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Pandemic Influenza Preparedness (PIP) Framework 2014 Partnership Contribution Questionnaire
Preliminary Results (1 September 2014)
Questionnaire Purpose The purpose of the annual PIP Partnership Contribution Questionnaire is to determine if an entity is an "influenza vaccine, diagnostic [or] pharmaceutical manufacturer using the WHO Global Influenza Surveillance and Response System (GISRS)" under PIP Framework section 6.14.3. Preliminary results for the 2014 PIP Partnership Contribution Questionnaire are set forth in the Tables below.
Table 1 provides a comparison of Questionnaire results for 2013 and 2014;
Table 2 lists the entities contacted by WHO and the status of their response; and
Table 3 provides the detail of responses provided by each entity. In 2014, the PIP Secretariat refined the Questionnaire with the aim of identifying more Contributors than in previous years. Question 3 was therefore revised extensively, to clarify the concept of “use of GISRS”. This was done by introducing several sub-questions to sensitize influenza manufacturers to the fact that they might be using GISRS indirectly. In order to be identified as a Contributor, an entity must have answered:
YES to Question 1 or 2 (which identifies the entity as an influenza vaccine, diagnostic or pharmaceutical manufacturer) and
YES to Question 3a or 3b or 3d (which identifies the entity as using GISRS). Question 3f identifies entities that are using GISRS on behalf of another entity that may be an influenza vaccine, diagnostic and pharmaceutical manufacturers. As stated in the Questionnaire, information provided in answer to Questions 3c, 3e and 3g is confidential. Process A link to the Questionnaire was sent by email to entities that might be influenza vaccine, diagnostic or pharmaceutical manufacturers using GISRS. The list was developed by the PIP Secretariat, using information from manufacturer associations and internet searches. Additionally, for 2014, the PIP Secretariat sent the Questionnaire to all non-GISRS recipients of PIP Biological Materials (PIP BM) recorded in the Influenza Virus Traceability Mechanism (IVTM) (see https://extranet.who.int/ivtm/). Thus, academic institutions, governmental institutions, and non-profit organizations were requested to complete it. This allowed the Secretariat to contact a greater number of entities than in previous years which resulted in a greater number of responses and identification of more Contributors. The Secretariat welcomes comments or questions on this or other matters related to implementation of the PIP Framework. Please send inquiries to pipframework@who.int.
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Table 1: Comparison of 2013 and 2014 Questionnaire Results
Category 2013 2014 Change Entities contacted 193 249 56
Questionnaire responses 88 100 12
Contributors identified 37 44 7
Table 2: Entities identified by WHO
Company Responded
No Yes 3M Health Care
Abbott Biologicals BV
Abcam
Access Bio, Inc.
Akonni Biosystems Inc.,
Alere Inc.
AlphaVax, Inc.
Altona Diagnostic
Alverix, Inc.
Arisan Therapeutics
ARUP Laboratories
Aspen Pharma
ATCC
Australia Animal Health Laboratory
Austrian Institute of Technology GmbH
Autoimmune Technologies
AVIR Green Hills Biotechnology
Baxter International, Inc.
Baylor College of Medicine
Becton, Dickinson and Company
BEI Resources
Beijing Zhongyuan, Ltd.
Beximco Pharma
Bharat Biotech International Limited
BIKEN
Bio Net Asia Co.
BioCryst Pharmaceuticals, Inc.
bioCSL Pty Ltd
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Company Responded
No Yes BioDiem Ltd
BioFire Diagnostics, LLC
Biomedical Primate Research Centre
BioMerieux
BiondVax pharmaceuticals Ltd
Bioneer
Biopharma (NVVL)
Bio-Rad Laboratories
Bioreliance Corporation
Bioscience Laboratories
Biosearch Technologies
Biota Scientific Management
Burnet Institute
Cadila Healthcare Ltd
Cantacuzino Institute
Cellex, Inc
CEL-SCI
Cepheid
CerTest Biotec
CEVEC PharmaceuticalsGmbH
Changchun BCHT Biotechnology Co.
Changchun Changsheng Life Sciences Limited
Cipla
CNBG - Beijing Tiantan Institute of Biological Products Co., Ltd.
CNBG - Changchun Institute of Biological Products Co., Ltd.
CNBG - Lanzhou Institute of Biological Products Co., Ltd.
CNBG - Shanghai Institute of Biological Products Co., Ltd.
CNBG - Wuhan Institute of Biological Products Co., Ltd.
Cocrystal Discovery, Inc.
Crucell
Dalian Aleph Biomedical Co.
Denka Seiken Co., Ltd.
Diagnostic Hybrids
Diatherix Laboratories
DxNA
Dynavax
ELITechGroup S.p.A.
Emergent Biosolutions
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Company Responded
No Yes Eskayef
EuBiologics, Ltd.
Euroimmun
Exploit Technologies Pte Ltd. (ETPL) Agency for Science Technology and Research (A*STAR)
F Hoffmann - La Roche, Ltd.
Fab'entech
Fast-track Diagnostics Ltd
Finlay Institute
FluGen, Inc.
Focus Diagnostics/Quest Diagnostics
Forwell Biopharm Co. Ltd.,
Fraunhofer Inc.
Friedrich-Loeffler-Institut
Gamma Vaccine
Gen-Probe (Hologic)
GlaxoSmithKline
Green Cross Corp.
Greffex
Grifols International, S.A.
Harbin Veterinary Research Institute
Helmholts Centre
Hetero India
Hualan Biological Bacterin Co., Ltd.
Humasis Co., Ltd
iBio
IDT Biologika
IIT Research Institute
Immune Design
Immune Targeting Systems
Immunobiological Technology Institute - Biomanguinhos | Oswaldo Cruz Foundation
Immunovaccine
Incepta Vaccine Limited
InDevR
Indofarma
Inovio Pharmaceuticals, Inc.
Institut für Virologie, Philipps-Universität Marburg
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Company Responded
No Yes Institute of Vaccine and Medical Biologicals (IVAC)
Institute of Virology and Immunoprophylaxis (IVI)
Institute of virology Slovak Academy of Science
Institute of Virology, Vaccines and Sera Torlak
Instituto Butantan
Instituto Zooprofilattico Sperimentale delle Venezie
Intelligent Medical Devices, Inc. (IMDx)
Intercell
International Vaccine Institute
Inviragen
Iomai Corporation
IQuum
Isconova
Jiangsu Walvax Biotech Co., Ltd.
Johan Bela National Center for epidemiology (OEK)
Juvaris
Kirin company limited, Frontier laboratories for Key Technologies, Research & Development division
Kitasato Daiichi Sankyo Vaccine Co., Ltd.
Korea Vaccine Company, Kovax
Lab of Virology, Faculty of Veterinary Medicine, Ghent University
Laboratorios de Biologicos y Reactivos de Mexico (BIRMEX)
Lentigen
LG Life Sciences, Ltd.,
Liaoning Cheng Da Biotechnology Co.Ltd
Life Technologies
Ligocyte
Liquidia
Longhhorn Vaccines and Diagnostics LLC
Lovelace Respiratory Research Institute
Luminex
MacroGenics Inc.
Marinomed Biotechnologie GmbH
Medicago Inc.
Medigen
MedImmune (AstraZeneca)
MediVector Inc.
Merck & Co Inc.
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Company Responded
No Yes Meridian Bioscience, Inc.
Meso Scale Diagnostics
MicroBioTest, Division of Microbac Laboratories, Inc.
Microbiotix
Microbix Biosystem Inc.
Microfluidic Systems
Microgen
Micropathology
Midwest Research Global (MRI Global)
Milipore
Mizuho Medy
Mucosis BV
Mymetics
NanoBio Corporation
Nanosphere, Inc.
Nanotherapeutics
Nanoviricides, Inc.
Natco Pharma
National Administration of Laboratories and Institute of Health - ANLIS
National Institute for Public Health and the Environment
National Institute of Animal Health
National Research Center
National Veterinary Institute
Novartis Vaccines
Novavax, Inc.
Okarios
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
Panacea Biotech Ltd.
Paragon Bioservices
Pasteur Institute of Iran
PaxVax, Inc.
Pfizer Inc.
Princeton BioMeditech Corporation
Protein Sciences Corporation
PT Bio Farma (Persero)
Qiagen
Quidel Corporation
RapiGEN Inc.
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Company Responded
No Yes Razi Vaccine & Serum Research Institute
Reagent Proteins (a Pfenex group)
Reckitt Benckiser Inc.
Redx Pharma
Research Institute for Biological Safety Problems (RIBSP)
Research Institute of Influenza of Ministry of Healthcare
Response Biomedical Corp
Retroscreen Virology Ltd
Roche Molecular Systems
Rocky Mountain Laboratories
Romark Laboratories, L.C.
SA Scientific
Saint-Petersburg Scientific Research Institute of Vaccines and Sera
Sanofi Pasteur
Seek
Sekisui
SERION Immundiagnostic GmbH
Serum Institute of India
Shiga University of Medical Science
Shinogi & Co.
Sigma Aldrich
Simcere Group
Sinergium Biotech
Sino Biological Inc.
Sinovac Biotech Ltd.
SK Chemicals
Southeast Poultry Research Laboratory, U.S. Department of Agriculture
Southern Research Institute
SRI International
Standard Diagnostic
Strides Arcolabs
Symwell Pharmaceuticals Private Ltd.,
Synthetic Genomics
Technovax
Temasek Life Sciences Laboratory Limited
TessArae, LLC
Tetragenetics Inc.
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Company Responded
No Yes The Biovac Institute
The Center for Genetic Engineering and Biotechnology (CIGB)
The Chemo-Sero-Therapeutic Research Institute (Kaketsuken)
The Government Pharmaceutical Organization (GPO)
The Pirbright Institute
Theraclone Sciences
Theranos
Thermo Fisher Scientific
Trellis
UMN Pharma Inc.
University of Florida, Emerging Pathogens Institute
University of Wisconsin - Madison
Vabiotech
Vaccines Business Division, Takeda Pharmaceuticals International GMBH
VACSERA
Vanderbilt Vaccine Center, Vanderbilt University
Vaxart
Vaxine
Vaxinnate
VBI Vaccine
Vertex Pharmaceutical Inc.
Vical
Viracor IBT Laboratories
Virapur
Vircell Microbiologists
Viro Dynamics
Viroclinics Biosciences B.V.
Viro-Immun Labor Diagnostika Gmbh
VisMederi srl
Visterra Inc.
Wistar Institute
Wuhan Institute of Virology
Xenetic (Lipoxen)
Xiamen Innovax Biotech Company Ltd.
ZeptoMetrix Corporation
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Table 3: 2014 Questionnaire Detailed responses by entity
Company Question 1 Question 2 Question
3a Question
3b Question
3d Question
3f
Abbott Biologicals BV No No No No No No
Access Bio, Inc. Yes Yes No No No No
Alere Inc. Yes Yes Yes No No No
Arisan Therapeutics No No No No No No
Becton, Dickinson and Company Yes Yes Yes No Yes No
Bharat Biotech International Limited Yes Yes Yes No Yes No
BIKEN No Yes Yes No No No BioCryst Pharmaceuticals, Inc. No No No No No No
bioCSL Pty Ltd Yes Yes Yes No Yes No
BioDiem Ltd No No No No No No BioFire Diagnostics, LLC Yes Yes Yes Yes Yes No
Biomedical Primate Research Centre No No No No No No
BiondVax pharmaceuticals Ltd Yes No Yes No No No
Biota Scientific Management No No Yes No No No
Cadila Healthcare Ltd Yes No Yes No No No
Cellex, Inc Yes No Yes No Yes No
Cepheid Yes Yes Yes No Yes No
CEVEC Pharmaceuticals GmbH No No No No No No Changchun BCHT Biotechnology Co. No No No No No No
Changchun Changsheng Life Sciences Limited Yes Yes No No No No
CNBG - Shanghai Institute of Biological Products Co., Ltd. Yes Yes Yes No Yes No
Crucell No No Yes Yes No No
Denka Seiken Co., Ltd. Yes No Yes No No No
Diatherix Laboratories No No No No No No
ELITechGroup S.p.A. Yes Yes No No No No
Fab'entech Yes No No Yes Yes No
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Company Question 1 Question 2 Question
3a Question
3b Question
3d Question
3f
Fast-Track Diagnostics Ltd Yes Yes Yes No Yes No
FluGen, Inc. No No No No No No
Focus Diagnostics/Quest Diagnostics No Yes Yes No No No
Friedrich-Loeffler-Institut Yes No Yes No No No
GlaxoSmithKline Yes Yes Yes Yes No No
Green Cross Corp. Yes Yes Yes Yes Yes No
Grifols International, S.A. No No No No No No
Humasis Co., Ltd Yes Yes No No No No
IDT Biologika No No No No No No
Immunobiological Technology Institute - Biomanguinhos | Oswaldo Cruz Foundation Yes No Yes No No No
Incepta Vaccine Limited No No No No No No
InDevR Yes No Yes No No No
Inovio Pharmaceuticals, Inc. No No No No No No
Institut für Virologie, Philipps-Universität Marburg No No No No No No
Institute of Vaccine and Medical Biologicals (IVAC) Yes No Yes No Yes No Institute of Virology and Immunoprophylaxis (IVI) No No No No No No
Institute of virology Slovak Academy of Science No No No No No No
Instituto Butantan No No Yes No No No
Intelligent Medical Devices, Inc. (IMDX) No No Yes No No Yes
Istituto Zooprofilattico Sperimentale delle Venezie No No No No No No
Jiangsu Walvax Biotech Co., Ltd. Yes No Yes No No No
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Company Question 1 Question 2 Question
3a Question
3b Question
3d Question
3f
Kirin company limited, Frontier laboratories for Key Technologies, Research & Development division No No Yes No No No
Kitasato Daiichi Sankyo Vaccine Co., Ltd. Yes Yes Yes No No No
Lab of Virology, Faculty of Veterinary Medicine, Ghent University No No No No No No
Laboratorios de Biologicos y Reactivos de Mexico (BIRMEX) No No No No No No
Life Technologies Yes Yes No No No No
Lovelace Respiratory Research Institute Yes No Yes No No Yes
Marinomed Biotechnologie GmbH No No No Yes No No
Medicago Inc. No No Yes Yes Yes No
MedImmune (AstraZeneca) Yes Yes Yes No No No
Meridian Bioscience, Inc. No No No No No No
MicroBioTest, Division of Microbac Laboratories, Inc. No No No No No No
Mucosis BV No No No No Yes No
Nanosphere, Inc. Yes Yes Yes No No No
NanoViricides, Inc. No No No No No No
National Institute for Public Health and the Environment No No Yes No No No
National Institute of Animal Health No No No No No No
Novartis Vaccines Yes Yes Yes Yes Yes No
Novavax, Inc. Yes No Yes No No No Omninvest Vaccine Manufacturing, Researching and Trading Ltd. Yes Yes Yes No Yes No
PaxVax, Inc. No No Yes No No No
Pfizer Inc. No No No No No No
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Company Question 1 Question 2 Question
3a Question
3b Question
3d Question
3f
Princeton BioMeditech Corporation Yes Yes Yes No No No
Protein Sciences Corporation Yes Yes Yes No No No
PT Bio Farma (Persero) No No Yes No Yes No
Qiagen Yes Yes No No No No Quidel Corporation Yes Yes Yes No No No
Razi Vaccine & Serum Research Institute Yes No No No No No
Redx Pharma Yes No No No No No
Research Institute of Influenza of Ministry of Healthcare Yes Yes Yes Yes Yes Yes
Response Biomedical Corp Yes Yes Yes No No No
Retroscreen Virology Ltd No No Yes No Yes Yes
Roche Molecular Systems No No No No No No
Romark Laboratories, L.C. No No No No No No
Saint-Petersburg Scientific Research Institute of Vaccines and Sera Yes Yes Yes No No No
Sanofi Pasteur Yes Yes Yes No No No SERION Immundiagnostic GmbH No No Yes No Yes No
Serum Institute of India Yes No No No Yes No
Sinovac Biotech Ltd. Yes Yes Yes No Yes No
Southeast Poultry Research Laboratory, U.S. Department of Agriculture No No No No No No
Southern Research Institute No No No No No Yes
Temasek Life Sciences Laboratory Limited Yes No No No No No
The Chemo-Sero-Therapeutic Research Institute (Kaketsuken) Yes Yes Yes No No No
The Government Yes No Yes No No No
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Company Question 1 Question 2 Question
3a Question
3b Question
3d Question
3f
Pharmaceutical Organization (GPO)
The Pirbright Institute Yes No Yes No No No
UMN Pharma Inc. Yes No No No No No
University of Florida, Emerging Pathogens Institute No No No No No Yes
University of Wisconsin - Madison No No No No No No
Vaccines Business Division, Takeda Pharmaceuticals International GMBH Yes No Yes Yes Yes No
Vacsera No No No No No No
Vanderbilt Vaccine Center, Vanderbilt University No No No No No No
Viroclinics Biosciences B.V. No No Yes No No Yes
VisMederi srl No No Yes No No No
ZeptoMetrix Corporation No No No No No No
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Annex 1
2014 PIP Framework Partnership Contribution Questionnaire Instructions The purpose of this questionnaire is to determine if your company/institution/establishment is an "influenza vaccine, diagnostic [or] pharmaceutical manufacturer using the Global Influenza Surveillance and Response System (GISRS)." Under the PIP Framework, to be identified as a contributor to the annual Partnership Contribution, an entity must be an influenza manufacturer and use GISRS. Entities that are ‘manufacturers’ under the PIP Framework but do not ‘use GISRS’ will not be identified as contributors. Likewise, entities that ‘use GISRS’ but are not ‘manufacturers’ will not be identified as contributors. The questionnaire consists of 3 questions, one of which has several sub-questions. Question 3 contains several sub-questions which are aimed at assisting WHO to better understand the range of entities that use GISRS and that are involved in the development of influenza products. These sub-questions are also meant to sensitize influenza manufacturers to the fact that they may be using GISRS indirectly through subcontractors or by using components developed or produced by another laboratory or company that itself uses GISRS. Please note the following: Sub-questions 3c), 3e) and 3g) are optional. The Questionnaire may be submitted without filling in those fields or by answering “Do not know” or “Confidential information”. That said, WHO will greatly appreciate any information that may be shared by you in relation to these sub-questions. Please further note that any information provided in these sub-questions 3c), 3e) or 3g) will not be released or shared by WHO with any company, institution, establishment or other entity. Question 1: In the past 15 years have you developed, or are you currently developing, human influenza vaccines or other products derived from or using H5N1 or other influenza viruses of human pandemic potential? "Develop" is understood to mean that you have developed or are currently developing a product (including human influenza vaccine, antiviral, diagnostic or other product) to prevent, treat or diagnose infections from H5N1 or other influenza viruses with human pandemic potential, and you have obtained a provisional or final licensure, registration or market authorization for such product, but have not implemented production, distribution or sales. The phrase “using H5N1 or other influenza viruses of human pandemic potential” is understood to include use of viruses for product development, testing, production or marketing purposes. Question 2: In the past 15 years have you produced, or are you currently producing, human influenza vaccines or other products derived from or using H5N1 or other influenza viruses of human pandemic potential? “Produce" is understood to mean that you have produced or are currently producing a product (including human influenza vaccine, antiviral, diagnostic or other product) to prevent, treat or diagnose infections from H5N1 or other influenza viruses with human pandemic potential, and such product has obtained national licensure, registration or market authorization, and you have implemented production, distribution or sales of such product. This would include, for example, producing vaccine from procured bulk material. The phrase “using H5N1 or other influenza viruses of human pandemic potential” is understood to include use of viruses for product development, testing, production or marketing purposes. Question 3: For purposes of this question:
I) “product” means human influenza vaccine, antiviral, diagnostic, or other product to prevent, treat or diagnose infections from H5N1 or other influenza viruses with human pandemic potential.
II) “use GISRS” means to use or receive:
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1) materials (e.g. virus materials, such as candidate vaccine viruses, wild-type viruses, cDNA, plasmids, or reagents); and/or
2) services (e.g. antigenic and genetic characterization of candidate vaccine viruses/seed material, antiviral susceptibility assays); and/or
3) information (e.g. sequence information, epidemiological data, antiviral susceptibility data, pre- and post-vaccine composition meeting reports); developed and/or provided by or through GISRS.
Questions: a) In your product development, testing, production or marketing do you use GISRS? b) Has another company or laboratory used GISRS to develop, test, produce or market your product on your
behalf? That would be the case if, for example, you outsourced testing of your product to another company or laboratory that used GISRS.
c) If you answered “YES” to 3b) above, please provide the name of the company or laboratory. d) Has the development, testing or production of your product, required a component developed or produced
by another company or laboratory that used GISRS. For example: a component (e.g. primer, probe, protein, antibody, etc. ) of your product is developed or produced
by another laboratory or company that uses GISRS; or, the testing, validation, or quality control of your product requires the use of another laboratory or
company’s material or product (e.g. a reagent) which was developed or produced using GISRS. e) If you answered “YES” to 3d) above, please provide the name of, or describe the component, material or
product, and provide the name of the company or laboratory that developed or produced it. f) Have you used GISRS to develop, test or produce another company’s or laboratory’s product? g) If you answered “YES” to 3f) above, please provide the name of the company or laboratory.