In Phase II-IV

PharmaNet offers all the clinical development services traditionally associated with conducting Phase II-IV programs. A key differentiating factor of PharmaNet is that in every program we conduct, PharmaNet provides an unrivaled combination of experienced project-management teams, senior management oversight, and an exclusive approach to building relationships with sponsors.

Infectious Disease and Vaccines

PharmaNet’s Infectious Disease team consists of dedicated professionals committed to anti-infective drug development. Team members include clinicians, project managers, clinical research associates, data analysts, biostatisticians, and medical writers. These professionals offer a broad range of therapeutic expertise in bacteriology, virology, mycology, and associated diseases and syndromes and have a proven record of success working with:

All forms of regulated anti-infective and immunologic agents, including drugs, biologics, and devices
All commonly studied populations, including pediatric
Populations with unique clinical issues, including HIV infection and other immunocompromises, stem cell transplantation, chronic hepatitis, multidrug resistance, sepsis/septic shock, and trauma

 

 

Global Clinical Development Services

The Infectious Disease Division provides a comprehensive range of services, with the ability to reach patients and investigators throughout the Americas, Europe, and the Asia-Pacific region. Available services include:

Project feasibility studies, including epidemiological assessment
Clinical/Regulatory strategic planning and protocol development
Study design using targeted package-insert specifications
Identification of optimal regions and patient populations

 

 

Case Studies

1. Meeting Enrollment Goals in a Hepatitis C Virus (HCV) Study

2. Overcoming a Short Enrollment Period in a Seasonal-Flu Study

 


William M. Egan, PhD

Vice President, PharmaNet Consulting

Dr. Egan offers more than 30 years of industry experience, including 28 years at FDA. At FDA, Dr. Egan served in various director-level positions in the Office of Vaccines Research and Review for more than 10 years. In those positions, Dr. Egan had oversight responsibility for the vaccine regulatory process in the United States. Dr. Egan's research experience within FDA also includes 13 years as the Chief for OVRR’s Biophysics Laboratory. Dr. Egan is a member of numerous professional organizations, including the American Chemical Society and the International Society for Biologicals, where he serves on the Scientific Conferences Committee.


Patricia A. Mosher

Vice President, Infectious Disease Operations

Ms. Mosher provides clinical oversight to the management of projects conducted within the Infectious Disease Division. She has been in the industry for more than 23 years and has experience in the management of global trials from Phase I-IV involving:

Magainins
Antimicrobials
Anti-virals
Anti-endotoxins
Anti-fungals

 

Her experience with these therapies involves the treatment of:

Sepsis MAC infections
Hemorrhagic trauma Dermatophyte infections
Complicated infections COPD
HIV/AIDS Allergic Rhinitis
HCV Asthma
MDR-TB Pulmonary mycoses
TB, RTIs Catheter site infections
H. pylori Caccines

 

Prior to joining PharmaNet, Ms. Mosher was involved in studies that lead to the approval of itraconazole in the treatment of histoplasma and blastomycosis in pulmonary mycoses in HIV/AIDS patients, as well as all the dermatophyte infection trials with this compound.


Jeff Smith

Director, Infectious Disease Operations

Mr. Smith has worked in the pharmaceutical industry for more than 10 years, managing domestic and global trials in Phases I–IV. His experience emphasizes both infectious diseases and pulmonology trials involving vaccines, quinolones, and long-acting beta agonists in managing indications including influenza, complicated skin infections, tuberculosis, community-acquired pneumonia, bronchitis, and chronic obstructive pulmonary disease. In his current role, Mr. Smith provides operational oversight to the management of infectious disease programs. Mr. Smith was trained as a registered nurse and holds a Masters Certificate in Project Management.

PharmaNet Development Group, Inc.504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390