24+ years in glycobiology and the M6P pathway

Scientific Strategy. Program Stewardship. Rare Disease Partnerships.

24+ years in glycobiology and the M6P pathway

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Years of Expertise
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Core Service Pillars
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Foundation Partnerships
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Programs Navigated

Let's Navigate Forward Together

Glyko Consulting has spent over two decades working at the intersection of glycobiology, enzyme replacement therapy, and rare disease drug development. We work with biotech companies, foundations, and research institutions to guide programs through regulatory pathways, coordinate multi-stakeholder efforts, and build strategies that move therapies closer to patients.

We bring scientific strategy and dedicated program stewardship to every rare disease program we work on.

What We Do

Our Core Service Pillars

Scientific Strategy

Grant writing (EIC/Horizon, SBIR), study design, regulatory pathway navigation, and IND-enabling program oversight.

Program Stewardship

Full program management across multi-partner collaborations, milestone tracking, and team coordination.

Rare Disease Partnerships

Foundation engagement (ForeBatten, Lost Enzyme), patient organization strategy, and advocacy-driven development plans.

Deep Specialization

Areas of Expertise

Decades of hands-on experience across the full arc of rare disease drug development, from early discovery through regulatory submission.

  • NHP Waiver Risk Assessment & Regulatory Analysis
  • FDA Pre-IND & BLA Pathway Navigation
  • ICH S6(R1) Compliance Strategy
  • Preclinical & Clinical Program Roadmaps
  • ERT Development Strategy
  • Budget & Timeline Planning for Drug Development

Trusted Relationships

Partner Organizations

We collaborate with leading foundations and rare disease organizations to accelerate therapies to patients.

ForeBatten Foundation
Lost Enzyme Foundation
National Organization for Rare Disorders
Global Genes
Rare Disease Research Partners

Ready to Navigate Forward Together?

Let's discuss how we can accelerate your program.

We typically respond within 24 hours.