Vadim Paluy, Md Email & Phone Number

Basel, Baselstadt, Ch

- Provide medical/scientific expertise in the area of Clinical Drug Development- Primary medical responsibility for Development Clinical Trials: protocol feasibility, physician to physician contact, protocol training, medical issue/question management, safety review and local regulatory interaction. review and revise protocols, CRFs, training materials, project specific tools, analysis plans design, clinical trial reports and NDA- Identify/involve investigators and key opinion leaders - Lead and/or perform protocol, country and site feasibility and site selection - Provide protocol, Risk management plan & disease training as appropriate at Investigator’s Meetings or scientific venues or internally- Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical input as appropriate as this relates to clinical trials- Support Local and Global teams in interaction with regional regulatory agencies- Provide assistance to Local and Global teams and sites for IEC/IRB Interactions- Support planning, implementation and follow-up of regulatory agency inspections and internal audits

New York, Ny, Us

- provide expert advice and guidance to global investment clients on a variety of pharmaceutical and biotechnology-related businesses. - Founded in 2001, the Network of Advisors is an exclusive community of academic and industry professionals who provide consulting services to the financial industry.Members of the Network of Advisors provide financial clients with cutting-edge insights into the latest scientific and industry developments through their participation in private and telephonic consultations, on-line surveys and lecture forums.

•PRODUCT DEVELOPMENT SERVICES: primarily responsible for Phase 1-3 of clinical research•MEDICAL MONITORING and SAFETY REPORTING•REGULATORY CONSULTANCY services (INTERNATIONAL and DOMESTIC) including site/CRO/vendor AUDIT on the sponsors behalf. •CLINICAL RESEARCH TRAINING AND DEVELOPMENT: offering a comprehensive Education and "Hands-On" Training for individuals or research organizations such as Pharmaceutical, Biotechnology, Medical Device Companies, CROs, Academic Institutions, and Independent Research sites.

Princeton, New Jersey, Us

• Serves as project physician - Provides medical/scientific expertise to project teams - Develops, reviews and revises all applicable research documents - Assumes responsibility for medical and safety monitoring on assigned projects• Develops training modules and provides training in disease states across Company

• Provide operational and implementation leadership and expertise to the project teams as well as interface with business development activities to ensure that outsourcing to CROs/vendors will meet expected standards for quality, timeliness and budget.• Key interface with all contract CROs and clinical sites involved in the clinical trials• Develop and maintain contacts with Key Opinion Leaders and all PIs• Oversight of project specific performance of internal and external personnel, including QA and Regulatory teams, CROs, regional CRAs, scientific advisers and other vendors; conduct investigational site/CRO/vendor audit • Manage all aspects of clinical trials to assure the highest standards of clinical trial execution and GCP• Medical Safety Monitoring for Phase 1-3 studies including preparation of Investigator Alert letters and SAE reports as required and ensure reporting timelines are met• Development of Clinical Research departmental budget

•The new company is a spin-out of Ilypsa, Inc., a wholly-owned subsidiary of Amgen Inc. (acquired by Amgen in July 2007 for $ 420 M). •Successful planning and execution of clinical trials •Oversight of project specific performance of internal and external contracts, including CROs and other vendors •Preparation and review of study related documents(Protocols, CRFs, Reports, Data listing review, SOPs, etc)

•7/18/07: Amgen announced today the completion of its acquisition of Ilypsa, a private company developing non-absorbed drugs for renal disorders. The transaction provides Amgen with a late-stage phosphate binder for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients on hemodialysis. The acquisition was originally announced June 4.•Successful planning and execution of clinical trials•Oversight of project specific performance of internal and external contracts, including CROs and other vendors•Review of study related manuals, materials and reports (Protocols, CRFs, Data listing review, etc)•Accountable for successful operation of clinical trials through management and monitoring of progress, problem resolution and personnel issues•Direction of team assigned in-house CRAs, Clinical Trial Specialists and Field CRAs as required•Development of needed SOPs and working practices

· Participate in the conduct of clinical research studies (Phase III: Non-Small Cell Lung Cancer) · Investigational sites and CRO management for multi-center clinical trials(Visit Report Review and Approval; Lead statistical listings CRAs Review for accuracy and completeness; etc)

Us

· Participate in the conduct of clinical research studies (Phase I and II: Reumatoid Artritis and Multiple Myeloma)· Investigational sites and CRO management for multi-center clinical trials · Co-Monitoring Sites to audit a regional CRA's work· Responsible for Visit Report Review and Approval· Lead statistical listings CRAs Review for accuracy and completeness · Create and present Training materials for CRAs and provide guidance and direction to contract CRAs in the field.· Provide input for definitions of new or revised process development, contribute to creation and review of clinical study documents, monitoring tools and potential vendors Master Service Agreements.· Maintain regular internal contact with relevant departments such as DM, regulatory affairs, QA, pre-clinical, drug safety and others as necessary.

South San Francisco, California, Us

· Participate in the conduct of multi-center clinical research studies (Phase III: Ophthalmology)· Provide input for definitions of new or revised process development, contribute to creation and review of clinical study documents and monitoring tools· Determine resource requirements and evaluates the need to outsource; manage vendors to achieve team goals and specifications.· Identify potential investigators in collaboration with Project Management and Marketing to ensure the acceptability of qualified investigative sites · Co-monitor (audit) sites in compliance with protocol, FDA guidelines, SOPs, and Study Monitoring Plan · Lead CRF Review and all statistical listings for accuracy· Contribute to the project team by mentoring new members, assisting in preparations of project publications and/or tools, and sharing ideas/suggestions with team

Wilmington, Nc, Us

• Participate in the conduct of multi-center clinical research studies • Participate and presented at investigator meetings • Identify potential investigators in collaboration with Client Company to ensure the acceptability of qualified investigative sites • Contribute to the project team by mentoring new members, assisting in preparations of project publications/tools, and sharing ideas/suggestions with team members

• Conduct Pre-Study, Initiation, Interim Monitoring, and Close-Out Visits for clinical trials at assigned investigative sites in Phases II, III, and IV• Assist in protocol, CRF & final report preparation.• Organize and conduct Investigator meetings • Investigator selection and site management • Prepare/negotiate study budgets and research agreements.• Tracking of study progress, identify/implement actions to keep projects on track.• Review of ongoing summary data including: safety, primary efficacy variables, laboratory data • Responsible for accurate quality control & medically consistent data. • Assist in CROs, contractors & other vendor selection and management. • Interface with project team members including: Drug Supply, Regulatory, Data management, Statistics, Drug Safety & Project Mgmt.

Us

•Conduct Pre-Study, Initiation, Interim Monitoring, and Close-Out Visits for clinical trials at assigned investigative sites in Phases II-IV•Participate in the development and review of appropriate documents (design of CRF, data management plan, SOPs, etc.) to facilitate the effective review of clinical data as well as to ensure consistency of the clinical data activities•Set-up and conduction of investigating meetings

Palo Alto, California, Us

• Member of a Clinical Trial Teams conducted clinical trials in fields of Psychiatry, Dermatology and Pediatric Organ Transplants

Westminster, Colorado, Us

· Providing medical assessment, prophylactic measures, advice and treatment to space launch team Members (EarthWatch, Inc)· Developing a Medical Kit for the Field Campaign· Preparing medical part of Environmental Report (Plesetsck Cosmodrom and environment, conditions and risks)• writing MEDICAL ASPECTS OF THE INTERNATIONAL TRAVEL, providing it to team members starting from November 2000. · Providing logistic support· Serving as the focal point for Medical Insurance and Medical Evacuation consultations and acquisition· Establishing professional relationships with the local Medical facilities

Broomfield, Co, Us

· Providing medical assessment, prophylactic measures, advice and treatment to space launch team Members as a part EarthWatch, Inc expeditions· Logistic support

• as a second-in-command of a platoon (24 soldiers) being trained as squad-level sniper and Surgeon’s Field Assistant• Recognized as the Best Battalion Sharpshooter, 1988 • Member of the protection team for the first Official US Sixth Fleet visit to the U.S.S.R. that took place in Sebastopol (Crimea, Black Sea) in 1989.• Provide preventive, general medical and surgical as well as emergency care to military patients• Staff of an Operating Room, assisted during operations, performed minor surgeries

Md, Internal Medicine

Clinical Trial Monitoring, Clinical Foundation Program

Education record

Education record

Internal Medicine