Quick Guidelines for Identifying a CRO with Experience with IND Applications

The Food and Drug Administration of the United States reports receiving an increased number of applications for investigational novel medicines (INDs) in recent years.

Pharma Tech Outlook | Monday, January 17, 2022

The global pharmaceutical industry has a bright future ahead of it in terms of medication research and development. CROs will play a critical role in new medication research and development globally.

FREMONT, CA: The Food and Drug Administration of the United States reports receiving an increased number of applications for investigational novel medicines (INDs) in recent years. A few years ago, the annual number of IND applications submitted was in the 300-400 range. Nonetheless, the FDA received 675 IND submissions during the 2018 fiscal year. And in the first three quarters of 2019, 487 applications were submitted. This increase in IND submissions is part of a global trend of increasing biotech investment, accelerating medication research and development.

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Asia, in particular, has seen a significant increase in spending. As a result, this region has developed into a biotechnology and pharmaceutical research hub. According to Pharma Intelligence, Asia currently accounts for over a quarter (23.6 percent) of the world's pharmaceutical companies. Additionally, Market Research Future forecasts that the preclinical contract research organization (CRO) market in Asia will expand significantly soon.

Biotechnology and pharmaceutical businesses understand the stakes when selecting a CRO partner. As a result, sponsors must thoroughly assess CRO candidates to guarantee they can sustain them during preclinical testing, Phase II, and beyond. Biotechnology and pharmaceutical firms seeking confidence in their CRO selection can perform the following while evaluating candidates:

INQUIRE IF CRO CANDIDATES OFFER A FORMAL IND PACKAGE

Developing and submitting an IND application to the FDA is a time-consuming process. The more experience a CRO has with IND applications, the more equipped it will be to execute a strategic preclinical program and compile a comprehensive and expert appraisal of a drug candidate. Because experience and expertise are critical, sponsors should seek a CRO partner to provide a formal IND package. Inquiring about a prospective CRO's IND offerings will reveal how frequently the CRO completes IND applications and whether this service is actually within the CRO's wheelhouse.

Sponsors are required to submit preclinical data with their IND application. In an ideal world, a sponsor would collaborate with a single CRO that could plan, execute, and conduct all relevant studies. Working with a single CRO rather than several CROs is preferable since it ensures continuity rather than disjointedness during research investigations. A seasoned CRO with a formal IND offering should understand FDA preclinical study standards and manage all stages of the process efficiently.

PREFER FULL-SERVICE APPLICANTS WITH A GLOBAL PRESENCE

By selecting a full-service CRO with global capabilities, the medical researchers not only ensure mobility and the ability to conduct testing in multiple locations, but they also make it easier to adhere to the quality standards set by the China FDA, Taiwan FDA, US FDA, and EMA registration. As a result of these considerations, any applicants shortlisted should be global CROs.

Consider the advantages of conducting preclinical research in one region and conducting clinical trials in other parts of the world. To begin, there is the possibility of financial savings. In the United States, establishing an IND entails a large upfront price and significant research expenses. However, the process is frequently faster and less expensive in other places. Investigating opportunities to undertake early research outside the United States can help reduce costs. Not only are financial savings possible, but having the option to research more than one location enables studies to be conducted in areas with readily available patients. For instance, a global CRO partner may undertake cost-effective preclinical testing in Asia and subsequently relocate clinical trials to the United States to gain access to patients with specific disease indications.

The notion is that shifting between locations throughout various research periods might be useful. However, it necessitates a CRO with global competencies and the ability to facilitate the seamless transfer of information throughout the firm. As a result, preference should be given to full-service applicants with a global presence when assessing CRO prospects.

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