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EU COMBACTE
Consortium: Combatting
bacteria multi-resistance in
Europe in a public-private
partnership
19 NOVEMBER 2016RON DE WINTER
XXXVII. TÜRK MİKROBİYOLOJİ KONGRESİ
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La résistance des bactéries aux
antibiotiques a atteint une dimension
planétaire.
“Three million Europeans catch
infections in hospital annually”
Antibiotic resistance:
we must act now,
says WHO Antibiotics resistance 'as big a risk
as terrorism' – UK medical chief
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3
Klebsiella pneumoniae,
carbapenems non-susceptible2006 2014
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Multi-resistant bacteria: not just a
European issue
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Why we don’t get new antibiotics
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Yeni antibiyotikler ile tipik faz III çalışmaları
(klinisyenin bakış açısından)
• Çalışma dizaynı her zaman memnun etmez
• Araştırmacı ve farmasötik şirketler arası etkileşimi az
• Ana çalışmaya alt çalışmaların eklenme olasılığı düşük
• >80% oranda tek bir hasta kaydı olmamakta
• Uzun zaman alır (en azından planlanandan daha uzun)
• Veri koleksiyonu kalitesi uygun olmayabilir
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• Klinisyenler neden belli görünüşlerin gerekli olduğunu anlamamaktadır
• Global CRO bütün araştırmacıları kişisel olarak bildiğini belirtirler, çoğu
zaman doğru çıkmamaktadır
• Araştırrmacılar her zaman klinik olarak alt çalışmalarla ilgili farklı birşey
istemektedir
• >80% oranda tek bir hasta kaydı olmamakta
• Uzun zaman alır (en azından planlanandan daha uzun)
• Veri koleksiyonu kalitesi uygun olmayabilir
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Yeni antibiyotikler ile tipik faz III çalışmaları
(farmasotik şirketlerin bakış açısından)
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• >80% oranda tek bir hasta kaydı olmamakta
• Uzun zaman alır (en azından planlanandan daha uzun)
• Veri koleksiyonu kalitesi uygun olmayabilir
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Yeni antibiyotikler ile tipik faz III çalışmaları
(klinisyen ve farmasotik şirketlerin
anlaşmaları)
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Innovative Medicines Initiative (IMI):
İş birliği için yeni bir yol Yaşam bilimlerinde en büyük kamu- özel ortaklığı R&D
IMI1 başlangıcı 2008, sona erişi 2014
• 11 Calls launched
13
EFPIA = European Federation of Pharmaceutical Industries and Associations
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Innovative Medicines Initiative (IMI):
Çalışma için yeni bir yol
Ana hatlar :
– Avrupada hastalar için daha güvenli ve daha etkili ilaçların geliştirilmesini hızlandırmak– Avrupada biyofarmasötik sektörü geliştirmek
– Akademi ve endüstri için iş birliği ortamı yaratır
ND4BB , Kasım 2011 de Avrupa komisyonu tarafından AMR lansmanlarının artan tehditlerine karşın eylem planının bir parçasıdır
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ND4BB Vizyonu: Hastalara yeni
antibakteriyal ajanları sağlama yolları
15
Discovery
&
Preclinical
Phase I Phase II Phase IIIRegulatory
Review
Clinical Development
Phase IV
Discovery Commercialisation
Early
Discovery
COMBACTE-MAGNET
ENABLETranslocation COMBACTE-NET
COMBACTE-CARE
DRIVE-AB
iABC
Filling the
pipeline
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ND4BB Programının genel yapısı
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ND4BB cross topic collaboration and dissemination
COMBACTE-
NET
a) Enabling
Clinical
Collaboration and
Refining Clinical
Trial Design
b) Clinical
Development of
compound(s) for
Gram-positives
c) Clinical
Development of
MEDI4893
TRANS-
LOCATION
Research
penetration and
efflux Gram-
negatives Data
Hub and
Learning from
R&D experience
ENABLE
Discovery &
development of
new drugs
combatting
Gram-negative
infections
DRIVE-AB
Driving re-
investment in
R&D and
Responsible use
of antibiotics
COMBACTE-
CARE
Clinical
Development of
antibacterial
agents for
Gram-negative
antibiotic
resistant
pathogens
COMBACTE-
MAGNET
Systemic
molecules
against HAIs
due to clinically
challenging
Gram-negative
pathogens
iABC
Inhaled
Antibacterials in
CF and non-CF
BE
ND4BB Information CenterAll data generated is submitted and is accessible to all consortium partners
Drug development Gram-positives
Drug development Gram-negativesDrug discovery
Economics and stewardship
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ND4BB programında 7 konunun zaman
çizelgesi ve toplam bütçe tahmini(EFPIA contribution)
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COMBACTE hedefleri
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Süregelen antibakteriyal gelişim ağını yaratmak
• Araştırmacı merkezler ile klinik araştırmaların optimum şekilde hızlanması
• Klinik ve epidemiyolojik veriler elde etmek
Antimikrobiyal ilaç geliştirme verimliliğini arttırma
• En yeni moleküler metodolojileri ve çalışma dizaynı ile klinik araştırmaları kapsar
Klinik çalışmaları gerçekleştirmek
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55 academic partners
8 EFPIA partners
42 countries
COMBACTE işbirliği
>800 hospitals
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The COMBACTE pipeline
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ASPIRE-ICU AZ/MI ICU_VAP Epi 207 2000
ASPIRE-SSI AZ/MI Epi 5000
SAATELLITE AZ/MI ICU RCT 107 462
WP6C SSI AZ/MI RCT
WP6E tbd AZ/MI ICU RCTANTICIPATE DaV Epi 1 1000
WP8 MedComp ICU RCT
EURECA AZ Epi 111 800
REJUVENATE AZ ICU+ RCT 9 40WP2B AZ ICU+ RCT 240
EVADE AZ/MI ICU_VAP RCT 6 492
WP4B AZ/MI ICU_VAP RCT
RESCUING 1009/1000
WP6G AiCuris cUTI RCT WP6H AiCuris cIAI RCT
WP3 ARBO Epi 1
MERMAIDS ARI Epi 85 AD-SCAP ICU adaptRCT 2
MK-7655A Protocol 13 Merck RCT
HABP/VABP CTTI EpiColistine NIAID RCT
preparation phase trial period
COMBACTE NET
COMBACTE
MAGNET
980
2015 2016 2017 2018
1500
20004000
COMBACTE CARE
240225
PREPARE
Total enrolled: 1,538 pts
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COMBACTE’nin hedefleri
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2-3 years
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The European hospital network in
COMBACTE
Complemented by the European
laboratory network LAB-Net
COMBACTE CLIN-Net
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Develop and maintain a premier clinical
research infrastructure in the field of
infectious diseases
Optimize execution of clinical studies
COMBACTE CLIN-Net objectives
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Marc Bonten Ron de WinterMiquel
EkkelenkampMiranda Hopman
Nienke Cuperus
Katina Kardamanidis
Claire-Marie Martis
Sophie Corthals
Belmira Behlić
Academic lead Head of PMO Medical coordinatorOrganisationcoordinator
CLIN-Net team
UMCU CLIN-Net üyeleri
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CLIN-Net çalışmaları
• Merkez değerlendirme ve seçimi
• Çalışma desteği
• Eğitim
• Good Clinical Practice (GCP)
• Site-trainings
• Güvenilir uluslararası işbirliğinin kurulması ve devamlı bir hale
getirilmesi
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CLIN-Net PMO
CLIN-Net infrastructure
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CLIN-Net PMO
CLIN-Net infrastructure
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CLIN-Net PMO
CLIN-Net infrastructure
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CLIN-Net PMO
Regional team
CLIN-Net infrastructure
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CLIN-Net PMO
Regional team
CLIN-Net infrastructure
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CLIN-Net PMO
Coordinator 1 subnetwork / specialty
LAB-Net PMO
Coordinator 2 subnetwork / specialty
Coordinator 3 subnetwork / specialty
Regional team Main contact person LAB-Net coordinator
CLIN-Net infrastructure
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CLIN-Net merkez seçim işlemleri
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•CLIN-Net, LAB-Net, the industry sponsor, study lead and invited consultants
•Voting and non-voting members
•SSB and voting procedures
Create site selectionplan
•Metadatabase and baseline questions as basis
•Streamline questionnaires so that pre-filling is available
•Create separate clinical and laboratory questionnaires
•Review questionnaires by the study team
Create feasibilityquestionnaire
•Notify CLIN-Net andLAB-Net of selectioncriteria
•Ask nationalcoordinator foradvise/support
•Pre-select sites from NMS based on specific requirements
Site pre-selectionand recruitment
•Send an invitationletter to the investigators
•Send CDA, ifapplicable
•Follow up sites to obtain signed CDA’s
•Send protocols
Send out invitation letter
•Send out feasibilityquestionnaire
•Remind sites to complete the questionnaires via NMS/e-mail/phone
Send out questionnaires
•Provide feasibility report
•Follow-up on additional information (national coordinator)
•Vote on whether to include sites
Site selectionboard meetings
•Inform sites on the voting results via a feasibility conclusion letter
•Inform national coordinators/ networks of the results
Finalize site selection process
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Fizibilite anketleri
• Clinical and laboratory feasibility questionniares are created based on
a list of requirements for clinical sites and local laboratories
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Bazı raporlar:
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Önceden doldurulmuş anketler
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Merkezlerin önseçimi ve denemeleri
CLIN-Net ve LAB-Net, devam eden çalışmanın özel
gereksinimlerine dayanarak seçilmiş merkezlerin bir başlangıç
listesini oluşturur.
1. Based on information COMBACTE has on a large and growing number of
hospitals aligned with laboratories in the COMBACTE Network
Management System (NMS).
2. Ask national network coordinator(s) to pre-select sites within their network
based on their experiences with the sites.
37
Invitation letter with link
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Fizibilite anketleri
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Çalışma grupları
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The COMBACTE Merkez seçim masası
• Fizibilite anketlerinde verilen bilgiler temelinde SSB
merkezleri değerlendirir :
• Seçilen merkez
• Yedek merkez
• Seçilmeyen merkez
• Her merkez bir “karar mektubu” göderilerek
bilgilendirilir
• Ulusal koordinatörlere ülkelerindeki seçim bölgesi
ve seçim sürecinin sonuçları hakkında bilgi verilir
40
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Çalışma bilgisi ve süreci
41
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GCP in COMBACTE
• Adequate training in GCP essential for reliable execution of trials
• COMBACTE will (in the near future) require all personnel actively involved in studies to be GCP compliant
• Basically: all people obtaining informed consent and completing research files (CRFs)
• CLIN-Net GCP-training complies with TransCelerate requirements
• Also with PharmaTrain requirements (EU accreditation) and EU directives and regulations
• Where feasible and necessary, obtaining national or EU accreditation (CME) is sought for its courses
• If solicited by participants / national coordinator
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Online GCP Kursu
Partnership with Elevate Health, a company specialized
in online education, to develop an interesting, online
GCP Course
• Interactive, e-moderator
• Takes 6 to 8 hours to complete, must finish within one calendar
month
• Compliant with TransCelerate and PharmaTrain requirements
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F2F eğitimi: EF-GCP
ile işbirliği
• 1 or 2-day training
• Since our last meeting:
• Belgrade
• Budapest
• Madrid
• Athens
• In planning: Sofia
• Others: when requested by investigators / NC
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OPTIONAL TEXT
Investigators GCP trained by
CLIN-Net
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Year Online GCP course Face to face GCP courses
2016 108 102
2015 96 55
2014 38 22
Total 242 179
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Diğer iletişim kanalları
• Ulusal koordinatörler ile
• Country visits
• Quarterly updates to NC
• Diğer katılımcılar ile
• Yearly ECCMID-meeting
• Kamu ile
• Website and newsletter
• New: Dashboard on website
• Magazine
• Presence at meetings
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Website: www.combacte.com
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Çalışma gösterge tablosu
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