NIAID Funding opportunity + FDA guidance x 3: revisions for cIAI and cUTI + new for uUTI (draft)

Dear All:

First up, NIAID has released a BAA (Broad Agency Announcement) regarding up to $15.5m in funds for awards in two research areas. Here is a brief description … see below my signature for more details. To my eye, this looks like a very broad and inclusive call for proposals. 

• Area 1: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases
• Area 2: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Second, FDA has released three guidance documents. The first two (cIAI and cUTI) are updated guidance documents that provide some fixes that I believe help bring FDA and EMA into closer harmonization, something that is very important for global development! The third is a very welcome draft guidance document for uUTI:

• The Feb 2015 cIAI (complicated intra-abdominal infection) guidance has been revised effective May 2018.
  • A comparison document generated by Acrobat suggests that the changes are minor. I note that upper GI perforations are now disallowed unless there is an established secondary infection but see little else beyond some small typography fixes.
• Ditto for the Feb 2015 cUTI (complicated UTI) guidance now revised effective June 2018.
  • An Acrobat comparison document shows that the main change is that the preferred CFU/ml cutoff for success is now 1,000 CFU/mL rather than 10,000 CFU/mL. A comment in the Appendix suggests that the two cut-off values have similar performance but the lower cut-off is preferred.
• New draft guidance for uUTI (uncomplicated UTI), effective May 2018.
  • This is very good to see! It proposes a primary endpoint of clinical + microbiological response (here again the 1,000 CFU/mL cutoff appears) and provides a justification in its appendix for a non-inferiority margin of 10%.

Many thanks to both Team NIAID and Team FDA for their continued efforts!

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: http://amr.solutions/blog/

NIAID BAA — addtional details:

• Research Area 001: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases
  • The objective of this Research Area is the development of broad-spectrum therapeutic products for use in post-event settings following the intentional release of select pathogens, or in response to naturally-occurring outbreaks of infectious diseases caused by pathogens identified in this Research Area.
  • Solicited products are anticipated to include: Antibacterial Therapeutics; Antiviral Therapeutics; and, Anti-toxin Therapeutics.
• Research Area 002: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases
  • The objective of this Research Area is the development of vaccines for scenarios associated with intentional release of a NIAID Category A, B, or C Priority Pathogen, or in response to naturally-occurring outbreaks of infectious diseases caused by these pathogens or Zika virus (Zika virus vaccine would be included only as a component of a multivalent vaccine for other pathogens such as a vaccine for Flavivirus family).
  • Solicited Products are anticipated to include: Technology Gaps that Slow Progression to Clinical Testing; Novel Vaccine “Plug-and-Play” Technologies; Enhanced Vaccine Performance (with special interest in simplicity and speed of delivery, rapid immune response and sterilizing immunity); and Vaccines Against Antimicrobial Resistance Threats.

Upcoming meetings of interest to the AMR community:

• 4-7 Jun 2018 (Boston): BIO. The anti-infective track includes sessions that cover bacteria, fungi, viruses (Ebola, Influenza), and vaccines. Note especially the session at 11a on 6 June entitled “The value of addressing AMR” with speakers Colm Leonard (NICE) and Mark Sculpher (EEPRU at York) as well as the session at 4p on 4 June entitled “Forging antimicrobial R&D pacts”.
• 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.
• 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