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Participate In Initial Industry-FDA Meetings

Prepare for the Meeting

Pre-IND meetings are the most productive when they are focused on specific issues, like regulatory requirements, previous studies, IND application requirements, and so on. Therefore prior to the meeting, it is important that you:

  • Identify the purpose and goal of the meeting from the Sponsor’s point of view.
  • Become familiar with the information provided to the FDA by the Sponsor in the meeting packet.
  • Understand the role of the FDA:
    • Review Working with Regulators: A Focus on the FDA (2015) is a resource developed by the Cancer Support Community to provide patient groups with information about working with the FDA. The resource contains information about the role of the FDA, the relationship between the FDA and patient groups, and new initiatives that allow patients to have better access to therapies.
    • Be aware that the FDA does not conduct medical research or regulate the practice of medicine. 
    • Reach out to the FDA Patient Affairs , available at +1-301-796-8460. The FDA Patient Affairs Staff can help you understand more about pre-IND meetings and how your participation may be helpful.
  • Know what is included in an IND application (specific to therapies classified as drugs):
    • Chemical composition of the drug being studied in the clinical trial.
    • Studies performed in animal or cell models supporting safety and the potential benefits of the investigational treatment.
    • Methods to assure safety, including range of possible doses.
    • Recommendations for size and scope of clinical trials.
    • Controls, i.e. what the investigational therapy will be compared to.
    • Study endpoints throughout the different phases of the clinical trial process.
    • Multiple designated points of interaction between the FDA and the Sponsor during the clinical trial process to assure that every clinical trial is addressed in detail, the development program is well designed, and to establish safety profile and determine efficacy.
    • To learn more about the comparable application process for biologics, you may reference FDA: Biologics License Applications (BLA) Process (CBER) .
  • Learn about Target Product Profile (TPP) and how it may be used in a pre-IND meeting.
    • The TPP is a template that summarizes the information that a Sponsor hopes to include in the drug (biologic or device) label after FDA approval. In other words, it is beginning the therapy development process with the goals in mind. 
    • A TPP is filled out by the Sponsor of the investigational therapy and submitted to the FDA, often with the pre-IND packet. It is however not a required document.
    • A TPP has been found to increase constructive discussions with the FDA in the pre-IND meeting and throughout the clinical trial process.
    • A TPP helps focus a Sponsor’s therapy development team and FDA review staff on the therapy development goals in terms of labeling. 
    • A TPP can help address issues early on in the therapy development process thereby preventing late stage failures and decreasing the total time involved with treatment development.  
    • The final version of the TPP will be similar to the annotated draft labeling submitted with a New Drug Application (NDA) or BLA.
    • The U.S. Department of Health and Human Services (HHS) provides an example of a TPP: Target Product Profile
    • The Center for Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) webpage for industry education also has a 15 minute webinar on The Target Product Profile .
  • Recognize the difference between 505(b)(1) and 505(b)(2) New Drug Applications (NDA) and how they affect the IND for investigational drugs (similar standards apply to biologics and medical devices).
    • 505(b)(1) application is for new drugs that have not previously been studied. It requires the Sponsor to conduct all necessary safety and efficacy studies. The IND application of a 505(b)(1) must contain a report that includes the results of the pre-clinical trial studies performed in cell and/or animal models.
    • 505(b)(2) is for new drugs containing previously approved active ingredients. This allows the Sponsor to submit an IND (and later a New Drug Application) which uses some of the safety and efficacy information on the active ingredient from studies not conducted by or for the applicant. The 505(b)(2) can be a less expensive and faster route of approval compared with the 505(b)(1) process. Examples of investigational drugs that may be eligible for 505(b)(2) include:
      • A new dosage form that is faster acting.
      • A combination drug using 2 active ingredients in a novel way.
      • A drug delivery mechanism that patients or doctors prefer over previous versions (for example, a pill form of a drug previously only available in liquid form).
      • A new use of a drug that already has FDA approval to treat a different disease or symptom.

Resources

Overview
How to Study and Market Your Device U. S. Food and Drug Administration (FDA) (link)
The Device Development Process U. S. Food and Drug Administration (FDA) (link)
Learn about Pre-IND Meetings
Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review U. S. Food and Drug Administration (FDA) (link)
Developing Products for Rare Diseases & Conditions U. S. Food and Drug Administration (FDA) (link)
Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting U. S. Food and Drug Administration (FDA) (link)
Prepare for the Meeting
Working with Regulators: A Focus on the FDA Cancer Policy Institute at the Cancer Support Community (link)
FDA Patient Affairs U. S. Food and Drug Administration (FDA) (link)
Biologics License Applications (BLA) Process (CBER) U. S. Food and Drug Administration (FDA) (link)
Target Product Profile Template Health and Human Services (HHS) ASPR (link)
The Target Product Profile Webinar Center for Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) (link)
Tips for Success
Making Data Talk: A Workbook by the National Cancer Institute National Cancer Institute (NCI) (link)
FDA Patient Affairs U. S. Food and Drug Administration (FDA) (link)