Skip links

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

Last week, we posted the first part of Q&A from recent webinar 505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success Camargo President and Co-founder, Ken Phelps, held with Fierce Biotech. Because of the great questions asked by the many active participants, we are sharing Part 2 of the Q&A here with our brief answers, along with a link to access the recorded webinar, below.

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

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


8. If route of administration and dose are the same and only indication is changed, how do we go for a pre-IND meeting?

If you are only changing indication, hopefully you have evaluated the possibility of a generic out there, which means your product may not have much commercial value. What is required is what public info do you have on that indication already? To go to the FDA, you should know how old is the current drug? How long has it been on market? You will have to bring all info up to current NDA standards. You may have to do additional clinical work to bring it up to current standards. Look at current environment as far as patient population. Pediatrics? Maybe the current approved one is only for adults. You have to figure out what extra needs to be done because pediatric is now required. Then go to Pre-IND with studies we are proposing.


9. Have you worked with digital medicine? If so, what are your opinions regarding the 505(b)(2) pathway for digital cognitive therapies?

Digital medicine examples include sensor-enabled drug products with signals to encourage compliance. These types of digital examples come in pill or patch form, or as a drug-device combination product. These products are combination products – about 30% of Camargo’s work is in combination products, where the FDA reviews are conducted by CDER and CDRH, through the Office of Combination Products.


10. Can one product have two storage conditions for a single 505(b)(2) application? Or do we need two separate applications?

Yes, one product could have one product application with 2 different packaging, which could have different storage conditions.


11. Can you explain effects of market exclusivity term and patency term of parent drug to apply for 505(b)(2) drug development?

  • Patents are issued by the US Patent and Trade Office based on intellectual property.  A patent lasts for 20 years yet, can be challenged and found invalid.
  • Marketing Exclusivity is granted by the FDA as an incentive to conduct studies.  The term ranges from 3-7 years and can be extended by 6 months in some cases by pediatric studies.  Exclusivity cannot be challenged or taken away.

We have many articles expanding upon the topic of Exclusivity, found here.


12. Would a PK bridging strategy be possible if a sponsor is combining 2 separate FDA approved drugs for the same indication to show increased efficacy when combined, or would a traditional development approach be the only option?

This could be a 505(b)(2) situation. Yes, you would have to do PK for bridging for safety for a fixed-dose combination. This would allow you to reference known tox studies for those drugs.


13. You mentioned that we have to look outside of PubMed for data. Where do you suggest we look?

Camargo has an extensive database of literature developed for this purpose. We also have many literature-only NDA approvals (see link). Drugs with a long history of clinical use and significant clinical literature appear particularly amenable to the literature-only NDA strategy, which blends well with a push from the FDA for sponsors to gain approval for unapproved but long-marketed drugs. Most programs utilized pre-approval meetings with the FDA, suggesting that obtaining clear expectations from the Agency on the suitability of literature and the bridging strategy are critical to the success of this strategy.

More info: Dramatically Decrease Drug Development Costs Through Literature-Only 505(b)(2) NDA Submissions


14. What kind of clinical studies are expected for a quasi-DESI drug (used before FDA safety/efficacy requirements but included in the Federal Register under pharmacology class)?

DESIs are referred to as drugs which were on the market pre-1938 or 1962.DESIs are grandfathered but have no formal approval by the FDA. Camargo does a lot of DESI work and has been involved in getting many approved. The kind of work that is required varies widely. In general, they are probably safe, believed to be efficacious, but need additional proof.


15. When is good time to go for a pre-IND meeting? Can we go with public information, formulation, and a clinical development plan?

Camargo led 57 pre-IND meetings in 2017. In general, a pre-IND meeting can be based on ideas, with little or no studies conducted by the sponsor. These ideas are constructed with TPPs, giving the product and what it would look like. As part of preparation, we take an idea to the marketplace with proposed results, ask doctors if that data would be compelling enough, then set up the studies protocol, expected results, and ask if the FDA will accept that idea.


16. How many times can we go to pre-IND meeting for one drug development?

You need a lot of help on that request because they are usually denied.

A first pre-IND meeting might fail for many reasons. Often, a sponsor doesn’t provide sufficient information or what is provided lacks clarity to allow FDA to have a reasonable understanding of the development requirements. Sometimes the sponsor doesn’t understand the FDA’s goals and approval requirements.  Other issues include using the public literature incorrectly or inadequately. Sometimes, the development program is unclear, there is insufficient detail on the proposed studies or there are gaps which prevents the FDA and sponsor from finding common ground. Both parties need to come away knowing exactly what the development program is going to be. Because of some significant deficiency in the original meeting, a second one may be granted. For more on the importance of teamwork and strategy before the Pre-IND, read


17. Does the reference drug have to be approved for 505(b)(2)?

In some cases, an RLD is simply not necessary. Active pharmaceutical ingredients (APIs) with a long history of use may have enough publicly available data to “cover all the bases” for safety or efficacy. More info here.


Last week’s blog covered the first 7 questions from webinar 505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success, which ran live on May 9, 2018, with Fierce Biotech. Click here to gain direct access to the on-demand version of the hour-long webinar.

Further questions:

For questions about your specific product idea and / or 505(b)(2) drug development, or to schedule a meeting with us at BIO International Convention in Boston, June 4 – 7, please contact Camargo or email us.