Glycobiology · Rare Disease · Regulatory Science · Fractional CSO

Your Scientific Navigator from Discovery to IND

25+ years at the intersection of glycobiology, M6P pathway biology, and rare disease drug development — guiding programs to their True North milestone.

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Years in Industry

Programs Supported

Service Verticals

INDs

Cleared & Submitted

About & Background

The Navigator

Decade 1

Early Career — Core Scientific Foundation

M.S. Biology with glycobiology emphasis from Wichita State University. Research roles in analytical assay development and pediatric pharmacology.

Decade 2

Industry Leadership — VP R&D at Amicus Therapeutics

Managed pre-clinical R&D, built world-class discovery organization. Led protein engineering and analytics for novel gene therapy pipeline with University of Pennsylvania.

Recent

Consulting Era — Founding Glyko Consulting

Independent scientific advisory and fractional CSO services across rare disease, LSD, cardiovascular, and CKD programs. Building the Glyko and RGlyko ecosystem.

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Russell Gotschall

Founder & Principal Consultant

Russell brings more than 25 years of drug discovery and development experience. Prior to founding Glyko Consulting, he served as VP of R&D at Amicus Therapeutics, where he managed pre-clinical R&D and helped build a world-class discovery and research organization maximizing protein engineering and analytics capabilities in the development of a robust pipeline of novel gene therapy programs in collaboration with the University of Pennsylvania.

M.S. Biology (Glycobiology emphasis), Wichita State University

Deep Expertise Areas

Glycobiology & M6P pathway

Lysosomal Storage Disorders

Pompe / Batten Disease / CLN3

Protein Engineering & Analytics

Gene Therapy Programs

Pediatric Pharmacology

Cardiovascular & CKD

IND-enabling study oversight

FDA Pre-IND strategy

Orphan Drug Designation

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What does scientific navigation actually mean for a biotech client? It means having someone who has walked the path before, who understands the terrain, and who can help you find the most direct route to your next milestone.

Portfolio & Programs

Strategic Impact

IND Clearance

Pompe Disease

Lysosomal Target Program A

ModalityEnzyme Replacement Therapy

RoleScientific Lead

Orphan Drug Designation

Batten Disease / CLN3

Lysosomal Target Program B

ModalityGene Therapy

RoleFractional CSO

Pre-IND Meeting Success

Rare Metabolic Disorder

Metabolic Program C

ModalitySubstrate Reduction

RoleNonclinical Strategy

Organizational Relationships

Trusted by Leading Institutions

Partner A

Partner B

Pending

Partner C

Pending

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The Virtual C-Suite

A Complete Service — Without the Overhead

Glyko brings together a network of specialized professionals who work as a coordinated team on your program, giving you C-suite caliber coverage at a fraction of the cost.

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Toxicology Expert

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CMC Strategy Specialist

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Bioanalytics Lead

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Regulatory Affairs

What We Do

Three Lanes of Expertise

Vertical 01

Scientific Strategy

From assay development to IND-enabling study oversight, we build the scientific foundation your program needs to move forward with confidence.

Assay development & optimization
Nonclinical program design
IND-enabling study oversight
Scientific due diligence
M6P pathway expertise

Vertical 02

Executive Stewardship

Whether you need a fractional CSO or a scientific voice in the boardroom, we bring senior-level guidance without the overhead of a full-time hire.

Fractional CSO services
Board advisory roles
Investor preparation
Scientific narrative for grants
Partner and CRO selection

Vertical 03

Regulatory Navigation

We map the regulatory path from early strategy through Pre-IND meetings, Orphan Drug Designation, and FDA submission preparation.

Pre-IND meeting strategy
Orphan Drug Designation
NHP waiver development
FDA meeting preparation
Early Phase regulatory plan

The Glyko Brief

Regulatory Intelligence & Perspective

Featured

Glyko Take

New FDA Guidance on IND-Enabling Studies: What It Means for Your Rare Disease Program

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Industry News

Glycobiology's Expanding Role in Next-Gen Enzyme Replacement

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Regulatory Update

Orphan Drug Designation Changes: Implications for Rare Disease Sponsors

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