DIA 2026 · Jun 14–18 · Philadelphia
AuroraPrime · DIA 2026 strategic prep
AuroraPrime · DIA 2026 主舞台战略准备
Program & Keywords议程与关键词
DIA 2026 program structure, keynote signal, and keyword frequency vs. AuroraPrime's narrative slot.
DIA 2026 议程结构、主题演讲信号、关键词频率，及 AuroraPrime 的话语切入点。
Dates
日期
5-day program · Philadelphia
5 天议程 · 费城
Tracks
议程主题
10 (down from 12 in 2025, 13 in 2024)
较 2025 年从 13 收敛至 10
Persona pathways
角色路径
New navigation framing
全新导览框架
Attendance
参会规模
50+ countries
50+ 国家与地区
Track relevance to AuroraPrime与 AuroraPrime 的相关度
10 tracks scored by overlap with AuroraPrime's lifecycle (study design → eCTD).
10 条议程与 AuroraPrime 全生命周期（研究设计 → eCTD）的重叠度评分。
AuroraPrime Relevance | |
|---|---|
1. Clinical Safety, Pharmacovigilance, and Risk ManagementPost-market safety | Low |
2. Clinical Trial Operations and InnovationCovers protocol/study execution surface | Med-High |
3. Data, Technology and AIAI promoted into the track title for the first time in 2026 | Highest |
4. Medical Affairs & Scientific CommunicationMedical writing audience lives here | High |
5. Personalized Medicine, Combination Products and DiagnosticsTherapeutic-area framed | Low |
6. Professional Development and Project, Program and Portfolio ManagementAI-for-the-workforce sessions land here | Medium |
7. Regulatory CMC and Product QualityCMC documents are part of eCTD M3 | Medium |
8. Regulatory Policy, Strategy and Global CollaborationeCTD/RIM/global submission strategy | High |
9. R&D Quality and ComplianceGxP, validated AI, computer-system validation | High |
10. Statistics, Evidence Generation and Real-World DataStudy design / RWE | Medium |
Track & short-course trajectory议程与短课程演进
Track count is consolidating (13 → 10) while AI-flagged short courses are expanding.
议程主题在收敛（13 → 10），同时带 AI 标签的短课程在扩张。
Track count议程主题数量
Consolidation signal — agendas are getting tighter, persona pathways replacing track sprawl.
收敛信号 —— 议程在变紧凑，角色路径取代了议程主题的横向扩张。
Short courses · AI vs total短课程：AI vs 总数
- 2024AI 0 / 2
- 2025AI 1 / 7
- 2026AI 2 / 6
Daily keynote signal每日主题演讲信号
Color tags whether AI is the direct frame or peripheral context.
标签区分 AI 是直接主题还是边缘语境。
Hidden Potential: Turning Today's Science into Tomorrow's Cures
Hidden Potential：把今日科学变为明日疗法
Keynote: David Fajgenbaum (Every Cure). Moderator: Audrey Greenberg (Mayo Venture Partners). Panel: Rahul Gupta (GATC Health); Dave Pfeiffer (Acrisure Re Bio-Tech / ARCAS); Greg Sarafin (Sovereign AI)
主讲：David Fajgenbaum（Every Cure）。主持：Audrey Greenberg（Mayo Venture Partners）。圆桌：Rahul Gupta（GATC Health）；Dave Pfeiffer（Acrisure Re Bio-Tech / ARCAS）；Greg Sarafin（Sovereign AI）
AI in biopharma drug-discovery framing
AI 赋能生物制药药物发现的开场议题
Transforming Obesity Patient Care: Past, Present, and Future Innovation in the Age of GLP-1 Therapies
GLP-1 时代下的肥胖患者管理：过去、现在与未来的创新
Brad Jordan (AVP Reg Policy & Strategy, Eli Lilly); W. Scott Butsch (Intl Medical VP — Obesity, Novo Nordisk); Robert Califf (Instructor of Medicine, Duke; former FDA Commissioner); Maria Vassileva (Chief Science & Regulatory Officer, DIA); Jingyu Luan (Exec Reg Science Director, AstraZeneca)
Brad Jordan（Eli Lilly 监管政策与策略 AVP）；W. Scott Butsch（Novo Nordisk 国际医学副总裁——肥胖）；Robert Califf（Duke 医学院讲师；前 FDA 局长）；Maria Vassileva（DIA 首席科学与监管官）；Jingyu Luan（AstraZeneca 监管科学执行总监）
Therapeutic-area focus
以治疗领域为核心
From Breakthrough to Life: Engineered T Cells, Patients, and the Future of Biotech
从突破到落地：工程化 T 细胞、患者与 biotech 的未来
Bruce Levine (Founding Director CVPF, University of Pennsylvania); Bradley Watts (VP Business Development, Conner Strong & Buckelew); Maria Vassileva (Chief Science & Regulatory Officer, DIA)
Bruce Levine（UPenn CVPF 创始主任）；Bradley Watts（Conner Strong & Buckelew 业务发展副总裁）；Maria Vassileva（DIA 首席科学与监管官）
Cell & gene therapy
细胞与基因治疗
No More Incremental Change: The Radical Future of Healthcare
告别渐进式改变：医疗的彻底重塑
Moderator: Eli Weinberg (Partner, Bain & Company). Panel: Carlos Garner (SVP Global Regulatory Affairs, Eli Lilly); Susan Furth (EVP & Chief Scientific Officer, Children's Hospital of Philadelphia); Dhruv Jayanth (Business Lead Life Sciences, OpenAI); Shweta Maniar (Global Director, Strategic Industries — Life Sciences, Google Cloud)
主持：Eli Weinberg（Bain & Company 合伙人）。圆桌：Carlos Garner（Eli Lilly 全球监管事务高级副总裁）；Susan Furth（费城儿童医院 EVP 兼首席科学官）；Dhruv Jayanth（OpenAI 生命科学业务负责人）；Shweta Maniar（Google Cloud 战略行业总监——生命科学）
Closing plenary places OpenAI & Google Cloud on DIA main stage
闭幕全体大会让 OpenAI 与 Google Cloud 登上 DIA 主舞台
Keyword frequency in DIA marketingDIA 营销层关键词频率
Direct mentions in DIA 2026 program titles / track names. Many AuroraPrime-relevant terms are white space — implicit but unclaimed.
许多与 AuroraPrime 高度相关的术语在 DIA 营销层为'空白地带'——隐含但未被明确占领。
White-space themes for AuroraPrimeAuroraPrime 可占据的话语空白
Terms with structural relevance and zero direct DIA mentions — the narrative slots to claim on stage.
结构性相关、但 DIA 营销层零直接提及的词汇 —— 主舞台可占据的话语切口。
End-to-end AI lifecycle: study design → eCTD
端到端 AI 全生命周期：研究设计 → eCTD
white spaceEvidence: No DIA 2026 marketing surface stitches study-design and submission together; tracks are functionally siloed.
证据：DIA 2026 宣传层面没有把研究设计与递交串起来；各 track 在功能上彼此割裂。
Angle: Direct match to AuroraPrime talk title — own this slot.
切入点：与 AuroraPrime 演讲标题完全契合——抢占这个空位。
eCTD-readiness as an AI output
eCTD 就绪作为 AI 输出
white spaceEvidence: Zero DIA-marketing-layer mentions of eCTD.
证据：DIA 宣传层面对 eCTD 零提及。
Angle: Differentiator vs. all 'GenAI for pharma' talks that stop at 'draft a section'.
切入点：相对于所有「停留在写几段草稿」的 GenAI for pharma 演讲，这是清晰的差异化点。
ICH M11 operationalization
ICH M11 落地实施
white spaceEvidence: Zero mentions; ICH M11 entered Step 4 in Oct 2024.
证据：零提及；ICH M11 已于 2024 年 10 月进入 Step 4。
Angle: Use M11 as the technical anchor that makes the talk credible.
切入点：用 M11 作为技术锚点，让演讲更具可信度。
Validated, GxP-compliant AI authoring
GxP 合规 AI 文档生成
white spaceEvidence: Track 9 home, no marketed session ties AI-authoring + GxP.
证据：Track 9 本是其阵地，但没有任何已宣传议题把 AI 撰写与 GxP 结合。
Angle: Bridge to R&D Quality audience without being a pure-AI talk.
切入点：可桥接 R&D Quality 受众，又不至于变成纯 AI 演讲。
Agentic workflows for regulatory authoring
监管文档智能体工作流
white spaceEvidence: 'Agentic AI' absent from DIA-published surface.
证据：DIA 公开材料中完全没有「Agentic AI」这一表述。
Angle: Be the talk that introduces the term to the DIA audience with a concrete demo.
切入点：做那场用具体 demo 把这个词引入 DIA 受众的演讲。
Pre-conference short courses会前短课程
| # | Course课程 | Date日期 | AI? |
|---|---|---|---|
| 1 | Real-World Evidence for Regulatory Decision-Making 真实世界证据在监管决策中的应用 Reg Policy / Stats & RWD 监管政策 / 统计与 RWD | Mon Jun 8 | — |
| 2 | AI Applications, Ethics, Regulations, and Governance for Life Sciences 生命科学领域的 AI 应用、伦理、监管与治理 Data, Technology and AI 数据、技术与 AI | Tue Jun 9 | AI |
| 3 | Aggregate Safety Assessment Planning Process 综合安全性评估规划流程 Safety/PV 安全性 / PV | Wed Jun 10 | — |
| 4 | Navigating Gen AI Revolution in Pharma 驾驭药企的生成式 AI 革命 Professional Development & PMO 职业发展 & PMO | Wed Jun 10 | AI |
| 5 | Cell and Gene Therapies 101 细胞与基因治疗入门 Clinical Ops / Reg Policy 临床运营 / 监管政策 | Thu Jun 11 | — |
| 6 | Regulatory Strategy for Complex Devices and Combination Products 复杂器械与组合产品的监管策略 Personalized Med / Reg Policy 个性化医疗 / 监管政策 | Fri Jun 12 | — |
Notable speakers / sponsors值得关注的演讲者 / 赞助商
- Mon Jun 15 plenary周一 6/15 全体大会
Greg Sarafin
Sovereign AI
Sovereign AI
- Mon Jun 15 plenary周一 6/15 全体大会
Rahul Gupta
GATC Health
GATC Health
- Thu Jun 18 closing周四 6/18 闭幕
Dhruv Jayanth
OpenAI
OpenAI
- Thu Jun 18 closing周四 6/18 闭幕
Shweta Maniar
Google Cloud
Google Cloud
- Thu Jun 18 moderator周四 6/18 主持人
Eli Weinberg
Bain & Company
Bain & Company
- Global Executive Day facilitatorGlobal Executive Day 主持方
McKinsey & Co.
Strategy
战略咨询
- DIA Celebrate sponsorDIA Celebrate 赞助方
Microsoft
Hyperscaler
云超大规模厂商
- GED reception sponsorGED 招待会赞助方
Celonis
Process automation
流程自动化