R&D Insight

Commissioner Gottleib (New FDA initiatives, need for Pull incentives) + updated Pew pipeline analyses

Dear All: It was a HUGE day at the Pew Charitable Trusts today! First, Commissioner Scott Gottleib gave a superb and very exciting speech. You can either read or listen to the entire speech. There is also a panel discussion after his talk that is worth replaying. Here are some highlights from Commissioner Gottleib’s talk: FDA is working to coordinate

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FDA workshop on non-traditional antibacterials (21-22 Aug 2018)

 Please be sure to look closely at the events calendar: Q&A with Scott Gottlieb, Lipinski on Lipinski, and more! Dear All: FDA’s 21-22 Aug 2018 workshop on the development of non-traditional antibacterial agents was an excellent discussion of core challenges in this area. The agenda plus all the meeting materials (including the public comment slides and

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New IMI Accelerator Program For AMR-Focused Product Development

Dear All: EU’s IMI (Innovative Medicine Initiative) has initiated a new accelerator program for AMR-focused products! I added the links in the last newsletter … now it’s time for the details. (And separately please also note that there are 6 new meetings in the future meetings list … look closely … it is impossible to keep up!) This new

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FORWARD Act For Antifungals, NTAP Achaogen And Melinta, Novo REPAIR Funding Round

Dear All: I hope your summer is going well! Below, three items of interest. See as well several updates to the future meetings list.  First,Rep. McCarthy recently introduced the FORWARD (Finding Orphan-disease Remedies with Antifungal Research & Development) Act to the United States House. Seeking to support “endemic orphan fungal disease research, incentivize Valley Fever vaccine development, discover

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REVAMP, a pull incentive in the US: Time to make it happen!

Dear All: I previously wrote about the nascent REVAMP legislation that would create a Pull incentive in the US market. With everybody back from the July 4th holiday, the goal for this week is to get REVAMP into position to be offered as an amendment at the House Energy & Commerce Committee’s PAHPA mark-up (expected next week).

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Approaches to antifungal R&D: A lecture from ISHAM

Dear All: ISHAM 2018, the meeting of the International Society for Human and Animal Mycology, is now happening in Amsterdam. I was given an opportunity to talk today on antifungal R&D and I thought I would share the slides with the broader community. It was really interesting to think about the parallels between antibacterials and

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