Preparing for Successful Pre-IND FDA Meeting
David R. Dills - Director, Regulatory Services, CROMSOURCE and Regulatory SME has more than 33 years of leadership experience in the biopharmaceutical and medical device industry within the regulatory affairs and compliance space. He has held positions of increasing responsibility with sponsors and service providers of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid, and large-sized enterprises. He has worked with clients in EMEA, Asia-Pacific and The Americas, and certainly with FDA and the global Health Authorities with product portfolios covering multiple therapeutic areas and medical specialties. He is providing the global regulatory capabilities and regulatory intelligence support for clients and collaborating with internal and external stakeholders. In addition, to being a professional member with industry associations, advisory boards, prolific speaker at industry events, he navigates the regulatory landscape throughout the product life cycle and regulatory crisis management. In addition, David is responsible for the development and launch of new services in the Regulatory and Strategic Consulting space. He is engaged in Strategic Regulatory Consulting for strategy and development planning for US, Europe and other global markets and regulatory consultation and support for clinical trials and studies. He also manages pre-Submission FDA/EMA and Sponsor meetings with briefing packages and negotiation. This includes Pre-IND consultation, and preparing and dispatching submissions such as the IND, ANDA, BLA, NDA, regulatory strategies and pathways such as[505(b)(1) and 505(b)(2)], MAA, IMPD, including 510(k), PMA, and De Novo applications under medical devices. He also works with Orphan Drugs under Rare Diseases and consults on the Orphan Drug Designations for FDA and EMA and also offers consultative advice and support for CTIS under the CTR for Europe. He explores various regulatory options and develops optimal and efficient regulatory strategies to: get products registered and approved in a timely manner; reacts proactively to minimize and eliminate risks and uncertainty while maximizing the potential for commercial success; and certain stay in compliance with the multiple regulatory and health authorities and agencies with different regulatory requirements while expanding globally.
FDA and regulatory guidelines allow for formal meetings between the FDA and sponsors or applicants to discuss the development and review of an investigational new drug (IND) application for drugs or biologic products. This meeting, known as a pre-IND meeting, is intended to address specific questions related to the initial US clinical study (also known as a first-in-human [FIH] study for new drugs and biologics) and other questions that could affect the IND application, including those related to the nonclinical program, manufacturing and product quality for the investigational product, and regulatory considerations. Once the meeting request has been submitted, it is up to the FDA to decide whether to grant or deny the request and to determine the appropriate format for an approved meeting. For pre-IND meeting requests (and requests for other “Type B” meetings), the FDA will typically respond within 21 days of receiving the request, and meetings are generally scheduled within 60 days of the request. Sponsors should therefore submit their request approximately two months before they would like to have the pre-IND meeting.
Areas Covered
- Requesting a Pre-IND Meeting and Timelines
- Different Types of Meetings Such as Type B and now Type D
- Prepare Meeting Request
- Prepare Briefing Packet
- Best Tips and Best Practices for Successful Meetings
- Managing Negotiations
- Assign roles and responsibilities for team members both during the preparatory stage and at the meeting
- Outline and rehearse contingency plans
- Consider the need for a formal presentation
- Critically evaluate preliminary feedback from the FDA and the implications for your program
- Prepare follow-up discussion points, questions, and “fallback positions” on key questions at the meeting
- Tips and recommendations for all Sponsors/Applicants
Course Level - Basic/Intermediate/Advance (could be all categories)
Who Should Attend
Chief Medical Officer, VP of Regulatory Affairs, Director of Regulatory Affairs, Manager of Regulatory Affairs, Regulatory Specialists, Consultants, R&D, CMC and even Biostatistics personnel will benefit
Why Should You Attend
The information gained from the meeting can help ensure a complete IND application is submitted and potentially help avoid clinical holds.
The meeting presents a formal opportunity to gather the FDA’s perspectives, recommendations, and preliminary agreement (or disagreement) on critical aspects of your development program.
The meeting is an opportunity to build a constructive relationship with the FDA.
Because the pre-IND (investigational new drugs) meeting represents a critical milestone in the regulatory process, it is important that sponsors maximize the value of the meeting.
There is typically only one pre-IND meeting allotted per investigational product, so sponsors must prepare well for this meeting to ensure they get all the feedback they need to progress their development program.
Phrasing and structure of questions is critical. So is adequate preparation and the key to a successful outcome at these meetings.
Seize the opportunity to connect and establish rapport with the review division staff by using open and transparent communication.
Learn the proven tips and best practices to address the Meeting Request, Briefing Packet to Post-Meeting Closure and your next steps with your submission and for a successful review and approval process.
Dos and Don’ts: If you and your team decide to pursue a pre-IND meeting with the FDA, consider the hard-won advice to be provided. Your reputation with the agency is formed with this first impression. It’s critical to thoroughly prepare for any question the FDA might ask. Know your position and science clearly.
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$200.00
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