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Client Projects
For six (6) clients, Dr. Lovell participates as a member of Product Development Management teams. He is responsible for the chemistry, manufacturing and control section of INDs and NDAs for:
An injectable male erectile dysfunction product
An oral male erectile dysfunction product
An anti-hypertensive agent
An antiviral product
Two antibiotic programs
A gastrointestinal program
A congestive heart failure program (Phase III Clinical Program)
Three (3) anti-cancer agents (Phase I Clinical Programs)
Activities for these programs include design of development studies, management of contract organizations, budget negotiations and trouble-shooting of project studies.
Dr. Lovell is assisting a client in developing a patented drug delivery system to improve the oral bioavailability of an antibiotic. Initial animal and human studies demonstrated the potential use of the drug delivery system for human products.
Dr. Lovell assisted a client in successfully starting and completing three clinical trials on time by managing the development of the formulations and the manufacture and distribution of clinical trial materials.
Dr. Lovell assisted a client in developing a new subcutaneous drug delivery device by identifying and managing the conduct of studies to assure the compatibility of the device and the drug formulation. Dr. Lovell also participated in the client’s discussions with potential licensors of the technology to identify and help solve issues that might delay or prevent the successful adoption of the technology by the licensors.
Dr. Lovell assisted a client in implementing a strategy to screen new drug product leads in-house by training the client’s staff in prototype formulation development activities. This allowed the client to rapidly identify lead compounds for further development and minimize the cost of lead identification.
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Email: mwlovell@acrapharm.com
Michael W. Lovell, Ph.D.
AcraPharm Consulting, Inc.
260 N. Bartram Trail , Saint Johns, FL 32259
Phone: 508.520.9594 or 904.201.1628 Fax: 904.201.1637
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