R&D Strategy

General Firm Information

Firm Name

Point of Contact

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Headquarters Location(Required)

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Other Office Locations

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Does your firm have Pharma/Biotech Experience?(Required)

Yes

Let us know if you have Trademark experience in the following three areas, select all that apply.

Experience in the Following:(Required)

1. Analysis of FDA Requirements for a Phase II Platform Study: (1) What is required for a Phase II platform vs. a Phase III Platform?; (2) What are the risks associated with doing a PHII and converting to a registrational PHIII?

2. FDA’s view on registrational PHII open label studies: When can these be used as support for an NDA/BLA and when does FDA require a closed/masked study, and are there any exceptions? What may be the ramifications of doing an open label when FDA has requested a blinded/masked study?

3. Examples of where sponsors have successfully re-used existing Data to save on developmental timelines (Safet, Tox, etc.), and gone straight to registrational trials with a different product. (i.e. a follow-on product with a different active ingredient was able to utilize past studies as some properties of the new product was similar/comparable to the original product)

You chose #1, please share a brief description of your experience.

You chose #2, please share a brief description of your experience.

You chose #3, please share a brief description of your experience.