Demonstrating potential of drug and device candidates.
Biotechnology companies continue to drive innovation at the frontlines of pharmaceutical research and development. The continued growth of this industry is, in part, supported by partnerships, mergers and acquisitions. To ensure the success of such agreements, organisations and investors will need to understand the value of assets and to determine the optimal development pathway for them.
ICON can increase efficiency in this process by assisting biotechnology companies with portfolio prioritisation and technical and commercial evaluation of out- or in-licensed assets. These services include:
- preclinical review for pharmacology, toxicology and drug metabolism, clinical pharmacology and PK/PD model review, CMC and supply chain, clinical and commercial assessment including forecast and pricing review.
- advising on clinical development strategy including clinical trial design, endpoint selection and statistical considerations, cost and timeline assessments and regulatory strategy.
ICON due diligence experience
Many small biotechnology companies and investors lack the internal expertise to assess every element of a particular asset. For investors thinking of investing in an asset or series of assets we take a holistic look at all the data the sponsor has generated and interpret that in the wider context of the proposed target product profile, current standard of care and the potential pathway to regulatory approval and reimbursement. This involves the coordination and collaboration of multiple subject matter experts within ICON.
ICON has experience reviewing regulatory, pre-clinical, CMC, clinical and commercial information on behalf of many biotech and investment clients for the purposes of acquistion, partnership, divestment or investment.
Our due diligence process consists of a three stage approach:
- Pre-diligence: A small team of high level experts will assess information available in the public domain to determine the potential opportunity for an asset.
- Stage one: The asset will undergo further evaluation by a more specilaised team of experts, often involving the assessment of confidential information provided by the sponsor and to highlight areas for further diligence in the next stage.
- Stage two: Subject matter experts will conduct a detailed analysis of the risks highlighted in the previous stage to fully assess the opportunity for investment and deal structuring.
When it comes to valuation of the cost of development or assessment of a product’s market potential, our team has assessed more than 70 assets in over 40 indications across 10 therapeutic areas. These assets have spanned a variety of modalities including small molecules, biologics, regenerative medicines and vaccines, in addition to medical devices.
Pricing and market access
With over 650+ product launches, ICON provides in-depth pricing and market access expertise with integrated, cross-functional health economics, medical and value communications, patient-centred outcomes, real world evidence, regulatory and clinical teams to define, capture and communicate the value of novel medical therapies for optimal commercial results and greater patient access.