Sanchita Bhattacharya, Scientific Project Lead, ImmPort; Senior Bioinformatics Research Specialist, Division of Systems Medicine, Stanford University School of Medicine
Sanchita Bhattacharya is a lead data scientist for ImmPort, an immunology based data portal and a senior bioinformatics research staff in Dr. Atul Butte’s lab at Stanford School of Medicine. She is actively involved in the area of bioinformatics and has be for over a decade doing collaborative research as a computational research scientist with biologists in academia. She was previously affiliated with Lawrence Berkeley National Laboratory, Center for Environmental Health Sciences at MIT, and the Protein Expression Technology Center at UCLA before coming to Stanford. Her research interest includes immunoinformatics with expertise in integrative analyses of multi parameter measurements coupled with knowledge in statistical modeling and molecular biology. She has over 25 publications (journals, technical reports, peer-reviewed conference and workshop proceedings) in the areas of gene expression, molecular networks and pathways with emphasis on cancer, immunology and human genetics.
Anastasia Christianson, Head, Translational R&D IT, Bristol-Myers Squibb
Dr. Christianson is currently the Head of Translational R&D IT at Bristol-Myers Squibb. Most recently she was Senior Director in R&D Information at AstraZeneca Pharmaceuticals responsible for delivering the information needs of the Neuroscience virtual Innovative Medicines Unit and Global Product teams, and R&D Strategy, Portfolio and Performance Function. Anastasia obtained her Ph.D. in Biological Chemistry from the University of Pennsylvania followed by postdoctoral training at Harvard University in Cellular and Developmental Biology. She began her professional career at a small biotech company, DNX Biotherapeutics, Inc., before moving to AstraZeneca, then Zeneca. She has a broad range of experience in both Discovery and Development ranging from leading drug projects, to setting up Genomics and Bioinformatics in Wilmington, and establishing Biomedical Informatics in Clinical Development. Outside AstraZeneca, Anastasia has held adjunct professor appointments at area universities has helped establish and chairs the external advisory committee of the Quantitative Biology degree program at the University of Delaware and was a member of the External Advisory Panel for establishing the Center for Visual and Decision Informatics, a collaborative center established by the University of Louisiana and Drexel University and funded by NSF Industry/University Cooperative Research.
Leonard D'Avolio, Director, Informatics, Ariadne Labs; Assistant Professor, Harvard Medical School
Len D’Avolio, Ph.D., is the Director of the Informatics and Measurement Platform at Ariadne Labs. In this role, Len works across all project teams to design and develop infrastructure and methods that turn raw data into actionable knowledge. This includes building a scalable infrastructure, supporting an international project data capture and analysis, and developing software capable of detecting novel relationships across heterogeneous data sources.
For the past five years, Len was head of an informatics group he founded within the Department of Veterans Affairs, at the Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC). There he was responsible for the development of national programs such as the development of the VA’s genomic science infrastructure and the first randomized controlled trial embedded entirely within an electronic medical record system. He also developed several software programs to make data mining and natural language processing accessible to nontechnical end users. Len has also been an investigator on several projects funded by the Agency for Healthcare Research and Quality (AHRQ), Department of Defense, and the National Institutes of Health (NIH) focused on using information technology to improve the conduct of clinical science and care.
Len earned his Master’s Degree in Information Technology from the McCallum School of Business at Bentley University and his PhD, which brought him expertise in data mining and natural language processing, from the University of California, Los Angeles. Prior to obtaining his graduate degrees he spent several years in the software industry.
Howard L. Golub M.D., Ph.D., Vice President, Clinical Research, Walgreen Company
Howard received his Ph.D. in BioElectrical Engineering from M.I.T. in 1979, and medical degree from Harvard Medical School (M.I.T.-Harvard Joint Program: H.S.T) in 1983. In 1980, Dr. Golub was the CEO and founder of PDS Inc., a medical computer based diagnostic device company, which was sold to Tokos Medical Corp. in 1990. Also in 1980, he was one of the founders of Venturcom Inc. (a computer software company) and had served on its board of directors which was acquired in 1998. Since 1990, Dr. Golub served as the President and founder of Cry Research Inc. a company formed to determine the clinical usefulness of infant cry analysis (a technology he developed as part of his Ph.D. work), and he is one of the founders, the patent holder of the central IP and CEO of DxTek Inc. a medical device company (that developed a continuous, cuffless non-invasive blood pressure device). In 1995, Dr. Golub was founder and CEO of MSO-NY, a Management Service Organization setup as a partnership of physicians and managed care experts to provide all necessary managed care services (especially data outcomes and information systems management) to one of the first fully integrated physician networks that was able to accept full-risk payer contracts in the New York City area.
Also in 1995, Dr. Golub was founder, president and one of the medical monitors for CareStat Inc. CareStat, based in Boston, was a full service Clinical Research Organization (CRO) specializing in FDA based registration trials for pharmaceuticals, biotech and medical devices. CareStat was acquired by Battelle Memorial Institute in 2005, where he served as the president of their clinical trials subsidiary until 2008. In 2008, Dr. Golub helped form and was one of the Principals of Care-Safe LLC, a multidisciplinary consulting group of senior individuals providing clinical development consulting for large and small healthcare companies.
In 2014, Dr. Golub became VP, Clinical Research for Walgreen Co., and is responsible for all clinical research activities at Walgreens.
In addition, Dr. Golub has been the Principal Investigator on 2 large N.I.H. sponsored trials. Dr. Golub is currently holds an appointment as Senior Lecturer in the M.I.T.-Harvard Joint Program (H.S.T.), as a Distinguished Fellow at the Center for Biomedical Innovation also at M.I.T and a consultant to the National Bureau of Economic Research (NBER). In addition, he has an adjunct appointment at the Boston University School of Public Health in Biostatistics and Epidemiology.
Francis Kendall, Global Head, Statistical Programming and Analysis, Roche
Francis graduated from Sheffield Hallam University in the United Kingdom with a BSc (Hons) in Applied Statistics. During his 26 years working in the Pharmaceutical industry, he has also gained an MBA and succeeded in qualifying as a Chartered Statistician and Chartered Manager.
Francis’ career began at Hoechst as a Biometrician where he carried out Statistical and Computing activities. Throughout his career, Francis has worked for several major Pharmaceutical companies (Sandoz, Nycomed, Pfizer, Novartis, and Roche), holding diverse roles from Company Statistician and Biometrics Manager, to his current role of Global Head of Statistical Programming and Analysis at Roche/Genentech.
Francis has a great appreciation of country and company cultures by living and working in Norway, Switzerland, USA and the UK, as well as managing teams in India, Japan and China.
He is passionate about all aspects of Statistical Programming and about the opportunities that are on the horizon for programming groups as Big Data becomes reality.
Nirmal Keshava, Ph.D., Senior Principal Informatics Scientist, Research & Development Information, AstraZeneca PLC
Nirmal is an experienced big data scientist and leader that has developed innovative solutions for multi-disciplinary problems involving advanced sensor platforms and algorithms, rigorous performance evaluation, and creative visualization. His contributions have spanned biomedical image/signal processing, neuroimaging, genomics, clinical informatics, biometrics, neuroscience, and multi-modal physiology. His goal is to generate insight and value by creatively exploiting data sets of all sizes and types and to work across boundaries to achieve project and institutional goals. Nirmal‘s background in signal processing is complemented by several years of in-depth technical and management experience and collaboration with many different academic, government, and commercial partners. He has served in a variety of leadership roles and enjoy defining visions and leading teams to achieve challenging goals.
Nicholas LaRusso, M.D., Director, Center for Innovation, Mayo Clinic
Prior to becoming Center Director in 2008, he was Vice Chair for Research of the Department of Medicine (DOM), Chair of the Division of Gastroenterology and Hepatology, and Chair of the DOM at Mayo Clinic. Before assuming a faculty position at Mayo in 1977, he was a guest investigator at the Rockefeller University in the laboratory of the Noble laureate, Christian de Duve. A member of the American Association of Clinical Investigation and the Association of American Physicians, he is the former editor of GASTROENTEROLOGY and past president of the American Association for the Study of Liver Diseases (AASLD). Among other honors, he is a recipient of a MERIT Award and the Principle Investigator on two R01s from the NIH; he also received Distinguished Achievement Awards from both the American Gastroenterological Association (AGA) and the AASLD, and the Distinguished Mentor Award of the AGA. He is currently President of the AGA. He received his undergraduate degree (magna cum laude) from Boston College, his M.D. degree from New York Medical College, and his training in internal medicine and gastroenterology at Mayo, the latter as an NIH fellow in the laboratory of Alan Hofmann.
Michael Liebman, Managing Director & Co-Founder, IPQ Analytics LLC
Michael Liebman, Ph.D., is a leading scientist and thought leader in the field of biomedical informatics with many years of academic and corporate experience. He serves on 14 scientific advisory boards, including the PhRMA Foundation and is on the Board of Directors of the Nathaniel Adamczyk Foundation for Pediatric ARDS. Michael has been the Managing Director of Strategic Medicine, Inc. after serving as the Executive Director of the Windber Research Institute since November, 2003. Previously, he was Director, Computational Biology and Biomedical Informatics at the University of Pennsylvania Cancer Center since September, 2000. He served as Global Head of Computational Genomics at Roche Pharmaceuticals and Director, Bioinformatics and Pharmacogenomics at Wyeth Pharmaceuticals, Director of Genomics for Vysis, Inc. He was a co-founder of Prosanos, Inc (2000), which became part of United BioSource Corporation in 2011. He was on the faculty of Mount Sinai School of Medicine in Pharmacology and Physiology/Biophysics. He is an Invited Professor at the Shanghai Center for Bioinformatics Technology. Michael is Chair of the Informatics Program of the PhRMA Foundation and also Chair of its new program in Translational Medicine and Therapeutics and is a member of the PhRMA Scientific Advisory Board. He is on the Advisory Board of the International Society for Translational Medicine and on the Editorial Board for the Journal of Translational Medicine, for Clinical and Translational Medicine and for Molecular Medicine and Therapeutics. His research focuses on computational models of disease progression stressing risk detection, disease process and pathway modeling and analysis of lifestyle interactions and causal biomarker discovery and focuses on moving bedside problems into the research laboratory to improve patient care and their quality of life. He received a Ph.D. in physical chemistry and protein crystallography from Michigan State University in 1977.
Catherine Marshall, Director, Information Strategy & Analytics, Clinical Informatics and Innovations, Pfizer
Cathy is an Information Strategist in the Clinical Informatics & Innovations Group at Pfizer. She has been with Pfizer for 8 years and has focused extensively on data integration, discoverability, and search in order to enable decision support in the Drug Discovery and Development Process. For the last year, she has been working a project at Pfizer to establish a clinical data blueprint to enable precision medicine research from very early drug discovery through patient selection in the clinical trials process.
Muzafar Mirza, Director, Information Strategy and Analytics, Clinical Informatics and Innovation, Pfizer, Inc.
Bio coming soon
Sally Okun, RN, MMHS, Vice President, Advocacy, Policy & Patient Safety, PatientsLikeMe
As Vice President of Advocacy, Policy and Patient Safety, Sally ensures the patient voice, represented in PatientsLikeMe’s member community, is heard, collected and disseminated to affect better treatment, services and care. Sally also serves as the company’s liaison with government and regulatory agencies. She actively participates in national and international discussions to educate policy makers on the benefits of sharing health data, and to ensure patient needs are at the front of the healthcare discussion. In addition, Sally’s position includes responsibility for PatientsLikeMe’s ongoing work in drug safety. She ensures the data collected about treatments and their impact become even more transparent to members and the healthcare community at large.
Sally joined PatientsLikeMe in 2008 and led the team responsible for the website’s medical ontology and curation of patient-reported health data. She has since been a frequent speaker at policy workshops and forums and has contributed to peer reviewed publications and discussion papers for the Institute of Medicine (IOM) and others. A registered nurse for over three decades, Sally’s clinical practice specialized in palliative and end-of-life care. She received her nursing diploma from the Hospital of St. Raphael School of Nursing and holds a bachelor’s degree in Nursing from Southern Connecticut State University as well as a master's degree in health and human services management from Brandeis University’s Heller School for Social Policy and Management.
Stuart Pearce, Director, Information Strategy and Analytics, Development Operations, Worldwide Research & Development, Pfizer, Inc.
Bio coming soon
Johann Proeve, Ph.D., Global Strategy and Development Advisor, Bayer Healthcare, Leverkusen, Germany
Studied agro-biology and started his business life in 1980 at Bayer in Clinical Data Management. Between 1990 and 1994 he was Head of Clinical Data Management at Bayer Corp in West Haven, Connecticut, USA. Since 2000 he was the Head Global Data Management at Bayer Healthcare. In November 2013 he was appointed to Global Strategy and Development Advisor in Global Data Sciences and Analytics. He enjoys canoeing and mountain-biking.
Kesha Rodgers, Associate Director, Clinical Systems, BioMarin
Bio coming soon
Tomasz Sablinski, M.D., Ph.D., Founder and CEO, Transparency Life Sciences
Dr. Sablinski is the CEO of Transparency Life Sciences which he co-founded stimulated by the opportunities to introduce a new model of drug development afforded by modern computer sciences, technology, and new communication and knowledge generation patterns. He has over thirty years of experience in healthcare. This includes fifteen years of pharmaceutical development in a major pharmaceutical company, a CRO, and consulting for small biotechnology companies. His experience in these roles include time in the United States, Europe and Japan. In the 1990s he was a member of Harvard Medical School (Brigham and Women's and Massachusetts General hospitals) teams conducting pioneering work in developing biologic immunosuppressive regimens, induction of transplantation tolerance and xenotransplantation. In parallel, and prior to this, he practiced as a surgeon specializing in renal transplantation and general surgery in his native Poland and in Boston. Transparency Life Sciences’ origins lie in a strong belief that the current system of drug development must be completely changed, and in a passion for development of medications at a fraction of current cost. Dr. Sablinski is also currently Head of Development and a Managing Director of Celtic Therapeutics Development, a development subsiduiarey of Auven Therapeutics. Sablinski received his M.D. and Ph.D. from Warsaw Medical School in Poland.
Alexander Sherman, Director, Strategic Development and Systems, Neurological Clinical Research Institute at MGH, Massachusetts General Hospital
Alex's interests and passion are in developing collaborations in clinical research and building disease-specific research networks and consortia. He is a frequent speaker at academic and industry conferences and has many publications on the topics of collaboration in clinical research, data and biospecimen sharing and technology utilization for these purposes. Alex Sherman has spent 30 years in research, research infrastructure development, software development, software architecture, expert systems design, clinical trials systems design, data management and clinical research management. For the past 12 years Alex works with Massachusetts General Hospital (MGH) and the Neurological Clinical Research Institute. He is responsible for successful design, development and deployment of systems for clinical trials and biomarker studies in CNS diseases and for the Platform for Clinical Research Networks that is the backbone of the NEALS ALS Consortium (www.alsconsortium.org), a research network of 109 academic institutions around the world. Alex Sherman holds Master’s of Science degree in Nuclear Engineering and graduated from a doctorate program in Nuclear Engineering.
Barbara Tardiff, M.D., Vice President, Development Operations; Global Head, Clinical Innovation and Informatics, Worldwide Research & Development, Pfizer
Dr. Barbara Tardiff is Worldwide Head of Clinical Informatics and Innovation at Pfizer. She brings twenty years of broad experience at the intersection of medical practice, clinical data management, and business - in academia, with manufacturers, as well as at contract research organization Parexel.
Dr. Tardiff brings a unique blend of expertise and experience in biomedical and information sciences and is an executive leader with experience in major global business transformations. Over the course of her career she has participated in a broad range of scientific and operational activities related to medical product development including protocol design, project leadership and administration, data management, information systems, and interpretation and presentation of study findings. She is an expert in integration, deployment and evaluation of biomedical data. She is also a member of the Steering Committee for the Clinical Trial Transformation Initiative (CTTI), a collaboration between the FDA and Duke University directed at improving the quality and efficiency of clinical trials. She has also established standards through the Clinical Data Interchange Standards Consortium (CDISC) and Health Level Seven (HL7).
Prior to joining Pfizer, Dr. Tardiff was Executive Director, Clinical and Regulatory Information Services at Merck & Co; subsequently, she served as Corporate Vice President, Clinical Research Services, at Parexel. Earlier positions include VP Biomedical Informatics at the SAS Institute, as well as Assistant Professor at Duke University. Barbara is Board certified in both Pediatrics and Anesthesiology with subspecialty training in cardiothoracic anesthesia. She obtained her MBA at Duke University, her M.S. (Applied Information Management) at University of Oregon, and her MS and M.D. at Yale.
Katherine Vandebelt, Senior Director, Clinical Development Innovation, Eli Lilly and Company
Katherine (Kathy) Vandebelt believes patients are the most important constituent in clinical development. She is collaborating with various companies to deliver a new and better clinical development model that makes clinical trials more accessible to patients and provide them with responsive and considerate care.
Kathy has experience in setting up a network of strategic partnerships to increase flexibility, capacity and capabilities to meet the ever changing needs of drug development. Being part of an international company, Kathy is well aware of the challenges of working with a distant work force. She believes there is tremendous value in developing a diverse work force and is always trying to discover ways to ensure the talents of the people can be leveraged to bring innovative health care solutions to patients.
Kathy received her Bachelor of Science specializing in Pharmacology with a minor in Physiology from Trinity College at the University of Toronto. She started her career at Lilly in Toronto, Canada as a Clinical Research Associate and led clinical development programs across various therapeutic areas. In 1999, Kathy moved to Sydney, Australia to build and lead the Clinical Outcomes and Research Institute. Over a four year period, the research investment tripled, the scope of responsibility expanded to support a larger geographical area, and the scientific and technologic advancements were externally recognized as being innovative and world class. In 2003, Kathy moved to Indianapolis, Indiana (Lilly headquarters) and has held senior leadership roles in Data Sciences / Solutions and Statistics accountable for ensuring clinical data integrity and quality for worldwide medical research conducted for human pharmacology, therapeutic exploratory, therapeutic confirmatory and therapeutic use.
Ronald S. Waife, MS, President and Founder, Waife & Associates, Inc.
Ronald S. Waife is President and Founder, Waife & Associates, Inc., a change management consultancy focusing on clinical research in the pharmaceutical industry. Since 1993, Waife & Associates has been helping health care companies build competitive advantage through process improvement and technology. The company has served over two hundred clients, including biopharmaceutical research sponsors, CROs, AROs, technology vendors and investors. Services include clinical operations and drug safety process improvement, technology strategy, Organizational Preparedness™ for technology and process implementation, virtual executive services in clinical operations and CDM, vendor selection and implementation management, general management of application development projects, and investor advising. Mr. Waife has been Chair of the Editorial Board of the Association of Clinical Research Professionals (ACRP), the first Chair of its Technology Forum, and writes a bimonthly column for Clinical Researcher. He also wrote a regular column on process improvement for Applied Clinical Trials. Mr. Waife was listed in the PharmaVOICE 100 for 2008, and received The Meritorious Service Award from the ACRP in 2006. Mr. Waife received his undergraduate degree in social and behavioral sciences from The Johns Hopkins University, and his masters in public health from Harvard.