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What comes next after your drug discovery and safety assessment phase is nearly complete and you have secured funding? What are the relationships your company needs to build to continue your drug development program? What do you need to get into first in human clinical trials successfully? From partnering with a contract research organization (CRO) to helping your company conduct preclinical studies and clinical trials to discussing the intellectual property with a patent attorney, here are some tips for moving your drug to the next phase.

When to Contact a CRO

Regulatory processes and clinical studies have become more complex in recent years. Specialized knowledge is needed for smooth drug development. In-house experts can be expensive. Instead, many pharmaceutical companies are outsourcing to CROs, and biotech start-ups may rely on CROs to perform up to 90% of their tasks. Before starting your preclinical program or initiating clinical trials, consult with a CRO to develop a customized plan. If you choose a CRO that specializes in early clinical development, they will already have the expertise and resources needed to provide regulatory guidance and conduct the trials for you. This streamlines the process, with far fewer moving parts in the process.

How to Protect Your Intellectual Property

The individual set of circumstances for your company and drug can help determine when it’s the right time to start thinking about intellectual property protection. This may have been done when a therapeutic indication and mechanism of action were identified or when one or more compounds were discovered and selected. There is also a question of whether you should include one or more lead candidates in one application, or they should be separate. Your company needs to contact a lawyer early in the process so that they can help you navigate IP law complexities and help you find the best decision that suits your needs.

Understanding Regulatory Bodies

You must familiarize yourself with the requirements of the regulatory bodies in every country in which you hope to gain approval. In the US, for example, you will need to make an Investigational New Drug submission to the Food and Drug Administration. At the same time, there are several paths in Europe to regulatory approval. You might need to file applications with an individual or multiple agencies, or you might be able to submit a Clinical Trial Agreement with the European Union’s European Medicines Agency. You can begin by gathering information on animal pharmacology and toxicology studies, manufacturing information, and completing your investigator brochure, which you will need to submit. Meet with regulatory authorities as soon as possible to ensure your plan meets their requirements.

About Altasciences

Altasciences, a mid-sized drug development solution company, has more than 25 years of research experience. Altasciences has used an innovative approach to build a foundation that pharmaceutical and biotechnology companies have come to rely on. Clients are guided through the drug development process with tailor-made program roadmaps, from lead candidate selection to preclinical to clinical proof of concept, and beyond. Altasciences offers their partners expertise in various study types and therapeutic indications. Altasciences has key experience in CNS clinical trials, first-in-human clinical trials, and Ethnobridging. The CRO provides access to dedicated Phase 1 clinical trial units across North America in both the USA and Canada. Those resources include access to over 580 beds, a database with more than 400,000 potential participants, and a highly trained and experienced staff. Altasciences is the perfect choice for drug development for sponsors that need dedicated and integrated CRO/CDMO services.

Altasciences is ready to streamline your early clinical development at https://www.altasciences.com/

Original Source: https://bit.ly/3JNuEbd

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