R&D Insight

BARDA seeks to support a VC-like mechanism for Medical Countermeasure (MCM) innovation / Your chance to provide input!

Dear All, BARDA is (yet again!) pushing the envelope with novel ways to support innovation. Their DRIVe group has just released an RFI in which they request input on their plans to create a VC-like mechanism through a third party to support innovation in the MCM (medical countermeasure) space. Go here for the complete RFI, but I’ll reproduce a

30 October 2019 No Comments

Save the date: 18-19 Nov 2019 FDA-IDSA-NIAID-Pew-sponsored workshop: “How can we improve antibacterial development?”

Dear All, Please mark your calendar now to be in the Washington, DC area on 18-19 Nov 2019 for a 2-day workshop at FDA’s White Oak Campus focused on enhancing the clinical trial enterprise for antibacterial drug development. Jointly co-sponsored by FDA, IDSA, NIAID, and Pew Trusts, this meeting will have a particular focus on (a)

4 October 2019 No Comments

ASM-ESCMID (3-6 Sep 2019, Boston): Post-meeting notes and annotated presentations

Dear All, Apologies for the delay, but I’ve held off on this note until the majority of the presentations from the 3-6 Sep 2019 ASM-ESCMID meeting (Boston) were online. You can now access the program, most of the presentations, and the meeting abstracts here. It was a wonderful meeting with over 400 attendees. And, please be sure

28 September 2019 No Comments

Superb podcast series: From “We can treat your cancer but you’ll die of infection” to “Tracking AMR by analyzing airplane toilet waste”

Dear All, I previously wrote (link) about the first of Jason Gale‘s 4-part podcast series on AMR. The whole series is now out and definitely worth your time. Each podcast is about 30 minutes long … please set aside a bit of time to listen to all four! Here they are: #1: In a detailed look at

27 September 2019 No Comments

DHHS Secretary Alex Azar, CDC, and Dame Sally Davies: An event to celebrate AMR fighters around the globe

Dear All, If you’re going to be in New York City on 23 Sep for the UN General Assembly, you are invited to join U.S. Health and Human Services Secretary, Alex Azar, experts from the U.S. Centers for Disease Control and Prevention, and hundreds of organizational and global leaders at an evening celebrating global AMR

16 September 2019 No Comments

Superb podcasts x 2: “Your cancer will be controlled, but you may die of infection” and “Pharma needs to be (and stay) engaged”

Dear All, Clear analyses by our colleagues in the science-focused media are invaluable ways to educate both ourselves and others: we learn new viewpoints while our non-technical friends and colleagues learn what keeps us up at night. On this note, we have two recently released 30-minute podcasts that are very much worth hearing and sharing.

15 September 2019 No Comments

Clostridioides difficile / CARB-X Year 3 Annual Report / White House OSTP seeks input on the US Bioeconomy

Dear All, Committing serial email this afternoon… First, the note I just sent on FMT for Clostridium difficile (link) prompted comments that the organism is now called Clostridioides difficile. This name change slipped past me, I’ll admit! But it does seem a settled change … see this helpful editorial from May 2019 in Lancet ID for a summary of how the new

11 September 2019 No Comments

FDA public hearing on Fecal Microbiota Transplantation (FMT) to Treat Clostridium difficile

Dear All, On 4 Nov 2019 at their White Oak Campus, FDA will hold a public hearing from 9a-4p on fecal microbiota transplantation (FMT) to treat Clostridium difficile infections that are not response to standard therapies. Go here for the online FR notice and here for the .pdf version. The background on this topic goes back several years and is well

11 September 2019 No Comments

Novo REPAIR’s 2019 US-Canada funding round is open; Global AMR R&D hub seeks your input

Dear All, Two time-limited opportunities have been announced in the past few days. First, the Novo REPAIR Impact Fund has opened its 2019 US-Canada-focused investment round. Non-confidential proposals are due by 11 Oct … go here for details. Note that you need to dig all the way to the bottom of the web page to find the information.

6 September 2019 No Comments

Alan Carr’s Sep 2019 Antibacterial-Antifungal Update; Pews’ updated pipeline review

Dear All, First, Alan Carr’s Sep 2019 Antibiotic and Antifungal Update (link) is, as usual, required reading (see also this prior blog). Key highlights: He provides an updated by-month sales report from Jan 2016 through Jul 2019 of all products approved since 2009. Sadly, it remains the case that only 4 drugs have sold more than $100m in the