Nonclinical Development & Translational Strategy

LOPBaTI Solutions

Your premier solution partner in preclinical pharmacology and translational biomarkers consulting for precision medicine.

Our Services Get In Touch

Who We Are

About LOPBaTI Solutions

LOPBaTI Solutions is a boutique scientific consulting firm founded by Dr. Lawrence Owusu, PhD, with deep expertise in nonclinical development and translational strategy. We serve biotechnology and pharmaceutical companies navigating the complex journey from discovery through IND-enabling studies and beyond.

Our team brings decades of hands-on experience in gene therapy and small molecule product development, offering tailored guidance that accelerates timelines, reduces risk, and strengthens regulatory submissions.

How We Work

Our Approach

We combine rigorous scientific thinking with strategic foresight to deliver actionable, client-centered solutions. Our work is characterized by precision, transparency, and a commitment to your program's success.

🔬

Science-First

Every recommendation is grounded in current literature, regulatory precedent, and mechanistic understanding.

🎯

Program-Centric

We immerse ourselves in your program to provide guidance that fits your specific molecule and indication.

⚡

Agile & Responsive

We adapt quickly to evolving data, regulatory feedback, and shifting development priorities.

🤝

Collaborative

We function as an extension of your team — available, invested, and aligned with your goals.

Where We Engage

Partnership Areas

We partner with sponsors across the development spectrum — from early-stage startups establishing their nonclinical frameworks to established organizations seeking specialized expertise for critical program milestones.

Gene Therapy Programs Small Molecule Development IND-Enabling Studies Translational Biomarkers Regulatory Submissions Pharmacology Strategy

Explore Our Services →

Why Choose LOPBaTI

Why Partner With Us

Senior-Level Expertise

Direct engagement with PhD-level scientists who have led programs at major pharma and biotech companies.

Cross-Modality Experience

Fluency across gene therapy vectors and small molecule modalities means integrated, holistic program thinking.

Regulatory Acumen

Deep familiarity with FDA and global regulatory expectations shapes every nonclinical strategy we craft.

Flexible Engagement

From targeted project support to ongoing advisory roles, we scale our involvement to match your needs and budget.

What We Offer

Our Services

LOPBaTI Solutions provides specialized consulting across the full nonclinical development continuum, with deep expertise in gene therapy and small molecule programs.

Nonclinical Development Strategy

Comprehensive strategy development for IND-enabling nonclinical programs. We help sponsors design efficient, risk-based study plans that satisfy regulatory requirements while minimizing time and cost. Services include package design, study timeline planning, CRO selection support, and data interpretation.

🧬

Gene Therapy Development Support

Specialized nonclinical support for AAV, lentiviral, and other gene therapy vectors. We provide guidance on biodistribution, tropism, immunogenicity, genotoxicity, and germline transmission studies — translating complex biology into clear regulatory strategy.

💉

Translational Biomarker Strategy

Development and qualification of translational biomarkers that bridge nonclinical findings to the clinic. We assist with biomarker selection, assay strategy, PK/PD modeling, and dose-response relationships to strengthen your clinical rationale and enable precision dosing.

📊

Small Molecule Product Development

Full nonclinical development support for small molecule candidates across therapeutic areas. Services span ADME/PK strategy, safety pharmacology, genotoxicity, repeat-dose toxicology, and carcinogenicity risk assessment — all aligned to ICH guidelines.

⚗️

Regulatory Strategy & Submission Support

Expert guidance on IND, CTA, and NDA/BLA nonclinical sections. We review and author nonclinical summaries, participate in pre-IND meeting preparations, and respond to FDA correspondence — ensuring your submissions are scientifically compelling and strategically sound.

📋