2017 DIA Annual Meeting

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

Click to Listen Full Click to Listen to the to Fullthe Session

Session

Click to Read the Full Synopsis

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

Click to Listen to the Full Session Click to Read the Full Synopsis

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

Click to Listen to the Full Session Click to Read the Full Synopsis

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