Frequently Asked Questions
Updated 6 Nov 2025
Is there a known link between the microbiome and neurodevelopmental challenges, in particular autism spectrum disorder (ASD)?
Today, there is much scientific debate about results suggesting a link between the early-life microbiome and neurodevelopmental challenges, including autism. There is, however, little debate that more research is needed.
The intent of the FORM program is to conduct multiple strands of research in parallel: large, well-controlled longitudinal studies including multi-omics profiling; microbial culturing and metabolic characterization; the testing of potential causal pathways in validated model systems; and, where applicable, carefully designed studies to assess new support options.
By combining these approaches, FORM aims to provide greater, scientifically rigorous insights that could, in future, improve real-world outcomes for autistic individuals and their families.
How does FORM plan to involve individuals, families, and the community?
In FORM, our goal is research that is transparent and connected to improving real-world outcomes for autistic individuals and their families. The FORM Partnership and Trust Principles outlined here are intended to set expectations for efforts throughout the program including how teams will work with parents, caregivers, children, families with autistic children, the autism community, as well as biological samples and data. FORM applicants will be expected to agree that, to the best of their ability, they will adhere to these principles and to outline how they plan to do so beginning at the Proposal phase. Our hope is that in so doing, together, we will create a mutually respectful environment that allows for different points of view to be expressed as we work together in this spirit.
Why conduct multiple streams of research in parallel?
Use-inspired, project-oriented research can be an important alternative approach for challenging ‘what if’ questions that often require multi-disciplinary, multi-team, concurrent investigations that inform each other in real time. This can accelerate learning cycles, iteration, and enable replication of results between teams. It creates teams of researchers working together to accomplish what they cannot accomplish alone.
FORM aims to provide greater, scientifically rigorous insights that could, in future, improve real-world outcomes for individuals and their families.
Why focus on the maternal and infant microbiome before age 2, instead of studying children already diagnosed with neurodevelopmental challenges?
Most existing studies begin after a diagnosis, when the child is 3 or older and critical windows of brain and microbiome development have already passed. By that stage, it’s difficult to tell whether microbiome changes are a cause of neurodevelopmental differences or a result of them — because diet, medication, and behaviors are bi-directional and have already diverged.
FORM is focused on maternal and the early infant gut microbiome before age 2, when the microbiome and brain are still co-developing and most responsive to environmental inputs. Studying this period allows us to capture how early-life exposures — such as infection, antibiotics, diet, stress, and birth mode — may interact to influence microbiome function.
By observing and modelling these microbiome pressures together rather than one at a time, FORM can conduct the research to help identify whether cumulative stresses to microbiome function precedes measurable differences in the more severe forms of neurodevelopmental challenges that could impact daily life.
How many awards will be funded?
There are no pre-set number of awards.
How much is each individual award?
Award sizes will vary based on the scope and requirements of the selected proposals. Collectively, all performer budgets will comprise the program’s total funding of up to $50 million. Award amounts are dependent on specific proposals and work selected for funding.
Is the Program open to applicants from outside the United States and UK?
Yes, it is open to applicants around the world.
Is the Program open to applicants who are not a part of the Wellcome Leap Health Breakthrough Network?
What is the working model or program structure of Wellcome Leap programs?
Performers are from universities and research institutions: small, medium and large companies (including venture-backed); and government or non-profit research organizations. Our programs are actively led and orchestrated by a Program Director who adjusts, iterates, and directs teams working together so as to solve problems they cannot solve alone. The program timeline begins after the program kickoff meeting and ends at the three-year mark.
Are animal studies excluded?
All study proposals aligned to the program goals are welcome and are reviewed case by case. All proposals involving human or animal studies must follow appropriate ethical practices.
Who can I contact if I have a question about the program?
Send an email with your question to form@wellcomeleap.org.
Is there a specific format for Wellcome Leap program applications?
Please see the abstract template and format guidelines.
Is the online application portal the only way to provide a submission?
Yes. Abstracts and proposals are not accepted via email.
Is it possible to have multiple applicants on a submission?
Yes. Multiple collaborators can be on a single submission, but only the Principal Investigator (PI) will be able to submit the application on the portal. There is no limit to the number of Co-PIs.
Is it necessary to form a consortium when applying?
No. We encourage individuals or small teams to apply in the thrust area(s) best aligned with their expertise and capabilities. It is not necessary to form a large consortium or team a priori to address all thrusts or an entire goal in a single abstract or proposal. Indeed, we intend to facilitate synergies dynamically among FORM performers as we make progress together toward the program’s goals.
What are the eligible costs?
Full direct and government-certified indirect costs appropriate to the execution of the research, are eligible.
Can you have multiple submissions?
Yes.
Am I able to edit my submission once submitted?
No.
When will I receive feedback on my submission?
Please see the program announcement for the program timeline.
May I still submit a full proposal if I receive a recommendation to not submit on my abstract feedback?
Yes.
Will my idea be treated as confidential during the review process?
Please see the program page for confidentiality of submission details.
What is the review process?
Please see the program page for information on the review process in each round. Applications for FORM go through a structured peer-review process. We have a reviewer roster that includes the Program Director, the Scientific and Engineering Program Coordinator, as well as several internal and external reviewers, with oversight from the Wellcome Leap CEO, COO and the Director of Program Development.
What is the travel requirement when participating in a Wellcome Leap program?
There are typically two required PI meetings a year, so 6 throughout the 3-year program. Reporting and check-ins will vary by Program Director, research thrust area, and performer.
If you are planning travel related to your research goals, please include it in your submitted budget for consideration.
Are references required?
Yes, please include your references as part of the required page limit.
What should be included in the budget submission? Are there any caps?
The budget should be submitted in USD and also include full university overhead direct costs (supplies, equipment, salaries, depreciation, training, travel) and government-certified indirect costs appropriate to the execution of the research. There are no overhead or salary caps.
Is the submitted budget locked, or can it be changed later?
A draft budget is required with the abstract submission. At this stage, estimations for budget assumptions are requested but not finalized until later on in the process. Proposals may be selected in full or in part.
If we have questions, can we meet with the Program Director?