Attachment_-_Organizations_Advertising_Their_Interest_in_Collaborating.pdf

Organizations Advertising Their Interest in Collaborating (alphabetical order)

Description and contact information were supplied by each interested organization.

This list is made available as courtesy and should not be considered an endorsement of either the organizations or their capabilities.

• Caprion Biosciences Inc – is a leading contract research organization with an innovative track record in pre-clinical and clinical projects with pharma, biotech, and government research institutions. The company specializes in cell based and soluble host biomarker development for diagnostic, disease progression, and vaccine response applications. The company offers multiple in-house platforms, with particular expertise in mass spectrometry, flow cytometry, elisa-based assays, and has developed extensive multi-platform data generation and cross-platform synthesis expertise. Caprion’s previous work has identified potential immune response biomarkers in infectious disease, particularly for intracellular bacterial infections as well as viral infections such as flu. Caprion’s expertise and existing pool of biomarker candidates are available for further collaborations.

Contact info:

Eustache Paramithiotis, Ph.D.

Vice-President, Discovery

201 avenue President Kennedy, Suite PK-3900

Montreal, Quebec, Canada H2X 3Y7

T: 514-228-3627 eparamithiotis@caprion.com http://www.caprion.com

Bob Fritzen

Regional Director, Business Development

Caprion Biosciences Inc.

201 avenue President Kennedy

Second Floor, Suite 2880

Montreal, Quebec Canada H2X 3Y7

M: 610-334-0708 bfritzen@caprion.com http://www.caprion.com

• Emmes Corporation – is known for excellence in clinical trial support, stemming from our roots in statistical science and unwavering dedication to delivering superior research support.

Emmes has extensive experience in the successful conduct of clinical trials, with over 20 years of experience working in influenza studies including over 80 influenza vaccine trials in phases I-III.

Emmes offers a full range of contract research organization (CRO) services for clinical trials, including the following areas of the NIAID 2018 Omnibus Broad Agency Announcement, Topic

003 - Collaborative Influenza Vaccine Innovation Centers (CIVIC):

http://www.caprion.com/

1. Clinical Research Management

a. Facilitate collaborations with SDMC and other contractors (pg 37) – process development, meeting coordination

2. Protocol Development – medical writing, statistical consulting, Protocol Specialist support for coordinating protocol reviews, formatting to meet eCTD requirements

(pg 27, 30, 35)

3. Data Management/Data warehousing

a. Develop a plan for the management of experimental and processed data (pg 27)

b. Develop a plan for data sharing (pg 28)

c. Ensure timely submission of data to collaborators or public repositories

(pg 28)

4. Electronic tracking system for samples (pg 35) and/or reagents (pg 27)

5. Statistical expertise in design and analysis of immunology and vaccine clinical trials and challenge studies (pg 29, 35)

6. Bioinformatics data management or analysis support (pg 29)

7. Regulatory affairs support (pg 31)

Karen Stablein

Business Development/Marketing Manager kstablein@emmes.com

401 N. Washington St. /Suite 700

Rockville, MD 20850

T: 301-251-1161 x10198 www.emmes.com

Abbie Bellamy, PhD

Vaccine and Infectious Diseases Research Unit Leader abellamy@emmes.com

T: 301-251-1161 x 10800

• InDevR Inc. - InDevR is seeking to partner with other groups interested in NIAID’s CIVICs program. InDevR is ISO13485:2016 certified and we have expertise in vaccine potency determination. We offer innovative instrumentation, custom software and assay development. Our VaxArray product line is a new multiplexed platform for rapid vaccine potency testing. The test is 2 hours sample-to-result and we currently offer off-the-shelf reagent kits for seasonal hemagglutinin, “pandemic” hemagglutinin and seasonal neuraminidase. We also perform contract vaccine potency testing for influenza vaccines, including VaxArray HA (H1, H3, B/Y, B/V, H5, H7, H9), NA (N1, N2, B-NA), NP and M1, purity-adjusted SDS-PAGE, SRID, and NA activity by MUNANA

K.L. Rowlen, Ph.D.

CEO & CSO

mailto:kstablein@emmes.com http://www.emmes.com/ mailto:abellamy@emmes.com

InDevR Inc.

2100 Central Ave., Suite 106

Boulder, CO 80301

Phone: 303-402-9100

• Lovelace Biomedical - We are actively growing our influenza program and we are interested in partnering with other institutions to develop a Collaborative Influenza Vaccine Innovative

Center. We have broad in vivo capabilities in influenza modeling and vaccine testing. We have a strong track record of influenza infection studies in ferrets, mice and NHPs, including both ABSL-

2 and ABSL-3 viruses. We have capabilities to conduct high-throughput studies, including head-to-head comparisons of vaccine candidates in multiple species, with consideration to age / sex / pre-existing immunity, etc. Additionally, we have a large aerosol group and toxicology department, and can help to develop and test novel vaccine formulations and perform IND-enabling pre-clinical toxicity studies in compliance with GLP standards.

As a veterinarian-scientist with background in influenza pathogenesis, I am also very interested in the development and characterization of animal models, including comparative studies across multiple species, to help define correlates of protection and evaluate vaccine efficacy.

Contact info:

Meghan Vermillion, DVM, PhD, Dipl. ACLAM

Veterinary Research Scientist mvermillion@lrri.org

Office: 505-348-9749

Cell: 505-218-0030

Lovelace Biomedical

2425 Ridgecrest Dr. SE

Albuquerque, NM 87108 USA

• Medicago (MDG) - is a leading clinical-stage biotechnology company that uses proprietary plant-based technologies to rapidly develop and produce novel vaccines and antibodies. Our

North Carolina facility is dedicated to influenza vaccine production, and rapid influenza vaccine manufacturing. Our QIV seasonal influenza vaccine is currently in Phase III development. Medicago’s technology platform can produce large quantities of vaccines rapidly – with clinical-grade batches ready for testing typically within 5-6 weeks. In 2009, Medicago produced research-grade H1 VLPs in 19 days after strain identification. In 2012, Medicago demonstrated the ability to produce 10 million doses of a plant-based H1N1 influenza vaccine in one month.

Potential Areas of Collaboration

• Collaborates with and leverages other NIAID extramural and intramural research programs to contribute to the development of universal and improved seasonal influenza vaccines.

• Provide potential support for Research Area 003 Component C is to design, implement and manage ethical and statistically sound clinical trials and human challenge studies for influenza vaccines, vaccine components and delivery systems developed by the Vaccine Centers.

- Primary focus would be on different Medicago vaccine formulations that could be tested at the vaccine centers

Mr.Thomas Hess

Director, Global Business Development

Medicago Inc.

1020 Route de l'Eglise suite 600

Quebec Quebec

G1V 3V9

Phone: 418-6589393, ext. 156

Mobile: 224-688-6500 hesst@medicago.com

• Meso Scale Diagnostics ®, LLC. - offers a versatile and robust multiplex testing platform for quantitative and sensitive measurement of antibody responses to vaccines and measurement of biomarkers of infection and host immune response markers. We have significant assay development expertise; our platform is widely used by vaccine developers and we have also worked on multiple grant-sponsored projects.

Anu Mathew, Ph.D

P: 301-284-7056 www.mesoscale.com

1601 Research Boulevard

Rockville, MD 20850-3126

Main T: 240-314-2600

Fax: 240-632-2219

• Sanofi Pasteur- Please find below the list of topics that are considered by Sanofi

Pasteur/FluNXT for potential collaborations under the CIVIC program. Topics are not in any particular order of priority:

a. Role of NA as protective and/or disease modifying antigen for HA matched and mismatched strains

b. Structural biology determinants associated with NA antigenicity and immune benefit.

c. Improvement and use of Human Challenge Models in support of vaccine effect or vaccine improvement – Ex: rapid development of challenge strains to access broad protection

d. Comparative clinical research and evaluation of novel vaccine concepts vs standard of care (SOC)

e. Immune dominance and vaccine development – Ex: HA head vs HA stem vs NA immunity

f. Evaluate of other biomarkers of protection than HAI – Ex: non neutralizing effectors

g. Biomarker discovery for duration and antigenic coverage for natural influenza infection and influenza vaccines.

mailto:hesst@medicago.com http://www.mesoscale.com/

h. Detailed study of immunological memory and it’s relative advantages and disadvantages for seasonal influenza vaccination. Ex: Use of serological profiling and system serology using different methodologies

i. Development of animal models that can recapitulate some of the preexisting immunity effects observed in human

j. Immunological and physiological studies of SOC vaccine non-responders

k. How to leverage immunological history to influenza towards building next generation influenza vaccine?

l. Increase the sequencing and characterization of circulating viruses, especially outside US

m. Can we create a better bridge from vaccine to vaccination by leveraging epidemiological data?

n. Evaluation of viral sequence with vaccine effectiveness – Ex: Consortium/prospective cohort studies that collect VE data while analyzing viral isolates from nasal swabs from people.

o. How could influenza vaccination further improve preventive medicine broader than just the intended disease?

p. Use of MIMIC system to support evaluation and development of novel vaccine candidates

Mario Barro, PhD.

Senior Director and Head of Technology and External Networks

FluNXT Biotech at Sanofi Pasteur

Cell: 407-450-1808

• St. Jude Children’s Research Hospital

a. If groups are looking for collaborators with unique model systems (obese mice and ferrets, immunocompromised, and aged/neonates) we are available.

Stacey Schultz-Cherry, PhD

Member, Department of Infectious Diseases

St. Jude Children’s Research Hospital

Memphis, TN 38105

Stacey.schultz-cherry@stjude.org

P: 901-595-6629

F: 901-595-3099

Cell: 901-216-2627

b. We can provide expertise and ability to conduct preclinical testing of candidate vaccines in mice and ferret models with virologic and immunologic measurements. We can also provide expertise in characterization of immune response from clinical studies.

Contact info:

Richard Webby and Paul Thomas

Contact Richard Webby at +1-901-595-3014 or Richard.webby@stjude.org mailto:Stacey.schultz-cherry@stjude.org mailto:Richard.webby@stjude.org

• Vaxine Pty Ltd – would like to express interest in Component A: Vaccine Center to advance programs to develop 1. Improved seasonal influenza vaccines with longer and broader cross-protection, 2. Pandemic influenza platform and 3. Universal influenza vaccine platform based on

M2 immunity.

Nikolai Petrovsky

Research Director and Professor

Endocrinology Department, Room 6D313

Flinders Medical Centre

Bedford Park SA 5042

Australia

P: +61 (0)8 8204 4572

F: +61 (0)8 8204 5987

Nikolai.petrovsky@flinders.edu.au mailto:Nikolai.petrovsky@flinders.edu.au