Q&A: 505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success

1. When is the right time to go for a pre-IND meeting? What is needed: an idea, some literature (non-clinical data from literature), and a proposed clinical development plan in place?

Before filing an IND, it is desirable (we counsel imperative) to have a pre-IND meeting with the FDA. The goal is to get the FDA’s concurrence with the proposed development plan and regulatory submission pathway. The steps for this meeting (known as a Type B meeting) can be found here,

2. Could a 505(b)(2) also be a different dosage form?

Yes, definitely. There are numerous reasons why a Sponsor may wish to market a new dosage form of an approved product. Aside from the obvious financial benefits to the sponsor, providing a more convenient and/or faster-acting dosage form of a well-chosen drug provides significant benefits for patients.

3. What kind of published data does 505(b)(2) require? Is peer-reviewed research also possible to use in 505(b)(2)?

Peer-reviewed articles have a higher standard than anecdotal reports. Data sourced from the New England Journal of Medicine, etc., has a higher quality of data and is regarded as higher than more obscure journals which are not peer reviewed. The best source might be, with a new indication, 3 different articles by 3 different sets of authors, done at different times in different locations. When the data and results are similar in that situation, it makes for very strong data. Robustness is one thing the FDA views to make sure they come to the same conclusion.

4. I want to pick up a drug dropped by a drug developer. Will I be liable for the accuracy of the drug’s public info the original drug developer generated?

The word “liable” brings in a legal angle, and we are not legal experts, so I won’t address question of liability. If you are taking public info, there are ways to look at the veracity of that information. There are certain standards that we, and the FDA, use to look at for evaluation of that data. Yes, if you rely on that data, the FDA is also going to question the value of that data as well. Approval can be based on public information.

5. Which studies are needed for a prodrug of a known active molecule? How can I make sure that my prodrug is a 505(b)(2)?

A more complete answer is on our website, link below. A prodrug of a currently approved drug depends on where the prodrug splits and activates. If the prodrug splits on the cell level, it becomes a 505(b)(1) program. If it splits in the stomach level, it becomes a 505(b)(2) and is a pharmacokinetic-based program.

6. Does Biotech Research Group provide manufacturer’s guidance/education on reimbursement considerations for a 505(b)(2) NDA vs innovator & current/potential ANDAs in the market?

Absolutely. Part of the considerations of our service is to look at the commercial, what is being developed for that therapeutic area, the current practice of medicine, the thought process of doctors and how the prescribing habits and disease states are changing, and the drugs given in conjunction with other drugs.

7. How many 505(b)(2) products has Biotech Research Group worked on? What is your experience with 505(b)(2)?

Great question. Biotech Research Group has worked on more than 1630 products in our 15 years (celebrated next month). We are very proud of our experience with 505(b)(2), especially with our teams always built of multidisciplinary experts for all aspects of drug development.

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