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Virtual

Nov 14, 2022 7:00 AM - Nov 15, 2022 7:00 PM

Data Science Conference

Bridging Data Science and Clinical Development!

Speakers

Pritibha  Singh, MBA, MSc

Pritibha Singh, MBA, MSc

Senior Manager, Corporate Affairs Analytics & Insights, Novartis AG, Switzerland

Pritibha Singh, a leader at Novartis data42, brings 17 years of global experience spanning Switzerland, Germany, the United Kingdom, Australia, and New Zealand with extensive cross-sector experience (Tech space, Pharmaceutical, Biosimilar, Academia, FMCG, and Banking). Her expertise covers diverse therapeutic areas, including Cardiovascular, Diabetes, Neuroscience, Respiratory, Oncology, Immunology, and Hematology, with a comprehensive background in discovery, development, and late-phase. A blend of expertise in Drug Development (Psychology, Statistics, and Business). Currently pursuing a Doctorate (Dr. sc. ETH Zurich), specializing in sustainable strategies for decentralized clinical trials.

Ruthie  Davi, PhD, MS

Ruthie Davi, PhD, MS

Vice President, Data Science and Statistician, Medidata, a Dassault Systèmes Company, United States

Ruthie Davi is a Statistician and Vice President, Data Science at Acorn AI by Medidata (a Dassault Systèmes Company) and has a background in pharmaceutical clinical trials with more than 20 years working as a Statistical Reviewer, Team Leader, and Deputy Division Director in the Office of Biostatistics in CDER at FDA. At Acorn AI Ruthie is part of a team creating analytical tools to improve the efficiency and rigor of clinical trials, an example of which is her Synthetic Control work. Ruthie holds a Ph.D. in Biostatistics from George Washington University.

Nan  Shao, PhD

Nan Shao, PhD

Executive Vice President, Global Operations, Veristat, United States

Steve  Wilson, PhD

Steve Wilson, PhD

Senior Staff Fellow, OB, OTS, CDER, FDA, United States

Dr. Wilson has worked as a mathematical statistician at FDA for more than 33 years.  He is currently a Senior Staff Fellow with the Office of Biostatistics at the Center for Drug Evaluation and Research (CDER).  Steve received his doctorate in Biostatistics from the University of North Carolina, Chapel Hill, in 1984. His professional experience has also included positions with the East West Center, the Indonesian Central Bureau of Statistics, the University of North Carolina, the Federated States of Micronesia and the World Bank. His professional interests and activities are currently focused on issues related to the improvements in clinical trials science and practice, data standards, and the review of drug and biological therapies.

Jingjing  Ye, PhD

Jingjing Ye, PhD

Executive Director, Global Head of Data Science & Operational Excellence (DSOE), Global Statistics and Data Science (GSDS), BeiGene USA, United States

Jessica  Federer, MPH

Jessica Federer, MPH

ex-CDO , Bayer AG, United States

Jessica is an investor and board member adept at deploying technology to make meaningful advancements for both business and society. She was one of the first Chief Digital Officers in the pharma industry, leading the digital transformation for Bayer A.G. across the Pharmaceutical, Consumer Care, Crop Science and Animal Health businesses. She is recognized as one of the top 100 CDOs and a leading health tech influencer, and served on the United Nations ITU advisory board. Federer began her public health career as an analyst at the Agency for Healthcare Research and Quality in the US Department of Health and Human Services. She earned a Bachelor of Science from the George Washington University, and a Master of Public Health from Yale.

Jerald  Schindler, DrPH

Jerald Schindler, DrPH

Chief Executive Officer, Strategic Statistics, United States

Rebecca  Taha, PhD, MBA

Rebecca Taha, PhD, MBA

Director Biostatistical Consulting, ICON Biotech Solutions, United States

Rebecca Taha PhD, MBA, a statistician and portfolio strategist has served the life sciences and healthcare industry for over 20 years. As Director, she supports biotechnology and biopharma organizations around the globe, providing strategic consulting and advisory services. Previously, she supported numerous pharmaceutical and device development programs, most recently as a senior research scientist at Eli Lilly and Company in Global Statistical Sciences. Dr. Taha received her MS and PhD from the University of Kentucky in in Statistics and Gerontology, respectively, and her MBA from the Kelley School of Business.

Chava  Zibman, PhD

Chava Zibman, PhD

Mathematical Statistician, CDRH, FDA, United States

Joan  Buenconsejo, PhD, MPH

Joan Buenconsejo, PhD, MPH

Head of Cardiovascular and Neuroscience Biostatistics , Bristol Myers Squibb, United States

Joan Buenconsejo is VP, Head of Cardiovascular, Neuroscience, and Early Development Biostatistics at Bristol Myers Squibb (BMS). Prior to BMS, she was a strategy lead at AstraZeneca and a statistics team leader at CDER, FDA. She is a long-time DIA member, has chaired the DIA Statistics and Data Science Community, has worked with the Advisory Council of North America, and served as program chair and steering committee member for the Annual FDA/DIA Statistics Forum, and track co-chair for the DIA Annual Meeting. Dr. Buenconsejo received a master’s degree in mathematical statistics from University of California, Irvine, and a MPH and PhD in biostatistics from Yale University.

Aloka  Chakravarty, PhD

Aloka Chakravarty, PhD

Director, Data Analytics, Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States

Dr. Aloka Chakravarty is currently the Sr. Statistical Advisor in the Office of the Commissioner, FDA for real-world data and evidence activities related to collaborations on COVID-19 and others. She is also working on select strategic data initiatives at FDA with the Chief Data Officer.Prior to that, she was the Deputy Director of the Office of Biostatistics in CDER, FDA. She is an internationally recognized thought leader in multi-regional clinical trials, safety evaluation, real world data and evidence, surrogate markers and biomarkers in drug development. Dr. Chakravarty served as an Adjunct Faculty in Department of Statistics, FAES, NIH and has been on Advisory Board of multiple academic institutions.

Mariann  Micsinai-Balan, PhD

Mariann Micsinai-Balan, PhD

Head of Data Science, Bristol Myers Squibb, United States

Mariann Micsinai-Balan is VP, Head Data Science and Statistical Methodology at Bristol Myers Squibb (BMS). Prior to joining BMS, Mariann was Head of Data Science at E*Trade. Before that, she spent 7 years at Pivotal Software, where she was involved in solving big data problems, building and deploying cutting edge machine learning models in the financial services, healthcare, e-commerce and government sectors. Mariann started her career working in market risk management on the trading floor at Lehman Brothers.

Amy  Abernethy, MD, PhD

Amy Abernethy, MD, PhD

President of Clinical Studies Platforms, Alphabet’s Verily, United States

Amy P. Abernethy, MD, PhD is the President of Product Development and Chief Medical Officer at Verily, where she leads teams in the development and delivery of solutions that bridge the gap between clinical research and care. Before joining Verily, Dr. Abernethy was Principal Deputy Commissioner and Acting Chief Information Officer of the US Food & Drug Administration. Prior roles include serving as CMO/CSO of Flatiron Health and multiple roles at Duke University, where she was Professor of Medicine. Dr. Abernethy went to the University of Pennsylvania and then Duke University Medical School, and received her PhD from Flinders University in Australia.

Ella  Balasa

Ella Balasa

Patient Advocate and Engagement Consultant, United States

A chronic disease patient who advocates research and advisory boards, optimizing clinical trial designs and reviewing protocols, composing lay clinical summaries and op-eds, collaborating on white paper development, moderating patient and industry panel discussions, as well as sharing my own healthcare perspectives. I believe in the importance of engaging patient communities to be active participants in health care across the continuum by empowering and educating them to collaborate with various stakeholders to improve disease outcomes.

Joy  Bhosai, MD, MPH

Joy Bhosai, MD, MPH

CEO & CO-Founder , Pluto Health, United States

Joy Bhosai, MD MPH is the co-founder/CEO of Pluto Health, a company focused on improving patient access and care through a health platform that bridges siloed real world data (RWD). She previously served as Chief of Digital Health and Strategy for the Duke Clinical Research Institute. Through previous public health work in Africa and Asia, she developed innovations focused on improving access to health services that were used for clinical trials, which then lead to her founding ChatrHealth, a health tech organization dedicated to developing patient safety and communication tools. Joy received a Masters of Public Health from Yale, focusing on global health management, and an MD with distinction from UCSF.

Ram  Iyer, MS

Ram Iyer, MS

Chief Data Officer, FDA, United States

As the Chief Data Officer of the FDA, Ram C Iyer has the accountability to develop and execute an agency wide data modernization strategy, building robust central functions that can be leveraged by the centers and the agency for high value decisions. The scope spans the entire stack from data identification to actionable decision, including data policies and governance. Ram is an industry and peer recognized data and technology professional with experience in the Pharma, Consulting, Telecom and International Government organizations. His expertise includes Data and Decision Sciences, Digital and Technology Architecture, and Talent Development with a focus on building collaborative partnerships and Ecosystems.

Adam  Pavlicek, PhD

Adam Pavlicek, PhD

Founder and CEO, Monoceros Biosystems, LLC, United States

Dr. Pavlicek received his PhD in Human Genetics from the Jacques Monod Institute, University of Paris, and has more than 15 years of experience working in the pharmaceutical industry including Pfizer Oncology and Regulus Therapeutics. Throughout his career, Dr. Pavlicek has acquired substantial expertise in applying bioinformatics to drug discovery across many unique therapeutic areas including oncology, rare diseases, as well as disorders of the liver, kidney, CNS, and eye. He is the founder and CEO of Monoceros Biosystems, a bioinformatics consultancy company, co-founder of DTx Pharma, and advisor for multiple drug discovery companies.

Lee  Albacker, PhD

Lee Albacker, PhD

Senior Director, Biomarker Development and Analytics, Foundation Medicine, United States

Vaishali  Popat, MD, MPH

Vaishali Popat, MD, MPH

Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States

Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of pre-marketing data more efficient and consistent, data standards, as well as leveraging data from internal and external sources to make regulatory decisions.

Miruna  Sasu, PhD, MBA

Miruna Sasu, PhD, MBA

President and Chief Executive Officer , COTA, United States

With over 20 years of experience leading digital health teams at large pharmaceutical companies, Miruna brings great insight and expertise to her new role at COTA. Since joining the company last year, she has made a significant impact driven by her commitment to better cancer care for patients.

Bertrand  Sohier

Bertrand Sohier

Senior Vice President, Global Medical Services, Parexel International, France

Bertrand is a seasoned medical leader in the drug development industry, board-certified pulmonologist with 12 years patient-facing medical experience, 13 years at local and corporate level in a major pharmaceutical company and 12 years in a Contract Research Organization. His main areas of expertise and experience include internal medicine, drug development, medical affairs, shaping, and implementing innovations in clinical research. As an executive leader, he heads a global medical team of 100 + physicians so that study sponsors are provided with appropriate medical support in their outsourced trials from strategic advice to thorough execution of medical monitoring tasks. He also provides consultancy in drug development programs.

Sunil  Talathi

Sunil Talathi

Director, Global Head - Data Engineering, Data Science and Operational Excellenc, BeiGene USA, United States

Abena  Agyeman, PhD

Abena Agyeman, PhD

Senior Biologist, FDA, United States

Dr. Agyeman is a Senior Biologist in the Division of Pharmacology and Toxicology supporting the Division of Rare Diseases, Pediatrics, Urologic & Reproductive medicine at FDA. She also serves as the co-chair for the FDA Biomarker Working Group and is a member of the FDA-NIH Biomarker Working Group. Prior to this she was a team lead in the Biomarker Qualification Program and was the subject matter expert for surrogate endpoints. Dr. Agyeman has a PhD in Biochemistry and Molecular Biology from John Hopkins School of Public Health and was a Postdoctoral Scholar at The University of Chicago. In both roles she focused on biomarker discovery and development for breast cancer prevention and treatment from the translational science perspective.

Anastasia  Christianson, PhD

Anastasia Christianson, PhD

Vice President, Head of AI, ML, Advanced Analytics, and Data, Pfizer, United States

Anastasia Christianson is VP and Global Head AI, ML, Advanced Analytics, and Data in Pfizer’s Digital Organization. She has more than 25 years of experience in Pharma and is a highly respected thought leader in biomedical informatics, data science, advanced analytics, and digital and connected health. A scientist by training, she has championed numerous initiatives to drive innovation and adoption of digital technologies and advanced analytics in drug discovery and development to fuel translational science, precision medicine, and digital health. Anastasia earned her B.S. degree from the College of New Jersey, her Ph.D, in Biological Chemistry from the University of Pennsylvania, and completed postdoctoral training at Harvard University.

Chao  Liu, PhD

Chao Liu, PhD

Senior Director, PI Health, United States

Ali  Neishabouri, PhD

Ali Neishabouri, PhD

Head of Data Science, Actigraph, United States

Kevin  Snyder, PhD

Kevin Snyder, PhD

Computational Pharmacologist, OND, CDER, FDA, United States

Qian   Meng, PhD

Qian Meng, PhD

Senior Biostatistician, Servier Pharmaceuticals, United States

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