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Aurex Biopharma Consulting

Aurex helps biopharma companies mitigate risk, accelerate timelines, and solve complex CMC challenges at critical inflection points across the product lifecycle.

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When to Engage Aurex

Strategic Advisory & Portfolio Valuation

  • Independent technical due diligence is required to de-risk investments or acquisitions.
  • Long-term CMC roadmaps and capital allocation strategies must be established for Board or financial planning.
  • Manufacturing models require strategic restructuring or Cost of Goods (COGS) optimization.

Clinical Transition & Regulatory Execution

  • Preclinical programs require rapid, compliant translation into Phase 1 clinical manufacturing.
  • Impending global regulatory filings (IND, IMPD, NDA, BLA) require end-to-end Module 3 direction.
  • Fractional or interim executive CMC leadership is needed to bridge organizational transitions.

Operational Recovery & Commercial Scalability

  • Critical-path development timelines are compressed or milestones are at risk.
  • High-value CDMO relationships or complex technology transfers require immediate remediation or acceleration.
  • Pre-Approval Inspection (PAI) readiness and global commercial supply networks must be built and validated.

Executive Leadership

Sachin Chandran, PhD

President & Principal Consultant

During his tenure as Vice President of Pharmaceutical Sciences & Technical Operations at Astria Therapeutics, Dr. Chandran orchestrated the end-to-end technical lifecycle and CMC asset pathways for the company’s entire development portfolio, steering multi-modality pipelines with over 30 regulatory filings under his belt.

Prior to this, he advanced small molecules, biologics, and first-in-class continuous commercial manufacturing capabilities at Vertex Pharmaceuticals and Bristol-Myers Squibb.

Ph.D., Chemical and Biomolecular Engineering, Johns Hopkins University.

The Aurex Advantage

Accelerated Timelines: Shortened critical path from IND to NDA/BLA through lean operational execution and embedded leadership.

Proven Global Reach: Orchestrated complex technology transfers and directed regulatory submissions across the US, EU, India, and China.

Broad Modality Expertise: Deep technical mastery scaling complex biologics, High-Potency ADCs, heavily cross-linked peptides, and specialized continuous manufacturing platforms.