When and How to Develop a Regulatory Roadmap

By Amy Duncan, Goldfish Consulting, Inc.

Regulatory approval is a major inflection point and value driver for companies, yet many wait too long to develop a roadmap for success. To help put things in perspective, San Diego Entrepreneurs Exchange (SDEE) hosted a workshop, “Planning for Success: When and How to Develop a Regulatory Roadmap,” on October 9, 2018, at Hera Hub in San Diego.

Leading the workshop were local experts with first-hand experience in all phases of the regulatory process for drugs and IVD/devices:  Luis Jimenez, Vice President, Business Development, Brandwood Biomedical; Jennifer Grodberg, Sr. Vice President, Regulatory Affairs and Program Management, Forge Therapeutics; and Michael Monahan, Sr. Director, Regulatory Affairs and Quality Assurance, Crinetics Pharmaceuticals. Speakers provided advice for developing a regulatory roadmap, including interactions with FDA:

Key FDA Regulatory Meetings – Meet Early and Often

The motto “Meet Early and Often” was echoed throughout the workshop. Three of those meetings are core regulatory interactions with the US Food and Drug Administration (FDA). The first is the pre-investigational new drug application (pre-IND) meeting during the preclinical phase, or the investigational new drug (IND)-enabling phase, to discuss overall plans; followed by the End-of-Phase 2 meeting; and the pre-new drug application (pre-NDA) meeting. After filing the IND and before the End-of-Phase 2 meeting, some companies have minimal interactions with the FDA. It’s recommended to avoid a gap in communications during this period. If your interactions are limited early on, it can be too late to course correct if there’s an issue. Furthermore, by starting early to build a relationship with the agency, you may learn about things you don’t need to do, making the process more efficient.

Interacting with the FDA – In Person, Phone, or Email

You can interact with the agency through face-to-face, teleconference, or written communication. There’s a formal process and guidance that describes the procedure for requesting a meeting, the timing for providing background information to help facilitate the discussion, the meeting process itself, and follow up of the meeting with meeting minutes.   

The Inside Scoop on How the FDA Can Help You

The overall goal of these meetings is to establish effective communication between your organization and the agency to ultimately facilitate more efficient drug development. Consider the FDA a partner, not an adversary. There are some groups within the FDA who are open and eager to help you develop your program. At the pre-IND meeting, they may offer to answer a written request for comment prior to filing the IND. This means you can ask questions and get clarification on what you’re thinking about doing before filing the IND. It’s a lot of time and work on their end to shepherd a program from beginning to end, so they want to make the most of their time.

The Value of the Pre-IND Meeting – If You Don’t Ask, You Don’t Know

At the pre-IND meeting, the first formal interaction with the FDA, this is the opportunity for a startup company to introduce the organization, demonstrate your demeanor, the way you work, and thoughtfulness in developing your program. It’s a good opportunity to showcase your abilities and demonstrate your competencies, while establishing the working relationship. You can also discuss the uniqueness of your molecular entity, studies, or indications you are pursuing. The intent is to preview your clinical development program at time of IND, the remaining work needed to be done, and raise questions. You can talk about opportunities for expediting development and streamlining your process. Simply put, if don’t ask, you don’t know. It’s worthwhile laying it all out and asking questions to see if on you’re on the right track, especially for something novel.

The ABCs of FDA Meeting Types

The FDA has categorized meetings types based on the level of urgency. Type A meetings are most urgent, when resolution is necessary to move a stalled program forward. Type B meetings have specific objectives and are typically held during development, such as the pre-IND, the pre-NDA/BLA, and the End-of-Phase 2 meetings previously mentioned. Type C meetings are for other topics. Each meeting type varies in duration between when the meeting is requested and held. Type A and B meetings span 30 and 60 days respectively. End-of-phase meetings are held within 70 days of request due to the significant amount of content to review.

FDA Email – How Long to Hear Back?

Unlike requesting a meeting, email requests for comments and advice are open-ended with no set turnaround time. However, different divisions and review teams may have soft guidance to respond in 30 to 60 days. This used to be an effective approach to get a quick read, but because of the agency’s tremendous workload, they will often have you resubmit these written requests as a Type C meeting. This gives them more time and requires only a written response only.

Learn From Others

Another way to get insights is to see what competitors did. The FDA website, Drugs@FDA, has summary documents from the whole assessment of approved drugs. You can look at safety profile documentation to see what issues arose during a program and understand tox studies you may be expected to address or prove aren’t relevant. You can see if a program was subjected to an advisory meeting and what was considered a successful approach. This can help not only determine your potential clinical development plan, but also what regulatory opportunities to accelerate.

Hiring Regulatory in Startups

When hiring for a regulatory position in a startup, consider that the employee will likely wear many hats. Regulatory professionals not only provide input on strategy but also end up serving as a submission tactician, helping to operationalize the plan, in addition to generating templates for SOPs and reports. They can also provide valuable oversite on vendor selection and project management.

Importance of Quality Assurance

Adherence to requirements in all stages is essential for success. If records aren’t kept and activities aren’t documented, then essentially it wasn’t done. Develop a base quality system with SOPs, oversite, and management. Importantly, ensure you have a development history file with organized and controlled submission documents in a place you can easily access. Retain and organize CMC documents that didn’t make it into submission. All of this contributes to a state of institutional memory. Because when those one or two key people walk out the door, you may never find this information again, which can be a massive set back in time, if not a killer to your program. Establishing development plans early on gets you to an institutional memory state.


The key take-home message is to communicate early and often to establish a collaborative relationship and avoid future pitfalls. It’s better to seek permission as you likely won’t receive forgiveness.

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