R&D Insight

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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In Praise of Non-Inferiority

Dear All (wonkish but intended for everybody to read and absorb): There’s been a lot of recent discussion about “lessons learned from COVID-19.” Indeed, there are many valuable points: global cooperation, preparedness, supply chains, and so forth. As an example, I note the 17 Sep 2020 communique from the G20 Health Ministers (link): it was heavily

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FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference

Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The

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