UK Department of Health Funding for a Zika and Chikungunya Vaccines
How GRA worked with a vaccine company to raise £3 million in funding for the development of a Zika vaccine.
Maximising commercial value across the product lifecycle
Strategic insights and planning to drive commercial success at every stage.
GRA delivers business intelligence and strategic planning to support clients across all commercial aspects of their programs. Whether it's ensuring robust preparedness for fundraising discussions or facilitating successful licensing agreements, our specific expertise in performing risk-adjusted Net Present Value (rNPV) assessments (alongside other AI based assisted tools), which account for the inherent uncertainties of drug development, provides a crucial advantage.
Business Intelligence
Business intelligence involves the collection and analysis of market data, competition, licensing opportunities and regulatory landscapes. This information informs the strategic direction of the business. In addition, the intelligence underpins risk management and allows the business leaders to make confident, evidence-based decisions across development and investment timelines.
Market & Competition Analysis
Market and competition analysis evaluates unmet needs, emerging technologies and competitor positioning. Furthermore, it supports innovation and helps identify areas of strategic opportunity. Building a thorough understanding of competitive landscapes improves decisions around differentiation, timelines and commercial positioning.
Pricing Analysis
The analysis of pricing and value positioning of medicines help ensure a product is not mis-priced or poorly differentiated. Effective pricing strategies must be built on market evidence, payer expectations and benchmarking. This supports accurate valuation, risk mitigation and long-term commercial viability.
Portfolio
The portfolio analysis considers the balance and alignment of assets across development stages and therapeutic areas. It involves strategic prioritisation based on scientific promise, market need as well as timing. If managed, the product portfolio supports the long-term vision of the business while allowing greater agility around evolving scientific and commercial risks.
Licensing
Licensing strategy requires understanding deal structures, risk-sharing models and asset valuation. Regardless of whether in-licensing or out-licensing, clear expression of an asset's value, its timelines and its data supports successful negotiations. Licensing assessments must align with strategic goals as well as include due diligence on competitor assets.
Clinical & Commercial Supply Agreements
Supply agreements support product availability through clinical trials and into the market. Ensuring scalability requires specialist CDMO management and programme oversight to align manufacturing capacity with long-term commercial goals. The agreement must be fair to both parties, include realistic timelines as well as risk mitigation throughout the development and launch phases. Ultimately the agreements must be a win-win for both parties to remain viable.
Quality Control (QC)
Developed methods are used routinely to test products produced in manufacturing facilities working to Good Manufacturing Practice (GMP) guidelines. QC methods are critical for ensuring that the integrity and quality of the biopharmaceutical throughout their development lifecycle.
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frequently asked questions
Frequently Asked Questions
A biotech due diligence report is an independent, evidence-based assessment of a company, technology platform, or development-stage asset. It is usually commissioned ahead of an investment, partnership, licensing deal, or acquisition.
While the precise scope may vary, technical due diligence typically covers:
- Scientific Rationale & Proof of Concept: Mechanism of action, differentiation, and the current stage/quality of preclinical and clinical evidence.
- Regulatory Path: Reviewing filings to date, agency feedback, and the anticipated path to approval.
- Intellectual Property (IP): Evaluating IP dependencies, strengths, weaknesses, patent validity, and freedom-to-operate (FTO) assessments (undertaken alongside specialist IP counsel).
- CMC & Operational Risk: Process robustness, manufacturing readiness, and supply chain continuity.
The goal is to give the commissioning party a clear view of opportunities and risks, enabling them to make an informed decision and negotiate terms that reflect the actual value of the asset.
The core difference lies in the decision the recipient is being asked to make and the scope of the opportunity being assessed:
- Private Equity / Investment Package: Designed to explain how additional capital will create future value. It typically covers the platform technology or product pipeline, scientific and clinical rationale, competitive differentiation, development strategy, key value-creating milestones, funding requirements, use of funds, management experience, and major risks. All claims must be substantiated with evidence that withstands careful scrutiny.
- Company Sale Package: Broader in scope because the entire operating business is being assessed. In addition to scientific and development aspects, it evaluates company assets, IP, contracts, employees, financial position, liabilities, regulatory and quality compliance, CMC capabilities, manufacturing arrangements, supply chain, and operational risks. The supporting data room must provide a complete, consistent record for forensic examination.
- Out-Licensing Asset Package: Focused primarily on a specific product or platform rather than the entire corporate entity. It presents the scientific rationale alongside non-clinical and clinical evidence, competitive positioning, development plans, CMC and regulatory readiness, IP position, third-party obligations, and risk registers.