Drug repurposing — finding new uses for existing drugs is an attractive means to expedite the availability of therapies for diverse diseases. Even though there is potential for repurposing the existing drugs, the number of clinical trials in drug repurposing that make their way to market is lower at an abysmal 15% success rate. The top five challenges that stand in the way of Drug repurposing and how Biotech consulting in Boston can help you overcome them are presented here.
Regulatory Hurdles
The regulatory landscape is one of the biggest hurdles in drug repurposing. The FDA and other regulatory agencies have stringent requirements for showing the safety and efficacy of repurposed drugs. Given that the original indications are already in clinical practice, this level of requirement may even be stricter for new drugs.
Intellectual Property Issues
IP rights can be a major barrier However, because many repurposed drugs are off-patent, companies find it hard to establish a profit motive to invest in the clinical studies needed to approve an old drug for use in a new disease. In addition, negotiating current patents and patent exploration can be convoluted processes and can have expensive liabilities.
Funding Constraints
In addition, obtaining funding for drug repurposing projects is often difficult. Repurposing is typically seen as less profitable than developing new drugs for investors. The financial and market costs for clinical trials, compliance of regulations, and launch are still very high.
The Term Fear in Scientific and Clinical Challenges
However, drugs that had been repurposed for new indications sometimes do not have the same pharmacokinetic and pharmacodynamics profiles. In contrast, the demonstration of the effectiveness and safety of a drug in another setting invokes numerous preclinical and clinical investigations. Furthermore, because of less recognized mechanisms of action, additional studies may be required.
Market and Commercialization Barriers
Even if a repurposed drug does well, the next struggle will be getting popular in the market. Challenges include competition with established therapies, overcoming market perception and gaining insurance reimbursement and creating a strong commercialization plan
Therein lies the potential revolution brought on by new drug repurposing procedures. Yet, strategic solutions are still needed to overcome hurdles on a large scale. However, with help from hands-on BioBoston consulting services in Boston, there are chances that you will now be able to overcome these challenges better to guarantee the success of clinical trials and their market entry. Although its high failure rate has been intimidating, drug repurposing does hold out the promise of saving new lives and represents a source of hope for newly diagnosed patients all around the world.
Conclusion
Contact BioBoston Consulting today or explore our website to discover how we can help your team.
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