FastTrack IND

FastTrack IND

One Roadmap. One Accountable Partner. IND Delivered

You have a preclinical development candidate. What comes next is another complex part of the journey: navigating cell line development, upstream and downstream process development, GMP manufacturing, performing optimally-designed toxicology evaluation to derisk safety aspects of your molecule and IND writing across multiple vendors, timelines, and regulatory requirements. FastTrack IND takes full responsibility for that journey, acting as your independent preclinical CRO and CMC broker from development candidate to IND batch

Discuss Your IND Programme

One Roadmap. One Accountable Partner. IND Delivered

You have a preclinical development candidate. What comes next is another complex part of the journey: navigating cell line development, upstream and downstream process development, GMP manufacturing, performing optimally-designed toxicology evaluation to derisk safety aspects of your molecule and IND writing across multiple vendors, timelines, and regulatory requirements. FastTrack IND takes full responsibility for that journey, acting as your independent preclinical CRO and CMC broker from development candidate to IND batch

Discuss Your IND Programme

One Roadmap. One Accountable Partner. IND Delivered

You have a preclinical development candidate. What comes next is another complex part of the journey: navigating cell line development, upstream and downstream process development, GMP manufacturing, performing optimally-designed toxicology evaluation to derisk safety aspects of your molecule and IND writing across multiple vendors, timelines, and regulatory requirements. FastTrack IND takes full responsibility for that journey, acting as your independent preclinical CRO and CMC broker from development candidate to IND batch

Discuss Your IND Programme

What FastTrack IND solves

The Challenge: Navigating the Labyrinth

The path from preclinical candidate to IND batch involves two major tasks: (i) non-GLP and regulated toxicology evaluation and (ii) CMC package. They are performed by different organizations.  For example, CMC activities require more than nine key decisions across cell line development, upstream processing, downstream processing, formulation, tox batch manufacturing, fill and finish, IND sections writing, and regulatory submission. Without an experienced partner managing all of these in parallel, the risks are real: delays, wrong partner selections, misaligned goals, re-design, and re-work — each one adding months and cost.

The FastTrack IND Solution


  • One roadmap: a single, clear CMC plan from sequence to IND

  • One accountable partner: FJBio takes full responsibility

  • Dedicated project manager across all vendors

  • Optimized timelines between preclinical CRO and CDMO

  • Access to best-in-class CLD platforms and CDMOs, selected independently

  • IND delivered faster


What FastTrack IND solves

The Challenge: Navigating the Labyrinth

The path from preclinical candidate to IND batch involves two major tasks: (i) non-GLP and regulated toxicology evaluation and (ii) CMC package. They are performed by different organizations.  For example, CMC activities require more than nine key decisions across cell line development, upstream processing, downstream processing, formulation, tox batch manufacturing, fill and finish, IND sections writing, and regulatory submission. Without an experienced partner managing all of these in parallel, the risks are real: delays, wrong partner selections, misaligned goals, re-design, and re-work — each one adding months and cost.

The FastTrack IND Solution


  • One roadmap: a single, clear CMC plan from sequence to IND

  • One accountable partner: FJBio takes full responsibility

  • Dedicated project manager across all vendors

  • Optimized timelines between preclinical CRO and CDMO

  • Access to best-in-class CLD platforms and CDMOs, selected independently

  • IND delivered faster


What FastTrack IND solves

The Challenge: Navigating the Labyrinth

The path from preclinical candidate to IND batch involves two major tasks: (i) non-GLP and regulated toxicology evaluation and (ii) CMC package. They are performed by different organizations.  For example, CMC activities require more than nine key decisions across cell line development, upstream processing, downstream processing, formulation, tox batch manufacturing, fill and finish, IND sections writing, and regulatory submission. Without an experienced partner managing all of these in parallel, the risks are real: delays, wrong partner selections, misaligned goals, re-design, and re-work — each one adding months and cost.

The FastTrack IND Solution


  • One roadmap: a single, clear CMC plan from sequence to IND

  • One accountable partner: FJBio takes full responsibility

  • Dedicated project manager across all vendors

  • Optimized timelines between preclinical CRO and CDMO

  • Access to best-in-class CLD platforms and CDMOs, selected independently

  • IND delivered faster


Value chain positioning

FastTrack IND operates at the downstream end of the FairJourney Bio value chain: connecting discovery output directly to the clinic.

Explore discovery-to-IND

Explore discovery-to-IND

Independent. Experienced. Fully Accountable

The Service

FastTrack IND acts not only as an independent broker, but as the expert project manager who selects, contracts, and oversees all the necessary providers on your behalf. FairJourney Bio's independence means every recommendation is based on what is best for your molecule, not on which partner generates the most revenue.

Independent. Experienced. Fully Accountable

FastTrack IND acts not only as an independent broker, but as the expert project manager who selects, contracts, and oversees all the necessary providers on your behalf. FairJourney Bio's independence means every recommendation is based on what is best for your molecule, not on which partner generates the most revenue.

Independent. Experienced. Fully Accountable

The Service

FastTrack IND acts not only as an independent broker, but as the expert project manager who selects, contracts, and oversees all the necessary providers on your behalf. FairJourney Bio's independence means every recommendation is based on what is best for your molecule, not on which partner generates the most revenue.

What independence means in practice  

  • No bias toward any cell line development platform or CDMO

  • Recommendations based on open-source, best-fit approach

  • Access to the best and most-validated technologies at every stage of the journey to IND

  • Full transparency on risks, timelines, and cost impact

  • A partner focused solely on your molecule's success


What independence means in practice  

  • No bias toward any cell line development platform or CDMO

  • Recommendations based on open-source, best-fit approach

  • Access to the best and most-validated technologies at every stage of the journey to IND

  • Full transparency on risks, timelines, and cost impact

  • A partner focused solely on your molecule's success


What independence means in practice  

  • No bias toward any cell line development platform or CDMO

  • Recommendations based on open-source, best-fit approach

  • Access to the best and most-validated technologies at every stage of the journey to IND

  • Full transparency on risks, timelines, and cost impact

  • A partner focused solely on your molecule's success


How FJBio manages it

  • Centralized partner management: FJBio holds the MSA with each vendor, not the partner

  • Easy invoicing: vendor costs consolidated into one FJBio invoice

  • Pre-negotiated rates: access to volume discounts not available to individual sponsors

  • Dedicated project manager: single point of accountability across all workstreams

  • Proactive forward planning: experienced toxicology and CMC advisors who anticipate and mitigate common pitfalls


How FJBio manages it

  • Centralized partner management: FJBio holds the MSA with each vendor, not the partner

  • Easy invoicing: vendor costs consolidated into one FJBio invoice

  • Pre-negotiated rates: access to volume discounts not available to individual sponsors

  • Dedicated project manager: single point of accountability across all workstreams

  • Proactive forward planning: experienced toxicology and CMC advisors who anticipate and mitigate common pitfalls


How FJBio manages it

  • Centralized partner management: FJBio holds the MSA with each vendor, not the partner

  • Easy invoicing: vendor costs consolidated into one FJBio invoice

  • Pre-negotiated rates: access to volume discounts not available to individual sponsors

  • Dedicated project manager: single point of accountability across all workstreams

  • Proactive forward planning: experienced toxicology and CMC advisors who anticipate and mitigate common pitfalls


  Principles  

FairJourney Bio takes responsibility to: (i) pre-negotiated competitive pricing, (ii) execute on timelines, (iii) take full responsibility of Pharmacology, Toxicology and CMC sections towards IND filing, (iv) maintain cost control.

  Principles  

FairJourney Bio takes responsibility to: (i) pre-negotiated competitive pricing, (ii) execute on timelines, (iii) take full responsibility of Pharmacology, Toxicology and CMC sections towards IND filing, (iv) maintain cost control.

  Principles  

FairJourney Bio takes responsibility to: (i) pre-negotiated competitive pricing, (ii) execute on timelines, (iii) take full responsibility of Pharmacology, Toxicology and CMC sections towards IND filing, (iv) maintain cost control.

Your development journey — key considerations


Molecule Format & Complexity

Determines CLD strategy, expression characteristics, and developability /manufacturability. FJBio provides access to various CLD platforms to best fit molecule characteristics, with early developability and manufacturability assessments.

Process Development Implications

Impacts USP/DSP strategy, upstream productivity, downstream recovery/yield, formulation, and stability. FJBio's integrated USP/DSP team designs one coherent process, with high-throughput scouting runs to select optimal conditions early.

Exploratory and regulated toxicology

Dose-range finding, tissue cross-reactivity, immunogenicity assessment and ADA testing, GLP toxicology and toxico-kinetic study, incorporate New Alternative Methodologies (NAMs) approaches  

Regulatory / IND Considerations

Drives critical quality attribute strategy, analytical package, and timelines. FJBio provides IND writing support with experience across multiple IND filings.

Your development journey — key considerations


Molecule Format & Complexity

Determines CLD strategy, expression characteristics, and developability /manufacturability. FJBio provides access to various CLD platforms to best fit molecule characteristics, with early developability and manufacturability assessments.

Process Development Implications

Impacts USP/DSP strategy, upstream productivity, downstream recovery/yield, formulation, and stability. FJBio's integrated USP/DSP team designs one coherent process, with high-throughput scouting runs to select optimal conditions early.

Exploratory and regulated toxicology

Dose-range finding, tissue cross-reactivity, immunogenicity assessment and ADA testing, GLP toxicology and toxico-kinetic study, incorporate New Alternative Methodologies (NAMs) approaches  

Regulatory / IND Considerations

Drives critical quality attribute strategy, analytical package, and timelines. FJBio provides IND writing support with experience across multiple IND filings.

Your development journey — key considerations


Molecule Format & Complexity

Determines CLD strategy, expression characteristics, and developability /manufacturability. FJBio provides access to various CLD platforms to best fit molecule characteristics, with early developability and manufacturability assessments.

Process Development Implications

Impacts USP/DSP strategy, upstream productivity, downstream recovery/yield, formulation, and stability. FJBio's integrated USP/DSP team designs one coherent process, with high-throughput scouting runs to select optimal conditions early.

Exploratory and regulated toxicology

Dose-range finding, tissue cross-reactivity, immunogenicity assessment and ADA testing, GLP toxicology and toxico-kinetic study, incorporate New Alternative Methodologies (NAMs) approaches  

Regulatory / IND Considerations

Drives critical quality attribute strategy, analytical package, and timelines. FJBio provides IND writing support with experience across multiple IND filings.

12 Months to Your First Clinical Batch

Process & Deliverables

FairJourney Bio's integrated approach seamlessly connects discovery to GLP toxicology and to CMC, with parallel workstream management that eliminates the sequential delays of fragmented vendor management.

12 Months to Your First Clinical Batch

FairJourney Bio's integrated approach seamlessly connects discovery to GLP toxicology and to CMC, with parallel workstream management that eliminates the sequential delays of fragmented vendor management.

12 Months to Your First Clinical Batch

Process & Deliverables

FairJourney Bio's integrated approach seamlessly connects discovery to GLP toxicology and to CMC, with parallel workstream management that eliminates the sequential delays of fragmented vendor management.

Workflow

01

Customer onboarded via MSA

Partner signs a Master Service Agreement with FJBio: establishing the single contractual relationship for the entire preclinical development program

02

FJBio signs MSA with vendors required for the program

FJBio contracts directly with the selected service providers: the partner has no direct contractual relationship with any vendor

03

Vendor preselection

FJBio has preselected various toxicology and NAMs CROs and CDMOs to cover all possible program needs

04

Vendor fit to program

FJBio presents the selected vendor recommendations to its partner with molecule fit, technical capabilities, timeline and pricing

05

Vendor invoices FJBio

All vendor costs are invoiced directly to FairJourney Bio

06

FJBio invoices customer

Partner receives a single consolidated invoice from FJBio — one invoice, full transparency, no vendor management overhead

What You Receive

  • Compliant IND package for the Pharmacology, Toxicology and CMC sections: all reports required for submission

  • Exploratory and regulated toxicology strategy including use of NAMs as appropriate, relevant toxicology species argumentation, immunogenicity assessment

  • First-in-human starting dose selection based on pharmacology, PK and toxicology data and M&S

  • Clear manufacturing plan including toxicology batch up to Phase 1

  • Smooth GMP transfer and defined clinical path

  • Single framework contract with FairJourney Bio

  • Single invoice across vendors

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