`
`Steven E. Linberg, PhD
`
`
`
`
`
`
`
`
`Ph.D., Physiology
`M.S., Physiology
`B.A., Biology
`
`Pennsylvania State University
`Pennsylvania State University
`University of Delaware
`
`
`9601 Medical Center Drive
`Rockville, MD 20850
`
`
`
`PROFESSIONAL SUMMARY:
`
`Dr. Linberg has worked for over 35 years in academic clinical research and commercial drug and
`biologics development, with particular attention to the strategy of overall development programs,
`to individual clinical trial design, execution and reporting, and to regulatory interactions with the
`FDA. Over the course of that time, Dr. Linberg participated in the design, conduct, reporting
`and/or oversight of well over 100 clinical trials. Dr. Linberg has held senior positions in the drug
`and biologics industry and at contract research organizations. Dr. Linberg is the principal editor
`of, and a contributing author in the text Expediting Drug and Biologics Development, now in its
`3rd edition, and developed and taught graduate-level courses in Drug and Biologics Development,
`Clinical Trial Design, and Clinical Trial Operations for the Johns Hopkins University, and An
`Overview of Clinical Research for the University of Maryland.
`
`EDUCATION:
`
`1978
`1975
`1973
`
`PROFESSIONAL EXPERIENCE:
`
`2013-Present Consultant, S.E. Linberg Consulting, LLC
`Providing consulting to companies on clinical development strategies, clinical trial planning,
`operations and reporting, and FDA interactions including formal meetings and Advisory
`Committee preparation.
`
`2011-Present Co-Founder, Member, Airway Therapeutics, LLC.
`2011-2012
`President and Chief Executive Officer
`Developed the clinical program necessary for the approval of rhSP-D for the treatment and
`prevention of bronchopulmonary dysplasia in very premature neonates. Planned and conducted
`the Pre-IND Meeting with the FDA for rhSP-D. Secured the initial seed round of funding for the
`company.
`
`2009-2010 Managing Director, Vice President, Treasurer, Chiesi Pharmaceuticals Inc.
`2002-2009 Managing Director
`Oversaw all aspects of the US subsidiary of Chiesi Farmaceutici S.p.A. Directly responsible for
`the US development plans for Chiesi products identified for development in the US. Participated
`in the clinical trial planning and review of those same products in worldwide development.
`
`
`2001-2002 Managing Director, Senior Vice President, Cato Research Limited
`1996-2001 Vice President, Clinical Development
`Responsible for directing and managing all aspects of the Washington area office. Planned,
`managed and conducted business development activities on behalf of the company. Served as
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`22401 Rolling Hill Lane
`Laytonsville, MD 20882
`
`
`
`
`
`
`
`
`24 April 2015
`
`Page 1
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`Page 1 of 4
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`

`

`
`
`Steven E. Linberg, PhD
`
`
`
`
`
`
`
`
`Ph.D., Physiology
`M.S., Physiology
`B.A., Biology
`
`Pennsylvania State University
`Pennsylvania State University
`University of Delaware
`
`
`9601 Medical Center Drive
`Rockville, MD 20850
`
`
`
`PROFESSIONAL SUMMARY:
`
`Dr. Linberg has worked for over 35 years in academic clinical research and commercial drug and
`biologics development, with particular attention to the strategy of overall development programs,
`to individual clinical trial design, execution and reporting, and to regulatory interactions with the
`FDA. Over the course of that time, Dr. Linberg participated in the design, conduct, reporting
`and/or oversight of well over 100 clinical trials. Dr. Linberg has held senior positions in the drug
`and biologics industry and at contract research organizations. Dr. Linberg is the principal editor
`of, and a contributing author in the text Expediting Drug and Biologics Development, now in its
`3rd edition, and developed and taught graduate-level courses in Drug and Biologics Development,
`Clinical Trial Design, and Clinical Trial Operations for the Johns Hopkins University, and An
`Overview of Clinical Research for the University of Maryland.
`
`EDUCATION:
`
`1978
`1975
`1973
`
`PROFESSIONAL EXPERIENCE:
`
`2013-Present Consultant, S.E. Linberg Consulting, LLC
`Providing consulting to companies on clinical development strategies, clinical trial planning,
`operations and reporting, and FDA interactions including formal meetings and Advisory
`Committee preparation.
`
`2011-Present Co-Founder, Member, Airway Therapeutics, LLC.
`2011-2012
`President and Chief Executive Officer
`Developed the clinical program necessary for the approval of rhSP-D for the treatment and
`prevention of bronchopulmonary dysplasia in very premature neonates. Planned and conducted
`the Pre-IND Meeting with the FDA for rhSP-D. Secured the initial seed round of funding for the
`company.
`
`2009-2010 Managing Director, Vice President, Treasurer, Chiesi Pharmaceuticals Inc.
`2002-2009 Managing Director
`Oversaw all aspects of the US subsidiary of Chiesi Farmaceutici S.p.A. Directly responsible for
`the US development plans for Chiesi products identified for development in the US. Participated
`in the clinical trial planning and review of those same products in worldwide development.
`
`
`2001-2002 Managing Director, Senior Vice President, Cato Research Limited
`1996-2001 Vice President, Clinical Development
`Responsible for directing and managing all aspects of the Washington area office. Planned,
`managed and conducted business development activities on behalf of the company. Served as
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`22401 Rolling Hill Lane
`Laytonsville, MD 20882
`
`
`
`
`
`
`
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`24 April 2015
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`Page 2 of 4
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`principal contact for selected sponsors working with the company. Planned and managed FDA
`interactions on behalf of sponsors. Directed and participated in the design of clinical
`development programs, and the design, conduct and reporting of individual clinical trials.
`Directed the conduct and reporting the US clinical program for Duoneb®, and the design,
`conduct and reporting of the first US clinical trial of Curosurf®.
`
`
`1995-1996 Vice President, Clinical Development, Collaborative Clinical Research, Inc.
`Responsible for directing and managing all aspects of the Washington area office. Planned,
`managed and conducted business development activities on behalf of the company. Served as
`principal contact for selected sponsors working with the company. Directed and participated in
`the design of clinical development programs, and the design, conduct and reporting of individual
`clinical trials. Designed, directed and participated in the development program for Duoneb®
`(combination albuterol sulfate and ipratropium bromide), and directed and participated in the
`submission of the New Drug Application. Directed the design of the US clinical program for
`Duoneb®.
`
`Consultant, Linberg Research, Inc.
`1992-1995
`Provided consulting to companies on clinical development strategies, clinical trial planning,
`operations and reporting.
`
`1992-1992 Director, Clinical Research, Univax Biologics, Inc.
`Oversaw the clinical trial program for vaccine products, and directed and participated in the
`design, conduct and reporting of individual clinical trials.
`
`1986-1992 Associate Director, Clinical Research, Boehringer Mannheim
`Served as US Project Leader for Demadex® (torsemide), directed and participated in the design
`of the clinical development program, the design, conduct and reporting of individual clinical
`trials, and participated in the submission and defense of the successful New Drug Application.
`
`Project Leader and Clinical Research Scientist, Burroughs Wellcome Co.
`1985-1986
`Managed and participated in the design of the clinical development program for Zyloprim®
`(allopurinol) for the prevention of ischemia-reflow injury coincident with renal transplants.
`
`1980-1984 Assistant Professor of Pathology, University of Maryland, School of Medicine
`1978-1984
`Clinical Physiology Research Associate, Shock Trauma - Maryland Institute for
`Emergency Medical Services Systems, University of Maryland
`Responsible for designing and conducting clinical trials aimed at improving the outcomes of
`patients suffering from the sequelae of hemorrhagic and septic shock.
`
`ADDITIONAL EXPERIENCE:
`
`2014-Present Member of the Advisory Board
`
`
`Center for Rehabilitation Sciences Research
`
`
`Uniformed Services University of the Health Sciences
`
`
`Center for Rehabilitation Sciences Research, and the
`
`
`Henry M. Jackson Foundation for the Advancement of Military Medicine
`
`Chairman of the Advisory Board
`2010-2012
`2009-2013 Member of the Advisory Board
`
`
`School of Arts & Sciences
`
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`24 April 2015
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`The University of Delaware
`
`
`
`2002-2008 Member of the Board of Directors
`
`
`Graduate School Alumni Society
`
`
`The Pennsylvania State University
`
`1998-Present Adjunct Graduate Faculty
`Krieger School of Arts and Sciences
`Johns Hopkins University
`
`
`1992-Present President and Founder
`Research Fund, Inc. (501(c)(3) Charitable Foundation)
`
`
`HONORS:
`
`Distinguished Alumnus 2014, Department of Biological Sciences, University of Delaware
`Outstanding Alumni Award 2013, University of Delaware Alumni Association
`Alumni Achievement Award 2013, College of Arts & Sciences, University of Delaware
`
`PUBLICATIONS:
`
`Available upon request.
`
`
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`24 April 2015
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`Page 4 of 4
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