The IND Filing Process and Categories
Federal law mandates that drugs have an approved marketing application for interstate transport, but developers of new drugs must distribute their potential products nationwide in order to conduct clinical trials, and so must request an exemption through an Investigational New Drug (IND) application. The FDA processes around 1,500 initial IND applications annually and assesses them primarily to safeguard the safety of study participants, but also to ensure properly designed and conducted clinical trials.
INDs are categorized as Commercial, which corporate entities file when they are intending to pursue a marketing application for a product, and Research, sought by investigators, institutions, or nonprofit organizations for research purposes, typically with the goal of publication in peer-reviewed journals.
Other IND subclasses exist, too.
Investigator INDs are for physician-initiated investigations for research or treatment purposes; Emergency Use INDs permit experimental drug use when there is insufficient time for a more formal IND submission; Treatment INDs make promising experimental drugs for serious of life-threatening conditions with no alternative treatment options available to a broader patient population prior to full FDA approval; and Exploratory INDs are used to conduct limited exposure studies prior to initiating traditional Phase 1 safety and tolerability studies.
What the FDA Seeks in an Initial IND Submission, and How to Avoid Pitfalls
An IND application covers three primary areas: Animal Pharmacology and Toxicology studies, which summarize animal studies conducted to assess the safety of the drug for administration to humans, as well as studies designed to assess the drugs mechanism of action and potential efficacy in the intended indication; Manufacturing Information, which covers the characterization, stability and, controls of the drug substance production, as well as the composition, stability, and controls of and drug product production to ensure consistent batch quality; and Clinical Information, including protocols, investigator qualifications, informed consent commitments, institutional review board review, and compliance with other investigational new drug regulations.
There are common, though preventable, pitfalls that applicants may encounter, including incomplete or inadequate nonclinical data, which can be addressed by ensuring that the package of nonclinical studies submitted in the application adhere to applicable ICH and FDA guidelines. Insufficient manufacturing information can be mitigated by providing detailed manufacturing processes, critical steps, quality control protocols, and batch consistency data. Weak clinical trial design can be avoided by crafting well-designed trials with clearly defined endpoints, safety monitoring plans, and rigorous statistical analysis plans. Lastly, inadequate regulatory documentation can be avoided by meticulously compiling comprehensive, guideline-compliant, regulatory documentation.
Pre-IND Meetings
Pre-IND meetings offer substantial value in drug development, especially when sponsors have unanswered questions beyond FDA guidelines. These interactions with FDA staff can prevent review issues from arising by providing crucial insights into the preparation of a comprehensive IND application. Benefits can include reducing time to market by avoiding unnecessary studies and optimizing relevant ones to yield meaningful data, garnering FDA support, minimizing clinical hold risk, and gaining regulatory insights from the Agency. All in all, pre-IND meetings can be vital for proactive FDA engagement, ensuring a smooth drug development journey, resource efficiency, and a clear strategy.
Real World Example
A UK pharmaceutical firm sought help for its new asthma drug’s IND activities. A team of consultants with regulatory, clinical, nonclinical, and CMC expertise was assembled to provide strategic input and guidance on the US development program.
In the pre-IND phase, the team facilitated an FDA meeting, created the pre-IND briefing document, prepared the client for the meeting, and participated on behalf of the client. After the successful pre-IND meeting, they prepared and submitted the client’s IND application. All FDA queries were addressed and satisfactorily resolved, leading to FDA clearance in 30 days.
Thereafter the team managed virtually every aspect of the client’s IND maintenance, including acting as their representative to the FDA. The collaboration’s success in overcoming obstacles resulted in the client’s full trust and reliance and a comprehensive IND application that ultimately brought the novel asthma drug to market.
Partner for Success
Drug developers benefit significantly from consulting firms when preparing IND submissions. The experts at Syner-G not only possess extensive experience across all IND phases, but also understand the nuances required to address the unique nature of each client, product, and project.
CMC and regulatory demands for new products vary widely, influenced by factors such as molecule complexity, formulation, indication, and patient population. Partnering with a consulting firm such as Syner-G provides access to expert teams specialized in various aspects of drug development, emphasizing the value of staying current with those intricate processes.
While the client can define project scope, true security lies in knowing the consulting partner can manage the product’s path further if needed. A partnership with the experts at Syner-G represents a collaboration that relies on each stakeholder’s ingenuity, talents, and experience to navigate the ever-evolving healthcare landscape and deliver new, life-saving therapies to patients.