Dear All:
GARDP and CARB-Xed co-sponorsored yesterday an ECCMID symposium entitled “Expediting antibacterial development: core lessons and key tools for a rocky road.” A detailed tour of the many lessons we’ve learned in recent years, the program was (follow the links to download the talks):
- Marco Cavaleri (EMA): EU regulatory tools for expedited antibacterial development programmes
- EMA has a portfolio of regulatory tools to support expedited development of new antibacterial agents targeting unmet needs.
- A draft guidance on pediatric evaluation of novel antibacterials was released 22 Mar 2018, is open for comment, and will be the subject of a joint EMA-FDA-PMDA workshop on 21-22 June 2018 (you can mark your calendar now and expect an official announcement soon).
- Sumati Nambiar (FDA): US regulatory tools for expedited antibacterial development programmes
- Options to expedite exist and are grounded in the seriousness of the condition and the (lack of) availability of other therapeutic choices
- FDA is in the process of moving all Susceptibility Test Interpretive Criteria (STIC) from product labels to an online format (see also this discussion of same, the intent is be done by December of this year). Dr. Cavaleri noted that EMA is also planning to take this step.
- Both Dr. Nambiar and Dr. Cavaleri also emphasized:
- Early dialogue with regulators is important and is encouraged!
- EMA and FDA have implemented a Consultative Advice approach in which Scientific Advice is requested from only one agency but the briefing materials are shared with both agencies. As the agencies have monthly mutual update teleconferences, this facilitates common feedback and may have the advantage of increasing the conversation feel of interactions relative to formal Parallel Scientific Advice.
- William Hope (Liverpool): PK-PD in support of accelerated programmes: how much is enough?
- It is important to use multiple models and multiple model strains.
- You’ve done enough PK-PD studies when you would be prepared to be the first person to administer a new compound to a patient!
- John Rex (me): Alternatives to (classical) antibiotics: what will it take to convincingly develop a virulence inhibitor or similar indirect agent?
- Non-traditional products (e.g., virulence inhibitors) are intriguing but must still provide standard data proving their value.
- There are 4 archetypes for non-traditional therapeutic products (Create, Transform, Restore, and Enhance) and 4 recurring problems: Narrow-spectrum products are tricky, Standalone activity opens doors, Superiority is hard to show, and novel Endpoints may be needed but are as yet elusive.
I encourage you to download and review these talks! And if you are interested in non-traditional products, please consider attending the 14 June workshop on such products that is being organized by the Duke-Margolis Health Policy Center on behalf of FDA. And, don’t overlook the above-mentioned joint EMA-FDA-PMDA workshop on the EMA pediatric guideline for antbacterials on 21-22 June 2018.
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:
- 21-24 Apr 2018 (Madrid): ECCMID
- 4-7 Jun 2018 (Boston): BIO (multiple AMR-focused sessions are expected)
- 7-11 Jun 2018 (Atlanta): ASM Microbe
- 12-13 Jun 2018 (Washington): National Academies of Science workshop: Understanding the Economics of Microbial Threats
- 14 June 2018 (Washington): Duke-Margolis & FDA event: “Understanding the Development Challenges Associated with Emerging Non-Traditional Antibiotics”
- 21-22 Jun 2018 (I presume London but don’t know for sure, announcement is pending): joint EMA-FDA-PMDA workshop on pediatric development of antibacterial agents.
- 22-27 Jul 2018 (Bryant University, Smithfield, RI): Gordon Research Conference on Drug Resistance for Cancer, Infectious Disease and Agriculture
- 4-7 Sep 2018 ESCMID-ASM Conference (#3) on Drug Development for AMR (Lisbon, Portugal)
- 3-7 Oct 2018 (San Francisco): ID Week
- 6-14 Oct 2018 International Course on Antibiotics and Resistance (ICARe, Les Pensières, Annecy, France)