In collaboration with our business partners, we facilitate the process of developing, manufacturing, testing, registering, selling, and delivering the generic small-molecule drugs and biotechnologies for which we hold intellectual property. Here are the steps:
| Prior to Development | |
|---|---|
| Step 0: Name-brand Drug Creation |
Innovator pharmaceutical companies develop name-brand (originator) drugs |
| Pre-Production | |
| Step 1: Product Development |
Generics contract research organizations (CROs) perform research & development to identify and process originator drugs’ active pharmaceutical ingredients (API) |
| Step 2: Product Acquisition |
Boston Oncology acquires seed material of APIs from CROs, along with rights to use APIs within license regions, to create a world-class portfolio of treatments |
| Step 3: Equipment & Supply Acquisition |
Boston Oncology acquires the designs and equipment from pharmaceutical input suppliers to process APIs and produce final drugs |
| Step 4: Local Investment |
Boston Oncology joins with local partners to construct factories in developing nations and emerging markets to produce the drugs |
| Production | |
| Step 5: CMO Production |
While factory construction is underway, contract manufacturing organizations (CMOs) produce drugs in their own facilities so Boston Oncology can begin clinical trials and registration |
| Step 6: Clinical Trials & Product Registration |
Boston Oncology begins clinical trials to register drugs in host country |
| Step 7: Local Production |
Once factories are complete and drug registration is secured, CMOs hand off production to factories |
| Step 8: Factory Validation |
Regulators validate that Boston Oncology’s factories can produce drugs of the same quality as the drugs produced by the CMOs |
| Step 9: Local Sales |
Boston Oncology begin selling drugs to physicians, hospital administrators, and government health agencies and/or payers |
| Post-Production | |
| Step 10: Ongoing Relationships |
Boston Oncology maintains a pipeline of future products from CROs and quality assurance and maintenance support from CMOs; ensures global factories continuously communicate and implement best practices |