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Connecting Concept to Clinic

Advancing radiopharmaceutical development through specialized expertise in biotech innovation and clinical implementation.

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The Challenge

Transforming Scientific Promise into Clinical Reality

Many groundbreaking radiopharmaceutical therapies never reach patients because the journey from laboratory to clinic is fraught with disconnects between scientific vision and clinical practicalities. We create seamless pathways between these worlds, connecting promising discoveries with practical implementation strategies that accelerate the path to patient impact.

Specialized Expertise

Navigating Regulatory Pathways for Radiopharmaceuticals

Pharmaceutical companies face significant hurdles in radiopharmaceutical development due to gaps in expertise. Theragnostic Insights offers specialized knowledge of regulatory requirements, clinical protocols, and implementation strategies that accelerate the path to clinical application.

Our Expertise
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Strategic Guidance

Building Strategic Development Roadmaps

The journey from laboratory discovery to patient impact requires navigating complex logistical and operational challenges. Our team bridges scientific innovation with practical implementation, providing the strategic guidance needed to overcome barriers and accelerate development timelines.

Our Services
Implementation Focus

Building Successful Clinical Development Programs

We specialize in creating development strategies that anticipate implementation challenges before they become obstacles. Our approach integrates scientific rigor with practical clinical considerations, ensuring your radiopharmaceutical advances efficiently from concept to patient impact.

About Us
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Our Difference

Specialized Expertise That Accelerates Development

We combine clinical understanding with scientific insight to transform radiopharmaceutical innovations into patient treatments. Where others see complexity, we see connections that accelerate your development journey.

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Specialized Clinical Focus

Exclusive concentration on radiopharmaceutical development with deep understanding of the unique regulatory, logistical, and implementation challenges these specialized therapies face.

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Extensive Expertise

Combining years of clinical development experience with scientific knowledge creates a bridge between laboratory innovation and real-world patient care that accelerates progress.

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Accelerated Pathways

Strategic development approaches that identify critical-path activities and eliminate common delays, ensuring your radiopharmaceutical advances efficiently through development stages.

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Implementation-First Planning

Development strategies that anticipate clinical realities from day one, preventing late-stage obstacles and ensuring scientific innovation translates effectively to patient impact.

Specialized Solutions

Radiopharmaceutical Development Expertise

Targeted consulting services that address the unique challenges of bringing radiopharmaceutical innovations to patients. Our expert team bridges critical gaps in development, accelerating your journey from laboratory discovery to clinical implementation.

01 Strategic Development Planning

02 Regulatory Navigation

03 Clinical Trial Design

04 Site Selection & Management

05 Medical Monitoring

Fragmented Development Planning

We create comprehensive clinical pathways that anticipate implementation challenges from day one, establishing clear roadmaps from scientific concept to patient treatment.

Unique Regulatory Considerations

We provide specialized guidance through complex regulatory pathways specific to radiopharmaceuticals, translating scientific data into compelling regulatory strategies.

Protocol Implementation Challenges

We develop optimized protocols that balance scientific objectives with practical implementation considerations, ensuring feasible execution across clinical sites.

Limited Radiopharmaceutical Site Capabilities

We strategically identify and qualify clinical sites with appropriate radiopharmaceutical capabilities, ensuring efficient study execution and proper handling of specialized materials.

Specialized Safety Oversight Requirements

We provide expert medical monitoring tailored to radiopharmaceutical studies, ensuring proper safety assessment and management throughout clinical development.

Our Network of Expertise

Precision-Guided Support

We draw on a trusted network of senior experts to deliver precise radiopharmaceutical development support across clinical strategy, regulatory affairs, oncology, and health physics.

Alison Armour, MD, FRCP, FRCR
consultant

With deep oncology expertise and a track record in precision medicine, Dr. Armour has led global development efforts and pioneered radioligand therapies including Pluvicto.

Alicia Staz, MS, RAC
consultant

A regulatory strategist with 25+ years in pharma, Alicia bridges sponsors and health authorities, bringing advanced therapies to patients with speed and clarity.

Michael Lamba, PhD
consultant

A leader in radiation oncology physics, Dr. Lamba brings decades of experience implementing new radiotherapy technologies and guiding facility development.

A. Lake Wooten, Ph.D
consultant

Lake is a radiopharma expert with 12 years in isotope production and GMP manufacturing. He’s launched three RLT sites and advises on CMC, safety, and strategy.

Our Background & Approach

Learn more about our specialized expertise and unique methodology for bridging scientific innovation with clinical implementation in radiopharmaceutical development.

About Us
Our Insights

Expert Perspectives on Radiopharmaceutical Development

Stay informed on emerging trends, regulatory developments, and implementation strategies in the radiopharmaceutical space.

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Trends

Theragnostics in the Wild: How Real-World Oncology Trials Are Rewriting the Radiopharmaceutical Playbook

See how recent theragnostic trials are reshaping RPT design, endpoints, and expectations—with lessons biotech teams need now.
Read more
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Ready to Accelerate Your Radiopharmaceutical Development?

Schedule a consultation to discuss how our specialized expertise can help bridge the gap between your scientific innovation and clinical implementation.

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