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Eliminating non-viable compounds early saves $100Ms in Drug
Development Costs
Janet Woodcock, Acting Deputy FDA Commissioner states:
"There is
not enough research in finding new methods of understanding toxicology at the
basic scientific level... Improving any one of these issues could achieve a
10% improvement in predicting failures before clinical trials and could save
$100 million in development costs per drug."
The NTC Saves
Companies Time and Money, while Reducing Risk
The reasons for performing thorough neurotoxic evaluation on
promising compounds early in the drug development process are obvious:
1. Time and Resource Savings: Redesigning or eliminating neurotoxic compounds
early -possibly eliminating or reducing behavioral testing- ACCELERATING time
to market for viable, safe compounds
The NTC
protocols reduce development cycle times, reduce regulatory approval
timelines, and enable more effective use of R&D resources. The NTC provides a
new mechanism to "weed out" non-viable compounds. Resources can then be
directed toward modifying non-viable compounds, refocused on viable candidates
or reassigned to new candidates. Fewer resources are required to accomplish
the same amount of productive work. In addition, the NTC protocols are
executed rapidly so they will reduce cycle times for testing while meeting or
exceeding regulatory approval requirements.
2. Cost Avoidance: Preserving R&D money for NEUROSAFE compounds
Systematically
screening compounds for neurotoxicity eliminates non-viable compounds from the
development cycle. Removal of these drugs is a cost avoidance that will reduce
operating expenses. NTC's Short Term Effects Screening protocol is designed to
identify drugs exhibiting the highest potential for neurotoxicity based on a
single exposure to the drug. Based on industry average cost estimates to
develop one marketable drug, NTC would have to discover neurotoxicity in only
a small percentage of drug candidates for NTC clients to save considerable
operational costs, as suggested by Janet Woodcock (above).
3. Long Term Risk Mitigation: AVOIDING LIABILITY resulting from the delivery
of a neurotoxic drug to market
The NTC is
designed to protect both companies and consumers. The most advanced scientific
assessments of neurotoxicity, and of aggressively designed protocols, prevent
gaps in detection and false negatives. As a result, companies using NTC
certification are confident they have assured the safety of their product,
which protects not only consumers but also protects the companies from
negative public perception and potential litigation due to subsequent clinical
discoveries of neurotoxicity. |
