1

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.

2

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

3

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

4

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

5

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.

6

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.

7

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.

8

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

9

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

10

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

11

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

12

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

13

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

14

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:

15

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.