Rubedo FDA IND Clearance: Fuel Your Q4 Pipeline

🚀 Battle Card: Rubedo Life Sciences, Inc.

• Emma Guttman-Yassky, MD, PhD, Clinical Advisory Board Member · 🔗 LinkedIn

• IND clearance for a first-in-class GPX4 modulator fast-tracks a new Phase 1b/2a trial in actinic keratosis and brings top dermatology expertise onboard. → Source

• This Rubedo Life Sciences sales trigger signals heavy R&D momentum and regulatory confidence around RLS-1496.

• Complex trial startup: Coordinating sites, IND docs & FDA compliance for Q4 launch

• Data bottlenecks: Need real-time analysis across multiple skin-disease cohorts

• Primary: Cloud Clinical Trial Management System → Streamline IND filings, site activation & eTMF oversight

• Expansion: AI-Driven Data Analytics Platform → Deliver real-time insights across psoriasis, AD & AK cohorts

• HQ: Mountain View, CA

• Employees: ≈ 75

• Rev: ≈ $0 M (pre-revenue, Phase I stage)

• Website: rubedolife.com

🤼 Competitive Intel

• Veeva Systems — CTMS / eTMF
• Unique edge: Built-for-life-sciences regulatory workflows
• Evaluated by clinical ops for global site roll-out

• Medidata (Dassault Systèmes) — EDC / RTSM
• Unique edge: Integrated eCOA + risk-based monitoring
• Evaluated by data managers for seamless patient tracking

• Oracle Health Sciences — Clinical Trial Cloud
• Unique edge: End-to-end trial automation & scalability
• Evaluated by IT for enterprise-grade performance

• IQVIA — Trial Services & Analytics
• Unique edge: Deep skin-disease real-world data sets
• Evaluated by medical affairs for patient recruitment insights

• IBM Watson Health — AI-Driven Insights
• Unique edge: NLP-powered protocol optimization
• Evaluated by biostatistics for predictive enrollment

✅ Do-Now Checklist

Next Step

🧠 Copy My Prompt for Personalized Cold Outreach

────────────────────────────
✏️ YOUR COMPANY
────────────────────────────
OUR_COMPANY   = ❑<your company>❑
OFFER_BRIEF   = ❑Cloud Clinical Trial Management System❑
PROOF_METRIC  = ❑30% faster startup❑
CTA_STYLE     = ❑quick_call❑
TONE          = ❑friendly❑

────────────────────────────
📌 TARGET COMPANY
────────────────────────────
NAME        = Emma
COMPANY     = Rubedo Life Sciences, Inc.
DEPT        = Clinical Advisory Board
SIZE        = ≈ 5
BOTTLENECK  = coordinating sites & IND compliance
EVENT       = U.S. FDA Clearance of IND for RLS-1496
DETAIL      = FDA clearance of IND for Phase 1b/2a actinic keratosis trial
PAIN        = Need to streamline trial docs & site activation
SRC         = http://cts.businesswire.com/ct/CT?id=ftfLlWd9aZbF2NXfwppam3Bd664=&newsLang=en&newsId=20250917407244&div=41152219
SIM_CO      = Unity Biotechnology
WIN_METRIC  = 30% faster trial startup
NEXT_SIZE   = ≈ 15
EMP_EST     = ≈ 75
REV_EST     = ≈ $0 M

────────────────────────
TASK FOR CHATGPT
────────────────────────
Role: “NewsletterForLeads SDR-Assist”.

Validate any ≈ guesses via SRC.

EMAIL  (keep breaks):
Subject: ≈ 5-person Clinical Advisory Board

Emma—noticed your Clinical Advisory Board team is ≈ 5.

That’s when coordinating sites & IND compliance slows growth.

We helped Unity Biotechnology fix this with Cloud Clinical Trial Management System.

Result: 30% faster trial startup.  
Quick call?

PS—next bottleneck hits ≈ 15.

DM ≤45 words, TONE:
Saw your post about FDA clearance of IND for Phase 1b/2a actinic keratosis trial — Need to streamline trial docs & site activation.  
Cloud Clinical Trial Management System. 30% faster startup.  
Quick chat?