FDA workshop on complex innovative trial designs / WHO consultancy

Dear All,

First up today is a very interesting new workshop from FDA on 1-2 Sep entitled “Advancing the Development of Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design.” In brief:

  • “The Complex Innovative Trial Design Pilot Meeting Program (CID Program) facilitates and advances the use of complex and innovative trial designs that have the potential to optimize drug development in small populations.
  • “Innovations that have been proposed include Bayesian and other methods of utilizing external historical information from previous pediatric trials or other populations (such as adults), adaptive designs, bridging biomarkers, etc.” 
  • “The workshop will specifically focus on two topics of interest: bridging biomarkers in pediatric extrapolation and Bayesian techniques in pediatric studies.  In addition, the workshop will allow for an open dialogue around the use of these approaches among regulators, industry, academia, and patient organizations.”
  • This looks fascinating and could have relevance for small population programs such as those the AMR community has been considering for rare pathogens. Go here for the detailed Federal Register notice and here to register for the meeting itself.

Second, several other new meetings are now in calendar. These include a 30 Sep 2021 Vivli-sponsored workshop on their new surveillance sharing platform (Dame Sally Davies and Marc Mendelson are featured speakers) and dates for two meetings in 2022.

Third, we have a job posting from WHO with a deadline of 7 Sep. In brief, this is a 6-month “work from where you are” consultancy to support the Tripartite Joint Secretariat on Antimicrobial Resistance (TJS) of the Global Coordination and Partnership on Antimicrobial Resistance (GCP) Department in the development of guidance and advice on Integrated Surveillance for antimicrobial resistance (AMR), particularly in low- and middle-income countries.

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

=== DETAILS ON WHO CONSULTANCY ===
Contract Type: Individual consultancy
Application deadline: 7 September 2021, 12:00pm CET (noon)
Contact: Elizabeth Tayler and Miriam Holm
Email address: amr-tjs@who.int
Consultancy reference: HQ/AMR/GCP/2021/8

1. Purpose of the Consultancy
To support the Tripartite Joint Secretariat on Antimicrobial Resistance (TJS) of the Global Coordination and Partnership on Antimicrobial Resistance (GCP) Department in the development of guidance and advice on Integrated Surveillance for antimicrobial resistance (AMR), particularly in low- and middle-income countries.

2. Background
Antimicrobial resistance is a global public health threat. It is driven by inappropriate use of antimicrobials in human health, animal and plant health, food production and through environmental contamination, and as such requires a One Health approach to address it.
The TJS consolidates cooperation between the Food and Agriculture Organization (FAO) of the United Nations, and the World Organisation for Animal Health (OIE), and WHO, drawing on their core mandates to support the global response across the One Health spectrum through global advocacy and political engagement, creation of a shared vision and goals, and providing Secretariat services for global governance structures.

The consultancy is located within the TJS, which is hosted by WHO, and has dedicated liaison officers in FAO and OIE headquarters. It manages the day-to-day operations of the joint work of the Tripartite organizations on AMR, including the Multi-Partner Trust Fund on AMR (AMR-MPTF).

Good data is vital to inform decision making and antimicrobial policies and to track progress. While each sector will generally develop systems for surveillance of resistance and use of antimicrobials, these data need to be brought together and analysed and reviewed together. Data needs to be representative and standardized to allow meaningful interpretation. Tripartite organisations individually and collectively need to support this process, to maximize the quality, efficiency effectiveness and sustainability of the systems and to ensure that the data that is generated is useable and used.

Many countries are developing systems for integrated surveillance including six (Sudan, Peru, Ethiopia, Ghana, Morocco and Tajikistan) supported by the AMR-MPTF. Other countries are rolling out systems based upon the Tricycle protocol for surveillance of ESBL E. Coli across human health, poultry and the environment. While much technical support is provided by regions, there is need for HQ technical support to assist and to facilitate lesson learning and sharing of experience. The WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) developed guidance in 2013 and 2018. There is a working group in FAO that will build guidance for practical application of the forthcoming Codex guidelines for integrated surveillance of foodborne AMR. New techniques, such as whole genome sequencing, are becoming more widely available and affordable, but their role in surveillance systems, particularly in resource poor settings, needs to be determined. There is a growing expertise and interest on integrated surveillance in collaborating centres of WHO FAO and OIE.

The Global Leaders Group on AMR was established in 2020, is chaired by two Prime Ministers and comprises ministers of health, agriculture, and the environment civil society and private sector leaders. It is supported by the TJS. One of the priority areas of their workplan is integrated surveillance. An expert group, comprising members nominated by the Tripartite organisations and UNEP, is required to provide advice and guidance on how global and context-appropriate country systems for integrated surveillance should be developed.

A consultant is required to work with the six AMR-MPTF countries and provide very practical support and document lessons and experience, and well as working with the technical working group of the global leaders group to ensure that their work and recommendations are practical, workable and grounded in reality and country experience. The consultant will map current resources, and identify gaps, and provide recommendations as to how these will be filled.

Background materials
• IACG Discussion paper – Subgroup 6: https://www.who.int/antimicrobial-resistance/interagency-coordination-group/IACG_Surveillance_and_Monitoring_for_AMU_and_AMR_110618.pdf
• AGISAR Integrated Surveillance of AMR of foodborne bacteria: https://apps.who.int/iris/handle/10665/255747

3. Planned timelines
The consultant is expected to start work in October 2021.

4. Work to be performed/ Deliverables
As a part of the TJS in the GCP Department in WHO headquarters, and in collaboration with colleagues in FAO and OIE, the consultant will perform the following functions:

Task 1. Provide technical support on request to countries funded by the AMR MPTF for integrated surveillance.
Activity 1. Review current guidance from the Tripartite organisations, Codex Alimentarius, and other bodies on AMR surveillance and use, and specifically guidance on integrated surveillance.
Activity 2. Support the MPTF countries in developing sectoral systems on AMR surveillance and use, analysis and dissemination of data in a manner that is most effective, and supportive of a One Health approach to addressing AMR. Ensure that they are provided with the best relevant current evidence and guidance.
Activity 3. Facilitate lessons learning and sharing and synthesize emerging lessons.

Task 2. Manage the establishment and operation of an AMR integrated surveillance expert working group.
Activity 1. Manage the selection process for experts.
Activity 2. Organize and facilitate meetings of the working group.

The functions of this group will be to:
a. Advise on gaps and how it should be updated, in the light of emerging evidence and experience.
b. Provide technical advice and input to the Global Leaders Group on AMR when required.
c. Provide technical advice on issues emerging from Tripartite country work on integrated surveillance when required.
d. Provide technical advice to other countries on best practices for integrated surveillance, including technical advice to those countries who are scaling up their Tricycle protocol.
e. Leverage the work of Tripartite and UNEP Collaborating Centres working on AMR integrated surveillance.

It is envisaged that this group will work remotely.

5. Specific requirements
– Qualifications required:
• Advanced university degree in Epidemiology/ Microbiology, Statistics, Public Health, Veterinary Public Health or a related discipline.

– Experience required:
• At least 10 years of relevant experience in the area of surveillance of AMR or antimicrobial use, preferably using integrated approaches.
• At least seven years of working in or with developing/ resource limited countries.

– Skills / Technical skills and knowledge:
• Experience in managing expert working groups;
• Excellent writing skills;
• Ability to work under pressure with conflicting priorities;
• Excellent interpersonal and communication skills;
• Computer literacy (Word, Excel, PowerPoint etc.).

– Language requirements:
• English – proficient (reading, writing, speaking)

6. Place of assignment
Work will be carried out remotely. The consultant must however be prepared to engage routinely with colleagues during working hours for European time zones.

7. Travel
When the department or office concerned determines that travel is necessary in order for the consultant to perform the work, a travel request will be raised and per diem will be applied as per WHO payment regulations.

8. Fee rate, contract duration, timing of payments and performance evaluation
The remuneration will be based on a monthly fee in the range US$ 10,000 – US$ 12,500, depending on the selected consultant’s degree of specialization, knowledge, qualifications, experience and skills. This is in accordance with the WHO remuneration scales for international consultants. The fee will be agreed between WHO and the selected consultant in advance. The contract will cover a 6-month period. Payments will be made following satisfactory completion of a set of deliverables. Other terms and conditions of employment will be in accordance with WHO policy on the employment of consultants (details available upon request).

9. How to prepare and submit a proposal in reply to this tender?
a. Content of the proposal
1. A cover letter explaining the bidder’s motivation for applying to this position.
2. A copy, in .pdf format, of the bidder’s updated CV or Personal History Form (preferred option, detailed instructions on how to do this through the following link: http://www.who.int/careers/process/instructions-for-candidates.pdf?ua=1). PLEASE NOTE: The selected candidate(s) will be asked to produce copies of all degrees/diplomas/certificates as mentioned in their CVs or Personal History Forms, as well as a copy of their passport and other documents as appropriate.
3. Full contact details.
4. Description and contact details of at least two recent references (the references shall be related to the present Terms of Reference).

Incomplete proposals will not be considered.
b. Questions during preparation of proposal
A prospective bidder requiring any clarification on technical, contractual or commercial matters may notify WHO via e-mail (amr-tjs@who.int) no later than 31 August, noon, Geneva time. Please write in the subject line “Inquiry Integrated Surveillance Consultancy 2021”.

c. Deadline for submission of proposal
The deadline for final submissions of proposals is 7 September 2021, noon, Geneva time.

d. Email address for submission of proposal
Final duly completed proposals should be submitted in electronic format by e-mail to: amr-tjs@who.int. Please write in the subject line “Application [insert name] – Integrated Surveillance Consultancy 2021”.

Current funding opportunities (most current list is here):

  • CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (more than 80 total awards, and counting, as they include contracting from prior rounds). New rounds from CARB-X will occur only after new funding is obtained in 2021.
  • It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
  • In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my most current lists of R&D incentives (link) and priority pathogens (link).


Upcoming meetings of interest to the AMR community (most current list is here):

  • 24-26 Aug 2021 (virtual, EU-centered timings): The 5th edition of the annual AMR conference sponsored by the BEAM Alliance, CARB-X, the Novo REPAIR Impact Fund, the IMI Accelerator, and the European Biotechnology Network. The in-person version of this meeting is consistently excellent; the video-based version will have to do for 2021. Go here for details.
  • 30 Aug – 1 Sep 2021 (virtual, East Coast US timings): FDA (CBER)-NIAID-sponsored workshop entitled “Science and Regulation of Bacteriophage Therapy.” Go here for details and to register. 
  • [NEW] 1-2 Sep 2021 (virtual, 10a-3p EST on both days): FDA -sponsored workshop entitled “Advancing the Development of Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design.”
    • In brief, “The Complex Innovative Trial Design Pilot Meeting Program (CID Program) facilitates and advances the use of complex and innovative trial designs that have the potential to optimize drug development in small populations.
    • “Innovations that have been proposed include Bayesian and other methods of utilizing external historical information from previous pediatric trials or other populations (such as adults), adaptive designs, bridging biomarkers, etc.” 
    • “The workshop will specifically focus on two topics of interest: bridging biomarkers in pediatric extrapolation and Bayesian techniques in pediatric studies.  In addition, the workshop will allow for an open dialogue around the use of these approaches among regulators, industry, academia, and patient organizations.”
    • Looks fascinating. Go here for the detailed Federal Register notice and here to register. 
  • [NEW] 30 Sep 2021 (virtual, 9a-noon EST, 2-5p BST): Featuring Dame Sally Davies and Marc Mendelson, this is a Vivli-sponsored workshop entitled “A Foundation Briefing on Industry AMR Surveillance: Data for Action” that will discuss Vivli’s new surveillance sharing platform. Go here to register.
  • 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
  • 11-15 Oct 2021 (physical, somewhere in the UK): UK-focused Innovation Mission sponsored by Innovate UK in collaboration with AMR Insights and Oxford innovation. This free event seeks to connect AMR-focused start-ups, SMEs and Multinationals, Academia, Research Institutes, Regional Development Companies and other interested stakeholders in the UK, Europe and other parts of the world. Go here for more details.
  • 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students. Bonus feature: For obvious reasons, the course didn’t happen in 2020! But as a celebration of the course’s 5th year, a webinar version was held on 29 Oct 2020: go here to stream it. 
  • 5-8 Nov 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
  • 6-11 Mar 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.
  • [NEW] 9-13 May 2022 (Athens and online): 40th Annual Meeting of the European Society for Paediatric Infectious Diseases, Go here for details.
  • [NEW] 20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
  • 25-28 Oct 2022 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register.

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