Challenge
In discovery and pre-clinical development, you may not know what you don’t know, or have the bandwidth or expertise to address every challenge. Creating a clear and compelling product strategy, deciding which asset to advance and preparing for a smooth entry into the clinic requires rigorous cross-functional thinking. At this stage, critical gaps or fragmented decisions can lock in weak strategies, delay first-in-human readiness, and undermine investor confidence before your programme has truly begun.
How we can help you
- Product strategy, target product profile (TPP) and translational plan
- IND/CTA readiness and Gap Analysis
- Fractional Medical, Nonclinical, Regulatory and Commercial leadership
An investable proposition meeting medical, regulatory and commercial criteria
Biopharma needs a clear and investable proposition. A convincing cross-functional product strategy and a TPP are critical to identify the essential and desirable criteria for asset selection. A strong translational plan should then show how these criteria will be tested in nonclinical and clinical development to inform go/no-go decisions, thereby defining – if successful – the platform for the next stage of investment. Emerging biopharma often lack the full cross-functional expertise and experience to define these requirments, leading to difficulties in developing and executing a robust translational plan. Selecting the right asset depends critically on defining a commercially viable TPP.
tranScrip Solution
tranScrip works with you to create a clear product strategy and associated TPP, accompanied by a translational plan which allows you to make confident, evidence-led decisions at critical early inflection points, including asset selection. Acting as an extension of your team, we ensure all medical, regulatory, commercial and operational considerations are made, creating an investable proposition at all stages of your development.
What tranScrip provides
- Product strategy and TPP
- Asset selection
- Translational and early clinical strategy
- Development pathway planning
- Scientific/medical/commercial input into value proposition
- Pharmacokinetic (PK)/Pharmacodynamic (PD) modelling and dose optimisation for clinical planning
Proven Success
Indication Priotisiation & TPP Strategy
With an IND submission required in just 2–3 weeks, tranScrip provided focused regulatory and medical writing support to prepare critical IND-enabling documentation, manage late-arriving data, and deliver a submission-ready package within 5 days and 10% below budget.
Being truly ready to enter the clinic
Biopharma teams often approach clinic entry without true readiness, as strategy and execution develop in silos across science, regulatory, and operations. Early plans may be misaligned with medical, regulatory, operational, or funding expectations—leading to delays, setbacks, and failure to generate decision-grade data at critical inflection points.
tranScrip Solution
tranScrip delivers focused IND/CTA readiness and GAP analysis to ensure scientific coherence, regulatory defensibility, and cross-functional alignment. We support first-in-human (FIH) clinical trial strategy, protocol development, and regulatory interactions, which enable confident clinical entry while protecting timelines, investment, and asset value.
What tranScrip provides
- IND/CTA readiness assessments
- GAP analysis across nonclinical, clinical, regulatory, chemistry, manufacturing and controls (CMC)
- Exploratory clinical plans and FIH clinical trial synopsis, with full protocol as needed
- Nonclinical plans supporting clinic entry
- Early regulatory interactions
- Pre-IND and/or pre-CTA scientific advice preparation
- Regulatory and technical due diligence
- Medical writing (authoring and content strategy of key documents)
Proven Success
Time Sensitive IND Submission
tranScrip provided focused regulatory and medical writing support for a pre-clinical EGFR inhibitor programme facing a compressed IND timeline, delivering key documents including the nonclinical overview and Investigator Brochure despite late-arriving data and limited reviewer availability.
Building confidence to secure funding and momentum
Biopharma companies often struggle to build sustained confidence as they approach first-in-human (FIH) studies and associated critical funding milestones. Limited internal skills/experience and increasing programme complexity can strain capabilities to design and execute strategy effectively. This situation creates gaps in strategic clarity, delivery momentum, and investor-ready positioning at a pivotal stage of growth.
tranScrip Solution
tranScrip provides senior, flexible medical, nonclinical, regulatory, commercial and operational leadership to biopharma companies seeking high-calibre expertise without full-time hires. Our Fractional Chief Medical Officer (CMO) and fractional nonclinical, regulatory, commercial and operational leaders act as accountable members of your team—shaping strategy, overseeing execution, and ensuring a coherent, defensible development path aligned to key value inflection points. With clear, credible board and investor-facing leadership, we strengthen fundraising, partnering, and the confidence and momentum needed to advance successfully.
What tranScrip provides
- Fractional CMO
- Fractional nonclinical leadership
- Fractional regulatory leadership
- Fractional commercial leadership
- Fractional operational leadership
- Embedded senior nonclinical/medical/regulatory/commercial advisors
- Programme governance and senior oversight
- Board/investor-facing medical, regulatory and commercial input
Proven Success
Fractional CMO Leadership for a Novel Parkinson’s Candidate
tranScrip provided experienced fractional CMO leadership for a virtual biotech advancing a novel Parkinson’s disease candidate, helping guide the asset into the clinic, establish a comprehensive Quality Management System, and deliver early-phase clinical data that supported an ahead-of-schedule sale to a Top 50 pharma company
Fractional CMO Offering
At the discovery and pre-clinical stage, tranScrip’s fractional CMOs provide the senior medical leadership needed to shape product strategy, refine the target product profile, define a credible translational and regulatory path, and prepare programmes for first-in-human with confidence. Working as embedded partners, they help clients make better early decisions, reduce development risk, and build investor confidence without the fixed cost of a full-time CMO.
