DIA 2017 ANNUAL MEETING JUNE 18-22 | CHICAGO
Hot Topics for the DIA 2017 Annual Meeting
DIA was founded in 1964 as a neutral forum where critical issues in health care product safety, access, and efficacy could be discussed between stakeholders to ensure the health and well-being of patients. DIA’s founding was closely tied to the 1962 passage of sweeping legislation in the United States in response to the finding that use of thalidomide to treat morning sickness caused birth defects. The thalidomide problem was global, but there was no organization at the time that could foster cooperative efforts across the entire world to address the issues that emerged. Seeing the need, a group of 30 dedicated pharmaceutical professionals, medical writers, and academics created DIA as a fully independent and unbiased association to foster innovation in the development of life-improving health care products. In the 50 years since DIA’s creation, we have seen astounding advances in pharmaceutical and medical device technologies and the regulations and policies that govern their safe and effective use. DIA’s neutral forum has continued to provide unique opportunities for dialog and problem solving so participants worldwide can benefit from shared insights to build knowledge, drive action, and create the next generation of health care advances. While we reflect on our progress, successes, and failures in 2016, we look ahead to 2017 and the challenges and opportunities that still remain in health care product development. These opportunities and challenges, frequently residing at the system level, require knowledge sharing and collaboration across the stakeholder community, making DIA what it is today – the unique, global, and neutral convener of industry innovators, regulators, academicians, payers, clinicians, and patients, working to collectively bring forward our best thinking to advance solutions so patients can access new and improved therapies. An integral part of fulfilling DIA’s mission includes convening these stakeholders and discussing the most important challenges in health care product development in one place and platform, at the DIA 2017 Annual Meeting. As we look forward to DIA 2017, I invite you to review the insights shared at the DIA 2016 Annual Meeting and to bring your new knowledge and experiences to DIA 2017. We eagerly anticipate your attendance and collaboration in what I know will be our best, most transformative event yet. We are DIA! Warm Regards,
Barbara Lopez Kunz Global Chief Executive DIA
DIAglobal.org/DIA2017
The Countdown is On! Things to Look Forward To
Planned Sessions Include: • Radical Technologies: Changing the Future of Biopharma
Start every morning with our DIAmond Sessions, featuring the top thought leaders in drug development discussing key concepts on the future of thereapeutics, and how they affect you.
• The Microbiome: Reinventing Drug Development, Reimagining Health • Artificial Intelligence and Machine Learning • ICH Updates • Next Generation Predictive Analytics
Professional Development New professional development sessions this year focusing on how to advance YOUR career. Hear how your colleagues ended up on their career path, discuss the state of the job market, and learn how you can invigorate your career.
• Integrating the Patient’s Voice Across the Development Program of Rare Diseases eal World Data to Real World Evidence for Assessing Efficacy •R and Effectiveness alue-Based Conversation With Payers: Issues, Opportunities, •V and Barriers • Diversity Matters: Optimizing Clinical Trials
Early Bird Rate Ends December 31, 2016 REGISTER TODAY
“DIA has something for everyone, and everything offered is substantial. I come away from these meetings with a fresh take on my profession and a renewed enthusiasm!”
“If you have to choose one conference to go in a year, DIA is the one to choose.”
DIAglobal.org/DIA2017
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International Regulatory Convergence, Collaboration, and Cooperation A senior panel of global regulators convened to share the challenges in their respective jurisdictions, domestically and internationally, and to discuss mutual reliance activities, including the emerging International Coalition of Medicines Regulatory Authorities.
“My great hope from this group is that we end up with a situation where we can increasingly rely upon each other, don’t have to duplicate the work across the world, and take advantage of the knowledge and insights that we all have for a global system of very high-quality medical products.” Robert Califf, MD Commissioner FDA
Questions DIA 2017 Will Address • How can sponsors mitigate and filter the noise of burdensome, divergent advice with respect to their global development programs? • What is the current status of ongoing harmonization initiatives? • How can international regulators and industry continue to come together to provide health care solutions the public need and demand?
“We don’t know what or when the next global health crisis, the next public health emergency of international concern, will occur. But we do know that it will happen. And when it does happen, the regulators need to be ready.” Jarbas Barbosa, PhD, MD
Director-President Agência Nacional De Vigilância Sanitária (ANVISA), Brazil
DIAglobal.org/DIA2017
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Session
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This panel of health care experts had an in-depth and enlightening discussion to address the question, “What can we change today to make randomized clinical trial data more useful in determining therapeutic value in tomorrow’s context of personalized medicines, treatment algorithms for personalized combinations, gene and cell therapies, and extended monitoring?”.
“Combining these data sources with reliability, and combining these data sources with the value of what you’re trying to prove, is a very difficult proposition, but also one that we have to do. There is no choice. We need to reliably collect, aggregate, and give the data, fit for purpose, to the right person, at the right time, to make these important decisions.”
Questions DIA 2017 Will Address
Steve Rosenberg
Read the Full Synopsis here
Europe and the US: Making Outcomes-Based Health Care Possible
• What barriers do EHR’s and other data sources outside clinical trials present when evaluating safety and efficacy across the continuum of the product life cycle? • What does an HTA model for the 21st Century look like? How will it measure individual response to treatment based on the combination of clinical, genetic, and demographic factors?
Senior Vice President and General Manager, Health Sciences Global Business Unit Oracle Health Sciences
“We’re trying to drive better outcomes for patients, but just being patient-centered isn’t good enough. It has to be also acceptable to all the other stakeholders, otherwise it won’t be sustainable…How do we serve patients better and also do it in a way that is acceptable in terms of the trade-offs for all the other stakeholders?” Gigi Hirsch, MD
Executive Director MIT Center For Biomedical Innovation
DIAglobal.org/DIA2017
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Value-Based Health Care Decision Making: The Quest for Smarter Spending Implementation of value-based health care, particularly around the costs needed to do so, varies worldwide. A panel of esteemed professionals discussed in-depth evidence to more adequately address questions on health care spending based on value decisions and assessments to support this wave of change.
Questions DIA 2017 Will Address • What are the drivers and barriers to providers and payers for value-based contracting? • Can a solution be created to accelerate drug development via innovative trial design based on existing ideas? • How can we leverage big data to identify correlations and determinants of disease or to predict response to therapy?
“There’s never going to be a right answer about value. There is never a definitive answer. It is not a static, it is a dynamic, thing – lots of input, lots of experience – so it’s really important that you have a good process around the determination of value, the accountability for reasons with inclusiveness and transparency, to give everybody their say, and pay attention to the comments you receive.” Professor Sarah Garner, PhD, BPharm
Associate Director, Science Policy and Research National Institute for Health and Care Excellence (NICE), UK
“Patient value should drive market value of products and services.” Ben Heywood, MBA
President and Co-Founder PatientsLikeMe
DIAglobal.org/DIA2017
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Next Generation Collaborations: Transforming the Industry In 2015, the FDA approved 51 new drugs, all new class agents, the largest number of approvals over the past 66 years. A skilled panel focused on these advancements and the notion that convergence, collaboration, and cooperation in drug development, performed early and amongst stakeholders, can drive greater innovation, reduce time to market, and increase efficacy in product development.
Questions DIA 2017 Will Address • What does the future hold for the impact of industry consortia on creating collaborative solutions to drug development challenges? • How can we integrate patient’s voice across the development program of rare diseases? • What is the potential of 3D printing and how do we integrate this approach to provide personalized medicine within clinical trials and on the market?
“My guess is that the way you’re thinking about your trials and research today is the same as you were fifteen years ago, but clearly the industry, or rather the consumers who are in these trials, have changed… The companies who begin to understand that there’s a massive shift in the way that consumers are interacting with technology, the companies who adapt to that are going to be the companies who will be successful in the long term.” Drew Schiller, MD
Co-Founder and Chief Technology Officer Validic
“What was a dream of scientists ten years ago…is now here.” Dalvir Gill, PhD
Chief Executive Officer TransCelerate BioPharma Inc.
DIAglobal.org/DIA2017
Click to Listen to the Full Session Click to Read the Full Synopsis
CDER Town Hall Highlights of this interactive town hall included: How Dr. Richard Pazdur, acting leader of the FDA’s Office of Excellence in Oncology, will help establish this program to develop consistent policies/practices for oncology products across all FDA review centers; the package of proposed industry/FDA recommendations for reauthorization of PDUFA is in Obama Administration review; and how FDA continues to work closely with China to help establish quality standards for the drug supply chain.
Questions DIA 2017 Will Address • How can we break down the wall for FDA to leverage real-world data? • What are the FDA marketing enforcement updates for rare diseases and what do they mean for you? • Looking into the future: How will PDUFA VI affect you?
“Regulatory science includes what’s now being referred to as ‘the science of patient input,’ and there are a number of research questions related to that, a number of which have to do with the various kinds of performance outcome measures, the use of wearables, how you can use wearables as a data collection tool in clinical trials, other performance measures, and understanding how to really create fit for purpose patientreported outcome measures.” Theresa M. Mullin, PhD
Director, Office of Strategic Programs, CDER FDA
“That’s the research gap: What is the evidentiary standards to be comfortable using something that’s a biomarker as a surrogate so you can feel confident that you’re providing clinical benefit to the patient in the setting of a traditional approval, or that it’s reasonably likely to predict clinical benefit in the setting of accelerated approval?” John Jenkins, MD
Director, Office of New Drugs, CDER FDA
DIAglobal.org/DIA2017
DIA 2017 ANNUAL MEETING JUNE 18-22 | CHICAGO
Early Bird Rate Ends December 31, 2016 REGISTER TODAY
DIA 2017 Annual Meeting 0 01: Data-BigData-eHealth R 05: Regulatory
D 02: DisruptiveInnov
F 06: Safety-PV
N 09: TranslSci-Preclin-Clin-ProdDev
M 03: MedAffairs-SciComm
C 07: SpecialPops 1 10: Value-Access
L 14: ProfDevelopment
G 15:Engage-Exchange
9 19: DIACommunities
S Short Course
P 04: PatientEngagement
T 08: StratPlan-Exec-Partnershps Q 11: Quality
6 16: Posters
2 12: DIAmond
H 17: ContentHub
V 13: InnovTheater
Y 18: Plenary
JUNE 17 • SATURDAY 8:00am – 5:00pm
Exhibitor Registration
TBA
DIA 2017 Annual Meeting 0 01: Data-BigData-eHealth R 05: Regulatory
D 02: DisruptiveInnov
F 06: Safety-PV
N 09: TranslSci-Preclin-Clin-ProdDev
M 03: MedAffairs-SciComm
C 07: SpecialPops
T 08: StratPlan-Exec-Partnershps
1 10: Value-Access
L 14: ProfDevelopment
G 15:Engage-Exchange
9 19: DIACommunities
S Short Course
P 04: PatientEngagement
Q 11: Quality
6 16: Posters
2 12: DIAmond
H 17: ContentHub
V 13: InnovTheater
Y 18: Plenary
JUNE 18 • SUNDAY 8:00am – 9:00am
Registration for Full Day and Morning Preconference Short Courses
TBA
8:00am – 6:00pm
Exhibitor Registration
TBA
8:30am – 12:00pm
Half Day Morning Preconference Short Courses
TBA
8:30am – 12:00pm
S #23: Signal Detection: Identifying and Managing Safety Signals
Speakers: James Buchanan 8:30am – 12:00pm
S #25: Regulatory Considerations for Drug Development: Current Status and Trend of IND/NDA Practice
in China 8:30am – 12:00pm
S402ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
S404a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
S #21: Successful Drug Development: Best Practices for Drug Development Planning, Agency
Interactions, and Regulatory Document Writing Speakers: Elaine Taylor 8:30am – 12:00pm
S401bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
S #24: The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health
Technology Assessment
S403ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Louis Garrison, Jack Mycka 8:30am – 12:00pm
S #26: Smart, Innovative Risk-based Auditing: Shifting the Paradigm
Speakers: Joanne Malia, Sarah S404bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Ann Silvers 8:30am – 12:00pm
S #22: How to Prepare for an FDA Inspection
Speakers: Michael Hamrell 8:30am – 12:00pm
S #20: Leadership: How to Organize and Lead People in a Work Group
Speakers: Michael Laddin 9:00am – 5:00pm 9:00am – 5:00pm
S401d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
S401a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Full Day Preconference Short Courses
TBA
S #43: The Good Pharmacovigilance Practices in the EU: Global Applications
Speakers: Saad Shakir, Kristina S405b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Strutt 9:00am – 5:00pm
S #42: Analysis of Safety Data from Clinical Trials
Speakers: Jürgen Kübler 9:00am – 5:00pm
S #40: Clinical Statistics for Nonstatisticians
Speakers: Michael Mosier 10:30am – 12:00pm
S405a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
L Student Session
S404d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Prairie Room, Hyatt (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Alberto Grignolo, Mark Kryah, Raleigh Malik, Ranjini Prithviraj, Margaret Richards 12:00pm – 6:00pm
L DIA Drug Development and Life Sciences Career Fair: Career Fair Expo Hyatt Regency McCormick Place, Regency Ballroom (2233 S. King Drive Chicago, IL 60616)
12:30pm – 6:00pm
Registration for Afternoon Preconference Short Courses, Conference Attendees, and Speakers
TBA
1:00pm – 4:30pm
Half Day Afternoon Preconference Short Courses
TBA
1:00pm – 4:30pm
F #32: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
Speakers: Mark Ammann,
S401d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Catherine Sigler, Annette Stemhagen 1:00pm – 4:30pm
S #35: Digital Health Technologies for Combination Products and Beyond: Development and Regulation
Speakers: Wade Ackerman 1:00pm – 4:30pm
S404a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
S #30: Preparing for a US FDA Advisory Committee Meeting
Speakers: Neelu Agrawal, Pete S401a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Taft 1:00pm – 4:30pm
S #33: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes
Affecting Pharmaceutical Development Speakers: Alberto Grignolo 1:00pm – 4:30pm
S404bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
S #34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable
Model
S402ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Mary Arnould, Cecilie Freddie Lange, Stuart Shaw 1:00pm – 4:30pm
S #31: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation
Speakers: Michael Laddin 2:45pm – 4:00pm
S403ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
L #001: To Change or Not to Change, That is the Career Question: Knowing When it’s Time to Move On
(Not, Run From)
N426a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Kimberly Belsky, Stephen Knowles, Margaret Richards, Leigh Shultz 4:15pm – 5:30pm
L #002: Networking Within Your Company
Speakers: Nadia Bracken, Chris N426a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Matheus, Bob Muzerall
DIA 2017 Annual Meeting 0 01: Data-BigData-eHealth R 05: Regulatory
D 02: DisruptiveInnov
F 06: Safety-PV
M 03: MedAffairs-SciComm
C 07: SpecialPops
N 09: TranslSci-Preclin-Clin-ProdDev
T 08: StratPlan-Exec-Partnershps
1 10: Value-Access
L 14: ProfDevelopment
G 15:Engage-Exchange
9 19: DIACommunities
S Short Course
P 04: PatientEngagement
Q 11: Quality
6 16: Posters
2 12: DIAmond
H 17: ContentHub
V 13: InnovTheater
Y 18: Plenary
JUNE 19 • MONDAY 6:30am – 8:00am
CISCRP Medical Appreciation 5K
TBA
7:00am – 6:00pm
Attendee, Speaker, and Exhibitor Registration
TBA
7:30am – 8:15am
Annual Meeting Orientation
TBA
7:30am – 8:30am
Coffee and Light Refreshments
TBA
8:30am – 10:00am
2 #101: Drug Repurposing: Where Will it Take Us?
Speakers: K. Gary Barnette,
S105 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Bruce Bloom, Christine Colvis, Pamela Hill, Jill Pulley 8:30am – 10:00am
2 #102: The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of
Decision Making
S100a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Brian Bradbury, Alison Cave, Stephanie Devaney, Nancy Dreyer, Iris Loew-Friedrich, Robert Temple 8:30am – 10:00am
2 #103: The Future of Patient Engagement: Measuring What Matters
Speakers: Ronald Bartek, Anne S100c (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Beal, Juan Garcia-Burgos, Paul Kluetz, Debra Lappin, K. Kimberly McCleary 10:00am – 11:00am
Coffee Break
TBA
10:00am – 6:00pm
Exhibit Hall Open
TBA
10:15am – 10:45am
V #104: Cenduit LLC Innovation Theater: High-Profile Early Onset Alzheimer’s Disease Study in an
Academic Setting Requiring Highly Configurable IRT System for Complex Study Design. Speakers: Cenduit LLC 10:15am – 10:45am
Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
V #105: DBMS Consulting Innovation Theater: Replacing dsNavigator with Oracle TMS as a centralized
coding solution
Theater #1 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: DBMS Consulting 11:00am – 11:30am
L #130: Career Opportunities in Transitions in Life Science
Speakers: Linda
S400 Concourse (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Bowen, Bev Hudson 11:00am – 12:15pm
0 #106: Leveraging Big Data/ Real-World Data in Enabling Efficient and Data-Driven Clinical Research
From Sponsor, Vendor and National Health System Perspective: Case Studies Moderators: Crystal Ancona
N229 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Andrew Cassel, Kelly Han 11:00am – 12:15pm
D #107: Leveraging Wearables and Sensors in Clinical Trials and mHealth
Moderators: Bill Byrom
S501abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Daragh Ryan, Chris Watson 11:00am – 12:15pm
D #108: Artificial Intelligence/Machine Learning
Moderators: Badri Rengarajan S502ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Andrea Cherubini, Vladimir Pyagay, Aman Thukral 11:00am – 12:15pm
M #109: Submission Dossiers: Communications Excellence to Drive Speed and Quality
Moderators: Frank Hubbard
S503ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Lei Chuang, Kent Cochran, Steve Sibley 11:00am – 12:15pm
M #110: Globalization of Medical Affairs Departments
Moderators: Rebecca
S504abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Vermeulen Speakers: Mike Baker, Jay Mouser, Anja Schaefer 11:00am – 12:15pm
P #111: Patient Engagement: 4 W's and an H
Moderators: Jane Myles
N426a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Hollie Schmidt, Barbara Zupancic 11:00am – 12:15pm
P #112: Data Sharing: 2017 and Beyond
Moderators: Rebecca Li
N426b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Susannah Chang, Jill McNair 11:00am – 12:15pm
P #113: We Can't Forget the Children in This Process
Moderators: Lisa Kim
N426c (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Korey Capozza, Katie Palermo, Mary Short 11:00am – 12:15pm
R #114: PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the
Future - PDUFA VI
N228 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Kim Quaintance-Lunn Speakers: Patrick Frey, Sandra Milligan, Theresa Mullin, Lucy Vereshchagina 11:00am – 12:15pm
F #117: Postmarketing Safety Studies: Approaches and Regulatory Insights
Moderators: Elsie Grace
S401a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Javier Cid, Deborah Covington, Aarthi Iyer 11:00am – 12:15pm
F #118: Counting on Safety
S401d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: William Wang Speakers: Barbara Hendrickson, Alan Hochberg, Stephanie Shapley 11:00am – 12:15pm
F #119: Designing and Implementing a Robust Pharmacovigilance System for Vaccines
Moderators: Sanjeev Miglani
S401bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Seema Jaitly, Walter Straus 11:00am – 12:15pm
C #120: FDA Rare Disease Town Hall
Moderators: James Valentine
N227b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Jonathan Goldsmith, Ilan Irony, Michael Pacanowski, Gayatri Rao 11:00am – 12:15pm
T #121: Effective Life Cycle Management
Moderators: Keith Ruark
S505ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Kellie Combs, Maria Manley 11:00am – 12:15pm
N #122: GBM AGILE: A Transformative Global Adaptive Platform Clinical Trial
Speakers: Brian Alexander,
S404a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Donald Berry, Amy Heimberger, Mustafa Khasraw 11:00am – 12:15pm
N #123: Calling All Angels to the Valley of Death
Moderators: David Vulcano
S405b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Christine Colvis, Ginger Spitzer 11:00am – 12:15pm
N #124: Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies
Moderators: Galina Bernstein S402ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Justin Earp, Stephan Schmidt 11:00am – 12:15pm
N #125: Hybrid Study Designs: An Innovative Approach to Obtaining Valuable Information by Combining
Existing Data with New Data Length S404bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Bertrand Le Bourgeois, Hady Khoury, William Maier, Margaret Richards 11:00am – 12:15pm
1 #126: Breaking Down the Wall for FDA to Leverage Real World Data
Moderators: Sophie Janssens
N226 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Jonathan Jarow, Mary Jo Lamberti, John Reites 11:00am – 12:15pm
Q #127: The Evolving International Landscape of FDA Inspections: Data Integrity Violations in
Bioequivalence Studies in India Speakers: Leslie Ball, Arindam S405a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Dasgupta, Sean Kassim, Mathew Thomas 11:00am – 12:15pm
Q #128: Office of Pharmaceutical Quality Update: Innovative Approaches in Regulatory Assessment
Speakers: Lucinda Buhse,
N230b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Laurie Graham, Patrick Ricucci, Wendy Wilson-Lee 11:00am – 12:15pm
L #129: Engage and Exchange Student Forum
Speakers: Danny Benau,
Exhibit Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Emily Cox, Sameer Thapar 11:00am – 12:30pm
R #115: Update from the CFDA S403ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Duo Dong, Duo Dong, Xiaoling Qin, Zhimin Yang, Rong Zhang 11:45am – 12:15pm
H #131: A Day in the Life of A....
Speakers: Bev Hudson S400 Concourse (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) 12:00pm – 2:45pm 12:30pm – 1:00pm
Luncheon
TBA
V #132: QuintilesIMS Innovation Theater: The Next Generation of Clinical Development is Here
Speakers: Patrick Jordan,
Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Cynthia Verst 12:30pm – 1:00pm
V #133: Tata Consultancy Services Innovation Theater: Global Regulatory Information Portal (GRIP) – A
Regulatory Information Strategic Effectiveness Portal Speakers: Abhinav Gupta,
Theater #1 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Dominique Lagrave, Tata Consultancy Services 12:30pm – 1:30pm
9 DIA Patient Engagement Community Round Table Discussion: The Future of Patient Engagement:
Measuring What Matters Speakers: Mary
Community Corner (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Murray 12:30pm – 2:45pm
6 #134: Student Poster Session and Oral Presentations 1A Exh Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
12:30pm – 6:00pm
6 Student Poster Session
Speakers: Akhil Poster Area Exhibit Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Agarwal, Eliane Barras, Célia Bouharati, Ashnik Chauhan, Anh Duong, Deena D\'Souza, Susann Grill, Aurélien Grolleau, Noreen Hussain, Gian King, Meng Li, Yen Ping Lim, Kirolous Makarious, Mona Nili, Mio Saito, Muntazir Ali Sayed, Anne Shah, Seema Singh, Priyal Soni, Taylor Walsh 1:00pm – 5:00pm
L DIA Drug Development and Life Sciences Career Fair: Private Interviews Hyatt Regency McCormick Place, Regency Ballroom (2233 S. King Drive Chicago, IL 60616)
1:15pm – 1:45pm
V #135: PAREXEL International Innovation Theater: Developing Drugs in the New Era of Personalized
Medicines
Theater #1 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: PAREXEL International, Anita Nelsen, Sy Pretorius 1:15pm – 1:45pm
V #136: Covance Innovation Theater: Lessons Learned From Deploying Clinical Data Review: Ensuring
Patient Safety, Increasing Operational Efficiency and Creating New Insights Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Dimitris Agrafiotis, Covance Inc. 1:15pm – 1:45pm
H #138: Day in the Life of A…Part 2
Speakers: Kelly Smith S400 Concourse (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) 1:15pm – 2:15pm
G #137: The Worst Coworker on the Block: Can YOU Work with Difficult People? Yes, You Can!
Speakers: Robin Whitsell 1:45pm – 2:45pm
Exhibit Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
9 DIA Medical Writing Community Round Table Discussion: Submission Dossiers: Communications
Excellence to Drive Speed and Quality Speakers: David
Community Corner (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Clemow 2:00pm – 2:30pm
V #139: Deloitte Consulting Innovation Theater: 21st Century Cures and Person-Centered Research: A
Recipe for Innovation
Theater #1 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Asif Dhar 2:00pm – 2:30pm
V #140: SAS Institute Inc. Innovation Theater: Clinical Analytics Workflow Optimization
Speakers: Matt Becker,
Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Mike Henderson, SAS Institute Inc. 3:00pm – 4:30pm
Y #142: Opening Remarks and Keynote Address
Speakers: Alexander Arie Crown Theater (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Tsiaras 4:30pm – 6:00pm 4:45pm – 5:15pm
Opening Reception
TBA
V #143: Advanced Clinical Innovation Theater: Avoid Systems Overload: Connecting and
Operationalizing Disparate Technology Systems Supporting Clinical Trials Speakers: Stacey
Theater #1 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Arrambide, Advanced Clinical, Cheryle Evans 4:45pm – 5:15pm
V #145: Educational Measures Innovation Theater: EM Array™ Live Meeting Technology
Speakers: Ryan Mazon 4:45pm – 5:30pm
Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
6 #146: Student Poster Session and Oral Presentations 1B Exh Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
5:30pm – 6:00pm
V #147: Appian Innovation Theater: Product Lifecycle Management In The Digital Era
Speakers: Evjatar Cohen 5:30pm – 6:00pm
Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
V #148: DBMS Consulting Innovation Theater: Manage Customized SMQs/MedDRA Queries and
Customized SDGs/Drug Groupings and Facilitate Risk Profiling and Safety Analysis with OpenCQT Theater #1 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
DIA 2017 Annual Meeting 0 01: Data-BigData-eHealth R 05: Regulatory
D 02: DisruptiveInnov
F 06: Safety-PV
M 03: MedAffairs-SciComm
C 07: SpecialPops
N 09: TranslSci-Preclin-Clin-ProdDev
1 10: Value-Access
L 14: ProfDevelopment
G 15:Engage-Exchange
9 19: DIACommunities
S Short Course
P 04: PatientEngagement
T 08: StratPlan-Exec-Partnershps Q 11: Quality
6 16: Posters
2 12: DIAmond
H 17: ContentHub
V 13: InnovTheater
Y 18: Plenary
JUNE 20 • TUESDAY 7:00am – 8:00am
Coffee and Light Refreshments
TBA
7:00am – 5:15pm
Attendee, Speaker, and Exhibitor Registration
TBA
8:00am – 9:30am
2 #201: Paying for Value in Biopharmaceuticals: Trends in the United States
Speakers: Joel Beetsch, Shawn S105 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Davis, Phillip Lerner, Sudip Parikh, Sloane Salzburg 8:00am – 9:30am
2 #202: People Will Talk: Gathering Insights from Digital Listening
Moderators: Lorrie Schifano
S100c (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Chi Bahk, Gerald Dal Pan, Jeffery Painter, Phil Tregunno 8:00am – 9:30am
2 #203: Radical Technologies: Changing the Future of Biopharmaceuticals
Speakers: Jeffry James, Julian S100a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Jenkins, Craig Lipset, Alicia Staley 9:30am – 10:30am 9:30am – 10:30am
Coffee Break
TBA
G #204: Effective Team Management in Global Trials
Speakers: Peter DiBiaso 9:30am – 10:30am
Exhibit Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
6 #205: Professional Poster Session 2A Exh Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
9:30am – 5:00pm 9:30am – 5:00pm
Exhibit Hall Opens
TBA
6 Professional Poster Session 1
Speakers: Basirat Poster Area Exhibit Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Adeyemi, Alexandra Atkins, Catherine De Castro, Yen-Ming Chan, Tina Chhabra, Deborah Covington, Amy Curry, Nadeeka Dias, Meghan Donahue, Jennifer Emerson, Harry Gewanter, Kit Howard, Yi Tzu Hsu, Candice Hughes, Maori Ito, Dayna Lesueur, Lawrence Liberti, Jenny Ly, Melissa Mielcarz, Vineeth Nair, Daina Nanchanatt, Fatima Paruk, Katelyn Patterson, Vincent Philiponis, Srinivas Pai Raikar, Masooma Razvi, ChiTun Ruan, Jui Shah, Jennifer Shing, Scott Snyder, Judith Thompson, Priscilla Velentgas, Rod Walker, Kevin White, Rinah Yamamoto, Rinah Yamamoto, Zhongwei Zhou 9:45am – 10:15am
V #206: Covance Innovation Theater: Overcoming Study Complexity Through Data-Driven Design
Speakers: Bill Hanlon,
Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Covance Inc. 9:45am – 10:15am
V #207: Veeva Systems, Inc. Innovation Theater: 2017 Unified Clinical Operations Survey
Speakers: Michael Burton, Theater #1 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Veeva Systems, Inc. 10:30am – 11:00am
Q #231: A Risk-Based Approach to Quality Management for RWE Studies
Speakers: David
S400 Concourse (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Fryrear 10:30am – 11:30am
R #217: Update from CBER: Advancing the Development of Complex Biologic Products
Speakers: Peter Marks 10:30am – 11:30am
S404a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
R #218: ClinicalTrials.gov: Complying with Requirements in the Final Rule (42 CFR Part 11) and Impacts
of 21st Century Cures Act
S404bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Rebecca Williams 10:30am – 11:30am
F #220: Cardiac Safety
S401bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Snehal Kothari Speakers: Kenneth Getz, Jörg Täubel 10:30am – 11:30am
9 DIA Study Endpoints Community Round Table Discussion: Leveraging Wearables and Sensors in the
Clinical Trials and mHealth Speakers: Emuella
Community Corner (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Flood 10:30am – 11:45am
0 #208: Big Data: Regulatory Information
Moderators: Vada Perkins
N226 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: David Martin, Thomas Senderovitz, Vikesh Srivastava 10:30am – 11:45am
0 #209: Evolving Data Standards and Regulations
Speakers: Lauren Becnel,
N228 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Benedikt Egersdoerfer, Ron Fitzmartin, Michael Goedde, Dawn Kaminski, Vaishali Popat 10:30am – 11:45am
M #210: The New Business Reality for the Medical Science Liaison Community
Moderators: Kevin Henderson
S401d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Dipam Doshi, Paul James, Kimberly Johnson 10:30am – 11:45am
P #211: Sharing the Burden
N426b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Deborah Collyar, Deborah Howe, Paul O\'Donohoe 10:30am – 11:45am
P #212: Walking the Walk in Patient Focused Medicines Development: From Theory to Practice What
Have We Learned?
N426a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Marc Boutin Speakers: Juan Garcia-Burgos, Jan Geissler, Anton Hoos, Theresa Mullin 10:30am – 11:45am
R #213: Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?
Moderators: Nancy Myers
S403ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Anne-Virginie Eggimann, Richard Moscicki, Tal Zaks 10:30am – 11:45am
R #214: Recent Trends in Asian Regulations for Drug Development: What is Coming Next?
Speakers: Vicky (Fengyun)
N227b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Han, Yoshiaki Uyama, Chao-Yi Wang 10:30am – 11:45am
R #215: The Evolving Model of Using Artificial Intelligence to Deliver Actionable Regulatory Intelligence
Moderators: Linda Bowen
S404d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Patrick Brady, Tom Macfarlane 10:30am – 11:45am
R #216: International Collaboration in Times of Public Health Crisis
Moderators: Ian Hudson
N229 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Jarbas Barbosa, Carmen Maher, Agnès Saint-Raymond 10:30am – 11:45am
F #219: Safety Evaluation: Transforming Information into Evidence
Moderators: Olga Marchenko
S401a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Lorrie Schifano, Richard Zink 10:30am – 11:45am
F #221: Pharmacovigilance Inspections: Hot Topics and Proactive Approaches
Speakers: Michael Bean, Rory N230b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Littlebury, Carolyn Winter 10:30am – 11:45am
C #222: Serving the Patient Who Needs Early Access to Treatments and Achieving Meaningful
Outcomes
S505ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Stella Blackburn Speakers: Richard Scheyer, June Wasser 10:30am – 11:45am
C #223: Introduction to Rare Disease Studies: Challenges of Rare Disease From a Statistical, Protocol
Development, and Operations Perspective Moderators: William Smith
S503ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Yeh-Fong Chen, Robert Homolka, Gil Price 10:30am – 11:45am
C #224: Success in Early CNS Drug Development: Getting Proof-of-Principle by Stacking the Deck with
Biomarkers
S504abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Nita Ichhpurani Speakers: Keith Fargo, Michael Gold, Bruce Morimoto 10:30am – 11:45am
T #225: So You Say You're an Extrovert: Being an Effective Leader when All You Really Want Is a Stage
Moderators: Alice Ford-
S501abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Hutchinson Speakers: Cathie Snyder 10:30am – 11:45am
T #226: Accelerating Drug Development Through Innovation
Moderators: John Reites
S502ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Hassan Kadhim 10:30am – 11:45am
N #227: At the Cornerstone of Wearable Technology and Patient-Focused Clinical Trial Endpoints
Speakers: Robert DiCicco, E.
S405b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Ray Dorsey, Nikunj Patel, Leonard Sacks 10:30am – 11:45am
N #228: Master Protocols: New Approaches to Enrolling Hard-to-Find Subjects and Expediting Drug
Development
S405a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Theresa Ashton Speakers: Amy Burd, Nicholas Kenny, Ulrike Lorch, Kert Viele 10:30am – 11:45am
1 #229: Outcomes Standardization: An Imperative to Value Assessments
Moderators: Richard Gliklich
N426c (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Elise Berliner, John Powers, Paul Stang 10:30am – 11:45am
Q #230: Global Harmonization: Mutual Recognition
Speakers: Chi-Wan Chen,
S402ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Niraj Mehta, Roger Nosal, Terrance Ocheltree 10:45am – 11:45am
G #232: Healthy CRO/Sponsor Relations: “Sole” Mate or Flavor of the Month
Speakers: David Burnham, Exhibit Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Sondra Smyrnios 11:30am – 2:00pm 12:00pm – 12:45pm
Luncheon
TBA
V #234: QuintilesIMS Innovation Theater: Changing Trials Through Analytics: How it Works Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
12:00pm – 12:45pm
V #235: Amplexor Innovation Theater: Reduce Complexity – Increase Compliance – Decrease TCO’s:
Regulatory Vendor Promises - Innovations or Buzzwords? Theater #1 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
12:00pm – 1:00pm
9 DIA Communities Luncheon N427bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Tshaka Cunningham 12:00pm – 1:45pm
6 #236: Professional Poster Session and Oral Presentions 2B Exh Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
12:45pm – 1:30pm
L PowerUp!
N426a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Holger Adelmann, Kimberly Belsky, Larry Blankstein, Sudip Parikh, Angela van der Salm, Nancy
Smerkanich 12:45pm – 1:45pm
G #237: Strategies for Communicating with FDA
Speakers: Leah Christl, Kim Exhibit Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Quaintance-Lunn 1:00pm – 1:45pm
V #238: Veeva Systems, Inc. Innovation Theater: Tomorrow's Clinical Trial, Powered by Modern EDC
Speakers: Drew Garty,
Theater #1 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Veeva Systems, Inc., Richard Young 1:00pm – 1:45pm
V #239A: BioClinica Innovation Theater: Case Studies: How Companies Are Finally Reaping the Benefits
of Risk-Based Monitoring. Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Bioclinica 1:00pm – 1:45pm
9 DIA Patient Engagement Community Round Table Discussion: Walking the Walk in Patient Focused
Medicines Development: From Theory to Practice What Have We Learned? Speakers: Mary
Community Corner (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Murray 1:15pm – 1:45pm
T #239B: Strategies for Managing Difficult Stakeholders
Speakers: Karla
S400 Concourse (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Childers, Alice Ford-Hutchinson, Nita Ichhpurani, Leigh Shultz, Elizabeth Somers 1:30pm – 3:30pm 2:00pm – 3:00pm
Exhibit Guest Passes
TBA
0 #243: Data and Privacy Protection
Speakers: Peter Alterman,
N426a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Jonathan Andrus, Debra Diener 2:00pm – 3:00pm
1 #260: Comparative Effectiveness: State of the Art and Stakeholder Perspectives
Moderators: Robert DuBois
S405b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Jean Slutsky, David Thompson 2:00pm – 3:00pm
G #263: Mergers and Acquisitions: Due Diligence Considerations
Speakers: Donny Chen 2:00pm – 3:00pm
Exhibit Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
9 DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance
Inspections: Hot Topics and Proactive Approaches Speakers: Catherine Community Corner (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Baldridge 2:00pm – 3:15pm
0 #240: Mobile Health: Participatory Research
Speakers: Wayne Amchin,
N426c (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Craig Lipset, Mintu Turakhia 2:00pm – 3:15pm
0 #241: FDA Session: Electronic Submissions and Data
Speakers: Ron Fitzmartin,
N228 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Virginia Hussong, Colleen Ratliffe, Elaine Thompson, Weiya Zhang 2:00pm – 3:15pm
0 #242: Big Data: Current and Emerging Technologies
Moderators: David Kiger
N227b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Amy Abernethy, Mildred Menos 2:00pm – 3:15pm
D #244: New Trial Design Approaches: Including New Endpoints
Moderators: John Reites
S501abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Robert DiCicco, Christian Gossens 2:00pm – 3:15pm
D #245: Leveraging Wearables and Sensors in Clinical Trials: Case Studies
Moderators: Michael Phinney S502ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Richard Clark, Martin Daumer
2:00pm – 3:15pm
M #246: Medical Information and the Patient: Effective Communication and Handling of Requests
Moderators: Sara Doshi
S503ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Hanady Elhadidy, Brandi Gregg, Debbie Tennant 2:00pm – 3:15pm
M #247: Best Practice for Advisory Committee Meeting Preparation
Moderators: Chris Miller
S504abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Michael Bourque, Jeffrey Dayno, John Markman 2:00pm – 3:15pm
M #248: Building the Medical Strategy and Tactics
Speakers: Anny Chen, Bhakti
S401a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Kshatriya, Lou Lu, Chung H. (Lou) Lu, Fabrizio Tondolo 2:00pm – 3:15pm
P #249: Not Your Grandma's Patient Advocacy Group Anymore
Moderators: Mary Murray
S402ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Melissa Hogan, Melissa Hogan, Laura Kolaczkowski, K. Kimberly McCleary, Upal Basu Roy 2:00pm – 3:15pm
P #250: If You See Something (About a Clinical Trial), Do You Say Something (to Your Doctor?)
Moderators: Tyler Ludlow
S401d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Candice Junge, Greg Sweatt 2:00pm – 3:15pm
P #251: Defining the Science of Patient Input to Enhance Drug Development and Approval: Regulatory
Moderators: Bennett Levitan
N226 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Telba Irony, James Valentine, Lesley Wise 2:00pm – 3:15pm
R #252: What’s New in Devices: European Medical Device Regulations and MDUFA IV
Moderators: Angela Stokes
S404a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: LeeAnn Chambers, Theresa Jeary 2:00pm – 3:15pm
R #253: Regulatory Challenges with Next Generation Sequencing
Moderators: Kim Tyrrell-Knott S404bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Ingo Chakravarty, Laura Koontz, Kelli Tanzella 2:00pm – 3:15pm
F #254: New Considerations in Benefit-Risk Management
Moderators: Meredith Smith
S403ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Patrick Frey, Tarek Hammad, Steve Mayall 2:00pm – 3:15pm
C #255: Integrating the Patient's Voice Across the Development Program of Rare Diseases: Translation
Into Meaningful Outcomes
S505ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: David Schubert Speakers: Benoit Arnould, Lisa Dilworth, Lili Garrard 2:00pm – 3:15pm
T #256: Post-Trial Access: Ensuring Patient Access Across the Development Spectrum
Speakers: Luann Van Campen, N230b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Karla Childers, Rebecca Li, Walter Straus 2:00pm – 3:15pm
T #257: Strategic Planning Across Research Organizations
Moderators: Shurjeel Choudhri N426b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Janice Chang, Bambi Grilley 2:00pm – 3:15pm
N #258: Patient-Reported Outcomes (PROs): Hot Topics - Part 1 of 2
Speakers: Selena Daniels,
S404d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Arnold Degboe, Paul Kluetz, Ann Marie Trentacosti 2:00pm – 3:15pm
N #259: Novel Techniques for Improving Clinical Trial Subject Retention
Speakers: Karen Hauda, Jill
S405a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Platko, Valerie Powell, Francine Williams 2:00pm – 3:15pm
Q #261: Comparison of Inspection Findings and Recommendations of Registration Trials Submitted in
Support of Marketing Applications of New Drug Products to EMA and FDA
Speakers: Kassa Ayalew,
N229 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Sandra Kweder, Anabela Marcal, Ann Meeker-O\'Connell, Jenn Sellers 2:00pm – 3:15pm
Q #262: Clinical Relevant Specifications: Leveraging Principles of QbD
Speakers: Laurie Graham,
S401bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
John Joly, Sarah Pope Miksinski 2:45pm – 3:15pm
P #265: Patient Engagement in Study Endpoints: Will the Rising Tide Lift All Boats?
Speakers: Emuella
S400 Concourse (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Flood 3:00pm – 4:00pm 3:25pm – 3:55pm
Refreshment Break
TBA
V #266: BBK Worldwide Innovation Theater: Building a Patient-Centric Mindset through Theatrical
Contemplation
Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Ron Fassler, BBK Worldwide 3:25pm – 3:55pm
V #267: Veeva Systems, Inc. Innovation Theater: Unified RIM: End-to-end Submissions Development—
from Planning Through Archival Speakers: Marc Gabriel, Jim Theater #1 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Reilly, Veeva Systems, Inc. 4:00pm – 4:30pm
0 #292: How eSource Solutions are Impacting Clinical Research Sites, Patients, Regulators and Drug
and Device Companies Speakers: Jules
S400 Concourse (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Mitchel 4:00pm – 5:00pm
0 #268: FDA Session: Health IT at FDA
Speakers: Adam Asare, Mitra
N227b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Rocca 4:00pm – 5:00pm
D #272: Microbiome: Innovative Therapeutics, Challenges, and Opportunities
Moderators: Caroline Kurtz
S502ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Paul Plumb, James Weston 4:00pm – 5:00pm
N #286: Audits and Agency Inspections of Risk-Based Monitored Studies: The Results Are In...
Moderators: John Hicks
S405b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Esther Huffman, Maryrose Petrizzo 4:00pm – 5:00pm
G #291: Combination Products
Speakers: Khaudeja Bano Exhibit Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) 4:00pm – 5:15pm
0 #269: Big Data: Genomics and Personalized Medicine
Moderators: Arpit Dave
N226 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Bevan Huang, Michael Mentesana 4:00pm – 5:15pm
0 #270: Data Quality
N426a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Teresa Ancukiewicz Speakers: Scott Brand, Erik Doffagne, Kenneth Stoltzfus 4:00pm – 5:15pm
D #271: Next Generation Patient Recruitment: Part 1 of 2
Speakers: Wout Brusselaers, S501abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Bill Byrom, Gretchen Goller, Manish Khatri 4:00pm – 5:15pm
M #273: Creating Adaptive Contents for a Multichannel World
Moderators: Cecil Lee
S503ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Samuel Rosen 4:00pm – 5:15pm
M #274: Effective Collaboration Between Sponsors and Medical Writing Vendors
Moderators: Tammy Franklin
S403ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Timothy Garver, Nancy Pultorak 4:00pm – 5:15pm
P #275: Partnering with Patients: Virtual and Traditional Communities - When for What
Moderators: Kevin Campbell
S401d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: David Albert, T.J. Sharpe, Kristin Voorhees 4:00pm – 5:15pm
P #276: Defining the Science of Patient Input to Enhance Drug Development and Approval: Tools
Moderators: Roslyn Schneider S402ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Bennett Levitan, Kevin Marsh 4:00pm – 5:15pm
R #277: The Reauthorization of BsUFA and its Impact on Both the Regulator and Industry
Moderators: Juliana Reed
N228 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Leah Christl, Hillel Cohen, Kimberly Greco, John Pakulski 4:00pm – 5:15pm
R #278: PMDA Town Hall
S404a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Toshiyoshi Tominaga Speakers: Tatsuya Kondo, Kazuhiko Mori, Shinobu Uzu 4:00pm – 5:15pm
R #279: Brexit: Where Are We Now?
Speakers: Virginia Acha,
S404bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Sandra Kweder, Jonathan Mogford, Agnès Saint-Raymond 4:00pm – 5:15pm
F #280: Developing Pharmacovigilance Policy Based on Impact
Moderators: Alan Hochberg
S401bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Gerald Dal Pan, Shelley Gandhi 4:00pm – 5:15pm
C #281: Integrating the Patient's Voice Across the Development Program of Rare Diseases: At the Table -
Where to Sit?
S505ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: David Schubert Speakers: Wayne Amchin, Christine McSherry, James Valentine 4:00pm – 5:15pm
C #282: Challenges and Issues in Early-Phase Oncology Trials
Moderators: Elaine Paul
S504abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Leanne Cartee, Lindsay McNair, Sharon Murray 4:00pm – 5:15pm
T #283: The Impact of Industry Consortia on Creating Collaborative Solutions to Drug Development
Challenges: What Does the Future Hold? Moderators: Patricia Leuchten N426b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Barbara Beck, James Kremidas, Steven Whittaker 4:00pm – 5:15pm
N #284: Use of Novel Trial Designs to Accelerate Decision Making: To 'P' No More
Moderators: Jonathan Haddad S401a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Nusrat Rabbee, Kert Viele 4:00pm – 5:15pm
N #285: What Question Are You Trying to Answer? The Use of Estimands, Potential Revisions to ICH E-9
and the Impact to Trial Design and Analysis Speakers: Michael O\'Kelly,
S405a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Thomas Permutt, Fanny Ki Wong 4:00pm – 5:15pm
N #287: Patient-Reported Outcomes (PROs): Hot Topics - Part 2 of 2
Moderators: Dennis Revicki
S404d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Wen-Hung Chen, Laura Lee Johnson, Lisa Kammerman 4:00pm – 5:15pm
1 #288: Breaking Down the Wall for Global Regulators to Leverage Real World Data
Moderators: Duane Schulthess N230b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Nicola Bedlington, Alison Cave, Sebastian Schneeweiss, Radek Wasiak 4:00pm – 5:15pm
1 #289: Value and Access for Special Populations: From Access Restriction to Drug Mortgages
Moderators: Roxanne Tavakkol N426c (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: John Maddox, William Sarraille 4:00pm – 5:15pm
Q #290: Quality Metrics: The Carrot or the Stick?
Speakers: Barbara Allen, Tara
N229 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Bizjak, Michael Davidson, Steven Mendivil, Sarah Pope Miksinski, Alex Viehmann 4:45pm – 5:15pm
R #293: Conversations That Matter: How do Regulatory Affairs Professionals Wish to Engage with
Statisticians and Vice Versa? Speakers: Susan Duke S400 Concourse (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) 5:30pm – 6:30pm
N DIA Study Endpoints Community Meeting
Speakers: Emuella Flood
N139 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
DIA 2017 Annual Meeting 0 01: Data-BigData-eHealth R 05: Regulatory
D 02: DisruptiveInnov
F 06: Safety-PV
N 09: TranslSci-Preclin-Clin-ProdDev
M 03: MedAffairs-SciComm
C 07: SpecialPops 1 10: Value-Access
L 14: ProfDevelopment
G 15:Engage-Exchange
9 19: DIACommunities
S Short Course
P 04: PatientEngagement
T 08: StratPlan-Exec-Partnershps Q 11: Quality
6 16: Posters
2 12: DIAmond
H 17: ContentHub
V 13: InnovTheater
Y 18: Plenary
JUNE 21 • WEDNESDAY 7:00am – 8:00am
Coffee and Light Refreshments
TBA
7:00am – 5:15pm
Attendee, Speaker, and Exhibitor Registration
TBA
8:00am – 9:30am
2 #301: Progress in Pediatric Therapeutics
Speakers: Christoph Male,
S105 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Susan McCune, Marie-Helene Pinheiro, Ronald Portman, Mark Turner, Robert Ward 8:00am – 9:30am
2 #302: Does Diversity Matter in Clinical Trials?
Speakers: Karen Brooks, Nikos S100c (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Dedes, Regina Greer-Smith, Sam Oh, Joe Selby, John Whyte 8:00am – 9:30am
2 #303: International Regulatory Convergence
Speakers: Jarbas Barbosa,
S100a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Dara Corrigan, Ian Hudson, Tatsuya Kondo, Lorraine Nolan, Guido Rasi, Pierre Sabourin, Agnès SaintRaymond 9:30am – 10:30am 9:30am – 10:30am
Coffee Break
TBA
G #304: Mergers and Acquisitions: First, Do No Harm
Speakers: Margaret
Aisle 300/400 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Richards 9:30am – 10:30am
6 #305: Professional Poster Session 3A Exh Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
9:30am – 4:00pm 9:30am – 4:00pm
Exhibit Hall Opens
TBA
6 Professional Poster Session 2
Speakers: Kamal Poster Area Exhibit Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Abbassi, Gajanan Bhat, David Bristol, Magdalena Bujar, Jack Bush, Eunhee Chung, Kevin Craig, Meredith Culp, Qianyu Dang, Nancy Dreyer, Brittany Dustman, Matt Eberle, Jennifer Emerson, Sruthi Gaddam, Jorge Hechavarria, Khairul Faizi Khalid, Yueh Jung (Cynthia) Lee, Jenny Ly, Jia Ma, Cathy Marino, Anastasia McManus, Andrew Melli, Nozomu Miyawaki, Benjamin Moody, Saumya Nayak, Amanda Nguyen, Dawn Niccum, Dawn Niccum, Darin Oppenheimer, Shivam Patel, Krista Payne, Kiyoteru Takenouchi, Nancy Wang, Robin Whitsell, John Willmore, Robert Wittenberg, Rinah Yamamoto, Rinah Yamamoto 9:45am – 10:15am
V #306: Synchronoss Innovation Theater: Applying Telecom’s Mobility Best Practices to mHealth
Speakers: Andrew Mitchell Theater #1 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) 9:45am – 10:15am
V #307: SAS Institute Inc, JMP Division, Innovation Theater: Work with Me Here...(or There or
Anywhere!): Practical Cloud Collaboration with JMP Clinical Speakers: SAS Institute Inc. Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) JMP Division, Drew Foglia 10:30am – 11:00am
F #331: Conversations that Matter: How do Pharmacovigilance Professionals wish to Engage with
Statisticians and Vice Versa? Speakers: Joan Buenconsejo
S400 Concourse (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
10:30am – 11:30am
0 #308: Quantified Self Tracking
Moderators: Jonathan Helfgott N227b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Jennifer Goldsack, Scott Weidley, Keith Wenzel 10:30am – 11:45am
0 #309: Big Data: Combining Registries and Legacy Clinical Trial Databases
Speakers: Michael Elashoff,
S505ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Michael Elashoff, Abel Kho, Michael Pencina 10:30am – 11:45am
D #310: New Site Paradigm: Just in Time Sites
Moderators: Christine Pierre
N229 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Mary Elmer, Joseph Kim, Craig Lipset 10:30am – 11:45am
D #311: Next Generation Patient Recruitment: Part 2 of 2
Moderators: Neil Weisman
S501abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Kevin Bickford, Gwenn Oakes 10:30am – 11:45am
D #312: CRISPR: Regulatory Challenges in the Gene Editing Revolution
Moderators: Nancy Myers
N228 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Kurt von Emster, Eva Essig, Ritu Nalubola 10:30am – 11:45am
D #313: New Frontiers in Pharmaceutical Manufacturing
Speakers: Akm Khairuzzaman, S502ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Christine Moore, Peter Scholes 10:30am – 11:45am
M #314: Digital Channels and Artificial Intelligence in Medical Information and Communications
Speakers: Peter Baumeister,
S401d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Joseph Scrocco, Ron Segal 10:30am – 11:45am
M #315: How to Engage Patients Within Medical Affairs
Moderators: Iris Tam
S403ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Kevin Fowler, Valerie Powell, Suzanne Schrandt 10:30am – 11:45am
P #316: Quantitative Metrics to Capture the Value of Patient Engagement
Speakers: Marc Boutin,
N426a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Kenneth Getz, Bennett Levitan, Stella Stergiopoulos 10:30am – 11:45am
R #317: Evolution of Novel Registration Endpoints as Diseases Become Chronic
Moderators: Irene Nunes
S404bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: C. Ola Landgren, Rajeshwari Sridhara, Marc Theoret 10:30am – 11:45am
F #318: IMEDS: A Public-Private Partnership to Facilitate Real World Evidence Generation Based on the
FDA's Sentinel System
S404a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Jeffrey Brown, Kevin Haynes, David Martin, Robert Reynolds, June Wasser 10:30am – 11:45am
F #319: A New Age for Physician and Patient Labeling: Recommendations for Innovative Change in How
We Communicate
S404d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Tracy Rockney Speakers: Laurie Myers, Kellie Taylor, Michael Wolf 10:30am – 11:45am
F #320: The Brave New World: The Ongoing Globalization of Pharmacovigilance
Speakers: Glenn Carroll, Jeffrey N226 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Ho, Sandra van der Poel, Mirza Rahman 10:30am – 11:45am
C #321: Engagement, Education, Networks, Media, and Societies in Rare Diseases: The MUST Haves
Moderators: Scott Schliebner S503ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Bonnie Brescia, Kelly Franchetti, Dan Tierno 10:30am – 11:45am
C #322: Is the Future Bright for Treatment of Neurodegenerative Diseases?
Speakers: Juan Garcia-
S504abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Burgos, Laura Gault, Conrad Hawkins, Jamie Mullen, Susan Yule 10:30am – 11:45am
T #323: Effective Collaborations: Navigating the Grey Space
Moderators: Andrew
N426b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Townshend Speakers: Stephane Marzabal, Matthew Meitzner 10:30am – 11:45am
T #324: Keys to Effective Product Launch Preparation
Moderators: Stephanie Brown
N426c (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Matthew Curin, Matthew Curin 10:30am – 11:45am
T #325: Leading in the Midst of Ambiguity
Moderators: Nicky Rousseau
S401bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Jennifer Cubino 10:30am – 11:45am
N #326: Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation
Moderators: Alexander Varond S401a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Jeff Allen, Ilan Irony 10:30am – 11:45am
N #327: Multiregional Clinical Trials and the ICH E17
Moderators: William Wang
S402ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Bruce Binkowitz, Ling Su, Yoshiaki Uyama 10:30am – 11:45am
1 #328: Real-World Data to Real World Evidence for Assessing Efficacy and Effectiveness
Moderators: Lawrence Liberti
N230b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: James Harnett, Jonathan Jarow, Jean Slutsky 10:30am – 11:45am
Q #329: Measuring and Advancing the Clinical Quality Management System
Speakers: Mary Fleres, Robert S405a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Studt, Elizabeth Troll 10:30am – 11:45am
Q #330: Managing Acceleration and Quality In Product Development
Speakers: Anamitro Banerjee, S405b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Nirdosh Jagota, Diane Zezza 10:45am – 11:45am
G #332: Patient Perspective
Speakers: James Seaton Aisle 300/400 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) 11:15am – 11:45am
Q #333: Information Quality in EHR Computer Systems
Speakers: Calvin Kim, S400 Concourse (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Anu Virkar 11:30am – 2:00pm 12:00pm – 12:45pm
Luncheon
TBA
V #334B: Cognizant Technology Solutions Innovation Theater: The Shared Investor Platform - An
Innovative Open Technology Powering New possibilities for Site -Sponsor Relationship Speakers: Beenu Kapoor,
Theater #1 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Jeanette Teague 12:00pm – 12:45pm
V #334C: Accenture Innovation Theater: The Digital Clinical Trial – Placing the Right Bets
Speakers: Ian Shafer, Katie Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Strasser 12:00pm – 12:45pm
9 DIA Patient Engagement Community Round Table Discussion: Real-World Data to Real World
Evidence for Assessing Efficacy and Effectiveness Speakers: Mary
Community Corner (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Murray 12:00pm – 1:45pm
6 #334A: Professional Poster Session and Oral Presentions 3B Exh Hall (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
12:45pm – 1:45pm
G #335: Real-World Application of Risk-Based Monitoring
Speakers: Esther
Aisle 300/400 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Huffman 1:00pm – 1:45pm
V #336: QuintilesIMS Innovation Theater: Connecting People and Trials Through Innovative
Technologies
Theater #2 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Mike Montello, Josh Rose 1:00pm – 1:45pm
9 DIA Regulatory Affairs Community, Regulatory Intelligence WG Round Table Discussion: The Evolving
Role of Using Artificial Intelligence to Deliver Actionable Intelligence Speakers: Emily
Community Corner (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Huddle, Elizabeth Rosenkrands-Lange 1:30pm – 3:30pm 2:00pm – 3:00pm
Exhibit Guest Passes
TBA
1 #357: Biosimilars and Generics: Access Versus Innovation
Moderators: Kurt Karst
S405b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Richard Bankowitz, Christine Simmon 2:00pm – 3:00pm
G #359: Cultural Diversity Aisle 300/400 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Gareth Monteath 2:00pm – 3:15pm
0 #337: Big Data: Management and Analytics
Moderators: David Olaleye
N426a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Dave Handelsman, Lun Yang 2:00pm – 3:15pm
0 #338: Risk-Based Monitoring: Convergence of Technology, Processes, and People
Moderators: Mary Arnould
N226 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Keith Dorricott, Stephen Young 2:00pm – 3:15pm
M #339: Off-Label Communications to Health Care Providers and Consumers
Moderators: John Kamp
N229 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Kellie Combs, Todd Hobbs, James Spears 2:00pm – 3:15pm
M #340: Digital Innovations for Medical Information Contact Centers
Moderators: Holli Simmons-
S401a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Little Speakers: Joseph Falcone, Andrea Tenbarge 2:00pm – 3:15pm
M #341: EMA Policy 0070: A Game Changer for Industry
Moderators: Robert Paarlberg
N227b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Dairine Dempsey, Julie Holtzople, Marie-Helene Pinheiro 2:00pm – 3:15pm
P #342: Adoption and Implementation of Digital Platforms to Further Patient Interactions
Moderators: Betsy Fallen
N426c (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Jenny Lester, Vincent Miller, Keith Wenzel 2:00pm – 3:15pm
R #343: Expanded Access and Compassionate Use
Moderators: Ramana Sonty
N230b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Kevin Bugin, Elena Gerasimov, Grant Strachan 2:00pm – 3:15pm
R #344: Minding the Gaps: Using Totality of Evidence in the Clinical and CMC Contexts to Support
Regulatory Approval
S404a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Alexander Varond Speakers: Anne Morant, Charles Wu 2:00pm – 3:15pm
R #345: Global Perspective on ICH: Part 1 of 2
Speakers: Theresa Mullin, Cathy N228 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Parker, Amanda Roache, Toshiyoshi Tominaga, Gabriela Zenhausern
2:00pm – 3:15pm
R #346: Understanding the New Common Rule and Its Impact to Industry
Speakers: Laura Odwazny,
N426b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
James Riddle 2:00pm – 3:15pm
F #347: Integrated Life Cycle Approaches to Benefit -Risk Assessment, Communication, and Evaluation
Moderators: Simon Ingate
S401d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Dinah Duarte, Helen Edelberg, Simon Ingate 2:00pm – 3:15pm
F #348: Exploring the Evolution of Signal Detection
Moderators: Stephen Knowles S402ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: William Blackwell, Jeremy Jokinen 2:00pm – 3:15pm
F #349: Pharmacovigilance 2.0: Redesigning for the Future
Moderators: Annette Williams S403ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Glenn Carroll, Sundeep Sethi, Robert Taylor 2:00pm – 3:15pm
C #350: Innovative Designs and Statistical Approaches for Small Trials: Rare Disease or Pediatric
Indications
S502ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Susan Wang Speakers: Yeh-Fong Chen, Munish Mehra, MaryAnne Rizk 2:00pm – 3:15pm
C #351: Pregnancy and Lactation Labeling Rule: Unique Challenges to Meet Requirements
Moderators: Leslie Driver
S501abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Nicole Hurst, Nina Liang 2:00pm – 3:15pm
C #352: Collaborative Efforts to Accelerate Rare Disease Research and Development
Moderators: Judith Ng-Cashin S504abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Harry Alcorn, Trish Caruana 2:00pm – 3:15pm
N #353: What Do the Experts Believe? Translating Expert Knowledge and Judgment Into a Quantitative
Belief Distribution
S401bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Timothy Montague Speakers: Michael Sonksen 2:00pm – 3:15pm
N #354: Experimental Studies: New Approaches to Study Designs to Facilitate Early Phase Decision
Making
S405a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Moderators: Jonathan Haddad Speakers: Gengqian Cai, Adam Cohen 2:00pm – 3:15pm
N #355: FDA, NIH, and TransCelerate Collaborate to Accelerate Drug Development Through Protocol
Harmonization
S404bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Michelle Culp, Vaishali Popat 2:00pm – 3:15pm
1 #356: Value-Based Conversations with Payers: Issues, Opportunities, and Barriers
Moderators: Richard Gliklich
S503ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Jim Clement, Robert Duffield 2:00pm – 3:15pm
Q #358: Life Cycle Management: ICH Q12
Speakers: Andrew Chang,
S404d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Sarah Pope Miksinski, Moheb Nasr, Roger Nosal, Mahesh Ramanadham 2:45pm – 3:15pm
P #361: Online Health Communities: A New Frontier in Health Research
Speakers: Sara Hayes S400 Concourse (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) 3:00pm – 4:00pm 3:15pm – 4:00pm
Refreshment Break
TBA
G #362: Medical Affairs and KOL Management
Speakers: Rebecca Vermeulen
Aisle 300/400 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
4:00pm – 5:00pm
M DIA Medical Writing Community Round Table Discussion: EMA Policy 0070:A Game Changer for
Industry
Community Corner (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: David Clemow 4:00pm – 5:00pm
R #373: FDA–Health Canada Regulatory Cooperation Council Town Hall
Speakers: Sema Hashemi,
S401d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Isabel Romero 4:00pm – 5:15pm
0 #363: EHRs/eSource and Emerging Data Streams
Speakers: Lisa Amanti, Michael N230b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Ibara, Julian Jenkins, Michio Kimura, Mitra Rocca 4:00pm – 5:15pm
0 #364: Risk-Based Monitoring: Convergence of Technology, Processes, and People: Panel Discussion
Moderators: Francois Torche
N226 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Artem Andrianov, Jill Collins 4:00pm – 5:15pm
D #365: Next Generation Predictive Analytics
Moderators: Lucas Glass
S503ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Petra Lebeau, Aris Persidis 4:00pm – 5:15pm
D #366: Are We Ready for Telemedicine-Powered Clinical Trials?
Moderators: Karen Weiss
S504abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Wayne Amchin, Gerrit Hamre, Penny Randall 4:00pm – 5:15pm
M #367: Writing of Layperson Summaries of Clinical Trial Results According to the EU: Regulation and
Its Impact on Global Pharmaceutical Activities Speakers: Behtash Bahador,
S502ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Amber Barnes, Susannah Chang, Julie Dietrich, Tatyana Wanderer 4:00pm – 5:15pm
M #368: FDA Update on Prescription Drug Promotion
Moderators: John Kamp
N227b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Thomas Abrams, Helen Sullivan 4:00pm – 5:15pm
P #369: How Is Digital Patient Engagement Impacting Trial Participation?
Moderators: Abbe Steel
S404a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Kai Langel, Katie Mazuk 4:00pm – 5:15pm
R #370: Lessons Learned from the Sarepta Exondys 51 Approval
Moderators: Shamim Ruff
S404bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Christine McSherry, Alexander Varond 4:00pm – 5:15pm
R #371: Global and Regional Collaboration Initiatives: Challenges, Opportunities, and Case Studies
Moderators: Joseph Scheeren S403ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Petra Doerr, Mercè Caturla Goñi, Rajneesh Taneja 4:00pm – 5:15pm
R #372: The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator
Moderators: Linda Bowen
N229 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Robert Lionberger, Scott Tomsky, Keith Webber 4:00pm – 5:15pm
R #374: Global Perspective on ICH: Part 2 of 2
Moderators: Patrick Brady
N228 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Camille Jackson, Lawrence Liberti, Jerry Stewart 4:00pm – 5:15pm
F #375: Automation and Innovation in Clinical Trial Safety Assessment
Moderators: Susan Duke
S402ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Vasudeo Ginde, Wei Wang, Richard Zink 4:00pm – 5:15pm
F #376: Changing Environments Within Pharmacovigilance
Moderators: Stella Blackburn
S404d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Khaudeja Bano, LaShanda Long, Toshiyoshi Tominaga 4:00pm – 5:15pm
C #377: Increasing Participation in Clinical Trials Among Under-Represented Populations
Moderators: Mary Murray
S505ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Emily Cortez, Kelly Franchetti, Kim Ribeiro 4:00pm – 5:15pm
C #378: Looking to the Future for EU Pediatric Investigation Plans
Moderators: Maria Manley
S501abc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Melodi McNeil, Klaus Rose, Grant Strachan 4:00pm – 5:15pm
T #379: The Art of Negotiation: Preparing Yourself and Your Team for Their Seat at the Table
Moderators: Jennifer Emerson S401bc (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Speakers: Nathan Kreischer 4:00pm – 5:15pm
T #380: Effective Portfolio Management and How to Ensure You Get the Value Out of the Decisions Made
Moderators: Kemi Yusuf
N426a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Dan Tierno, Larissa Wilsie 4:00pm – 5:15pm
T #381: Maximizing Success in Partner Collaborations
Moderators: Shann Williams
N426b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Charles Raymond, Len Rosenberg 4:00pm – 5:15pm
N #382: Patient-Relevant, Fit-For-Purpose Endpoints: If You Can Believe It, You Can Achieve It
Speakers: Ebony Dashiell-Aje, S405a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Chad Gwaltney, Lisa Kammerman, Elektra Papadopoulos 4:00pm – 5:15pm
N #383: Safety Issues in First-in-Human Studies
Moderators: David Jones
S405b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Paul Baldrick, Charu Gautam 4:00pm – 5:15pm
1 #384: The Increasing Role for Big Data for Late Phase Drug and Postapproval Purposes
Moderators: Gregory Daniel
S401a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Gracie Lieberman, David Martin, Joe Selby 4:00pm – 5:15pm
Q #385: Patient-Centric Development Assessment
Speakers: Michael De Felippis, N426c (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616) Mahesh Ramanadham, Diane Zezza 5:30pm – 6:30pm
9 DIA Clinical Safety and Pharmacovigilance Community Meeting
Speakers: Catherine Baldridge
N139 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
JUNE 22 • THURSDAY 8:00am – 9:00am
Coffee and Light Refreshments
TBA
8:00am – 11:00am
Attendee and Speaker Registration
TBA
9:00am – 10:30am
2 #401: FDA Forum
S105 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Tamy Kim, Paul Kluetz, Angela Krueger, Peter Marks, Douglas Throckmorton, John Weiner 10:30am – 10:45am 10:45am – 11:45am
Coffee Break
TBA
M #403: Driving International Awareness and Use of Regulatory Writing Guidelines: Case Studies of the
Clarity and Openness in Reporting (CORE) Reference Guidelines Moderators: Art Gertel
S403ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Hiroko Ebina, Vivien Fagan 10:45am – 11:45am
N #411: Evolving Clinical Trial Guidance and Regulations: Am I Ready?
Moderators: Liz Wool
S405b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Mary Mills 10:45am – 12:00pm
D #402: Online Patient Networking
Moderators: Lindsay McNair
S404a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Andrew Cox, Eric Peacock 10:45am – 12:00pm
P #404: How Do You Build a Collaborative Community? What Advice Would You Give?
Speakers: Kathryn Burn,
N426b (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Christina Fawcett, Joseph Kim, Sara Loud, Kristin Voorhees 10:45am – 12:00pm
P #405: How Do We Retain Patients in Studies? Using the Patients’ Words to Explore Treatment
Acceptance and Patient Engagement Moderators: Benoit Arnould
N426c (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Brian Burns, Helen Kitchen, James Seaton 10:45am – 12:00pm
C #406: Recruiting Rare Disease Patients: A Unique Set of Challenges
Moderators: William Smith
S401a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Adina Knight 10:45am – 12:00pm
C #407: Exploration of Metabolic Diseases: Is the Liver the New Heart?
Moderators: Nita Ichhpurani
S401d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Naim Alkhouri, Clayton Dehn, Claudia Filozof, Melissa Palmer 10:45am – 12:00pm
T #408: Flexing Your Project Management Muscles Outside of Traditional Roles
Moderators: Gina Johns
S404d (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Juan Castano, Carrie Furin 10:45am – 12:00pm
N #409: Trial Master File: MHRA/EMA Inspections and Sponsor Audit Learnings
Speakers: Renee Heuser,
S402ab (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Tipsuda Kongtong, Bryan Souder 10:45am – 12:00pm
N #410: Of Course My Data Has Integrity … And I Can Prove It
Moderators: David Fryrear
S405a (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Speakers: Adam Donat, Sherri Hubby, Cinzia Piccini 10:45am – 12:00pm
2 #412: EMA/ FDA Question Time
Speakers: Alison Cave, Dara
S105 (McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616)
Corrigan, Jarilyn Dupont, Juan Garcia-Burgos, Sabine Haubenreisser, Sandra Kweder, Anabela Marcal, Peter Marks, Sarah Pope Miksinski, Agnès Saint-Raymond