How can Pharmacogenetics Add Value across the R&D Chain?
Pharmacogenetics can add value in the following areas:
- Providing an increased understanding of drug response profile and therefore confidence in a positive efficacy signal; which can be particularly important at the proof-of-concept stage;
- Identifying patient subpopulations which respond best and with the least side-effects to a given development compound or marketed drug. This leads to more effective and efficient clinical trials, resulting in improved pipeline productivity. Safety concerns have lead to some high-profile and costly marketed drug withdrawals in recent years. As well as leading to increased costs and loss of revenues and shareholder value for the companies involved, there has also been an impact on the industry?s reputation, and an increased regulatory focus on the safety of medicines. This been exemplified by an FDA Guidance for Industry in December 2008. In ?Diabetes Mellitus ? Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes (Dec 2008)? it discussed various issues such as ?how to demonstrate that a new therapy.....is not associated with unacceptable increase in cardiovascular risk?, and that safety concerns were to be addressed during drug development. By identifying those patients whose genetic make-up means that they will experience side-effects when given certain drugs, the use of pharmacogenetics can help improve safety.
- Strengthening submissions for regulatory approval;
- Generating data which supports cost-effectiveness claims,
leading to increased uptake and market share. This is an important
consideration in this era of constrained healthcare budgets,
particularly since severe side-effects can lead to significant
hospitalisation costs. Various bodies are undertaking studies looking at
the cost-effectiveness implications of prescribing based on genetic
make-up. It is increasingly recognised within the biopharmaceutical
industry that globally the payers will only pay for cost-effective
drugs. In its Pharma 2020: Challenging business models. Which
path will you take?, PriceWaterhouse Coopers believes that demand for
personalised medicine is increasing , and payers are starting to pay for
performance, outcomes and value for money.
- Via post-market surveillance, improving use of existing and recently launched drugs;
- Providing opportunities for lifecycle management.
