Radiopharmacy - PV HealthTech

Oncoworkz Project Consultancy Services for Medical Cyclotron and Radiopharmacy Projects

Overview

Advancing PET Tracer Solutions: Current and Future Trends in Radiopharmacy

Positron Emission Tomography (PET) is transforming precision medicine, driven by the evolving landscape of medical cyclotron-produced tracers. Today, widely used PET tracers such as ¹⁸F-FDG, ¹⁸F-PSMA, ¹⁸F-DOPA, and ⁶⁸Ga-labeled peptides play a crucial role in Oncology, Neurology, and Cardiology. As the field advances, the next generation of radiopharmaceuticals—including ⁸⁹Zr, ⁶⁴Cu, and novel peptide-based tracers—is poised to enhance imaging accuracy, theranostics, and personalized treatment strategies.

Our consulting expertise helps institutions navigate this dynamic landscape by integrating cutting-edge tracer technologies, optimizing cyclotron operations, and ensuring regulatory compliance. Whether establishing new facilities or expanding tracer production capabilities, we provide end-to-end solutions tailored for clinical and research excellence.

Creating a cyclotron facility is a multidisciplinary endeavor requiring meticulous project planning. Our consultancy services at Oncoworkz provide comprehensive guidance for establishing a cyclotron-based radiopharmaceutical production facility. This involves evaluating several critical factors to ensure the facility meets both operational and financial objectives.

Key Factors in Project Planning:

1. Assessment of Need: We help assess the demand for cyclotron-produced radionuclides and the specific requirements of potential users.

2. Cost-Benefit Analysis: We evaluate whether it is more beneficial to establish an in-house radionuclide manufacturing facility or to procure radionuclides from commercial suppliers.

3. Resource Evaluation: We assess available resources including technical expertise, infrastructure, and financial capabilities for establishing and operating the facility.

4. Market Analysis: We analyze the future availability of cyclotron-produced radionuclides from commercial suppliers and the impact of market competition.

5. Business Planning: We develop a comprehensive business plan that addresses all financial factors and ensures the financial viability of the facility.

Project Scope and Objectives

After evaluating the above factors, we formulate a realistic scope and objectives for the facility.

Key questions addressed include:

Should the facility manufacture its own products or source them from a supplier?
What size and type of cyclotron is required?
What resources are needed for successful implementation?
What are the mission and goals of the project?

Facility Requirements

The scope of the planned facility determines the type of cyclotron and associated resources needed. We assist in planning facilities ranging from comprehensive production units to smaller centers dedicated to specific radionuclides like fluorodeoxyglucose (FDG).

Cyclotron Facility Specifications:

A typical cyclotron facility with a focus on PET radionuclide production would include:

A cyclotron with proton energy between 10-24 MeV.
Production of FDG as the principal objective, with capabilities for producing other short-lived positron emitters.
Distribution of FDG to local hospitals, with minimal involvement in basic radiotracer development research.

Financial Viability and Costs

We provide detailed evaluations of financial viability, considering:

Buildings and Utilities: Site design, construction costs, space requirements, and compliance with GMP standards.
Equipment: Comprehensive list of necessary production and analytical instrumentation.
Operational Costs: Ongoing expenses including supplies, utilities, staff salaries, maintenance, and depreciation.

Business Plan Development

A sound business plan is crucial for the project's success. Our business plan outline includes:

Executive Summary: Overview of investment, market potential, marketing strategy, potential revenues, and management expertise.
Market Analysis: Evaluation of the market demand, competition, and strategies to increase awareness and demand.
Operational Plan: Detailed breakdown of production, synthesis, quality control, distribution, and marketing operations.
Management and Organization: Organizational structure and staffing requirements.
Financial Plan: Initial investment, cost of production, potential revenues, growth projections, and break-even analysis.

At Oncoworkz, we ensure that every aspect of the cyclotron project is meticulously planned and executed. From assessing the initial need to developing a comprehensive business plan, our consultancy services cover all essential areas to guarantee the success and sustainability of your radiopharmaceutical production facility.

PVHT would be happy to partner with the investors and Healthcare provider for this project.

The role of PVHT can be broadly outlined as below:

Project consulting for the proposed hospital project
Design validation of existing blueprints / architectural layouts
Technology planning of the hospital with a focus on Oncology
Care pathway design and development for Oncology
Patient experience and ambience design
Training of technologists, nurses, staff through PV HealthTech LLP’s Education vertical.

Project Consulting:

PVHT will act as a project consultant during the entire course of the project. PVHT can prepare a preliminary financial model to project potential revenues based on market assumptions and inputs from Hospital to provide guidance on the level of investment and the viability of the proposed project.

All services including advisory services & solutions for setting up the innovative cancer care center will be provided by PVHT against a fee, wherever applicable, to be decided through a commercial agreement.