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October 31, 2017updated 18 Jul 2018 10:24am

Regulatory Considerations for the Preclinical Trial Arena

CTA staff writer, Guglielmo Migliori, provides regulatory considerations for conducting pre-clinical trials

By Staff Writer

What problems are companies in preclinical trials, especially start-up companies currently facing? Finding funds to move along in their development process is an aspect in the field that may sometimes be underrated by management teams. There’s also the failure to properly understand the process, as well as the importance of what is needed to meet the regulatory requirements established by the FDA to gain approval.

To ensure the drug candidate is approved, it is crucial to understand how to utilize the data collected and transform them into documents that comply with FDA standards. There are many factors to be aware of – the FDA may introduce new rules that may not be expected. Therefore, pharma companies need to begin deep consultations with many other experts in the business (i.e. professors and peers in the industry) in order to find ways to fund their chemical and animal tests.

Building Relationships based on Trust

Additionally, there could be a lack of communication in relationships with CROs, occasionally due to the nature of small and virtual pharma companies. It is imperative to comprehend what the pharma companies are trying to develop in their early stage trials to obtain the best results from the partnership that will take shape. Building business relationships that are based on trust is extremely important; professionals may change the organization they work, for and it is important to keep working with them, even if in a different environment.

What’s more, consultants will be sourced to represent the company and be responsible for finding business opportunities adhering to the standards, certificates and design studies. After the study, the chosen personnel must be prepared to face scrutiny from the FDA and be prepared to represent the study if it is taken to the federal body. Failing to secure a beneficial partnership could have detrimental effects on the company and could lead to economic loss, ultimately damaging your reputation. Therefore, due course must be given in establishing a clear program, outlining all relevant information with expected results.

‘Pharma companies must have enough capital’

If, for instance, a partnership is not working, this could mean a great loss for the business in economic terms throughout the course of the study. With that said, the sponsor must have a clear program with all the information needed. Many consultants will try to do the programs with flexible criteria; ideally the process must be very clear from the beginning. They need to understand how to prepare relevant programs, otherwise there would be a gross loss of money if the process is carried out incorrectly. Virtual and some small companies don’t have many resources, so they need help in trying to bring value to the company.

Pharma companies must have enough capital for the portfolio and elaborate considerations, and understand what the people they hired can do once involved. Additionally, if there’s an issue, many providers are not set up for dealing with uncommon issues and challenging matters. If they are below the usual standard, the biotech partner can attempt to fix the problem that has compromised the study.

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Confronting Vendors’ Lack of Experience

Challenges can derive from a vendor’s inexperience and inadequate techniques, which is where pharma companies can assist with training. Also, there are many factors to consider within the planning process with the most prominent being FDA changes to established rules. The most important factor is the cost of the trials, as it is possible to commit early but it is necessary to pay throughout the process; some vendors offer a collaborative service, but it may happen to be a waste of money if something they need before the process, or in the middle of it, is not performed properly. Especially in biotech, obtaining a federal grant can be a slow process as there are many facets that must be considered.

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