Regulatory agency meetings are crucial milestones in drug development, but how can companies ensure they make the most of these essential interactions? What are the key differences between FDA and EMA approaches, and how should teams prepare for success?
We sat down with Ashley Preston, Head of Regulatory Affairs and Quality at BlossomHill Therapeutics, to explore these critical questions. With over 20 years of experience in regulatory affairs, GxP quality, medical writing, and operational excellence, Ashley shares some insight into maximizing the effectiveness of regulatory agency meetings.
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Summary, Key Points, and Practical Takeaways
This interview has been edited for clarity and length.
Nick Capman: Why is it so important to prepare for meetings with FDA and EMA?
Ashley Preston: In the drug development spectrum, when you're developing a drug from discovery through to market to your NDA approval, there are different phases of development — Phase 1, 2, 3 — and the lines blur between them as everybody tries to squeeze development, particularly clinical development, into a very small space to capture as much data as possible in the shortest possible time. This is all aimed at getting new medicines to patients approved and on the market as soon as possible.
The critical element is your ability to deliver the data regulators need to make decisions about your product. You need that data to demonstrate your medicine's efficacy, safety, and quality. FDA, EMA, and all global regulators have published different guidelines and regulations that tell you their expectations for that data. Meeting with regulators during your development pathway is critical to ensure that the development path, and particularly the clinical trials you're designing, will meet those needs and to get alignment and advice from the agencies along the way to make sure what you're designing will deliver the data they need to ultimately approve your products.
How do FDA and EMA differ in how they handle these meetings?
They are structurally different. FDA and EMA are the first tier of regulatory agencies. They have the greatest resources available, and most companies will pursue engagements with the FDA and/or EMA during their development cycle.
The FDA has a more developed process that allows for different types of meetings you can request. They have milestone meetings during development that they expect you to have with them, such as an end-of-phase one and an end-of-phase two meeting. You can have a pre-IND meeting before you submit your IND for clinical trials, and you would have a pre-NDA meeting to discuss what your NDA will look like.
In between, they have type C meetings available to sponsors to discuss any type of development topic — be it clinical, non-clinical, or CMC — and you can discuss it with the FDA at any time. You request the meeting and file your Briefing Book, and they will schedule a meeting with you to discuss any issues you're having and any questions or alignment you need.
In the last PDUFA, the FDA introduced a new type D meeting because the industry needed a mechanism to access very short timeframe, quick meetings with the FDA for a small number of topics, one or two at a time, and get a fast turnaround with FDA so they could very quickly get the answers they need to move forward.
The EMA takes a more committee-based approach through the CHMP Committee, which has representatives from all member state agencies. They have a scientific advice process that can be on any topic, but there's only one meeting type. You apply for scientific advice to EMA, and the CHMP will consider your submission, whether clinical, non-clinical, or otherwise, or a combination of topics. They will take that to the CHMP meeting, and all of the member states will provide their input and advice, which will be collated and distilled into a response on behalf of EMA.
The key difference is that in Europe, you typically won't meet with the regulators unless they see a need to meet with you to discuss more complex or challenging topics — it's predominantly paper-based. With the FDA, when you submit your meeting request, you can request the type of meeting you want — whether it's just written responses, via video conference like we are today, or in person. They will assess that need against their schedule and the gravity of the topics you're discussing, and then they will assign you a meeting type.
What are the costs of these different meeting types, which are required and optional?
The required meeting types, technically speaking, are the end of phase two, where you agree on your phase three or pivotal program with the FDA, and the pre-NDA meeting, where you agree with them on the structure and content of your NDA submission. More and more now, the end of phase one is becoming critical, if not required. You would be hard-pressed to get through phase one into phase two without having a meeting with the FDA. This is particularly true in the oncology space with Project Optimus, which the FDA has launched for oncology molecules to optimize dosing.
For optional meetings, you have the pre-IND meeting before you submit your IND for your first in human study. These are recommended because that is your opportunity to get a preview of FDA expectations for your IND package and address any shortfalls before you submit. During the whole cycle of development, you have those type C and type D meetings, which are optional and can be triggered at any time.
They all have their own set timeframes. Type C typically takes 75 days from filing the request to having the meeting, with about 40-45 days before the meeting when they expect you to file your Briefing Book. Type D is much faster — it's 30 days and 30 days, for a total of 60 days.
Regarding costs, meetings with the FDA are free; they're covered by the PDUFA filing fees when you file your NDA. EMA publishes a calendar for scientific advice with specific entry and exit points based on the CHMP meeting schedule. EMA typically charges around 70-80,000 euros per meeting unless you're an orphan drug or a small to medium enterprise. It's scaled depending on how many topics and different subject matter experts you need.
Is there a typical preparation process that is consistent across all these meetings, or are they very different in how you prepare?
I try to have a consistent preparation process. First, you want to understand why we want to meet with the agency. What is our end goal, and what is the outcome of that meeting that we need?
For instance, if we need alignment on the pivotal phase three study design, that could be the goal of an end-of-phase two meeting. Then, we want to make sure that we set out the timeline so that when we have to file that Briefing Book, we have enough information and data available to craft a persuasive argument as to why the design we put forward is the best design we think we should execute.
We often see companies try to have a meeting because it's a milestone. Some of the pitfalls are that they sometimes go too early — they don't have enough information for the FDA to give a solid answer. Sometimes, the FDA will say they can't answer that for you now, or if you don't have enough information, they can give you an answer that may not be ideal or favorable.
It's important to go to the meeting with a clear purpose and call it when you know you will have enough data to make your persuasive argument. You'll never have all the data you'd like to have available, but that's where the judgment call comes in. The regulatory professionals and the company's team will have to judge how much is enough to be persuasive.
How do you identify and prioritize the questions you're going to bring to these meetings?
You really want to think through carefully with the end in mind. If the outcome we want is agreement on the design of a study, we want to make sure we have a question on each of the critical elements of that study design. Make sure there's no ambiguity when we design that protocol so that we are clear it will meet the agency's needs and requirements.
For a protocol, you think about the overall study design, the randomization, blinding, the study population, inclusion/exclusion criteria, also the statistical designs, the sample size, how you arrived at the sample size, the endpoints you're using, the timing and the powering of those endpoints.
If you're thinking about a pre-IND meeting, you're focusing more on the safety, GLP toxicology safety studies that you've done in the non-clinical realm, in the animal models, making sure that they are adequate to support the dosing that you're proposing in that first in human study. You need to understand the basics of your drug's metabolism, at least in the pre-clinical space, so you can preempt any issues in the clinical space and modify your protocol accordingly.
Can you talk about the importance of team alignment when going into these meetings?
Team alignment, team preparation, and understanding of the role and responsibility of each person in that team are critical. We would prep ahead of time after filing our briefing book. We would take all of the questions we've provided to the FDA and run some positive and negative practice scenarios. If the FDA agrees with everything, that would be great. Is there anything else we need to clarify? If FDA disagrees with this question, what would be our fallback position? If they disagree with part of it, how will we handle that?
The other thing I like to do when preparing the team is to make sure people understand the regulatory professional's role, which is to facilitate and MC the meeting. It would be much better if you could get the subject matter experts at the FDA to discuss with the subject matter experts at the company and allow the regulatory professionals to facilitate that conversation and guide it. For instance, get your statistician to speak to the FDA statistician — they can run through the more technical aspects. Then, the regulatory professional will ensure we have clarity on the outcome, that it's minuted, and that we move forward to the next topic.
How do you handle moments of disagreement or negotiation in these meetings?
The best way is to listen and understand what's being said and the FDA's position. You can ask for clarification on those points. If they're saying, "No, we think this," they will typically explain it, but if they don't, ask for that explanation: "Can you help us better understand your perspective on X, Y, and Z?"
Most often, there is an opportunity to find some middle ground. You can suggest things — it doesn't have to be a yes/no battle. It's okay to mute the line and discuss amongst the team, and the FDA will do that, too, sometimes. They're like you and I — they need team alignment to be able to come forward with a position.
I think it's more important how you engage with them as professionals on a scientific, logical basis. Engage with them as a partnership for drug development – they have specific needs they have to meet, the company has particular needs, and we have to find a path forward. There is always a path, though it might not be your optimal path.
How do you ensure you're getting appropriate feedback that you can act on and implement adequately?
What I'm seeing more often these days in the COVID to post-COVID era is that the FDA is writing the minutes during the meeting itself. The project manager will be writing the minutes. It used to be that you'd have the meeting, then the company would submit their version of the minutes, the FDA would create theirs, and you'd negotiate over the content.
I've been in some meetings where the minutes are projected so you can see what's being written at that time. You can feel free to highlight, "Can we make sure that this outcome, this decision, is minuted?" When the meeting ends, they typically review the key aspects of the minutes with you, and that's your chance to agree and make changes.
What happens after the meeting is done?
Typically, post-meeting, the company would have a debrief to ensure everybody's aligned around what they heard, what the meeting outcomes mean, and what the next steps are. Sometimes, that could be providing additional data for the FDA. I have had an experience where the FDA said they couldn't decide on a particular question right now. Still, we discussed and presented in real time some additional data that had come late in the game, and they said to submit that afterward and add it to the minutes and their decision.
The company's other piece is to ensure we have a clear plan for implementing the FDA's recommendations. We need to consider whether any follow-up clarifications are needed quickly. If so, you can go back and informally clarify with your project manager.
Additionally, if you get a few months down the track and realize something will be a challenge, you can have another engagement with the FDA. It doesn't necessarily have to be a formal, full meeting engagement — there are other mechanisms, whether it's a type D meeting or even a written request for advice that you can file in your IND.
What trends are you seeing in these meetings heading into 2025?
Last year, the FDA started to open up more for face-to-face meetings, though I haven't been to one since pre-COVID. I've had several meetings in the online format, and my perspective is that it can be a lot easier to coordinate the video meetings. While you still get facial expressions and interpretation with all the agency representatives, it's not quite as effective as a face-to-face meeting. Still, it's a lot easier to schedule.
The FDA's meeting request numbers are only going up, and they have finite resources. Therefore, they're being more judicious about allocating meetings rather than written responses. These days, Many type D meetings are still given as written responses only. Hopefully, we'll see a trend toward type D meetings being short conversations rather than simply written responses, as that's the more valuable format. However, resource-wise, that can be challenging, as their funding needs to be approved by Congress.
How do you harmonize feedback when working with both the FDA and EMA?
There are a few options. One option is to have joint scientific advice from the FDA and EMA, though I'm not sure it's been used as frequently as possible. I've heard it can be cumbersome and challenging to execute effectively.
What I have done effectively is to stagger engagements. Typically, most industries would go to the FDA first by virtue of development programs and the availability of meetings and resources. We've gone to the FDA with our proposal, taken FDA feedback, modified it as necessary, and then taken that proposal to EMA.
EMA offers a preliminary advice mechanism that's a little different from the FDA. While CHMP makes the final determination, EMA employees coordinate activities and can give you a scientific perspective on what they think will be key factors for CHMP. The advice is not binding, but I've found it helpful to modify our meeting package to achieve the best outcome.
EMA recognizes that most companies have gone to the FDA first, so we sent the FDA minutes along with our EMA package. They try to harmonize as much as possible — it doesn't help drug development or patients if advice is completely divergent. This doesn't mean they'll always agree, but at least they have the FDA's perspective on a particular program. The different divisions talk to each other all the time, as most big molecules from pharma are being rolled out almost simultaneously.
Ashley’s key takeaways:
Understand the different meeting types available and their requirements. FDA offers various formats (Types A-D), while EMA takes a more committee-based approach.
Make sure you have sufficient data before requesting meetings. Going too early can result in delays and unfavorable outcomes.
Develop focused questions and present just enough data to make persuasive, science-based arguments without overwhelming regulators.
Prepare thoroughly with practice scenarios and ensure each team member understands their role in the meeting.
Approach regulatory interactions as collaborative partnerships aimed at bringing new medicines to patients.
Pay attention to meeting minutes and ensure critical decisions are properly documented during the meeting.
When working with both the FDA and EMA, consider how to harmonize different agency feedback through strategic meeting scheduling and transparent communication.
Have a clear plan for implementing agency recommendations and following up on any unclear points or additional requirements.
Ashley is the SVP of Global Regulatory Affairs & Quality Assurance at BlossomHill Therapeutics, where he leverages over 20 years of drug development experience to lead global development strategies for innovative medicines. As a US-certified RAC professional with a deep understanding of the US regulatory landscape, Ashley oversees regulatory affairs, medical writing, and quality assurance activities across multiple clinical-stage assets.
Before joining BlossomHill in January 2025, Preston spent over six years at Syros Pharmaceuticals, where he most recently served as SVP of Global Regulatory Affairs, Quality & Operational Excellence. During his tenure, he built and led the Global Regulatory Affairs and Quality Assurance organization, managing regulatory strategy for multiple clinical-stage assets while promoting quality compliance culture throughout drug development operations.
His experience includes leadership roles at H3 Biomedicine, EMD Serono, and Merck, where he demonstrated expertise in regulatory science, process improvement, and global regulatory policy. At Merck, he led International Regulatory and scientific Policy matters across Asia-Pacific, China, Japan, Russia/CIS, the Middle East, and Africa, engaging with regulatory agencies and representing the company on Industry Trade Association committees.
Preston holds a PhD in Pharmacology from RMIT University and a BSc (Honours) in Pharmacology from Monash University.
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