpoints that have nonlinear dose-response curves. Coffey received a number of merit-based accolades during his academic career, including recognition as a NIEHS T-32 Trainee, the VCU Award of Excellence and the Karl Peace Award for Excellence and Scholarship. He also was awarded numerous scholarships including the prestigious Karl G. Maeser Scholarship and the Biopharmaceutical Applied Statistics Scholarship. Since receiving his Ph.D. degree, Coffey has been the lead nonclinical biostatistician for three organizations in the biotechnology industry. While working with endocrine scientists in the research group at Amylin Pharmaceuticals in San Diego, Calif., Coffey helped elucidate the anti-obesity effects of novel peptides used in combination. The discovery of synergistic effects resulted in numerous publications and subsequent clinical trials that achieved proof-of-concept of peptide combination therapy for obesity.
Notably, Coffey was a co-inventor with two other scientists on a U.S. patent (pending) describing synergistic weight loss with peptide combinations. As the lead biostatistician at the Robert W. Franz Cancer Research Center in Portland, Ore., Coffey helped discover novel approaches for immunotherapy to treat a variety of cancers and designed clinical trials to take these discoveries from bench to bedside. He also received an appointment as an affiliate research instructor with Oregon Health and Science University’s Department of Surgery.
Coffey is currently the lead biostatistician for the development group at Seattle Genetics. He contributed to the approval of a first-in-class antibody-drug conjugate to treat Hodgkin’s Lymphoma and developed the statistical control strategy to monitor the commercial manufacturing process. Coffey is also the acting bBiostatistician on a committee sponsored by the American Association of Pharmaceutical Scientists that is developing standards for evaluating ligand binding assays for biosimilars.
Greg Enas received his Ph.D. in biostatistics from VCU in 1982. Upon graduation, Enas joined Eli Lilly and Company in Indianapolis as a senior statistician, ultimately serving as the corporate senior leader for global statistics, mathematical sciences and decision sciences within the company. He then assumed a leadership position within global regulatory affairs in 1998 and retired from Lilly in 2011 as the senior director of global regulatory affairs, diabetes. In this role, he oversaw the delivery of world-class regulatory strategies, negotiated for the development and approval of new products with the FDA and coordinated strategies for aligned global implementation. Enas is currently a senior advisor for FaegreBD Consulting with offices in Indianapolis, and Washington, D.C.
Michael Fay received his Ph.D. in biostatistics from VCU in 1993. Since then he’s worked primarily at the National Institutes of Health in two institutes: the National Cancer Institute from 1994-97 and 1999-2003 and the National Institute of Allergy and Infectious Diseases from 2004 to present. In 1998, he worked as a volunteer statistician at St. John’s Medical College in Bangalore, India. At NCI, Fay worked in the Surveillance Research Program, helping to develop statistical methods and software for cancer surveillance. At NIAID, he worked on statistical methods useful for infectious diseases and collaborated with medical colleagues in parasitic diseases. Fay’s current areas of interest are permutation tests, interval censored data, exact methods and parasitic diseases. He served as associate editor for Biometrics from 2006-2010. Two papers that he co-authored have been recognized by the statistical community. First, Fay helped develop a technique that uses a series of permutation tests with joinpoint regression on cancer rates to determine if there are significant changes in the cancer rates over time. The resulting paper, published as “Permutation Tests for Joinpoint Regression with Applications to Cancer Rates” in a 2000 issue of Statistics in Medicine, was ranked No. 40 of the top articles for applied biostatisticians from 1985-2002 by American Statitician.
Second, he helped develop chop-lump tests for vaccine trials described in Follmann, Fay and Proschan (2009). Chop-lump tests are a type of permutation test that can be used to test for effects of a vaccine in a clinical trial on a post-infection variable such as HIV viral load. Such trials may typically have many subjects with no HIV infection and hence no detectable viral load and the chop-lump test gives an efficient way to test for differences in viral load between groups when a high proportion of the subjects have zero values. The resulting paper, “Chop-lump tests for vaccine trials,” published in Biometrics in 2009, was named the publication’s best paper for that year.
Adam Hamm provided biostatistics leadership and oversight for the biostatistics department at Jubliant Clinsys, Inc. He has eight years of experience in clinical research as a senior biostatistician, biostatistics Team Lead, biostatistics Manager, associate director and director across phase I-IV studies in the CRO environment.
His responsibilities have included management of biostatistics staff, senior review of project deliverables, coordination of statistical programming, collaboration in protocol development and preparation of statistical analysis plans and the statistical section of CSRs. Prior to entering clinical research, his research focus was in the area of toxicology.
Anne S. Lindblad received a master’s degree from VCU in 1981 and initiated work at The EMMES Corporation in 1982. She earned a Ph.D. from George Washington University in 1990 and became vice president of EMMES in 1992 and executive vice president in 2006. During her 30-year career at EMMES, she has led major projects in ophthalmology, oncology, transplantation, neurology, stroke, traumatic brain injury, dental disease and swallowing disorders. Lindblad has been a National Institutes of Health reviewer on multiple project applications for the National Institute of Dental and Cranial Research, National Eye Institute, National Institute of Child Health and Human Development, National Institute of Diabetes and Digestive Kidney Diseases, National Institute of Neurological Disorders and Stroke, and the National Center for Complementary and Alternative Medicine. She has been a member or chair of several data and safety monitoring committees for NEI, NIDDK, NINDS and the National Institute of Alcohol Abuse and Alcoholism. She has also served as a member of a NIH advisory committee charged with drafting policy to shape the appropriate planning and conduct of intramural studies at NIH.
She was elected to the Board of Directors for the Society for Clinical Trials from 2003-06 and served as the 2002 program chair, an officer from 2006-11 and president for the 2012-13 term. Lindblad was selected to serve on the National Advisory Dental and Craniofacial Research Council of the National Institutes of Health for the December 2004 through November 2008 term. She is currently the clinical trials section editor for the Archives of Ophthalmology.
Her statistical interests include survival data analysis, longitudinal data analysis, sequential designs, propensity scores and centralized statistical monitoring approaches to detect anomalous data patterns.
Karl Peace holds a Ph.D. in Biostatistics from VCU, an M.S. in Mathematics from Clemson University, a B.S. in Chemistry from Georgia Southern College and a Health Science Certificate from Vanderbilt University. He now serves as a senior research scientist and professor of biostatistics in the Jiann-Ping Hsu College of Public Health and as an adjunct professor of biostatistics at VCU. Peace’s first career was in teaching and research at the university level. He previously taught at Georgia Southern, Clemson University, VCU and Randolph-Macon College, where he was a tenured professor of mathematics. He holds or has held numerous adjunct professorships at VCU, the University of Michigan, Temple University, the University of North Carolina and Duke University.
His second career was in research, technical support and management in the pharmaceutical industry. He held the positions of senior statistician at Burroughs Wellcome, manager of clinical statistics at A.H. Robins, director of research statistics at SmithKline and French Labs, senior director of GI Clinical Studies, data management and analysis at G.D. Searle and vice president of Worldwide Technical Operations at Warner Lambert/Parke-Davis. He then founded Biopharmaceutical Research Consultants, Inc., where he held the positions of president, chief executive officer and chief scientific officer.
He has made pivotal contributions in the development and approval of drugs to treat Alzheimer’s disease, to prevent and treat gastrointestinal ulcers, to reduce the risk of myocardial infarction, to treat anxiety, depression and panic attacks and to treat hypertension and arthritis, as well as several antibiotics.
Peace is the recipient of numerous other citations and awards, including Fellow of the American Statistical Association, the First President’s Medal for outstanding contributions to Georgia Southern University, the Deen Day Smith Humanitarian Award and the Tito Mijares Lifetime Achievement Award from the Philippine Statistical Association. In addition, his contributions to education, public health and drug development have been cited by both the Georgia and U.S. Houses of Representatives. He is or has been chair of the biostatistics subsection of the Pharmaceutical Manufacturers Association, the biopharmaceutical section of the ASA, the training committee of the PMA Biostatistics Subsection and the statistics section of the APHA.
His work has been published extensively in pharmaceutical, statistical, medical and scientific literature. He is the author or co-author of more than 150 articles and 10 books and the editor or reviewer of several peer-reviewed journals, including the founding editor of the Journal of Biopharmaceutical Statistics, now in its 22nd year.
Peace has a lengthy record of philanthropy to education. He has created 21 endowments at five institutions. Fourteen of these are at Georgia Southern, including five for students from his native Baker County, Ga. Additionally at Georgia Southern, Peace endowed the JPHCOPH — the first school of public health in the University System of Georgia — and the first Eminent Scholar Chair in Biostatistics. He founded the Karl E. Peace Center for Biostatistics and the Karl E. Peace Public Health Library and brought the Central Office of the International Chinese Statistical Association to the JPHCOPH. Peace is also founder and chair of the internationally renowned Biopharmaceutical Applied Statistical Symposium, which generates funds to support graduate work in biostatistics.
Frank Rockhold received a B.A. in Statistics from the University of Connecticut, an Sc.M. in Biostatistics from Johns Hopkins University and a Ph.D. in Biostatistics from VCU. He is currently senior vice president, global clinical safety and pharmacovigilance at GlaxoSmithKline Pharmaceuticals Research and Development and co-chair of the GSK Global Safety Board. His responsibilities include case management, signal detection, safety evaluation, risk management for all development and marketed products. In his 20 years at GSK, he has also held management positions within the Statistics and Epidemiology Department and Clinical Operations, both in R&D and in the U.S. Pharmaceutical Business, most recently serving as interim head of the Cardiovascular and Metabolic Medicines Development Center. Rockhold previously held positions of research statistician at Lilly Research Laboratories (1979-87) and executive director of biostatistics, data management and health economics at Merck Research Laboratories (1994-97). He has held several academic appointments at Butler University, Indiana University, Penn State University and the University of Pennsylvania.
Rockhold is currently chairman of the Board of Directors of the Clinical Data Interchange Standards Consortium and a member of the National Library of Medicine Advisory group for ClinicalTrials.Gov. He is past president for the Society for Clinical Trials, past chair for PhRMA Biostatistics Steering Committee and a member of the ICH E-9 and E-10 Expert Working Groups. He previously served as associate editor for Controlled Clinical Trials. He is a fellow of the American Statistical Association and a fellow of the Society for Clinical Trials. The author of more than 140 publications and abstracts, Rockhold is also a recipient of the PhRMA Career Achievement award.
Barry Schwab received his Ph.D. in Biostatistics from VCU in 1984. He currently serves asvice president and head of clinical statistics for the Neuroscience, Pain and Established Products programs at Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. He also has responsibility for the statistical support provided to the clinical programs from the J&J office in Shanghai. Schwab has been with J&J for 27 years, providing statistical expertise and strategic direction to many of the company’s investigational compounds, with contributions to product approvals in psychiatry, neurology, pain, dermatology, anti-infectives and hematology/oncology. His current job responsibilities include providing strategic input into development plans, trial designs, NDAs and WW regulatory submissions, product labeling and publications, participating in licensing and acquisition activities, and directing a staff of approximately 50 statisticians in the U.S., Belgium and China.
Schwab has been active in statistical professional society activities, serving on the PhRMA Biostatistics and Data Management Technical Group, as chair of the PhRMA/FDA Workshop on Risk Detection and as a program steering committee member and session chair for the ASA/Biopharm-FDA Workshop, the DIA Statistical Workshop and the BASS Statistical conference. For the past six years, Schwab has been the industry co-chair of the Annual FDA/DIA Statistics Forum, an open meeting to discuss regulatory and scientific issues associated with the development and review of therapeutic drugs and biologics. Schwab is an editorial advisory board member for Pharmaceutical Statistics, The Journal for Applied Statisticians in the Pharmaceutical Industry.
Anthony Segreti received a Ph.D. in Biostatistics from VCU, an M.S. in Biostatistics from the University of Pittsburgh’s Graduate School of Public Health and a B.S. in Mathematics from the University of Pittsburgh. He currently serves as senior director of biometrics at Targacept, Inc., where he has worked since 2009. Segreti has 27 years of experience at Burroughs Wellcome Co., Glaxo Wellcome and GlaxoSmithKline as a project statistician, manager, and group director of statisticians supporting Phase 1-4 clinical trials. He also held positions as senior director of biostatistics at RTI Health Solutions and Ockham. He has extensive experience consulting on the design of clinical trials and has interacted with the FDA on regulatory submissions. He has been active in the biostatistics section of the PhRMA, serving on the steering committee from 1988-98, as vice-chair in 1992 and as chair from 1993-94. He served on the steering committee for the Midwest Biopharmaceutical Statistics Workshop as a workshop chair in 1997 and a program co-chair in 1994 and 1997 and is active on the steering committee for the Biopharmaceutical Annual Statistics Symposium meeting.
After receiving his Ph.D. in Biostatistics from VCU in 1979, Donald Stablein began his career at the university as an assistant professor of biostatistics. He joined The EMMES Corporation in Rockville, Md., in 1980 as a staff statistician, advancing to vice-president in 1985 and president in 1992, a role he currently occupies. Since taking leadership responsibility, Stablein has grown the staff more than tenfold. Among more than 350 employees, there are approximately 50 statistical scientists; EMMES also maintains a subsidiary office in Bengaluru, India. Stablein has served as principal investigator for the Consortium of Food Allergy Research since 1987, continuously directing statistical center functions for an international pediatric renal transplant registry that involves 100 clinics. During his career he has led the statistical and data management centers for extended-term multicenter clinical trial programs in gastrointestinal cancer, solid organ transplantation and HIV vaccines. He recently led statistical design and analysis activities for a trial of the first partially effective HIV vaccine with 16,000 volunteers in Thailand. He has extensive experience in statistical conduct and analysis for clinical trials of transplantation, infectious disease and immune system disorders.
Stablein is a fellow of the American Statistical Society (1996) and statistical editor of the Journal of the National Cancer Institute. He serves as a member of multiple data and safety monitoring boards, including the National Institute of Child Health and Human Development Maternal Fetal Medicine Network, and is past chair of the NCI intramural DSMB. He was appointed by the Secretary of Health and Human Services to serve on the National Advisory Commission on Organ Transplantation and has participated in multiple World Health Organization-sponsored conferences on AIDS vaccine issues. In addition to clinical trial methodologies, Stablein has research interests in survival analysis and response surface methods and has more than 190 publications to his credit.
Phillip Yates received his Ph.D. from VCU in 2010. He has more than 15 years of statistical experience where he worked as a Technologies senior process engineer statistician with Intersil Corporation, a senior statistician at Intel Corporation and a staff expert at Infineon Technologies and Qimonda North America Corporation. During his time at VCU, he served as a graduate assistant in the Department of Social and Behavioral Health and currently is the manager at PharmaTherapeutics Research– Biostatistics, Pfizer Global R&D, in Groton, Conn.