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Big Data [clear filter]
Monday, June 27
 

10:45am EDT

#130: Take Two Aspirin and Text Me in the Morning: Technology Suited for 20,000 Virtual Patients on the PCORI Aspirin Trial
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-535-L04-P; CME 1.25; IACET 1.25; RN 1.25

The ADAPTABLE study, started in 2015, is the largest virtual study ever done in the clinical research industry. Speakers will review the lessons learned from establishing a technology process suited for 20,000 remote patients on this study.

Learning Objectives

Demonstrate a working knowledge of implementing remote consenting; Discuss updates on recent guidance documents and regulatory approvals for virtual data collection.

Chair

Anthony Costello

Speaker

ADAPTABLE: A 20,000 Patient Study Leveraging Health Systems, EHR, and Patients to Transform Clinical Research
Adrian Hernandez

REACHnet’s Recruitment for the ADAPTABLE Virtual Trial Using Technology at the Point-of-Care
Elizabeth Nauman



Chair
AC

Anthony Costello

Chief Executive Officer, Mytrus, Inc.
Anthony Costello: Co-Founder and CEO of Mytrus has co-founded many clinical & hi-tech start-up companies in N. CA. He was selected as PharmaVoice Top 100 Most Inspiring People in Clinical Research, served as Chairman of the Board for the Society for Clinical Data Management, on founding... Read More →

Speakers
AH

Adrian Hernandez

Co-Private Investigator, PCORnet Coordinating Center, Professor of Medicine, Duke Clinical Research Institute (DCRI)
Dr. Hernandez is a cardiologist with extensive experience in clinical research ranging from clinical trials to outcomes and health services research. He is the Faculty Associate Director of the Duke Clinical Research Institute and Director of the Health Services and Outcomes Research... Read More →
avatar for Elizabeth Nauman

Elizabeth Nauman

Research Director, Research Action for Health Network (REACHnet), Louisiana Public Health Institute (LPHI)
As REACHnet's Research Director, Dr. Nauman works with a multi-institutional team to develop and optimize the informatics and technology infrastructures as well as stakeholder engagement to support efficient pragmatic clinical research. She leads the development of the network’s... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session
 
Tuesday, June 28
 

10:30am EDT

#221: Envision the Future: How Big Data and Artificial Intelligence Change Our Regulatory Environment
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-555-L04-P; CME 1.25; IACET 1.25; RN 1.25

The complexity of the regulatory environment is growing rapidly in light of new technologies for disease surveillance, diagnostics, and medication. This session will focus on future knowledge and predictions in intelligence with an impact on the regulatory world.

Learning Objectives

Recognize the complexity of the future regulatory environment in light of new technologies; Identify challenges and opportunities in the field of digital data for disease surveillance, personalized medicines and individual stakeholder engagement through innovative tools; Evaluate future knowledge against new technologies.

Chair

Joseph C. Scheeren, PharmD

Speaker

Current Status of Big Data Use in the Health Care Sector: View from the Market
Luke D. Dunlap, MSc

Big Data Being Part of FDA eHealth Policy: Viewpoint of the Regulator
Robert M. Califf, MD

Challenges of Big Data in the Regulatory Environment from the Legal Point of View
Denise Esposito, JD



Chair
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →

Speakers
avatar for Robert Califf

Robert Califf

Commissioner, FDA
Robert M. Califf, MD, MACC, is the Food and Drug Administration's commissioner of food and drugs. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public healt... Read More →
LD

Luke Dunlap

Senior Principal, Real World Evidence Solutions, IMS Health
avatar for Denise Esposito

Denise Esposito

Partner, Covington & Burling LLP


Tuesday June 28, 2016 10:30am - 11:45am EDT
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Session
 
Wednesday, June 29
 

8:00am EDT

#301: The Future of Big Data
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

Just how BIG will Big Data be? Understanding how innovators plan to use it to disrupt drug development and advance new health care offerings across delivery systems will be HUGE for everyone involved in innovation.

Come hear from top thought-leaders about what innovations are in the pipeline that will both generate and harness BIG DATA. Learn how innovators will use Big Data to disrupt the health care system. This dynamic forward-focused session will bring together industry, technology innovators, academia, and government agencies to paint a colorful picture of how they will drive advances in health care founded on big data platforms.

Learning Objectives

Discuss how big data will impact innovation in health care; Describe the way academia, industry, government agencies, and technology innovators are advancing health care utilizing big data.

Chair

Nancy Bradish Myers, JD

Speaker

Panelist
Luciana Borio, MD

Panelist
Kara N. Dennis

Panelist
Michael J Doherty

Panelist
Brad Hirsch, MD

Panelist
Sally A. Howard, JD



Chair
avatar for Nancy Myers

Nancy Myers

President and Founder, Catalyst Healthcare Consulting, Inc
Nancy Bradish Myers, JD is President/Founder of Catalyst Healthcare Consulting, a boutique regulatory advisory firm that helps innovators navigate FDA and policy circles. She served as a senior advisor in FDA's Office of the Commissioner and held senior positions at PhRMA, BIO and... Read More →

Speakers
avatar for Luciana Borio

Luciana Borio

Acting Chief Scientist, Office of the Chief Scientist, OC, FDA
Dr. Luciana Borio is FDA’s acting chief scientist. In this capacity, she is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership... Read More →
avatar for Kara Dennis

Kara Dennis

Managing Director, Mobile Health, Medidata Solutions Worldwide
As managing director of mobile health, Kara leads Medidata’s efforts to support mobile-enabled clinical trials and launched mobile health (mHealth) as a new business unit in 2015. Prior to this, Kara served as chief of staff to the company's CEO and president, and a vice president... Read More →
avatar for Michael Doherty

Michael Doherty

Head, Strategic Innovation, Pharma Dev; Exec Advisor, Foundation Medicine Inc., Hoffmann-La Roche Ltd.
Head of regulatory affairs at Roche and Genentech from 2002 to 2016. Currently head of strategic innovation at Roche and Executive adviser to Foundation Medicine.
avatar for Brad Hirsch

Brad Hirsch

Senior Medical Director, Flatiron Health
Dr. Hirsch is a practicing medical oncologist with Texas Oncology in Dallas. At Flatiron Health, he helps to lead multiple efforts including value based care initiatives, collaborations with life sciences companies, and the development of novel research capabilities. Prior he served... Read More →
avatar for Sally Howard

Sally Howard

Head of Regulatory Affairs and Policy, Human Longevity, Inc.
Has more than two decades of health policy and regulatory expertise, leads all efforts related to federal and state regulatory oversight. She comes from the FDA where she served most recently as Senior Advisor and Acting Chief of Staff to the FDA Commissioner. She also spent two years... Read More →


Wednesday June 29, 2016 8:00am - 9:30am EDT
103ABC Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum

10:30am EDT

#313: The Future of Clinical Research Data: 2020 and Beyond
Limited Capacity seats available

Component Type: Forum
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will engage a panel of experts who will discuss current and emerging opportunities and trends in the representation and use of research data and describe a future vision for capitalizing on these to improve the future research process.

Learning Objectives

Describe current state, trends and opportunities such as data transparency, electronic health records, interoperability, wearable technologies, regulatory science, data standards and analytics; Describe a vision for future clinical research data systems and processes that can logically evolve from the current state to meet these requirements including opportunities to improve the research process.

Chair

Wayne R. Kubick, MBA

Speaker

Panelist
Dave Evans, MS

Panelist
Armando Oliva, MD

Panelist
Kenneth A. Getz, MBA



Chair
avatar for Wayne Kubick

Wayne Kubick

Chief Technology Officer, HL7
Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International... Read More →

Speakers
avatar for Dave Evans

Dave Evans

Managing Director, Accenture
Dave Evans is a senior technology and clinical research executive with over 35 years of experience in the clinical research, regulatory and healthcare industries. He is recognized industry-wide as a leading technology visionary for developing and implementing complex process and... Read More →
avatar for Kenneth Getz

Kenneth Getz

Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center... Read More →
avatar for Armando Oliva

Armando Oliva

President and Chief Medical Officer, Semantica LLC
His expertise includes clinical data standards, regulated study data submissions, and regulatory submission and review policy. A former Associate Director for Informatics in OCS, he focused on developing, adopting, and implementing clinical data standards to support premarketing assessment... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am EDT

#323: Social Listening for Pharmacovigilance: Practical Considerations and Challenges for Implementation
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-578-L04-P; CME 1.25; IACET 1.25; RN 1.25

A multiperspective, practical look at incorporating social listening into pharmacovigilance practices—including challenges, knowledge and guidance gaps, regulatory guidance, and recent research as well as experiential findings from both pharma and academia. Come hear some very up-to-date and practical learnings from social media in pharmacovigilance and be challenged to rethink some preconceptions about it.

Learning Objectives

Discuss current challenges and gaps in use of social media for pharmacovigilance including patient privacy, regulatory guidance, legal and reporter identification as global issues; Explain how some pharmaceutical companies have overcome some of those challenges to collect and analyze social media data to augment current postmarketing pharmacovigilance measures and where value has been found; Describe some findings from recent research efforts and data collection methods.

Chair

Laurie S. Anderson, PharmD

Speaker

Current Gaps and Challenges in Pharmacovigilance with Respect to Social Media
Lalitha P. Aiyer, MD, MBA, MS

A Real-World Look at Mining Social Media for Adverse Events: Impact of Regulatory Definitions and Methods
Michael A. Ibara, PharmD

Real-World Use of Social Listening for Pharmacovigilance Currently in the Pharmaceutical Industry
Lorrie Schifano, PharmD



Chair
avatar for Laurie Anderson

Laurie Anderson

Safety Evaluation and Risk Management Scientist, GlaxoSmithKline
Manager-Safety Evaluation and Risk Management Laurie joined GlaxoSmithKline in 2009 as a Medical Information Scientist. Prior to GSK Laurie worked as a clinical pharmacist at The University of California-San Francisco Medical Center and Duke University Medical Center. She earned her... Read More →

Speakers
avatar for Lalitha Aiyer

Lalitha Aiyer

President and Senior Medical Advisor, Medical and Pharma Advisors Group
Lalitha is a board certified physician with subspecialty training in Internal Medicine with 14 +years in clinical practice & over 15 years in the Pharmaceutical Industry. She runs an independent consultancy practice. Previously she worked in Ardea BioSciences as Head of Pharmacovigilance... Read More →
avatar for Michael Ibara

Michael Ibara

Managing Partner, Fathom Digital Healthcare Consulting
20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to... Read More →
avatar for Lorrie Schifano

Lorrie Schifano

Director, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline
Lorrie is Director, Safety Evaluation and Risk Management at GSK. She has more than 16 years experience in the pharmaceutical industry. Dr. Schifano obtained a B.S. in Pharmacy at Duquesne University in Pittsburgh, PA and her Pharm.D. at University of North Carolina, Chapel Hill... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, Session

10:45am EDT

#328: The Ethics of “Big Data” Biomedical Science
Limited Capacity seats available

Component Type: Workshop
Level: Basic

Drug developers, regulators, and payers are increasingly relying on large, linked, and networked databases to discover and test new therapies; inform regulatory and funding decisions; monitor therapies in practice and fine tune therapeutic approaches. The use of such “big data” resources is scientifically exciting but raises a number of ethical issues relating to participant consent and confidentiality; ownership, and benefit sharing; and effects on clinical trials, regulatory and funding processes, and the physician-patient relationship. This session will include an exercise to explore the ethical issues raised by biomedical research that uses “big data” resources.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Recognize that there are many different kinds of “big data” with many different applications in public health and biomedicine; Discuss the key ethical issues arising from research involving “big data,” including consent, confidentiality, ownership, benefit sharing, and effects on clinical trials, regulatory and funding processes and the physician-patient relationship; Express whether, when and how “big data” research should be conducted so it is ethically sound.

Chair

Wendy Louise Lipworth


Chair
avatar for Wendy Lipworth

Wendy Lipworth

Senior Research Fellow, Centre for Values, Ethics and the Law in Medicine, University of Sydney
Dr Wendy Lipworth is a medically trained bioethicist and qualitative social researcher from the Centre for Values, Ethics and the Law in Medicine, University of Sydney, Australia. Her program of research focuses on the ethics and politics of biomedical innovation, with a particular... Read More →

Wednesday June 29, 2016 10:45am - 11:45am EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 22: Engage and Exchange, Workshop

2:00pm EDT

#342: Big Data in Health Care and Life Sciences
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-542-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how big data and new technology can be used to enhance patient experience, manage outcomes, and enhance research and include recent developments and novel techniques applied to big data integration and analysis that have the potential to improve the quality and costs associated with both early stage discovery and clinical development from conduct to completion of clinical trials.

Learning Objectives

Discuss how big data and new technology can be used to enhance patient experience, manage outcomes, and enhance research; Identify how to use big data analytics to develop new insights from patient data long before previously possible.

Chair

John Piccone

Speaker

IBM Watson Health: Creative Innovation of Health Care and Life Sciences
John Piccone

Exploiting Big Data in Precision Medicine
Amrita Basu, PhD

The Big Data Gap: Harnessing Big Data to Accelerate Clinical Development
James Streeter



Chair
avatar for John Piccone

John Piccone

Lead Partner Life Sciences Strategy and Analytics, IBM Watson Health
John Piccone currently leads the Watson Health offerings for life sciences at IBM. In this role, he defines the analytics and cognitive solutions that Watson Health is offering to it’s pharmaceutical, biopharma, medical device and biotech clients. The current focus of his work is... Read More →

Speakers
AB

Amrita Basu

Genomics and Computational Biology Lead, Health and Life Sciences, Lockheed Martin Information Systems & Global Solutions
Amrita Basu is the Genomics and Computational Biology Lead at Lockheed Martin. Previously, she worked at the Broad Institute of Harvard and MIT on predictive modeling approaches for cancer drug discovery. Amrita holds a Bachelors degree in Electrical Engineering from Cornell University... Read More →
avatar for James Streeter

James Streeter

Global Vice President, Life Sciences Product Strategy, Oracle Health Sciences, United States
As the global head of life sciences product strategy for Oracle, Jim collaborates closely with Oracle customers, regulatory agencies, analysts, and industry thought leaders to develop and help execute the overall business and product strategy for Oracle Health Sciences. He previously... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm EDT

#371: FDA and PatientsLikeMe: Exploring the Use of Patient-Generated Data in Drug Safety
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-581-L05-P; CME 1.00; IACET 1.00; RN 1.00

PatientsLikeMe and FDA have a research collaboration agreement to explore how patient-reported data can give new insights into drug safety. In this session, we will discuss the objectives, agenda, progress, and findings from our early research.

Learning Objectives

Discuss the evolving research goals and findings from the collaboration between FDA and PatientsLikeMe; Outline identified applications of patient-generated data in a regulatory context to inform pharmacovigilance, pharmaco-epidemiology, medication error, and risk management efforts.

Chair

Ben Heywood, MBA

Speaker

Patient-Generated Data in Drug Safety
Ben Heywood, MBA

Systematic Exploration of Patient-Generated Health Data for Use in Postmarketing Safety Monitoring
Carol A Pamer

FDA Perspective
Sonja Brajovic, MD



Chair
avatar for Ben Heywood

Ben Heywood

President and Co-Founder, PatientsLikeMe
As President and Director of PatientsLikeMe, Benjamin Heywood is responsible for setting the company vision to improve healthcare and accelerate research, while directing its business growth strategy. Inspired by his brother Stephen’s battle with ALS, Heywood co-founded the company... Read More →

Speakers
avatar for Sonja Brajovic

Sonja Brajovic

Medical Officer, OSE, CDER, FDA
Sonja Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordination of projects related to the Medical Dictionary for Regulatory Activities... Read More →
CP

Carol Pamer

Program Lead for Pharmacovigilance, OSE, CDER, FDA
Carol Pamer is Program Lead for Pharmacovigilance in the FDA CDER Office of Surveillance and Epidemiology (OSE) Regulatory Science Staff. She is a Principal Investigator for the FDA-PatientsLikeMe Research Collaboration Agreement. She earned her B.S. degree in Pharmacy from Ohio State... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety/PV, Session

4:00pm EDT

#357: The Internet of Things and Clinical Research: Privacy, Security, and Ethical Aspects
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-515-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Internet of Things (IoT) refers to objects simultaneously producing data in an automated way. It is revolutionary to clinical research and pushes the limits of current policy, requiring us to examine regulation that could limit its potential.

Learning Objectives

Describe potential advantages and benefits of the Internet of Things (IoT) in clinical research, and the complexities and barriers to adoption; Summarize the impacts and issues involved in leveraging the IoT within health care and clinical research in particular.

Chair

Ellen Kelso

Speaker

Does “Big Data” for Enhanced Recruiting Invade Patient Confidentiality?
Lea Studer



Chair
avatar for Ellen Kelso

Ellen Kelso

Executive Director, Chesapeake IRB
Founder, managing member & CEO of Goodwyn IRB, Ellen Kelso is recognized for her experience & expertise in clin. trial mgt & reg. affairs. Has provided educ., consultation & services to the pharma industry supporting clinical research & regulatory strategies, submissions & compliance... Read More →

Speakers
avatar for Lea Studer

Lea Studer

Senior Vice President of Marketing Communications, SCORR Marketing
Studer is an accomplished marketing and communications professional with more than 20 years of experience developing and implementing compelling, award-winning marketing and communication strategies and tactics in the global life sciences industry.


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Session
 
Thursday, June 30
 

10:45am EDT

#410: The Role of Big Data in Transforming the Detection of Adverse Drug Reactions
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-579-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will provide an overview of ongoing initiatives at government, industry, and academic sites on leveraging Big Data for adverse drug reactions detection.


Learning Objectives

Discuss how Big Data can improve the detection of adverse drug reactions; Identify the data sources that will likely to be part of the Big Data paradigm envisioned for pharmacovigilance; Define the strengths, limitations, and challenges associated with the use of each of the identified data sources for improving the detection of adverse drug reactions.

Chair

Rave Harpaz, PhD

Speaker

Harnessing Scientific Literature Reports for Pharmacovigilance: FDA Perspective
Alfred Sorbello, DO, MPH

Maximizing Data Sources for Signal Detection: Pharmaceutical Company Perspective
Amy Purrington, MD

Social Media Mining for Public Health Monitoring and Surveillance
Graciela Gonzalez Hernandez, PhD



Chair
avatar for Rave Harpaz

Rave Harpaz

Senior Research Scientist, Oracle Health Sciences
Rave Harpaz is a Senior Research Scientist at Oracle Health Sciences. Previously, Rave was a Research Scientist at Stanford University, a post-doctoral fellow at Columbia University, and a quantitative risk modeling analyst at Merrill Lynch. Rave holds a PhD in Computer Science from... Read More →

Speakers
GG

Graciela Gonzalez Hernandez

Associate Professor, Department of Biomedical Informatics, Arizona State University
avatar for Amy Purrington

Amy Purrington

Head, Signal Management Group, Janssen Pharmaceuticals, Inc.
Amy is an experienced pharmacovigilance physician, focusing on proactive surveillance. She has been in industry for 15 years and at JNJ for the last 12. She is currently the lead of the Signal Management Group, which is dedicated to the development and implementation of new signal... Read More →
avatar for Alfred Sorbello

Alfred Sorbello

Medical Officer, Office of Translational Sciences, CDER, FDA
Dr. Alfred Sorbello is a Medical Officer at FDA in the Office of Translational Sciences of the Center for Drug Evaluation and Research (CDER). Previously, he worked in CDER’s Office of Surveillance and Epidemiology /Division of Pharmacovigilance II and in CDER’s Office of New... Read More →


Thursday June 30, 2016 10:45am - 12:00pm EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA