Drug sponsors looking to initiate clinical trials for new products must first secure approval from regulators. This authorization can only be granted following an Investigational New Drug (IND) submission, and the entire development process is on hold until approval is granted. In the U.S., regulators have 30 days to respond to an IND submission. They can either approve the submission or ask for additional information. If additional information is sought, the submission is put on clinical hold until the sponsor corrects the deficiencies found. The ultimate goal of an IND submission is to provide data to regulators assuring them the product is safe for human use.<\/p>\n\n\n\n
A regulator\u2019s review process focuses on protecting study participants from any “unreasonable risk of significant illness or injury” during early clinical trials. INDs lacking sufficient safety evidence may face a “clinical hold” until the completion of a thorough review.<\/p>\n\n\n\n
While only 9% of applications are placed on clinical hold1<\/sup>, such a designation can swiftly derail a program. For drug sponsors addressing rare diseases or responding to widespread emergencies, delays due to clinical holds can have costly consequences.<\/p>\n\n\n\n There are three sections of IND applications that regulators need: preclinical testing data; chemistry, manufacturing, and controls; and clinical protocol or investigator information. These are some of the key elements of a submission.<\/p>\n\n\n\n Applications for IND vary across new and existing drugs, with specific FDA pathways for each category.<\/p>\n\n\n\n Pre-IND meetings allow questions related to the initial first-in-human (FIH) study for new drugs and biologics. To initiate this process, a formal request should be directed to the relevant Review Division overseeing products in the therapeutic area of the IND application.<\/p>\n\n\n\n The Office of New Drugs (OND) oversees pre-IND consultations, determining whether the benefits of a new drug outweigh its known risks. The OND offers guidance on various aspects, including:<\/p>\n\n\n\n Pre-IND interactions begin with written comments and may progress to teleconferencing or in-person meetings. Sponsors should prepare a briefing package, including Chemistry, Manufacturing, and Controls (CMC) data, preliminary pharmacology and toxicology data, Drug Metabolism and Pharmacokinetics (DMPK) data, and a clinical protocol with investigator information.<\/p>\n\n\n\n When to Schedule: <\/p>\n\n\n\n 1 <\/sup>Lapteva L, Pariser AR. Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold. J Investig Med. 2016 Feb;64(2):376-82. doi: 10.1136\/jim-2015-000010. PMID: 26911627.<\/sub><\/p>\n\n\n\n <\/p>\n\n\n\n <\/p>\n\n\n\n As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec\u2019s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, advanced therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the third consecutive year in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need \u2013 and to realize the vision that “every drug can be made and every disease can be treated.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":" Drug sponsors looking to initiate clinical trials for new products must first secure approval from regulators. This authorization can only be granted following an Investigational New Drug (IND) submission, and the entire development process is on hold until approval is granted. <\/p>\n","protected":false},"author":16,"featured_media":7688,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","content-type":"","footnotes":""},"categories":[8,40,11],"tags":[37],"yoast_head":"\nWhat goes into an IND submission?<\/h3>\n\n\n\n
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IND applications for new versus existing drugs<\/h3>\n\n\n\n
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Scheduling a pre-IND meeting<\/h3>\n\n\n\n
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<\/strong>A pre-IND meeting offers a unique opportunity to engage with regulators and ensure a comprehensive IND application. A successful outcome helps minimize errors and clinical holds. Typically, regulators respond within 21 days, and meetings are scheduled within 60 days of the request. Thus, sponsors should aim to submit their request approximately two months before the desired meeting date. However, compiling the required information demands extra time and resources, underscoring the complexity of the IND submission process.<\/p>\n\n\n\n
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