Food and Drug Administration s9

XY Month 200X

Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901-B Ammendale Rd. Beltsville, Md. 20705-1266

Attn: Jane Doe, MD Director, Division of Something

Type B Meeting Request: Pre-IND Meeting

Dear Dr. Doe:

I am requesting a Pre-IND meeting to discuss a preclinical, product and clinical issues for Phase I and the overall drug development program for the use of “Drug XY” in the treatment of “WZ Syndrom”

We have assembled large amount of information on the use of “Drug XY” to treat “ZW Syndrome” in experimental animals. We have, however, a number of questions that pertain to the proposed administration of “Drug XY” in the “ZW affected patient population”. The issues that we wish to discuss and obtain Agency guidance and approval relate to aspects of the clinical study design (for example) and the choice of endpoints (for example) that could be the basis of approval for Drug XY in treatment of ZW Syndrome. Enclosed is the required information relating to this Pre-IND meeting.

Sincerely,

John Doe, MD Professor, Department of Something Duke University School of Medicine Tel: 919 684 xxxx Fax: 919 684 xxxx email: [email protected] Pre-IND Meeting Request Information

1. Product name Examples:  “Drug XY”-name of the drug  “Biologic XY”-name of the biologic such as vaccine construct for example

2. Chemical name and structure Examples:  “Drug XY is a 24-amino-acid peptide with a sequence:...”  “Drug XY is a protease inhibitor protein, whose main function is to …”  “Drug XY is chemically described as (chemical formulation). Drug XY has a molecular weight (Mr) and empirical formulation is (emp. formulation). The structural formula is provided below (paste the formula below)”  Biologic XY is a 1 and 2 region deleted adenoviral vector expressing “this and that” human cDNA…”

3. Proposed indication Treatment for ZW Syndrome

4. Type of meeting requested. This is a Type B Meeting Request; Pre-IND meeting. We request that the meeting be a 60 minute teleconference.

5. Purpose of the meeting Examples:  “This meeting is to discuss the design of a clinical study (for example) to study the safety and effectiveness (for example) of “Drug XY” in the treatment of “ZW Syndrome” in “such and such” patient population. Initial specific questions relating to the protocol are listed in Item #8.  “This meeting is to discuss the overall drug development program including preclinical, product and clinical issues as well as the study protocol for initial Phase I study for the treatment of “ZW Syndrome” Specific questions relating to preclinical, product and clinical protocols are listed in Item #8.

6. Specific objectives/outcomes expected from the meeting Example: “The major objective is to gain a clear understanding of any issues or concerns by the Agency and the potential options in resolving these issues/concerns in the clinical protocol.”

7. Preliminary Agenda Example  Introductions 5 min  Discussion of questions submitted 20 min  Discussions of issues identified by the Agency 30 min  Summary of conclusions reached at the meeting 5 min

8. Draft list of questions Please, list the questions that you wish to discuss with the Agency. The examples of those you can find in the Section 2.5 in the “Pre-IND Briefing Package Document”

9. Individuals attending the Pre-IND meeting Examples: John Doe, MD, Professor of Something Duke University School of Medicine Bruce K. Burnett, PhD, RAC, Director of Regulatory Affairs, Duke University

10. Agency staff requested by Sponsor to attend Pre-IND meeting Jane Doe, MD, Division Director

11. Approximate date that briefing package will be sent to the review division Example: The briefing package will be sent at least 30 days prior to the scheduled meeting. The briefing package will contain the final list of questions, a copy of the clinical protocol and any other supporting information for the meeting.

12. Suggested dates for Pre-IND meeting Week of Month XY, 200X; Week of Month XY, 200X; excluding this and that date.