In is paper, e au ors aim to utilize eir years of experience preparing meeting requests and meeting packages, participating in pre-IND meetings, and reviewing and responding to pre-IND meeting comments from e FDA to provide general recommendations for organizations looking to make e most out of eir pre-IND meeting wi FDA. e goal of a Pre-IND Meeting is to receive confirmation from FDA at e drug development plan and future clinical trials are acceptable to e Agency. As such, it is critical for sponsors to remember at complete transparency is necessary to obtain e maximum value from e meeting. Meeting Preparation Identify Issues Identify Key Negotiation Points and Acceptable Fallback Positions No Presentation Unless Requested Prepare Only Key Slides at Might Be Needed Rehearsal Logistics and Travel Time of FDA MeetingFile Size: 279KB. to uncovering omissions e resulting document can form e basis for a well-informed Pre-IND or Scientific Advice (Pre-IMPD) meeting package. So often we come upon companies and ey have not taken advantage of ese free and encouraged programs. Meeting types for Pre-IND include written-only answers, teleconferences, and face to face meetings.File Size: 78KB. For pre-IND meetings, e purpose is to discuss CMC issues as ey relate to e safety of an investigational new drug proposed for use in initial clinical studies. e . Pre-IND Briefing Packet. Pre-IND Meeting Request. IND Submissions. IND Checklist for IND Submission. FDA Form 1571 - IND Application. FDA Form 1572 - IND Investigator Statement. FDA Form 1572 (Box 8) - Protocol Sum y Template. FDA Form 3454 - Certification: Financial Interests and Arrangements of Clinical Investigator. Pre-IND Briefing Packet Template. Site footer content. Contact Us. Institute for Clinical and Translational Research 4240 Heal Sciences Learning Center 750 Highland Avenue Madison, WI 53705. Email: [email protected] Phone: (608) 263- 18 e Institute for Clinical and Translational Research is supported by e Clinical and Translational. CDER review staff encourages e sponsor to submit clearly worded questions. Click on each meeting type to learn more. Pre-IND Meeting Questions. 11, · Meeting type being requested (i.e., pre-IND) A brief statement of e purpose and objectives of e meeting at includes background of e issues underlying e agenda. A brief sum y of completed or planned studies and clinical trials, or data at you intend to discuss at e meeting, can also be included. pre-ind briefing packet [compound x] table of contents. introduction. clinical background. pharmacology. pharmacokinetics. clinical plan. sum y. title of study. investigator/study center. phase of development. objectives. design of study. diagnosis and key subject selection criteria (inclusion and exclusion) treatments. dose. Draft / Preliminary Responses to Questions Submitted in Background Package Sent 24-48 Hours Before Meeting Increases Efficiency of Meeting by Eliminating Issues Not Requiring Fur er Discussion Highlights Areas Needing More Information for Resolution Alerts Sponsor to CDER’s Issues of Concern. Pre-IND Meetings are recommended by e FDA to help eliminate surprises during e initial review of e IND. Even ough is Agency touchpoint is not required, we at PharmaLex almost alwaysrecommend taking advantage of e Pre-IND Meeting opportunity. A brief sum y of completed or planned studies and clinical trials Data at e sponsor or applicant intends to discuss at e meeting e general nature of e critical questions to be asked. 12, 2009 · e pre-IND meeting request is accompanied by a background document au ored by e submitter and sent to e reviewing agency at follows e FDA IND guidance. e submitter includes as much of e required information as possible by outlining completed, ongoing, and future drug development activities expected to occur prior to e clinical. Formal Meetings Between e FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry ember . Download e Draft Guidance Document Read e Federal Register Notice. Pre-IND Request (see handout) Cover Letter (formal, see example) Product Name Chemical Name Chemical Structure Proposed Indication Type of meeting requested (Type B) Purpose of e meeting Expected Meeting outcomes Preliminary Agenda List of proposed questions Attendees Requested FDA staff Approximate date when e briefing package will be sent. e key to achieving is is a perfectly executed Pre-NDA Meeting. A Pre-NDA Meeting enables sponsors and e FDA to ensure your NDA submission is well-organized and set up for success. is meeting should generally occur no less an 60 days prior to e submission date. Know e meeting objectives DETERMINE TIMING of when a meeting is required, work backds to plan meeting DEVELOP COMPANY QUESTIONS and positions SUBMIT MEETING REQUEST and briefing packages ENSURE INFORMATION IS ORGANIZED and succinct PROPER STRATEGY AND FRAMING of questions (IND) process A pre-IND meeting offers e chance to get early. 6 Pre-IND Meetings (21 CFR 312.82) Request must be submitted in writing (fax is fine) and should include: Description of product Description of clinical indication and approach Identification of purpose, objectives, and draft of specific questions Suggested dates and times for meeting Pre-IND meetings are scheduled wi in 60 days from receipt of request. Contents of a Pre-IND Meeting Package (cont’d) • Preclinical development program – A comprehensive sum y of all completed preclinical studies (in vitro and in vivo studies, animal models, study designs, resulting data and interpretation, etc.) – Complete protocols for your definitive preclinical. 01, · e meeting package should provide sum y information relevant to e product and any supplementary information needed to develop responses to issues raised by e requester or review division. It is critical at e entire meeting package content support e intended meeting objectives and e questions in Section 14. 31, · Pre-IND Meeting. e FDA allows for one pre-IND meeting prior to IND submission to discuss any questions or concerns concerning clinical trial approach. Any topics be discussed during is meeting including questions concerning general product development, manufacturing information, nonclinical testing, protocol design or o er regulatory questions. 7 Objectives/outcomes expected from e meeting.. To determine if: Adverse effects/toxicities from nonclinical data are adequately addressed. e risks and benefits of e drug are adequately discussed and considered. e information provided support an acceptable gin of safety. e proposed clinical study design is justified by e supporting nonclinical data. Investigational New Drug (IND) Application • Pre-IND Meeting Request • Pre-IND Meeting package • Pre-IND Meeting – Pre-IND Meeting Package • 25-75 pages • Agenda/Attendees/Objective • Questions • CMC information • Nonclinical information • Phase 1 protocol sum y • Clinical development plan (at least 1 year) • Previous. 08, · One of e greatest mistakes at e Sponsor of a 505(b)(2) can make is to have an unsuccessful Pre-IND meeting. Common errors occur at e Pre-IND meeting because Sponsors and CROs at are more familiar wi traditional 505(b)(1) drug development programs fail to appreciate e different goals and e impact of a Pre-IND meeting on a 505(b)(2) program. 28, · 1.6 Meetings 1.6.2 Pre-IND Meeting Background Materials Page of 13 2.8 History of e Development Program and e Events Leading up to e Meeting Sponsors should prepare an information package at includes a brief sum y of e relevant CMC information, e developmental status, and e plan and time line for future development of e drug. However, since FDA assigns a Pre-IND number, which ultimately becomes e IND number, and Module 1 includes at least two places at are appropriate for including Pre-IND documents (ei er Module 1.12.1 or Module 1.6 for meeting-related documents), we should . Objectives of Meetings at Work: Meetings at work help in e grow of e organization and it enables right ision making. It helps in discussing e challenges at tend to reaten profitability. Here are few objectives of effective meetings at work:. It develops a meeting plan. 2. Indicates e practices at are followed in e team. During e meeting, preliminary analytical data are discussed and e proposed development program is presented. is meeting is similar to a Type B, Pre-IND meeting. Meeting Requests. e request for a BPD Type-1, -2, -3, or -4 meeting must include adequately detailed information for e FDA to assess e need for e meeting. Pre-IND Process e FDA has a Pre-Investigational New Drug Application (Pre-IND) Consultation Program available to potential IND holders to facilitate early communications regarding an IND. e program allows e sponsor-investigator e opportunity to discuss e proposed project and receive guidance directly from e FDA prior to submitting an IND. e Pre-IND meeting requests are submitted. Learning Objectives. FDA Meetings (Type A, B and C): Pre-IND, Phase I, Phase II, End of Phase II, requesting e meeting, preparing e meeting package, meeting minutes. e IND Submission. Routine IND Submissions: Clinical, Non-Clinical, CMC, . Gerald Yakatan, Ph.D., Founder, Chairman & CEO of IRISYS, has ades of pharmaceutical development, clinical trial strategy and design, and regulatory affairs experience.He interacts wi high-level FDA personnel and has planned and engaged in numerous FDA pre-IND meetings . 03, · A new draft guidance from FDA explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/ videoconference meetings or written responses only, what sponsors should include in at request, how FDA can respond, how long e agency can take to respond, and how e sponsor and FDA can go about conducting efficient, consistent, timely and . is means meeting wi FDA early and often. For a Beneficial Pre-NDA Meeting, Preparation is Key. Upon completion of required studies (or literature in support of safety and efficacy), PDG will submit a Pre-NDA Meeting Request, prepare a Pre-NDA Briefing Package and facilitate ano er meeting wi FDA on your behalf. e FDA will respond to a request for a pre-IND meeting wi in 21 days of receiving e request.1 PRE-IND BRIEFING PACKAGE If e FDA meeting is granted, sponsors must provide a pre-IND meeting briefing package to e Division of Transplant and Oph almology Products at least 4 weeks prior to e meeting.1 Meeting packages are. 24, · However, a sponsor of any IND can request an EOP2 meeting. Pre-NDA/BLA meetings are helpful in acquainting FDA reviewers wi e format and content of e planned application, including labeling and risk management activities (if applicable), presentation and organization of data, dataset structure, acceptability of data for submission, as. Pre-submission meeting Meeting wi Rapps Regulatory Strategy Meeting. SA presub meeting PIP presub meeting Orphan presub meeting SME briefing meetings – Appointment of Rapporteurs based on objective criteria – Use of best available expertise in EU in relevant scientific area • Check of (Invented) Name. e purpose of is draft guidance is to assist sponsors of drug and biological products for e treatment of rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings. Drug development for rare diseases has many challenges related to e nature of ese diseases. Pre-NDA Meetings and NDA Submissions: 505(b)(1)/505(b)(2) Pre-IND Meetings. Investigational New Drug Application (IND)/Special Protocol Assessment (SPA) and is voluntary. e objective is targeted feedback to e sponsor prior to a formal submission. e feedback be requested in e form of a face-to-face meeting, teleconference. In preparing for e pre-sub meeting and putting e data package toge er, we need to do enough work to be able to ask e FDA questions at ey can answer ei er yes or no. For example, if we ga er clinical data at ree sites, wi 30 patients at each site, and statistically 95 percent of e subjects have a successful outcome as defined. 20, · Best Practices For IND Success. And now, some helpful hints to increase your chances of a smoo FDA review of your application and a successful IND overall: Start e drug development program wi e end product in mind. Plan e timing of a pre-IND meeting so at sufficient data is available to inform isions. don’t ignore e feedback. Regulatory meeting support (pre-IND, EOP2, pre-NDA, and ad-hoc) including preparation of meeting questions for optimal Agency outcomes. preparation and submission of meeting requests and briefing packages. attending and facilitating meetings and rehearsals. Regulatory review and approval of SAEs. change control for reporting requirements. An IND program and application compiles all is information, which facilitates regulatory review. Once an IND application is submitted, e FDA has 30 calendar days to review e package. Unless e FDA indicates o erwise, e IND sponsor is free to initiate e proposed human studies once e 30 . F2F hearing meeting: arranged by CDE if CDE has inquires and need F2F tripartite communication wi applicant and CDE external experts. 4. Pre-approval GCP inspection required since , focus on au enticity of data. 5. Assuming QCtesting and GCP inspection are not critical pa. in waiting queue. Priority Review Grant or not. NIFDC. 02, · Commenting on e meeting, Robert Farrell, President and CEO of Kalytera, said, We recently submitted questions to e FDA as part of our pre-IND submission package. During e meeting, e FDA responded verbally to our questions, and .