LOPBaTI Solutions

Premier solution partner in AAV-based nonclinical pharmacology and translational biomarker consulting services.

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Who We Are

LOPBaT Solutions (LOPBaTS) is a premier technical guidance and support provider of nonclinical pharmacology and biomarker development strategy for AAV-based gene therapies. At LOPBaTI Solutions, we are FOCUSED and committed to delivering exceptional services by providing executive-level expertise to help you achieve your drug development goals in time.

Our Approach

As unique as every program is, so is our approach to addressing your needs. Our multidisciplinary experts, with 40+ years of combined experience, are dedicated to advancing your candidate from concept to early clinical development through a comprehensive suite of support services tailored to meet the unique scientific and regulatory needs of your project. We combine rigorous scientific thinking with regulatory foresight to deliver actionable solutions. Our client-centric approach ensures that each project receives personalized attention and the resources necessary for milestone advancement.

Our approach is SIMPLE: if we can't support you, we re-direct you elsewhere. Why? Because we take pride in your success.

Partnership Areas

We specialize in providing strategic advice and operational support to biotech and precision drug development companies from therapeutic concept development through first-in-human (FIH) studies. We focus on sponsors developing AAV-based gene therapies for both rare and nonrare disease therapeutic areas with translational pharmacology and biomarker strategy services.

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Why Partner With Us

Fractional Leadership

When you don't have a full-time (FT) pharmacology or translational sciences lead, we fill in the gap. Get seasoned, executive-level support without the overhead.

Adaptable Services

Whether you need full end-to-end support or partial support for specific tasks, our services are adaptable to meet your needs.

Cost-Effective

We provide quality and timely services at a fraction of the cost of an FTE.

Our Services

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Preclinical Pharmacology Services

End-to-end support from study design to data interpretation

Study Design: Design of customized studies (IND-enabling, proof of concept, proof of biology) to evaluate the therapeutic potential of gene therapy candidates, with emphasis on both traditional translatable endpoints and clinically relevant proactive innovative endpoints.
Study Coordination and Monitoring: End-to-end management of preclinical studies, ensuring efficient execution and adherence to timelines and quality standards.
CRO Qualification and Engagement: Selection and management of Contract Research Organizations (CROs) to optimize project outcomes and cost-effectiveness.
Data Analysis and Interpretation: Comprehensive analysis and insightful interpretation of preclinical data of prior studies to inform strategic decisions.

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Biomarker Strategy Service

Guiding biomarker strategy from discovery through regulatory submission

Development and implementation of biomarker strategies, including exploratory biomarker analysis plan (EBAP), guiding development from early research (R&D) through clinical stage, enhancing decision-making and regulatory submissions.
Lead contracting, development supervision and validation due diligence of fit-for-purpose assays for pharmacodynamic and immunogenicity evaluations.

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Translational Sciences Strategy Services

Bridging preclinical research to first-in-human trials

Formulation of strategies to translate preclinical research into clinical applications, facilitating a seamless transition to first-in-human (FIH) trials.

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Due Diligence and Gap Analysis Services

Identifying gaps and building a path to compliance

Critical review of study reports, identification of data gaps and development of a remediation plan to ensure compliance with regulatory requirements.

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Publication and Report Writing Services

Clear, accurate documentation for your program's record

Nonclinical pharmacology study report re-writing to ensure accuracy, scientific validity and program alignment.
Biomarker endpoint (exploratory, secondary, surrogate) justification document.
Sponsor data publications and/or white paper writing/review.

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New Therapeutic Concept Support

Rigorous analysis to guide your go/no-go decisions

Comprehensive literature search, meta-analysis and report development for initial go/no-go decision guidance.