Business Models
Biosimilar Strategy
1.
There are numerous biosimilars that have been successfully developed by international manufacturers and approved by their local FDA. PDTi will select some of these biosimilar products that have the high market ratings validated by their consumer’s records of safety, efficacy, and cost.
2.
PDTi enters corporate partnerships with the manufacturers of these selected biosimilar products to produce the GMP grade drug substances that will be exported by its wholly-owned subsidiary to the US with its new quality control standards in compliance with the US FDA.
3.
Construction of a state-of-the-art fill and finish manufacturing facility for biosimilars in the United States that will apply for US FDA approval through new clinical trials conducted in US. PDTi’s new US manufacturing facility will be able to produce drugs in significantly less time and at dramatically lower cost.
The Redfield Model
1. In-country distribution assistance
Our regional “field marshals” with their decades of in-country operational experience, will create and manage a country specific strategy to address “the last mile” of vaccine distribution and uptake working with locally assembled country teams.
2. In-process quality control & assurance
Provides In-process quality control and assurance that incorporates testing at four junctures. Can test a country’s current vaccine stockpile to establish the quality.
1) Purchased vaccine arrival at country port of entry
2) Arrival at local distribution center
3) Departure from local distribution center
4) Post vaccination sample
3. Post-vaccination services
PDTi will provide metrics and evaluation for vaccines. Our services include a multi-platform immunity test that will gauge an individual’s immunity and determine if they require a booster.
4. Education and Training
Education and training of local health administrators and populations addressing vaccine hesitancy, the length of immunity that the vaccines produce, and the need for a vaccine strategy focusing on immunity.