Company A is working to develop an oral drug for osteoporosis. Company B is working to develop a topical drug to treat a bacterial infection. The development programs for these two drugs will need to answer the same general questions, but they will look very different from one another. Understanding why such differences exist can be one of the most frustrating aspects of drug development.
Development programs must demonstrate the safety and efficacy for the intended human use and the ability to manufacture the drug with a defined quality, strength, potency and purity. They must address route of administration, duration of treatment and influences of the disease process, age, gender, and drug-drug interactions. During development, a company must determine the appropriate dose to have a clinical effect and what adverse events to expect while using the drug. One can only predict so far into the future, and must allow for adjustments in the development plan as data is collected.
Development plans can also vary depending on the company and its overall goals. A large company that is planning on carrying a product all the way through the development process may approach things differently than a small company whose overall goal may be to develop a product portfolio to attract investors or a partner.
As you can see, companies have many things to consider when creating a drug development strategy, and many come to The Weinberg Group for help in creating a strategy that suits their individual business goals.