Service

Preclinical Strategy

A study-by-study plan from lead candidate to IND. Model selection, endpoint choices, go/no-go gates, timelines, and budgets. Flexible scope, shaped on an intro call

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Why This Roadmap Is Different

Built by someone who has designed IND-enabling programs and evaluated them. That combination informs what ends up on the page

Hands-On Industry Experience

BridgeLine brings operator experience designing and executing IND-enabling programs at Spark Therapeutics and StrideBio, plus buy-side evaluation at Sarepta Therapeutics. That mix informs every plan.

Study-Level Specificity

Models, endpoints, success criteria, budgets, and CRO shortlists specified for each study. Not strategy slides with TBD timelines. One engagement cut 14 months off a client's development timeline through study sequencing decisions that came out of this process.

2-4 Week Delivery

BridgeLine delivers in 2-4 weeks. The person scoping the work is the same person doing it.

What the Roadmap Includes

Four workstreams, one integrated deliverable. Every section supports your team and your regulatory path

01

Unmet Need and Positioning

A clear competitive position anchors everything else. This section builds the case for why this target, this indication, and why now.

Target rationale that connects mechanism to clinical differentiation
Competitive landscape with explicit positioning against current SOC and pipeline
Indication selection grounded in unmet need, feasibility, and market opportunity
Narrative framing that connects target, indication, and timing into a coherent story

02

Study-by-Study Plan

Exactly what to run, when to run it, what it costs, and what a successful result looks like.

Model selection with species, strain, and scientific rationale for each study
Endpoint design with predefined success criteria and go/no-go triggers
Timeline with milestones, decision gates, and critical-path dependencies
Budget with quarterly capital requirements and burn-rate projections
CRO shortlists with selection criteria and specific recommendations
Biomarker strategy with sample types, collection timepoints, and connection to future clinical endpoints

03

Regulatory Path

Designed so every study is aligned with FDA or EMA expectations from the start, reducing the risk of costly repeats.

IND/CTA submission timeline with FDA or EMA requirements specific to your modality
Dose rationale framework (MABEL/NOAEL) with the data each agency expects to see
Pre-IND meeting strategy, briefing document outline, and question list
Nonclinical package gap analysis with study-specific remediation steps

04

Board and Investor Deliverables

Packaged for direct use in board decks, investor conversations, and internal planning. The board, the team, and outside reviewers all see the same coherent plan.

Visual timeline with milestones and decision gates
Risk register with specific mitigations, not generic categories
Gap closure plan with specific studies, timelines, and costs to resolve each gap
Executive summary ready for board decks and investor conversations

What Your Roadmap Looks Like

Every study is specified at the level a CRO can quote against and a board can evaluate

Study-by-Study Plan (Sample)

Study	Model + Rationale	Timeline	Budget
Efficacy POC	KO Mouse (target homology validated)	12 wks	$85K
Biodistribution	NHP (FDA precedent for vector class)	16 wks	$280K
28-Day GLP Tox	Rat + NHP (ICH S6/M3 aligned)	24 wks	$450K

Go/No-Go Gate: Post-POC

Proceed to IND-enabling if efficacy exceeds predefined threshold in disease model. Clear decision criteria at each gate so resources are committed only when the data supports it.

Illustrative example. Your roadmap is built around your specific program, modality, and regulatory path.

Flexible scope

Every engagement is shaped on the intro call. Scope can cover a single study plan, a full IND-enabling roadmap, or anything in between. Timeline and deliverables are set based on what you need.

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Who This Is For

Teams building toward a fundraise, a partner meeting, or a board review who want a clear, specific plan

Seed/Series A Biotech

A lead candidate and a fundraise on the calendar. A plan specific enough to execute on and clear enough to bring into investor and partner conversations.

Academic Spinouts

Promising discovery data, but no development plan that translates the science into timelines, budgets, and risk-adjusted milestones.

Multi-Program Companies

Multiple programs competing for capital. The Roadmap gives each program the study-level specificity, regulatory clarity, and budget projections needed to make honest portfolio allocation decisions.