Dear All: I don’t mean to inundate your inbox (this is my 3rd email this week!), but these two things have just hit my inbox and one of them has very tight timing:
First, I previously wrote about job opportunities with BARDA’s new DRIVe initiative. With the goal of revolutionizing the way we prevent, detect, and respond to major health security threats, the initiative was described in public at BIO and has now gone live at https://drive.hhs.gov/. Initial programs will focus on (a) sepsis and (b) early detection of infection.
Second, I’ve just seen a Federal Register notice about an FDA workshop to be held 27 June 2018 from 8:30 a.m. to 4:30 p.m (yes, 19 days from now) on inhaled antibacterial drugs for Cystic Fibrosis (CF) and Non-Cystic Fibrosis Bronchiectasis (NCFB). Especially given the negative outcomes in the two recent efforts to develop an inhaled drug for NCFB, this is a welcome discussion. The planned discussions look very interesting :
- Trial design challenges
- Trial endpoints
- Trial populations, duration of therapy, duration of microbiologic testing and followup
- Device considerations
So many good meetings and discussions are planned … it’s excellent to see all this effort underway! All best wishes, –jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://13.43.35.2/blog/
Upcoming meetings of interest to the AMR community:
- [OLD MEETING, detailed summary now out] 14-15 Jun 2017: NIAID PK-PD workshop. A detailed summary document is now available. See also my prior blog on this meeting.
- 7-11 Jun 2018 (Atlanta): ASM Microbe
- 8 June 2018 (Atlanta): Antibiotic R&D Networking Event hosted by Pew Trusts and GARDP. Venue details and registration are here.
- 12-13 Jun 2018 (Washington): National Academies of Science workshop: Understanding the Economics of Microbial Threats
- 13 June 2018 (webinar, 5-6.30p CEST): The first of a series of GARDP+CARB-Xed webinars on development: Antibacterial drugs: clinical development for non-developers Part 1: Traditional development – tiers A and B
- 14 June 2018 (Washington): Duke-Margolis & FDA event: (link to register) “Understanding the Development Challenges Associated with Emerging Non-Traditional Antibiotics”
- 21-22 Jun 2018 (London): joint EMA-FDA-PMDA workshop on pediatric development of antibacterial agents.
- 22-26 Jun 2018 (Saskatoon, Canada): 5th International One Health Congress, including a dedicated AMR track
- 26 June 2018 (CDD-sponsored webinar at 11a EST): “SAR data in Drug Discovery”. Andrew Leach (ChEMBL) and Evan Bolton (PubChem) will discuss drug discovery informatics and ways to use the freely available PubChem and ChEMBL SAR data.
- [NEW] 27 June 2018 (Washington): FDA workshop on inhaled antibacterial drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis
- 22-27 Jul 2018 (Bryant University, Smithfield, RI): Gordon Research Conference on Drug Resistance for Cancer, Infectious Disease and Agriculture
- 21-22 Aug 2018 (Rockville, MD): NIAID-NINDS-DTRA workshop entitled “Infectious Disease in The CNS and Therapeutic Strategies to Cross the Blood-Brain Barrier”
- [UPDATED with full program] 4-7 Sep 2018 ESCMID-ASM Conference (#3) on Drug Development for AMR (Lisbon, Portugal). Full program is now posted.
- 24-28 Sep 2018 (Big Sky, Montana): MSG-ERC (Mycoses Study Group) Biennal meeting
- 3-7 Oct 2018 (San Francisco): ID Week
- 6-14 Oct 2018 International Course on Antibiotics and Resistance(ICARe, Les Pensières, Annecy, France)
- 26 Oct 2018 (London): EMA information day for SMEs: “Regulatory toolbox for medicines and combined devices developers”. Here is the current agenda. Webcast will be available. More details from sme@ema.europa.eu.
- 7-9 Nov 2018 (Seville, Spain): Better Methods for Clinical Studies in Infectious Diseases and Clinical Microbiology: A Hands-on Workshop
