In Vivo toxicology proof-of-concept (PoC) testing plays a crucial role in evaluating the potential risks and hazards associated with new compounds in the early stages of lead generation and pre-candidate selection, when developers are assessing the likelihood of scientific success, and investors are calculating the likelihood of financial return on their investment.

Choosing the right toxicology testing provider at this stage is an essential step in ensuring that safety, compliance and risk are clearly defined at what can be a nail-biting time for developers and investors. 

At Hoeford Research we believe early collaboration between developer, investor and laboratory alleviates many of the challenges and difficulties of communicating, presenting and interpreting in vivo PoC data, and avoids common mistakes that developers often make with their investors at this stage.

Challenges and Mistakes
Drug development companies face several challenges and potential pitfalls when presenting in vivo PoC data to investors. These include limited understanding due to the complexity of the data, lack of transparency, overselling, ignoring regulatory requirements, limited data availability, poor communication and uncertainty of outcomes. 

For investors, these factors can create unrealistic expectations and lack of confidence, and lead to disappointment. In some cases poor understanding of the data leads to poor investment decisions that create scepticism from investors and delays in the programme. In the worst cases, investors might completely lose trust in the research and stop funding altogether.

It is therefore vital that drug development companies communicate the significance of the data to their investors while effectively and objectively being transparent about the uncertainties associated with it. This is where an independent toxicology laboratory can help.

Why Collaborate?
The global systems that ensure the safety of new compounds are complex and highly-regulated because the quality and accuracy of PoC testing results ultimately have a direct impact on the well-being of patients. 

In our experience it is better that investors are not left waiting on the sidelines until the testing is over to be presented with difficult to understand results. Instead, they should pro-actively participate with their investee companies in the in vivo toxicology laboratory selection process, bringing often overlooked business and financial perspectives to a due diligence checklist that should include careful evaluation of the laboratory’s expertise, experience, accreditations, technical capabilities, turnaround times, data quality, flexibility, confidentiality, cost, and reputation. 

What Collaboration Looks Like

A collaborative model between developer, investor and laboratory can inform decision-making, risk assessment and investment justification, while enhancing the overall value of the programme. Collaboration at an early stage establishes a framework for shared expertise, resources, and insights that will pay dividends throughout the longer-term preclinical and clinical drug development process. Here’s how:
 
Regular communication: Regular communication between partners is essential. This can be achieved through meetings, progress reports, and updates on the in vivo PoC testing and data. Open and transparent communication ensures that all parties are sharing and working from the same information.

Define common goals: Partners can align on common goals and objectives, including defining the desired outcomes of the in vivo PoC studies, the level of risk tolerance, and the investment criteria. Clear goals help guide decision-making and ensure that everyone is working towards the same objectives.

Collaborative study design: While the developer and laboratory collaborate on the design of the in vivo PoC studies – which includes determining the appropriate animal models, endpoints, and study parameters – the involvement of investors in the study design can provide valuable input and ensure that the studies address their specific concerns and requirements.

Data sharing and analysis: Sharing study data allows for independent analysis and evaluation, while collaborative discussion on the interpretation of the data can help inform decision-making, especially in justifying continuing and/or additional investment.

Risk assessment and mitigation: Collective risk assessment of the potential efficacy, safety, and regulatory implications of test results means mitigation strategies can be developed collaboratively to address any identified risks and uncertainties.

Investment justification: The developer and laboratory are able to present the data on safety and efficacy of a drug candidate to investors in a clear and concise manner, highlighting the significance of the data, the potential value of the drug development programme, and the investment opportunity. Open discussions and Q&A sessions increase investor confidence and can further enhance the understanding and justification for investment, development, and commercialisation.

Benefits of Collaboration

A collaborative model between developer, investor and in vivo toxicology testing partner offers many benefits, including:

Shared expertise and resources: Sharing of expertise and resources between stakeholders allows investors to have a direct involvement in the critical “Go/NoGo” decision-making based on the in vivo PoC data.

Reduced redundancy: Sharing of data and resources avoids duplication of effort and keeps all parties focused on advancing the drug development programme more efficiently.

Improved safety and efficacy: In addition to data on the safety and efficacy of drug candidates, in vivo toxicology testing labs provide valuable experience, adding further support to decision-making and reducing the risk of later failure.

Accelerated drug development: By working together, stakeholders can identify and address challenges more quickly, leading to faster development and commercialisation of drug candidates.

Enhanced regulatory compliance: Collaboration creates an opportunity to go beyond basic compliance by also addressing ethical and regulatory challenges. These include working together to develop alternative testing methods to reduce the use of animals in testing as well as improve safety-related attrition rates. By collaborating on these issues, stakeholders can collectively enhance the ethical and regulatory aspects of drug development while improving the overall process.

By far the single most important benefit of collaboration between developers, investors, and in vivo toxicology testing labs in early-stage drug development is the reduction of risk associated with drug development. 

Engaging with an in vivo toxicology testing partner at the PoC stage provides investors with a more comprehensive understanding of the drug development programme through access to expertise and additional resources. This can reduce the risk of failure in later stages of development, accelerate the development process and enhance the overall value of the drug development programme.

Whether you are a drug development company or an investor in an early-stage programme, Hoeford Research’s 60 years of experience in regulatory in vivo toxicology testing means we deliver results you can trust, and help you understand them.

Contact us today to find out how we can help keep your Pre-Candidate Selection in vivo toxicology proof-of-concept programme on track.