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14: DIAmond [clear filter]
Monday, June 24
 

8:00am

#100: Opening Plenary, Keynote, and DIAmond Session
Component Type: Forum
Level: Basic
CE: ACPE 1.50 Knowledge UAN: 0286-0000-19-730-L04-P; CME 1.50; IACET 1.50; RN 1.50

Join us for the DIA 2019 Global Annual Meeting Keynote Address and Opening DIAmond Session!
Keynote speaker Dr. Gibbons oversees the third largest institute at the NIH, with an annual budget of approximately $3 billion and a staff of nearly 2,100 federal employees, contractors, and volunteers. NHLBI provides global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so they can live longer and more fulfilling lives.

Advancing Discovery Science for Public Health Impact
Dr. Gibbons will address the value of implementation science that turns discovery science into improved population health, as well as the innovation of evidence-based initiatives in the treatment of chronic disease, to balance the scales of health equity in all populations.


DIAmond Session: Who Owns My Health Data: Patients, Data, and the Future of R&D
Data is the fuel for modern medical research. From enabling precision medicine to innovative uses of real world data, regulators, researchers, and the bio-pharmaceutical industry are increasingly dependent upon access to data sets of increasing size and scope. Consumers today are increasingly sensitive to how their data is used and monetized, largely in the wake of Facebook/Cambridge Analytica and other high profile scandals. Use of personal health data is not immune from these concerns, from GDPR and California Consumer Privacy Act to the rise of state bills challenging ownership over personal health data even if de-identified.


These consumer and policy trends are raising new questions and challenging norms -- Who should be the legal owner of personal health data? Should patients be notified when their data is monetized even if it lacks identifying information? If personal health data is being sold, should patients be able to participate in the monetization or would this practice exploit underserved populations? What are the potential implications of this shifting landscape on medical research and public health?


Learning Objectives

Review the evolving relationship of patients and health data, from access and sharing to privacy and ownership; Discuss the consumer and policy trends that may reshape expectations when personal health data is monetized; Discuss the data dependence of drug development today and the implications for medical research tomorrow.

Chair

Barbara Lopez Kunz, MSc

Speaker

Honorary Chair Welcome
Guido Rasi, MD

Honorary Chair Welcome
Joanne Waldstreicher, MD

Keynote Address
Gary Gibbons, MD

DIAmond Session: Who Owns My Health Data - Patients, Data, and the Future of R&D
Craig Lipset, MPH

Panelist
Harlan M. Krumholz, MD

Panelist
Doug Peddicord, PhD

Panelist
Deven McGraw, JD, LLM, MPH

Panelist
Donna R. Cryer, JD



Speakers
avatar for Gary Gibbons

Gary Gibbons

Director, National Heart, Lung, and Blood Institute, NIH
Dr. Gibbons oversees the third largest institute at the NIH, with an annual budget of more than $3 billion and a staff of 917 federal employees.The NHLBI provides global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung... Read More →
avatar for Barbara Lopez Kunz

Barbara Lopez Kunz

Global Chief Executive, DIA
Barbara Lopez Kunz, MS, is responsible for the leadership and oversight of DIA global operations, implementing strategies that focus on driving thought leadership and innovation in therapeutic development to improve the health of people worldwide. Ms. Lopez Kunz previously served... Read More →
avatar for Craig Lipset

Craig Lipset

Former Head of Clinical Innovation, Pfizer
Craig Lipset has led at the intersection of patient engagement, personal health data, and accelerating clinical research. He created and led Clinical Innovation at Pfizer, developing and scaling “first in industry” approaches to improving patient experience and innovative data... Read More →
avatar for Guido Rasi

Guido Rasi

Executive Director, European Medicines Agency (EMA)
Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member... Read More →
avatar for Joanne Waldstreicher

Joanne Waldstreicher

Chief Medical Officer, Johnson & Johnson
Joanne Waldstreicher, M.D., is Chief Medical Officer, Johnson & Johnson. In this role, she has oversight across pharmaceuticals, devices and consumer products for safety, epidemiology, clinical and regulatory operations transformation, collaborations on ethical science, and technology... Read More →
avatar for Donna R. Cryer

Donna R. Cryer

Interim Executive Director, People-Centered Research Foundation
Donna R. Cryer, JD, has channeled her personal experience as an IBD and liver transplant patient into professional advocacy as president and chief executive officer of the Global Liver Institute, the innovation and collaboration platform for the liver community. For almost a decade... Read More →
avatar for Harlan Krumholz

Harlan Krumholz

Harold H. Hines, Jr. Professor of Medicine and Director CORE, Yale University
Harlan Krumholz, the Harold H. Hines, Jr. Professor of Medicine at Yale School of Medicine, is a cardiologist and the Director of the Center for Outcomes Research and Evaluation at Yale-New Haven Hospital, where he leads initiatives to improve the quality and outcomes of clinical... Read More →
avatar for Deven McGraw

Deven McGraw

Chief Regulatory Officer, Ciitizen
Deven McGraw is the Chief Regulatory Officer for Ciitizen, a consumer health technology start-up. Prior to joining Ciitizen, she directed U.S. health privacy and security through her roles as Deputy Director, Health Information Privacy at the HHS Office for Civil Rights (the office... Read More →
avatar for Doug Peddicord

Doug Peddicord

Executive Director, Association of Clinical Research Organizations (ACRO)
Following a career as a clinical psychologist, Doug Peddicord came to Capitol Hill as an American Association for the Advancement of Science (AAAS) Congressional Fellow in 1994. With policy expertise in the conduct and regulatory oversight of clinical trials, Dr. Peddicord serves... Read More →


Monday June 24, 2019 8:00am - 10:00am
Ballroom 20 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum
 
Thursday, June 27
 

9:00am

#412: Keeping Up with FDA and EMA Collaborations: Question Time
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-728-L04-P; CME 1.25; IACET 1.25; RN 1.25

How do large regulatory agencies collaborate? What are the challenges they face, in organizations with different structures and working under different legislative frameworks, in finding ways to align to facilitate and enhance global medicines development? This forum brings together pairs of experts from FDA and EMA to launch discussion in such context, with focus on several themes that will provide a foundation for discussing challenges and successes in communication and collaboration covering four areas. These include how we have collaborated on urgent public health issues (with valsartan contamination as an example) and, from there, are working to address shared goals of enhancing global focus on quality manufacturing. From a more clinical perspective, both agencies have matured in experience managing programs for advising companies on potentially important products that could address unmet medical needs, as well as scientific challenges of how to design clinical trials that will be robust and informative in that setting of urgency.

This 75-minute session will engage the audience as a priority, drawing on the extensive experience and expertise of the panel. The audience is invited to submit questions both on the topics explored. Please come prepared with your questions for the EMA/ FDA Question Time panel. You may submit questions in advance to annualmeetingprogram@diahome.org, and include “EMA/ FDA Question Time” in the subject line.

Learning Objectives

Discuss scientific and regulatory challenges of coordinating a response to product contamination on a global scale; Describe factors in developing a strategic approach to globally applicable product quality standards; Identify how the FDA and EMA share information about expedited development scientific advice today and opportunities for the future.

Chair

Sandra L. Kweder
Tânia Teixeira, PharmD

Speaker

Panelist
Anthony Humphreys, MPharm

Panelist
Andrew Thomson, PhD, MA, MS

Panelist
Zahra Hanaizi, PharmD, MPharm

Panelist
Agnès Saint-Raymond, DrMed, MD

Panelist
Brad Leissa, MD

Panelist
Laura Lee Johnson, PhD

Panelist
Christopher Joneckis, PhD

Panelist
Peter P. Stein, MD



Speakers
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA Office of International Programs. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research, where she actively led numerous... Read More →
avatar for Zahra Hanaizi

Zahra Hanaizi

Scientific officer, PRIME Coordinator, Scientific and Regulatory Management Dept, European Medicines Agency (EMA)
Zahra Hanaizi joined EMA in 2007 as Product Team Leader, managing centralised medicinal products initial marketing authorisation applications, maintenance and life-cycle activities, mostly in the therapeutic area of Oncology. Since 2015, she has been working on the creation, implementation... Read More →
avatar for Anthony Humphreys

Anthony Humphreys

Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency (EMA)
He is the Head of Scientific Committees Regulatory Science Strategy Division (SciRS). He is responsible for providing leadership in the Agency in the areas of Scientific Committees Coordination and Regulatory Science Strategy in support of delivering the EMRN 2020 Strategy. He chairs... Read More →
LL

Laura Lee Johnson

Director Division III, Office of Biostatistics, OTS, CDER, FDA
Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
Head of International Affairs, Head of Portfolio Board MD and qualified Paediatrician. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio... Read More →
avatar for Tânia Teixeira

Tânia Teixeira

EMA Liaison Official at FDA, European Medicines Agency (EMA)
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →
AT

Andrew Thomson

Statistician, Biostatistics and Methodology Support Office, European Medicines Agency (EMA)
Andrew Thomson is a statistician in the Office of Biostatistics & Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics subgroup of ICH... Read More →
CJ

Christopher Joneckis

Associate Director for Review Management, CBER, FDA
*
avatar for Brad Leissa

Brad Leissa

Deputy Director and Emergency Coordinator, OCD, CDER, FDA
Brad Leissa began his career at FDA in 1989 as a Medical Officer in the Center for Drug Evaluation and Research (CDER). Following the October 2001 anthrax attacks, Dr. Leissa began work on drug-related regulatory emergencies. In June 2018, he became the lead coordinator for the CDER... Read More →
avatar for Peter Stein

Peter Stein

Director, Office of New Drugs, CDER, FDA
Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related... Read More →


Thursday June 27, 2019 9:00am - 10:15am
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:45am

#413: FDA Town Hall
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-729-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will include discussions and updates from FDA leadership on regulatory issues and the audience will be invited to submit questions of general interest.

Learning Objectives

Discuss regulatory issues and updates to include hot topics.

Chair

Sudip Parikh, PhD

Speaker

Panelist
Patrizia Cavazzoni, MD

Panelist
Christopher Joneckis, PhD

Panelist
Tamy Kim, PharmD



Speakers
avatar for Sudip Parikh

Sudip Parikh

Senior Vice President and Managing Director, DIA Americas, DIA
Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial... Read More →
avatar for Patrizia Cavazzoni

Patrizia Cavazzoni

Deputy Director for Operations, OCD, CDER, FDA
Dr. Cavazzoni received her medical degree at McGill University and completed a residency in Psychiatry and a fellowship in mood disorders at the University of Ottawa. She subsequently joined the faculty of medicine at the University of Ottawa as an assistant professor, where she was... Read More →
CJ

Christopher Joneckis

Associate Director for Review Management, CBER, FDA
*
avatar for Tamy Kim

Tamy Kim

Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER, FDA
Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including... Read More →


Thursday June 27, 2019 10:45am - 12:00pm
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA