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Track 9: Translational Science: Preclinical/Clinical and Product Development
With 19 sessions specific to Preclinical/Clinical and Product Development, DIA’s Translational Science track covers the intersections of preclinical research, clinical research, and product development. Sessions explore current and innovative methods to:
- Evaluate scientific and medical information
- Optimize clinical trial enrollment and novel technique for trial retention
- Identify new clinical questions and gaps in care
- Expedite drug development using novel protocol techniques
Highlights in Preclinical/Clinical and Product Development
- Patient-reported outcomes in drug development
- Innovative trial designs to accelerate decision-making
- Updates to ICH E17
DIA recommends this track and associated sessions to professionals involved in: clinical operations, clinical research, safety and pharmacovigilance, project management, patient centricity, and statistics.
Sessions in Preclinical/Clinical and Product Development
Monday, June 19
Drug Repurposing: Where Will it Take Us?
- Calling All Angels to the Valley of Death
- Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies
Patient Engagement: What’s in it for Me?
The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision-Making
Tuesday, June 20
People Will Talk: Gathering Insights from Social Listening for Pharmacovigilance
- The Use of Wearable Devices in Clinical Trials, or My iPhone Just Took My Blood Pressure!
- Patient-Reported Outcomes (PROs): Hot Topics - Part 1 and Part 2
- Use of Novel Trial Designs to Accelerate Decision Making: To 'P' No More
- Master Protocols: New Approaches to Enrolling Hard-to-Find Subjects and Expediting Drug Development
- Novel Techniques for Improving Clinical Trial Subject Retention
- 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
- Audits and Agency Inspections of Risk-Based Monitored Studies: The Results Are In…
- Creating Adaptive Contents for a Multichannel World
Wednesday, June 21
Pipeline to Value: Decoding Payer Science
- Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation
- What Do the Experts Believe? Translating Expert Knowledge and Judgment Into a Quantitative Belief Distribution
- Patient-Relevant, Fit-For-Purpose Endpoints: If You Can Believe It, You Can Achieve It
- Multiregional Clinical Trials and the ICH E17
- Experimental Studies: New Approaches to Study Designs to Facilitate Early Phase Decision-Making
- Safety Issues in First-in-Human Studies
Does Diversity Matter in Clinical Trials?
Thursday, June 22
EMA/FDA Question Time
- Trial Master File: MHRA/EMA Inspections and Sponsor Audit Learnings
- Of Course My Data Has Integrity … And I Can Prove It
- Evolving Clinical Trial Guidance and Regulations: Am I Ready?
Translational Medicine and Regulatory Science: How We Think at DIA
Need More on Translational Medicine and Regulatory Science?
DIA’s Learning portfolio offers multiple face-to-face and online training opportunities. Our courses provide comprehensive coverage of the full discovery, development, and life cycle management of health care products. DIA’s unique multidisciplinary environment provides learning opportunities not only in participants’ respective fields, but also in related fields—lending new perspectives that help teams collaborate more efficiently and effectively. DIA wants to ensure you’re prepared with the knowledge, solutions, and strategies you need to be successful in in today's complex global regulatory environment.
Click to learn about the Drug Development and Life Cycle Management and Clinical Trial Fundamentals eLearning Programs designed for professionals new to the field. DIA offers group rates to companies interested in purchasing eLearning modules for multiple users within a team.
Upcoming Online and Face-to-Face Learning
- Oversight of Clinical Monitoring: Trends and Strategies (Who's Monitoring the Monitor?)
- New Drug Product Development and Life Cycle Management
- Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America, and Other Emerging Markets
- Innovative Statistical Approaches for Clinical Trials
- Adaptive Design