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Clinical
technology leader with 15 years of experience at Immunex/Amgen and Pfizer.
Experience gained through leading technology planning and implementation
teams for clinical trial operations, clinical data, drug safety
surveillance, and regulatory submissions. Involvement included process
analysis, reengineering, requirements definition, vendor evaluation,
application development, system integration, system validation, software
testing, user training, implementation, maintenance, and support.
Committed to the goals of reducing pharmaceutical product development time
and improving quality. Created and streamlined development operations in
small, growing, established, and merger environments. Affected bottom line
through leading edge technology implementation, computer assisted system
engineering, software quality assurance, and vendor negotiation. Expertise
supported by a Master's degree of Business Administration in Information
Systems.
David Sabritt has twenty years’ experience managing clinical research technologies and clinical data operations. At Immunex as Director of Clinical Data Systems and Data Management, and then as Director of Strategic Technologies, he built the company’s clinical data management capabilities and led the effective use of technology across the clinical development organization. As Director of Clinical Operations at Amgen, he directed a cross-functional globalization project harmonizing data management operations world-wide.
Sabritt Solutions is prepared to assist clients with needs in clinical data management, technology assessment, vendor selection, electronic data capture, CRO selection and management, training and staff development, and global strategy.
Dr. Richard Stead has more than 15 years of experience in the biotechnology and pharmaceutical industry directing clinical trials, in- and out- licensing, as well as preclinical research and development. Most recently he was Vice President of Clinical Research and Development at Immunex. He has worked as an independent consultant to small to medium sized biotechnology companies in several therapeutic areas since 2002. He focuses on clinical and regulatory strategy for product development as well as operational issues in executing clinical development programs.
Dr. Stead was named Vice President, Clinical Research of Immunex Corporation in October 1999. Dr. Stead was responsible for clinical research and development programs for all Immunex products and product candidates being marketed or researched in the fight against cancer, leukemia and multiple sclerosis. He worked closely with Discovery Research on several new pipeline molecules in clinical development and with Sales and Marketing on the commercialization of Leukine and Novantrone. He played a key role in the FDA approval of Novantrone for a broad indication in multiple sclerosis.
Prior to Immunex, Dr. Stead joined Amgen in 1988 as its first physician and served in various positions in clinical development over the course of more than 11 years. He played significant roles in the clinical development, FDA approval and commercialization of Amgen’s first two products, Epogen and Neupogen. He also directed research on the preclinical pharmacology and toxicology of other clinical candidates and spearheaded a major effort to in-license products.