Dr. Dale W. Usner co-authored an article published in the Journal of Infectious Diseases about a Phase 2a trial of TCN-032, a human monoclonal antibody targeting a conserved epitope on M2e, in experimental human influenza. The data presented in the article supports that TCN-032 may provide immediate immunity and therapeutic benefit in influenza A infection without resistant virus emerging or immune exacerbation. Dr. Usner has over 20 years of experience leading and executing clinical trials and currently serves as President of Statistics and Data Corporation, where he previously held other positions including Vice President of Biostatistics & Data Management.

1. Dale W. Usner, Ph.D.
Co‐Author of Article Published in
Journal of Infectious Diseases
Efficacy and Safety of Treatment with an Anti‐M2e Monoclonal
Antibody in Experimental Human Influenza
Eleanor L. Ramos1, Jennifer L. Mitcham1, Teri D. Koller1, Aurelio Bonavia1, Dale W. Usner2, Ganesh
Balaratnam3, Paul Fredlund1, and Kristine M. Swiderek1
1Theraclone Sciences, Seattle, Washington, USA
2Statistics and Data Corporation, Tempe, Arizona, USA
3Retroscreen Virology Ltd, London, UK
Tempe, AZ, October 20, 2014 – Dr. Dale W. Usner, President of SDC, co‐authored the article “Efficacy
and Safety of Treatment with an Anti‐M2e Monoclonal Antibody in Experimental Human Influenza,”
which was published by Oxford Journals in the Journal of Infectious Diseases on Friday, October 3, 2014.
Dr. Usner has approximately 20 years of experience leading and executing clinical trial research. Joining
SDC in September 2011, Dale has since served the company in various positions of increasing
responsibility, including most recently as Vice President of Biostatistics & Data Management and
currently as President. Prior to his position with SDC, he worked at AVI BioPharma and ZymoGenetics as
the head of statistics and data management, at Bausch & Lomb, Inc. as the global head of statistics and
data management, and at PPD, Inc. He maintains an array of therapeutic area expertise, including anti‐viral/
anti‐infective, oncology, ophthalmic device, ophthalmic pharmaceuticals, and gastrointestinal. Dale
also has a breadth of regulatory body meeting experience with the FDA, PMDA, and EMA, including
involvement in advisory committee meetings. Dale holds a Ph.D. in Statistics from Oregon State
University.
“Efficacy and Safety of Treatment with an Anti‐M2e Monoclonal Antibody in Experimental Human
Influenza” describes the methods, results and conclusions of the Phase 2a trial of TCN‐032, a human
mAb targeting a conserved epitope on M2e, in experimental human influenza. The data presented in the
publication support that “TCN‐032 may provide immediate immunity and therapeutic benefit in
influenza A infection, with no apparent emergence of resistant virus. TCN‐032 was safe with no evidence
of immune exacerbation based on serum cytokine expression.” For access to the abstract and full
publication, please visit:
http://jid.oxfordjournals.org/content/early/2014/10/03/infdis.jiu539.abstract?keytype=ref&ijkey=t3TM
cJo23PuBSHr

2. Efficacy and Safety of Treatment with an Anti‐M2e Monoclonal Antibody in Experimental Human
Influenza
Eleanor L. Ramos; Jennifer L. Mitcham; Teri D. Koller; Aurelio Bonavia; Dale W. Usner; Ganesh
Balaratnam; Paul Fredlund; Kristine M. Swiderek
Journal of Infectious Diseases 2014;
doi: 10.1093/infdis/jiu539
About SDC
Statistics & Data Corporation (SDC) delivers leading‐edge statistical analysis and data management
services to pharmaceutical, biotechnology, and medical device companies, as well as CRO partners. With
biostatistics and data management expertise at our core, SDC also provides scalable full service clinical
trial outsourcing via our diverse and complementary strategic partnerships. Speak with us today about
how SDC will take ownership of your clinical project needs – www.sdcclinical.com.