Scientific Consulting

Scientific Strategy.
Program Stewardship.
Rare Disease Partnerships.

24+ years in glycobiology and the M6P pathway

M6P

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

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.

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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
What We Do

How We Partner With You

01

Scientific Strategy

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

02

Program Stewardship

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

03

Rare Disease Partnerships

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

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Custom engagements available

Expertise

Navigating complex regulatory pathways

Our regulatory and scientific experience covers the full drug development lifecycle, from preclinical study design through IND filing and beyond. We turn complexity into clear, actionable strategy.

  • 01.NHP Waiver Risk Assessment & Regulatory Analysis
  • 02.FDA Pre-IND & BLA Pathway Navigation
  • 03.ICH S6(R1) Compliance Strategy
  • 04.Preclinical & Clinical Program Roadmaps
  • 05.ERT Development Strategy
  • 06.Budget & Timeline Planning for Drug Development
Our Partners

Foundations & Organizations

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

Ready to Navigate Forward Together?

Let's discuss how we can accelerate your program.

We typically respond within 24 hours.