Our Team

Berry Consultants employs world renowned experts in Bayesian statistics and clinical trial strategy, and strives to set the standard for innovative clinical trial design, analysis, and implementation.   Meet our growing team.

Founders

Don Berry, Ph.D. / Founder & Senior Statistical Scientist

Don Berry is Founder of Berry Consultants, and a professor in the Department of Biostatistics at the University of Texas M.D. Anderson Cancer Center. He was founding Chair of this department in 1999. Dr. Berry received his Ph.D. in statistics from Yale University, and previously served on the faculty at the University of Minnesota and at Duke University. He has held endowed faculty positions at Duke University and M.D. Anderson. Since 1990 he has served as a faculty statistician on the Breast Cancer Committee of the Cancer and Leukemia Group B (CALGB), a national oncology group. In this role he has designed and supervised the conduct of many large U.S. intergroup trials in breast cancer.  Through Berry Consultants, he has designed many innovative designs of clinical trials for pharmaceutical and medical device companies and for federally funded collaborations in many different diseases. He is well known as a developer of Bayesian adaptive designs that efficiently use information that accrues over the course of the trial. These trials minimize sample size while increasing the likelihood of detecting drug activity.  READ MORE

Scott Berry, Ph.D. / President & Senior Statistical Scientist

Scott Berry is President and a Senior Statistical Scientist at Berry Consultants. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. He has led Berry Consultants to be widely regarded as the premier Bayesian consulting company in the world.  Since 2000, he has been involved in the design of hundreds of Bayesian adaptive clinical trials of pharmaceuticals and medical devices and has become an opinion leader in the field of Bayesian adaptive clinical trials. Some of these trials have been groundbreaking trial designs, setting new standards for innovation and flexibility in trial design. These include the trials supporting the first fully Bayesian approval by the center for drug evaluation of the United States FDA (Pravastatin-Aspirin combination) and the statistical design for Time Magazine’s #2 Medical Breakthrough of 2007 (Veridex’s GeneSearch BLN Assay).  READ MORE

 

 

Statistical & Software Team

 

Kristine Broglio, M.S. / Director & Senior Statistical Scientist

Kristine Broglio is a Director & Senior Statistical Scientist at Berry Consultants with interests in adaptive clinical trials, Bayesian statistics, and survival analysis. First studying economics, she spent two years at RTI International where she was involved in CMS demonstrations studies and CDC sponsored studies related to the prevalence and cost of diabetes. After earning her MS in Biostatistics from the University of Washington in 2003, she joined The University of Texas M.D. Anderson Cancer Center. As a Senior Statistical Analyst, she specialized in breast medical oncology, authoring more than 80 papers in the medical and statistical literature. Kristine joined Berry Consultants in 2010 where she has been involved in the design of Bayesian adaptive clinical trials and comparative effective studies using Bayesian hierarchical modeling for pharmaceutical and medical device companies.

Jason Connor, Ph.D. / Director & Senior Statistical Scientist

Jason Connor is a Director & Senior Statistical Scientist for Berry Consultants with expertise in Bayesian statistics and designing adaptive clinical trials. He works primarily with pharmaceutical companies, medical device companies, and academic investigators and has collaborated in the design of over 200 tailored Bayesian adaptive designs; nearly all were reviewed by the U.S. Food and Drug Administration (FDA).  Dr. Connor currently has appointments as a Assistant Professor of Medical Education at the University of Central Florida College of Medicine (2008-present) and Visiting Professor each summer at the Bloomberg School of Public Health at Johns Hopkins University (2010-present) teaching a week-long course in Bayesian Adaptive Designs. READ MORE

Michelle Detry, Ph.D. / Adaptive Trial Execution Mgr. & Statistical Scientist

Michelle A. Detry is the Adaptive Trial Execution Manager & Statistical Scientist for Berry Consultants with expertise in Phase I, II, and III clinical trial design and analysis/reporting in support of Data Monitoring Committees (DMCs). She received her PhD in Biometry in 2003 from the University of Texas-Houston School of Public Health. Prior to joining Berry Consultants in 2011, Dr. Detry was an Assistant Scientist in the Department of Biostatistics & Medical Informatics in the University of Wisconsin School of Medicine and Public Health. In that role, she led projects focused on the design and creation of reports prepared for independent DMCs for multicenter Phase II/III and Phase III industry sponsored clinical trials, frequently taught seminars on study design and statistical methods to postdoctoral clinical fellows, and co-developed the workshop series “Clinical Research Study Design”. Prior to her position at the University of Wisconsin, Michelle was a Principal Statistical Analyst at the University of Texas M. D. Anderson Cancer where she designed clinical trials using Bayesian methods. In addition to clinical trials, Dr. Detry has experience in the analysis of data for healthcare quality improvement, epidemiology, and basic science research.

Mark Fitzgerald, Ph.D. / Statistical Scientist

Mark Fitzgerald joined Berry Consultants as a Statistical Scientist in 2013. He earned his PhD in statistics from Carnegie Mellon University in 1996, and has since worked at Los Alamos National Laboratory, University of Colorado at Denver, and Neptune and Company. He has broad experience with statistical and mathematical modeling in a wide range of scientific disciplines. He especially enjoys collaborating with other researchers, which has led to work in a variety of fields, including medicine, functional magnetic resonance imaging, physics, chemistry, ecology, manufacturing, and environmental science. His research efforts emphasize stochastic simulation, Bayesian analysis, decision analysis, and expert elicitation. He has contributed to papers across disciplines with his many collaborators, as well as serving as Associate Editor for the Journal of Computational and Graphical Statistics.

Todd Graves, Ph.D. / Statistical Scientist

Todd Graves joined Berry Consultants as a Statistical Scientist in January 2012 and focuses his work on the design of adaptive clinical trials for a variety of clients. For twelve years he was a member of the Statistical Sciences group at Los Alamos National Laboratory. At Los Alamos he specialized in statistical computation, Bayesian data analysis, and reliability problems, especially combining multiple sources of information. He and his coauthors won the American Society for Quality's 2007 Frank Wilcoxon Prize. He was a Postdoctoral Fellow of the National Institute of Statistical Sciences from 1995 through 1999 after receiving his Ph.D. in Statistics from Stanford University in 1995. He has served as Associate Editor for the Journal of Computational and Graphical Statistics.

 

Michael Jackson / Software Engineer

Michael Jackson is a Software Engineer for Berry Consultants. He has over thirty years of experience in software design, architecture and development. Prior to joining Berry Consultants, he worked at The University of Texas at Austin in the Petroleum Engineering and Geoservices Department as a Senior Software Developer/Analyst in the research group. For ten years prior to UT, Michael worked as an independent consultant, providing software and IT services to multiple industries. Early in his career, Michael co-owned and managed one of the largest home care provider agencies in Texas and focused his efforts on the company’s software and IT infrastructure.

 

Liz Krachey, Ph.D. / Statistical Scientist

Liz Krachey is a Statistical Scientist for Berry Consultants. She earned her Ph.D. in Statistics from North Carolina State University in 2009. Prior to joining Berry Consultants, she was a Statistics Manager supporting Oncology and Infectious Diseases at GlaxoSmithKline (GSK). In that role, Dr. Krachey led the adoption of numerous Bayesian adaptive trials and supported multiple statistical initiatives promoting the use of Bayesian Statistics at GSK. Dr. Krachey has collaborated broadly across project teams, providing strategic input into clinical development plans, study designs and analyses, IDMC activities, and regulatory interactions.

 

Roger Lewis, M.D., Ph.D. / Senior Medical Scientist

Roger J. Lewis, MD, PhD, is the Senior Medical Scientist for Berry Consultants. He received his PhD in Biophysics in 1986 and his MD in 1987 from Stanford University. He completed clinical training in emergency medicine in 1990 and is currently a Professor at the David Geffen School of Medicine at UCLA and Chair of the Department of Emergency Medicine at Harbor-UCLA Medical Center. Dr. Lewis’s expertise centers on clinical research methodology, including adaptive and Bayesian trial design, and he participates in the design and analysis of numerous laboratory, clinical, and health services research studies. His areas of interest include adaptive and Bayesian clinical trials; translational, clinical, health services and outcomes research; emergency department crowding and disaster preparedness, interim data analysis; the role and function of data monitoring committees; and difficulties surrounding informed consent in emergency research studies. Dr. Lewis has served as a research mentor for numerous fellows and junior faculty and frequently lectures on the topics of clinical research design and the statistical analysis of clinical trials.  READ MORE

Anna McGlothlin, Ph.D. / Statistical Scientist

Anna McGlothlin is a Statistical Scientist for Berry Consultants. She earned her Ph.D. in Statistics from Baylor University, with research focused on Bayesian methodology and measurement error. Prior to joining Berry Consultants, she was a Senior Research Scientist in the early phase oncology group at Eli Lilly and Company. While at Lily, she was frequently sought out by colleagues for consultation on clinical trial design, especially adaptive design.

Rob Nelson, Ph.D. / Senior Software Engineer

Rob Nelson is a Senior Software Engineer for Berry Consultants. He received his Ph.D. in astronomy from the University of Manchester in 1989. Prior to joining Berry Consultants, he worked for over 25 years at Tessella Ltd. While there he worked on a wide range of projects including mining genomic, interfacing to a video extensometer, a beam line control system for a neutron spallation source, analyzing election backscattering diffraction data and oil reservoir simulations. His involvement with Bayesian statistics began with modeling asset conditions for the water industry. He has worked on many adaptive clinical trial projects starting with Pfizer's ASTIN stroke trial. This included clinical trial simulators for Pfizer and Wyeth, and now culminating in Berry Consultants’ FACTS (Fixed and Adaptive Clinical Trial Simulator). For FACTS he has developed and continues to support the user interface and the dose escalation engine as well as performing validations on the other engines.

Tom Parke / Director of Software Solutions

Tom Parke is Director of Software Solutions for Berry Consultants. Tom’s passion and experience has been software for adaptive clinical trials. Prior to joining Berry Consultants, he was Head of Clinical Trial Solutions for Tessella Ltd. While at Tessella for nearly 20 years, he managed the development and running of the software system to support Pfizer’s ASTIN Stroke trial, and has setup multiple software systems to support different aspects of many adaptive clinical trials, mostly designed by Berry Consultants. In parallel, he managed projects to develop clinical trial simulators, first with Pfizer, then Wyeth, before acting as the expert advisor and reviewer to the joint development of FACTS with Berry Consultants. Prior to working at Tessella, he worked for Inmos, Imperial Software Technology, and Praxis on compilers, operating systems and real time control systems. He graduated with a Joint First Class Honours in Math and Computer Science from Bristol University in 1979.

Melanie Quintana, Ph.D. / Statistical Scientist

Melanie Quintana is a Statistical Scientist for Berry Consultants. She earned her Ph.D. in Statistics from Duke University in 2010. Afterwards she pursued a Postdoc in Biostatistics at The University of Southern California. While at Duke and USC, she has worked closely with collaborators within multiple large studies and consortiums around the nation to develop and implement analytical strategies to assess genetic risk factors for various complex diseases. These collaborations have sparked and continue to fuel her interests in developing Bayesian methods for high-dimensional genetic applications.

Ashish Sanil, Ph.D. / Senior Statistical Scientist & Software Architect

Ashish Sanil is a Senior Statistical Scientist & Software Architect at Berry Consultants, where he is responsible for the development and packaging of the core statistical components of FACTS software. He received his Ph.D. in statistics from Carnegie Mellon University and was a postdoctoral fellow at the National Institute of Statistical Sciences. Also prior to joining Berry Consultants, he was a Quantitative Analyst at Google, Inc. and a Senior Research Biostatistician at Bristol-Myers Squibb. He has authored more than 20 papers and book chapters in the statistical literature.

Ben Saville, Ph.D. / Statistical Scientist

Ben Saville is a Statistical Scientist for Berry Consultants, where he specializes in the design of innovative Bayesian adaptive clinical trials.  He works primarily with medical device companies, pharmaceutical companies, and academic investigators to solve challenging problems via Bayesian designs, many of which are reviewed by the U.S. Food and Drug Administration (FDA).  He is a frequent invited speaker at various statistical conferences, academic seminars, and lecture series, including short courses on adaptive clinical trial design.  Dr. Saville earned his Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill in 2008.  Prior to joining Berry Consultants in 2014, he was an Assistant Professor of Biostatistics at Vanderbilt University School of Medicine where his methodological research focused on Bayesian hierarchical models, Bayesian adaptive clinical trials, and nonparametric methods for randomized clinical trials.  At Vanderbilt, he collaborated extensively with medical researchers in the Department of Pediatrics and the Vanderbilt-Ingram Cancer Center, and was co-leader of an adaptive trials design workforce to promote innovative Bayesian methodology in clinical trials.  In addition, he taught undergraduate and graduate courses in the Department of Biostatistics and Department of Biomedical Engineering.  Dr. Saville has authored over 50 peer-reviewed publications in the statistical and medical literature.

Kert Viele, Ph.D. / Director & Senior Statistical Scientist

Kert Viele is a Director & Senior Statistical Scientist with Berry Consultants. His research interests involve Bayesian computational methods applied to adaptive clinical trials, functional data analysis, mixture modeling, and model selection. Dr. Viele received his Ph.D. from Carnegie Mellon University and prior to joining Berry Consultants in 2010, he was an Assistant and Associate Professor at the University of Kentucky. He has been a principal investigator (or co-PI) on NIH and NSF funded grants and has led statistical collaborations in proteomics, biology, medicine, psychology, and engineering. He has received numerous teaching awards, served as chair for data safety monitoring boards, and chaired numerous university committees. Dr. Viele has contributed more than 20 papers to the statistical literature and is currently an editor of the journal Bayesian Analysis. Dr. Viele is a software architect for FACTS (Fixed and Adaptive Clinical Trial Simulator), a Bayesian adaptive design software product currently licensed to 25% of the top 20 Pharmaceutical companies in the United States.

Barbara Wendelberger, Ph.D. / Statistical Scientist

Barbara Wendelberger is a Statistical Scientist at Berry Consultants. She earned her PhD in 2016 from the University of Wisconsin. Her doctoral research focused on a Variational Bayesian method for estimating neural effective connectivity networks using information from multiple imaging modalities. While at Wisconsin, Barbara collaborated extensively with other investigators and academic departments to explore statistical methodology in a variety of biomedical applications. She was a predoctoral trainee on NIH training grants administered through the Institute for Clinical and Translational Research, the Computation and Informatics in Biology and Medicine Program, and the Clinical Neuroengineering Training Program. Previously, Barbara was a member of the Genomics group at Los Alamos National Laboratory, participating in both sequencing technology and metagenomics research. Barbara received her BS (Mathematics, Biological Sciences) from the University of Notre Dame in 2010 and her MS  (Statistics, Biostatistics emphasis) from the University of Wisconsin in 2013. Her research interests continue to focus on data-driven inference at the juncture between statistics, mathematics, biology, and medicine.

 

 

Clinical Trial Strategy Team

 

Meredith Buxton, MPH, Ph.D. / Director, Clinical Trial Strategy

Meredith Buxton is Director of Clinical Trial Strategy for Berry Consultants’ Clinical Trial Strategy Team, whose mission is to accelerate the clinical development process by designing and implementing innovative, adaptive, and platform trials across all therapeutics areas. Dr. Buxton’s experience and skills include adaptive and platform trial operational design and implementation expertise; clinical trial design experience, including novel trial designs; clinical trial oversight, including safety, regulatory, clinical, project management and data management; strong knowledge and experience in oncology and infectious disease research; strong medical writing background including protocols, publications, and grant applications; extensive program, staff, and financial management experience.  READ MORE

Julia L. Clennell / Manager, Operations and Quality

Julia Clennell is Manager of Operations and Quality for Berry Consultants’ Clinical Trial Strategy Team, whose mission is to accelerate the clinical development process by designing and implementing innovative, adaptive, and platform trials across all therapeutics areas. Julia’s experience and skills include adaptive and platform trial operational expertise; clinical trial design experience (with an emphasis on phase I and II clinical trials); clinical trial management with a focus on innovating the clinical operations process, protocol development, CRO selection and management, pharmacovigilance and regulatory; forming and maintaining strategic collaborations; identifying programmatic challenges and opportunities and developing result-driven operational strategies. Strong knowledge and experience in oncology and immunology.  READ MORE

Melissa C. Paoloni, MA, DVM, DACVIM-O / Director, Clinical Trial Science

Melissa Paoloni is Director of Clinical Trial Science for Berry Consultant’s Clinical Trial Strategy Team, whose mission is to accelerate the clinical development process by designing and implementing innovative, adaptive, and platform trials across all therapeutic areas. Dr. Paoloni’s expertise is in innovative clinical trial design in all phases of drug development (preclinical-phase 3) and platform and adaptive trial implementation. She has specific phase 1 proficiency, a medical oncology background, genomics and molecular oncology knowledge, intellectual property understanding, and strong business development and relationship building skills.                                        READ MORE

 

 

Finance & Operations Team

 

Shawn Andersson / Vice President, Finance & Operations

Shawn Andersson is Vice President, Finance & Operations for Berry Consultants.  Shawn is responsible for overseeing business operations, strategic planning and analysis, finance, human resources, contract management, and compliance for Berry Consultants.  He earned his Bachelor of Business Administration in Finance from Texas A&M University and Master of Business Administration from The University of Texas at Dallas.  Prior to joining Berry Consultants in 2012, he held similar operational roles for 15 years within the semiconductor industry and higher education.

Misty Vasquez / Operations Manager

Misty Vasquez is the Operations Manager for Berry Consultants.  Misty joined Berry Consultants in December 2007 and handles the overall accounting, client invoicing, accounts receivable, accounts payable, and payroll for Berry Consultants.  Prior to joining Berry Consultants, she worked for Texas A&M University for 17 years.  Her last position there was in the Dean’s Office of the College of Engineering where she supported the advising and recruiting programs.  She also was the coordinator of the College of Agriculture and Life Sciences scholarship program for 10+ years.

 

 

Information Technology

 

Henrik Schmiediche, Ph.D. / IT Engineering

Henrik Schmiediche supports the IT infrastructure and computing needs for Berry Consultants.  He is also currently the head of IT at the Department of Statistics at Texas A&M where he directs the computing operations in support of faculty, staff and students. In addition to his departmental duties, he serves on several university-wide policy and technology advisory committees to help direct the course of IT at the university level. As former primary System Administrator and current member of the Brazos Architecture and Oversight Committee he oversees the continue expansion and use of the Linux based Brazos HPC cluster, a 300+ node, 3000+ core Infiniband interconnected system with 200TB of high speed parallel file storage using GlusterFS and FhGFS. Some of his recent work for Berry Consultants, includes converting FORTRAN console based software for the design of clinical trials into Windows and creating Graphical User front end interfaces written for those applications in C# and .NET; deploying Amazon EC2 cloud compute instances to support simulation intensive projects; optimize and improve code using Intel compilers and high performance MKL libraries both in Windows and Linux; and overall support Clinical Design Statisticians with their Mac and Linux computing environment. He earned his M.S. and Ph.D. in Statistics from Texas A&M University with an emphasis on statistical graphics.