Save Your Project from an Unjust Death

Signs of liver toxicity from experimental results can mean that a project is killed or investors walk away, but this is often an inappropriate response. Liver toxicity is a highly complex issue and in an attempt to provide some light on the issue the FDA has recently published guidelines on Drug Induced Liver Injury (DILI). These guidelines set the regulatory standard and take a very pragmatic position on liver tox and encourage industry to likewise take a pragmatic view.

However Companies need help in reviewing data and taking that pragmatic view, in response to this IDA consultants have made available a number of experts to provide the review that will help you:

• DON’T kill your project without good cause
• DO understand what the data actually means
• PLACE your results in therapeutic context
• REASURE investors with expert opinion

Liver Toxicity Data Review and Expert Opinion

Worrying liver tox results can come from a number of sources:

• Pre-Clinical
• Clinical
• In-Vitro
• Metabolite Studies
• Class effects

IDA consultants has arranged a group of high caliber experts, all with masses of FDA and EMEA experience who can review your data and make recommendations that put it in context of the DILI regs and the therapeutic / technology risk profile:

• PK/PD
• Standards of Care
• Co-morbidities
• Product specific factors
• Risk/Benefit ratio

Re-capture the value in your project

The outcomes of this work is an expert report that puts the Liver tox data in context, and puts the value back in your technology. The expert report is of a standard suitable for investors, and regulators alike.

This review can save your project from an un-just death, and is available from £7000. The first step is to organize a Free review so you can understand the options available for your technology without spending a penny.

Get in touch for your free Consultation.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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