Track 7: Special Populations

 

With 16 sessions specific to Special Populations, this track focuses on some of the greater challenges in therapeutic development for special populations, providing current thinking and sharing real-world experiences and outcomes that attendees can apply in their own programs. Special populations, when looked at together, make up a large component of the total population whose health concerns we seek to address. Each special population has unique characteristics and needs, which present challenges during the development of effective and accessible treatments. 

This year’s program is rich with topics of relevance to those developing or contemplating development of rare disease therapies. Additionally, therapeutic development issues for pediatric, prenatal, and lactating populations are addressed. Innovations in research and development with promise to accelerate the availability of treatments for the special therapeutics areas of CNS and neurodegenerative diseases and oncology will be highlighted.

Highlights in Special Populations

• Introduction to rare disease studies
• Patient voice in rare disease across the development continuum and the key to meaningful patient outcomes
• MUST haves: engagement, education, networks, media, and societies in rare disease research
• Collaborative efforts to accelerate rare disease research and development
• Recruiting rare disease populations
• Innovative design and statistics for small populations
• Serving the patient in need of early access to treatment
• Pregnancy and lactation – meeting the requirements for labeling 
• Pediatric populations
• CNS impairment guidelines and impact on therapies for brain diseases/disorders
• State of neurodegenerative disease therapy research
• Featured Topics in Rare Disease, Patient Centricity, Pediatrics, Academic Clinical Researcher, and Career Development

DIA recommends this track and associated sessions to professionals involved in: clinical research, early development (including Clinical Pharmacology), rare disease therapy development or approvals, regulatory affairs, medical affairs, patient affairs or advocacy, patient support services, statistics, pediatrics, and population and health outcomes research.

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Sessions in Special Populations

Monday, June 19

Drug Repurposing: Where Will it Take Us?
• FDA Rare Disease Town Hall
• Dealing with Difficult Clients/Conversations

Tuesday, June 20

• Integrating the Patient's Voice Across the Development Program of Rare Diseases: Translation Into Meaningful Outcomes
• Serving the Patient Who Needs Early Access to Treatments and Achieving Meaningful Outcomes
• Integrating the Patient's Voice Across the Development Program of Rare Diseases: At the Table - Where to Sit?
• Introduction to Rare Disease Studies: Challenges of Rare Disease From a Statistical, Protocol Development, and Operations Perspective
• Challenges and Issues in Early-Phase Oncology Trials
• Success in Early CNS Drug Development: Getting Proof-of-Principle by Stacking the Deck with Biomarkers

Wednesday, June 21

Does Diversity Matter in Clinical Trials?
Progress in Pediatric Therapeutics
• Engagement, Education, Networks, Media, and Societies in Rare Diseases: The MUST Haves
• Is the Future Bright for Treatment of Neurodegenerative Diseases?
• Innovative Designs and Statistical Approaches for Small Trials: Rare Disease or Pediatric Indications
• Increasing Participation in Clinical Trials Among Under-Represented Populations
• Pregnancy and Lactation Labeling Rule: Unique Challenges to Meet Requirements
• Looking to the Future for EU Pediatric Investigation Plans
• Collaborative Efforts to Accelerate Rare Disease Research and Development
• Patient Perspective
• Cultural Diversity

Thursday, June 22

EMA/FDA Question Time
• Recruiting Rare Disease Patients: A Unique Set of Challenges
• Exploration of Metabolic Diseases: Is the Liver the New Heart?
• Recruiting Rare Disease Patients: A Unique Set of Challenges

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