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YJ

Yueh Jung (Cynthia) Lee

Autotelic Inc
Director of R&D
Monday, June 19
 

7:30am CDT

Annual Meeting Orientation TBA

8:30am CDT

#101: Drug Repurposing: Where Will it Take Us? S105 #102: The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision Making S100a

11:00am CDT

#109: Submission Dossiers: Communications Excellence to Drive Speed and Quality S503ab #114: PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the Future - PDUFA VI N228 #120: FDA Rare Disease Town Hall N227b #124: Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies S402ab

12:00pm CDT

Luncheon TBA

1:15pm CDT

#135: PAREXEL International Innovation Theater: Developing Drugs in the New Era of Personalized Medicines Theater #1

1:45pm CDT

DIA Medical Writing Community Round Table Discussion: Submission Dossiers: Communications Excellence to Drive Speed and Quality Community Corner

2:00pm CDT

#140: SAS Institute Inc. Innovation Theater: Clinical Analytics Workflow Optimization Theater #2

3:00pm CDT

#142: Opening Remarks and Keynote Address Arie Crown Theater
 
Tuesday, June 20
 

8:00am CDT

#203: Radical Technologies: Changing the Future of Biopharmaceuticals S100a

9:30am CDT

#204: Effective Team Management in Global Trials Exhibit Hall

9:45am CDT

#206: Covance Innovation Theater: Overcoming Study Complexity Through Data-Driven Design Theater #2

10:30am CDT

#213: Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation? S403ab #214: Recent Trends in Asian Regulations for Drug Development: What is Coming Next? N227b #223: Introduction to Rare Disease Studies: Challenges of Rare Disease From a Statistical, Protocol Development, and Operations Perspective S503ab #226: Accelerating Drug Development Through Innovation S502ab

11:30am CDT

Luncheon TBA

12:45pm CDT

#237: Strategies for Communicating with FDA Exhibit Hall

2:00pm CDT

#241: FDA Session: Electronic Submissions and Data N228 #244: New Trial Design Approaches: Including New Endpoints S501abc #252: What’s New in Devices: European Medical Device Regulations and MDUFA IV S404a #257: Strategic Planning Across Research Organizations N426b #263: Mergers and Acquisitions: Due Diligence Considerations Exhibit Hall

3:25pm CDT

#267: Veeva Systems, Inc. Innovation Theater: Unified RIM: End-to-end Submissions Development—from Planning Through Archival Theater #1

4:00pm CDT

#274: Effective Collaboration Between Sponsors and Medical Writing Vendors S403ab #277: The Reauthorization of BsUFA and its Impact on Both the Regulator and Industry N228 #280: Developing Pharmacovigilance Policy Based on Impact S401bc

4:45pm CDT

#293: Conversations That Matter: How do Regulatory Affairs Professionals Wish to Engage with Statisticians and Vice Versa? S400 Concourse
 
Wednesday, June 21
 

8:00am CDT

#302: Does Diversity Matter in Clinical Trials? S100c #303: International Regulatory Convergence S100a

9:30am CDT

#304: Mergers and Acquisitions: First, Do No Harm Aisle 300/400 #305: Professional Poster Session 3A Exh Hall Professional Poster Session 2 Poster Area Exhibit Hall

10:30am CDT

#317: Evolution of Novel Registration Endpoints as Diseases Become Chronic S404bc #324: Keys to Effective Product Launch Preparation N426c #326: Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation S401a

12:00pm CDT

#334A: Professional Poster Session and Oral Presentions 3B Exh Hall

2:00pm CDT

#341: EMA Policy 0070: A Game Changer for Industry N227b #343: Expanded Access and Compassionate Use N230b #344: Minding the Gaps: Using Totality of Evidence in the Clinical and CMC Contexts to Support Regulatory Approval S404a #345: Global Perspective on ICH: Part 1 of 2 N228 #357: Biosimilars and Generics: Access Versus Innovation S405b

3:15pm CDT

#362: Medical Affairs and KOL Management Aisle 300/400

4:00pm CDT

#372: The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator N229 #373: FDA–Health Canada Regulatory Cooperation Council Town Hall S401d #374: Global Perspective on ICH: Part 2 of 2 N228 #379: The Art of Negotiation: Preparing Yourself and Your Team for Their Seat at the Table S401bc #381: Maximizing Success in Partner Collaborations N426b
 
Thursday, June 22
 

9:00am CDT

#401: FDA Forum S105

10:45am CDT

#406: Recruiting Rare Disease Patients: A Unique Set of Challenges S401a #408: Flexing Your Project Management Muscles Outside of Traditional Roles S404d #410: Of Course My Data Has Integrity … And I Can Prove It S405a #412: EMA/ FDA Question Time S105