Full-day Virtual Seminar: IND Applications for the US FDA

Instructor: Mukesh Kumar
Product ID: 702018
  • Duration: 6 hrs

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Learn in detail about INDs, the various types, its 10 essential sections, structure and content of IND, how to submit an IND, pre-IND meeting and best practices of maintaining INDs.

Why Should You Attend:

All sponsors of clinical trials in the US for drug and biologics have to first file an Investigational New Drug (IND) application with the FDA containing extensive information in support of the proposed clinical trial. Each year hundreds of new INDs are submitted to the FDA, about half of which are not cleared to proceed with the planned clinical trial within the 30 day review period mostly due to deficiencies in the information provided in the IND. Failure to submit a satisfactory IND could lead to FDA imposing a clinical hold on the clinical trial in turn adding additional expense and delay to a clinical trial.

Attend this full day virtual workshop to understand how to make sure, your next IND meets FDA requirements and gets a “Safe to Proceed” letter from the FDA within 30 days from submission. This virtual workshop contains a collection of practical tips from the trainer's extensive IND submission experience.

How It Works :

The virtual work shop has a series of modules and our speaker, Dr. Mukesh Kumar , will deliver the modules using PowerPoint slides. At the end of each module, there is an interactive portion where participants can ask questions and clarify information. These modules may include multiple-choice questions to help participants assure they understand the material. Some of the modules contain exercises for participants that help illustrate the points covered and further increase learning. The interactive portion includes a discussion of the questions and exercises.

Convenience for Attendees :

This training is convenient to attend; you just need an internet connection. You don't have to travel from your office. Your team members can learn the material together when you sign up for a group option. Who should attend? The “Who Will Benefit” will help you select the right people in your organization.

Modules to be Covered:

  1. Overview and background of FDA’s IND requirements
  2. Commercial and investigator-led INDs
  3. Structure of an IND document
  4. Granular and sectional IND creation strategies
  5. Practical approaches for an IND submission strategy
  6. Paper and electronic INDs
  7. Follow-up to an IND submission

Agenda: (All time in EDT)

  • 10.00am EDT to 12.00 noon (Session 1 and Session 2)
  • 12.00 Noon EDT to 1.00pm EDT (Break)
  • 1.00pm EDT to 3.00pm EDT (Session 3 and Session 4)
  • 3.00pm EDT to 3.15pm EDT (Break)
  • 3.15pm EDT to 4.00pm EDT (Session 5)
  • 4.00pm EDT (Q&A Session)

Detailed Area Covered in each Session:

Session 1: What you must know about an IND: Overview of FDA's IND requirements

This session will discuss the basics of an IND application along with rationale for various types of information required in an IND application. Elements of 21 CFR 312 will also be discussed in this session.

Topics Covered:

  • Historical overview of IND regulations
  • Types of INDs
  • Commercial verses investigator-led INDs
  • 10 essential sections of an IND
  • What information to be included and what to be avoided
  • Overview of practices at FDA regarding review and management of INDs

Session 2: The Structure of an IND: Content and Format of IND sections

This session will discuss the various sections of an IND with tips about which information to be included and in how much detail, suggestions about how to format the content for best presentation of information, and practical tips about including or avoiding supporting information.

Topics Covered:

  • Key elements of an IND application
  • Collecting information supportive of the IND application including product background (CMC), preclinical and clinical testing, clinical protocol, etc
  • Creating proposed clinical development plan, scientific rationale, and clinical practices to be followed
  • Using non-IND information, publications and marketing experience from other countries
  • Best practices for format and content arrangement
  • Managing the tone of the content
  • Granulating the IND content for optimum presentation of information
  • List of common mistakes and tips to address the same

Session 3: Logistics of IND Submission: Best Practices for timely good quality IND application

This session will discuss practical issues with IND creating including project management; role of different personnel is compiling individual pieces of information; and logistical issues such as compiling, printing, binding, and mailing.

Topics Covered:

  • Evaluating adequacy for available information in support of a clinical trial
  • Creating an IND submission strategy
  • Sectional IND: Parallel creation individual sections of a IND
  • Collecting cross-reference information
  • Practical tips for compiling individual pieces into a full application
  • Electronic verses paper IND submissions
  • Electronic verses paper IND submissions

Session 4: Pre- and Post-Submission Interactions with FDA for a Given IND

This session will train attendees in best methods for requesting a pre-IND meeting, preparing a pre-IND information package, logistics of the meeting, follow-up with FDA, and using information from such meetings for successful IND applications.  Also discussed will be best practices for a post-IND follow-up with FDA till approval of an IND.

Topics Covered:

  • Logistics of a pre-IND meeting with the FDA
  • Best practices for preparing a pre-IND package
  • Do's and don'ts of pre-IND meetings
  • Interacting with the FDA project manager after IND submission
  • Post-IND discussions with the FDA: Managing verbal and written comments

Session 5: Best Practices for Maintaining an IND with FDA

This session will discuss the best practices to keep an IND in regulatory compliance, and contacting FDA for guidance.  Role of the sponsor, all the reports and documents that need to be submitted to an IND, what needs to pre-approval and what can just be notified to FDA, process for IND amendments, using same IND for multiple protocols, etc will be discussed

Topics Covered:

  • IND annual reports
  • Amending clinical protocols and informed consent,manufacturing information,providing additional preclinical and clinical information,etc
  • Adverse event reporting
  • Adding new clinical protocols to or creating a new IND for each new protocol
  • Change in sponsor, vendors, investigators, manufacturers, clinical sites, etc
  • Written and verbalrequest for comments and FDA meetings for further guidance
  • Suspending, reopening, closing and withdrawing an IND

Who will benefit:

This virtual seminar will provide invaluable assistance to all sponsors, regulatory affairs and project management personnel in the pharmaceutical and biotechnology industry planning to conduct clinical trials under a US IND . Also benefiting would be : Principal Investigators and sub investigators, clinical research scientists, manufacturing personnel, clinical trial personnel, IRB personnel, and preclinical study personnel.

Instructor Profile:

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( ). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has written more than 40 new INDs for FDA submission and reviewed more than 100 INDs. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Back Ground:

An IND submission is usually the first time FDA hears from a sponsor about the development program for an investigational product. Each year hundreds of new INDs are submitted to the FDA, about half of which are not cleared to proceed with the planned clinical trial within the 30 day review period mostly due to deficiencies in the information provided in the IND. A good first step to creating a successful IND is to understand the basics of IND requirements with a rationale for the various pieces of information included in the IND. The IND application contains all available preclinical and clinical testing information, and all manufacturing information for the investigational product, along with clinical protocol, informed consent template, investigator's brochure and other relevant information.

FDA requirements for an IND include detailed information on all aspects of the proposed product such as manufacturing, preclinical and clinical testing, scientific background, proposed clinical development plan, clinical protocol, etc. This information needs to be presented in a format aimed towards clarifying the rationale of the proposed clinical trial, and for ease of review by the FDA reviewers.

But Creating an IND is a daunting task that requires a team of experts with diverse talents work in sync to create a detailed, precise and adequate document. The various sections of the IND need to be of similar quality and consistent across various sections of the application. In addition, IND projects require high level project management skills to assure timely and in-budget submission.

To get it right a pre-IND meeting is highly recommended as it provides an insight into FDA's concerns about available information and helps preempt any potential deficiencies that FDA may find upon submission of the IND. These meetings exponentially increase the likelihood of timely FDA clearance to proceed with an IND when submitted. Post-submission of an IND, FDA reviewers may need clarifications or additional information before making a decision. Not responding to FDA comments in time is a number one reason for most INDs going into clinical hold.

An IND is a “living” document. A sponsor is required to submit various reports and updates to keep the FDA aware of all new information regarding the product under investigation under the IND. In addition, FDA may contact the sponsor with additional information requests. Depending on the nature of the new information, the sponsor may simply notify FDA or have to wait for FDA guidance before proceeding further. A sponsor may also decide to amend an IND for business or logistical reasons.

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