Preclinical Project Management
The two principals of DRUQUEST have extensive experience in subcontracting and managing safety testing programs for both the pharmaceutical and the chemical industries. Dr. Kopplin managed the outsourcing of a series of INDs and a PLA at Cetus as Director of Toxicology & Pathology and then was responsible for outsourcing safety studies at Bristol-Myers Squibb (New Brunswick) as Director of Drug Safety Operations. Dr. Richter managed and monitored outsourcing of work for the Chevron Environmental Health Center as Coordinator of Pesticide Product Safety. Both of these principals have extensive experience working for CROs where they were responsible for the
management and conduct of many development programs for large and small pharmaceutical companies and chemical companies from the U.S., Europe and Japan. Their experience in outsourcing and as contractors makes them uniquely qualified to manage your drug or chemical development program.
We are prepared to manage all or part of your preclinical safety program. If you are a virtual company, we can be your preclinical department, becoming part of your development team. The spectrum of services includes:
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Evaluation of compounds for in-licensing
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Assistance in preparing summary documents to seek funding or a development partner
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Design of regulatory strategy and design of individual safety studies needed to achieve an IND or NDA/BLA
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Coordination of all activities with your staff including working with your clinical experts prior to the finalization of a regulatory strategy and throughout the development process
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Preparation of briefing book for pre-IND meeting with the FDA
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Evaluation and recommendation of contract laboratories to conduct studies
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Negotiation of prices with contract laboratories
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Preparation of protocols, initiation of studies, monitoring the work and review of the resulting reports
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Design of special studies for test articles with unusual mechanisms of action or to elucidate the mechanism of action for any unexpected or unusual findings in safety studies
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Assistance in the preparation of an IND or NDA/BLA, managing and coordinating the process for you |
