Background
Navigating the Drug Development Journey
The Early Stages of Drug Development: Discovery and Preclinical
The early stages of drug development include discovery and preclinical research. During discovery, researchers identify and test new compounds with potential therapeutic benefits. In preclinical research, these compounds are further evaluated in laboratory and animal studies to assess their safety and efficacy. If a compound shows promise in preclinical research, it may move on to the next stage of development.
The Clinical Stages of Drug Development
Clinical stages of drug development involve testing the new drug in human subjects to evaluate its safety, efficacy, and dosing. Clinical trials are conducted in three phases, with each phase serving a different purpose and involving increasing numbers of patients. Phase I trials assess safety, Phase II trials assess efficacy, and Phase III trials confirm efficacy and monitor side effects in a larger patient population.
The Path to Approval
In the US, the FDA is responsible for evaluating and approving new drugs for marketing. The approval process typically involves several steps, including submission of an Investigational New Drug application, review of clinical trial data, and review of a New Drug Application. The FDA may also conduct its own inspections and assessments of the drug's manufacturing facilities. Approval from the FDA is required before a drug can be marketed and sold in the US.
In Europe, the European Medicines Agency (EMA) is responsible for evaluating and approving new drugs for marketing. The approval process in Europe is similar to that in the US, with a focus on the safety and efficacy of the drug as demonstrated in clinical trials. The EMA also evaluates the quality of the manufacturing process and the risk-benefit ratio of the drug. Approval from the EMA is required before a drug can be marketed and sold in Europe. Since Brexit, in the U.K. drugs must be approved by the MHRA (The Medicines and Healthcare products Regulatory Agency).
Oter countries have their own regulatory agencies and many only review approval applications after a drug has been approved in the EU or the US.
The Need for Licensing in the Pharma Industry
The pharmaceutical industry has a strong need for licensing new drugs from biotech companies. With a constantly evolving landscape of medical conditions and treatments, pharmaceutical companies are always searching for the next innovative drug to add to their portfolios. This creates significant opportunities for biotech companies like ours, as we work to bring new treatments to market through licensing and collaboration agreements.
It's estimated that approximately 35-40% of drugs in the pharmaceutical industry come from external collaborations. This highlights the importance of partnerships and licensing agreements in the industry, and the potential for success through these types of arrangements. Our company's strategic approach to partnering with pharmaceutical companies aligns with this proven track record, and we believe it offers a solid foundation for bringing our treatments to market.
Partnering for Progress:
A winning strategy for success
Our company's strategy of partnering with pharmaceutical companies to complete development and commercialize our drugs is a solid approach with reduced risk. By leveraging the resources and expertise of our partners, we are able to bring our treatments to market more efficiently and with a reduced level of risk. With the strong need for licensing in the pharmaceutical industry, we believe that our approach will allow us to succeed and make a positive impact in the treatment of CNS diseases.