DIA 2019 Annual Meeting (Schedule) by medical writing

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

DIA 2019 Global Annual Meeting 0 01: ClinSafety-PV

C 02: ClinTrials -ClinOps

P 05: Patient Engagement

R 06: PreClin Dev-EarlyPhaseCR

Q 08: R-D Quality-Compliance V 12: Value-Access

D 03: Data-Data Standards

G 09: Regulatory

F 13: ProfDevelopment

M 04: MedAffairs-SciComm

J 07: ProjMgt-StrategicPlanning

1 10: RegCMC-Product Quality N 14: DIAmond

T 11: Statistics

S Short Course

JUNE 23 • SUNDAY 9:00am – 12:30pm

S #20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know? Speakers: Brian Bradbury, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Nancy Dreyer

9:00am – 12:30pm

S #21: Basics of European Medical Device Regulation Speakers: Neil Armstrong, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Angela Stokes

9:00am – 12:30pm

S #22: Protocol Co-Design with Patients and Advocates Speakers: Kelly Franchetti TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

9:00am – 12:30pm

S #23: Preparing for a US FDA Advisory Committee Meeting Speakers: Kaia Agarwal, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Lisa Peluso

9:00am – 12:30pm

S #24: Data Visualization in the Life Sciences Speakers: Kelci Miclaus, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Richard C. Zink

9:00am – 12:30pm

S #25: Assessment of Analytical Similarity TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

9:00am – 12:30pm

S #26: Leadership: How to Organize and Lead People in a Work Group Speakers: Michael Laddin TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

9:00am – 12:30pm

S #27: eCOA 101: The What, Why, and How of eCOA to Reduce Barriers to Adoption in Clinical Studies TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Paul O\'Donohoe, Susan Vallow

9:00am – 12:30pm

S #28: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle Speakers: Victoria Burk, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Kevin Grebner, Tim Grey

9:00am – 5:00pm

S #40: Interdisciplinary Safety Evaluation During Product Development Speakers: Greg Ball, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Jeremy Jokinen

9:00am – 5:00pm

S #41: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Christy Mazzarisi, Danielle Metzger

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1/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

9:00am – 5:00pm

S #42: Patient Preferences: Using Conjoint Analysis and Stated Preferences in Drug Development and Regulatory Decision Making Speakers: Rachael TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) DiSantostefano, Brett Hauber, Carol Mansfield, Rebecca Noel, Christine Poulos

9:00am – 5:00pm

S #43: Back to the Future: Combination Products in the 21st Century Speakers: Caitlin Bancroft, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Lynn Hansen

11:00am – 12:30pm

F Forum for Students and Emerging Professionals Speakers: Nancy TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Smerkanich

1:30pm – 5:00pm

S #30: Machine Learning in Pharmacovigilance Speakers: Shaun Comfort, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Bruce Donzanti, Mick Foy

1:30pm – 5:00pm

S #31: Value Pricing Bootcamp: A Crash Course in How to Use Real World Evidence to Better Measure Outcomes and Evaluate New Innovative Therapies Speakers: Amr Makady, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Duane Schulthess

1:30pm – 5:00pm

S #32: CDER Direct: FDA's User Friendly Tool to Submit Registration and Listing Data TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

1:30pm – 5:00pm

S #33: European Regulatory Meetings: How Best to Prepare and Perform Speakers: Steffen Thirstrup TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

1:30pm – 5:00pm

S #34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Barbara Suarez

1:30pm – 5:00pm

S #35: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development Speakers: Alberto Grignolo TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

1:30pm – 5:00pm

S #36: A Novel Interactive Safety Graphic to Evaluate Potential Drug-Induced Hepatotoxicity Speakers: James Buchanan TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

1:30pm – 5:00pm

S #37: Patient Literacy 101: Practical Strategies for Improving Your Patient Materials Speakers: Kelly Franchetti TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

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2/17

2/8/2019

0 01: ClinSafety-PV

DIA 2019 Global Annual Meeting: Print Schedule

C 02: ClinTrials -ClinOps

P 05: Patient Engagement

R 06: PreClin Dev-EarlyPhaseCR

Q 08: R-D Quality-Compliance V 12: Value-Access

D 03: Data-Data Standards

G 09: Regulatory

F 13: ProfDevelopment

M 04: MedAffairs-SciComm

J 07: ProjMgt-StrategicPlanning

1 10: RegCMC-Product Quality N 14: DIAmond

T 11: Statistics

S Short Course

JUNE 24 • MONDAY 11:00am – 12:00pm

Addressing Heterogeneity of Real World Evidence in Drug Safety TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

11:00am – 12:00pm

Moving Forward in EU Pharmacovigilance Speakers: Robert Massouh TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

11:00am – 12:00pm

C Emerging Technologies in Clinical Research Speakers: Bill Byrom, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Sonya Eremenco, Dina Katabi, Chris Watson

11:00am – 12:00pm

C Innovation in Enrollment, Recruitment, and Retention Speakers: Aaron TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Fleishman, Paul Ivsin, Debora Moritz, Neil Weisman

11:00am – 12:00pm

C When Disaster Strikes: Developing a Proactive Plan to Address Challenges Brought on by Large Scale Natural Disasters Speakers: Mark Summers TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

11:00am – 12:00pm

D Automation with Intelligence: Transformation From Human Resource to Artificial Intelligence in Risk Management TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Edward Ikeguchi, Hanming Tu

11:00am – 12:00pm

M PhactMI Benchmarking Survey Highlights: How are the Twenty Seven Member Companies Executing on Medical Information Initiatives Speakers: Teresa Flowers, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Rania Gaspo, Andrew Gazo, Kirstie Marasigan, Meera Patel

11:00am – 12:00pm

P Collecting Better Patient Experience Data: Lessons Learned from Patient Organizations Speakers: Laura Trutoiu TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

11:00am – 12:00pm

R Applications of ArtificiaI Intelligence in Drug Discovery Speakers: Cartic TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Ramakrishnan

11:00am – 12:00pm

Q Quality Management Post-Quality Management System Implementation In The Wake of ICH E6 (R2) TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Michael Husovich, Cristin MacDonald

11:00am – 12:00pm

G Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Susant Mallick

11:00am – 12:00pm

G International Regulatory Convergence

Patient Perspective Diversity: Taking Cultural Differences in Patient Views Into Drug Development in West and East Speakers: Noriko Fujiwara, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Atsushi Tsukamoto

TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

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3/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

11:00am – 12:00pm

Statistical Considerations for Trials Using Surrogate Endpoints for Accelerated Approval Speakers: Yeh-Fong Chen TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

11:00am – 12:00pm

V FDA Payer Communication Guidance, Twenty Years in the Making: Now What? Speakers: Mitchell Higashi, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Chris Pashos, Sissi Pham

11:00am – 12:00pm

V Making Value-Based Contracting Stick Speakers: Richard Gliklich, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Denise Meade, Thomas Renshaw

11:00am – 12:00pm

Junior DIA Attendees: Making the Most of the DIA Experience Speakers: Jateh Major TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:15pm – 3:15pm

Interpretation of New Pharmacovigilance Regulations: Key Insights Speakers: David Lewis TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:15pm – 3:15pm

Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and PostMarket Continuity TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Jeremy Rassen, Sebastian Schneeweiss, Darren Toh

2:15pm – 3:15pm

C Blockchain in Clinical Trials Demo: Truth or Dare Speakers: Adama Ibrahim TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:15pm – 3:15pm

C Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:15pm – 3:15pm

C Emerging Technology to Improve Sponsor-Site Interactions Speakers: Johan Chaparro, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Lisa Moneymaker

2:15pm – 3:15pm

D Use of Real World Data in Clinical Trials: Abstracting Endpoints from Encounters Speakers: Richard Gliklich, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Debra Harris

2:15pm – 3:15pm

M Knowledge Management and Information Sharing to Support Business Continuity Speakers: Divya Raman TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:15pm – 3:15pm

P Show me the Money! Patient and Caregiver Roles and Compensation in Research, Development, and Innovation Speakers: Sarah Krug, BrayTBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Patrick-Lake, Jaye Bea Smalley

2:15pm – 3:15pm

R Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Sherry Leonard, Lindsay McNair

2:15pm – 3:15pm

Q Getting More Value and Accountability from Vendors Through Governance and Data Transparency TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Leo Dodds

2:15pm – 3:15pm

G Communications with Regulators Beyond Formal Meetings Speakers: Christopher TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Joneckis, Sandra Kweder, Nicole Mahoney, Khyati Roberts

2:15pm – 3:15pm

G Hot Topics in Digital Health: How is FDA’s Approach Evolving, and What Do Industry and Patients Need to Know? TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Nancy Myers

Ready or Not: Business Continuity Planning Speakers: Colleen Severyn, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Leigh Shultz

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4/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

2:15pm – 3:15pm

G Update from Health Canada: The Health Protection Branch Speakers: Agnes Klein TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:15pm – 3:15pm

Update on ICH Quality Topics Speakers: Camille Jackson TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:15pm – 3:15pm

Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis Speakers: Demi Niforos TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

3:30pm – 4:30pm

Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI Speakers: Theresa Mullin, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Judith Zander

3:30pm – 4:30pm

Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

3:30pm – 4:30pm

C Clinical Research in Emerging Regions Speakers: Nadina Jose, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Eunyoung Kim, Avik Pal, Asita De Silva

3:30pm – 4:30pm

C Enhancing Patient-Focused Outcome Assessment in Medical Product Development TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

3:30pm – 4:30pm

C Wonder at Scale: Microsoft and Johns Hopkins Changing the Face of Disease Speakers: Dwight Raum TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

3:30pm – 4:30pm

D Understanding the Data Journey In Virtual Trials Speakers: Jon Roth TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

3:30pm – 4:30pm

M New Communication Channels for Medical Information Speakers: David Bowers, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Dinah Duarte, Walter Frank Eng

3:30pm – 4:30pm

P Making Trials Work for Special Populations Speakers: Deborah Collyar, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Caroline Donovan, Dinah Duarte, Diana Foster

3:30pm – 4:30pm

R Precision Medicines in Clinical Trials: Understanding and Overcoming Barriers to Adoption Speakers: Anita Nelsen TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

3:30pm – 4:30pm

Q Compliance: The Importance of Periodic Screenings to Ensure Good Inspection Health Speakers: Grace Crawford, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Barbara Maley

3:30pm – 4:30pm

G Drug Development Tools (DDTs) in a Digital Era Speakers: Lauren Oliva TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

3:30pm – 4:30pm

G ICMRA Update

3:30pm – 4:30pm

G National Medical Products Administration (NMPA) Town Hall Speakers: Ling Su TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

3:30pm – 4:30pm

Regulating Innovation in Chemistry, Manufacturing, and Controls: Challenges and Opportunities TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Nina Cauchon, J.Christopher Love

3:30pm – 4:30pm

How Statistics Can Help Improve Data Quality: ICH E6 R2 Speakers: Taras Carpris, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Aaron Mackey, Cheng Su, Stephen Young

Strategic Integration: Is Anyone Getting it Right? Speakers: Viju Agnani, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Sarah Capuano, Erin Mulrooney

TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

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5/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

3:30pm â&#x20AC;&#x201C; 4:30pm

V Making Early Access for Patients Happen Speakers: Stella Blackburn, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Monika Schneider, Dan Tierno

3:30pm â&#x20AC;&#x201C; 4:30pm

The Courage of Career Transitions: Just Do It! Speakers: Dan Fredeman, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Jasminder Kumar, Matthew Wong

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6/17

2/8/2019

0 01: ClinSafety-PV

DIA 2019 Global Annual Meeting: Print Schedule

C 02: ClinTrials -ClinOps

P 05: Patient Engagement

R 06: PreClin Dev-EarlyPhaseCR

Q 08: R-D Quality-Compliance V 12: Value-Access

D 03: Data-Data Standards

G 09: Regulatory

F 13: ProfDevelopment

M 04: MedAffairs-SciComm

J 07: ProjMgt-StrategicPlanning

1 10: RegCMC-Product Quality N 14: DIAmond

T 11: Statistics

S Short Course

JUNE 25 • TUESDAY 8:00am – 9:15am

To Err is Human: Progress and Challenges in the Prevention of Medication Errors Speakers: Tony Catka, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Michael Cohen, Raffaella Balocco Mattavelli

8:00am – 9:15am

Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration Speakers: Michael Forstner,TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Jose Vega

8:00am – 9:15am

C Driving Enrollment with a Patient-Centric Focus to Artificial Intelligence Speakers: Craig Morgan TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

8:00am – 9:15am

C eConsent Done Right TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Bill Byrom, Lauren McCormack, Robyn Shapiro, Cassandra Smith

8:00am – 9:15am

C Protocol Developments of the Future Speakers: Bob Brindle, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Robert DiCicco, Nathaniel Root, Rachael Song

8:00am – 9:15am

D Single Source of Truth, Integrations, or IoT (Internet of Things): Exploring Ways to Improve Connectedness of Clinical Data Speakers: Mayank Anand, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Joby John, Nick Neri, Jennifer Price, Kelly Ritch

8:00am – 9:15am

M Leveraging Artificial Intelligence and Natural Language Processing in Medical Writing Speakers: Anand Kiran, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Robin Whitsell

8:00am – 9:15am

P Patient Focus as Part of the Regulatory Affairs DNA: Opportunities and Challenges Speakers: Theresa Mullin, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Max Wegner

8:00am – 9:15am

R CRISPR and Gene Editing Symposium Speakers: Philip (P.J.) TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Brooks

8:00am – 9:15am

Q Pharmacovigilance Reporting and Quality Speakers: Steven Beales, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Andrea Best, David Fryrear, Kelly Traverso

8:00am – 9:15am

Q Translating Academic Research into Product Development: Integrating GXPs into the Process (Part 1 of 4) TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Nancy Smerkanich

Increasing Personal Resilience To Manage Change Speakers: Ryan Bailey, Kim TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Przenioslo

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7/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

8:00am – 9:15am

G Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges Speakers: Peter Robinson TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

8:00am – 9:15am

G Facilitating Access: Patient Perspectives on a Streamlined Development Approach for Treatments for Severely-Debilitating or Life-Threatening Diseases Speakers: Cynthia TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Grossman, Catherine Kopil, Judith Prescott

8:00am – 9:15am

G Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504? Speakers: Stacey Adam, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Melodi McNeil, Karen Weiss

8:00am – 9:15am

Quality Considerations for Complex Generics Speakers: Scott Tomsky TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

8:00am – 9:15am

Real World Data to Real World Evidence Speakers: Sarah Short, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Andrew Wilson, Richard C. Zink

8:00am – 9:15am

V Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine? Speakers: Michelle Hoiseth, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Denise Meade, Natalia Sadetsky

8:00am – 9:15am

DISC and RISK: How DISC Profile in Clinical Trial Teams Impact Implementation of RiskBased Approaches TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Dawn Auerbach

10:30am – 11:30am

An Industry Collaboration on Pharmacovigilance Analytics Speakers: Andres Gomez TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

10:30am – 11:30am

Emerging Safety Challenges in New Oncology Treatments Speakers: William Gregory TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

10:30am – 11:30am

C Assessing Outsourcing Model Usage, Oversight Practices, and Their Impact Speakers: Kenneth Getz, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Liz Wool

10:30am – 11:30am

C Innovations in Generating Therapeutic Outcomes Speakers: Imad Al-Dakkak, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Christopher Randolph, Brad Sanderson

10:30am – 11:30am

C Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring Speakers: Linda Sullivan TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

10:30am – 11:30am

D Creating Clarity: Changes at CDISC to Make Standards Implementation Easier for all Stakeholders TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Kit Howard

10:30am – 11:30am

M Quality and Compliance Management in Medical Information/Medical Affairs Speakers: Philippe Sorel TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Takam

10:30am – 11:30am

P Our Doors are Open! Pathways and Programs for Patient Stakeholders to Engage with FDA TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

10:30am – 11:30am

P Walking the Talk: Using Home Nursing as a Patient-Centric Service in Clinical Trials - From Multiple Perspectives TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Cory Gutterman

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8/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

10:30am – 11:30am

R The Rare Disease Experience in Clinical Trials Speakers: Marieke Cajal, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Steven Roberds

10:30am – 11:30am

Q Improving Clinical Trial Risk Management: How To Leverage the IRB's Designed Purpose Speakers: Mitchell Parrish TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

10:30am – 11:30am

G Harmonizing Regulatory Science Through the International Council for Harmonization (ICH) Speakers: Camille Jackson TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

10:30am – 11:30am

G PMDA Town Hall TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Nobumasa Nakashima

10:30am – 11:30am

G Use of Real World Evidence to Support Regulatory Decision-Making: First-Year Findings From the RCT-DUPLICATE Project Speakers: Jessica Franklin, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Sebastian Schneeweiss

10:30am – 11:30am

Patient-Focused Specifications: Where Quality Meets Safety and Efficacy Speakers: Bowman Cox TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

10:30am – 11:30am

Artificial Intelligence Enhanced Data Analytics for Clinical Trials Speakers: Felix Frueh TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

10:30am – 11:30am

V How Employers are Reinventing Healthcare and What it Means for Research Participation and Evidence TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Mary Murray, Michelle Rice

10:30am – 11:30am

Pregnancy, Breastfeeding, Childcare, Oh My! Finding a Balance for Working Moms Speakers: Rachel Turow TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:00pm – 3:15pm

Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Shaun Comfort, Bruce Donzanti, Mick Foy, Lisa George

2:00pm – 3:15pm

C Build-a-Bot Workshop: Design and Build a Conversational Agent that Speaks for You Speakers: Bryan Hill TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:00pm – 3:15pm

C Clinical Trial Diversity: Moving from Admiring the Problem to Solving it Speakers: Jane Myles, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Jayne Ware

2:00pm – 3:15pm

C Wearables and Patient Technologies Utilized in Clinical Trials Speakers: Gina Calarco, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Mickael Montembault, Isabelle de Zegher

2:00pm – 3:15pm

D FDA Data Standards Update Speakers: Ron Fitzmartin TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:00pm – 3:15pm

M Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients Speakers: Deborah Collyar, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Andre Molgat, Robert Paarlberg, Liz Roberts

2:00pm – 3:15pm

P Patient Experience Data: How Could this Data Enhance Decision-Making at Different Stages of Medical Product Development?

Build and Leverage Your Networks to Influence Stakeholders Speakers: Gi Gi Galiano, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Maureen McNamara, Jayanthi Reddy

TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

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9/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

2:00pm – 3:15pm

R Drug Development for Ocular Disease, New Therapies, Regulations, and Patient Perspectives TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Nita Ichhpurani

2:00pm – 3:15pm

R Immuno-Oncology Product Development: Overcoming Scientific and Regulatory Challenges Speakers: Rakesh Dixit, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Analeah Heidt, Laurie Iciek, Karin Staflin, Theresa Sweeney

2:00pm – 3:15pm

Q Electronic Systems: Are Yours Fit for Purpose? Speakers: Gail Francis, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Jean Mulinde

2:00pm – 3:15pm

Q Translating Academic Research Into Product Development: The What and Why of cGMP in Translational Science (Part 2 of 4) Speakers: Paul Price, Olive TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Sturtevant

2:00pm – 3:15pm

G Current Status of FDA Framework for the Evaluation of Real World Evidence

Decision Leadership: How Using a Structured Approach to Decision Making Can Help You Lead Teams Better TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Tyler Ludlow

TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:00pm – 3:15pm

G Driving Complex Generics to Approval: What are the Keys to Success TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:00pm – 3:15pm

Patient-Focused Quality Standards: An Interactive Experience Speakers: Christine Moore TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:00pm – 3:15pm

Master Protocols: Applications in Oncology Speakers: Amy Xia TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:00pm – 3:15pm

V Aligning Facilitated Regulatory and Access Pathways: Observations from the North American Experience TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Lawrence Liberti, Maria Manley

2:00pm – 3:15pm

4:15pm – 5:15pm

R The Responsibility Industry, Agencies, and Early Education own in Cure-Model Based Therapeutics TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Dan Tierno

4:15pm – 5:30pm

Structured Evidence Planning, Production, and Evaluation (SEPPE): A “Quality-Based” Framework for Drug Development Speakers: Naomi Aronson, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Marc Boutin, Robyn Lim, Meredith Smith

4:15pm – 5:30pm

Why is International Product Labeling the Elephant in the Room? Speakers: William Gregory, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Judith Jones, Rie Matsui

4:15pm – 5:30pm

C Let's Talk Risk-Based Monitoring Speakers: Susan Callery- TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) D\'Amico, Penelope Manasco

4:15pm – 5:30pm

C Using Mobile Sensors in Clinical Trials and Evidentiary Considerations for Electronic Submissions TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Bill Byrom

Presentations as Listeners Like Them: How to Tailor Messaging Speakers: Frank Carillo TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

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10/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

4:15pm – 5:30pm

C Virtual Clinical Trials TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Aarthi Iyer, Matthew McCarty, Juliana Nino

4:15pm – 5:30pm

D Artificial Intelligence in Pharma: Real or Hype? Speakers: Malin TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Jakobsson, Cartic Ramakrishnan, Stacey Yount

4:15pm – 5:30pm

M A Case Study in Structuring Clinical Content and Structured Content Management (SCM) Speakers: TK Booker TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Porter

4:15pm – 5:30pm

M The Changing Landscape of Medical Affairs: Are We Prepared For 2020? Speakers: J. Lynn Bass TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

4:15pm – 5:30pm

P Impact of Patient Engagement on the Biopharmaceutical Industry's Business and Organization TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: K. Kimberly McCleary

4:15pm – 5:30pm

R Transgenic Products: A DNA Construct Goes Regulatory-A Coming of Age Story Speakers: Charlene TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Sanders

4:15pm – 5:30pm

Q Real World Evidence: How Does its Use Challenge Quality and Compliance Programs? Speakers: Jonathan TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Andrus, Susan Beatty

4:15pm – 5:30pm

G Biosimilars Update Speakers: Leah Christl

4:15pm – 5:30pm

G Prescription Drug Labeling: New Guidances and Updates from the US FDA

Conversations with the Participant: Layperson Summaries and Return of Results Speakers: Barbara Bierer, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Deborah Collyar, James Riddle

TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

4:15pm – 5:30pm

Integration of Manufacturing Quality Assessment and Pre-Approval Inspections Speakers: Nikolas Burlew, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Roger Nosal

4:15pm – 5:30pm

Clinical Safety Assessment: What’s a Statistician Got to Do with It? Speakers: Mary Nilsson TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

4:15pm – 5:30pm

V Public and Regulatory Response To Drug Pricing Concerns Speakers: Nielsen Hobbs, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Kiran Krishnan

4:15pm – 5:30pm

How Storytelling, Images, and Engagement Can Wow Your Audience: Presentations with Punch! TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Robin Whitsell

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11/17

2/8/2019

0 01: ClinSafety-PV

DIA 2019 Global Annual Meeting: Print Schedule

C 02: ClinTrials -ClinOps

P 05: Patient Engagement

R 06: PreClin Dev-EarlyPhaseCR

Q 08: R-D Quality-Compliance V 12: Value-Access

D 03: Data-Data Standards

G 09: Regulatory

F 13: ProfDevelopment

M 04: MedAffairs-SciComm

J 07: ProjMgt-StrategicPlanning

1 10: RegCMC-Product Quality N 14: DIAmond

T 11: Statistics

S Short Course

JUNE 26 • WEDNESDAY 8:00am – 9:15am

So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment Speakers: Tarek Hammad, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Douwe Postmus, Meredith Smith

8:00am – 9:15am

C Demystifying Technology Selection and Using Feasibility Studies to De-Risk Your Mobile Clinical Trials TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Aaron Coleman, Barry Peterson, Thomas Switzer

8:00am – 9:15am

C Disruptive Technology Transforming Clinical Trials: The Case for Artificial Intelligence, Blockchain, and Mobile Tech/Wearables Speakers: Karin Beckstrom, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Sheila Rocchio

8:00am – 9:15am

C Operationalizing Master Protocols Speakers: Mitzi Allred, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) MaryAnn Morgan-Cox, Karen Price

8:00am – 9:15am

D Methods for Integrating EHR Data into EDC and eSource Databases Speakers: Gene Vinson TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

8:00am – 9:15am

M Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines? Speakers: Frank Hubbard TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

8:00am – 9:15am

P Identifying High-Value Patient Engagement Opportunities: A Collaborative Three-Step Process for Sponsors and Patient Groups Speakers: Linda Brennan, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Bennett Levitan, Jaye Bea Smalley

8:00am – 9:15am

R Neoantigen-Based Cancer Therapies: Regulatory Challenges and Opportunities Speakers: Ke Liu, Alyssa TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Galaro, PhD

8:00am – 9:15am

Q Improving Trial Quality by Better Preparing Site Teams Speakers: Jimmy Bechtel, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Christine Hildebrand, Janette Panhuis

8:00am – 9:15am

Q Translating Academic Research into Product Development: The Importance of Understanding GLPs at an Early Stage (Part 3 of 4) Speakers: Isabel Jackson TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

8:00am – 9:15am

G Medical Devices: EU Medical Device Regulation, PMDA Updates, and US MDUFA IV – Where Are We Now? TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: LeeAnn Chambers, Nobuhiro Handa, Angela Stokes

Project Planning 101: Turning Strategy into Execution Speakers: Matthew Curin, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Ken Hays

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12/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

8:00am – 9:15am

G Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision Making: When, Where, and Why TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

8:00am – 9:15am

Measuring and Assessing Product Manufacturing Quality Speakers: Giuseppe TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Randazzo

8:00am – 9:15am

Designing Clinical Trials with the Right Endpoints: Getting the Questions Right (GTQR) and Handling Missing Data - ICH-E9(R1) Applying the Principles Speakers: Martin Clancy, Yi TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Liu, Munish Mehra

8:00am – 9:15am

Implementation of Innovative and Adaptive Designs in Clinical Trials Speakers: John Constant TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

8:00am – 9:15am

V Opportunities and Challenges of Collecting Data in a Pre-Approval Access Setting: A MultiStakeholder Perspective TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Beverly Harrison, Sasha Richardson

8:00am – 9:15pm

V How to Solve the Problem of Access for Rare Diseases Speakers: Nicole Boice, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Sissi Pham, Kari Rosbeck

10:30am – 11:30am

C A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Trials from eICF to Database Lock TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Jules Mitchel

10:30am – 11:30am

C Global Clinical Trials: Make Them Really Global and Involve Africa Speakers: Adama Ibrahim TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

10:30am – 11:30am

C Risk-Based Monitoring: Best Practice Today and Technology for Tomorrow Speakers: Virupaxkumar TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Bonageri, Suzanne Lukac, Hadley Stinson

10:30am – 11:30am

C The Analytics Revolution: Opportunities and Threats for Disrupting Clinical Development Operations TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Jacqueline Gough, Gary Thompson

10:30am – 11:30am

D eSource Adoption: Where We Are - TransCelerate Member Experiences from eSource Implementation TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Rakesh Maniar, Jennifer Price

10:30am – 11:30am

M Key Documents in Pediatric Drug Development Speakers: Judith TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Blacklidge, Nancy Katz, Mark Kieran

10:30am – 11:30am

P Understanding and Exploring Elements of a Patient-Focused Product Launch Speakers: Jennifer Helfer TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

10:30am – 11:30am

Q Expanding Use of Interactive Response Technologies in Clinical Trials: Maintaining Data Quality and Reliability TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Jean Mulinde, Stephen Vinter

Digital Risk Minimization: The “Next Generation” Risk Management Tools Speakers: Simon Ingate, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Meredith Smith, Carmit Strauss

Application of Project Management Methodologies and Tools in NonProfit Institutions Speakers: Neha Pannuri, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Rami Scharf, Elizabeth Somers

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13/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

10:30am – 11:30am

Q Global Regulatory Perspective on ICH E8(R1): General Considerations for Clinical Trials Speakers: Kerstin Koenig, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Joanne Palmisano

10:30am – 11:30am

G Hot Topics in Quality and Regulatory Affairs for Combination Products Speakers: Jim Kershner, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Rachel Turow, James Wabby

10:30am – 11:30am

G The Evolving Gene Therapy Regulatory Framework: A Brave New World Speakers: Anne-Virginie TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Eggimann, Sandy Macrae, Robert Pietrusko

10:30am – 11:30am

G Trends and Advances in Prescription Drug Labeling Speakers: Vicky (Fengyun) TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Han, Shimon Yoshida

10:30am – 11:30am

G When is Real World Evidence Ready for Prime Time? Speakers: Nancy Dreyer TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

10:30am – 11:30am

Efficient Preparation of Global CMC Dossiers Speakers: Monika Jain, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Angela McGillivary, Christine Moore

10:30am – 11:30am

Meaningful Patient-Focused Drug Development for Rare Disease and Personalized Medicine Speakers: Marc Buyse TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

10:30am – 11:30am

Achieving High Performance Through Emotional Intelligence: Self-Management Speakers: Jennifer Cubino, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Nicky Rousseau

10:30am – 11:30pm

R Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:00pm – 3:15pm

History of Risk Evaluation and Mitigation Strategies (REMS): What Have We Learned? Speakers: Hilda Chan, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Elaine Morrato

2:00pm – 3:15pm

C Accelerating Drug Development via Structured Content Reuse: Introducing the TransCelerate Clinical Template eSuite Speakers: Vivian Combs, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) TK Booker Porter, Stacy Tegan

2:00pm – 3:15pm

C Improving the Trial Experience for Rare Disease Patients: Identifying and Overcoming Obstacles TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Kelly Franchetti

2:00pm – 3:15pm

C Training for the Electronic Capture of PRO Data in Clinical Trials: Views from ePRO Vendors, Sponsors, Sites, and Patients Speakers: Serge Bodart, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Patricia DeLong, Jenny Ly, T.J. Sharpe, Sean Stanton

2:00pm – 3:15pm

D Identification of Medicinal Products: FDA's Perspective and Approach Speakers: Ron Fitzmartin TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:00pm – 3:15pm

M Returning Plain Language Summaries to Research Participants: Best Practices and the Role of the IRB TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Kenneth Getz, Jill McNair, Lindsay McNair

2:00pm – 3:15pm

P Patient Engagement Quality Guidance: Results and Learnings from Global Multistakeholder Pilots TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Nicholas Brooke

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14/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

2:00pm – 3:15pm

R Neurogenerative Diseases: Early-Stage Challenges and Optimal Models in Drug Development TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Dinah Duarte, Richard Scheyer

2:00pm – 3:15pm

Q Leveraging Data Analytics to Drive Compliance and Quality in a Risk-Based Monitoring Environment TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: David Fryrear, Matthew Krumrai, Aaron Mackey, Yuhi Sakajiri, Wei Xue

2:00pm – 3:15pm

Q Translating Academic Research into Product Development: Integrating GCP Training into the Process (Part 4 of 4) TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Eunjoo Pacifici

2:00pm – 3:15pm

G Global Rare Disease Town Hall Speakers: James Valentine TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:00pm – 3:15pm

G Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where are We and What Have We Learned? Speakers: Brian Corrigan, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Cristiana Mayer

2:00pm – 3:15pm

G User-Fee Programs Myth Busting: General Financial Principles Explained Speakers: Amy Bertha TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:00pm – 3:15pm

Challenges and Opportunities in Product Quality: Lifecycle Management Speakers: Lucy Chang TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

2:00pm – 3:15pm

Efficient Pediatric Drug Development: Incorporating Innovative Techniques Using Extrapolation and Historical Information Speakers: Margaret TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Gamalo-Stiebers, Jeen Liu, Robert Nelson

2:00pm – 3:15pm

V Advancing Value and Access With Technology Speakers: Richard Gliklich, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Denise Meade, Charles Nader, Ian Rentsch

2:00pm – 3:15pm

Success in the Workplace: What does that Mean and How Can You Achieve it? Speakers: Vidhi Vashisht TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

4:15pm – 5:30pm

From Trials to Real World: How Safety Protocols Impact REMS

Effective Portfolio Management of Assets Across an Organization Speakers: Kirstin Dawson, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Nathan Kreischer, Mark Kryah, Daniel Patrick

TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

4:15pm – 5:30pm

C A New Path Forward for Using Decentralized Clinical Trials Speakers: Gail Adinamis, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Michael O'Brien, Laura Podolsky, Penny Randall

4:15pm – 5:30pm

C Incorporating Patient Input into the Design and Conduct of Clinical Trials TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

4:15pm – 5:30pm

C Risk-Based Approach to Investigator-Initiated Trials Speakers: Susan Callery- TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) D\'Amico

4:15pm – 5:30pm

D Real World Data Quality for Regulatory Decision-Making Speakers: Rebecca Lipsitz TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

4:15pm – 5:30pm

M Next-Generation Approaches for Developing Narratives Speakers: Ulrike TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Kochendoerfer, Mary McKenna, Nirpal Virdee

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15/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

4:15pm – 5:30pm

P Patient Preferences in Decision Making and the PREFER Project: Past, Present, and Future Speakers: Kristin Bullok, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Rachael DiSantostefano, Juhaeri Juhaeri, Jenny Sharpe

4:15pm – 5:30pm

R The Importance of Human Translation for Successful Preclinical Drug Discovery and Cardiac Safety TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Christopher Mathes

4:15pm – 5:30pm

Q ICH E6 Renovation: Results from a CTTI Survey Speakers: Melissa Bomben,TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Melissa Mudrick, Theresa Mullin, Janette Panhuis, James Riddle, Pamela Tenaerts

4:15pm – 5:30pm

G Clinical Trial Innovation: Pathways for Selecting and Developing Novel, Fit-for-Purpose, Technology-Derived Study Endpoints Speakers: Jennifer TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Goldsack, Jean Paty

4:15pm – 5:30pm

G Convergence of the Regulatory Pathways for Advanced Therapy Medicinal Products

Setting the Stage for Effective Stakeholder Collaboration Speakers: Marina Acosta TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Enslen, M Christine Morris, Lydia Sbityakov

TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

4:15pm – 5:30pm

G Transparency, Expanded Access Navigator, Right to Try: Helping Patients Get Access to Investigational Medicines? Speakers: Alison Bateman- TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) House, Beverly Harrison, Andrew McFadyen, Kim Quaintance-Lunn, June Wasser

4:15pm – 5:30pm

Case Studies in Resolving Quality Issues Speakers: Daniel Bollag, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Clare Ryder

4:15pm – 5:30pm

Demystifying Basic Statistical Concepts for Anyone Involved with Clinical Trials Speakers: Matt Baldwin, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Stephen Corson, Munish Mehra

4:15pm – 5:30pm

Utilization and Evaluation of Innovative Approaches for Efficient Drug Development Speakers: Yuki Ando, Neal TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Thomas

4:15pm – 5:30pm

V Challenges to Access: Bringing Payers to the Table Speakers: Ruslan Horblyuk TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

4:15pm – 5:30pm

PowerUp: Stories of Career Transforming Moments Speakers: Robin Whitsell TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

9:00am – 10:15am

Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars Speakers: Kalindi Hapani, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Brad Jordan, Richard Markus, Philip Schneider

9:00am – 10:15am

C A New Path Forward for Using Real World Evidence in Randomized Clinical Trials Speakers: Richard Gliklich, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) John Sheehan

9:00am – 10:15am

C eSource and the Sites: Have They Bonded? Speakers: Nadina Jose TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

JUNE 27 • THURSDAY

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16/17

2/8/2019

DIA 2019 Global Annual Meeting: Print Schedule

9:00am – 10:15am

C Investigational Medicinal Products: eLabeling Initiative, Supply Management, and Medicinal Adherence TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Rocco Barone, Jan Pieter Kappelle, Mark Paul

9:00am – 10:15am

D Electronic Submissions Update TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

9:00am – 10:15am

M Scientific Exchange: New Interpretations? Speakers: Michael Swit TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

9:00am – 10:15am

P A Patient Engagement Wrap Up: Lessons Learned from DIA 2019 and Where Do We Go from Here TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Deborah Collyar, Jennifer Helfer, K. Kimberly McCleary, Steven Roberds, Kristin Voorhees

9:00am – 10:15am

R FDA Botanicals TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Nita Ichhpurani, Douglas Kalman

9:00am – 10:15am

Q Case Studies From FDA and MHRA: Good Clinical Practices Speakers: Gail Francis, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Jean Mulinde

9:00am – 10:15am

G Advancing Benefit-Risk Assessment to Support FDA’s Regulatory Review of Human Drugs and Biologics TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Hong Yang

9:00am – 10:15am

N FDA/EMA Question Time TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) Speakers: Sandra Kweder

10:45am – 12:00pm

N FDA Town Hall Speakers: Sudip Parikh

Recent CMC Changes in Emerging Regulatory Agencies in China, Brazil, and South Korea Speakers: Nirdosh Jagota, TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA ) YoungLim Kim

TBD (San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA )

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