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investigational new drug application

Filing an Investigational New Drug (IND) application in the United States (US) requires careful planning and early engagement with the Food and Drugs Administration (FDA). Key strategies for success include initiating a pre-IND meeting to receive feedback, aligning dose data with FDA safety assessments, and ensuring IND-enabling studies and chemistry, manufacturing, and controls (CMC) practices meet regulatory standards. Following these steps can effectively address potential issues and streamline the approval process.

Early Engagement and Strategic Planning

Initiating an early dialogue with the FDA through the request of a pre-IND meeting is suggested. This allows for the presentation of the compound and program to the FDA review team and receiving valuable feedback before an IND submission. The time invested in requesting, preparing a briefing package, and awaiting the FDA’s response can help mitigate program delays by addressing potential deficiencies before an IND filing. This increases the chances of success for IND approval. A pre-IND meeting facilitates alignment on the design elements of a first in human study, achieved by preparing a well-written briefing package and sharing a draft protocol for the FDA to comment on key study elements. These include the choice of primary and secondary endpoints, possible inclusion of a biomarker, agreement with the patient population defined in the protocol, planned statistical analyses, starting dose, and overall trial design. Furthermore, the meeting provides an avenue for obtaining early FDA feedback on the clinical development program.

Aligning Dose Data with FDA Safety Assessments

Dose Data With FDA Safety Assessments

In the briefing package supporting the meeting, inclusion of data justifying the starting dose and dose escalation for the study is crucial. Establishing plans for determining appropriate recommended phase 2 regimens for the next study is essential. Before submitting and IND, it is crucial to ask the FDA to ensure that the starting dose, dose escalation plans, and regimen are supported by data acceptable for the safety assessment regarding a subject’s exposure. This alignment helps ensure that the proposed dosing strategy meets regulatory expectations and mitigates safety concerns.

At this point, FDA may not be familiar with the program or the sponsor. If FDA has safety concerns, whether related to dosing or any other aspect of the study, it is beneficial to learn this now so that these elements can be modified or further supported with data in the actual IND filing. Learning of any deficiencies or safety concerns from FDA prior to actually filing an IND can prevent potential delays to the program overall, or even prevent a clinical hold based on FDA’s initial review of the IND. This proactive approach can save time and ultimately benefit the program by opting for the pre-IND meeting.

Effective IND-Enabling Pharm/Tox and CMC

This information requires description in the pre-IND meeting package, with appropriate questions posed to the FDA to gain useful and actionable feedback. It is important to ascertain whether the FDA agrees that all work has been adequately conducted and the data could support your first in human study, or else understand directly from the FDA what may be unclear, unclearly presented, or possibly incomplete. In other words, it is crucial to understand the FDA’s concerns and how these concerns can be mitigated in the IND filing.

This means that the sponsor needs to describe the IND enabling non-clinical pharmaceutical and tox studies that have been conducted and are in progress, and the data to support the clinical study that is proposed to the FDA and IND. This information should be presented in the briefing package in a manner that conveys that the IND filing will meet the FDA’s expectations, all requirements will have been met, and there will be no potential safety concerns left unmitigated.

Compliant CMC

From a CMC perspective, the information in module 3 of the IND filing needs to be accurate and complete, but not overly detailed, depending on the phase of the proposed study. In the pre- IND-meeting briefing package, it is important to explain the plan for the IND, provide the scientific rationale that demonstrates control of the drug’s identity, strength, potency, purity, quality, and health safety.

The agency will focus on the review of the IND on whether the drug substance center product can be consistently manufactured in compliance with good manufacturing practices (GMP) and whether the drug is reflective of what was used in the supportive non-clinical study. At the end of the day, the primary concern in a US IND is subject safety. This will be evident in the data presented, the quality and consistency of your manufacturing information, and the design of the clinical trial.

The pre-IND meeting provides a valuable opportunity to ask relevant questions of the agency and receive feedback. This allows for the mitigation of risks that could result in the IND filing not being cleared in 30 days and having to start over. This could result in significant time and financial costs. Therefore, requesting a pre-IND meeting at the onset is highly recommended.

Successfully filing an IND application in the US requires strategic planning and early FDA engagement. Key steps include pre-IND meetings, aligning dose data with FDA safety assessments, and ensuring compliance with regulatory standards to streamline the approval process.

Let’s shape the future of research and make a difference in the industry, gain Indero’s support in your upcoming trial and propel your study to new heights.

About the Author 

Staci Ellis

Staci, Vice President and Head of Regulatory Affairs at RegDev Inc, has extensive experience in both small and mid-size companies, she excels in late-stage to commercial and early-stage regulatory affairs. Known for her strategic, diligent, and articulate approach, she is a constructive team member with a quality mindset. Staci has successfully filed numerous complex regulatory submissions in areas such as oncology, diabetes, and infectious diseases. She enjoys mentoring and leads with kindness. Her expertise includes regulatory submission, eCTD, FDA, IND, regulatory strategy development, biotechnology, biopharmaceuticals, and pharmacovigilance.

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Jeff Smith

Chef de la direction

Jeff Smith, Chef de la direction d’Indero Recherches, apporte prĂšs de 30 ans d’expĂ©rience dans l’industrie pharmaceutique et CRO, s’Ă©tant distinguĂ© par son leadership exceptionnel, sa vision stratĂ©gique et son innovation. L’expertise de Jeff couvre des opĂ©rations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matiĂšre de crĂ©ation de valeur, de gestion des partenaires et d’opĂ©rations CRO ont toujours contribuĂ© au succĂšs dans ses fonctions prĂ©cĂ©dentes. Sous la direction de Jeff, Indero continue d’étendre ses capacitĂ©s, faisant progresser les connaissances mĂ©dicales et les nouvelles thĂ©rapies en dermatologie et en rhumatologie.

Is Now

We are excited to announce that Innovaderm is rebranding our CRO division as Indero (in-dAIR-oh). This rebranding reflects our ongoing commitment to innovation and our expansion into the field of rheumatology, a therapeutic area closely linked to dermatology. As a dual-focus CRO specializing in both dermatology and rheumatology, this strategic decision marks a significant milestone for our organization, and we are eager to embark on this new chapter with our valued partners and clients. Additionally, our Clinical Research Unit (CRU) will keep the name Innovaderm and will continue to conduct dermatology studies.