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Biosketches
Statistical Consultation Medical Writing Clinical Data Management SAS Programming Business
Statistical Consultation
Gregory D. Elfring, MA, MS
Greg joined Innovative Analytics as a partner in 2004 to coordinate and implement the statistical services offered by the company. Greg has worked in the pharmaceutical industry since 1998 and has provided statistical support for all facets of product development, including discovery research, clinical development, regulatory affairs, and marketing. He has been recognized for his contributions in statistical design, analysis, and inference. Since joining Innovative Analytics, Greg has consulted and analyzed a number of thorough QT (TQT) studies to assess prolongation in the QT interval. He is also an experienced mathematics and statistics instructor and co-developer of educational software for college statistics courses. Greg received graduate degrees in mathematics from Indiana University and in statistics from The Ohio State University and is a member of the American Statistical Association.
Linda B. Leonard, MA, MS
Linda joined Innovative Analytics in 2006 as a clinical biostatistician. Linda has worked in the pharmaceutical industry for 16 years. After receiving a BS in medical technology from Ohio State University, Linda worked in the clinical chemistry laboratory at Johns Hopkins Hospital and then as a clinical chemistry supervisor at St. Joseph Hospital in Baltimore. She completed an MA in supervision during this time. Linda worked as a medical technologist at Borgess Medical Center for 7 years. After receiving an MS in statistics from Western Michigan University, Linda worked for The Upjohn Company in Stability Administration and then in the Biostatistics Unit. She has worked on projects from phase I-III in the areas of central nervous system, infectious disease, hair growth, and cardiovascular diseases research and was the lead statistician on several infectious disease studies. Linda played an important role in creating standards for output display tables and in the development of an automated system to create output tables and listings from the standard displays. After Pfizer acquired Pharmacia, Linda continued for 2 years as a clinical biostatistician for Pfizer before joining Innovative Analytics.
Gary L. Neidert, MS, PhD
Gary joined Innovative Analytics as the Principal Statistical Consultant for Innovative Analytics in 2006. He has worked for over 30 years in drug development for the federal government, major pharmaceutical companies, and contract research organizations. His experience spans professional and senior managerial responsibilities in statistics, clinical data management, and information technology. Gary received an undergraduate degree in mathematics from Wheeling Jesuit University and graduate degrees in statistics from the University of Kentucky. He has provided statistical support for all phases of drug development: nonclinical, clinical, and exploratory studies. He has particular expertise in support of infectious, central nervous system, and metabolic diseases and in regulatory requirements. Gary has participated in the development of ICH guidelines by serving on an expert working group. He is an active member of the American Statistical Association, serving as a past chairman of the Biopharmaceutical Section, the Southwest Michigan Chapter, and numerous committees. He is a member of the Drug Information Association (DIA) for which he has developed and taught courses on biostatistics and clinical data management and on the regulatory requirements for these. He also serves on the DIA Training Advisory Committee.
Thomas H Oliphant, MS, PhD
Tom joined Innovative Analytics as a partner in 2005 to coordinate and manage statistical support for clinical studies. Tom has over 18 years of experience in the pharmaceutical industry with Upjohn, Pharmacia, and Pfizer. He received undergraduate training in mathematics at Kent State University and graduate degrees in biometry and health information systems from the University of Minnesota. He has provided statistical support for registration and product support programs in the cardiovascular, critical care, anti-inflammatory, and infectious diseases therapeutic areas. Tom served as lead statistician for successful regulatory submissions in the United States, Europe, and Japan. For the 3 years before joining IA, he served as a director of clinical biostatistics at Pharmacia/Pfizer. He is a member of the American Statistical Association (ASA) and the International Biometric Society (IBS).
Kimberly T. Perry, MS, PhD
Kim joins Innovative Analytics as a partner in 2006 to provide and coordinate statistical support for clinical studies and registration activities. Kim has over 24 years of experience in the pharmaceutical industry, primarily with Upjohn, Pharmacia, and Pfizer. She received undergraduate training and graduate degrees in biostatistics and mathematics from Western Michigan University. She has provided statistical support for registration and product support programs in the central nervous system and critical care therapeutic areas, as well as for device programs. Kim served as lead statistician for successful US and EU regulatory submissions. Before joining Innovative Analytics, Kim served as a director of clinical biostatistics for 5 years, followed by 3 years in pharmaceutical sciences as a statistical research fellow at Pharmacia/Pfizer. Kim is a member of the American Statistical Association (ASA).
Patricia L. Ruppel, MPH, PhD
Patty is the President, CEO, and cofounder of Innovative Analytics. Patty has over 30 years of experience in the pharmaceutical industry, primarily with Upjohn and Pharmacia. With undergraduate schooling in mathematics from Western Michigan University and graduate training as a biostatistician from the University of Michigan, she has provided statistical support for a broad range of scientific/clinical programs ranging from discovery research, to exploratory clinical development, to marketing registration efforts. Her most recent focus has been in the identification of biomarkers (including genomic, biochemical and imaging markers) and their optimization and validation in the clinical setting. She has been involved with several development programs and US/EU regulatory submissions for central nervous system, cardiovascular, inflammation, and urogenital drug applications, device applications, and orphan drug submissions. She also has several years of project and people management experience. Patty is an active member of the Drug Information Association (DIA) and the American Statistical Association (ASA).
Matthew Schipper, MS, PhD
Matt joined Innovative Analytics in September of 2007. He received his BS and MS in statistics from Western Michigan University (WMU) and his PhD in Biostatistics from the University of Michigan (U of M). While at WMU, he had internships at National City Bank and Pfizer where he worked on the analysis of phase 2-3 studies. During his time at the U of M, he was a research assistant in the Radiation Oncology Department and a trainee on the National Institutes of Health (NIH)-funded Biostatistics in Cancer Training Grant and then spent 1 year as a faculty member in the Radiology Department at the U of M.. He collaborated on numerous imaging-related research projects and grant applications. He was an ad hoc reviewer for Academic Radiology and a teaching assistant for a faculty development course. He is an author of papers appearing in statistics, cancer, and cardiovascular disease journals. Matt is also an active member of the American Statistical Society and the International Biometric Society (ENAR).
Ann Weltevreden-Penix, MS
Ann Weltevreden-Penix joined Innovative Analytics in August of 2007. Ann has a bachelor’s degree in mathematics from Kalamazoo College and an MS in statistics from Iowa State University. She started her career at the Cleveland Clinic Foundation as a general statistician. Ann later joined The Upjohn Company/Pharmacia and Upjohn/Pharmacia as a phase 2-3 clinical trial statistician, specializing in infectious disease and head injury research. She spent her most recent years at MPI Research where she was involved in the analysis of preclinical studies and where she developed expertise in animal health studies. Ann also managed the Department of Biostatistics for 2 years at MPI. She is affiliated with both the American Statistical Association (ASA) and the Drug Information Association (DIA).
Fredrick S. Whaley, MSPH, PhD
Rick joins Innovative Analytics in 2007 to provide statistical support for clinical studies. Rick has over 16 years experience in the pharmaceutical industry with Adria Laboratories, Pharmacia, and Pfizer, where he worked with other members of project teams designing and analyzing clinical trials in a variety of therapeutic areas. These include infectious disease, inflammation, dermatology, neurology, ophthalmology, and oncology. Rick served as the lead statistician for successful regulatory submissions for drugs that treat infectious, neurologic, and oncologic diseases, and has presented results of clinical trials to senior management, therapeutic opinion leaders, and members of an FDA advisory committee. Prior to work in the pharmaceutical industry, he also worked at a medical school and at a school of public health. Rick received an undergraduate degree in statistics and computer science at the University of Delaware and graduate degrees in biostatistics at the University of North Carolina – Chapel Hill. He is a member of the American Statistical Association and the International Biometric Society.
Medical Writing
Lillian L. Neff, BA
Lillian, Executive Director of Medical Writing, joined Innovative Analytics in January 2008. Lillian has over 30 years of experience in the pharmaceutical industry, including 27 years in industry at the legacy Pharmacia companies and 4 years of experience as a medical writer/consultant and president of The WRITE Phase, LLC, a company that she founded upon leaving Pharmacia. Her 27 years of experience in industry include several years in the laboratory and 5 years as a clinical research coordinator (during which she implemented and monitored clinical studies in depression, insomnia, and analgesia). However, her main focus while in industry, and before joining Innovative Analytics, has been medical writing. She has extensive (24 years) hands-on experience in writing all types of clinical drug development documents, from Investigational New Drug Applications (INDs) through registration documents in the Common Technical Document (CTD) format to advisory committee brochures to manuscripts. She has written documents in a variety of therapeutic areas, including cardiovascular diseases, central nervous system diseases, dermatology, oncology, and women’s health. Before leaving industry, Lillian was the global head of medical writing at Pharmacia and, thus, also brings both people and time management skills with her to Innovative Analytics. She has been a member of the American Medical Writers Association (AMWA) since 1984 and holds a medical writing certificate from that organization
Clinical Data Management
James M. Dancy, BSE, MBA
Jim is the Vice President, COO, and cofounder of Innovative Analytics. Before Innovative Analytics, Jim held several key positions in data management, including the titles of Director of Clinical Database Operations (Pharmacia) and Director of Experimental Medicine Informatics (Pfizer). While at Pfizer, Jim implemented a data warehouse to support clinical biomarker analysis, which earned a Bio?]IT “Best Practices” award in 2003. Jim holds an engineering degree from the University of Michigan and an MBA from Oklahoma University. He is a member of the American Society for Quality (ASQ) and has been a Certified Quality Engineer (CQE) through that organization since 1991. He is also a member of the Drug Information Association (DIA).
Sara J. Glass, BS
Sara joined Innovative Analytics in October 2006. She has a BS from Spring Arbor College. She is a Programmer with 7 years programming experience during which she supporting both the pharmaceutical and automotive industries. Besides SAS programming for output displays, Sara provides programming support for the ClinPlus Data Management System and logical check process.
Sandra A. Mann, BS, MS
Sandra joined Innovative Analytics in February 2006 as a Clinical Data Manager, with over 6 years of experience in the pharmaceutical industry at Pharmacia & Upjohn and Pharmacia and over 18 years of experience in the clinical diagnostics industry. Following her tenure in project management for consumer healthcare products and data management support for central nervous system drug development, her most recent experience was the development and management of a logistical process for collecting, storing, and processing DNA samples for use in pharmacogenomic studies. Sandra holds a degree in biology from California State University in Fullerton and is a licensed medical technologist.
Adam C. Mintz, BBA
Adam joined Innovative Analytics in May 2006. He has a BBA from Western Michigan University, with a major in computer information systems, and graduated Cum Laude in 2006. Adam is trained and certified on the ClinPlus Data Management system and provides support for database and screen design, study definition, and system administration.
John D. Orr, BS, MPH
John joined Innovative Analytics as a senior clinical data manager in February 2007, after a 33-year career that included 8 years in academic research and 25 years as a programmer, statistician, data manager, and study manager with Upjohn, Pharmacia, and Pfizer. He has worked on projects in oncology, cardiovascular disease, inflammation, female health, antiviral and antibacterial research, and his efforts have contributed to numerous successful regulatory submissions. He has served on the faculty of training programs that are sponsored by the Pharmaceutical Education Research Institute (PERI). John has a BS in mathematics from Duke University and a master’s degree in statistics from the University of Michigan.
Susan L. Thayer, BS
Sue joined Innovative Analytics in 2007. She has a BS in biomedical engineering from Purdue University and is currently pursuing an MS in clinical research administration at George Washington University. Before joining Innovative Analytics, Sue was a project manager at the Kalamazoo Center for Medical Studies. She is a member of the Association of Clinical Research Professionals.
Karen M. Tindall, BS, CCDM
Karen is a certified clinical data manager with 10 years of experience in the bioscience industry (Pharmacia, Axio, and Icos) and joined Innovative Analytics in September of 2006. She has extensive experience in managing clinical data management efforts for a variety of phase 1-3 studies and has implemented data management systems and created and maintained standards. Karen’s primary interest is in optimizing data management processes through improved project management, data standards, and innovative solutions that will result in high-quality data and efficient timelines to database lock.
SAS Programming
Kay A. Bentley, BS
Kay joined Innovative Analytics in November 2005. She has a BS in Mathematics from Purdue University. She is a Senior Statistical Programmer with 23 years of programming experience, including 19 years of experience with SAS. She has supported pharmaceutical development for 16 years and has been involved with US, EU, and Japanese regulatory submissions in the areas of central nervous system, ophthalmology, and infectious diseases research, as well as with phase I-IV trials. Kay also has expertise in computer systems validation and SAS programming validation. Kay supports the MidWest SAS Users Group and SAS Global Forum.
Sherry L. Higgins, MS
Sherry Higgins joined Innovative Analytics in September 2007 as a Clinical Programmer/Analyst. She has a BS in medical technology from Michigan State University and worked for several years in hospital laboratories as a general medical technologist. She has undergraduate and graduate degrees in computer science from Western Michigan University. Her programming experience includes SAS experience working on Phase II/III trials for the Upjohn Company. She also has over 10 years experience programming and support of a document management system for Pfizer and Pharmacia and Upjohn.
Joel A. Koestner, BS
Joel joined Innovative Analytics in May 2006. He has a BS in computer science and mathematics from Western Michigan University. He is a Senior Statistical Programmer with 18 years of programming experience, including 13 years of experience with SAS. He has supported pharmaceutical development for small and large companies and has been involved in both clinical and preclinical efforts. Joel has experience with a variety of operating systems and computer languages.
Griff N. McTume, PhD
Griff joined Innovative Analytics in August 2007 as a Clinical Programming Analyst. He received his PhD in mathematics from Auburn University and a graduate diploma in computer science from the University of Lagos. Griff worked for 7 years at Ferris State University where he attained tenure and was promoted to Associate Professor of Mathematics. He taught a wide variety of courses, including “Statistics for the Life Sciences,” and served as an academic advisor to prepharmacy students. Griff’s primary interest is writing efficient programs to summarize or analyze large clinical data sets. He is certified in Base SAS 9.
Business
Vickie L. Gordon, BBA, CEBS
Vickie joined Innovative Analytics in 2007 as the Business Manager after spending 28 years with a Fortune 500 medical technology company. Vickie’s background includes a variety of financial and employee benefit positions, including experience with stock option administration. Vickie is also certified in employee benefits. Vickie is a graduate of the University of Miami where she majored in accounting.
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