Randal R. Lane

Biography

Mr. Lane serves as Vice President of the pharmaceutical development function at Cato Research and serves as managing director for Cato Research's San Diego office. Mr. Lane has more than 35 years' experience in the pharmaceutical, medical device and diagnostics areas. Before joining the Cato team, Mr. Lane served for 8 years as senior director of Manufacturing and Pharmaceutical Development for Maxim Pharmaceuticals, and before that he worked for Accumetrics, Pacific Pharmaceuticals, and for Lilly subsidiaries Pacific Biotech and Hybritech. Mr. Lane has certifications in Production and Inventory Control, Materials Management, and Regulatory Affairs. He has had responsibility for directing the pharmaceutical development and CMC activities for numerous products, including recombinant and natural proteins, peptides, DNA, stem cells, small molecules, oligonucleotides, radiopharmaceuticals, and devices in parenteral, oral, and topical dosage forms; CMC sections for global regulatory filings; defining and designing development plans for sponsors; helping sponsors complete all necessary activities to file successful regulatory documents and helping sponsors manufacture clinical trial material. Other areas of experience include planning and attending a variety of FDA meetings; conducting GMP and GLP audits; and overseeing the complete development programs of various products. Mr. Lane serves as Vice President of the pharmaceutical development function at Cato Research and serves as managing director for Cato Research's San Diego office. Mr. Lane has more than 35 years' experience in the pharmaceutical, medical device and diagnostics areas. Before joining the Cato team, Mr. Lane served for 8 years as senior director of Manufacturing and Pharmaceutical Development for Maxim Pharmaceuticals, and before that he worked for Accumetrics, Pacific Pharmaceuticals, and for Lilly subsidiaries Pacific Biotech and Hybritech. Mr. Lane has certifications in Production and Inventory Control, Materials Management, and Regulatory Affairs. He has had responsibility for directing the pharmaceutical development and CMC activities for numerous products, including recombinant and natural proteins, peptides, DNA, stem cells, small molecules, oligonucleotides, radiopharmaceuticals, and devices in parenteral, oral, and topical dosage forms; CMC sections for global regulatory filings; defining and designing development plans for sponsors; helping sponsors complete all necessary activities to file successful regulatory documents and helping sponsors manufacture clinical trial material. Other areas of experience include planning and attending a variety of FDA meetings; conducting GMP and GLP audits; and overseeing the complete development programs of various products.

Research Interest

Pharmaceutical Development