PharmaNet’s Phase IV Development team comprises dedicated professionals with extensive experience in Phase IIIb–IV trials, expanded access programs, and patient registries. These professionals are experts at handling the complexities of late phase studies and can design and execute studies that meet the highest standards of scientific integrity and regulatory compliance while meeting commercial objectives. The team has the capabilities and dedicated resources to implement programs of any scale.

Comprehensive Solutions Throughout the Product Life Cycle

PharmaNet is committed to adding commercial value to a product throughout its life cycle with services that include:

Sean P. Larkin Senior Executive Vice President, The Americas, Late Stage Development During a pharmaceutical career of more than 25 years, Mr. Larkin has held a wide range of clinical operations and senior-management positions and has managed numerous project teams. At PharmaNet, Mr. Larkin is responsible for the North American Regional Monitoring Network, clinical operations in Latin America and Canada, and the Phase IV Development Division. Many of the projects managed by these divisions are large-scale, multicenter, and multinational clinical trials often involving hundreds of sites and thousands of patients.

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Agnès Rivaille-Pinatel, PharmD Director, Clinical Research, Phase IV Development Ms. Rivaille has 20 years' experience in CRO's and pharmaceutical industries, including management positions in clinical operations and marketing. She has extensive development and Late Phase experience covering large-scale global observational and interventional trials in diverse therapeutic areas including diabetes, respiratory disorders, psychiatry, rheumatology, cardiovascular, and oncology. Prior to joining PharmaNet, she directed programs focusing on patient reported outcomes and health economics.

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Peggy Schrammel Vice President, Clinical Research, Phase IV Development Ms. Schrammel's professional experience includes senior-level positions in the late phase divisions of major CROs. As Vice President, Strategy and Development for the late phase division of an international research organization, she directed all business development and marketing initiatives and led the division's North American accelerated launch. During her career, Ms. Schrammel has designed and managed late phase programs, including patient registries, clinical-experience trials, pharmacoeconomic trials, and managed-care-based effectiveness trials. Her therapeutic experience includes mental health, gene therapy, diabetes, gastrointestinal disorders, epilepsy, and allergic disorders.

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Jan Willem van der Velden, MD, FFPM, FISPE Senior Vice President, Global Safety and Pharmacovigilance Dr. van der Velden has more than 24 years of experience, including 7 years in oncology trials at the Rotterdam Radiotherapeutic Institute, where he was in charge of cancer epidemiology and the coordination and assessment of experimental treatment research. He also served 16 years in global safety at Solvay and Yamanouchi Europe. At PharmaNet, Dr. van der Velden is in charge of drug safety, pharmacovigilance, risk-and-crisis management, and pharmacoepidemiology of pharmaceuticals and devices.