The Future of Data-Driven Medicine

Thursday, September 13, 2018 from 1:00 PM to 5:00 PM EDT

District Architecture Center (421 7th St NW, Washington, DC)

With the advent of electronic health records, low-cost genome sequencing, molecular imaging, and wearable devices, the digital footprint of the average patient is rapidly expanding. As an increasing number of data scientists and computer scientists join those on the front lines of medical research and these researchers gain access to an enormous amount of computing power in the cloud, there will be unprecedented opportunities to use data to accelerate medical research and develop more cost-effective, personalized treatments.

The Center for Data Innovation will host a public forum with key stakeholders from government, the private sector, and academia to discuss the latest developments in using data to improve health care outcomes, reduce health care costs, and empower patients. In particular, this event will focus on the successful ways the pharmaceutical industry is using data to create more value in health care, especially by using data to drive down costs, bring drugs to market faster, and address the needs of different patient populations.

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Speakers

Elaine Johanson

Director of Health Informatics

Food and Drug Administration

Since July of 2016, Elaine Johanson has served as the Director of Health Informatics within the Office of the Chief Scientist at the Food and Drug Administration.  In this position, she utilizes non-traditional mechanisms to share FDA data and to engage external experts in evolving areas of regulatory science.  In addition, she facilitates agency-wide participation in international health data and terminology standards, leads the identification and curation of substance information and the exchange of product labeling information for FDA. Public facing examples of activities under Elaine Johanson’s leadership include:

OpenFDA - An FDA open data platform that has made it easier for researchers, scientists and developers to access publicly available FDA data related to drug adverse events, drug labeling, medical devices, and food recalls.  To date, there have been more than 20 million API calls, more than 6,000 registered users, 21,000 connected systems, and dozens of new software applications devoted to making FDA data and analysis available to a wider audience.

PrecisionFDA - A collaboration space for genomics researchers around the world to work with FDA scientists to advance regulatory science through competition, sharing of tools, testing and comparision of tools, and expert dialogue. PrecisionFDA has over 3,000 members, and offers: (1) 42 terabytes of reference data, (2) an extensive library of NGS analysis tools and applications, (3) computational resources, (4) a discussion forum (5) expert blog posts, (6) app-a-thons, and (7) community challenges which promote crowd-sourced scientific innovation and advancement.

Healthy Citizen - A new exploratory initiative piloting in 2019 to provide cross-cutting FDA product information directly to healthcare providers and citizens by making tools available for use via healthcare portals. This project will enable the FDA to, (1) disseminate recall information, consumer complaints, and adverse event trends to the public in a consistent, targeted and timely manner, (2) collect and analyze de-identified citizen data related to usage of FDA-regulated products, and (3) send targeted invitations for relevant clinical and regulatory research and trials to citizens that fit the profile of the studies.

With thirty-three years' experience in information technology (IT) and health informatics, including fourteen years as a senior, strategic leader, Elaine Johanson has led an office of as many as 415 IT personnel, scientists and public health specialists.  She has managed a portfolio of projects in excess of $400 million and has extensive knowledge of scientific computing, health informatics, genomics and next generation sequencing (NGS), cloud computing, crowd-sourcing, international data standard management, data harmonization, data analysis, strategic planning, software development, infrastructure operations, budget formulation and execution, human resources management, governance, project, risk, program and portfolio management. She has presented at and facilitated meetings with a wide range of internal and external stakeholders including, scientists, regulators, foreign dignitaries, congressional personnel, senior executives, and industry representatives.

Kenneth Bengtson

Director

Pfizer

Kenneth Bengtson is the Director of eSource, within the Center of Excellence at Pfizer. eSource at Pfizer will utilize Electronic Health records and other digital sources to support the next generation clinical trials. He has been at Pfizer for 19 years and has held many positions within the Data Management and Clinical trial application work area.

Elliot Menschik

Sr. Manager, Business Development, Healthcare and Life Science Ventures

Amazon Web Services

Elliot is a physician/scientist/engineer turned repeat entrepreneur and investor. At Amazon’s cloud computing arm, AWS, he is responsible for relationships with healthcare and life science ventures and their investors, partnering to speed their products to market. Earlier he founded the healthcare practice of Dreamit Ventures where he led investments in 40+ seed-stage startups. Elliot was previously the founder and CEO of HxTechnologies, a pioneer in health information exchange which he sold to Health Care Service Corporation, the parent of Blue Cross Blue Shield of TX, IL, OK, NM and MT. An NIH Fellow in the Medical Scientist Training Program, Elliot received his MD and PhD in Neuroscience from the University of Pennsylvania and holds MSE and BSEE degrees in Electrical and Computer Engineering from Johns Hopkins.

Gil Alterovitz

Presidential Innovation Fellow

Dr. Alterovitz received his PhD under the joint Harvard/MIT Division of Health Sciences and Technology in Electrical and Biomedical Engineering under Prof. Marco Ramoni, creator of the first commercial Bayesian Network program for Artificial Intelligence (AI), and Prof. Isaac Kohane, current chair of the Harvard Department of Biomedical Informatics. He then continued on as faculty at Harvard Medical School and specializing in biomedical informatics with the Computational Health Informatics Program at Boston Children's Hospital.  Dr. Alterovitz’s
academic research work has led to international collaborations involving genomics/clinical data integration.   His work on integrative methods for “big data” in the biomedical informatics space has been published or presented in more than 30 peer-reviewed publications ranging from
academic journals and international conferences to three books (including “Systems Bioinformatics: An Engineering Case-based Approach,” ranked #1 in new Amazon bioinformatics category).  He is former Fulbright Scholar and Fulbright Fellow. As a Presidential Innovation Fellow, he worked with the National Cancer Institute (NCI), General Services Administration (GSA), and Department of Health and Human Services (HHS) Immediate Office of the Secretary (IOS) on piloting novel AI approaches for setting up an ecosystem to match patients to cancer clinical trials.

Srini Ramanathan

Vice President, Development Sciences

Horizon Pharma

Srini Ramanathan, Ph.D. is currently Vice President, Development Sciences, at Horizon Pharma, with portfolio oversight of clinical development functions including Biometrics, Clinical Pharmacology, Bioanalysis and Translational Sciences and Preclinical Development. Dr. Ramanathan is an experienced leader with more than 17 years of drug development expertise across wide range of disease areas and responsible for several global drug approvals in infectious disease and oncology. Dr. Ramanathan has previously served leadership roles at Abbvie and Gilead Sciences, and has extensively published/presented. He received his Ph.D. degree from Rutgers University, M.S. in Pharmaceutics from Duquesne University and B. Pharm (Hons) from Birla Institute of Technology and Science.

Nate Crisel

Vice President, Real World Informatics & Analytics

Astellas

Nate Crisel is Vice President and head of Astellas’ Real World Informatics and Analytics division – a central function accountable for expanding efficient, effective and responsible use of healthcare data across Astellas entire value chain. Crisel’s background at Astellas includes roles in New Product Analysis, Product and Portfolio Strategy and Corporate Strategy. Nate began his professional career as an analytical chemist and pharmaceutical development project manager at Eli Lilly & Co. After Lilly he held roles in biotech start-ups, including Embedded Concepts, LLC. and Tracera, LLC ranging from business development to executive leadership. Nate received his Master of Business Administration in finance and entrepreneurship at Krannert School of Management, Purdue University and his Bachelor of Science in chemistry from Indiana University.

Neil Chilson

Senior Research Fellow for Technology and Innovation

Charles Koch Institute

Neil Chilson is the Senior Research Fellow for Technology and Innovation at the Charles Koch Institute. His research guides the Institute’s ongoing efforts to promote digital free speech and free association, to lower and eliminate barriers to innovation, and to foster a culture that welcomes innovation as the best way to improve individual and societal well-being.

Before joining CKI, Neil was the Chief Technologist at the Federal Trade Commission. His work focused on understanding the economics of privacy, convening a workshop on informational injury, and establishing the FTC’s Blockchain Working Group, among other things. Prior to his appointment, he was an advisor to Acting FTC Chairman Maureen K. Ohlhausen. In both roles he advised Chairman Ohlhausen and worked with Commission staff on nearly every major technology-related case, report, workshop, or other proceeding since January 2014, when he joined her office. Neil joined the FTC from Wilkinson Barker Knauer, LLP, where he advised clients on telecommunications, privacy, cybersecurity, and other matters.

Neil has a J.D. from The George Washington Law School, a M.S. in computer science from University of Illinois, Urbana-Champaign, and a B.S. in computer science from Harding University.

Daniel Castro

Director

Center for Data Innovation

Daniel Castro is the director of the Center for Data Innovation and vice president of the Information Technology and Innovation Foundation. Mr. Castro writes and speaks on a variety of issues related to information technology and internet policy, including data, privacy, security, intellectual property, internet governance, e-government, and accessibility for people with disabilities. His work has been quoted and cited in numerous media outlets, including The Washington Post, The Wall Street Journal, NPR, USA Today, Bloomberg News, and Businessweek. In 2013, Mr. Castro was named to FedScoop’s list of “Top 25 most influential people under 40 in government and tech.” In 2015, U.S. Secretary of Commerce Penny Pritzker appointed Mr. Castro to the Commerce Data Advisory Council. Mr. Castro previously worked as an IT analyst at the Government Accountability Office (GAO) where he audited IT security and management controls at various government agencies. He contributed to GAO reports on the state of information security at a variety of federal agencies, including the Securities and Exchange Commission (SEC) and the Federal Deposit Insurance Corporation (FDIC). In addition, Mr. Castro was a Visiting Scientist at the Software Engineering Institute (SEI) in Pittsburgh, Pennsylvania where he developed virtual training simulations to provide clients with hands-on training of the latest information security tools. He has a B.S. in Foreign Service from Georgetown University and an M.S. in Information Security Technology and Management from Carnegie Mellon University.

Faisal Khan

Executive Director of Advanced Analytics and Artificial Intelligence

Astrazeneca

Faisal M. Khan, PhD is an Executive Director of Advanced Analytics and Artificial Intelligence at Astrazeneca. He is a highly regarded expert in the intersections of data science, biostatistics, bioimaging, personalized medicine and healthcare delivery. His career has encompassed all aspects of healthcare and biomedical analytics, including diagnostics, devices, clinical trials\therapeutics, and payers. He has worked or consulted across academia and industry, including startups and Fortune-50 companies. He has over 90 published papers, abstracts and patents.

Qingsong Zhu

COO

Insilico Medicine

Dr. Qingsong Zhu is the Chief Operating Officer of Insilico Medicine, Inc. and is responsible for Insilico Medicine operations and drug development. He obtained his Ph.D. degree from Kansas State University in biochemistry. Dr. Zhu received his postdoctoral training at Johns Hopkins under the supervision of Dr. Nancy Davidson in breast cancer field. He has over 12 years of experience in genomics research and drug development. His latest entrepreneurial endeavors focused on improving the early diagnosis and personalized treatment of cancer and other age-related diseases.

Robert Kowalski

Head of Regulatory Affairs

Novartis

Rob Kowalski is currently the Head of Regulatory Affairs for Novartis and the US Head of Global Drug Development, based in East Hanover, New Jersey, USA.

Under his leadership, Rob has successfully brought dozens of new products to the market, including many new chemical entities across a wide array of therapeutic areas in the small molecule, biologics, and Cell & Gene Therapy spaces. In addition, he has been fortunate in his career to be able to work on innovative therapies and important access medicines in the areas of rare diseases, pediatrics, devices, companion diagnostics, digital medicine and new technologies (smart devices), and biosimilars.

Rob has 25 years of regulatory and drug development experience in the industry, including past regulatory leadership roles at Pharmacia (now Pfizer) and Schering-Plough (now Merck). Rob has also previously served as the Global Head of Development Medical Affairs for Novartis.

In addition to being an active member in multiple professional organizations, Rob currently serves as the Chair of PhRMA’s Regulatory Affairs Committee and recently completed his term as the Vice-Chairman of the Board of Directors for the R&D Council of New Jersey. Rob was a member of the FDA Rare Disease Advisory Panel and an industry representative for both PDUFA V and VI reauthorization negotiations. He is also a member of the TOPRA and Industry Pharmacists Organization Advisory Boards.

Rob attended the University of Wisconsin–Madison where he received both a Bachelor of Science in Pharmaceutical Sciences and a Doctorate in Pharmacy. Rob completed his post-doctoral training at Rutgers University / Sandoz Pharmaceuticals and has trained at the Executive Forum of the Harvard Business School.

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Agenda

  1. 12:30 PM - 13:00 PM : Doors Open
  2. 13:00 PM - 13:05 PM : Introduction & Welcome

    Daniel Castro, Director of the Center for Data Innovation, will kick off Data Innovation Day 2018.

  3. 13:05 PM - 13:20 PM : Opening Keynote: The Impact of AI on Drug Discovery

    Dr. Qingsong Zhu, COO of Insilico Medicine, will discuss the impact AI is having on drug discovery and what this means for the industry, patients, and regulators.

  4. 13:20 PM - 14:30 PM : Panel 1: Accelerating Data-Driven Drug Discovery

    Pharmaceutical research is an increasingly data-driven process. Researchers are using artificial intelligence to automate the drug discovery and development processes. For example, researchers can use recommendation algorithms to predict which untested compounds show the most promise and send these for more advanced testing in the lab. Similarly, researchers are using machine learning techniques and image recognition technology to extract biological insights from new experimental compounds. And researchers are making significant advances in using in silico research methods to predict how patients might respond to various experimental treatments. What are the opportunities and challenges that will arise from these advances in data-driven medical research, and how can government help accelerate these types of innovations?

  5. 14:30 PM - 14:40 PM : Break
  6. 14:40 PM - 15:50 PM : Panel 2: The Future of Data-Driven Clinical Trials

    New technologies, particularly wearables and mobile apps, present new opportunities for collecting data during clinical trials, while the growth of electronic health records and online communities creates new opportunities to recruit qualified participants for clinical trials as well as using new research designs that embed clinical research into traditional medical care. What are the technical, organizational, and legal obstacles to data sharing in clinical research settings, and what improvements would allow patients, researchers, and companies to extract more value from health data? Moreover, how can policymakers support growing the patient data pool, increasing data sharing, and addressing the needs of diverse populations, including patients that suffer from rare diseases?

  7. 15:50 PM - 17:00 PM : Panel 3: Modernizing Regulatory Processes for Data-Driven Medicine

    Proper government oversight of medical products is responsible for delivering safe, effective, and affordable treatments to patients. As drug research and development and clinical trials evolve to make use of expanding data sets and new technologies, regulatory agencies need to keep pace with these changes. For example, regulatory agencies can use artificial intelligence to analyze diverse data sets to improve the speed and accuracy of regulatory decisions, as well as enhance post-market surveillance. How are regulatory agencies adapting to recent innovations in medical research, and how can better use of data improve the regulatory review process?

  8. 17:00 PM - 17:30 PM : Reception

Contact

Center for Data Innovation

[email protected] https://datainnovation.org