Apply for Bio-Therapeutics Impact Grant Program (US and Canada)

Deadline: 09-Jun-2026

The ALSF Bio-Therapeutics Impact Grant Program supports investigator-initiated clinical trials focused on biologic therapies for childhood cancers. The programme funds innovative pediatric oncology trials involving immunotherapy, cell-based therapies, gene therapy, and small molecule biologics designed to improve treatment outcomes for children with cancer.

The grant provides up to USD 1.8 million over three years to nonprofit institutions in the United States and Canada. Funding supports clinical trial implementation, correlative studies, manufacturing, trial-related procedures, and biologic therapy development aimed at advancing promising pediatric cancer treatments into clinical application.

What is the ALSF Bio-Therapeutics Impact Grant Program?

The ALSF Bio-Therapeutics Impact Grant Program is a pediatric oncology funding initiative designed to accelerate innovative biologic therapies for childhood cancers through investigator-initiated clinical trials.

The programme supports translational and clinical research focused on developing advanced biologic treatment strategies for pediatric cancer patients. It aims to move promising therapies from pre-clinical stages into clinically meaningful pediatric trials while improving frontline treatment approaches and patient outcomes.

The initiative places strong emphasis on scientifically rigorous trial design, biologic innovation, and integrated translational research approaches.

Programme Objectives

The programme aims to:

• Accelerate innovative biologic therapies for pediatric cancers.
• Support investigator-initiated clinical trials.
• Advance immunotherapy and gene-based cancer treatments.
• Improve clinically meaningful outcomes for childhood cancer patients.
• Strengthen translational pediatric oncology research.
• Promote integration of correlative and biomarker studies.
• Advance frontline pediatric cancer therapy strategies.

Key Focus Areas

The ALSF Bio-Therapeutics Impact Grant Program supports several pediatric oncology research priorities.

Main focus areas include:

• Pediatric oncology biologic therapies.
• Immunotherapy approaches.
• Cell-based therapies.
• Gene therapy.
• Small molecule biologics.
• Investigator-initiated clinical trials.
• Trial-embedded correlative studies.
• Translational pediatric cancer research.
• Frontline cancer therapy improvement.
• Clinical development of innovative biologics.

The programme prioritizes therapies with strong scientific rationale and clinical potential for pediatric patients.

Types of Therapies Supported

The programme supports biologic treatment approaches including:

• Cell-based immunotherapies.
• Gene therapies.
• Small molecule biologics.
• Novel immunotherapeutic strategies.
• Translational biologic therapies for pediatric oncology.

Projects should focus on therapies with the potential to improve treatment outcomes for children with cancer.

Clinical Trial Requirements

The programme specifically supports:

• Investigator-initiated clinical trials.

Funded studies should demonstrate:

• Strong clinical trial design.
• Feasible implementation strategies.
• Clear therapeutic rationale.
• Potential for clinically meaningful outcomes.

The initiative emphasizes practical and well-structured trial execution in pediatric oncology settings.

Correlative and Translational Studies

The programme encourages integration of:

• Trial-embedded correlative studies.

These activities may include:

• Biomarker analysis.
• Translational laboratory studies.
• Mechanistic evaluations.
• Clinical response assessments.

Up to:

• 15 percent of the total budget

may be allocated to correlative study activities.

These studies help strengthen scientific understanding and treatment optimization.

Pre-Clinical and IND Requirements

Applicants must demonstrate:

• Completion of relevant pre-clinical research.

The proposed therapy must also have:

• An approved Investigational New Drug (IND) application in place.

This requirement ensures projects are sufficiently advanced for clinical implementation.

Funding Available

The programme provides:

• Up to USD 1.8 million over three years.

Funding limits include:

• Maximum USD 600,000 per year.

Indirect Costs

Indirect costs are:

• Not permitted.

Salary Requirements

Funding must comply with:

• NIH salary cap regulations.

Allowable Costs

The programme supports a range of direct clinical trial and research expenses.

Allowable costs include:

• Patient procedures not covered by insurance.
• IRB and regulatory costs.
• Drug distribution expenses.
• Cell therapy manufacturing.
• Essential laboratory assays.
• Fringe benefits.
• Research supplies.
• Limited equipment costs.
• Travel related to project implementation.

Excluded Costs

The programme does not support:

• Tuition remission expenses.

Applicants should ensure all proposed costs align with programme guidelines.

Who is Eligible?

The programme is open to applicants affiliated with:

• Nonprofit institutions in the United States or Canada.

Applicant Qualifications

Eligible applicants must:

• Hold an MD, PhD, MD/PhD, or equivalent qualification.
• Be appointed at the level of Assistant Professor or higher.

Citizenship Requirement

Citizenship is:

• Not restricted.

Experience Requirements

Applicants must demonstrate prior experience in:

• Implementing biologics-based clinical trials.

Eligible experience may include:

• Serving as Principal Investigator.
• Active participation on a clinical trial study committee.

The programme prioritizes investigators with demonstrated expertise in biologic therapy clinical development.

Consortium Participation

Participation through consortia is permitted.

However:

• Established networks with existing per-patient reimbursement mechanisms may not qualify under certain circumstances.

Applicants should ensure consortium arrangements comply with programme requirements.

Project Evaluation Criteria

Applications are likely to be evaluated based on:

• Scientific merit and innovation.
• Clinical relevance and feasibility.
• Strength of biologic therapy rationale.
• Quality of trial design and implementation plans.
• Translational and correlative study integration.
• Investigator expertise and leadership.
• Potential for meaningful pediatric cancer outcomes.

Projects demonstrating strong scientific and clinical potential are prioritized.

Why This Programme Matters

The ALSF Bio-Therapeutics Impact Grant Program plays an important role in advancing pediatric cancer treatment innovation.

Key benefits include:

• Supporting development of novel biologic therapies.
• Accelerating translation of research into clinical care.
• Improving treatment options for childhood cancers.
• Strengthening pediatric oncology clinical research.
• Encouraging innovative immunotherapy and gene therapy approaches.
• Supporting clinically meaningful treatment advancements.
• Improving long-term outcomes for pediatric cancer patients.

The programme contributes to expanding therapeutic possibilities in pediatric oncology.

Expected Outcomes

The initiative is expected to support:

• High-impact pediatric oncology clinical trials.
• Advancement of biologic cancer therapies.
• Improved translational research integration.
• Development of innovative frontline therapies.
• Increased understanding of pediatric cancer biology.
• Improved patient outcomes and treatment responses.
• Expansion of clinically validated pediatric biologic therapies.

The programme aims to accelerate meaningful progress in childhood cancer treatment.

How Applications are Evaluated

Applications are likely to be assessed based on:

• Innovation and scientific significance.
• Clinical trial readiness and feasibility.
• Strength of pre-clinical evidence.
• Quality of translational and correlative components.
• Investigator and study team expertise.
• Potential impact on pediatric oncology care.
• Budget appropriateness and project management capacity.

Strong proposals should combine scientific rigor with clear clinical implementation strategies.

Tips for Preparing a Strong Application

Applicants can strengthen their proposals by focusing on the following areas:

• Present strong pre-clinical evidence supporting the therapy.
• Demonstrate clinical feasibility and readiness.
• Clearly explain the biologic mechanism and rationale.
• Include robust correlative study integration.
• Provide realistic implementation and recruitment plans.
• Highlight prior clinical trial experience.
• Demonstrate potential for meaningful pediatric patient impact.

Common Mistakes to Avoid

Applicants should avoid the following issues:

• Weak translational or clinical rationale.
• Incomplete IND or regulatory preparation.
• Poorly designed clinical trial methodology.
• Unrealistic budgets or timelines.
• Limited investigator experience in biologics-based trials.
• Weak integration of correlative studies.

Frequently Asked Questions (FAQs)

What is the ALSF Bio-Therapeutics Impact Grant Program?

It is a funding programme supporting investigator-initiated clinical trials using biologic therapies for childhood cancers.

How much funding is available?

The programme provides up to USD 1.8 million over three years, with a maximum of USD 600,000 per year.

What therapies are supported?

The programme supports immunotherapy, cell-based therapies, gene therapy, and small molecule biologic approaches for pediatric oncology.

Who can apply?

Applicants must be affiliated with nonprofit institutions in the United States or Canada and hold an MD, PhD, or equivalent qualification.

Are indirect costs allowed?

No. Indirect costs are not permitted under the programme.

Can correlative studies be included?

Yes. Up to 15 percent of the budget may support trial-embedded correlative studies.

Is an IND required?

Yes. Proposed therapies must have an approved IND application in place before application.

Conclusion

The ALSF Bio-Therapeutics Impact Grant Program provides substantial funding support for innovative biologic therapy clinical trials focused on childhood cancers. Through support for immunotherapy, gene therapy, translational research, and investigator-led clinical studies, the programme aims to accelerate the development of more effective pediatric cancer treatments.

The initiative emphasizes scientific excellence, clinical readiness, and meaningful patient outcomes while supporting promising biologic approaches that can improve frontline pediatric oncology care. Qualified investigators and nonprofit research institutions are encouraged to develop strong and impactful clinical trial proposals aligned with the programme’s priorities.

For more information, visit ALSF.