Mahmoud El-khateeb, Ph.D.

Principal Consultant: Strategic CMC, Technical Operations & Product Development

Bridging Complex Science and Commercial ROI—From IND-Enabling Milestones to Global Scale-Up

Strategic Value Creation | $20B+ Revenue Enablement | Multi-Sector Advisory Board Member

Executive Advisory & Board Leadership

• Life Sciences & Chemical Industry: Fractional Advisor to mid-market and growth-stage firms, specializing in CMC strategy, risk mitigation for high-value chemical assets, and regulatory pathways.

• Capstone Development Services: Executive Steering Committee Member, overseeing a $100M+ strategic transaction portfolio.

• OncoVation Therapeutics: Board-level strategist for IND planning, capital raising, and AI-integrated preclinical modeling.

• Chicago AC Soccer Team: Member of the Advisory Board, providing strategic oversight on organizational growth, community engagement, and operational scaling.

Executive Summary

Visionary Biopharmaceutical Executive with 20+ years of experience directing the end-to-end product lifecycle for global leaders (Gilead, Boehringer Ingelheim) and innovative startups. Expert in bridging high-level corporate strategy with technical execution to drive P&L optimization, M&A readiness, and market exclusivity. Certified in Lean Six Sigma and Executive Management, with a proven history of securing first-to-file approvals and reducing COGS by 10%+ across global portfolios.

Key Professional Impact

• Commercial Success: Enabled $20B+ in revenue through the development of blockbuster brands including Sovaldi®, Addyi®, and Imvexxy®.

• Strategic Transactions: Directed technical due diligence and CMC strategy for projects resulting in $100M+ buyback deals and a $1B asset acquisition.

• Operational Excellence: Modernized R&D workflows using AI and PBPK modeling to virtualize milestones, cutting IND-enabling costs and timelines by 25%.

• Regulatory Leadership: Secured 180-day marketing exclusivity for 5+ products via Competitive Generic Therapy (CGT) designations.

Professional Experience

Fractional Consultant / Chief Strategy Officer | OncoVation Therapeutics | 2024 – Present

• Secured $1M in seed capital and designed an $18M roadmap for gene therapy development.

• Leveraged the FDA Modernization Act 3.0 to compress timelines for WWOX platform clinical entry.

Executive Director / Senior Director, Product Development | Capstone Development Services | 2018 – Present

• Secured 10+ strategic project acquisitions and delivered $10M in annual savings by optimizing the CMC lifecycle.

Director of Product Development | TherapeuticsMD | 2016 – 2018

• Increased portfolio valuation by $200M through priority review filings and new formulation launches.

Scientific Authority & Education

• Global Patents 

• Peer-Reviewed Publications: on the fileds of anticancer drugs and DNA.

• Postdoctorate: Pharmaceutical Sciences – Stony Brook University.

• Ph.D.: Anti-Cancer Drug Metabolism – The University of Queensland.

• Lean Six Sigma Certified: Management & Strategy Institute.

Expertise for Hire:

• Complex Issue Resolution: Troubleshooting at development and commercial manufacturing scales.

• CMC Regulatory Reviews: Forensic auditing of technical submissions.

• Scale-Up Strategy: Transitioning assets from R&D to commercial production.