Concept papers for comment: EMA Antibacterial Guidance + IACG global action action

Dear All: Also appearing today are two valuable opportunities to comment on key global strategy documents. I do hope each of you can make time to look at these materials and consider sending in your thoughts — it really does make a difference when central leadership groups hear from a broad array of stakeholders!

First, EMA has released a concept paper describing their intent to update and combine their core antibacterial guidance [CPMP/EWP/558/95 Rev 2] from 2011-12 and its addendum [EMA/CHMP/351889/2013] from 2013-14. The update will also include better synchronization with: 

1. Their core PK-PD antibacterial guidance [EMA/CHMP/594085/2015],
2. Their TB-specific guidance [EMA/CHMP/EWP/14377/2008 Rev 1],
3. An update to the EMA pediatric antibacterial addendum [EMA/187859/2017] that is expected soon, and
4. Output from the tripartite conversations being held between the EMA, US FDA, and Japanese PMDA.

The concept paper briefly summarizes the intent to merge and revise the core guidance and addendum in a fashion that appears very sensible to my eye. We (the public) are invited to comment during a public consultation period that ends 13 Sep 2018.

Second, and while you are in thinking mode, you should also look at concept papers now released for comment by the UN IACG (Interagency Coordination Group). As you may recall, the UN IACG has a mandate to provide guidance on ways to ensure effective global action to address AMR. With the goal of a full report to the UN Secretary-General in 2019, the IACG has divided their thinking into six areas:

1. Public awareness, behaviour change, and communication,
2. National Action Plans,
3. Optimizing use of antimicrobials,
4. Innovation, research, and development, and improved access,
5. Surveillance and monitoring, and
6. Global governance post-IACG and alignment with the Sustainable Development Goals (SDGs).

As a prelude to this, the IACG seems to be preparing concept papers for each topic and you will now find online the concept papers for topics 2, 4, and 5. A timeline is not given for concept papers on other topics, but the concept paper most central to many of us will be the innovation report (topic 4). I need to spend more time with this one, but it appears to be a good general survey of the problem. In particular, it includes a reasonable discussion of the need for Pull incentives that concludes with these open questions:

• How could R&D funding be better channeled?
• What will it take to increase and sustain donor and private funding of R&D in AMR?
• Which incentives and de-linkage mechanisms could best address each of the challenges and barriers identified?
• How should the design of incentive mechanisms be coordinated at global, regional and national levels?
• How could current efforts in R&D coordination be strengthened?

I am pleased to see the clear mention of the need for delinkage and Pull incentives and a focus on HOW to do it rather than WHETHER to do it. Again we (the public) are invited to comment during a consultation period that ends 9 July 2018.

Put on your thinking caps and send in your ideas! Now’s the time!

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:

• 21-22 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.
• 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
• [NEW] 21-22 Aug 2018 (FDA White Oak Campus, Silver Spring, MD): workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections”. Meeting notice is here.
• 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”
• 21-23 Aug 2018 (Cardiff, UK): BSAC Standardized Susceptibility Testing Residential Workshop. Register here.
• [Don’t miss this one!] 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